0A4F4F9BD490A749D5437F821CF06DF1
Austrian Drug Law (2013)
https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=10010441&ShowPrintPreview=True
http://leaux.net/URLS/ConvertAPI Text Files/869106991B9EA78E2109C673C78A8C43.en.txt
Examining the file media/Synopses/869106991B9EA78E2109C673C78A8C43.html:
This file was generated: 2020-07-14 06:22:27
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator crime:
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p.(None): Tasks according to § 8 paragraph 2 lines 13 to 16 of the Health and Food Security Act, Federal Law Gazette I
p.(None): № 63/2002, or staff involved in surveillance or by the Federal Office for Security in the
p.(None): Healthcare does not mandate experts with fi nancial or other interests in the
p.(None): pharmaceutical industry that could affect their impartiality. These people are
p.(None): undertakes to submit an annual declaration to the Federal Office for Safety in Health Care that
p.(None): to be sent to the Federal Ministry of Health on request.
p.(None): (2) As part of the performance of its duties under this Federal Act, the Federal Office of
p.(None): Healthcare safety rules and the agendas and minutes of the
p.(None): Votings generally accessible on the Internet. More about the publication of the agendas and
p.(None): Protocols are regulated in the rules of procedure of the Federal Office.
p.(None): XIII. SECTION
p.(None): sanctions
p.(None): Acts punishable by law
p.(None): Section 82b. (1) Anyone who falsifies medicinal products, active substances or auxiliary substances with the intention (§ 1 para. 25 and 26) that
p.(None): if they are handed over to another, they are punished with imprisonment for up to three years.
p.(None): (2) Anyone who falsifies medicinal products, active substances or auxiliary substances must also be punished
p.(None): offers, exports or surrenders or keeps with the intent, executes or introduces that one
p.(None): left to others.
p.(None): (3) Anyone who is a criminal offense under paragraph 1 or 2 as a doctor, dentist, veterinarian, pharmacist, dentist or midwife
p.(None): commits is punishable by imprisonment for up to five years.
p.(None): (4) Anyone who commits a crime under paragraph 1 or 2 with the intention of enforcing his
p.(None): recurring inspection to miss a continuous intake, and already because of a
p.(None): such a crime has been convicted.
p.(None): (5) Anyone who committed the offense (para. 4) as a doctor, dentist, veterinarian, pharmacist, dentist or midwife
p.(None): commits is punishable by imprisonment for up to ten years.
p.(None): (6) If the offense referred to in paragraphs 1 or 2 results in the death of a person or serious physical injury (Section 84
p.(None): Paragraph 1 of the Criminal Code) results in a larger number of people, the perpetrator is sentenced to imprisonment from five to
p.(None): punish fifteen years.
p.(None): (7) Who the commercial pack or other document that relates to a drug, an active ingredient
p.(None): or obtains an auxiliary material with the intent to forge or falsify that the document uses it
p.(None): to pass on counterfeit medicines, active ingredients or auxiliary substances to another - provided that the perpetrator
p.(None): is not to be punished according to paragraph 1 or 2 - punishable by imprisonment up to one year.
p.(None): (8) Anyone who induces another person or otherwise contributes to him or him or a relative
p.(None): (§ 72 StGB) falsified medicines so that they can be used by him or his family,
p.(None): is not to be punished according to paragraphs 1 to 7.
p.(None): collection
p.(None): § 82c. (1) Counterfeit drugs, active ingredients, auxiliary substances and documents (§ 82b (7)) are - provided
p.(None): the conditions for confiscation according to Section 26 of the Criminal Code have not already been met - also to confiscate if none
p.(None): certain person can be persecuted or convicted of an offense pursuant to Section 82b, unless the or
...
Political / Indigenous
Searching for indicator native:
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p.(None): 6a. the Federal Ministry of the Interior, the authorities and childcare facilities subordinate to it
p.(None): for emergency care, prevention and care of operations, provided that the medicines for
p.(None): Need to perform their duties
p.(None): 7. Institutions, the provisional judicial safekeeping or arrests, judicial
p.(None): Prison sentences or preventive judicial measures related to deprivation of liberty
p.(None): Take measures if they need drugs to perform their tasks
p.(None): 8. scientific institutes and research institutes of the local authorities and the
p.(None): Universities and the Austrian Agency for Health and Food Security, if these
p.(None): Need medicines to perform their tasks
p.(None): 9. Organized emergency medical services, provided they are addictive substances, which they use for their emergency medical services
p.(None): Need activity, and
p.(None): 10. Have a doctor who is sufficiently familiar with questions of substance abuse
p.(None): Institutions according to § 15 of the Addictive Substances Act, Federal Law Gazette I № 112/1997, for evidence-based and
p.(None): quality-assured support for clients as part of damage minimization measures,
p.(None): except drugs containing addictive substances.
p.(None): (2) At hospitals without institutional pharmacies, the manufacturer, depositeur or pharmaceutical
p.(None): Wholesalers are given:
p.(None): 1. whole blood preserves, suspensions of cellular or corpuscular blood components,
p.(None): Single donor preparations,
p.(None): 2. native human or animal tissue.
p.(None): (3) Paragraphs 1 and 2 do not apply to radioactive medicinal products. These may be from the manufacturer, depositeur
p.(None): or pharmaceutical wholesalers only to holders of a license to handle radioactive materials
p.(None): according to the Radiation Protection Act, Federal Law Gazette No. 227/1969.
p.(None): (4) Feed medicines may be purchased from the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): Prescription of the treating veterinarian can be given directly to consumers. The repeated
p.(None): Delivery on a prescription is not permitted.
p.(None): (5) Paragraph 1 does not apply to pharmaceutical specialties according to § 7 Paragraph 4 and § 59 Paragraph 7a.
p.(None): (6) From the manufacturer, depositeur or pharmaceutical wholesaler, medicinal products whose delivery in
p.(None): Retail sales are not reserved for pharmacies, directly to bandagists, orthopedic shoemakers,
p.(None): Orthopedic technician, dental technician, podiatrist, holder of a hoof and
p.(None): Claw fittings and massage therapists are given, provided they are medicinal products
p.(None): Traders need for the exercise of their activity.
p.(None): (7) From the manufacturer, depositeur or pharmaceutical wholesaler, dental medicinal products that
p.(None): 1. are not subject to the prescription requirement and
p.(None): 2. are exclusively intended by dentists, specialists in dentistry, oral and maxillofacial medicine
p.(None): or being applied to the patient by dentists,
p.(None): are given directly to them and to dental outpatients.
p.(None): (8) Medical gases may come from the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): Hospitals without a pharmacy and to traders who are in accordance with the
p.(None): Trade regulations 1994 are authorized to deliver compressed technical gases.
...
Political / Persecuted
Searching for indicator persecuted:
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p.(None): such a crime has been convicted.
p.(None): (5) Anyone who committed the offense (para. 4) as a doctor, dentist, veterinarian, pharmacist, dentist or midwife
p.(None): commits is punishable by imprisonment for up to ten years.
p.(None): (6) If the offense referred to in paragraphs 1 or 2 results in the death of a person or serious physical injury (Section 84
p.(None): Paragraph 1 of the Criminal Code) results in a larger number of people, the perpetrator is sentenced to imprisonment from five to
p.(None): punish fifteen years.
p.(None): (7) Who the commercial pack or other document that relates to a drug, an active ingredient
p.(None): or obtains an auxiliary material with the intent to forge or falsify that the document uses it
p.(None): to pass on counterfeit medicines, active ingredients or auxiliary substances to another - provided that the perpetrator
p.(None): is not to be punished according to paragraph 1 or 2 - punishable by imprisonment up to one year.
p.(None): (8) Anyone who induces another person or otherwise contributes to him or him or a relative
p.(None): (§ 72 StGB) falsified medicines so that they can be used by him or his family,
p.(None): is not to be punished according to paragraphs 1 to 7.
p.(None): collection
p.(None): § 82c. (1) Counterfeit drugs, active ingredients, auxiliary substances and documents (§ 82b (7)) are - provided
p.(None): the conditions for confiscation according to Section 26 of the Criminal Code have not already been met - also to confiscate if none
p.(None): certain person can be persecuted or convicted of an offense pursuant to Section 82b, unless the or
p.(None): the person entitled to dispose makes a legitimate intended use credible and guarantees that
p.(None): that the drug, the active substance, the excipient or the document is not placed on the market.
p.(None): (2) Sections 443 to 446 of the Code of Criminal Procedure 1975 (StPO), BGBl. Apply to the procedure.
p.(None): No. 631/1975, accordingly. For the application of the StPO are counterfeit medicines, active substances, auxiliary substances
p.(None): and treat documents as items the possession of which is generally prohibited.
p.(None): Authorization to provide security and duty to inform the customs authorities
p.(None): § 82d. (1) If certain facts indicate that counterfeit medicinal products, active substances,
p.(None): Auxiliary materials or documents (Section 82b (7)) are transported to or from Austria are the customs organs
p.(None): authorized to ensure this. From the seizure you have the responsible immediately
p.(None): Prosecutor to report. Declares that the conditions for a guarantee (§ 110 StPO)
p.(None): if there is no such security, it must be canceled immediately.
p.(None): (2) In connection with the control of counterfeit medicines, active ingredients, auxiliary substances or
p.(None): Documents may be processed by the customs authorities personal data (Art. 4 Z 2 data protection
p.(None): Basic regulation) and transmit this to the responsible law enforcement authorities, insofar as this is to be fulfilled
p.(None): whose legal role is required.
p.(None): administrative Penalties
p.(None): § 83. (1) Who
...
p.(None): 27. contravenes an order pursuant to Section 69 (1) no. 1,
p.(None): 28. with the tasks of a competent person or with the management of the control laboratory or the
p.(None): Producing a person entrusted with scientific professional training or practical
p.(None): Do not provide evidence of training in the sense of an ordinance pursuant to Section 69a (2) or Section 70 (2)
p.(None): can
p.(None): 29. in a company within the meaning of section 62 (1) or section 63a (1) a person contrary to section 71 (1)
p.(None): employed,
p.(None): 30. in an establishment within the meaning of Section 62 (1) or Section 63a (1) persons within the meaning of Section 71 (1)
p.(None): employed who have not been examined in accordance with Section 71 (2),
p.(None): 31. instructs a person to act as a pharmaceutical representative contrary to Sections 72 to 74,
p.(None): 32. contravenes the rulings pursuant to Section 77 or Section 78, or
p.(None): 33. the supply and provision obligations in accordance with an ordinance pursuant to Section 94d (2)
p.(None): does not comply
p.(None): makes itself up if the offense does not constitute the offense of a criminal offense falling within the jurisdiction of the courts
p.(None): Action forms, is guilty of an administrative offense and is fined up to 25,000 euros, in
p.(None): Repetition trap up to 50,000 euros.
p.(None): (2) The attempt is punishable.
p.(None): (3) In the criminal penalty according to paragraph 1 Z 1, 2, 3, 5, 6, 7, 7a, 8, 9, 16, 17 and 32, the forfeiture of the
p.(None): Medicinal products constituting the subject of the criminal offense are recognized. Decay can also
p.(None): be recognized independently if no specific person can be persecuted or punished.
p.(None): § 84a. The customs authorities have the copy to the Federal Office for Safety in Health Care
p.(None): of your notification of a violation of the Pharmaceuticals Imports Act 2010.
p.(None): Section 85. (1) The Federal Office for Safety in Health Care may authorize a pharmaceutical specialty
p.(None): cancel if the authorization holder at least three times because of one and the same in § 83 Z 1 and 2 and
p.(None): § 84 Z 4, 12, 16, 19 and 21 violation was punished.
p.(None): (2) The Federal Office for Safety in Health Care can issue a license in accordance with Section 63 (1)
p.(None): revoke if the license holder at least three times because of one and the same in § 84 Z 24 to 28
p.(None): and 32 the above-mentioned violation.
p.(None): (3) The Federal Office for Safety and Health Care may appoint a knowledgeable person on time or
p.(None): permanently prohibit the authorization to carry out the work of a competent person if they
p.(None): has been punished at least three times for violations of medicinal product regulations.
p.(None): injunctions
p.(None): Section 85a. (1) Anyone who advertises that does not comply with sections 50 to 56 can file an injunction
p.(None): become. There is no risk of a corresponding breach if the entrepreneur receives a warning
p.(None): by an institution entitled to bring an action within a reasonable period of time, within a reasonable time
p.(None): Conventional penalty (§ 1336 ABGB) provides for a cease and desist declaration.
p.(None): (2) The claim can be made by the Austrian Chamber of Commerce, the Federal Chamber of Labor, the
p.(None): Austrian Chamber of Agricultural Workers, the Presidents' Conference of the Chambers of Agriculture
p.(None): Austria, the umbrella organization of social security institutions, the Austrian Federation of Trade Unions, the
...
Political / criminal
Searching for indicator criminal:
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p.(None): and reports are to be sent immediately to the sampling agency. If the
p.(None): Investigation center comes to a reasoned opinion that the suspicion of the violation of
p.(None): Legislation is in place, so it has to determine this in its report and the responsible person
p.(None): To inform the authority immediately.
p.(None): (7) The Federal Minister of Health and Women has the one in question by ordinance
p.(None): Investigation facility or the relevant investigation facilities in accordance with Paragraph 6 - if there is
p.(None): to carry out investigations into bumps within the meaning of Section 1 (2) (1) of the Anti-Doping
p.(None): Federal Act 2007 acts in agreement with the Federal Chancellor.
p.(None): Section 76b. (1) Supervisory bodies pursuant to Section 76a (2) have to confiscate the goods temporarily or securely
p.(None): if there is reasonable suspicion that these substances within the meaning of section 1 (2) no.
p.(None): Federal doping law 2007 contains, or this a danger to the life or health of
p.(None): Represent human or animal.
p.(None): (2) The supervisory body has so far been informed of the provisional confiscation or seizure
p.(None): Hand over a certificate to those entitled to dispose, stating the location and type and
p.(None): The quantity of the seized or seized goods must be stated.
p.(None): (3) In the event of a preliminary seizure, the supervisory body must immediately notify the
p.(None): District administrative authority, but in the case of seizure the public prosecutor through the
p.(None): Ensuring reporting, depending on whether the violation is likely to be a criminal offense
p.(None): or represents an administrative violation. The provision expires in the event of an administrative offense
p.(None): Seizure, unless a seizure notice is not issued within four weeks.
p.(None): (4) The right to dispose of the goods which have been temporarily confiscated or seized is initially in place
p.(None): the authority to which the supervisory body belongs and if the violation constitutes an administrative violation,
p.(None): from the issuance of the confiscation notice by the authority that issued the confiscation notice,
p.(None): to. If the violation constitutes a criminal offense, the right to dispose of it is effective upon receipt
p.(None): of the report to the public prosecutor's office, to the court from the time the charge is brought.
p.(None): (5) The goods seized or seized must be left in the company. You are so
p.(None): to seal or to mark that a change without breaching the containers, the
p.(None): Packaging or labeling is not possible. The person who is previously authorized to dispose of the goods
p.(None): by the supervisory body in writing on the criminal consequences of the transfer or change of the
p.(None): confiscated or seized goods and the violation of the official seal
p.(None): do.
p.(None): (6) The preservation of the goods left in the company from damage is the responsibility of the previous one
p.(None): Person entitled. If special measures are required for this, he has the responsible authority
p.(None): to inform beforehand; at the expense of the person concerned, the latter has, if necessary, instructions regarding
p.(None): shipment, storage, sealing or labeling. The measures are, except
p.(None): in the event of imminent danger, in the presence of a supervisory body.
p.(None): (7) During the seizure or seizure, samples of the goods may only be ordered by the
p.(None): competent authority or the responsible public prosecutor.
p.(None): (8) The provisions of Sections 87 and 106 StPO apply mutatis mutandis.
p.(None): (9) The district administrative authority has forfeited the seized goods as a security measure
p.(None): to explain if there is a serious and significant danger to humans or animals and the
p.(None): Authorized party does not guarantee that the goods will not be placed on the market after their release
p.(None): becomes.
p.(None): (10) With regard to the costs of an investigation, § 381 (1) 3 StPO applies in criminal proceedings. in the
p.(None): Administrative criminal proceedings are punitive in the penalty of reimbursement of the cost of the investigation
p.(None): to prescribe the respective research institute.
p.(None): Section 76c. (1) Before recovery of the goods that have been expired, the authority must inform the accused and the
p.(None): to give the person affected by the decay the opportunity to make a statement.
p.(None): (2) The expired goods are to be used in a useful manner. The expired goods are at the expense of
p.(None): Accused or destroy the person affected by the forfeiture if there is a useful recovery
p.(None): is not possible or the exploitation of the goods does not lead to the expectation that the achievable proceeds will
p.(None): Recovery costs will exceed. The destruction of the expired goods is by the accused or
p.(None): permitted by the person affected by the forfeiture at his own expense under the supervision of a supervisory body.
p.(None): (3) The proceeds of the exploitation are after deduction of the associated expenses and any
p.(None): irrecoverable costs of the criminal proceedings as well as the burden on the case
p.(None): To transfer liabilities to the federal government.
p.(None): Surveillance and protective measures
p.(None): Section 77. Is determined during a check in accordance with Section 76 or is the Federal Office for Security receiving
p.(None): Healthcare otherwise aware that a drug or active ingredient is subject to this federal law or to
p.(None): Does not comply with regulations or other administrative acts enacted on the basis of this federal law
p.(None): the Federal Office for Safety in Health Care to take measures to place the product on the market
p.(None): hinder or restrict. If applicable, section 76b (10) applies.
p.(None): Section 78. (1) The Federal Office for Safety in Health Care becomes aware of facts
p.(None): The reason for concern is that a medicinal product or active substance on the market is a hazard
p.(None): represents the life or health of humans or animals, the Federal Office for Security has
p.(None): To have all necessary measures in accordance with the extent of the risk,
p.(None): which prevent the placing on the market of the medicinal product or active substance or the use of the medicinal product
p.(None): or restrict.
p.(None): (2) In the event of imminent danger from a drug or an active ingredient, measures in accordance with Paragraph 1
p.(None): 1. even without previous procedure or
p.(None): 2. be made before issuing a decision.
p.(None): In the case of Z 2, however, is from the Federal Office for Safety in Health Care within two weeks
p.(None): to issue a written notice, otherwise the measure taken is deemed to have been revoked.
p.(None): (3) The Federal Office for Safety in Health Care has the drug it has confiscated
p.(None): or to declare the seized active ingredient verf as a precautionary measure if it has one
p.(None): serious and significant danger to humans or animals and the person entitled to dispose does not
p.(None): ensures that the drug or active substance is not placed on the market after its release.
p.(None): Preliminary seizure
p.(None): Section 78a. Organs of the Federal Office for Safety in Health Care have considered
p.(None): to temporarily confiscate the protective objectives of this federal law on medicinal products or active substances if the
p.(None): there is reasonable suspicion that this
p.(None): 1. contrary to the provisions of this federal law or regulations based thereon or
p.(None): other administrative acts are placed on the market and
p.(None): 2. pose a threat to the life or health of humans or animals.
p.(None): The regulations of § 76b on the provisional seizure by supervisory bodies and on measures
p.(None): the district administrative authorities in administrative criminal proceedings as well as § 76c are to be applied.
p.(None): Section 78b applies to the enforcement of a provisional seizure.
p.(None): Section 78b. The business owner or his / her authorized representative refuses to act after this
p.(None): Tolerating surveillance or protective measures provided for by federal law can enforce them
p.(None): become.
p.(None): X. SECTION
p.(None): fees
p.(None): Section 79. (1) The Federal Minister of Health and Consumer Protection, in agreement with the
p.(None): Federal Minister of Finance Fees for the permits to be issued under this Federal Act and
p.(None): other activities of federal agencies whose necessity changes
p.(None): 1. from this Federal Act and the ordinances issued on the basis thereof or
p.(None): 2. relevant legal acts of the European Union
p.(None): results, according to experience, from the average growing costs in a tariff
p.(None): set. The tariff and its changes are to be published in the “Official Gazette of the Wiener Zeitung”.
p.(None): Copies of the tariff are from the Federal Ministry (correct: Federal Ministry) for health and
p.(None): To provide consumer protection on request against reimbursement of costs.
p.(None): (2) Is the result of this Federal Act, the regulations issued on the basis thereof
p.(None): or the legal acts within the meaning of paragraph 1 no. 2 the necessity of activities of departments of the
p.(None): Federal government for which a tariff has not been set, the costs actually incurred must be stipulated.
p.(None): (3) The Federal Minister of Health and Consumer Protection can distance himself from this in individual cases
...
p.(None): Section 82a. (1) The Federal Office for Safety in Health Care and the Austrian Agency for
p.(None): With regard to independence and transparency, health and food security ensure that
p.(None): all members and substitute members of the Federal Office mentioned as well as all in connection with the
p.(None): Tasks according to § 8 paragraph 2 lines 13 to 16 of the Health and Food Security Act, Federal Law Gazette I
p.(None): № 63/2002, or staff involved in surveillance or by the Federal Office for Security in the
p.(None): Healthcare does not mandate experts with fi nancial or other interests in the
p.(None): pharmaceutical industry that could affect their impartiality. These people are
p.(None): undertakes to submit an annual declaration to the Federal Office for Safety in Health Care that
p.(None): to be sent to the Federal Ministry of Health on request.
p.(None): (2) As part of the performance of its duties under this Federal Act, the Federal Office of
p.(None): Healthcare safety rules and the agendas and minutes of the
p.(None): Votings generally accessible on the Internet. More about the publication of the agendas and
p.(None): Protocols are regulated in the rules of procedure of the Federal Office.
p.(None): XIII. SECTION
p.(None): sanctions
p.(None): Acts punishable by law
p.(None): Section 82b. (1) Anyone who falsifies medicinal products, active substances or auxiliary substances with the intention (§ 1 para. 25 and 26) that
p.(None): if they are handed over to another, they are punished with imprisonment for up to three years.
p.(None): (2) Anyone who falsifies medicinal products, active substances or auxiliary substances must also be punished
p.(None): offers, exports or surrenders or keeps with the intent, executes or introduces that one
p.(None): left to others.
p.(None): (3) Anyone who is a criminal offense under paragraph 1 or 2 as a doctor, dentist, veterinarian, pharmacist, dentist or midwife
p.(None): commits is punishable by imprisonment for up to five years.
p.(None): (4) Anyone who commits a crime under paragraph 1 or 2 with the intention of enforcing his
p.(None): recurring inspection to miss a continuous intake, and already because of a
p.(None): such a crime has been convicted.
p.(None): (5) Anyone who committed the offense (para. 4) as a doctor, dentist, veterinarian, pharmacist, dentist or midwife
p.(None): commits is punishable by imprisonment for up to ten years.
p.(None): (6) If the offense referred to in paragraphs 1 or 2 results in the death of a person or serious physical injury (Section 84
p.(None): Paragraph 1 of the Criminal Code) results in a larger number of people, the perpetrator is sentenced to imprisonment from five to
p.(None): punish fifteen years.
p.(None): (7) Who the commercial pack or other document that relates to a drug, an active ingredient
p.(None): or obtains an auxiliary material with the intent to forge or falsify that the document uses it
p.(None): to pass on counterfeit medicines, active ingredients or auxiliary substances to another - provided that the perpetrator
p.(None): is not to be punished according to paragraph 1 or 2 - punishable by imprisonment up to one year.
p.(None): (8) Anyone who induces another person or otherwise contributes to him or him or a relative
p.(None): (§ 72 StGB) falsified medicines so that they can be used by him or his family,
p.(None): is not to be punished according to paragraphs 1 to 7.
p.(None): collection
p.(None): § 82c. (1) Counterfeit drugs, active ingredients, auxiliary substances and documents (§ 82b (7)) are - provided
p.(None): the conditions for confiscation according to Section 26 of the Criminal Code have not already been met - also to confiscate if none
p.(None): certain person can be persecuted or convicted of an offense pursuant to Section 82b, unless the or
p.(None): the person entitled to dispose makes a legitimate intended use credible and guarantees that
p.(None): that the drug, the active substance, the excipient or the document is not placed on the market.
p.(None): (2) Sections 443 to 446 of the Code of Criminal Procedure 1975 (StPO), BGBl. Apply to the procedure.
p.(None): No. 631/1975, accordingly. For the application of the StPO are counterfeit medicines, active substances, auxiliary substances
p.(None): and treat documents as items the possession of which is generally prohibited.
p.(None): Authorization to provide security and duty to inform the customs authorities
p.(None): § 82d. (1) If certain facts indicate that counterfeit medicinal products, active substances,
p.(None): Auxiliary materials or documents (Section 82b (7)) are transported to or from Austria are the customs organs
p.(None): authorized to ensure this. From the seizure you have the responsible immediately
p.(None): Prosecutor to report. Declares that the conditions for a guarantee (§ 110 StPO)
p.(None): if there is no such security, it must be canceled immediately.
p.(None): (2) In connection with the control of counterfeit medicines, active ingredients, auxiliary substances or
p.(None): Documents may be processed by the customs authorities personal data (Art. 4 Z 2 data protection
p.(None): Basic regulation) and transmit this to the responsible law enforcement authorities, insofar as this is to be fulfilled
p.(None): whose legal role is required.
p.(None): administrative Penalties
p.(None): § 83. (1) Who
p.(None): 1. places medicinal products on the market contrary to Section 15 or a regulation pursuant to Section 15 (7),
p.(None): 2. Medicinal specialties contrary to §§ 16 to 16b or a regulation according to § 16 paragraph 6, § 16a
p.(None): 4 or Section 26, Section 8,
p.(None): 3. Medicinal specialties contrary to § 17 or § 17a or a regulation according to § 17 paragraph 5a or 9 in
p.(None): Brings traffic,
p.(None): 4. as the holder of a license according to § 7a or the holder of a registration of a medicinal product
p.(None): Breaches the duty to notify § 24 Paragraph 1, 2, 5 or 7,
...
p.(None): 6. dispenses medicinal specialties contrary to § 61,
p.(None): 7. as an employee within the meaning of section 71 (1), the existence of those mentioned in section 71 (1) nos. 1 to 3
p.(None): Does not report circumstances immediately,
p.(None): 8. in an establishment within the meaning of Section 62 (1) or Section 63a (1) persons within the meaning of Section 71 (1)
p.(None): employed who were not instructed in accordance with Section 71 (3),
p.(None): 9. as the holder of an operating license in accordance with section 63 (1) or section 65 (1) of his reporting obligation
p.(None): fails to comply with Section 65 (3),
p.(None): 10. the activity of a knowledgeable person without the required quali fi cation in the sense of a
p.(None): Exercises ordinance pursuant to Section 69a (2) or Section 70 (2),
p.(None): 11. as a knowledgeable person, who is responsible for it on the basis of a regulation pursuant to Section 62 (1)
p.(None): Violated obligations,
p.(None): 12. the activity of a pharmaceutical representative without the requirements of § 72 or intentionally contrary
p.(None): §§ 73 or 74,
p.(None): 13. as a marketing authorization holder, registration holder or marketing authorization holder
p.(None): in parallel import its obligations under IX. Section or § 94h does not comply, or
p.(None): 14. violates the reporting obligation in accordance with sections 75g, 75n or 75q,
p.(None): 15. the activity of a pharmaceutical intermediary without the requirements according to Section 71a (1) or
p.(None): exercises contrary to the requirements of an ordinance pursuant to Section 71a (3), or
p.(None): 16. as a pharmaceutical intermediary does not fulfill his obligation under § 94i (5).
p.(None): makes itself up if the offense does not constitute the offense of a criminal offense falling within the jurisdiction of the courts
p.(None): Action forms, is guilty of an administrative offense and is fined up to 7 500 euros, in
p.(None): Repetition trap up to 14,000 euros.
p.(None): (2) The attempt is punishable.
p.(None): § 84. (1) Who
p.(None): 1. places medicinal products on the market that have harmful effects within the meaning of Section 3,
p.(None): 2. Manufactures or places drugs or active substances on the market that meet the quality requirements of § 4
p.(None): 1 and 2 do not comply or contravene the prohibitions in paragraph 3,
p.(None): 3. contravenes an ordinance pursuant to Section 5 (1),
p.(None): 4. violates the prohibitions of Section 6,
p.(None): 5. Medicinal products which are subject to authorization according to §§ 7 or 7a without authorization or
p.(None): Approval or not in accordance with the approval or approval in Germany or for which
p.(None): Provides domestic levy or that pursuant to Section 18 subsection 3 or 4, Section 19a subsection 1 or Section 24a subsection 2
p.(None): prescribed requirements are not met,
p.(None): 6. Medicinal products that are in accordance with Regulation (EC) № 724/2004, Regulation (EC) № 724/2004
p.(None): In connection with the regulation (EG) № 1901/2006, or the regulation (EG) № 1394/2007 of the
p.(None): Subject to approval, domestically without corresponding approval or not according to one
p.(None): issues such approval or holds it ready for delivery,
p.(None): 6a. its obligations under Regulation (EC) № 1901/2006 not or not in time
p.(None): enforcement,
p.(None): 7. dispenses homeopathic medicinal specialties within the meaning of Section 11 (1) domestically or for dispensing
p.(None): ready without being registered in accordance with § 27,
p.(None): 7a. dispenses pharmacy specialties within the meaning of Section 11a domestically or for dispensing
p.(None): ready without being registered in accordance with § 27,
...
p.(None): 25. an establishment within the meaning of Section 62 (1) or Section 63a (1) without a license within the meaning of Section 63 (1),
p.(None): Section 63a (2) or Section 65 (1) leads or exceeds a license within the meaning of Section 64 (4),
p.(None): 25a. as the agent responsible for the transport of medicinal products or active agents on the basis of a
p.(None): Contravenes regulations pursuant to Section 62 (1),
p.(None): 26. the persons named in sections 68 subsection 1, 76 subsection 1, 76a subsection 2 and 76b subsection 1,
p.(None): Visiting, checking or taking samples or inspecting after this
p.(None): Federal law to keep records or the orders of these people
p.(None): enforcement,
p.(None): 27. contravenes an order pursuant to Section 69 (1) no. 1,
p.(None): 28. with the tasks of a competent person or with the management of the control laboratory or the
p.(None): Producing a person entrusted with scientific professional training or practical
p.(None): Do not provide evidence of training in the sense of an ordinance pursuant to Section 69a (2) or Section 70 (2)
p.(None): can
p.(None): 29. in a company within the meaning of section 62 (1) or section 63a (1) a person contrary to section 71 (1)
p.(None): employed,
p.(None): 30. in an establishment within the meaning of Section 62 (1) or Section 63a (1) persons within the meaning of Section 71 (1)
p.(None): employed who have not been examined in accordance with Section 71 (2),
p.(None): 31. instructs a person to act as a pharmaceutical representative contrary to Sections 72 to 74,
p.(None): 32. contravenes the rulings pursuant to Section 77 or Section 78, or
p.(None): 33. the supply and provision obligations in accordance with an ordinance pursuant to Section 94d (2)
p.(None): does not comply
p.(None): makes itself up if the offense does not constitute the offense of a criminal offense falling within the jurisdiction of the courts
p.(None): Action forms, is guilty of an administrative offense and is fined up to 25,000 euros, in
p.(None): Repetition trap up to 50,000 euros.
p.(None): (2) The attempt is punishable.
p.(None): (3) In the criminal penalty according to paragraph 1 Z 1, 2, 3, 5, 6, 7, 7a, 8, 9, 16, 17 and 32, the forfeiture of the
p.(None): Medicinal products constituting the subject of the criminal offense are recognized. Decay can also
p.(None): be recognized independently if no specific person can be persecuted or punished.
p.(None): § 84a. The customs authorities have the copy to the Federal Office for Safety in Health Care
p.(None): of your notification of a violation of the Pharmaceuticals Imports Act 2010.
p.(None): Section 85. (1) The Federal Office for Safety in Health Care may authorize a pharmaceutical specialty
p.(None): cancel if the authorization holder at least three times because of one and the same in § 83 Z 1 and 2 and
p.(None): § 84 Z 4, 12, 16, 19 and 21 violation was punished.
p.(None): (2) The Federal Office for Safety in Health Care can issue a license in accordance with Section 63 (1)
p.(None): revoke if the license holder at least three times because of one and the same in § 84 Z 24 to 28
p.(None): and 32 the above-mentioned violation.
p.(None): (3) The Federal Office for Safety and Health Care may appoint a knowledgeable person on time or
p.(None): permanently prohibit the authorization to carry out the work of a competent person if they
p.(None): has been punished at least three times for violations of medicinal product regulations.
p.(None): injunctions
p.(None): Section 85a. (1) Anyone who advertises that does not comply with sections 50 to 56 can file an injunction
p.(None): become. There is no risk of a corresponding breach if the entrepreneur receives a warning
p.(None): by an institution entitled to bring an action within a reasonable period of time, within a reasonable time
p.(None): Conventional penalty (§ 1336 ABGB) provides for a cease and desist declaration.
p.(None): (2) The claim can be made by the Austrian Chamber of Commerce, the Federal Chamber of Labor, the
...
p.(None): Section 75g, Section 80 (1) to (4) and Section 82d (2) in the version of the 2nd Material Data Protection Adjustment Act,
p.(None): BGBl. I No. 37/2018, come into force on May 25, 2018.
p.(None): (17) Section 39 subsection 4, the introductory sentence of Section 43 subsection 1, Section 43 subsection 1 lines 2 to 4 and Section 43 subsection 2 and 3 of this
p.(None): Federal Law as amended by Federal Law Gazette I No. 59/2018 will come into force on July 1, 2018.
p.(None): (18) Section 62 (3a) in the version of the Federal Law Gazette I No. 104/2019 comes into force on July 1, 2020.
p.(None): Section 95a. The applies to all personal names used in this federal law
p.(None): chosen form for both genders.
p.(None): Section 96. (1) Unless otherwise stipulated in paragraph 2, the enforcement of this Federal Act shall mean that
p.(None): Federal Minister of Health and Women
p.(None): 1. With regard to Section 59 (3) and Section 60 (7) in agreement with the Federal Minister for
p.(None): Economy and work,
p.(None): 2. with regard to Section 79 (1) in agreement with the Federal Minister of Finance,
p.(None): 3. with regard to § 84a in agreement with the Federal Minister of Finance, and
p.(None): 4. With regard to Section 85b in agreement with the Federal Minister of the Interior.
p.(None): (2) With completion
p.(None): 1. of § 76a paragraphs 6 and 7 - insofar as it concerns the investigation for clashes within the meaning of § 1 paragraph 2 line 1
p.(None): of the 2007 Federal Anti-Doping Act - is the Federal Chancellor;
p.(None): 2. of § 76b - if it concerns a seizure or seizure in the procedure according to
p.(None): Criminal Procedure Code 1975 (StPO), BGBl. № 631, acts - and the §§ 82b, 82c and 85a this
p.(None): Federal law is the Federal Minister of Justice,
p.(None): 3. of § 82d is the Federal Minister of Finance
p.(None): entrusted.
p.(None): Section 97. The following directives of the European Union are implemented by this federal law:
p.(None): 1. Council Directive 65/65 / EEC of 26 January 1965 on the approximation of the legal and
p.(None): Administrative provisions on medicinal products (OJ No L 22, 9.2.2965);
p.(None): 2. Council Directive 75/318 / EEC of 20 May 1975 on the approximation of the laws and regulations
p.(None): Administrative provisions of the Member States on analytical, toxicological-pharmacological
p.(None): and medical or clinical regulations and evidence of trials with medicinal products (OJ.
p.(None): L 147, June 9, 1975);
p.(None): 3. Council Directive 75/319 / EEC of 20 May 1975 on the approximation of the laws and regulations
p.(None): Administrative provisions on medicinal products (OJ No L 147, 9. 6. 1975);
p.(None): 4. Council Directive 81/851 / EEC of 28 September 1981 on the approximation of laws
p.(None): of the Member States on veterinary medicinal products (OJ No L 317, 6.11.1981);
p.(None): 5. Council Directive 81/852 / EEC of 28 September 1981 on analytical, toxicological and
p.(None): pharmacological and veterinary or clinical regulations and evidence of experiments with
p.(None): Veterinary medicinal products (OJ No L 317, 6.11.1981);
p.(None): 6. Council Directive 83/570 / EEC of 26 October 1983 amending Directives 65/65 / EEC,
p.(None): 75/318 / EEC and 75/319 / EEC to approximate the laws, regulations and administrative provisions relating to
p.(None): Medicinal specialties (OJ No. L 332, 11/28/1983);
...
p.(None): Slovakia as contracting parties following their accession to the European Union, OJ № L 89/30 from
p.(None): March 28, 2006, Federal Law Gazette III No. 162/2006,
p.(None): 29. Directive 2010/84 / EU of the European Parliament and of the Council of December 15, 2010 on
p.(None): Amendment to Directive 2001/83 / EC creating a Community code for
p.(None): Human medicinal products with regard to pharmacovigilance, OJ. № L 348 of December 31, 2010, p 74, in
p.(None): the version of the correction No.L 21 dated January 25, 2011, page 8,
p.(None): 30. Directive 2011/62 / EU of the European Parliament and of the Council of 8 June 2011 on
p.(None): Amendment to Directive 2001/83 / EC creating a Community code for
p.(None): Medicinal products for human use to prevent the entry of counterfeit medicinal products into the
p.(None): legal supply chain, OJ No.L 174 from 01.07.2011 S 74,
p.(None): 31. Directive 2012/26 / EU of the European Parliament and of the Council of October 25, 2012 on
p.(None): Amendment to Directive 2011/83 / EC with regard to pharmacovigilance, OJ. L No. 299 of October 27
p.(None): 2012, S 1,
p.(None): 32nd Commission Directive (EU) 2017/1572 supplementing Directive 2001/83 / EC with regard to
p.(None): Principles and guidelines of good manufacturing practice for medicinal products for human use (OJ No L 238,
p.(None): 16.09.2017).
p.(None): Article 6
p.(None): final provision
p.(None): (Note: from BGBl. I No. 78/1998, § 60, BGBl. No. 185/1983)
p.(None): Any change in the legal form of the Federal Institute for Drugs remains its own
p.(None): Federal law reserved.
p.(None): Article XXIV
p.(None): Transitional provision
p.(None): (Note: from BGBl. I No. 112/2007, §§ 76b and 96, BGBl. No. 185/1983)
p.(None): The penal provisions amended by this federal law are not applicable in criminal matters
p.(None): who were given a judgment in the first instance before their entry into force. After a judgment has been set aside
p.(None): following an appeal for annulment, appeal, resumption or renewal of the criminal proceedings or
...
Political / political affiliation
Searching for indicator party:
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p.(None): (15) "Name of the medicinal product" is the name that is either not to be confused with the
p.(None): common name leading fancy name or a common or scientific name in
p.(None): May be associated with a trademark or the name of the marketing authorization holder.
p.(None): (16) "Strength of the medicinal product" is, depending on the form of administration, the amount of active ingredient per dose,
p.(None): Unit of volume or weight.
p.(None): (17) 'primary packaging' means the container or any other form of pharmaceutical packaging which
p.(None): comes into direct contact with the medicine.
p.(None): (18) "Agency" is the European Medicinal Products Agency established by Regulation (EC) № 726/2004
p.(None): Agency.
p.(None): (19) 'Generic' is a medicinal product that has the same qualitative and quantitative composition
p.(None): Active ingredients and the same dosage form as the reference drug and its
p.(None): Bioequivalence with the reference medicinal product has been demonstrated by means of suitable bioavailability studies.
p.(None): The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of one
p.(None): Active ingredients are considered to be one and the same active ingredient, unless their properties differ significantly
p.(None): in terms of safety or effectiveness. In this case, the applicant must provide additional data
p.(None): be presented, the safety or effectiveness of the various salts, esters or derivatives of a
p.(None): prove approved active ingredient. The different oral dosage forms with immediate
p.(None): Drug release is considered one and the same dosage form.
p.(None): (20) 'Reference medicinal product' is one in Austria or in another contracting party to the Agreement
p.(None): Pharmaceutical specialty approved through the European Economic Area.
p.(None): (21) “Plant pods” are all predominantly whole, shredded or cut plants,
p.(None): Parts of plants, algae, fungi, lichens in unprocessed condition, usually in the dried form, but
p.(None): sometimes also fresh. Certain plant excretions that have not undergone any special treatment
p.(None): were also considered herbal substances. Vegetable substances are due to the plant part and
p.(None): the botanical name according to the binomial system (genus, art. variety and author) is precisely defined.
p.(None): (22) 'Vegetable preparations' are preparations which are made by
p.(None): Impact treatments such as extraction, distillation, pressing, fractionation, purification, concentration or
p.(None): Undergo fermentation. These include grated or powdered plant matter,
p.(None): Tinctures, extracts, essential oils, press juices and processed plant excretions.
p.(None): (23) “Plant-based medicinal products” are all medicinal products that act exclusively as one or more active substances
p.(None): vegetable substances or one or more vegetable preparations or one or more such
p.(None): contain vegetable substances in combination with one or more such herbal preparations.
p.(None): (24) "Traditional herbal medicinal product specialty" is a herbal medicinal product that complies with the requirements of § 12
p.(None): specified conditions met.
p.(None): (25) 'Counterfeit medicinal product' means any medicinal product that has been counterfeited:
p.(None): 1. its identity, including its packaging and labeling, its name or its
p.(None): Composition related to any ingredient, including excipients and content
p.(None): of these components, or
p.(None): 2. its origin, including manufacturer, country of manufacture, country of origin and marketing authorization holder, or
p.(None): Registration holder, or
p.(None): 3. the records and documents related to the distribution channels used.
p.(None): (26) 'Counterfeit active substance' is an active substance in which the following has been falsified:
p.(None): 1. its labeling on the container with regard to the actual content, or
p.(None): 2. the records and documents in connection with the manufacturers involved or the
p.(None): distribution channels used.
p.(None): § 2. (1) "Users" are doctors, dentists, veterinarians, dentists, midwives, members of the
p.(None): Nursing, medical and technical services and first aid services and
p.(None): Legal entities of hospitals without their own institutional pharmacy and other medical facilities, insofar as
p.(None): need these medicines to do their job.
p.(None): (2) "pharmaceutical wholesaler" is a trader who, based on the 1994 Industrial Code,
p.(None): Federal Law Gazette № 194, is entitled to wholesale pharmaceuticals and has a corresponding license
p.(None): in accordance with section 63 (1), as well as a pharmaceutical company of another contracting party of the
p.(None): Agreement on the European Economic Area, which is authorized to wholesale pharmaceuticals
p.(None): float.
p.(None): (3) "pharmaceutical wholesaler" is a pharmaceutical wholesaler, according to which sufficient
p.(None): Warehousing, a corresponding assortment design and a corresponding
p.(None): Willingness, regularity and intensity of care, capable of supplying drugs in the sense
p.(None): of § 57 in a certain area.
p.(None): (3a) "Mediator" is one in a contracting party to the European Economic Area
p.(None): resident person authorized to act as a mediator of medicinal products for human use.
p.(None): (3b) "Bulkware" is a medicinal product that only needs to be filled or packaged to
p.(None): To become the final product.
p.(None): (4) “Batch” is the quantity of a drug manufactured in the course of a uniform manufacturing process.
p.(None): (5) "Batch name" is a characteristic combination of digits or letters used to
p.(None): serves to clearly identify a batch.
p.(None): (5a) "Compassionate Use Program" is the placing on the market of a medicinal product within the meaning of Art. 83
p.(None): of Regulation (EC) No. 726/2004.
p.(None): (6) “Depositeur” is
p.(None): 1. a trader who, on the basis of the 1994 Industrial Code, deals in the wholesale sale of medicines
p.(None): is entitled and has a corresponding license pursuant to Section 63 (1), or
p.(None): 2. the operator of a domestic public pharmacy,
p.(None): who markets a medicinal product manufactured abroad in its name on the domestic market.
p.(None): (6a) "End product" is a medicinal product that has gone through all the stages of manufacture but not yet
p.(None): released by a knowledgeable person.
p.(None): (7) "Mutual recognition procedure" and "decentralized procedure" are for the
p.(None): Contracting parties to the Agreement on the European Economic Area through Chapter 4 of the Directive
p.(None): 2001/83 / EG, in the version of the guidelines 2004/24 / EG and 2004/27 / EG, as well as in chapter 4 of the guideline
p.(None): 2001/82 / EG, in the version of the directive 2004/28 / EG, specified procedures.
p.(None): (7a) "Distance selling" means entering into a contract using only one or
p.(None): several means of distance communication.
p.(None): (7b) "Long-distance communication means" are means of communication that are used to conclude a contract without
...
p.(None): № 2377/90 establishing a Community procedure for the setting of quantitative limits for
p.(None): Veterinary drug residues in food of animal origin, OJ. № L 224 of August 18, 1990,
p.(None): defined quantities.
p.(None): (11) "Placing on the market" means holding stock, holding it for sale or dispensing medicinal products or
p.(None): Wirksto ff s. A placing on the market does not exist if it is ensured by suitable measures that a
p.(None): Medicines that do not comply with the law do not reach consumers or users.
p.(None): (11a) "Magistral preparation" means any medicinal product that is available in a pharmacy on the basis of a
p.(None): medical or dental prescription for a specific patient or by veterinary
p.(None): Prescription is made for a particular animal.
p.(None): (11b) "O ffi zinal preparation" means any drug that is in a pharmacy after a monograph
p.(None): the pharmacopoeia is produced in accordance with § 1 of the Pharmacopoeia Act and is intended to be used in pharmacies,
p.(None): in which it was manufactured to be sold directly to the consumer.
p.(None): (11c) "Re-blistering" is the automated patient-specific compilation of the one-time, daily,
p.(None): Weekly or monthly ration of medicines in blisters.
p.(None): (12) "Non-clinical investigation" is the pharmacological or toxicological examination of a medicinal product,
p.(None): that is not done on humans.
p.(None): (13) Pharmaceutical officers are persons who are doctors, dentists, veterinarians, dentists, midwives,
p.(None): Visit pharmacists or traders mentioned in section 59 (3), (4) and (8) to find out about medicines
p.(None): to provide technical information.
p.(None): (13a) "Marketing Authorization Holder" is a party to the Agreement on the
p.(None): European Economic Area (EEA Agreement) resident entrepreneur who is entitled to
p.(None): To market, manufacture or wholesale pharmaceuticals or active ingredients under his name
p.(None): to drive.
p.(None): (13b) "Expert person" is a person as defined in Article 48 of Directive 2001/83 / EC, as amended
p.(None): of Directives 2004/24 / EC and 2004/27 / EC, or Article 52 of Directive 2001/82 / EC, in the version of the
p.(None): Directive 2004/28 / EC, or Article 13 (1) of Directive 2001/20 / EC.
p.(None): (14) "Harmlessness" means that when used as intended, the foreseeable risk
p.(None): undesirable effects in consideration of the effectiveness or purpose according to the knowledge
p.(None): medical science is justifiable.
p.(None): (15) “Consumers” are physical or legal persons who take medicinal products for their own use
p.(None): purchase.
p.(None): (15a) "Mediation of medicinal products" includes all activities, with the exception of wholesale, in the
p.(None): Connection with the sale or purchase of medicinal products for human use, which consist of self-employed and in
p.(None): Negotiate the name of another legal or natural person without using these drugs
p.(None): Acquiring property or physically handling these medicines.
p.(None): (16) “Expiry date” is the term after which the shelf life of a medicine
p.(None): is no longer guaranteed.
p.(None): (17) Waiting time is the period between the last administration of a drug to animals under
p.(None): Compliance with drug regulations and the time up to which these animals are not available
...
p.(None): is responsible for conducting the clinical trial in a trial center. Will an exam in
p.(None): a test center carried out by a team, the examiner is the responsible head of the team.
p.(None): (12) "Examiner Information" is a compilation of the information for the investigations with investigational medicinal products on
p.(None): Human relevant clinical and non-clinical data on the preparations concerned.
p.(None): (13) "Test plan" is the entirety of the documents in which objectives, planning, methodology,
p.(None): statistical considerations and organization of an examination are described. The term “test plan” relates
p.(None): the test plan itself and its subsequent versions and changes.
p.(None): (14) "investigational medicinal product" is a pharmaceutical form of an active ingredient or placebo that is contained in a
p.(None): clinical trial or used as a reference substance; also an approved one
p.(None): Pharmaceutical specialty when used or provided in a form other than that authorized or for
p.(None): used an unauthorized area of application or to receive additional information on the
p.(None): approved form is used.
p.(None): (15) "Examiner" (healthy subject or patient) is a person who is either the recipient
p.(None): of the investigational medicinal product or as a member of a control group takes part in a clinical trial.
p.(None): (16) "Sponsor" is any physical or legal person who is responsible for planning the
p.(None): Initiation, supervision and funding of a clinical trial. The sponsor or be
p.(None): Authorized representatives must be established in a contracting party to the European Economic Area.
p.(None): The auditor has to assume the additional duties and responsibilities of the sponsor if he has one
p.(None): conducts clinical trials independently of the manufacturer of the medicinal product and under their own responsibility.
p.(None): (17) "Standard Operating Procedures (SOPs)" are standardized, detailed, written
p.(None): Procedural rules of the sponsor for all activities related to the clinical trial
p.(None): are necessary.
p.(None): (18) “Adverse event” is any harmful event that occurs to a subject
p.(None): happens and that is not necessarily causally related to the clinical trial.
p.(None): (19) “Side effect” is any harmful and unintended reaction to an investigational medicinal product.
p.(None): (20) "Serious adverse event or serious side effect" is a
p.(None): adverse event or side effect that is fatal or irrespective of the dose
p.(None): is life-threatening, requires inpatient treatment or its extension to become one
p.(None): permanent or serious disability or disability or a congenital anomaly or
p.(None): is a birth defect.
p.(None): (21) "Unexpected side effect" is a side effect that depends on the type or severity due to the
p.(None): available product information is not expected.
p.(None): (22) "Pediatric investigation concept" is a research and development program that ensures
p.(None): the data that is required to determine the prerequisites should be developed,
p.(None): among which a drug will be approved for treatment in the pediatric population
p.(None): can. The pediatric population includes people from birth to the age of 18.
p.(None): Birthday.
...
p.(None): (14) "Pharmacovigilance Risk Assessment Committee (PRAC)" is the one at the agency
p.(None): Committee set up under Article 56 of Regulation (EC) No 726/2004.
p.(None): (15) "Eudravigilance database" is the database operated by the Agency in accordance with Art. 24 of the
p.(None): Regulation (EC) No. 726/2004.
p.(None): (16) "Data archive for the regularly updated safety reports" is that of the agency
p.(None): Data archive operated in accordance with Art. 25a of Regulation (EC) No. 726/2004.
p.(None): Pharmaceutical requirements
p.(None): Section 3
p.(None): scientific knowledge and based on practical experience does not appear to be certain that it
p.(None): When used as intended, they have no harmful effect beyond what is known
p.(None): that is acceptable to medical science.
p.(None): (2) It is also prohibited to place veterinary medicinal products on the market if, according to the respective status of the
p.(None): scientific knowledge and based on practical experience it does not appear certain that
p.(None): the veterinary medicinal product has no undesirable effects on the
p.(None): Environment that is not outweighed by the positive therapeutic benefits.
p.(None): § 4. (1) It is forbidden to manufacture medicinal products or active substances or to place them on the market in their
p.(None): Quality does not correspond to the current state of science.
p.(None): (2) The quality of pharmaceuticals or active ingredients corresponds to the current state of science
p.(None): especially not if they
p.(None): 1. the quality requirements of the pharmacopoeia within the meaning of Section 1 of the Pharmacopoeia Act 2012,
p.(None): BGBl. I № 44/2012, or the quality requirements of the pharmacopoeia of another contracting party
p.(None): the European Economic Area,
p.(None): 2. the quality requirements of other pharmacopoeias, the standard of which corresponds to that of the pharmacopoeia
p.(None): § 1 of the Pharmacopoeia Act 2012 can be kept the same, provided there are no standards in accordance with Z 1,
p.(None): 3. Other existing internationally recognized minimum standards, provided there are no standards according to
p.(None): Z 1 and 2 exist, or
p.(None): 4. the standards set by the manufacturer himself according to the current state of science, if
p.(None): there are no standards according to Z 1 to 3,
p.(None): do not match.
p.(None): (3) It is prohibited to place medicinal products on the market
p.(None): 1. whose durability is no longer given,
p.(None): 2. whose expiry date has passed,
p.(None): 3. whose commercial packs can have an adverse effect on the quality of the medicinal product,
p.(None): or
p.(None): 4. which are intended for use on animals, which serve for the production of food and their
p.(None): pharmacologically active ingredients not in Annexes I to III of Regulation (EEC)
p.(None): No. 2377/90 are included.
p.(None): (4) Pharmaceutical specialties whose expiry date has passed may be used if the
p.(None): Federal Armed Forces in accordance with Section 2 (1) lit. a of the Wehrgesetzes 1990, Federal Law Gazette № 305, are placed on the market,
p.(None): if this is essential for the supply of medicinal products and research has shown that
p.(None): the protection of human and animal health is maintained.
p.(None): § 5. (1) The Federal Minister of Health and Environmental Protection has to ensure the
...
p.(None): Novel therapies based on individual medical prescription specifically for a particular patient
p.(None): Austria is not routinely manufactured in an Austrian hospital under the
p.(None): exclusive professional responsibility of a doctor to be applied to this patient.
p.(None): (6b) Anyone who uses medicinal products in accordance with paragraph 6a is obliged to take measures to
p.(None): Ensure follow-up of effectiveness and side effects.
p.(None): (6c) Medicinal products that consist of or consist of human cells or tissues
p.(None): are made, but not always made in advance in the same composition and under the same
p.(None): Placed on the market in a form intended for delivery to the consumer or user
p.(None): on the basis of the approval of the processing procedure pursuant to Section 23
p.(None): Tissue Safety Act, Federal Law Gazette I No. 49/2008.
p.(None): (6d) Live animals are not considered to be medicinal products that are subject to approval in accordance with paragraph 1.
p.(None): (6e) Blood and. Are not considered to be pharmaceutical specialties that are subject to approval in accordance with paragraph 1
p.(None): Blood components for direct transfusion.
p.(None): (6f) Newly blistered are not considered to be medicinal specialties that are subject to approval according to Paragraph 1
p.(None): Drug.
p.(None): (7) Radioactive pharmaceutical specialties that are subject to approval in accordance with paragraph 1 also apply
p.(None): Generators, kits and precursors of radioactive drugs.
p.(None): (8) In individual cases, the Federal Office for Safety in Health Care must determine by decision that
p.(None): that a radioactive pharmaceutical specialty does not require approval if the pharmaceutical company
p.(None): proves that this
p.(None): 1. in a contracting party to the Agreement on the European Economic Area
p.(None): is permitted or a monograph of the pharmacopoeia within the meaning of § 1 of the Pharmacopoeia Act
p.(None): corresponds,
p.(None): 2. is required for medical treatment and an equivalent pharmaceutical specialty at the time of
p.(None): Application is not approved and available in Austria,
p.(None): 3. is likely to be rarely used due to the intended indication,
p.(None): 4. corresponds to sections 3 and 4,
p.(None): 5. is harmless to radiation,
p.(None): 6. contains no monoclonal antibodies and
p.(None): 7. is not intended for intrathecal use.
p.(None): The Federal Office for Safety in Health Care has to revoke this decision if one of these
p.(None): Requirements no longer exist or were not originally met. The frequency of
p.(None): The Federal Office for Safety in Health Care is used by pharmaceutical companies
p.(None): to be documented annually.
p.(None): (9) Paragraph 2 does not apply to
p.(None): 1. pharmaceutical specialties within the meaning of § 26,
p.(None): 2. Pharmaceutical specialties for injection,
p.(None): 3. sterile, pyrogen-free rinsing liquids,
p.(None): 4. radioactive pharmaceutical specialties and
p.(None): 5. Medicinal specialties that are in accordance with § 2 Paragraph 1 of the Prescription Law or for addictive law
p.(None): Provisions are subject to prescription requirements.
p.(None): § 7a. (1) Medicines containing antigens or semi-antigens and the detection of speci fi c ones
p.(None): Defense and protective substances, desensitization or hyposensitization may, if they
p.(None): not always made in advance in the same composition and under the same name in one
p.(None): placed on the market for supply to the consumer or user, domestically only
p.(None): delivered or kept ready for delivery in Germany if the Federal Office for Security in
p.(None): Healthcare the manufacturing process to be used with this drug
p.(None): including chemical pharmaceutical documentation has been approved by notice.
p.(None): (2) Sections 8 to 25 apply mutatis mutandis to procedures in accordance with para
p.(None): the documents that are sufficient for the assessment of the intended end products are to be enclosed.
p.(None): § 7b. (1) If there is no authorization and no application for authorization for a human medicinal product,
p.(None): the Federal Minister of Health and Women may do so in another party to the agreement
p.(None): Medicinal product approved for use in the European Economic Area for public reasons
p.(None): Allow health.
p.(None): (2) The Federal Minister of Health and Women may, by ordinance, specify further provisions on
p.(None): the procedure to be used, in particular with regard to the selection of the authorization holder,
p.(None): adopted. It is particularly important to ensure that the marketing authorization holder is informed about the
p.(None): necessary organizational and technical prerequisites for fulfilling him after a possible
p.(None): Approval according to this federal law.
p.(None): § 8. (1) Medicinal products do not require approval if
p.(None): 1. these to conduct non-clinical or clinical trials or clinical trials
p.(None): are determined, or
p.(None): 2. certifies a doctor, dentist or veterinarian who is authorized to practice his profession independently in Germany,
p.(None): that the drug specialty to ward off a life threatening or serious health
p.(None): Damage is urgently needed and this success with an approved and available
p.(None): Pharmaceutical specialty probably cannot be achieved according to the state of the art, or
p.(None): 3. the pharmaceutical specialty for medical treatment
p.(None): a) in the event of deployment of the Federal Army in accordance with Section 2 (1) lit. a of the Defense Act 2001,
p.(None): BGBl. I No. 146, or
p.(None): b) in preparation for a posting under the Federal Constitutional Law on Cooperation and
p.(None): Solidarity when sending units and individuals abroad (KSE-BVG),
p.(None): BGBl. I No. 38/1997, or in the context of such a posting
p.(None): is needed and the success of this treatment with an approved and available
...
p.(None): to define a defined group of patients who have a chronic or
p.(None): suffer from serious illness or whose illness is life-threatening and who has an approved and
p.(None): available medicinal product cannot be treated satisfactorily.
p.(None): (2) Is entitled to apply for a permit in accordance with paragraph 1
p.(None): 1. the manufacturer if he sponsors an approved clinical trial for the medicinal product in question
p.(None): is, or
p.(None): 2. the applicant for a marketing authorization pursuant to Article 6 of the Regulation
p.(None): No. 726/2004 for the medicinal product in question.
p.(None): (3) The Federal Minister of Health may, by ordinance, provide more detailed regulations on the procedure
p.(None): to authorize the placing on the market of a medicinal product as part of a “Compassionate use
p.(None): Program ”as far as this is necessary to protect the health of patients.
p.(None): (4) The holder of an authorization for the implementation of a "Compassionate use program"
p.(None): ensure that the medicinal product is included in the patients included in the program even after the
p.(None): Granting of marketing authorization until the actual marketing is available
p.(None): is provided.
p.(None): Application for Admission
p.(None): § 9. (1) The following are entitled to apply for approval or to register a pharmaceutical specialty:
p.(None): 1. a trader who, on the basis of the 1994 Trade Ordinance, is responsible for the manufacture of the
p.(None): Is wholesaling with the pharmaceutical specialty in question, or
p.(None): 2. an operator of a domestic public pharmacy, or
p.(None): 3. one in another party to the Agreement on the European Economic Area
p.(None): resident pharmaceutical entrepreneur who is authorized to sell the pharmaceutical specialty in question
p.(None): To bring traffic.
p.(None): (2) A separate application is required for each pharmaceutical form, composition, strength and type of application
p.(None): put.
p.(None): (3) For radioactive medicinal products containing a radionuclide, a single application is for one
p.(None): Range of radioactivity levels sufficient.
p.(None): (4) For medicinal products that are dental medicines and are only in color
p.(None): Make a difference, provided that the respective color does not affect the effectiveness, durability or
p.(None): A single application is sufficient to tolerate the medicinal product.
p.(None): Note for the following provision
p.(None): For the reference period cf. § 94h.
p.(None): Approval documents
p.(None): § 9a. (1) The following must be attached to an application for admission:
p.(None): 1. Name or company name and registered office of the applicant and if the applicant is not with the manufacturer
p.(None): is identical, name or company and registered office of the manufacturer, as well as proof of authorization to
p.(None): Application,
p.(None): 2. Name of the pharmaceutical specialty,
p.(None): 3. Composition by type and amount of all components of the medicinal product, including the
p.(None): Mention of the international free name (INN) recommended by the World Health Organization,
p.(None): if there is an INN for the medicinal product or the relevant chemical name,
p.(None): 4. Assessment of the possible environmental risks of the pharmaceutical specialty; precautions must be taken if necessary
p.(None): to provide and justify their limitation,
p.(None): 5. Information about the manufacturing process,
...
p.(None): create that have the required professional quali fi cation. This is with the application for admission
p.(None): to be demonstrated by means of a curriculum vitae.
p.(None): (3) An application for approval of a veterinary specialty is also a commenting and
p.(None): Assessing scientific summary of those contained in the documents in accordance with paragraph 1
p.(None): 1. Safety and residue tests and
p.(None): 2. Tests to assess the possible environmental risks
p.(None): to add. Submission of the results of clinical trials and safety and
p.(None): Residue tests are not required for immunological veterinary specialties if they are in
p.(None): duly substantiated cases, in particular based on European Union legislation,
p.(None): cannot be carried out. These documents are to be prepared by persons who are responsible for the
p.(None): have the required professional quali fi cation. This is with the application for admission via resume
p.(None): demonstrated.
p.(None): (4) The risk management system must be proportionate to the identified and
p.(None): potential risks of the pharmaceutical specialty and the need for data on the safety after approval
p.(None): or registration. For veterinary specialties, in deviation from para. 1 no
p.(None): Submit risk management plan only if this is in view of the identified and potential
p.(None): Risks of the drug specialty is required.
p.(None): (5) In addition to the information according to paragraphs 1 to 4, an application for admission may be required
p.(None): to add:
p.(None): 1. Copies of all in another Contracting Party to the Agreement on the European
p.(None): Economic area or a third country granted marketing authorizations for the
p.(None): related pharmaceutical specialty, along with a list of parties to the agreement
p.(None): the European Economic Area in which a according to Directive 2001/83 / EC or Directive
p.(None): 2001/82 / EG application for approval is examined;
p.(None): 2. For human medicinal products, a summary of the safety data including the
p.(None): available data from the regularly updated reports on the safety of
p.(None): Medicines and reports of suspected side effects from other parties to the
p.(None): Agreement on the European Economic Area or a third country;
p.(None): 3. copies of those proposed by the applicant or by the competent national authorities
p.(None): Approved Summary of Product Features (SmPC) and Package Leaflet;
p.(None): 4. The details of all decisions to refuse approval in another
p.(None): Contracting party to the European Economic Area or in a third country and the reasons for this
p.(None): Decision and
p.(None): 5. the copy of the designation of the medicinal product as an orphan medicinal product according to the
p.(None): Regulation (EC) № 141/2000 on orphan medicinal products, OJ. № L 18 from 01/22/2000 p.
p.(None): 1, as amended by Regulation (EC) No. 596/2009, OJ. L 188 from 07/18/2009 p. 14.
p.(None): (6) If the medicinal product is only to be exported, the applicant must contact
p.(None): Submitting the application in writing to make a declaration that the medicinal product is not domestically in
p.(None): Is placed on the market.
p.(None): (7) The applicant is responsible for the accuracy of the information provided and the documents submitted
p.(None): responsible.
p.(None): § 9b. (1) An application for approval of a homeopathic medicinal specialty must include documents
p.(None): according to § 9a paragraph 1 lines 18 to 20 are not included. Furthermore, documents according to Section 9a (2) are not
p.(None): enclosed, however
p.(None): 1. documents that are important for the toxicological assessment of the medicinal product, and
p.(None): 2. Documents on the speci fi c homeopathic or, if applicable, on the speci fi c one
p.(None): anthroposophical effectiveness
p.(None): to join.
p.(None): (2) For homeopathic medicinal products, which are produced by dilution of only one substance
p.(None): a single application is sufficient for the substance and its dilutions.
p.(None): § 9c. An application for approval of a pharmaceutical specialty, which is a monograph of the pharmacopoeia in the
...
p.(None): fulfilled, is not mentioned in Section 7 (9) and is not subject to registration in accordance with Section 12, documents must be provided
p.(None): 8, 12 to 15, 18 to 21, 24 to 27 and 29 to 31 may not be added in accordance with Section 9a (1) no. documents
p.(None): According to § 9a para. 1 no. 5 and 11, the application only has to be attached if during the production and
p.(None): Testing other methods or devices are used than described in the pharmacopoeia
p.(None): are.
p.(None): § 9d. Section 9a does not apply to medicinal specialties within the meaning of Section 7 (9) lines 2 and 3, which are based on a monograph of
p.(None): Pharmacopoeia in the sense of § 1 of the Pharmacopoeia Act. An application for admission to a
p.(None): such a medicinal product, documents according to § 9a paragraph 1 lines 1 to 9 as well as 14 and 15 are to be attached.
p.(None): § 9e. An application for approval of a generator must be submitted in addition to the documents pursuant to Section 9a
p.(None): to connect the following documents:
p.(None): 1. a general description of the system with a detailed description of the components of the
p.(None): Systems that can influence the composition or quality of the daughter nuclide preparation
p.(None): and
p.(None): 2. Information on the qualitative and quantitative peculiarities of the eluate or sublimate.
p.(None): Reference approval
p.(None): Section 10. (1) Notwithstanding Section 9a (1) lines 19, 20 and 28, the applicant is not obliged to:
p.(None): Results of non-clinical trials and clinical trials or trials and the results of
p.(None): Submit safety and residue tests if he can prove that it is
p.(None): Medicinal product is a generic of a reference medicinal product and
p.(None): 1. initial approval in a contracting party to the Agreement on the European
p.(None): Economic area at least eight years ago, or
p.(None): 2. the authorization holder of the reference medicinal product has a reference to that of the authorization
p.(None): the underlying documents have been irrevocably approved in writing.
p.(None): (2) A generic drug that has been authorized in accordance with paragraph 1 may only be used after ten years
p.(None): First authorization for the reference medicinal product to be placed on the market.
p.(None): (3) If the marketing authorization holder of a reference human medicinal product within the first eight years
p.(None): After granting the first approval, approval of one or more new areas of application
p.(None): the scientific evaluation prior to its approval by the Federal Office for Security in
p.(None): Healthcare according to paragraph 14 as of significant clinical benefit compared to the existing ones
p.(None): Therapies are considered, the period provided for in paragraph 2 is extended to 11 years.
p.(None): (4) The period specified in paragraph 2 is extended for medicinal products
p.(None): 1. which are intended for use in fish or bees, for 13 years, and
p.(None): 2. which are intended for use in one or more animal species which are intended for the extraction of
p.(None): Serve food, and which contain a new active ingredient, which will expire on April 30, 2004
p.(None): was not authorized in the Union with each change to another animal, the extraction of
p.(None): Serves food that is obtained within five years of first approval, each by
p.(None): a year. However, this period can be a maximum of 13 years.
p.(None): However, the extension mentioned in Z 2 only takes place if the license holder originally also
p.(None): the establishment of maximum residue levels in accordance with Regulation (EEC) № 2377/90 for those of
p.(None): Has requested a change in the approval of the animal species concerned.
p.(None): (5) Paragraph 1 also applies if the reference medicinal product is not authorized in Austria
p.(None): if it is in another party to the Agreement on the European Economic Area
p.(None): was approved. In this case, the applicant has the name of the contracting party of the
p.(None): Agreement on the European Economic Area to specify in which the reference medicinal product
p.(None): is or has been approved. In this case, the Federal Office for Safety in Health Care has the
p.(None): competent authority of the other party to the Agreement on the European Economic Area
p.(None): request within a month to send confirmation that the reference medicinal product
p.(None): is or has been approved, as well as the full composition of the reference medicine and others
p.(None): Documents if required for the approval of the generic. If the
p.(None): The Federal Office for Safety in Health Care asks the agency for the
p.(None): corresponding information and documents.
p.(None): (6) Were in an amendment for a new area of application of a human medicinal product in
p.(None): Regarding an already well-established drug related to non-clinical or clinical studies
p.(None): the new area of application carried out by the Federal Office for Safety in Health Care
p.(None): Paragraph 14 were considered to be significant, so with an application according to § 10 or according to the
p.(None): Regulation (EC) № 1234/2008 on the examination of changes in the authorization of human and
p.(None): Veterinary medicinal products, OJ. № L 334 of 12.12.2008 p. 7 as amended by Regulation (EU) № 712/2012, OJ.
p.(None): № L 209, 4.8.2012 p. 4, one year not to refer to this data. This
p.(None): Exclusive period is not cumulative.
p.(None): (7) If the approval or its modification of a veterinary specialty, its active substance or active substances
p.(None): used for veterinary purposes in the Union for at least ten years, for another for
p.(None): Obtaining food certain target animal species, and will be new residue attempts
p.(None): according to Regulation (EEC) № 2377/90 and submitted new clinical trials, so can apply
p.(None): in accordance with section 10 or section 24, no reference is made to this data for three years.
...
p.(None): October 30, 2005.
p.(None): § 10a. (1) In deviation from Section 9a (1) nos. 19 and 20, the applicant is not obliged to submit the results
p.(None): the non-clinical trials or the clinical trials or trials or in deviation from Section 9a (1)
p.(None): Item 28 does not undertake to submit the results of the safety and residue tests if it
p.(None): can prove by means of detailed bibliographical documents that
p.(None): 1. the active substance or substances of the medicinal specialty in the Union for at least ten years
p.(None): generally used medicinally or veterinary and
p.(None): 2. the efficacy and safety of the medicinal product recognized for approval are given
p.(None): is.
p.(None): (2) The assessment report issued by the Agency after the assessment of an application for the fixing of
p.(None): Maximum residue levels according to Regulation (EEC) № 2377/90 can be published in
p.(None): appropriately as a corresponding bibliographical document, especially for
p.(None): Safety tests are used.
p.(None): § 10b. In the case of a new pharmaceutical specialty, which consists of known ingredients within the meaning of § 10a,
p.(None): which have so far not been approved in this combination are the results of new non-clinical trials
p.(None): or clinical trials or trials and, if applicable, the results of safety and
p.(None): Residue tests only for this combination, but not for the individual components.
p.(None): Authorization for distribution in parallel import
p.(None): § 10c. (1) medicinal specialties,
p.(None): 1. the one approved or registered in Austria on the basis of this federal law
p.(None): Pharmaceutical specialty (approval),
p.(None): 2. from another party to the Agreement on the European Economic Area
p.(None): be introduced, and
p.(None): 3. in which the assessment of the already approved or registered pharmaceutical specialty
p.(None): Safety and effectiveness can be used for health protection without any risk
p.(None): can
p.(None): may only be placed on the market if the Federal Office for Safety in Health Care
p.(None): Has given approval for sales in parallel imports.
p.(None): (2) With regard to the application for approval for sales in parallel import, § 9 Paragraph 1 and
p.(None): Section 9a (1) 1 accordingly.
p.(None): (3) The application for approval for distribution in parallel import must contain:
p.(None): 1. proof of the right to apply in accordance with § 9,
p.(None): 2. the name and registration or registration number of the licensed or registered in Austria
p.(None): registered pharmaceutical specialty,
p.(None): 3. the composition according to the type and amount of the active ingredients,
p.(None): 4. the party to the Agreement on the European Economic Area in which the imported
p.(None): Pharmaceutical specialty is authorized or registered and in which it is distributed (home Member State),
p.(None): 5. the name and the approval or registration number of the medicinal product in the
p.(None): Member State of origin
p.(None): 6. the name and address of the authorization holder in the home Member State,
p.(None): 7. where applicable, the name and address of the manufacturer in the home Member State,
p.(None): 8. the type of packaging of the imported medicinal product,
p.(None): 9. the pack sizes intended for distribution in Austria,
p.(None): 10. the description of the process of re-labeling or repacking,
p.(None): 11. the name and address of the person who will carry out the re-labeling or repackaging
p.(None): company
p.(None): 12. A statement that the texts for the outer packaging, primary packaging, and where appropriate
p.(None): Package leaflet and technical information except for speci fi c information as well as information on
p.(None): Avoidance of senselessness no textual deviations from the labeling,
p.(None): where applicable, package leaflet and specialist information for those authorized or
p.(None): have registered pharmaceutical specialty and
p.(None): 13. A description of the pharmacovigilance and, if necessary, the risk management system
p.(None): the applicant will introduce.
p.(None): (4) Pharmaceutical specialties that have been granted an authorization in accordance with Regulation (EC) № 726/2004 and
p.(None): Paragraph 1 lines 2 and 3 may only be placed on the market if they are in German
p.(None): Labeling and instructions for use are provided and there is German-language technical information
p.(None): and a notification to the agency and the Federal Office for Safety in Health Care has been made beforehand.
p.(None): This message must contain:
p.(None): 1. proof of the right to apply in accordance with § 9,
p.(None): 2. Name and registration number of those approved according to Regulation (EEC) № 726/2004
p.(None): Medicinal product,
p.(None): 3. the party to the Agreement on the European Economic Area in which the imported
p.(None): Drug specialty is distributed (home Member State),
p.(None): 4. the name and address of the authorization holder,
p.(None): 5. the name and address of the manufacturer,
p.(None): 6. the pack sizes intended for distribution in Austria,
p.(None): 7. A declaration that the texts for outer packaging, primary packaging, instructions for use and
p.(None): Specialist information, apart from company-specific information, no textual deviations from the
p.(None): Labeling, instructions for use and specialist information according to the regulation (EWG)
p.(None): No. 726/2004 approved pharmaceutical specialty.
p.(None): To the agency is a fee for checking compliance with the conditions set out in Union law
p.(None): Medicines and are specified in the marketing authorizations. their
p.(None): Dimensioning is based on Union law regulations.
p.(None): (5) The applicant is obliged to submit the application pursuant to paragraph 3 to the authorization holder
p.(None): or owner of the registration. The same applies to the notification according to paragraph 4.
p.(None): (6) If this is necessary for reasons of drug safety, with the consent of the
p.(None): Federal Office for Safety in Health Care of the requirements for labeling in paragraph 3
p.(None): Z 12 can be deviated with regard to the primary packaging.
p.(None): Registration of homeopathic medicinal specialties
p.(None): § 11. (1) Homeopathic medicinal products are not subject to the authorization requirement according to § 7 if
p.(None): she
...
p.(None): (2) Registration as a traditional herbal medicinal specialty is only possible if the following
p.(None): Requirements are met:
p.(None): 1. The fields of application correspond exclusively to those of traditional herbal medicinal products which
p.(None): are intended according to their composition and purpose, without prescription
p.(None): to be applied.
p.(None): 2. They are to be administered only in a certain strength and dosage.
p.(None): 3. They are intended exclusively for oral or external use or for inhalation.
p.(None): 4. The period for traditional vegetable use within the meaning of Section 12a (2) (2) is
p.(None): elapsed. To prove this period, it is not necessary for the product to have a
p.(None): Approval, registration or other approval has been granted. Furthermore, it is irrelevant if
p.(None): the number or amount of ingredients has been reduced during this period.
p.(None): 5. The information on traditional plant use within the meaning of Section 12a (2) (2)
p.(None): including safety and plausibility of effectiveness have been adequately proven.
p.(None): (3) Registration as a traditional herbal medicinal specialty is also possible if these vitamins
p.(None): or contains minerals, provided that the vitamins or minerals with regard to the area of application or
p.(None): the areas of application complement the action of the herbal active ingredients.
p.(None): (4) With regard to the authorization to register, Section 9 (1) applies. Registration documents
p.(None): § 12a. (1) Registration for registration are those in § 9a (1) 1 to 11, 13, 14, 17, 21 and 23
p.(None): The documents mentioned must be enclosed, whereby the specialist information does not have to contain any non-clinical information.
p.(None): There are also copies of all permits and registrations that the applicant has in another
p.(None): Contracting party to the Agreement on the European Economic Area or in a third country
p.(None): and details of any decision to refuse authorization or registration in another
p.(None): Contracting party to the Agreement on the European Economic Area or in a third country and the
p.(None): Submit reasons for this decision.
p.(None): (2) A registration for registration are also
p.(None): 1. a commenting and evaluating scientific summary of those in the documents
p.(None): pharmaceutical data contained in paragraph 1,
p.(None): 2. Bibliographical information on traditional plant use or reports from
p.(None): Experts from which it appears that the relevant or a corresponding drug
p.(None): at least 30 years at the time of application, including at least 15 years in
p.(None): European Economic Area, used medicinally, the drug among the specified
p.(None): Conditions of use is harmless and the pharmacological effect or effectiveness
p.(None): are plausible due to many years of application and experience,
p.(None): 3. A bibliographical overview of the information on safety with a scientific
p.(None): Rating,
p.(None): 4. Evidence that the applicant has a pharmacovigilance officer and
p.(None): necessary infrastructure has to any side effect, their occurrence within the European
p.(None): Economic area or in a third country is suspected, and
p.(None): 5. A description of the pharmacovigilance and, if necessary, the risk management system
p.(None): the registrant will introduce
p.(None): to add. To the extent that the Federal Office for Safety in Health Care to assess the
p.(None): The information required for their assessment is also considered to be harmless
p.(None): to add.
p.(None): (3) A medicinal product is deemed to be corresponding within the meaning of para. 2 no. 2 if it
p.(None): used auxiliary substances contains the same active substances and, the same or a similar one
...
p.(None): or
p.(None): 9. the requirements of section 18a (5) are met.
p.(None): (3) If a registration has been made on the basis of Section 12a (5) second sentence, and subsequently the
p.(None): vegetable crop, the vegetable preparation or a combination thereof from the list of vegetable crops,
p.(None): herbal preparations or combinations for use in traditional herbal medicinal products
p.(None): in accordance with Article 16f (1) of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and
p.(None): 2004/27 / EG, deleted, the registration has to be canceled, if not within three months
p.(None): Deletion of the registration holder's documents in accordance with section 12a (1) last sentence and section 12a (2) no.2
p.(None): and 3 submitted.
p.(None): (4) The Federal Office for Safety in Health Care may appoint the Committee for Plant Medicinal Products
p.(None): request an opinion on the evidence of traditional use if in doubt in the
p.(None): With regard to the existence of the requirements according to § 12a para. 2 no.2.
p.(None): (5) If the medicinal product has been in the European Economic Area for less than 15 years
p.(None): has been used, but otherwise the requirements for registration according to § 12 and § 12a
p.(None): are available, the Federal Office for Safety in Health Care has that in accordance with Article 16c (4) of the
p.(None): Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC
p.(None): with the participation of the Committee for Herbal Medicinal Products.
p.(None): (6) The Federal Office for Safety in Health Care notifies the Commission and everyone responsible
p.(None): Authority of another contracting party to the Agreement on the European Economic Area on request
p.(None): every negative decision about the registration and the reasons for it.
p.(None): statutory authorization
p.(None): § 14. The Federal Minister of Health and Women may consider the requirements
p.(None): an in-depth and rapid examination of the application and the admission and registration documents
p.(None): by regulation, more detailed provisions on applications and notifications as well as on content, scope, form,
p.(None): Issue the nature and submission of the samples and documents in accordance with sections 9a to 12a and 24.
p.(None): Product Information
p.(None): Technical information (summary of product characteristics - SMPC)
p.(None): § 15. (1) About medicinal specialties that are in accordance with § 7 of the approval or in accordance with § 12 of the registration
p.(None): is subject to doctors, dentists, dentists, midwives, veterinarians, pharmacists and those in § 59 para. 3
p.(None): to make available technical information in German to the traders mentioned, provided that it
p.(None): are not pharmaceutical specialties according to § 9c.
p.(None): (2) The subject information must contain at least the following information in the following order:
p.(None): 1. Name of the pharmaceutical specialty, followed by the strength and the dosage form,
p.(None): 2. Qualitative and quantitative composition according to active ingredients using the usual
p.(None): common or chemical name,
p.(None): 3. pharmaceutical form,
p.(None): 4. Clinical information:
p.(None): a) fields of application,
p.(None): b) dosage and type of use in adults and, if necessary, in children,
p.(None): c) contraindications,
p.(None): d) special warnings and cautions for use and in immunological
...
p.(None): Application of the drug specialty,
p.(None): 2. Conducting safety studies after approval,
p.(None): 3. Obligations with regard to the recording or reporting of suspected side effects that are related to the
p.(None): the obligations set out in Section IX,
p.(None): 4. other conditions or restrictions regarding the safe and effective use of the
p.(None): Medicinal product,
p.(None): 5. Operating a risk-adequate pharmacovigilance system and
p.(None): 6. Conducting efficacy studies after approval, as far as concerns regarding individual
p.(None): There are aspects of the effectiveness of the medicinal product that are only assessed after it has been placed on the market
p.(None): can be.
p.(None): (4) If this is necessary in view of a therapy-appropriate application, the Federal Office can
p.(None): for safety in health care by stipulating that the marketing authorization holder holds the
p.(None): Medicinal product also available in certain pack sizes within a certain period of time
p.(None): has brought.
p.(None): (5) The authorization for parallel import is, if necessary, subject to mandatory conditions
p.(None): issue, the fulfillment of which protects human or animal health, drug safety or
p.(None): Ensure consistency with the pharmaceutical specialty approved or registered in Austria.
p.(None): Such requirements can also be stipulated retrospectively.
p.(None): Mutual recognition and decentralized procedures
p.(None): § 18a. (1) If after the entry into force of the Medicinal Products Act, Federal Law Gazette № 185/1983, in the
p.(None): Version of the Federal Law BGBl. № 379/1996, already submitted application for admission in one
p.(None): other party to the Agreement on the European Economic Area or has one
p.(None): Contracting party to the Agreement on the European Economic Area the medicinal product that is made in Austria
p.(None): The subject of an application for admission is already admitted, according to the Federal Office for Security
p.(None): Healthcare that in Chapter III of Title III of Directive 2001/83 / EC, as amended
p.(None): 2004/24 / EG and 2004/27 / EG, or that in Title III, Chapter 4 of Directive 2001/82 / EG, in the version of the
p.(None): Directive 2004/28 / EC to apply the procedures listed and to meet the deadlines specified therein.
p.(None): (2) If the pharmaceutical specialty has not yet been approved at the time of application, the Federal Office has
p.(None): for safety in health care, provided Austria at the request of the applicant as
p.(None): Reference Member State within the meaning of Article 28 (1) of Directive 2001/83 / EC, as amended by the
p.(None): Directives 2004/24 / EC and 2004/27 / EC, or Article 32 of Directive 2001/82 / EC, in the version of the
p.(None): Directive 2004/28 / EC acts, an assessment report, a draft of the specialist information
p.(None): (Summary of product characteristics - SmPC), a draft of the package leaflet and for the
p.(None): To create labeling and to the applicant and the other parties to the agreement
p.(None): the European Economic Area, to which an authorization dossier has been submitted.
p.(None): (3) Is one after the entry into force of the Medicines Act, Federal Law Gazette № 185/1983, in the version
p.(None): of Federal Law BGBl. I No. 153/2005, submitted application for registration of a homeopathic
p.(None): Medicinal product already in another party to the Agreement on the European
p.(None): Economic area checked or has one of the contracting parties to the Agreement on the European
p.(None): Economic area the medicinal product which is the subject of an application for registration in Austria,
p.(None): has already been registered, the Federal Office for Safety in Health Care has this in Articles 28 and 29 (1)
p.(None): to 3 of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or that in
p.(None): Articles 32 and 33 (1) to (3) of Directive 2001/82 / EC, as amended by Directive 2004/28 / EC
p.(None): Apply procedures and meet the deadlines specified there.
p.(None): (4) If the homeopathic medicinal product is not registered at the time of registration, this has
p.(None): Federal Office for Safety in Health Care, provided Austria at the request of the applicant as
p.(None): Reference Member State within the meaning of Article 28 (1) of Directive 2001/83 / EC, as amended by the
p.(None): Directives 2004/24 / EC and 2004/27 / EC, or Article 32 of Directive 2001/82 / EC, in the version of the
p.(None): Directive 2004/28 / EC, acts, an assessment report, a draft of the package leaflet and for
p.(None): to produce the label and to the applicant and the parties to the Agreement on the
p.(None): European Economic Area, to which the registration documents have been submitted.
p.(None): (5) The registration for registration concerns a traditional herbal medicinal specialty for which the
p.(None): Committee for Plant Medicinal Products a Community plant monograph in accordance with Article 16h (3)
p.(None): Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or
p.(None): a vegetable crop, a vegetable preparation, or a combination thereof, in the list
p.(None): vegetable substances, vegetable preparations or combinations thereof for use in traditional
...
p.(None): 7. the name of the medicinal product or the information in the authorization documents to mislead
p.(None): are suitable,
p.(None): 8. the effectiveness of the medicinal product has not been sufficiently demonstrated by the applicant,
p.(None): 9. the pharmaceutical specialty with regard to its effectiveness, composition, strength, quality,
p.(None): Pharmaceutical form, dosage, shelf life, type of application or its area of application are not appropriate
p.(None): Preparation represents
p.(None): 10. the commercial packs intended for the pharmaceutical specialty with regard to the composition,
p.(None): Strength, condition, dosage form, dosage, shelf life, type of application or that
p.(None): The area of application of the pharmaceutical specialty is unsafe or inappropriate,
p.(None): 11. the draft of the labeling does not comply with Section 17 or an ordinance issued under Section 17 (9)
p.(None): corresponds,
p.(None): 12. the draft information for use is not in accordance with section 16 or one issued in accordance with section 16 (6)
p.(None): Corresponds to regulation,
p.(None): 13. the draft of the specialist information does not comply with Section 15 or an ordinance issued under Section 15 (7)
p.(None): corresponds,
p.(None): 14. the specified waiting time was not sufficient or was insufficiently justified,
p.(None): 15. The non-clinical trials, the results of which are attached to the application, do not correspond to the
p.(None): current state of science or an ordinance issued in accordance with § 48
p.(None): were,
p.(None): 16. The clinical data are unsuitable for the assessment of the pharmaceutical specialty or not the
p.(None): correspond to the current state of science or
p.(None): 17. an identical application for admission from or with the same applicant
p.(None): affiliates in another party to the Agreement on the European
p.(None): Economic area has been submitted or the application for one is already in another
p.(None): Contracting party to the Agreement on the European Economic Area
p.(None): Pharmaceutical specialty relates.
p.(None): (2) An application for approval of a veterinary specialty is made by the Federal Office for Safety in the
p.(None): Healthcare further reject if according to the current state of scientific
p.(None): Findings and after the practical experience does not appear to be certain that the medicinal product
p.(None): When used as intended, it does not have any undesirable effects on the environment that are not caused by
p.(None): the positive therapeutic benefits are outweighed. The Federal Office for Security in
p.(None): Healthcare has submitted an application for approval of a veterinary specialty for use on animals,
p.(None): which is intended for the production of food or medicinal products, even if
p.(None): the pharmacologically active substances contained therein are not listed in Annex I, II or III to Regulation (EEC)
p.(None): № 2377/90 are called. Relevant Community framework regulations are imminent
p.(None): The Federal Office for Safety in Health Care has issued an application for approval
p.(None): Veterinary specialty not to be allowed if this is to protect public health, to protect the
p.(None): Consumer or animal health is required.
p.(None): (3) If paragraph 1 applies mutatis mutandis, an application for approval for distribution in the
p.(None): Rejection of parallel imports by the Federal Office for Safety in Health Care even if the
p.(None): applied for medicinal product does not correspond to the medicinal product approved in Austria, in particular
p.(None): because the composition of the type and amount of the active ingredients is not the same as in Austria
...
p.(None): of medicinal products in Germany can only be delivered or kept ready for delivery if by a
p.(None): a testing institute designated by the Federal Minister for Health and Women was determined,
p.(None): that the batch conforms to the speci fi cations approved in the approval, in the case of non-approved
p.(None): Medicinal specialties correspond to the state of the art in science and technology. The decision has been made by
p.(None): the designated institute within 60 days of submitting an application and the
p.(None): necessary documents to be made. The applicant must be informed immediately. comes
p.(None): there is no positive opinion within 60 days, the applicant can contact the
p.(None): Federal Office for Safety in Health Care submit an application for a decision by the Federal Office.
p.(None): (4) The Federal Office for Safety in Health Care has an exception to the requirement upon application
p.(None): the batch release within the meaning of paragraph 3 if this is with regard to the special
p.(None): Condition, type of application or area of application of this medicinal specialty without
p.(None): Impairment of drug safety is justified. The exception must be revoked if the
p.(None): There are no prerequisites for this. Foreign medicinal specialties that are intended for a specific purpose in the
p.(None): 12 to 14 and 14 to 14 of the 2010 Medicinal Products Imports Act
p.(None): not batch release. Drug specialties by the state testing agency of another contracting party
p.(None): of the Agreement on the European Economic Area checked and approved in Austria
p.(None): Compliant specifications are also not subject to batch release.
p.(None): (5) The following principles apply when assessing the batch:
p.(None): 1. The testing institute named by ordinance of the Federal Minister for Health and Women can
p.(None): submit an assessment without performing an additional analytical test if
p.(None): Manufacturing and control methods the required quality, safety and harmlessness
p.(None): guarantee.
p.(None): 2. If the named test institute carries out an analytical test, this is based on the information provided in the frame
p.(None): of the admission procedure and if necessary available in the course of the application
p.(None): provided samples of the end product or samples of certain intermediate products (bulk
p.(None): Batches). It is important to ensure that the product meets the approval requirements
p.(None): approved specifications.
p.(None): 3. Can the testing institute named by the Federal Minister for Health and Women be approved on the basis of the
p.(None): submitted control reports and, if applicable, the analytical results obtained in the
p.(None): If the approval documents do not confirm the defined quality, the institute has the test report with it
p.(None): Justification to be forwarded immediately to the Federal Office for Safety in Health Care. This
p.(None): has in the case of an application for decision by the Federal Office for Security in the
p.(None): Healthcare to hear the applicant and within 30 days of receiving the application
p.(None): to decide on the batch release by notice. Results from the test report and the
p.(None): Justification the need to carry out an additional analytical test
...
p.(None): European Economic Area, every batch, regardless of whether it is in the
p.(None): European Economic Area has been produced by a full pharmaceutical entrepreneur
p.(None): qualitative and quantitative analysis, at least with regard to effective components, as well as all
p.(None): other tests or examinations that are necessary to check the quality of the
p.(None): To ensure pharmaceutical specialty in accordance with the requirements on which the approval is based.
p.(None): (2) In the case of bulk goods or intermediate products that are approved for manufacturing in Austria
p.(None): Medicinal products are used and imported from outside the European Economic Area
p.(None): each batch, regardless of whether it was manufactured in the European Economic Area, from
p.(None): pharmaceutical entrepreneurs a full qualitative and quantitative analysis, at least in the
p.(None): With regard to effective components, as well as all other tests or tests,
p.(None): which are required to ensure the quality of the bulk goods or the intermediate product in accordance with the
p.(None): To ensure approval based on requirements.
p.(None): (3) For investigational medicinal products imported from outside the European Economic Area
p.(None): each batch, regardless of whether it was manufactured in the European Economic Area, from
p.(None): pharmaceutical entrepreneurs to undergo all the necessary analyzes and tests to ensure quality
p.(None): the investigational medicinal products in accordance with the basis for the proper application for approval in accordance with Section 40
p.(None): Ensure information. This also applies to investigational medicinal products that are considered in a clinical trial
p.(None): Comparative medicinal products are to be used in a country that is not a party to the
p.(None): Agreement on the European Economic Area is made, manufactured and placed on the market there
p.(None): may be imported from outside the European Economic Area, if none
p.(None): Documents are available to confirm that each batch has been manufactured to standards that comply with the
p.(None): standards set by the European Union are at least equivalent.
p.(None): (4) In another party to the Agreement on the European Economic Area pursuant to
p.(None): Paragraphs 1 to 3 checked batches are exempt from the above-mentioned checks when imported into Austria,
p.(None): if signed by the competent person of the pharmaceutical company
p.(None): Control reports are attached.
p.(None): (5) If appropriate agreements between the European Union and the exporting country
p.(None): have been taken to ensure that the manufacturer of the drug is in the process of manufacture
p.(None): Followed rules that are at least those under Community law
p.(None): comply with the stipulated regulations, and that the controls according to paragraphs 1 to 3 are already in the exporting country
p.(None): have been carried out, the pharmaceutical entrepreneur is exempt from the obligation according to paragraphs 1 to 3
p.(None): freed.
p.(None): Internet portal for pharmaceuticals and pharmaceutical specialty registers
p.(None): Section 27. (1) In a register to be kept at the Federal Office for Safety in Health Care
p.(None): (Pharmaceutical Specialty Register)
p.(None): 1. approved pharmaceutical specialties,
p.(None): 2. homeopathic medicinal specialties within the meaning of § 11 paragraph 1, provided that their registration is not
p.(None): to be rejected in accordance with Section 11 (4),
p.(None): 3. Pharmacy-owned pharmaceutical specialties within the meaning of Section 11a (1), unless their registration
p.(None): is to be rejected in accordance with Section 11a (3),
p.(None): 4. traditional vegetable medicinal specialties within the meaning of § 12, provided that their registration is not in accordance with
p.(None): § 13 paragraph 2 is to be rejected,
p.(None): to be entered under a consecutive number (registration or registration number). Medicinal specialties that
...
p.(None): operate. This serves to inform the public and the involved public about pharmaceuticals and
p.(None): is closed with the European Internet portal set up according to Art. 26 of the Regulation (EG) № 726/2004
p.(None): to link.
p.(None): (5) In this portal, every admission, every registration within the meaning of para. 1 nos. 2 to 4, each
p.(None): Approval according to § 10c and any change of a medicinal product that is necessary for its identification by the
p.(None): Users or pharmacists can be of importance immediately, but no later than two months after their
p.(None): Publish enactment in a generally accessible manner. The Federal Office for Security in
p.(None): Healthcare the approved specialist information and the approved package leaflet and their
p.(None): approved changes and any conditions or requirements for admission according to §§ 18 Para. 3,
p.(None): 19 paragraphs 4 and 19a paragraphs 1 and 2, which were carried out for pharmacovigilance reasons, and the deadlines for their
p.(None): Publish compliance publicly available. Before publication, the approval or
p.(None): Hear registry holder.
p.(None): (6) The Federal Office for Safety in Health Care is obliged, each in connection with
p.(None): Every application for approval and registration for registration (expert report as well as
p.(None): the opinion on the results of the
p.(None): pharmaceutical, non-clinical pharmacological and toxicological trials and the results of
p.(None): clinical trials or trials, the assessment of the risk management system and the
p.(None): Summary of the pharmacovigilance system and, where appropriate, the safety and
p.(None): Residue tests) for each requested area of application, after all for commercial reasons in the
p.(None): The party's confidentiality interests have been removed immediately, but at the latest
p.(None): generally accessible three months after the notification in full text on the Internet portal for medicinal products
p.(None): to publish. The assessment report is a generally understandable summary
p.(None): publish, which must in particular contain a section on the conditions of the application. In front
p.(None): The approval or registration holder can be heard in the publication.
p.(None): III. SECTION
p.(None): Clinical trial
p.(None): general requirements
p.(None): § 28. (1) Clinical trials may only be carried out if
p.(None): 1. as expected, they meet the objectives of section 2a (1),
p.(None): 2. Information about relevant physical and chemical data or biological properties as well
p.(None): about the applied pharmaceutical technology and
p.(None): 3. Meaningful results of non-clinical tests are available, which correspond to the respective
p.(None): State of the art.
p.(None): (2) The planning and implementation of clinical trials must comply with the regulations
p.(None): Federal law according to the state of the sciences and according to the principles of good clinical
p.(None): Practice. To interpret the principles of good clinical practice, those are generally accepted
p.(None): To use the principles and requirements set out in Volume 10 of the regulations for medicinal products in the
p.(None): European Union are published.
p.(None): § 29. (1) When planning, setting up and carrying out clinical trials, the health
p.(None): To keep risks and burdens for the test participant as low as possible.
p.(None): (2) The clinical trial of medicinal products may only be carried out if the risks associated with it for
p.(None): the test participants are connected, measured by the expected meaning of the result of the
...
p.(None): (6) The Federal Office for Safety in Health Care can apply to the authorization holder
p.(None): exempt pharmaceutical specialties that do not comply with Paragraph 5 from the pharmacy reservation,
p.(None): if there is no hazard due to the special composition or the intended indication
p.(None): to get. Such a decision must be revoked if it subsequently becomes known that the
p.(None): The requirements for this are not met.
p.(None): (7) Paragraphs 1 to 6 do not apply to medicinal products within the meaning of Section 7 paragraph 4.
p.(None): (7a) If it is medicinal products for animals intended for external use on the skin
p.(None): are, or are medicinal specialties for bees, due to the special composition
p.(None): or the intended indications of these medicinal specialties upon application by the marketing authorization holder
p.(None): Federal Office for Safety in Health Care through a notice outside of pharmacies and
p.(None): Provide drug stores. Such a decision must be revoked if it subsequently becomes known that the
p.(None): The requirements for this are not met.
p.(None): (8) Medical gases may also be supplied by traders who, in accordance with the
p.(None): Trade Regulations 1994 are authorized to supply compressed technical gases in retail sales.
p.(None): (9) The dispensing of medicines by self-service or by distance selling is prohibited.
p.(None): (10) The distance selling ban according to paragraph 9 does not apply to those who are not registered or registered in Austria
p.(None): prescription-only human medicinal products sold by distance selling
p.(None): 1. within Austria through public pharmacies, or
p.(None): 2. to Austria through pharmacies of another EEA contracting party, according to those applicable there
p.(None): Legislation are empowered to
p.(None): be delivered.
p.(None): (11) The distance selling ban in accordance with paragraph 9 does not apply to human medicinal products that comply with the national
p.(None): Legal requirements of another EEA contracting party correspond, provided that they do not require a prescription there
p.(None): are by means of distance selling through public pharmacies in the territory of this EEA Contracting Party
p.(None): be delivered.
p.(None): Note for the following provision
p.(None): For the entry into force cf. Section 13 (2) of the Distance Selling Ordinance, Federal Law Gazette II No. 105/2015, and Section 94i (3).
p.(None): distance Selling
p.(None): Section 59a. (1) The supply of human medicinal products by means of distance selling in accordance with Section 59 (10)
p.(None): Z 1 and Paragraph 11 may only be carried out by public pharmacies that meet the requirements of Paragraphs 2 and 3
p.(None): fulfill.
p.(None): (2) Public pharmacies that intend to sell human medicinal products to the public
p.(None): to offer by means of distance selling, the Federal Office for
p.(None): Healthcare security with the name of the operator and the address, the date
p.(None): the start of the activity and the address of the websites used for this purpose, including all
p.(None): Display information for their identification. Changes to this information must be reported immediately.
p.(None): (3) The websites according to paragraph 2 must at least
p.(None): 1. the address and other contact details of the Federal Office for Safety in Health Care
p.(None): exhibit,
p.(None): 2. On every page of the website that deals with the offer of sales of human specialties
p.(None): obtains through distance selling, the common logo according to Art. 85c (3) of Directive 2001/83 / EC, which
p.(None): must contain a link to the list in accordance with paragraph 4 no. 3, display it in a clearly visible manner, and
p.(None): 3. a connection to the Internet portal of the Federal Office for Health Care in accordance with
p.(None): Section 27 (4).
p.(None): (4) The Federal Office for Safety in Health Care has via the Internet portal in accordance with § 27 para. 4
p.(None): provide at least the following information:
p.(None): 1. Information on the offer to the public for the sale of human medicinal products
...
p.(None): intended for transfusion, processed, stored or distributed, once in two years, by others
p.(None): Operate at least once every five years. You are in default unless there is a danger or if
p.(None): there is a reasonable assumption that the effectiveness of the official act is impaired,
p.(None): to announce in advance. Checks according to Art. 8 of Directive 96/22 / EC are without prior notice
p.(None): perform.
p.(None): (3) The Federal Minister of Health and Environmental Protection is authorized to deal with the highest
p.(None): Health authorities of those countries to which drugs or active substances are exported or from which drugs are exported
p.(None): or active substances are to be imported, administrative convention regarding the review of the
p.(None): Establishments in which these medicinal products or active substances are manufactured, mutual recognition
p.(None): to complete these reviews and exchange of information about these establishments.
p.(None): (4) The Federal Office for Safety in Health Care may carry out operational reviews by third countries
p.(None): Perform drug manufacturers to determine if they are manufactured according to standards and
p.(None): have been checked in accordance with the standards of good manufacturing practice set by the European Union
p.(None): are at least equivalent. The Federal Office for Safety in Health Care can
p.(None): Suspicion of a violation of the requirements of this section or based on this
p.(None): Section decrees for manufacturers or distributors of third-party countries
p.(None): Carry out active ingredient checks. The Federal Office for Safety in Health Care has contributed
p.(None): Co-ordinate operational reviews in third countries with the Agency and these
p.(None): to inform about planned and carried out operational reviews.
p.(None): (5) The Federal Office for Safety in Health Care can, if there are suspicion reasons
p.(None): Violation of the provisions of this section or those adopted on the basis of this section
p.(None): Regulations for companies that manufacture or import auxiliary materials, carry out company reviews.
p.(None): The Federal Office for Safety in Health Care can also in the premises of
p.(None): Marketing authorization holders, registration holders or pharmaceutical intermediaries
p.(None): carry out.
p.(None): (6) Operational reviews in accordance with paragraphs 1 and 4 and operational reviews in accordance with paragraph 5 of
p.(None): Companies that manufacture or import auxiliary materials can, at the request of another Member State,
p.(None): the European Commission or the Agency. Without prejudice to any agreements
p.(None): between the European Union and countries that are not parties to the Agreement on the
p.(None): Are European Economic Area, the Federal Office for Safety in Health Care one
p.(None): Manufacturer in the country that is not a contracting state to the Agreement on the European Economic Area,
p.(None): request to undergo an operational review in accordance with the requirements of the European Union
p.(None): (7) The Federal Office for Safety in Health Care has company reviews of companies that
p.(None): 1. Human medicinal products or
p.(None): 2. Active ingredients
p.(None): manufacture, control or place on the market according to the guidelines of the European Commission
...
p.(None): Healthcare experts are authorized to
p.(None): 1. Companies in accordance with § 62 Paragraph 1 and
p.(None): 2. Facilities and means of transport of such companies that are operated by companies in accordance with Section 62 (1) with
p.(None): Storage or transport have been commissioned, provided that they are for storage or transport
p.(None): of drugs or active ingredients can serve
p.(None): to enter, to visit, to check and to take samples in the quantity required for an examination
p.(None): and to inspect the records of the company, which according to drug law
p.(None): Regulations are to be kept, and copies thereof as well as photographs and video recordings in the company
p.(None): to be made if this is necessary to preserve evidence. You can also inspect the certificate
p.(None): the necessary business license according to the trade regulations 1994 taken
p.(None): become. These official acts are, except in the event of imminent danger, during the operating hours
p.(None): perform.
p.(None): (2) The organs and experts within the meaning of paragraph 1 must take care that each
p.(None): disruption or obstruction of the operation that is not absolutely necessary is avoided.
p.(None): (3) No compensation is due for the samples taken in accordance with paragraph 1.
p.(None): (4) A record according to §§ 14f AVG and its content is to be recorded for each company audit
p.(None): from the Federal Office for Safety in Health Care to the holder of the operating license
p.(None): bring is. In terms of content, the minutes are based on those of the European Commission
p.(None): published guidelines in accordance with Art. 51 of Directive 2001/82 / EC or Art. 111a of Directive 2001/83 / EC
p.(None): to orient. Upon reasoned request from another party to the Agreement on the European
p.(None): Economic area or Switzerland, the Federal Office for Safety in Health Care has this
p.(None): Send the record to the requesting state.
p.(None): (5) The Federal Office for Safety in Health Care has within 90 days of completion
p.(None): to issue a certificate of an operational audit if the operational audit has shown
p.(None): that the operation complies with the provisions of this section, those adopted on the basis of this section
p.(None): Regulations and the operating license. The form and content of the certi fi cate are those of the
p.(None): European Commission published guidelines according to Art. 51 of Directive 2001/82 / EC and Art. 111a
p.(None): of Directive 2001/83 / EC. If these requirements are not met, that has
p.(None): Federal Office for Safety in Health Care with notice within the specified period
p.(None): determine. The certi fi cate is to be withdrawn if it subsequently becomes known that the requirements
p.(None): did not exist. It must be revoked if the requirements are no longer met.
p.(None): (6) The Federal Office for Safety in Health Care has the certificates it has issued in accordance with
p.(None): Paragraph 5 in the Union database in accordance with Art. 111 Paragraph 6 of Directive 2001/83 / EC. In these
p.(None): The Federal Office for Safety in Health Care also has information about companies that database
p.(None): the provisions of this federal law or ordinances issued on the basis of this federal law
p.(None): do not correspond to enter. This also applies to the registration and deletion of pharmaceutical intermediaries.
p.(None): Section 69. (1) In cases of imminent danger to human or animal health caused by medicinal products
p.(None): Federal Office for Safety in Health Care according to the extent of the risk
...
p.(None): are subjected, in particular to the presence of diseases and circumstances within the meaning of
p.(None): Paragraph 1 is to be observed.
p.(None): (3) The persons named in paragraph 1 are at the beginning of their employment via paragraphs 1 and 2 as well
p.(None): to be instructed by the employer about § 83 Z 7.
p.(None): drug agent
p.(None): Section 71a. (1) A medication broker who is based in Austria has the Federal Office for Security in
p.(None): Healthcare to report his name, company name and permanent address. each
p.(None): The mediator must report any changes to this data immediately. The Federal Office for Security
p.(None): in the healthcare sector, a register has to be kept of reports from pharmaceutical intermediaries. This is
p.(None): on the website of the Federal Office for Safety in Health Care.
p.(None): (2) The Federal Office for Safety in Health Care has on application for registration
p.(None): to issue a confirmation. The registration must be denied or deleted if the in
p.(None): this federal law or on the basis of an ordinance issued under this federal law
p.(None): specified requirements have not been met or have subsequently ceased to apply.
p.(None): (3) The Federal Minister of Health may, by ordinance, provide more detailed provisions regarding the
p.(None): Issue requirements for the mediation of medicinal products, in particular via
p.(None): Documentation requirements and quality assurance measures.
p.(None): VIII. SECTION
p.(None): Pharmareferent
p.(None): qualification
p.(None): Section 72. (1) The activity of a pharmaceutical representative may only be carried out by persons who:
p.(None): 1. a university course in human medicine, dentistry, veterinary medicine
p.(None): or pharmacy in Austria or in another party to the Agreement on the
p.(None): European Economic Area or successful in the Swiss Confederation
p.(None): have completed or have the qualifications of a competent person,
p.(None): 2. have demonstrated by means of an examination that their vocational training with a view to the activity of a
p.(None): Pharmaceutical officers are to be equated with professional training according to Z 1.
p.(None): (2) The examination in accordance with paragraph 1 no. 2 is to be taken at the Federal Ministry of Health and
p.(None): Examination committee to be set up for environmental protection.
p.(None): (3) The Federal Minister of Health and Environmental Protection has more detailed regulations by ordinance
p.(None): about the composition of the examination board, the examination subjects, the examination requirements and
p.(None): to issue the conduct of the test.
p.(None): (4) In any case, the ordinance pursuant to para. 3 must stipulate that
p.(None): 1. the examination committee to be appointed as members by the Federal Minister for Health and Women
p.(None): Experts from the areas mentioned in Z 2, as well as one representative of each
p.(None): Austrian Chamber of Commerce, the Federal Chamber of Labor and the Austrian Medical Association as
p.(None): Assessors have to belong
p.(None): 2. the exam at least the subjects
p.(None): a) General principles of physics and chemistry,
p.(None): b) anatomy and physiology,
p.(None): c) pathology,
p.(None): d) hygiene, medical microbiology and parasitology,
p.(None): e) pharmacology and pharmaceutical technology,
p.(None): (f) pharmaceutical chemistry and pharmacognosy; and
p.(None): g) Pharmaceutical Law
p.(None): has to include, and
p.(None): 3. The prerequisite for taking the exam is at least the general university entrance qualification
p.(None): or represents a professional qualification in the higher service for health and nursing.
p.(None): (5) Nationals of a contracting party to the Agreement on the European Economic Area
p.(None): or the Swiss Confederation, who have a certificate of competence within the meaning of the directive
p.(None): 2005/36 / EG on the recognition of professional qualifications, which is necessary for the practice of
p.(None): Authorized to work as a pharmaceutical officer, the Federal Minister of Health has granted approval for
p.(None): To exercise a profession as a pharmaceutical officer.
p.(None): (6) Admission to practice is conditional on the successful completion of a
p.(None): Aptitude test to be linked if it can be proven by submitting the relevant documents
p.(None): Knowledge of the applicant differ significantly from the required Austrian knowledge.
p.(None): (7) The decision on admission to practice has to be made within four months of submission
p.(None): of these documents.
p.(None): (8) More detailed regulations on the documents to be submitted by the applicant and on the
p.(None): The Federal Minister of Health and Women has carried out and assessed the aptitude test in
p.(None): of a regulation in accordance with paragraph 3.
p.(None): obligations
p.(None): Section 73. (1) Pharmaceutical officers have the information in the exercise of their activity that the specialist information
p.(None): according to § 15, must convey without restriction. Statements made by the content of the
p.(None): Subject information that is not covered is not permitted.
p.(None): (2) Pharmaceutical officers are obliged to provide them with information in accordance with Section 75a
p.(None): to be sent to your client immediately.
p.(None): Section 74. Pharmaceutical officers may not place orders for medicinal products when performing their duties
p.(None): answer.
p.(None): IX. SECTION
...
p.(None): Health care immediately, but at the latest within 24 hours, information to the public
p.(None): about the lack of quality and the resulting dangers. Any from
p.(None): Approval holders have already taken measures to be taken into account. Section 75c (2) applies
p.(None): analogous.
p.(None): (8) Paragraphs 2 to 4, 6 and 7 apply analogously to counterfeit medicinal products.
p.(None): sampling
p.(None): Section 76. (1) Medicines are issued by organs of the Federal Ministry of Health and Women
p.(None): Organs of the Federal Office for Safety in Health Care or commissioned by them
p.(None): Control experts.
p.(None): (2) The control has by sampling in the company of the 1st manufacturer,
p.(None): 2. Depositeurs,
p.(None): 3. pharmaceutical wholesaler or
p.(None): 4. Pharmaceutical retailer
p.(None): to take place during operating hours.
p.(None): (3) Feed medicinal products can also be checked by the consumer.
p.(None): (3a) Radioactive medicinal products can also be checked by the user.
p.(None): (4) The organs of the Federal Ministry of Health and Women are responsible for carrying out the control
p.(None): and the Federal Office for Safety in Health Care or experts commissioned by them
p.(None): To grant access to the companies mentioned in paragraph 2 and the necessary sampling. this applies
p.(None): analogously also for the control of feed medicinal products at the consumer and of radioactive ones
p.(None): Medicines for the user.
p.(None): (5) The sample taken is, insofar as this is possible by nature and therefore not hers
p.(None): faultless assessment is frustrated to be divided into two equal parts that are officially closed. On
p.(None): Part is to be left to the party for evidence.
p.(None): (6) No compensation is due for the samples taken. Are the samples in factories according to
p.(None): Paragraph 2 no. 3 or 4, taken from the consumer according to Paragraph 3 or from the user according to Paragraph 3a
p.(None): the manufacturer or depositeur must provide replacement by providing the same pieces.
p.(None): Section 76a. (1) Monitoring food traffic suspected of being
p.(None): Medicinal products are or banned active substances in accordance with Section 1 (2) (1) of the 2007 Anti-Doping Act
p.(None): included (hereinafter referred to as "goods") is the responsibility of the governor.
p.(None): (2) The governor has chosen to perform this task as specially trained bodies
p.(None): To use supervisory bodies. The following are considered specially trained:
p.(None): 1. Doctors who have passed the physics examination and
p.(None): 2. People who meet the training requirement in accordance with Section 24 (3) LMSVG.
p.(None): (3) Supervisory bodies are entitled to inspect wherever goods are placed on the market
p.(None): hold and take samples. For this purpose, they must be granted access to all places where
p.(None): are goods. The review is, apart from the control of means of transport or at
p.(None): Danger of being delayed during normal business or operating hours. The disturbance of the
p.(None): Business operations should be avoided if possible.
p.(None): (4) The sample taken is, insofar as this is possible by nature and therefore not hers
p.(None): faultless assessment is frustrated to be divided into two equal parts that are officially closed. On
p.(None): Part is to be left as a cross-check of the party for evidence purposes. If a division is not possible, it has
p.(None): Supervisory body to supply the sample without prior division of the investigation. For the samples taken
p.(None): no compensation is due.
p.(None): (5) On the occasion of the sampling, the supervisory body must issue a cover letter and everyone
p.(None): Include part of the sample in which the observations and observations are noteworthy for the assessor
p.(None): of the organ are included. The Federal Minister is responsible for the details of the sample accompanying letter
p.(None): for health and women.
p.(None): (6) The sample taken is to be sent to the investigating institution. This
p.(None): The investigation institute has to examine the sample and to produce findings and expert opinions. findings
p.(None): and reports are to be sent immediately to the sampling agency. If the
p.(None): Investigation center comes to a reasoned opinion that the suspicion of the violation of
p.(None): Legislation is in place, so it has to determine this in its report and the responsible person
p.(None): To inform the authority immediately.
p.(None): (7) The Federal Minister of Health and Women has the one in question by ordinance
p.(None): Investigation facility or the relevant investigation facilities in accordance with Paragraph 6 - if there is
p.(None): to carry out investigations into bumps within the meaning of Section 1 (2) (1) of the Anti-Doping
p.(None): Federal Act 2007 acts in agreement with the Federal Chancellor.
p.(None): Section 76b. (1) Supervisory bodies pursuant to Section 76a (2) have to confiscate the goods temporarily or securely
...
p.(None): of the report to the public prosecutor's office, to the court from the time the charge is brought.
p.(None): (5) The goods seized or seized must be left in the company. You are so
p.(None): to seal or to mark that a change without breaching the containers, the
p.(None): Packaging or labeling is not possible. The person who is previously authorized to dispose of the goods
p.(None): by the supervisory body in writing on the criminal consequences of the transfer or change of the
p.(None): confiscated or seized goods and the violation of the official seal
p.(None): do.
p.(None): (6) The preservation of the goods left in the company from damage is the responsibility of the previous one
p.(None): Person entitled. If special measures are required for this, he has the responsible authority
p.(None): to inform beforehand; at the expense of the person concerned, the latter has, if necessary, instructions regarding
p.(None): shipment, storage, sealing or labeling. The measures are, except
p.(None): in the event of imminent danger, in the presence of a supervisory body.
p.(None): (7) During the seizure or seizure, samples of the goods may only be ordered by the
p.(None): competent authority or the responsible public prosecutor.
p.(None): (8) The provisions of Sections 87 and 106 StPO apply mutatis mutandis.
p.(None): (9) The district administrative authority has forfeited the seized goods as a security measure
p.(None): to explain if there is a serious and significant danger to humans or animals and the
p.(None): Authorized party does not guarantee that the goods will not be placed on the market after their release
p.(None): becomes.
p.(None): (10) With regard to the costs of an investigation, § 381 (1) 3 StPO applies in criminal proceedings. in the
p.(None): Administrative criminal proceedings are punitive in the penalty of reimbursement of the cost of the investigation
p.(None): to prescribe the respective research institute.
p.(None): Section 76c. (1) Before recovery of the goods that have been expired, the authority must inform the accused and the
p.(None): to give the person affected by the decay the opportunity to make a statement.
p.(None): (2) The expired goods are to be used in a useful manner. The expired goods are at the expense of
p.(None): Accused or destroy the person affected by the forfeiture if there is a useful recovery
p.(None): is not possible or the exploitation of the goods does not lead to the expectation that the achievable proceeds will
p.(None): Recovery costs will exceed. The destruction of the expired goods is by the accused or
p.(None): permitted by the person affected by the forfeiture at his own expense under the supervision of a supervisory body.
p.(None): (3) The proceeds of the exploitation are after deduction of the associated expenses and any
p.(None): irrecoverable costs of the criminal proceedings as well as the burden on the case
p.(None): To transfer liabilities to the federal government.
p.(None): Surveillance and protective measures
p.(None): Section 77. Is determined during a check in accordance with Section 76 or is the Federal Office for Security receiving
...
p.(None): Section 78b applies to the enforcement of a provisional seizure.
p.(None): Section 78b. The business owner or his / her authorized representative refuses to act after this
p.(None): Tolerating surveillance or protective measures provided for by federal law can enforce them
p.(None): become.
p.(None): X. SECTION
p.(None): fees
p.(None): Section 79. (1) The Federal Minister of Health and Consumer Protection, in agreement with the
p.(None): Federal Minister of Finance Fees for the permits to be issued under this Federal Act and
p.(None): other activities of federal agencies whose necessity changes
p.(None): 1. from this Federal Act and the ordinances issued on the basis thereof or
p.(None): 2. relevant legal acts of the European Union
p.(None): results, according to experience, from the average growing costs in a tariff
p.(None): set. The tariff and its changes are to be published in the “Official Gazette of the Wiener Zeitung”.
p.(None): Copies of the tariff are from the Federal Ministry (correct: Federal Ministry) for health and
p.(None): To provide consumer protection on request against reimbursement of costs.
p.(None): (2) Is the result of this Federal Act, the regulations issued on the basis thereof
p.(None): or the legal acts within the meaning of paragraph 1 no. 2 the necessity of activities of departments of the
p.(None): Federal government for which a tariff has not been set, the costs actually incurred must be stipulated.
p.(None): (3) The Federal Minister of Health and Consumer Protection can distance himself from this in individual cases
p.(None): to collect fees for certain activities if these are based on a party request
p.(None): are to be carried out and the interests of public health in this application are party interest
p.(None): significantly exceed.
p.(None): (4) For cash expenses, the party, regardless of the fees specified in the tariff in accordance with § 76 of the
p.(None): General Administrative Procedure Act 1991, Federal Law Gazette No. 51.
p.(None): XI. SECTION
p.(None): Automation-supported data traffic
p.(None): § 80. (1) To ensure drug safety and to ensure the protection of
p.(None): Life and health of humans and animals may be required for the implementation of this federal law
p.(None): personal data about pharmaceutical companies and users of pharmaceuticals in the
p.(None): Relation to the manufacture, control, distribution and use of medicinal products by
p.(None): processed by the Federal Office for Safety in Health Care.
p.(None): (2) To ensure drug safety and to ensure the protection of life and
p.(None): Human and animal health are allowed for the enforcement of this federal law with regard to
p.(None): Medicinal product monitoring requires personal data related to patients
p.(None): Use of medicinal products by the reporting agents are transmitted pseudonymized. The
p.(None): Processing by the Federal Office for Safety in Health Care has increased in pseudonymized form
p.(None): as long as the data is required in this form for the purposes of drug monitoring.
p.(None): (3) The Federal Office for Safety in Health Care is authorized to process the data in accordance with paragraphs 1 and 2
p.(None): to be transmitted with automation support
p.(None): 1. the Federal Ministry of Health and Women and subordinate authorities for purposes in the sense
p.(None): paragraphs 1 and 2,
...
p.(None): Humans and animals are protected.
p.(None): (2) In the event of a disaster, epidemic, pandemic, terrorist threat, martial
p.(None): The Federal Minister of Health and Women,
p.(None): if the necessary supply of the population would otherwise be seriously and significantly endangered by
p.(None): Ordinance Regulations on supply and provision obligations for marketing authorization holders,
p.(None): Depositeurs, manufacturers, pharmaceutical wholesalers, pharmaceutical wholesalers and public pharmacies
p.(None): adopted if and as long as this is necessary due to the special situation.
p.(None): (3) A regulation pursuant to Paragraph 1 or Paragraph 2 applies for a maximum of six months.
p.(None): § 94e. (1) As long as the World Health Organization (WHO) has declared a pandemic of influenza
p.(None): 1. A license that is in accordance with the provisions of this federal law and approved for Austria
p.(None): Vaccine for vaccination against New Influenza A (H1N1) directly from the manufacturer or marketing authorization holder
p.(None): on
p.(None): (a) local authorities, and
p.(None): b) by the public sector (local authorities, health insurance providers and
p.(None): Health care facilities) certain distribution centers
p.(None): be delivered and
p.(None): 2. the vaccine by means of the local authorities or distribution centers to from the public
p.(None): Hand (local authorities, health insurance providers and health care institutions)
p.(None): certain vaccination sites are given. For the distribution of the vaccine, the
p.(None): Manufacturers, marketing authorization holders who serve local authorities and third-party distribution centers.
p.(None): (2) Medicines used in the event of a disaster, terrorist threat, martial
p.(None): Confrontation, epidemic, pandemic or other crisis situation to those in § 57 Paragraph 1 Numbers 5 and 5a
p.(None): given to maintain the drug supply and from these to
p.(None): Averting the danger posed by such a crisis situation may be kept in
p.(None): of their intended commercial packaging or original packaging to manufacturers, depositors, pharmaceutical
p.(None): Wholesalers, public pharmacies and institutional pharmacies are sold.
p.(None): (3) Pharmaceutical specialties that are available through a regional authority or on behalf of a regional authority
p.(None): Averting from a catastrophe, terrorist threat, armed conflict,
p.(None): Epidemic, pandemic or other crisis situation pending dangerous situation held in stock
p.(None): may be kept in stock even after the expiry date has passed and for stockpiling
p.(None): be handed in as well as given when the specific danger occurs, if on a professional basis
p.(None): Investigations by the Federal Office for Safety in Health Care have found that their
p.(None): Quality and impact are still guaranteed.
p.(None): § 94f. (1) Pharmacy proprietary medicinal products, which according to § 9d in the version before the entry into force
p.(None): of this federal law in the version of the federal law BGBl. I № 63/2009 have been approved
p.(None): as registered pharmacy specialties according to § 11a of this federal law in the version of the
p.(None): Federal Law BGBl. I No. 63/2009.
...
Health / Cognitive Impairment
Searching for indicator impaired:
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p.(None): 7. if necessary, special precautionary measures for storage,
p.(None): 8. special warnings,
p.(None): 9. batch number,
p.(None): 10. Registration number,
p.(None): 11. the note “Homeopathic medicinal specialty without approved therapeutic
p.(None): Application areas",
p.(None): 12. the indication that a doctor should be consulted if symptoms of illness persist, and
p.(None): 13. the date of creation of the package leaflet, in the case of a change the date of the last
p.(None): Modification.
p.(None): (3) The Federal Office for Safety in Health Care can request an exception from one
p.(None): Grant requirement according to paragraphs 1 and 2 if this is necessary for reasons of expediency, especially in
p.(None): With regard to the type of pharmaceutical specialty and its primary or outer packaging offered and with the
p.(None): Principles of drug safety is compatible.
p.(None): (4) If this is for the sake of expediency, in particular with regard to the type of
p.(None): Pharmaceutical specialty and its primary or outer packaging is offered and it with the principles of
p.(None): Pharmaceutical safety is compatible, the Federal Minister of Health and Women can by ordinance
p.(None): considering the requirements of protecting human or animal health exceptions
p.(None): issued from the requirements of paragraphs 1 and 2.
p.(None): Obligations in connection with the package leaflet
p.(None): § 16c. (1) The authorization holder or the holder of a registration must ensure that the
p.(None): Package leaflet is available at the request of patient organizations in formats suitable for blind and
p.(None): visually impaired people are suitable.
p.(None): (2) The package leaflet has the results of cooperation with patient target groups
p.(None): reflect. The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): adopted to ensure the readability, clarity and user-friendliness of the package leaflet.
p.(None): Note for the following provision
p.(None): For the entry into force cf. Section 38 (2) of the Medicinal Products Regulations 2009, Federal Law Gazette II No. 41/2019 and Section 94i (2).
p.(None): Labelling
p.(None): Section 17. (1) Pharmaceutical specialties that are in accordance with Section 7 of the approval or in accordance with Section 11a of the registration
p.(None): are only allowed to be placed on the market unless they are radioactive pharmaceutical specialties
p.(None): if the following information is in German on the outer packaging and the primary packaging
p.(None): are included:
p.(None): 1. Name of the medicinal product, followed by the strength and the dosage form; where appropriate
p.(None): Indication of whether it is intended for use by infants, children or adults; contains the
p.(None): Pharmaceutical specialty up to three active ingredients, the international free name (INN) must be listed
p.(None): or, if this does not exist, the common name; this applies to veterinary specialties
p.(None): However, there is an obligation for such pharmaceutical specialties that do not contain more than one active ingredient
p.(None): 2. Name and address of the authorization holder,
p.(None): 3. approval number,
p.(None): 4. qualitative and quantitative composition of active ingredients according to dosage unit or depending on
p.(None): Form of administration for a given volume or weight using the
p.(None): common names,
...
p.(None): Provisions of this section or the regulations issued on the basis of this section
p.(None): is complied with and is necessary for the health and life of humans or animals
p.(None): Condition of the drug or active ingredients is guaranteed. The Federal Minister of Health can
p.(None): authorize the provincial governors to regulate such types of businesses
p.(None): Check state where this is due to the product range with regard to
p.(None): Drug safety appears justified.
p.(None): (1a) The Federal Office for Safety in Health Care has the Federal Minister of Health
p.(None): a risk-based inspection and sample plan for the implementation of the
p.(None): Operational reviews and the controls according to § 76 for the following calendar year for approval
p.(None): required. The approval is deemed to have been granted if no objections are raised within three months of receipt
p.(None): become. The Federal Office for Safety in Health Care has approved the
p.(None): Inspection and rehearsal plan to be submitted to the Federal Ministry of Health by March 31 of
p.(None): report on the execution of the following calendar year.
p.(None): (2) The reviews of companies that manufacture or control pharmaceuticals or active ingredients are
p.(None): at least once in three years, from establishments that provide human blood or blood components, provided that
p.(None): intended for transfusion, processed, stored or distributed, once in two years, by others
p.(None): Operate at least once every five years. You are in default unless there is a danger or if
p.(None): there is a reasonable assumption that the effectiveness of the official act is impaired,
p.(None): to announce in advance. Checks according to Art. 8 of Directive 96/22 / EC are without prior notice
p.(None): perform.
p.(None): (3) The Federal Minister of Health and Environmental Protection is authorized to deal with the highest
p.(None): Health authorities of those countries to which drugs or active substances are exported or from which drugs are exported
p.(None): or active substances are to be imported, administrative convention regarding the review of the
p.(None): Establishments in which these medicinal products or active substances are manufactured, mutual recognition
p.(None): to complete these reviews and exchange of information about these establishments.
p.(None): (4) The Federal Office for Safety in Health Care may carry out operational reviews by third countries
p.(None): Perform drug manufacturers to determine if they are manufactured according to standards and
p.(None): have been checked in accordance with the standards of good manufacturing practice set by the European Union
p.(None): are at least equivalent. The Federal Office for Safety in Health Care can
p.(None): Suspicion of a violation of the requirements of this section or based on this
p.(None): Section decrees for manufacturers or distributors of third-party countries
p.(None): Carry out active ingredient checks. The Federal Office for Safety in Health Care has contributed
p.(None): Co-ordinate operational reviews in third countries with the Agency and these
p.(None): to inform about planned and carried out operational reviews.
p.(None): (5) The Federal Office for Safety in Health Care can, if there are suspicion reasons
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p.(None): to determine whether the respective pharmaceutical specialties are new and for what period or what number of
p.(None): Batches are subject to batch inspection.
p.(None): (2) Batch release is subject to certain immunological conditions for use on or in animals
p.(None): Medicinal specialties that consist of vaccines, toxins, sera or allergens and for the defense against
p.(None): Notifiable animal diseases according to § 16 animal diseases law, RGBl. No. 177/1909.
p.(None): (3) Pharmaceutical specialties in accordance with paragraphs 1 and 2 may be without prejudice to the provisions on approval
p.(None): of medicinal products in Germany can only be delivered or kept ready for delivery if by a
p.(None): a testing institute designated by the Federal Minister for Health and Women was determined,
p.(None): that the batch conforms to the speci fi cations approved in the approval, in the case of non-approved
p.(None): Medicinal specialties correspond to the state of the art in science and technology. The decision has been made by
p.(None): the designated institute within 60 days of submitting an application and the
p.(None): necessary documents to be made. The applicant must be informed immediately. comes
p.(None): there is no positive opinion within 60 days, the applicant can contact the
p.(None): Federal Office for Safety in Health Care submit an application for a decision by the Federal Office.
p.(None): (4) The Federal Office for Safety in Health Care has an exception to the requirement upon application
p.(None): the batch release within the meaning of paragraph 3 if this is with regard to the special
p.(None): Condition, type of application or area of application of this medicinal specialty without
p.(None): Impairment of drug safety is justified. The exception must be revoked if the
p.(None): There are no prerequisites for this. Foreign medicinal specialties that are intended for a specific purpose in the
p.(None): 12 to 14 and 14 to 14 of the 2010 Medicinal Products Imports Act
p.(None): not batch release. Drug specialties by the state testing agency of another contracting party
p.(None): of the Agreement on the European Economic Area checked and approved in Austria
p.(None): Compliant specifications are also not subject to batch release.
p.(None): (5) The following principles apply when assessing the batch:
p.(None): 1. The testing institute named by ordinance of the Federal Minister for Health and Women can
p.(None): submit an assessment without performing an additional analytical test if
p.(None): Manufacturing and control methods the required quality, safety and harmlessness
p.(None): guarantee.
p.(None): 2. If the named test institute carries out an analytical test, this is based on the information provided in the frame
p.(None): of the admission procedure and if necessary available in the course of the application
p.(None): provided samples of the end product or samples of certain intermediate products (bulk
p.(None): Batches). It is important to ensure that the product meets the approval requirements
p.(None): approved specifications.
p.(None): 3. Can the testing institute named by the Federal Minister for Health and Women be approved on the basis of the
p.(None): submitted control reports and, if applicable, the analytical results obtained in the
...
p.(None): to publish. The assessment report is a generally understandable summary
p.(None): publish, which must in particular contain a section on the conditions of the application. In front
p.(None): The approval or registration holder can be heard in the publication.
p.(None): III. SECTION
p.(None): Clinical trial
p.(None): general requirements
p.(None): § 28. (1) Clinical trials may only be carried out if
p.(None): 1. as expected, they meet the objectives of section 2a (1),
p.(None): 2. Information about relevant physical and chemical data or biological properties as well
p.(None): about the applied pharmaceutical technology and
p.(None): 3. Meaningful results of non-clinical tests are available, which correspond to the respective
p.(None): State of the art.
p.(None): (2) The planning and implementation of clinical trials must comply with the regulations
p.(None): Federal law according to the state of the sciences and according to the principles of good clinical
p.(None): Practice. To interpret the principles of good clinical practice, those are generally accepted
p.(None): To use the principles and requirements set out in Volume 10 of the regulations for medicinal products in the
p.(None): European Union are published.
p.(None): § 29. (1) When planning, setting up and carrying out clinical trials, the health
p.(None): To keep risks and burdens for the test participant as low as possible.
p.(None): (2) The clinical trial of medicinal products may only be carried out if the risks associated with it for
p.(None): the test participants are connected, measured by the expected meaning of the result of the
p.(None): Examination for medicine are justifiable and the risk of impairment of the
p.(None): Examiner health
p.(None): 1. is not significant or
p.(None): 2. is outweighed by the benefit to be expected from the use of the drug
p.(None): Health.
p.(None): (3) The clinical trial of a medicinal product may only be carried out on patients if
p.(None): 1. Results of clinical trials on healthy volunteers are available, unless
p.(None): The investigational medicinal product may not be tested on healthy volunteers in accordance with paragraph 2 no
p.(None): no meaningful result can be expected from healthy subjects, and
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is to treat the disease or the patient on whom the clinical trial is to be performed
p.(None): to recognize their course, to heal or alleviate them or to prevent them from further illnesses
p.(None): protect.
p.(None): If there is meaningful data according to Z 1 and from clinical trials on patients, this may not be available
p.(None): the requirements of Z 2, a clinical trial on the patient can also be carried out if
p.(None): A certain illness of the test participant is a prerequisite for that for the in the test plan
p.(None): the relevant question is expected to result.
p.(None): (4) (Note: repealed by Federal Law Gazette I No. 35/2004)
p.(None): § 30. The clinical trial of medicinal products may be performed on women of childbearing potential, with the exception of cases of
p.(None): Section 44, can only be carried out or continued if before and in sufficient repetition during the
...
p.(None): other predictable risks, including the risk threshold as well as the
p.(None): Degree of exposure specifically defined and constantly checked,
p.(None): 9. The test plan by an ethics committee that has knowledge in the field of children and
p.(None): Juvenile medicine or who deals with clinical, ethical and psychosocial issues on the
p.(None): Had been advised in the area of pediatrics and adolescent medicine, and was approved
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of
p.(None): Science stand.
p.(None): (2) Deviating from Paragraph 1 No. 2, a clinical trial on minors is also permitted if
p.(None): 1. The clinical trial is an essential extension of the scientific understanding of the
p.(None): Condition, illness or disorder of the minor and thereby either
p.(None): Can benefit patients or the patient group to which the minor belongs, and
p.(None): 2. The clinical trial for the minor with only a minimal risk and minimal burden
p.(None): brings oneself; a clinical trial has minimal risk and minimal burden if
p.(None): it is to be expected that at most it will be a minor and merely temporary
p.(None): Impairment and the symptoms or inconvenience at best only
p.(None): could occur temporarily and will be very minor.
p.(None): § 43. (1) The clinical trial on an adult who is due to a mental illness or
p.(None): a comparable impairment of their ability to make decisions regarding representation regarding medical
p.(None): Treatments that have a legal representative (§ 1034 ABGB) may only be carried out if
p.(None): 1. the medicinal product being tested is intended to identify, cure, alleviate or prevent it
p.(None): and is the clinical trial for the confirmation of data used in clinical trials
p.(None): Consent obtained from persons capable of providing information or using other research methods
p.(None): were absolutely necessary,
p.(None): 2. the use of the drug that is being tested, according to the knowledge of medical
p.(None): Science is shown to work in the person who is suffering from a mental illness or an
p.(None): comparable impairment in their ability to make decisions is limited to this disease
p.(None): or to recognize impairment or its course, to heal or alleviate it or to prevent it
p.(None): to protect further diseases, and the associated with the inclusion in the clinical trial
p.(None): Benefit for the test subject outweighs the risk,
p.(None): 3. the consent of the legal representative after appropriate clarification demonstrably and
p.(None): was issued in writing; the presumed will of the test participant must be observed,
p.(None): 4. The test participant has also given evidence and in writing, provided that
p.(None): After appropriate information, he is able to understand the nature, meaning, scope and risks of the
p.(None): to inspect the clinical trial and then determine his will,
p.(None): 5. The consent can be withdrawn at any time without the exam participant
p.(None): Disadvantage arises
p.(None): 6. The candidate, depending on his ability to understand this, information regarding the
p.(None): Testing that has received risks and benefits
p.(None): 7. with the participation in the clinical trial, no incentives or financial benefits
p.(None): Exception to an expense allowance,
p.(None): 8. the clinical trial is planned so that it takes into account the disease and the
p.(None): Developmental stage with as little pain, discomfort, fear and others as possible
p.(None): predictable risks are associated; Both the risk threshold and the degree of exposure must be
p.(None): specifically defined and constantly checked,
p.(None): 9. The test plan from an ethics committee that has knowledge of the area concerned
p.(None): Disease and in relation to the affected patient group or in clinical, ethical
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): to make, provided their application and effect on healthy skin and its appendages
p.(None): are limited and unless they are for use on patients before surgery or others
p.(None): medical interventions that require skin disinfection are intended,
p.(None): 9. Materials or preparations made from materials that are intended exclusively for
p.(None): complementary medical methods to be used, provided that they neither serve nor
p.(None): are intended to fulfill the purpose of paragraph 1, unless it concerns
p.(None): Stumps or preparations from stumps that are made according to homeopathic principles and
p.(None): Process technologies are produced,
p.(None): 10. Substances or preparations made from substances intended for use on animals and
p.(None): a) for cleaning, grooming, imparting certain odor impressions to the animal, influencing the
p.(None): Look or serve to protect the skin and
p.(None): b) do not contain any substances that are in accordance with food law provisions in cosmetic products
p.(None): may not be included
p.(None): 11. Medical devices in the sense of the Medical Devices Act, Federal Law Gazette No. 657/1996 and
p.(None): 12. Organs or parts of organs within the meaning of the Organ Transplantation Act, Federal Law Gazette I No. 108/2012.
p.(None): (3a) A product fulfills both the definition of the medicinal product in accordance with paras. 1 to 3 and the definition
p.(None): of a product regulated in another federal law, only that product is included in this product
p.(None): Apply provisions of this federal law.
p.(None): (3b) At the request of a person who has a product in
p.(None): To market to determine whether a product falls under the definition of a drug. The Federal Office
p.(None): Healthcare Safety may also determine ex officio whether a product is under the
p.(None): De fi nition of the drug falls. As part of these procedures, there may be an opinion from the Delimitation Advisory Board
p.(None): Obtain according to § 49a.
p.(None): (4) are "substances"
p.(None): 1. chemical elements, natural chemical substances and synthetic processing
p.(None): chemical compounds obtained,
p.(None): 2. Plants, parts of plants and plant components in any form, including by extraction
p.(None): obtained substances,
p.(None): 3. Animal bodies as well as body parts, components and metabolic products of humans or animals in
p.(None): of any shape and
p.(None): 4. Microorganisms and viruses and their components or products.
p.(None): (4a) "Active substances" are substances or mixtures of substances which are intended to be used in the manufacture
p.(None): of a drug to be used and when used in drug manufacturing
p.(None): to become medicinally active components of the drug.
p.(None): (4b) "Auxiliary substance" is every component of a medicinal product with the exception of the active substance and the
p.(None): Packaging material.
p.(None): (5) “Medicinal specialties” are medicinal products that are always prepared in advance in the same composition
p.(None): and under the same name in one intended for delivery to the consumer or user
p.(None): Be placed on the market and medicinal products for distribution to consumers or users
p.(None): whose manufacture otherwise uses an industrial process or which is manufactured commercially
p.(None): become.
p.(None): (6) "Pharmacy proprietary medicinal products" are medicinal products that, unless they are
p.(None): Components within the meaning of paragraph 2 no. 2 are only manufactured from components that are in the
p.(None): Austrian medical taxes are listed, which are not of the dosage and type of application
p.(None): Prescriptions are subject to prescription and are only available in the pharmacy in which they are wholly or predominantly
p.(None): getting produced.
p.(None): (6a) “Medicinal products for novel therapies” are gene therapeutics and somatic cell therapeutics according to
p.(None): Part IV of Annex I to Directive 2001/83 / EC of the European Parliament and of the Council of 6 November
p.(None): 2001 on the creation of a Community code for medicinal products for human use, most recently amended by the directive
p.(None): 2009/120 / EG, as well as biotechnologically processed tissue products in accordance with Article 2 Paragraph 1 lit. b the
p.(None): Regulation (EC) № 1394/2007 of the European Parliament and of the Council of November 13, 2007 on
...
p.(None): Establishment of a European Medicines Agency, OJ. № L 136 from 04/30/2004 p. 1, last changed
p.(None): by Regulation (EU) No. 1235/2010, OJ. L 348 from December 31, 2010 p. 1.
p.(None): (12) "Generator" is a system with a fixed parent radionuclide, on the basis of which a
p.(None): Daughter radionuclide is generated, which is extracted by elution or another method and in one
p.(None): radioactive medicine is used.
p.(None): (13) "Kit" is a preparation that - usually before its administration - is in the final
p.(None): radioactive drugs are newly formed or combined with radionuclides.
p.(None): (14) “Precursor” is another one, for radiolabelling another substance before administration
p.(None): produced radionuclide.
p.(None): (15) "Name of the medicinal product" is the name that is either not to be confused with the
p.(None): common name leading fancy name or a common or scientific name in
p.(None): May be associated with a trademark or the name of the marketing authorization holder.
p.(None): (16) "Strength of the medicinal product" is, depending on the form of administration, the amount of active ingredient per dose,
p.(None): Unit of volume or weight.
p.(None): (17) 'primary packaging' means the container or any other form of pharmaceutical packaging which
p.(None): comes into direct contact with the medicine.
p.(None): (18) "Agency" is the European Medicinal Products Agency established by Regulation (EC) № 726/2004
p.(None): Agency.
p.(None): (19) 'Generic' is a medicinal product that has the same qualitative and quantitative composition
p.(None): Active ingredients and the same dosage form as the reference drug and its
p.(None): Bioequivalence with the reference medicinal product has been demonstrated by means of suitable bioavailability studies.
p.(None): The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of one
p.(None): Active ingredients are considered to be one and the same active ingredient, unless their properties differ significantly
p.(None): in terms of safety or effectiveness. In this case, the applicant must provide additional data
p.(None): be presented, the safety or effectiveness of the various salts, esters or derivatives of a
p.(None): prove approved active ingredient. The different oral dosage forms with immediate
p.(None): Drug release is considered one and the same dosage form.
p.(None): (20) 'Reference medicinal product' is one in Austria or in another contracting party to the Agreement
p.(None): Pharmaceutical specialty approved through the European Economic Area.
p.(None): (21) “Plant pods” are all predominantly whole, shredded or cut plants,
p.(None): Parts of plants, algae, fungi, lichens in unprocessed condition, usually in the dried form, but
p.(None): sometimes also fresh. Certain plant excretions that have not undergone any special treatment
p.(None): were also considered herbal substances. Vegetable substances are due to the plant part and
p.(None): the botanical name according to the binomial system (genus, art. variety and author) is precisely defined.
p.(None): (22) 'Vegetable preparations' are preparations which are made by
p.(None): Impact treatments such as extraction, distillation, pressing, fractionation, purification, concentration or
p.(None): Undergo fermentation. These include grated or powdered plant matter,
p.(None): Tinctures, extracts, essential oils, press juices and processed plant excretions.
p.(None): (23) “Plant-based medicinal products” are all medicinal products that act exclusively as one or more active substances
p.(None): vegetable substances or one or more vegetable preparations or one or more such
p.(None): contain vegetable substances in combination with one or more such herbal preparations.
p.(None): (24) "Traditional herbal medicinal product specialty" is a herbal medicinal product that complies with the requirements of § 12
p.(None): specified conditions met.
p.(None): (25) 'Counterfeit medicinal product' means any medicinal product that has been counterfeited:
p.(None): 1. its identity, including its packaging and labeling, its name or its
p.(None): Composition related to any ingredient, including excipients and content
...
p.(None): 1. its labeling on the container with regard to the actual content, or
p.(None): 2. the records and documents in connection with the manufacturers involved or the
p.(None): distribution channels used.
p.(None): § 2. (1) "Users" are doctors, dentists, veterinarians, dentists, midwives, members of the
p.(None): Nursing, medical and technical services and first aid services and
p.(None): Legal entities of hospitals without their own institutional pharmacy and other medical facilities, insofar as
p.(None): need these medicines to do their job.
p.(None): (2) "pharmaceutical wholesaler" is a trader who, based on the 1994 Industrial Code,
p.(None): Federal Law Gazette № 194, is entitled to wholesale pharmaceuticals and has a corresponding license
p.(None): in accordance with section 63 (1), as well as a pharmaceutical company of another contracting party of the
p.(None): Agreement on the European Economic Area, which is authorized to wholesale pharmaceuticals
p.(None): float.
p.(None): (3) "pharmaceutical wholesaler" is a pharmaceutical wholesaler, according to which sufficient
p.(None): Warehousing, a corresponding assortment design and a corresponding
p.(None): Willingness, regularity and intensity of care, capable of supplying drugs in the sense
p.(None): of § 57 in a certain area.
p.(None): (3a) "Mediator" is one in a contracting party to the European Economic Area
p.(None): resident person authorized to act as a mediator of medicinal products for human use.
p.(None): (3b) "Bulkware" is a medicinal product that only needs to be filled or packaged to
p.(None): To become the final product.
p.(None): (4) “Batch” is the quantity of a drug manufactured in the course of a uniform manufacturing process.
p.(None): (5) "Batch name" is a characteristic combination of digits or letters used to
p.(None): serves to clearly identify a batch.
p.(None): (5a) "Compassionate Use Program" is the placing on the market of a medicinal product within the meaning of Art. 83
p.(None): of Regulation (EC) No. 726/2004.
p.(None): (6) “Depositeur” is
p.(None): 1. a trader who, on the basis of the 1994 Industrial Code, deals in the wholesale sale of medicines
p.(None): is entitled and has a corresponding license pursuant to Section 63 (1), or
p.(None): 2. the operator of a domestic public pharmacy,
p.(None): who markets a medicinal product manufactured abroad in its name on the domestic market.
p.(None): (6a) "End product" is a medicinal product that has gone through all the stages of manufacture but not yet
p.(None): released by a knowledgeable person.
p.(None): (7) "Mutual recognition procedure" and "decentralized procedure" are for the
p.(None): Contracting parties to the Agreement on the European Economic Area through Chapter 4 of the Directive
p.(None): 2001/83 / EG, in the version of the guidelines 2004/24 / EG and 2004/27 / EG, as well as in chapter 4 of the guideline
p.(None): 2001/82 / EG, in the version of the directive 2004/28 / EG, specified procedures.
p.(None): (7a) "Distance selling" means entering into a contract using only one or
p.(None): several means of distance communication.
p.(None): (7b) "Long-distance communication means" are means of communication that are used to conclude a contract without
p.(None): simultaneous physical presence of the parties can be used, especially with printed matter
p.(None): or without address, catalogs, press advertising with order form, pre-made standard letters,
p.(None): Long-distance calls with people or machines as conversation partners, radio, videophone, fax,
p.(None): Teleshopping as well as publicly accessible electronic media that allow individual communication
p.(None): enable, such as the Internet or electronic mail.
p.(None): (8) "Shelf life" is the property of a medicinal product during a certain period of time
p.(None): proper storage, its quality, especially with regard to quality and effect, not
p.(None): to change.
p.(None): (9) "Retail package" is the container, as well as all package elements including package inserts and all
p.(None): Components with which the medicinal product is placed on the market with the respective labels.
p.(None): (10) "Manufacturing" is the extraction, the making, the preparation, the working or processing, the
p.(None): Decanting including the filling and packaging of drugs or active ingredients as well as the
p.(None): Labeling of medicinal specialties and investigational medicinal products.
p.(None): (10a) "Maximum amounts of residues" are those pursuant to Article 1 (1) lit. b of Regulation (EEC)
p.(None): № 2377/90 establishing a Community procedure for the setting of quantitative limits for
p.(None): Veterinary drug residues in food of animal origin, OJ. № L 224 of August 18, 1990,
p.(None): defined quantities.
p.(None): (11) "Placing on the market" means holding stock, holding it for sale or dispensing medicinal products or
p.(None): Wirksto ff s. A placing on the market does not exist if it is ensured by suitable measures that a
p.(None): Medicines that do not comply with the law do not reach consumers or users.
p.(None): (11a) "Magistral preparation" means any medicinal product that is available in a pharmacy on the basis of a
p.(None): medical or dental prescription for a specific patient or by veterinary
p.(None): Prescription is made for a particular animal.
p.(None): (11b) "O ffi zinal preparation" means any drug that is in a pharmacy after a monograph
p.(None): the pharmacopoeia is produced in accordance with § 1 of the Pharmacopoeia Act and is intended to be used in pharmacies,
p.(None): in which it was manufactured to be sold directly to the consumer.
p.(None): (11c) "Re-blistering" is the automated patient-specific compilation of the one-time, daily,
p.(None): Weekly or monthly ration of medicines in blisters.
p.(None): (12) "Non-clinical investigation" is the pharmacological or toxicological examination of a medicinal product,
p.(None): that is not done on humans.
p.(None): (13) Pharmaceutical officers are persons who are doctors, dentists, veterinarians, dentists, midwives,
p.(None): Visit pharmacists or traders mentioned in section 59 (3), (4) and (8) to find out about medicines
p.(None): to provide technical information.
p.(None): (13a) "Marketing Authorization Holder" is a party to the Agreement on the
p.(None): European Economic Area (EEA Agreement) resident entrepreneur who is entitled to
p.(None): To market, manufacture or wholesale pharmaceuticals or active ingredients under his name
p.(None): to drive.
p.(None): (13b) "Expert person" is a person as defined in Article 48 of Directive 2001/83 / EC, as amended
p.(None): of Directives 2004/24 / EC and 2004/27 / EC, or Article 52 of Directive 2001/82 / EC, in the version of the
p.(None): Directive 2004/28 / EC, or Article 13 (1) of Directive 2001/20 / EC.
p.(None): (14) "Harmlessness" means that when used as intended, the foreseeable risk
p.(None): undesirable effects in consideration of the effectiveness or purpose according to the knowledge
p.(None): medical science is justifiable.
p.(None): (15) “Consumers” are physical or legal persons who take medicinal products for their own use
p.(None): purchase.
p.(None): (15a) "Mediation of medicinal products" includes all activities, with the exception of wholesale, in the
p.(None): Connection with the sale or purchase of medicinal products for human use, which consist of self-employed and in
p.(None): Negotiate the name of another legal or natural person without using these drugs
p.(None): Acquiring property or physically handling these medicines.
p.(None): (16) “Expiry date” is the term after which the shelf life of a medicine
p.(None): is no longer guaranteed.
p.(None): (17) Waiting time is the period between the last administration of a drug to animals under
p.(None): Compliance with drug regulations and the time up to which these animals are not available
p.(None): Extraction of food or medicinal products may be used, must be observed and the
p.(None): ensures that residues of the substances administered in these foods comply with the
p.(None): Regulation (EEC) № 2377/90 maximum permissible quantities for pharmacologically active substances
p.(None): do not exceed.
p.(None): (18) "Efficacy" is the suitability of a drug, the intended uses mentioned in § 1 Paragraph 1
p.(None): to fulfill.
p.(None): (19) "Effect" is an influenceable influence of the
p.(None): Condition or function of a biological object.
p.(None): (20) 'Central procedure' is one for the Member States of the European Union through the Regulation
p.(None): (EG) № 726/2004, OJ. № L 136/1 of March 31, 2004, established procedure for the approval of certain
p.(None): Medicinal specialties, that for medicinal products covered by the annex to the aforementioned regulation
p.(None): compulsory for pharmaceutical specialties covered by Article 3 Paragraph 2 of the Ordinance on request as required
p.(None): the requirements mentioned there apply.
p.(None): (21) 'Intermediate' is a medicinal product that is still in one or more manufacturing phases
p.(None): needs to become bulk goods.
p.(None): Definitions regarding clinical trials
p.(None): § 2a. (1) "Clinical Trial" is a systematic examination of a drug on one
p.(None): Test taker that is conducted with the goal
p.(None): 1. to research or prove the effects of investigational medicinal products,
p.(None): 2. determine side effects of investigational medicinal products, or
p.(None): 3. absorption, distribution, metabolism and excretion of investigational medicinal products
p.(None): investigate.
p.(None): This includes clinical trials conducted in one or more test centers in one or more
p.(None): Contracting parties to the European Economic Area. No clinical trial is one
p.(None): Non-interventional study within the meaning of paragraph 3.
p.(None): (2) “Multicentre clinical trial” is a clinical trial conducted under a single trial plan
p.(None): Examination that takes place in more than one test center and is therefore carried out by more than one examiner
p.(None): the test centers are located in a single or in several contracting parties to the European
p.(None): Economic area or in contracting parties and third countries.
p.(None): (3) "Non-interventional study" is a systematic examination of approved pharmaceutical specialties
p.(None): to patients, provided
p.(None): 1. the pharmaceutical specialty only among those mentioned in the approval or registration
p.(None): Conditions is used
p.(None): 2. The non-interventional study does not require additional diagnostic or therapeutic measures
p.(None): makes necessary and does not involve any additional burdens on the patient, and
p.(None): 3. The application of a particular treatment strategy is not set out in advance in a test plan
p.(None): it corresponds to medical practice and the decision to prescribe the
p.(None): Drug specialty is clearly separated from the decision to include a patient in the study.
p.(None): Epidemiological methods are used to analyze the data collected. Not-
p.(None): interventional studies are to be planned and carried out according to the state of the art in science.
p.(None): (4) "Final Report" is a complete and detailed account of the clinical trial
p.(None): their termination.
p.(None): (5) "Audit" is a comparison of the raw data with the corresponding records in the test sheets
p.(None): to determine whether the raw data were reported correctly and the conduct of the clinical trial
p.(None): was carried out in accordance with the test plan and the standard operating procedures (SOPs).
p.(None): An audit must be carried out either by an internal sponsor unit, but independently of that unit
p.(None): that is responsible for clinical research or through an external scientific
p.(None): Establishment to be carried out.
p.(None): (6) "Ethics Committee" is an independent body consisting of members of
p.(None): Health professions and people working in non-medical areas and their
p.(None): The task is to protect the rights, security and welfare of the test takers
p.(None): secure and create public trust in this regard.
p.(None): (7) "Inspection" is one by the Federal Office for Safety in Health Care or by one of
p.(None): experts commissioned by him or carried out by a foreign health authority
p.(None): Review of documents, facilities, records, quality assurance systems and all
p.(None): other resources which, in the opinion of the Federal Office for Safety in Health Care or a
...
p.(None): Initiation, supervision and funding of a clinical trial. The sponsor or be
p.(None): Authorized representatives must be established in a contracting party to the European Economic Area.
p.(None): The auditor has to assume the additional duties and responsibilities of the sponsor if he has one
p.(None): conducts clinical trials independently of the manufacturer of the medicinal product and under their own responsibility.
p.(None): (17) "Standard Operating Procedures (SOPs)" are standardized, detailed, written
p.(None): Procedural rules of the sponsor for all activities related to the clinical trial
p.(None): are necessary.
p.(None): (18) “Adverse event” is any harmful event that occurs to a subject
p.(None): happens and that is not necessarily causally related to the clinical trial.
p.(None): (19) “Side effect” is any harmful and unintended reaction to an investigational medicinal product.
p.(None): (20) "Serious adverse event or serious side effect" is a
p.(None): adverse event or side effect that is fatal or irrespective of the dose
p.(None): is life-threatening, requires inpatient treatment or its extension to become one
p.(None): permanent or serious disability or disability or a congenital anomaly or
p.(None): is a birth defect.
p.(None): (21) "Unexpected side effect" is a side effect that depends on the type or severity due to the
p.(None): available product information is not expected.
p.(None): (22) "Pediatric investigation concept" is a research and development program that ensures
p.(None): the data that is required to determine the prerequisites should be developed,
p.(None): among which a drug will be approved for treatment in the pediatric population
p.(None): can. The pediatric population includes people from birth to the age of 18.
p.(None): Birthday.
p.(None): Definitions regarding drug monitoring (pharmacovigilance)
p.(None): § 2 B. (1) “Side effect” of a medicinal product for human use is a harmful and unintended reaction to
p.(None): the Medicine. “Side effect” of a veterinary medicinal product is a harmful and unintended reaction to
p.(None): the medicinal product that occurs at doses normally used in animals for prophylaxis, diagnosis or
p.(None): Therapy for diseases or for changing a physiological function.
p.(None): (2) "Side effect in humans" is a reaction that is harmful and unintentional and in
p.(None): People experience exposure to a veterinary drug.
p.(None): (3) "Serious side effect of a human medicinal product" is a side effect that is fatal or
p.(None): is life-threatening, requires inpatient treatment or its extension, more permanent
p.(None): or severe disability or disability or a congenital anomaly or
p.(None): Birth defect is.
p.(None): (4) "Serious side effect of a veterinary medicinal product" is a side effect that is fatal or
p.(None): is life-threatening, leads to significant disability or disability, congenital anomalies or
p.(None): Causes birth defects in the following generation or in the treated animals constantly occurring or
p.(None): causes long-lasting symptoms.
p.(None): (5) "Misuse of a drug" is the intended, permanent or sporadic excessive
p.(None): Use of a drug with physical or mental damage as a result.
p.(None): (6) "Improper use" is the use of a veterinary medicinal product contrary to
p.(None): Information about the summary of product characteristics, including the improper one
p.(None): Use or serious abuse.
p.(None): (7) “Risk management system” is a series of pharmacovigilance activities and measures that
p.(None): identified, described, avoided or minimized by the risks associated with pharmaceutical specialties
p.(None): should be; this also includes evaluating the effectiveness of such activities and measures.
p.(None): (8) “Risk Management Plan” is a detailed description of the risk management system.
p.(None): (9) “Pharmacovigilance system” is a system that the marketing authorization holder or holder of a
p.(None): Registration and the Federal Office for Safety in Health Care apply to the in Section IX
p.(None): to carry out the tasks and duties mentioned and the surveillance of the safety of authorized
p.(None): or registered pharmaceutical specialties and the discovery of all changes in the benefit-risk
p.(None): Relationship serves.
p.(None): (10) “Pharmacovigilance Master Documentation (Pharmacovigilance Master File)” is a detailed one
p.(None): Description of the system of pharmacovigilance that the marketing authorization holder applies to one or more
p.(None): uses authorized medicinal products.
p.(None): (11) "Pharmacovigilance Officer" is a person responsible for drug monitoring,
p.(None): suitably qualified person.
p.(None): (12) "Regularly updated report on the safety of medicinal products (PSUR)" is a
p.(None): Report with those specified in Art. 75 of Directive 2001/82 / EC or Art. 107b of Directive 2001/83 / EC
p.(None): Records.
p.(None): (13) “Post-approval safety study” is any clinical trial or non-interventional
p.(None): Study on an approved or registered medicinal product that is being carried out to
p.(None): Identifying, describing or quantifying the safety risk is the safety profile of a medicinal product
p.(None): to confirm or measure the efficiency of risk management measures.
p.(None): (14) "Pharmacovigilance Risk Assessment Committee (PRAC)" is the one at the agency
p.(None): Committee set up under Article 56 of Regulation (EC) No 726/2004.
p.(None): (15) "Eudravigilance database" is the database operated by the Agency in accordance with Art. 24 of the
p.(None): Regulation (EC) No. 726/2004.
p.(None): (16) "Data archive for the regularly updated safety reports" is that of the agency
p.(None): Data archive operated in accordance with Art. 25a of Regulation (EC) No. 726/2004.
p.(None): Pharmaceutical requirements
p.(None): Section 3
p.(None): scientific knowledge and based on practical experience does not appear to be certain that it
p.(None): When used as intended, they have no harmful effect beyond what is known
p.(None): that is acceptable to medical science.
p.(None): (2) It is also prohibited to place veterinary medicinal products on the market if, according to the respective status of the
p.(None): scientific knowledge and based on practical experience it does not appear certain that
p.(None): the veterinary medicinal product has no undesirable effects on the
...
p.(None): the European Economic Area,
p.(None): 2. the quality requirements of other pharmacopoeias, the standard of which corresponds to that of the pharmacopoeia
p.(None): § 1 of the Pharmacopoeia Act 2012 can be kept the same, provided there are no standards in accordance with Z 1,
p.(None): 3. Other existing internationally recognized minimum standards, provided there are no standards according to
p.(None): Z 1 and 2 exist, or
p.(None): 4. the standards set by the manufacturer himself according to the current state of science, if
p.(None): there are no standards according to Z 1 to 3,
p.(None): do not match.
p.(None): (3) It is prohibited to place medicinal products on the market
p.(None): 1. whose durability is no longer given,
p.(None): 2. whose expiry date has passed,
p.(None): 3. whose commercial packs can have an adverse effect on the quality of the medicinal product,
p.(None): or
p.(None): 4. which are intended for use on animals, which serve for the production of food and their
p.(None): pharmacologically active ingredients not in Annexes I to III of Regulation (EEC)
p.(None): No. 2377/90 are included.
p.(None): (4) Pharmaceutical specialties whose expiry date has passed may be used if the
p.(None): Federal Armed Forces in accordance with Section 2 (1) lit. a of the Wehrgesetzes 1990, Federal Law Gazette № 305, are placed on the market,
p.(None): if this is essential for the supply of medicinal products and research has shown that
p.(None): the protection of human and animal health is maintained.
p.(None): § 5. (1) The Federal Minister of Health and Environmental Protection has to ensure the
p.(None): Drug safety, to prevent harmful effects within the meaning of § 3 and to secure the
p.(None): Quality in the sense of § 4 by ordinance, more detailed provisions on the use of certain substances,
p.(None): Preparations from materials, processes or articles for the manufacture and control of medicinal products
p.(None): or active substances and on the placing on the market, import and use of medicinal products or
p.(None): To adopt active substances.
p.(None): (2) The Federal Minister of Health and Women may consider an application in accordance with
p.(None): § 18a or according to Art. 3 of Regulation (EC) № 726/2004 medicinal specialties from the area of application
p.(None): exempt from a regulation in accordance with paragraph 1, if this results from the latest state of medical
p.(None): Science a threat to drug safety cannot be feared.
p.(None): (3) The Federal Minister of Health and Women may consider an opinion
p.(None): of Article 27 of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or the
p.(None): in Art. 31 Directive 2001/82 / EC, as amended by Directive 2004/28 / EC
p.(None): Coordinating group of medicinal specialties that are based on a regulation issued on the basis of paragraph 1
p.(None): not comply, by decision exempt from the scope of this regulation if after the
p.(None): state of the art in medical science not to worry about a threat to drug safety
p.(None): is. Such notice is to be revoked if it subsequently becomes known that the requirements for this
p.(None): are not given.
p.(None): misleading
p.(None): § 6. (1) It is forbidden to place medicinal products or active substances on the market which are not the facts
p.(None): corresponding information or other misleading designations or packaging
p.(None): exhibit.
p.(None): (2) It is also prohibited in connection with the placing on the market of medicinal products or
p.(None): Effective about this information that does not correspond to the facts or is misleading
p.(None): do.
p.(None): (3) A misleading situation exists in particular if
p.(None): 1. The medicinal products are considered to have an efficacy or the active substances have a property that
p.(None): according to the current state of scientific knowledge or practical
p.(None): Experience is not sufficiently documented, or
p.(None): 2. the impression is incorrectly given that success is to be expected with certainty or that after
p.(None): Intended or prolonged use, no harmful effects occur, or
p.(None): 3. the name or presentation is suitable for confusion.
p.(None): (4) It is also prohibited to announce or place objects on the market that are to be used
p.(None): are determined on or in the human body and which are based on the type and form of the announcement or the
p.(None): Placing on the market are likely to mislead consumers to expect these items
p.(None): are themselves medicinal or medicinally effective, or contain medicinal products or would be compatible with them
p.(None): Medicines applied.
p.(None): Section II
p.(None): Proprietary medicinal Products
p.(None): Approval of pharmaceutical specialties
p.(None): § 7. (1) Medicinal products may only be delivered in Germany or kept ready for delivery in Germany
...
p.(None): Veterinary medicinal products isolated on the basis of from an animal or animals of the same animal population
p.(None): Pathogenic organisms and antigens are manufactured and used exclusively for the treatment of this animal or
p.(None): of this animal population can be used in the same place.
p.(None): (6a) Medicinal products are not considered to be pharmaceutical specialties that are subject to approval in accordance with paragraph 1
p.(None): Novel therapies based on individual medical prescription specifically for a particular patient
p.(None): Austria is not routinely manufactured in an Austrian hospital under the
p.(None): exclusive professional responsibility of a doctor to be applied to this patient.
p.(None): (6b) Anyone who uses medicinal products in accordance with paragraph 6a is obliged to take measures to
p.(None): Ensure follow-up of effectiveness and side effects.
p.(None): (6c) Medicinal products that consist of or consist of human cells or tissues
p.(None): are made, but not always made in advance in the same composition and under the same
p.(None): Placed on the market in a form intended for delivery to the consumer or user
p.(None): on the basis of the approval of the processing procedure pursuant to Section 23
p.(None): Tissue Safety Act, Federal Law Gazette I No. 49/2008.
p.(None): (6d) Live animals are not considered to be medicinal products that are subject to approval in accordance with paragraph 1.
p.(None): (6e) Blood and. Are not considered to be pharmaceutical specialties that are subject to approval in accordance with paragraph 1
p.(None): Blood components for direct transfusion.
p.(None): (6f) Newly blistered are not considered to be medicinal specialties that are subject to approval according to Paragraph 1
p.(None): Drug.
p.(None): (7) Radioactive pharmaceutical specialties that are subject to approval in accordance with paragraph 1 also apply
p.(None): Generators, kits and precursors of radioactive drugs.
p.(None): (8) In individual cases, the Federal Office for Safety in Health Care must determine by decision that
p.(None): that a radioactive pharmaceutical specialty does not require approval if the pharmaceutical company
p.(None): proves that this
p.(None): 1. in a contracting party to the Agreement on the European Economic Area
p.(None): is permitted or a monograph of the pharmacopoeia within the meaning of § 1 of the Pharmacopoeia Act
p.(None): corresponds,
p.(None): 2. is required for medical treatment and an equivalent pharmaceutical specialty at the time of
p.(None): Application is not approved and available in Austria,
p.(None): 3. is likely to be rarely used due to the intended indication,
p.(None): 4. corresponds to sections 3 and 4,
p.(None): 5. is harmless to radiation,
p.(None): 6. contains no monoclonal antibodies and
p.(None): 7. is not intended for intrathecal use.
p.(None): The Federal Office for Safety in Health Care has to revoke this decision if one of these
p.(None): Requirements no longer exist or were not originally met. The frequency of
p.(None): The Federal Office for Safety in Health Care is used by pharmaceutical companies
p.(None): to be documented annually.
p.(None): (9) Paragraph 2 does not apply to
p.(None): 1. pharmaceutical specialties within the meaning of § 26,
p.(None): 2. Pharmaceutical specialties for injection,
p.(None): 3. sterile, pyrogen-free rinsing liquids,
p.(None): 4. radioactive pharmaceutical specialties and
p.(None): 5. Medicinal specialties that are in accordance with § 2 Paragraph 1 of the Prescription Law or for addictive law
p.(None): Provisions are subject to prescription requirements.
p.(None): § 7a. (1) Medicines containing antigens or semi-antigens and the detection of speci fi c ones
p.(None): Defense and protective substances, desensitization or hyposensitization may, if they
p.(None): not always made in advance in the same composition and under the same name in one
p.(None): placed on the market for supply to the consumer or user, domestically only
p.(None): delivered or kept ready for delivery in Germany if the Federal Office for Security in
p.(None): Healthcare the manufacturing process to be used with this drug
p.(None): including chemical pharmaceutical documentation has been approved by notice.
p.(None): (2) Sections 8 to 25 apply mutatis mutandis to procedures in accordance with para
p.(None): the documents that are sufficient for the assessment of the intended end products are to be enclosed.
p.(None): § 7b. (1) If there is no authorization and no application for authorization for a human medicinal product,
p.(None): the Federal Minister of Health and Women may do so in another party to the agreement
p.(None): Medicinal product approved for use in the European Economic Area for public reasons
p.(None): Allow health.
p.(None): (2) The Federal Minister of Health and Women may, by ordinance, specify further provisions on
p.(None): the procedure to be used, in particular with regard to the selection of the authorization holder,
p.(None): adopted. It is particularly important to ensure that the marketing authorization holder is informed about the
p.(None): necessary organizational and technical prerequisites for fulfilling him after a possible
p.(None): Approval according to this federal law.
p.(None): § 8. (1) Medicinal products do not require approval if
p.(None): 1. these to conduct non-clinical or clinical trials or clinical trials
p.(None): are determined, or
p.(None): 2. certifies a doctor, dentist or veterinarian who is authorized to practice his profession independently in Germany,
p.(None): that the drug specialty to ward off a life threatening or serious health
p.(None): Damage is urgently needed and this success with an approved and available
p.(None): Pharmaceutical specialty probably cannot be achieved according to the state of the art, or
p.(None): 3. the pharmaceutical specialty for medical treatment
p.(None): a) in the event of deployment of the Federal Army in accordance with Section 2 (1) lit. a of the Defense Act 2001,
p.(None): BGBl. I No. 146, or
p.(None): b) in preparation for a posting under the Federal Constitutional Law on Cooperation and
p.(None): Solidarity when sending units and individuals abroad (KSE-BVG),
p.(None): BGBl. I No. 38/1997, or in the context of such a posting
p.(None): is needed and the success of this treatment with an approved and available
p.(None): Pharmaceutical specialty cannot be achieved according to the state of the art, or
p.(None): 4. the pharmaceutical specialty to prevent or in connection with a disaster,
p.(None): terrorist threat or armed conflict
p.(None): should be applied and the success with an approved and available pharmaceutical specialty
p.(None): the state of the art cannot be achieved, or
p.(None): 5. the medicinal product for use by doctors or paramedics related to a
p.(None): national major event according to § 26a Sanitary Act, Federal Law Gazette I № 30/2002, from abroad
p.(None): coming to work temporarily in Austria.
p.(None): (2) If an application for reimbursement of a pharmaceutical specialty not approved in Austria is submitted to
p.(None): an Austrian social security institution, the domestic manufacturer or the
p.(None): Applicant for an import license according to the Pharmaceuticals Imports Act 2010 or for
p.(None): Notification according to the Pharmaceutical Imports Act 2010 entitled to the Austrian social security institution
...
p.(None): 8. Technical information (summary of product properties - SmPC) according to § 15,
p.(None): 9. at the request of the authority, a sample of the outer packaging,
p.(None): 10. reasons for possible precautionary and safety measures when storing the medicinal product,
p.(None): their administration to patients and the disposal of the waste products (together with an indication
p.(None): potential risks that the pharmaceutical specialty poses to the environment),
p.(None): 11. information on the controls envisaged during manufacture,
p.(None): 11a. in the case of human medicinal products, a written confirmation from the manufacturer that he has audited the
p.(None): Compliance with the good manufacturing practice for active ingredients checked by the active ingredient manufacturer on site
p.(None): and has determined; the confirmation must also include the date of the audits,
p.(None): 12. Fully developed, reproducible analysis and standardization regulations for
p.(None): Starting and intermediate products and for the end product, optionally a complete one
p.(None): elaborated, reproducible analytical method for the detection of
p.(None): residues,
p.(None): 13. Indication of the quality criteria of the components of the medicinal product used,
p.(None): 14. A declaration that the substance samples required to carry out technical examinations
p.(None): be made available on official request
p.(None): 15. Indication of scientific knowledge and practical experience on the
p.(None): Harmlessness of the components of the medicinal product used,
p.(None): 16. Indication of the quality characteristics and properties of the packing elements, which with the
p.(None): Drug specialty come into contact, as well as specification of the test instructions for this
p.(None): Packing elements,
p.(None): 17. Test reports on the shelf life in the intended retail pack,
p.(None): 18. Information on the appropriateness of the dosage form,
p.(None): 19. non-clinical data,
p.(None): 20. clinical data,
p.(None): 21. Information on areas of application, contraindications, side effects, dosage (if necessary for
p.(None): each target species), type and form of application, if this is not in the documents according to Z 6 to 8
p.(None): are included
p.(None): 22. The risk management plan for the pharmaceutical specialty concerned, including a summary
p.(None): In accordance with paragraph 4,
p.(None): 23. Proof that the manufacturer has a license pursuant to Section 63 or a
p.(None): Manufacturer approval from the competent authority of another state for the manufacture of medicinal products
p.(None): has,
p.(None): 24. in the case of medicinal specialties that contain several components, the influence on the efficacy or the
p.(None): Have tolerance, information about the suitability of the combination of these components,
p.(None): 25. for medicinal products with antimicrobial activity, the specification of the test instructions of
p.(None): antimicrobial effectiveness, if chemical-physical tests are not sufficient,
p.(None): 26. for medicinal products, the safe and safe use of which requires sterility
p.(None): the sterilization method,
p.(None): 27. for pharmaceutical specialties, their safe and harmless use an examination for pyrogenic
p.(None): Substances required, the specification of the test specification,
...
p.(None): Slaughter intended for human consumption,
p.(None): 33. A statement that clinical trials are outside the European Economic Area
p.(None): have been carried out that are equivalent to the ethical requirements of Directive 2001/20 / EC,
p.(None): 34. for veterinary specialties, proof that the applicant has a
p.(None): Pharmacovigilance managers and the necessary infrastructure to each
p.(None): Side effect, its occurrence within the European Economic Area or in a third country
p.(None): is suspected to report. For human medicinal products, a summary of the
p.(None): The applicant's pharmacovigilance system, which must include:
p.(None): a) proof that the applicant has a pharmacovigilance officer,
p.(None): b) the place of residence and activity of the person responsible for pharmacovigilance in the European Union
p.(None): Economic Area,
p.(None): (c) the declaration signed by the applicant that he has the necessary resources to:
p.(None): fulfill its obligations under Section IX and
p.(None): d) the location of the place where the pharmacovigilance master documentation is kept.
p.(None): (2) An application for admission is also each a commenting and evaluating scientific
p.(None): Summary of those contained in the documents pursuant to Paragraph 1
p.(None): 1. pharmaceutical data,
p.(None): 2. Results of the non-clinical pharmacological and toxicological experiments and
p.(None): 3. Results of the clinical trials or clinical trials
p.(None): to add. This must contain all information relevant to the evaluation, whether cheap or unfavorable.
p.(None): This also applies to incomplete or canceled pharmacological or toxicological tests or
p.(None): clinical trials or clinical trials of the drug. These documents are from individuals too
p.(None): create that have the required professional quali fi cation. This is with the application for admission
p.(None): to be demonstrated by means of a curriculum vitae.
p.(None): (3) An application for approval of a veterinary specialty is also a commenting and
p.(None): Assessing scientific summary of those contained in the documents in accordance with paragraph 1
p.(None): 1. Safety and residue tests and
p.(None): 2. Tests to assess the possible environmental risks
p.(None): to add. Submission of the results of clinical trials and safety and
p.(None): Residue tests are not required for immunological veterinary specialties if they are in
p.(None): duly substantiated cases, in particular based on European Union legislation,
p.(None): cannot be carried out. These documents are to be prepared by persons who are responsible for the
p.(None): have the required professional quali fi cation. This is with the application for admission via resume
p.(None): demonstrated.
p.(None): (4) The risk management system must be proportionate to the identified and
p.(None): potential risks of the pharmaceutical specialty and the need for data on the safety after approval
p.(None): or registration. For veterinary specialties, in deviation from para. 1 no
p.(None): Submit risk management plan only if this is in view of the identified and potential
p.(None): Risks of the drug specialty is required.
p.(None): (5) In addition to the information according to paragraphs 1 to 4, an application for admission may be required
p.(None): to add:
p.(None): 1. Copies of all in another Contracting Party to the Agreement on the European
p.(None): Economic area or a third country granted marketing authorizations for the
p.(None): related pharmaceutical specialty, along with a list of parties to the agreement
p.(None): the European Economic Area in which a according to Directive 2001/83 / EC or Directive
p.(None): 2001/82 / EG application for approval is examined;
p.(None): 2. For human medicinal products, a summary of the safety data including the
p.(None): available data from the regularly updated reports on the safety of
p.(None): Medicines and reports of suspected side effects from other parties to the
p.(None): Agreement on the European Economic Area or a third country;
p.(None): 3. copies of those proposed by the applicant or by the competent national authorities
p.(None): Approved Summary of Product Features (SmPC) and Package Leaflet;
p.(None): 4. The details of all decisions to refuse approval in another
p.(None): Contracting party to the European Economic Area or in a third country and the reasons for this
p.(None): Decision and
p.(None): 5. the copy of the designation of the medicinal product as an orphan medicinal product according to the
p.(None): Regulation (EC) № 141/2000 on orphan medicinal products, OJ. № L 18 from 01/22/2000 p.
p.(None): 1, as amended by Regulation (EC) No. 596/2009, OJ. L 188 from 07/18/2009 p. 14.
p.(None): (6) If the medicinal product is only to be exported, the applicant must contact
...
p.(None): Testing other methods or devices are used than described in the pharmacopoeia
p.(None): are.
p.(None): § 9d. Section 9a does not apply to medicinal specialties within the meaning of Section 7 (9) lines 2 and 3, which are based on a monograph of
p.(None): Pharmacopoeia in the sense of § 1 of the Pharmacopoeia Act. An application for admission to a
p.(None): such a medicinal product, documents according to § 9a paragraph 1 lines 1 to 9 as well as 14 and 15 are to be attached.
p.(None): § 9e. An application for approval of a generator must be submitted in addition to the documents pursuant to Section 9a
p.(None): to connect the following documents:
p.(None): 1. a general description of the system with a detailed description of the components of the
p.(None): Systems that can influence the composition or quality of the daughter nuclide preparation
p.(None): and
p.(None): 2. Information on the qualitative and quantitative peculiarities of the eluate or sublimate.
p.(None): Reference approval
p.(None): Section 10. (1) Notwithstanding Section 9a (1) lines 19, 20 and 28, the applicant is not obliged to:
p.(None): Results of non-clinical trials and clinical trials or trials and the results of
p.(None): Submit safety and residue tests if he can prove that it is
p.(None): Medicinal product is a generic of a reference medicinal product and
p.(None): 1. initial approval in a contracting party to the Agreement on the European
p.(None): Economic area at least eight years ago, or
p.(None): 2. the authorization holder of the reference medicinal product has a reference to that of the authorization
p.(None): the underlying documents have been irrevocably approved in writing.
p.(None): (2) A generic drug that has been authorized in accordance with paragraph 1 may only be used after ten years
p.(None): First authorization for the reference medicinal product to be placed on the market.
p.(None): (3) If the marketing authorization holder of a reference human medicinal product within the first eight years
p.(None): After granting the first approval, approval of one or more new areas of application
p.(None): the scientific evaluation prior to its approval by the Federal Office for Security in
p.(None): Healthcare according to paragraph 14 as of significant clinical benefit compared to the existing ones
p.(None): Therapies are considered, the period provided for in paragraph 2 is extended to 11 years.
p.(None): (4) The period specified in paragraph 2 is extended for medicinal products
p.(None): 1. which are intended for use in fish or bees, for 13 years, and
p.(None): 2. which are intended for use in one or more animal species which are intended for the extraction of
p.(None): Serve food, and which contain a new active ingredient, which will expire on April 30, 2004
p.(None): was not authorized in the Union with each change to another animal, the extraction of
p.(None): Serves food that is obtained within five years of first approval, each by
p.(None): a year. However, this period can be a maximum of 13 years.
p.(None): However, the extension mentioned in Z 2 only takes place if the license holder originally also
p.(None): the establishment of maximum residue levels in accordance with Regulation (EEC) № 2377/90 for those of
p.(None): Has requested a change in the approval of the animal species concerned.
p.(None): (5) Paragraph 1 also applies if the reference medicinal product is not authorized in Austria
p.(None): if it is in another party to the Agreement on the European Economic Area
p.(None): was approved. In this case, the applicant has the name of the contracting party of the
p.(None): Agreement on the European Economic Area to specify in which the reference medicinal product
p.(None): is or has been approved. In this case, the Federal Office for Safety in Health Care has the
p.(None): competent authority of the other party to the Agreement on the European Economic Area
p.(None): request within a month to send confirmation that the reference medicinal product
p.(None): is or has been approved, as well as the full composition of the reference medicine and others
p.(None): Documents if required for the approval of the generic. If the
p.(None): The Federal Office for Safety in Health Care asks the agency for the
p.(None): corresponding information and documents.
p.(None): (6) Were in an amendment for a new area of application of a human medicinal product in
p.(None): Regarding an already well-established drug related to non-clinical or clinical studies
p.(None): the new area of application carried out by the Federal Office for Safety in Health Care
p.(None): Paragraph 14 were considered to be significant, so with an application according to § 10 or according to the
p.(None): Regulation (EC) № 1234/2008 on the examination of changes in the authorization of human and
p.(None): Veterinary medicinal products, OJ. № L 334 of 12.12.2008 p. 7 as amended by Regulation (EU) № 712/2012, OJ.
p.(None): № L 209, 4.8.2012 p. 4, one year not to refer to this data. This
p.(None): Exclusive period is not cumulative.
p.(None): (7) If the approval or its modification of a veterinary specialty, its active substance or active substances
p.(None): used for veterinary purposes in the Union for at least ten years, for another for
p.(None): Obtaining food certain target animal species, and will be new residue attempts
p.(None): according to Regulation (EEC) № 2377/90 and submitted new clinical trials, so can apply
p.(None): in accordance with section 10 or section 24, no reference is made to this data for three years.
p.(None): (8) A medicinal product that is similar to a biological reference medicine fulfills the definition
p.(None): of the generic not because in particular the raw materials or the manufacturing process of the biological
p.(None): Drug differ from that of the reference biological drug, so the results are
p.(None): suitable non-clinical trials or clinical trials or trials regarding these differences
p.(None): required. The type and number of additional data to be submitted must be in Annex I to the Directive
p.(None): 2001/83 / EG, in the version of the directives 2004/24 / EG and 2004/27 / EG or the directive 2001/82 / EG, in
p.(None): comply with the version of Directive 2004/28 / EC.
p.(None): (9) If the medicinal product does not fall under the definition of a generic or the bioequivalence can
p.(None): not demonstrated by bioavailability studies, as well as in the event of a change in the active ingredient or
p.(None): the active ingredients, the areas of application, the strength, the dosage form or the route of administration
p.(None): compared to the reference medicine, are the results of the corresponding non-clinical trials or
p.(None): clinical trials or trials as well as the results of the corresponding safety and
p.(None): To present residue tests.
p.(None): (10) If an authorization according to § 7 has been granted for a pharmaceutical specialty, then for the purposes of
p.(None): Paragraphs 1 to 9 and 12 all other approved strengths, dosage forms, routes of administration and
p.(None): Forms of administration, as well as all changes and extensions as part of the same comprehensive
p.(None): Viewed approval.
p.(None): (11) The applicant may be required to submit the bioavailability studies if he:
p.(None): can demonstrate that the generic meets the relevant criteria based on the current state of science
p.(None): Proof of bioequivalence does not appear to be necessary.
p.(None): (12) The Federal Minister of Health and Women has additional animal species by decree
...
p.(None): 8. the type of packaging of the imported medicinal product,
p.(None): 9. the pack sizes intended for distribution in Austria,
p.(None): 10. the description of the process of re-labeling or repacking,
p.(None): 11. the name and address of the person who will carry out the re-labeling or repackaging
p.(None): company
p.(None): 12. A statement that the texts for the outer packaging, primary packaging, and where appropriate
p.(None): Package leaflet and technical information except for speci fi c information as well as information on
p.(None): Avoidance of senselessness no textual deviations from the labeling,
p.(None): where applicable, package leaflet and specialist information for those authorized or
p.(None): have registered pharmaceutical specialty and
p.(None): 13. A description of the pharmacovigilance and, if necessary, the risk management system
p.(None): the applicant will introduce.
p.(None): (4) Pharmaceutical specialties that have been granted an authorization in accordance with Regulation (EC) № 726/2004 and
p.(None): Paragraph 1 lines 2 and 3 may only be placed on the market if they are in German
p.(None): Labeling and instructions for use are provided and there is German-language technical information
p.(None): and a notification to the agency and the Federal Office for Safety in Health Care has been made beforehand.
p.(None): This message must contain:
p.(None): 1. proof of the right to apply in accordance with § 9,
p.(None): 2. Name and registration number of those approved according to Regulation (EEC) № 726/2004
p.(None): Medicinal product,
p.(None): 3. the party to the Agreement on the European Economic Area in which the imported
p.(None): Drug specialty is distributed (home Member State),
p.(None): 4. the name and address of the authorization holder,
p.(None): 5. the name and address of the manufacturer,
p.(None): 6. the pack sizes intended for distribution in Austria,
p.(None): 7. A declaration that the texts for outer packaging, primary packaging, instructions for use and
p.(None): Specialist information, apart from company-specific information, no textual deviations from the
p.(None): Labeling, instructions for use and specialist information according to the regulation (EWG)
p.(None): No. 726/2004 approved pharmaceutical specialty.
p.(None): To the agency is a fee for checking compliance with the conditions set out in Union law
p.(None): Medicines and are specified in the marketing authorizations. their
p.(None): Dimensioning is based on Union law regulations.
p.(None): (5) The applicant is obliged to submit the application pursuant to paragraph 3 to the authorization holder
p.(None): or owner of the registration. The same applies to the notification according to paragraph 4.
p.(None): (6) If this is necessary for reasons of drug safety, with the consent of the
p.(None): Federal Office for Safety in Health Care of the requirements for labeling in paragraph 3
p.(None): Z 12 can be deviated with regard to the primary packaging.
p.(None): Registration of homeopathic medicinal specialties
p.(None): § 11. (1) Homeopathic medicinal products are not subject to the authorization requirement according to § 7 if
p.(None): she
p.(None): 1. are intended as a human medicinal product for external or oral use,
p.(None): 2. as a veterinary specialty for administration according to the European Pharmacopoeia or in
p.(None): Lack of this, according to the pharmacopoeia of the Member States currently in use
p.(None): described route of administration are determined,
p.(None): 3. no specific therapeutic indication in the name, labeling or, if applicable, in the
p.(None): Have package leaflet, and
p.(None): 4. are only given in dilutions that guarantee the safety of the medicinal product.
p.(None): Above all, the medicinal product must not contain more than one part per ten thousand of the mother tincture,
p.(None): or not more than one hundredth of the smallest dose that may be used in allopathy
p.(None): those active ingredients in the presence of which in an allopathic medicinal product, the latter
p.(None): requires a prescription.
p.(None): (2) Homeopathic medicinal specialties within the meaning of paragraph 1 may only be sold in Germany or for the
p.(None): Levy will be kept available when registered with the Federal Office for Safety in Health Care
p.(None): and have been registered in accordance with section 27 (1) 2. Section 9 (1) applies to the authorization to register
p.(None): If necessary, registration is to be issued subject to the stipulation of requirements, the fulfillment of which protects
p.(None): to ensure human or animal health or drug safety. Such conditions
p.(None): can also be prescribed subsequently.
p.(None): (3) The following documents must be enclosed with a registration in accordance with paragraph 2:
p.(None): 1. Name or company name and registered office of the applicant and if the applicant is not with the manufacturer
p.(None): is identical, name or company and registered office of the manufacturer, as well as proof of authorization to
p.(None): Application,
p.(None): 2. scientific or other name of the homeopathic name contained in a pharmacopoeia
p.(None): Original substance or substances with details of the various uses and
p.(None): dilutions
p.(None): 3. Documents in which the extraction and control of the original substance or substances
p.(None): described and their homeopathic use using appropriate bibliographic
p.(None): Documents are documented; contains the pharmaceutical specialty biological substances, also documents on the
p.(None): Measures taken to ensure their freedom from pathogens
p.(None): 4.Documents for the preparation and control of the dosage form and description of the dilution
p.(None): and dynamization method,
p.(None): 5. Evidence that the manufacturer has a license pursuant to Section 63 or a
p.(None): Manufacturer approval from the competent authority of another state for the manufacture of medicinal products
p.(None): has,
p.(None): 6. Copy of, where applicable, in other contracting parties to the Agreement on the European
p.(None): Economic area for registrations or permits received for the same drug,
p.(None): 7. Draft of the labeling according to § 17a (mock-up) and a sample of the at the request of the authority
p.(None): Outer packaging,
p.(None): 8. Information on the shelf life of the pharmaceutical specialty and
p.(None): 9. Justification for the proposed waiting period.
p.(None): The application can extend to a series of medicinal specialties made from the same or the same
p.(None): homeopathic original substance or original substances have been obtained.
p.(None): (4) Does the homeopathic medicinal specialty not comply with the provisions of paragraph 1 or are they
p.(None): Documents within the meaning of paragraph 3 incomplete or incorrect, the Federal Office for Security in
p.(None): Healthcare to refuse registration by notice.
p.(None): (5) Paragraph 1 does not apply to
p.(None): 1. pharmaceutical specialties within the meaning of § 26,
p.(None): 2. sterile, pyrogen-free rinsing liquids,
p.(None): 3. radioactive pharmaceutical specialties and
p.(None): 4. Medicinal specialties that are in accordance with § 2 Paragraph 1 of the Prescription Law or for addictive law
p.(None): Provisions are subject to prescription requirements.
p.(None): Registration of pharmacy specialties
p.(None): § 11a. (1) A registration for the registration of a pharmacy proprietary specialty must be
p.(None): Documents in accordance with section 9a (1) 8, 12, 18 to 20, and 23 and section 9a (2) cannot be attached. The
p.(None): Registration must also be attached:
p.(None): 1. Information on the specification of the finished pharmaceutical specialty and
p.(None): 2. a commenting and evaluating scientific summary of each
p.(None): a) pharmaceutical data contained in the registration documents,
...
p.(None): the number or amount of ingredients has been reduced during this period.
p.(None): 5. The information on traditional plant use within the meaning of Section 12a (2) (2)
p.(None): including safety and plausibility of effectiveness have been adequately proven.
p.(None): (3) Registration as a traditional herbal medicinal specialty is also possible if these vitamins
p.(None): or contains minerals, provided that the vitamins or minerals with regard to the area of application or
p.(None): the areas of application complement the action of the herbal active ingredients.
p.(None): (4) With regard to the authorization to register, Section 9 (1) applies. Registration documents
p.(None): § 12a. (1) Registration for registration are those in § 9a (1) 1 to 11, 13, 14, 17, 21 and 23
p.(None): The documents mentioned must be enclosed, whereby the specialist information does not have to contain any non-clinical information.
p.(None): There are also copies of all permits and registrations that the applicant has in another
p.(None): Contracting party to the Agreement on the European Economic Area or in a third country
p.(None): and details of any decision to refuse authorization or registration in another
p.(None): Contracting party to the Agreement on the European Economic Area or in a third country and the
p.(None): Submit reasons for this decision.
p.(None): (2) A registration for registration are also
p.(None): 1. a commenting and evaluating scientific summary of those in the documents
p.(None): pharmaceutical data contained in paragraph 1,
p.(None): 2. Bibliographical information on traditional plant use or reports from
p.(None): Experts from which it appears that the relevant or a corresponding drug
p.(None): at least 30 years at the time of application, including at least 15 years in
p.(None): European Economic Area, used medicinally, the drug among the specified
p.(None): Conditions of use is harmless and the pharmacological effect or effectiveness
p.(None): are plausible due to many years of application and experience,
p.(None): 3. A bibliographical overview of the information on safety with a scientific
p.(None): Rating,
p.(None): 4. Evidence that the applicant has a pharmacovigilance officer and
p.(None): necessary infrastructure has to any side effect, their occurrence within the European
p.(None): Economic area or in a third country is suspected, and
p.(None): 5. A description of the pharmacovigilance and, if necessary, the risk management system
p.(None): the registrant will introduce
p.(None): to add. To the extent that the Federal Office for Safety in Health Care to assess the
p.(None): The information required for their assessment is also considered to be harmless
p.(None): to add.
p.(None): (3) A medicinal product is deemed to be corresponding within the meaning of para. 2 no. 2 if it
p.(None): used auxiliary substances contains the same active substances and, the same or a similar one
p.(None): Intended use, an equivalent strength and dosage and the same or a similar one
p.(None): Has route of administration.
p.(None): (4) In the case of combinations within the meaning of Section 12 (3) or if the medicinal product has more than one
p.(None): plant active ingredient, the information on traditional use and the safety for
p.(None): submit the combination. Is the traditional application of the individual active ingredients of these combinations
p.(None): not documented, information on these individual active substances must also be provided.
p.(None): (5) It is not necessary to submit information and documents in accordance with paragraph 2 nos. 2 and 3 if there is a
p.(None): Community plant monograph prepared by the Committee for Herbal Medicinal Products in accordance with Article 16h
p.(None): Paragraph 3 of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, reference
p.(None): is taken. Regarding registration for registration, a plant-based crop, a plant-based one
p.(None): Preparation or a combination thereof which is in the list of plant substances, plant preparations or
p.(None): Combination for use in traditional herbal medicinal products in accordance with Article 16f (1) of the
p.(None): Directive 2001/83 / EG, as amended by Directives 2004/24 / EG and 2004/27 / EG, is the
p.(None): It is not necessary to submit the documents in accordance with paragraph 1 last sentence and paragraph 2 lines 2 and 3.
p.(None): Decision on registration
p.(None): Section 13. (1) Section 18 applies to the decision on registration for registration. The Federal Office
p.(None): for Healthcare Safety has made registrations as a traditional herbal
p.(None): Medicinal products of other parties to the Agreement on the European Economic Area, the
p.(None): in accordance with Chapter 2a of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and
p.(None): 2004/27 / EG, were included in his assessment. A registration is
p.(None): if necessary, stipulate that the fulfillment of the protection of health
p.(None): of humans or animals or to ensure drug safety. Such conditions can also
p.(None): be prescribed subsequently.
p.(None): (2) Registration must be refused if
p.(None): 1. the applicant is not authorized to register,
p.(None): 2. the registration contains incorrect or incomplete information or the information according to § 12a
p.(None): registration documents to be provided contain incorrect information, prove to be incomplete or
p.(None): prove inadequate for the assessment of the pharmaceutical specialty,
p.(None): 3. the qualitative or quantitative composition does not correspond to the information or otherwise the
p.(None): pharmaceutical quality is not appropriate
p.(None): 4. The medicinal product meets the requirements for approval according to § 7 or registration according to
p.(None): § 11 fulfilled,
p.(None): 5. the requirements of section 12 (2) lines 1 to 5 have not been met,
p.(None): 6. the pharmaceutical specialty can be harmful when used,
p.(None): 7. the harmlessness of vitamins or minerals contained in the medicinal specialty,
p.(None): has not been proven, or the requirements of Section 12a (4) have not been met,
p.(None): 8. the information on traditional use is insufficient or pharmacological
p.(None): Effect or effectiveness are not plausible due to the long-term use and experience,
p.(None): or
p.(None): 9. the requirements of section 18a (5) are met.
p.(None): (3) If a registration has been made on the basis of Section 12a (5) second sentence, and subsequently the
p.(None): vegetable crop, the vegetable preparation or a combination thereof from the list of vegetable crops,
p.(None): herbal preparations or combinations for use in traditional herbal medicinal products
p.(None): in accordance with Article 16f (1) of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and
p.(None): 2004/27 / EG, deleted, the registration has to be canceled, if not within three months
...
p.(None): g) use in pregnancy, egg or milk production,
p.(None): h) interactions with other medicinal products and other interactions,
p.(None): i) dosage and type of application,
p.(None): j) overdose (symptoms, emergency measures, antidotes),
p.(None): k) Waiting time for all foods, including those for which there is no waiting time.
p.(None): The information in accordance with para. 2 no. 5 lit. c and Z 14 are omitted.
p.(None): (4) The information in the technical information for a traditional herbal medicinal specialty is omitted
p.(None): Paragraph 2 No. 5.
p.(None): (5) For approvals according to § 10, the parts of the specialist information for the reference medicinal product that are
p.(None): refer to the areas of application, dosages or other subject matter of a patent which at the time
p.(None): the placing on the market of a generic still fell under patent law.
p.(None): (6) The subject information as well as any changes to the subject information in accordance with Regulation (EC)
p.(None): № 1234/2008 or according to §§ 24 or 25 are from the Austrian Chamber of Pharmacists under
p.(None): To publish the participation of the Austrian Medical Association. The publication has the date of
p.(None): Creation of the subject information, in the event of a change in the subject information, the date of the last change
p.(None): exhibit.
p.(None): (7) The Federal Minister of Health and Women has to determine by decree which others
p.(None): Information that is important for the application must be included in the specialist information and
p.(None): more detailed provisions on the type of publication and the availability of the specialist information as well as on
p.(None): Changes to the same and, if necessary with regard to drug safety, about content,
p.(None): To issue the type and form of the information specified in paras. 2 and 3.
p.(None): leaflet
p.(None): Section 16. (1) Medicinal specialties that are in accordance with Section 7 of the approval or in accordance with Section 11a of the registration
p.(None): may only be placed on the market if the commercial pack is in accordance with
p.(None): In the summary of the product characteristics, instructions for use in German
p.(None): contains.
p.(None): (2) The package leaflet for medicinal products for human use has the following information in the following
p.(None): To contain the order in a generally understandable form:
p.(None): 1. the name of the medicinal product, followed by the strength and the dosage form; possibly
p.(None): whether it is intended for use by infants, children or adults; the
p.(None): Common names must be given if the medicinal product contains only one active ingredient
p.(None): and her name is a fancy name,
p.(None): 2. the pharmaceutical-therapeutic class or mode of action in one easy for the patient
p.(None): understandable form,
p.(None): 3. the areas of application,
p.(None): 4. Contraindications
p.(None): 5. appropriate precautions for use,
p.(None): 6. Interactions with other medicinal products and other interactions that affect the
p.(None): Effect of the drug specialty can impair,
p.(None): 7. special warnings,
p.(None): 8. The usual instructions required for proper use, in particular:
p.(None): a) Dosage (if necessary with the indication that it is only valid if the doctor or
p.(None): Dentist does not prescribe otherwise),
p.(None): b) the type and route of administration, if necessary,
p.(None): c) frequency of administration, if necessary with indication of the exact time at which the
p.(None): Drug specialty can or must be administered,
p.(None): d) duration of treatment, if this has to be limited,
p.(None): e) measures in the event of an overdose (e.g. symptoms, first aid measures),
p.(None): f) measures in the event that the administration of one or more doses has been omitted,
p.(None): g) where appropriate, indication of the risk that the withdrawal of the medicinal product
p.(None): Can trigger withdrawal symptoms,
p.(None): h) the express recommendation, if necessary the doctor or pharmacist to clarify the
p.(None): To consult the use of the medicinal product,
p.(None): 9. a description of the side effects that can occur when used as intended,
p.(None): and any countermeasures to be taken,
p.(None): 10. Reference to the expiry date stated on the packaging, as well
p.(None): a) a warning against using the medicinal product after this date has passed,
p.(None): b) if applicable, the reference to special precautionary measures for storage,
p.(None): c) if applicable, the warning of certain visible signs that the medicinal product
p.(None): is no longer usable
p.(None): 11. complete qualitative composition (active ingredients and auxiliary substances) as well as quantitative
p.(None): Composition of active substances,
p.(None): 12. pharmaceutical form and content according to weight, volume or dosage units,
p.(None): 13. Name and address of the authorization holder,
p.(None): 14. Name and address of the manufacturer,
p.(None): 15. upon approval of the medicinal product in accordance with Articles 28 to 39 of Directive 2001/83 / EC, in which
p.(None): Version of the directives 2004/24 / EG and 2004/27 / EG, with different names in the concerned
p.(None): Member States a list of names approved in each Member State,
p.(None): 16. the date of creation of the package leaflet, in the case of a change the date of the last one
p.(None): Modification,
...
p.(None): stand for the user or pet owner are important and not the information of the specialist information
p.(None): disagree.
p.(None): (5) In addition to the information in accordance with paragraphs 2 and 4, the instructions for use must also include
p.(None): 1. Medicinal products that are feed medicines, the labeling according to
p.(None): Feed Act, a reference to the fact that it is a feed medicine, and a
p.(None): Directions for use,
p.(None): 2. Medicinal products that are feed premixes, the labeling according to the
p.(None): Feed Act, information on the type and amount of the ingredients contained in the feed,
p.(None): an indication that it is a feed premix that:
p.(None): Mixing instruction and the feeding instruction for that made from the premix
p.(None): Medicated feed,
p.(None): 3. radioactive pharmaceutical specialties, generators, kits or precursors of radioactive pharmaceutical specialties
p.(None): Precautions to be taken by the user and the patient during preparation and
p.(None): Administration of the product, as well as special precautions for the
p.(None): Disposal of the transport container and its unused content,
p.(None): 4. Medicinal specialties, the banned active substances according to § 1 para. 2 of the anti-doping
p.(None): Federal Law 2007, Federal Law Gazette I № 30, contain the following note: “The application of the
p.(None): Medicinal product [use the name of the medicinal product] can be positive in doping controls
p.(None): Results. " May result from misuse of the medicinal product for doping purposes
p.(None): If there is a risk to health, this must also be stated. These obligations do not apply to
p.(None): Medicinal specialties according to § 9b.
p.(None): (6) If this is necessary with regard to drug safety, the Federal Minister for
p.(None): Health and women through regulation more detailed provisions on content, type, shape, size and
p.(None): The nature of the information specified in paras. 2 to 5.
p.(None): Instructions for use for registered homeopathic medicinal specialties
p.(None): § 16a. (1) Medicinal products that are registered in accordance with § 11 may only be placed on the market
p.(None): if the retail pack contains instructions for use in German.
p.(None): (2) The package leaflet has the following information in the following order in general
p.(None): to contain understandable form:
p.(None): 1. scientific name of the original substance or substances and dilution; the are in
p.(None): European pharmacopoeia or, in the absence thereof, in one currently in use
p.(None): Pharmacopoeias of the parties to the Agreement on the European Economic Area
p.(None): to use the symbols it contains
p.(None): 2. Name and address of the registration holder,
p.(None): 3. Name and address of the manufacturer,
p.(None): 4. type and, if necessary, route of administration,
p.(None): 5. expiry date (month / year),
p.(None): 6. capacity of the primary packaging,
p.(None): 7. if necessary, special precautionary measures for storage,
p.(None): 8. special warnings,
p.(None): 9. batch number,
p.(None): 10. Registration number,
p.(None): 11. the note “Homeopathic medicinal specialty without approved therapeutic
p.(None): Application areas",
p.(None): 12. the indication that a doctor should be consulted if symptoms of illness persist, and
p.(None): 13. the date of creation of the package leaflet, in the case of a change the date of the last
p.(None): Modification.
p.(None): (3) The Federal Office for Safety in Health Care can request an exception from one
p.(None): Grant requirement according to paragraphs 1 and 2 if this is necessary for reasons of expediency, especially in
p.(None): With regard to the type of pharmaceutical specialty and its primary or outer packaging offered and with the
p.(None): Principles of drug safety is compatible.
p.(None): (4) If this is for the sake of expediency, in particular with regard to the type of
p.(None): Pharmaceutical specialty and its primary or outer packaging is offered and it with the principles of
p.(None): Pharmaceutical safety is compatible, the Federal Minister of Health and Women can by ordinance
p.(None): considering the requirements of protecting human or animal health exceptions
p.(None): issued from the requirements of paragraphs 1 and 2.
p.(None): Obligations in connection with the package leaflet
p.(None): § 16c. (1) The authorization holder or the holder of a registration must ensure that the
p.(None): Package leaflet is available at the request of patient organizations in formats suitable for blind and
p.(None): visually impaired people are suitable.
p.(None): (2) The package leaflet has the results of cooperation with patient target groups
p.(None): reflect. The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): adopted to ensure the readability, clarity and user-friendliness of the package leaflet.
p.(None): Note for the following provision
p.(None): For the entry into force cf. Section 38 (2) of the Medicinal Products Regulations 2009, Federal Law Gazette II No. 41/2019 and Section 94i (2).
p.(None): Labelling
p.(None): Section 17. (1) Pharmaceutical specialties that are in accordance with Section 7 of the approval or in accordance with Section 11a of the registration
p.(None): are only allowed to be placed on the market unless they are radioactive pharmaceutical specialties
p.(None): if the following information is in German on the outer packaging and the primary packaging
p.(None): are included:
...
p.(None): suitable collection systems,
p.(None): 13. batch name,
p.(None): 14. Areas of application for non-prescription medicinal products.
p.(None): (2) In addition to the information in paragraph 1, the marking of
p.(None): 1. Medicinal products for exclusive use on animals, a reference to it, and the
p.(None): Target species,
p.(None): 2. Medicinal specialties for use on animals from which medicinal products or foods are obtained
p.(None): the waiting time or the indication that no waiting time is required; the indication of the
p.(None): Waiting time for each affected animal species and for all affected foods, including
p.(None): those for which there is no waiting time to take place
p.(None): 3. Medicinal products for exclusive use on animals, from which no medicinal products or
p.(None): Foods are obtained, indicating that the medicinal product is only used on animals
p.(None): that are not used for the production of pharmaceuticals or food,
p.(None): to contain.
p.(None): (3) In addition to the information in accordance with Paragraphs 1 and 2, the label must contain at
p.(None): 1. Medicinal specialties, which according to the prescription law, BGBl. № 413/1972, only on prescription
p.(None): an indication that
p.(None): 2. Medicinal specialties, which may only be dispensed on a small scale in pharmacies, an indication that
p.(None): 3. Medicinal specialties that are only available in small pharmacies and from those mentioned in section 59 (3)
p.(None): Traders may be given an indication that
p.(None): 4.specialty medicinal products that may affect your ability to react or drive,
p.(None): Information about
p.(None): 5. Sera, details of the type of living being that served as the donor,
p.(None): 6. Homeopathic medicinal specialties, an indication that it is a homeopathic
p.(None): Drug specialty,
p.(None): 7. Pharmaceutical specialties that are subject to Section 26, information about batch release,
p.(None): 8. Medicinal products that are feed medicinal products, the labeling according to
p.(None): Feed Act as well as a note that it is a medicated feed,
p.(None): 9. Medicinal products that are feed premixes, the labeling according to the
p.(None): Feed Act, information on the type and quantity of the components contained in the feed
p.(None): and an indication that it is a feed premix, and
p.(None): 10. Dental medicinal products an indication that they are dental medicinal products.
p.(None): (4) The labeling of traditional herbal medicinal specialties has in addition to the information
p.(None): according to paragraphs 1 and 3 to contain the note that the product is a traditional herbal medicinal specialty
p.(None): for use in a specific area or areas of application only
p.(None): due to long-term use and that the consumer is a doctor, possibly a dentist,
p.(None): should consult if the symptoms persist when using the medicinal product or other than
p.(None): side effects mentioned in the package leaflet occur; provided the Federal Office for Security in
p.(None): Health care providers that require this when registering must also indicate the type of tradition concerned.
p.(None): (5) The outer packaging of the medicinal product must be in addition to that mentioned in paras. 1 to 4
p.(None): Information on the name of the medicinal product and the strength included in Braille. The Federal Minister for
p.(None): Health and women's health can be regulated by regulation regarding patient safety
p.(None): adopt the type and detailed form of the labeling obligation mentioned in the first sentence.
p.(None): (5a) On the outer packaging of medicinal products that are intended for use in humans,
p.(None): are security features and a device for detecting a possible manipulation of the
p.(None): Attach outer packaging, provided this is done by Art. 54a of Directive 2001/83 / EC to create a
p.(None): Community codes for medicinal products for human use, OJ. № L 311 from 11/28/2001 S 67, last changed by
p.(None): Directive 2011/62 / EU, OJ. № L 174 dated 01.07.2011 p. 74, prescribed or based on Art. 54a
p.(None): of Directive 2001/83 / EC. The Federal Minister of Health, if for reasons
p.(None): drug safety or to comply with EU law obligations, more details
p.(None): To issue provisions on the security features, in particular on which ones
p.(None): Human medicinal products carry safety features or do not have to carry them, as well as the type,
p.(None): Condition, properties, speci fi cations and other with the review of the security features in
p.(None): Related requirements.
p.(None): (6) Paragraphs 1 to 3, 5 and 5a do not apply to radioactive, subject to paragraph 1 of this paragraph
p.(None): Proprietary Medicinal Products. These must be identified by the following information:
p.(None): 1. The marking on the shielding must contain the information specified in Paragraph 1. Also has
p.(None): the labeling on the shielding indicates the coding used on the vials in plain text
p.(None): explain and if necessary at a given time and date the radioactivity amount per
p.(None): Dose or per vial and the number of capsules or, for liquids, the amount of milliliters in the
p.(None): Specify container.
p.(None): 2. The following information must be given on vials:
p.(None): a) Name or code of the medicinal product with the name or chemical formula of the
p.(None): radionuclide
p.(None): b) operational control number and expiry date,
p.(None): c) international symbol for radioactivity,
p.(None): (d) the name of the manufacturer and
p.(None): e) Amount of radioactivity according to Z 1.
p.(None): 3. The outer packaging and container of medicinal products containing radionuclides are in accordance with
p.(None): to mark the provisions on the transport of dangerous goods.
p.(None): (7) The primary packaging in the form of blister packs must at least have the short name
p.(None): the name and authorization holder as well as the batch number and expiry date
p.(None): his. It must be ensured that the name is legible until the last dosage unit is removed
p.(None): is.
p.(None): (8) Small primary packaging - if an outer packaging is available - only with the
p.(None): Information according to paragraph 1 Z 1, 7, 10, 13 and content by weight, volume or dosage units, and the
p.(None): Short name of the authorization holder. The name must include the
p.(None): Do not include dosage form if this does not affect the safety of the drug.
p.(None): (9) The Federal Minister of Health and Women may, if for reasons of expediency,
p.(None): especially with regard to the type of medicinal product, its primary or outer packaging offered and
p.(None): it is compatible with the principles of drug safety, taking into account the requirements
p.(None): the protection of human or animal health by regulation for certain types of
p.(None): Pharmaceutical specialties Exceptions to the labeling requirements of paras 1 to 5a and § 17a
p.(None): Paragraph 1 and, if necessary, additional labeling requirements.
p.(None): Labeling of registered homeopathic medicinal specialties
p.(None): § 17a. (1) Registered homeopathic medicinal products may only be placed on the market if
p.(None): The following information is contained in German on the outer packaging and the primary packaging:
p.(None): 1. scientific name of the original substance or substances and dilution; the are in
p.(None): European pharmacopoeia or, in the absence thereof, in one currently in use
p.(None): Pharmacopoeias of the parties to the Agreement on the European Economic Area
p.(None): use included symbols; the medicinal product consists of two or more original substances
p.(None): together, the scientific name of the original substances can be identified by an imaginary name
p.(None): be replaced,
p.(None): 2. Name and address of the registration holder,
p.(None): 3. Name and address of the manufacturer,
p.(None): 4. type and, if necessary, route of administration,
p.(None): 5. expiry date (month / year),
p.(None): 6. capacity of the primary packaging,
p.(None): 7. if necessary, special precautionary measures for storage,
p.(None): 8. special warnings,
p.(None): 9. Registration number,
p.(None): 10. batch number,
p.(None): 11. the note “Homeopathic medicinal specialty without approved therapeutic
p.(None): Areas of application ”, and
p.(None): 12. the indication that a doctor should be consulted if symptoms of illness persist.
p.(None): (2) The Federal Office for Safety in Health Care may, on request, exceptions to the
p.(None): Grant requirements according to para. 1 nos. 3, 11 and 12.
p.(None): Procedure for applications and registrations
p.(None): § 18. (1) Considering the requirements of an immediate and quick examination of
p.(None): Applications for approval and registrations for the registration of pharmaceutical specialties
p.(None): the Federal Office for Safety in Health Care without unnecessary postponement, but at the latest
p.(None): 1. seven months after receipt of the application for admission or registration for registration
p.(None): a pharmaceutical specialty and
p.(None): 2. 45 days after receipt of an application for approval for sales in parallel import
p.(None): to issue a decision.
p.(None): (2) Notification of the result of the investigation to the applicant or applicant
p.(None): and the order to improve the application or registration or the application or
p.(None): Registration documents inhibit the deadline according to paragraph 1 until the opinion of the
p.(None): Applicant or applicant or the improvement.
p.(None): (3) The approval or registration of a pharmaceutical specialty is subject to conditions
p.(None): or to impose orders if these protect human or animal health, for which
p.(None): Drug safety or effective disease control are required. These can in particular
p.(None): Include the following:
p.(None): 1. Certain measures contained in the risk management system to ensure safe
p.(None): Application of the drug specialty,
p.(None): 2. Conducting safety studies after approval,
p.(None): 3. Obligations with regard to the recording or reporting of suspected side effects that are related to the
p.(None): the obligations set out in Section IX,
p.(None): 4. other conditions or restrictions regarding the safe and effective use of the
p.(None): Medicinal product,
p.(None): 5. Operating a risk-adequate pharmacovigilance system and
p.(None): 6. Conducting efficacy studies after approval, as far as concerns regarding individual
p.(None): There are aspects of the effectiveness of the medicinal product that are only assessed after it has been placed on the market
p.(None): can be.
p.(None): (4) If this is necessary in view of a therapy-appropriate application, the Federal Office can
p.(None): for safety in health care by stipulating that the marketing authorization holder holds the
p.(None): Medicinal product also available in certain pack sizes within a certain period of time
p.(None): has brought.
p.(None): (5) The authorization for parallel import is, if necessary, subject to mandatory conditions
p.(None): issue, the fulfillment of which protects human or animal health, drug safety or
p.(None): Ensure consistency with the pharmaceutical specialty approved or registered in Austria.
p.(None): Such requirements can also be stipulated retrospectively.
p.(None): Mutual recognition and decentralized procedures
p.(None): § 18a. (1) If after the entry into force of the Medicinal Products Act, Federal Law Gazette № 185/1983, in the
p.(None): Version of the Federal Law BGBl. № 379/1996, already submitted application for admission in one
p.(None): other party to the Agreement on the European Economic Area or has one
p.(None): Contracting party to the Agreement on the European Economic Area the medicinal product that is made in Austria
p.(None): The subject of an application for admission is already admitted, according to the Federal Office for Security
p.(None): Healthcare that in Chapter III of Title III of Directive 2001/83 / EC, as amended
p.(None): 2004/24 / EG and 2004/27 / EG, or that in Title III, Chapter 4 of Directive 2001/82 / EG, in the version of the
p.(None): Directive 2004/28 / EC to apply the procedures listed and to meet the deadlines specified therein.
p.(None): (2) If the pharmaceutical specialty has not yet been approved at the time of application, the Federal Office has
p.(None): for safety in health care, provided Austria at the request of the applicant as
p.(None): Reference Member State within the meaning of Article 28 (1) of Directive 2001/83 / EC, as amended by the
p.(None): Directives 2004/24 / EC and 2004/27 / EC, or Article 32 of Directive 2001/82 / EC, in the version of the
p.(None): Directive 2004/28 / EC acts, an assessment report, a draft of the specialist information
p.(None): (Summary of product characteristics - SmPC), a draft of the package leaflet and for the
p.(None): To create labeling and to the applicant and the other parties to the agreement
...
p.(None): Pharmaceutical specialty relates.
p.(None): (2) An application for approval of a veterinary specialty is made by the Federal Office for Safety in the
p.(None): Healthcare further reject if according to the current state of scientific
p.(None): Findings and after the practical experience does not appear to be certain that the medicinal product
p.(None): When used as intended, it does not have any undesirable effects on the environment that are not caused by
p.(None): the positive therapeutic benefits are outweighed. The Federal Office for Security in
p.(None): Healthcare has submitted an application for approval of a veterinary specialty for use on animals,
p.(None): which is intended for the production of food or medicinal products, even if
p.(None): the pharmacologically active substances contained therein are not listed in Annex I, II or III to Regulation (EEC)
p.(None): № 2377/90 are called. Relevant Community framework regulations are imminent
p.(None): The Federal Office for Safety in Health Care has issued an application for approval
p.(None): Veterinary specialty not to be allowed if this is to protect public health, to protect the
p.(None): Consumer or animal health is required.
p.(None): (3) If paragraph 1 applies mutatis mutandis, an application for approval for distribution in the
p.(None): Rejection of parallel imports by the Federal Office for Safety in Health Care even if the
p.(None): applied for medicinal product does not correspond to the medicinal product approved in Austria, in particular
p.(None): because the composition of the type and amount of the active ingredients is not the same as in Austria
p.(None): approved drug specialty, the composition (according to type and amount) of the auxiliary substances
p.(None): does not coincide with the medicinal product approved in Austria and this affects the
p.(None): Efficacy, quality and safety, other differences to that approved in Austria
p.(None): There are specialty medicinal products that are therapeutically relevant, or the other requirements of Section 10c
p.(None): are not met.
p.(None): (4) Notwithstanding paragraph 1, an application for admission cannot be rejected if the applicant
p.(None): can prove that it is based on objectively comprehensible, listed in Annex I of Directive 2001/83 / EC
p.(None): No complete data on safety or effectiveness when used as intended
p.(None): can submit. Admission is to be granted under conditions or conditions that in particular the
p.(None): Safety of the pharmaceutical specialty, the obligation to inform the Federal Office for Safety in the
p.(None): Health care about all incidents related to its application and those to be taken
p.(None): Take measures. The approval must also be issued on condition that an annual
p.(None): Evaluation of the presence of the admission requirements has to be made as not complete data
p.(None): about safety and effectiveness. The authorization holder has submitted to the Federal Office for Security in
p.(None): Healthcare to submit all available updated data annually.
p.(None): § 19a. (1) Requirements or conditions according to § 18 paragraph 3 can be heard after hearing the approval or
p.(None): Registration holder may also be required subsequently.
p.(None): (2) The conduct of a safety study after admission must be prescribed if there are concerns
p.(None): exist with regard to the risks of the pharmaceutical specialty. Carrying out an effectiveness study after
p.(None): Admission must be prescribed if there is knowledge of the disease or the clinical methodology on it
...
p.(None): the marketing authorization holder has a consolidated list of all documents submitted in terms of quality,
p.(None): Submit harmlessness and effectiveness in all those made since the approval
p.(None): Changes were taken into account. The Federal Office for Safety in Health Care can
p.(None): Request authorization holders at any time to produce the listed documents. Becomes a consolidated list
p.(None): of these documents submitted in good time, the approval remains until the decision of the Federal Office for
p.(None): Healthcare security valid through renewal of approval.
p.(None): (3a) The authorization holder or registration holder can change the change in paragraphs 2 and 3
p.(None): apply for the planned period, which requires the approval of the Federal Office for Security in the
p.(None): Healthcare needs.
p.(None): (4) If the approval or registration in accordance with paragraphs 2 and 3 of the Federal Office for Security in the
p.(None): If the healthcare system is extended, this applies without time limit, unless the Federal Office for
p.(None): Healthcare security for pharmacovigilance reasons, including too few
p.(None): a further time limit of five for persons to whom the relevant pharmaceutical specialty is applied
p.(None): Years.
p.(None): Actual marketing
p.(None): § 21. (1) The authorization holder or the holder of a registration of a traditional vegetable
p.(None): or the pharmacy 's own pharmaceutical specialty, the Federal Office for Safety in Health Care has the
p.(None): Inform the date for the actual placing on the market of the medicinal product in Germany.
p.(None): (2) The authorization holder or the holder of a registration of a traditional vegetable or
p.(None): The Federal Office for Safety in Health Care has each pharmacy-specific drug specialty
p.(None): to report temporary or permanent cessation of the placing of the medicinal product on the domestic market.
p.(None): Unless there are special circumstances, this notification must be sent no later than two months before the appointment
p.(None): of placing on the market. The reasons for this measure must also be stated,
p.(None): in particular whether this measure is based on those listed in Art. 116 or 117 (1) of Directive 2001/83 / EC
p.(None): Reasons. If so, the agency must also be informed.
p.(None): (3) Paragraphs 1 and 2 do not apply to approvals for purposes according to § 9a paragraph 5.
p.(None): Expiry of approval
p.(None): § 22. (1) Becomes an approved or registered traditional vegetable or pharmacy-owned
p.(None): Drug specialty within three years after the approval or registration notice becomes final
p.(None): not actually placed on the market in Germany, or is previously on the market in Germany
p.(None): brought approved or registered traditional herbal or pharmacy proprietary medicinal product three
p.(None): For consecutive years no longer on the market, the approval or registration expires. The
p.(None): The Federal Office for Safety in Health Care has to determine this by decision.
p.(None): (2) The Federal Office for Safety in Health Care may for reasons of health protection
p.(None): or, for animal health reasons, provide for exceptions from paragraph 1.
p.(None): (3) Paragraphs 1 and 2 do not apply to approvals for purposes according to § 9a paragraph 5.
p.(None): (4) The period mentioned in paragraph 1 begins in cases in which the actual placing on the market only occurs
p.(None): Due to conflicting patent law, it is not possible until this ceases to exist
p.(None): Obstacle to run. Proof of this must be provided on presentation of suitable documents.
p.(None): repeal
p.(None): § 23. (1) The approval of a pharmaceutical specialty is to be revoked if
p.(None): 1. it becomes known that there was a reason for refusal in accordance with Section 19 (1) to (3) upon admission
p.(None): or has occurred subsequently, and the protection of human or animal health by
p.(None): Subsequent stipulation of requirements within the meaning of Section 18 (3) does not appear to be guaranteed,
p.(None): or
p.(None): 2. the medicinal product without fulfilling the requirements issued in accordance with section 18 (3) or section 24a (2)
p.(None): Marketing authorization holder is placed on the market and a marketing authorization is revoked to protect the
...
p.(None): Registration holder is placed on the market and a deregistration to protect the
p.(None): Human or animal health appears appropriate, or
p.(None): 3. the registration holder does not register.
p.(None): (7) Registration of a traditional herbal medicinal specialty should be revoked if
p.(None): 1. it becomes known that when deciding on the registration a reason for rejection according to § 13
p.(None): Paragraph 2 has existed or occurred subsequently, and the protection of human health
p.(None): or animal by subsequently stipulating requirements within the meaning of section 13 (1)
p.(None): appears guaranteed, or
p.(None): 2. the medicinal product without fulfilling the requirements given in accordance with section 13 (1) by the holder of a
p.(None): Registration is placed on the market and a deregistration to protect the
p.(None): Human or animal health appears appropriate, or
p.(None): 3. the owner of the registration waives the registration.
p.(None): (8) If a reason for annulment in accordance with paragraph 5 line 1 or 2, paragraph 6 line 1 or 2 or paragraph 7 line 1 or 2
p.(None): is present, but this may be within a reasonable time by the registration holder
p.(None): can be eliminated, the Federal Office for Safety in Health Care the resting of the
p.(None): Registration.
p.(None): Changes to registered pharmaceutical specialties and changes to the prescription status
p.(None): Section 24. (1) Any change in the data required for the approval pursuant to Section 7a or the registration pursuant to Section 11a
p.(None): or 12 were decisive, the Federal Office for Safety in Health Care must be informed immediately.
p.(None): (2) Changes in a drug specialty regarding
p.(None): 1. Name,
p.(None): 2. qualitative and quantitative composition,
p.(None): 3. Submission on a small scale,
p.(None): 4. Areas of application, excluding their restrictions, and
p.(None): 5. Dosage and type of application
p.(None): require the approval of the Federal Office for Safety in Health Care.
p.(None): (3) changes
p.(None): 1. the packaging of a pharmaceutical specialty, if the packaging elements to be changed with the
p.(None): Drug specialty are in constant contact, and
p.(None): 2. the labeling, instructions for use or specialist information of a pharmaceutical specialty with regard to
p.(None): a) contraindications,
p.(None): b) special warnings and precautions for use,
p.(None): c) interactions with other drugs and other interactions,
p.(None): d) fertility, pregnancy and lactation,
p.(None): effects on the ability to drive and use machines,
p.(None): f) side effects,
p.(None): g) overdose,
p.(None): h) habituation effects, and
p.(None): i) Waiting time
p.(None): require the approval of the Federal Office for Safety in Health Care, unless this
p.(None): Changes in labeling, instructions for use or specialist information are only with regard
p.(None): to improve product safety.
p.(None): (4) The consent according to paragraph 3 is deemed to be given if the change is not made within a period of six
p.(None): Months has been contradicted.
p.(None): (5) Changes to a medicinal product that do not fall under paragraph 2 or 3 are the Federal Office for
p.(None): Health Safety Report.
p.(None): (6) Those documents are an application in accordance with paragraph 2 or 3 and a notification in accordance with paragraph 5
p.(None): connect that allow an assessment of the change.
p.(None): (7) Changes to homeopathic medicinal specialties within the meaning of Section 11 (1) are the responsibility of the Federal Office for
p.(None): Healthcare reporting unless changes to the
p.(None): Composition with regard to therapeutically relevant components or changes in name,
p.(None): unless these changes are necessary due to the current state of science. Are a message
p.(None): to attach those documents that allow an assessment of the change. Changes in
p.(None): Composition with regard to therapeutically relevant components or the name, if any
p.(None): Changes that are not necessary due to the state of science are subject to one
p.(None): New registration according to § 11.
p.(None): (8) Any change in the data that was decisive for the prescription status of a medicinal product,
p.(None): must be reported to the Federal Office for Security immediately. Changes to the prescription requirement require
p.(None): Approval from the Federal Office for Safety in Health Care, unless it is a
p.(None): Prescription exemption, which is due to the invalidation of the prescription obligation according to § 2 Paragraph 1 of the
p.(None): Prescription Law, Federal Law Gazette No. 413/1972.
p.(None): (9) If an application for prescription exemption due to significant non-clinical or clinical
p.(None): Trials approved by the Federal Office for Safety in Health Care can be done within a year
p.(None): after this decision has become final, a prescription exemption for medicinal specialties based on this data
p.(None): other marketing authorization holder with the same active substance.
p.(None): § 24a. (1) The approval of a change in accordance with Regulation (EC) № 1234/2008 or in accordance with Section 24
p.(None): is
p.(None): 1. if there is a reason in accordance with § 19 paragraphs 1 and 2 or
p.(None): 2. in the event of changes that affect the basic nature of the medicinal product,
p.(None): to fail.
p.(None): (2) The approval of the change of a pharmaceutical specialty is, if necessary, prescribed
p.(None): To impose obligations, the fulfillment of which protects the health of humans or animals or the
p.(None): To ensure drug safety.
p.(None): § 24b. (1) The authorization holder or holder of a registration must ensure that in his
p.(None): Company complete documentation of everything related to approval or registration
p.(None): standing documents, their changes, as well as all notices and official notifications in
p.(None): Connection with this specialty drug is available at all times. This applies analogously to the
p.(None): Holder of a license for distribution in parallel import in accordance with § 10c.
p.(None): (2) The authorization holder or the holder of a registration has, in particular for the purposes of
p.(None): Pharmacovigilance, the Federal Ministry of Health and Women on its mandate all data
p.(None): in connection with the sales and sales volume of the pharmaceutical specialty as well as all available to it
p.(None): Provide data related to prescription volume. The authorization holder
p.(None): or the holder of a registration has furthermore for the purposes of pharmacovigilance the Federal Office for
p.(None): Healthcare security by ordering all data related to the health care system
p.(None): To provide sales volume of the drug specialty.
p.(None): (3) The authorization holder of a veterinary specialty is obliged, on request to the Federal Office for
p.(None): Healthcare safety free of charge Samples of the medicinal product in sufficient quantities for
p.(None): To provide that controls to identify residues of the medicinal product in question
p.(None): can be carried out. The license holder is also obliged to do so at the request of the Federal Office
p.(None): for healthcare safety to make the specialist knowledge available to him available to the
p.(None): Implementation of the analytical detection method for the determination of veterinary drug residues by the
p.(None): according to Council Directive 92/23 / EC of 29 April 1996 on control measures for certain
p.(None): Sto und e and their residues in live animals and animal products certain national
p.(None): To facilitate the reference laboratory.
p.(None): Transfer of rights
p.(None): § 25. The rights to an approved or registered pharmaceutical specialty go through legal transactions
p.(None): among the living or through inheritance from the license holder or registration holder to another
p.(None): according to § 9 for the application for approval or registration for the registration of this medicinal product
p.(None): Entitled over, are the Federal Office for Health Safety
p.(None): 1. if it is a legal transaction between living persons, from the previous license holder
p.(None): or registration holder a waiver on the admission or registration of the
p.(None): Specialty and
p.(None): 2. one of those to whom the rights to the medicinal product have passed
p.(None): Declaration of acceptance as well as all according to the regulation (EG) № 1234/2008 or according to § 24
p.(None): required notices
p.(None): required. After these statements have been received by the Federal Office for Safety in Health Care, the
p.(None): Authorized in the sense of Z 2 as authorization holder or registration holder of the pharmaceutical specialty. He kicks
p.(None): in all rights and obligations in connection with the admission or registration of the
p.(None): Drug specialty available.
p.(None): Selling periods after change or transfer of rights
p.(None): Section 25a. (1) Medicinal products to which changes according to Regulation (EC) № 1234/2008 or
p.(None): 24 or 25 may be carried out without this change
p.(None): 1. by the pharmaceutical company within one year after official approval or
p.(None): Notification of this change,
p.(None): 2. by others authorized to dispense until the expiry date of the medicinal product
p.(None): placed on the market unless this transition period is for reasons of medicinal product safety
p.(None): not justifiable.
p.(None): (2) Holders of a license for distribution in parallel import have all to protect the
p.(None): Conformity within the meaning of § 10c necessary changes within the period that the
p.(None): pharmaceutical entrepreneurs according to paragraph 1 is granted to understand.
p.(None): batch release
p.(None): § 26. (1) The batch release is subject to the following intended for use on or in humans
p.(None): Proprietary Medicinal Products:
p.(None): 1. Medicinal products that use human blood or blood plasma as a source ff
p.(None): were produced, as well
p.(None): 2. immunological medicinal specialties consisting of vaccines, toxins, sera or allergens,
p.(None): as far as this is concerned
p.(None): a) live vaccines,
p.(None): b) used for primary immunization of young children or other risk groups
p.(None): Drug,
p.(None): c) used in immunization programs in the context of public health
p.(None): Medicines, or um
p.(None): d) deals with medicinal products that are newly approved or manufactured using new techniques
p.(None): or are new to a particular manufacturer. These medicinal specialties are subject to the
p.(None): Batch release for a transition period to be specified.
p.(None): For medicinal specialties of Z 2 lit. d has the Federal Office for Safety in Health Care by notice
p.(None): to determine whether the respective pharmaceutical specialties are new and for what period or what number of
p.(None): Batches are subject to batch inspection.
p.(None): (2) Batch release is subject to certain immunological conditions for use on or in animals
p.(None): Medicinal specialties that consist of vaccines, toxins, sera or allergens and for the defense against
p.(None): Notifiable animal diseases according to § 16 animal diseases law, RGBl. No. 177/1909.
p.(None): (3) Pharmaceutical specialties in accordance with paragraphs 1 and 2 may be without prejudice to the provisions on approval
p.(None): of medicinal products in Germany can only be delivered or kept ready for delivery if by a
p.(None): a testing institute designated by the Federal Minister for Health and Women was determined,
p.(None): that the batch conforms to the speci fi cations approved in the approval, in the case of non-approved
p.(None): Medicinal specialties correspond to the state of the art in science and technology. The decision has been made by
p.(None): the designated institute within 60 days of submitting an application and the
p.(None): necessary documents to be made. The applicant must be informed immediately. comes
p.(None): there is no positive opinion within 60 days, the applicant can contact the
p.(None): Federal Office for Safety in Health Care submit an application for a decision by the Federal Office.
p.(None): (4) The Federal Office for Safety in Health Care has an exception to the requirement upon application
p.(None): the batch release within the meaning of paragraph 3 if this is with regard to the special
p.(None): Condition, type of application or area of application of this medicinal specialty without
p.(None): Impairment of drug safety is justified. The exception must be revoked if the
p.(None): There are no prerequisites for this. Foreign medicinal specialties that are intended for a specific purpose in the
p.(None): 12 to 14 and 14 to 14 of the 2010 Medicinal Products Imports Act
p.(None): not batch release. Drug specialties by the state testing agency of another contracting party
p.(None): of the Agreement on the European Economic Area checked and approved in Austria
p.(None): Compliant specifications are also not subject to batch release.
p.(None): (5) The following principles apply when assessing the batch:
p.(None): 1. The testing institute named by ordinance of the Federal Minister for Health and Women can
p.(None): submit an assessment without performing an additional analytical test if
p.(None): Manufacturing and control methods the required quality, safety and harmlessness
p.(None): guarantee.
p.(None): 2. If the named test institute carries out an analytical test, this is based on the information provided in the frame
p.(None): of the admission procedure and if necessary available in the course of the application
p.(None): provided samples of the end product or samples of certain intermediate products (bulk
p.(None): Batches). It is important to ensure that the product meets the approval requirements
p.(None): approved specifications.
p.(None): 3. Can the testing institute named by the Federal Minister for Health and Women be approved on the basis of the
p.(None): submitted control reports and, if applicable, the analytical results obtained in the
p.(None): If the approval documents do not confirm the defined quality, the institute has the test report with it
p.(None): Justification to be forwarded immediately to the Federal Office for Safety in Health Care. This
p.(None): has in the case of an application for decision by the Federal Office for Security in the
p.(None): Healthcare to hear the applicant and within 30 days of receiving the application
p.(None): to decide on the batch release by notice. Results from the test report and the
p.(None): Justification the need to carry out an additional analytical test
p.(None): this 30-day period was inhibited for the duration of this test.
p.(None): (6) The export of medicinal products for which no examination according to paragraphs 3 to 5 has been requested is only
p.(None): permitted if the health authority of the country of destination decides not to
p.(None): Batch inspection in Austria has been informed and demonstrably takes note of this fact.
p.(None): (7) The Federal Minister of Health and Women may consider the
p.(None): Drug safety enact more detailed provisions on batch release.
p.(None): (8) If this appears necessary considering the safety of the drug, the
p.(None): Federal Minister of Health and Women by prescription pharmaceutical specialties in accordance with paragraphs 1 and 2 or
p.(None): to determine other biological medicinal products that may only be placed on the market if the
p.(None): Retail pack contains a number of adhesive labels corresponding to the number of pharmaceuticals contained therein
p.(None): is attached to enable the medicinal product and the respective batch to be identified. The
p.(None): Ordinance also has more detailed provisions on the content, shape, size and nature as well as the type of
p.(None): Include the adhesive labels.
p.(None): import analysis
p.(None): Section 26a. (1) For pharmaceutical specialties that are approved in Austria and from outside the
p.(None): European Economic Area, every batch, regardless of whether it is in the
p.(None): European Economic Area has been produced by a full pharmaceutical entrepreneur
p.(None): qualitative and quantitative analysis, at least with regard to effective components, as well as all
p.(None): other tests or examinations that are necessary to check the quality of the
p.(None): To ensure pharmaceutical specialty in accordance with the requirements on which the approval is based.
p.(None): (2) In the case of bulk goods or intermediate products that are approved for manufacturing in Austria
p.(None): Medicinal products are used and imported from outside the European Economic Area
p.(None): each batch, regardless of whether it was manufactured in the European Economic Area, from
p.(None): pharmaceutical entrepreneurs a full qualitative and quantitative analysis, at least in the
p.(None): With regard to effective components, as well as all other tests or tests,
p.(None): which are required to ensure the quality of the bulk goods or the intermediate product in accordance with the
p.(None): To ensure approval based on requirements.
p.(None): (3) For investigational medicinal products imported from outside the European Economic Area
p.(None): each batch, regardless of whether it was manufactured in the European Economic Area, from
p.(None): pharmaceutical entrepreneurs to undergo all the necessary analyzes and tests to ensure quality
p.(None): the investigational medicinal products in accordance with the basis for the proper application for approval in accordance with Section 40
p.(None): Ensure information. This also applies to investigational medicinal products that are considered in a clinical trial
p.(None): Comparative medicinal products are to be used in a country that is not a party to the
p.(None): Agreement on the European Economic Area is made, manufactured and placed on the market there
p.(None): may be imported from outside the European Economic Area, if none
p.(None): Documents are available to confirm that each batch has been manufactured to standards that comply with the
p.(None): standards set by the European Union are at least equivalent.
p.(None): (4) In another party to the Agreement on the European Economic Area pursuant to
p.(None): Paragraphs 1 to 3 checked batches are exempt from the above-mentioned checks when imported into Austria,
p.(None): if signed by the competent person of the pharmaceutical company
p.(None): Control reports are attached.
p.(None): (5) If appropriate agreements between the European Union and the exporting country
p.(None): have been taken to ensure that the manufacturer of the drug is in the process of manufacture
p.(None): Followed rules that are at least those under Community law
p.(None): comply with the stipulated regulations, and that the controls according to paragraphs 1 to 3 are already in the exporting country
p.(None): have been carried out, the pharmaceutical entrepreneur is exempt from the obligation according to paragraphs 1 to 3
p.(None): freed.
p.(None): Internet portal for pharmaceuticals and pharmaceutical specialty registers
p.(None): Section 27. (1) In a register to be kept at the Federal Office for Safety in Health Care
p.(None): (Pharmaceutical Specialty Register)
p.(None): 1. approved pharmaceutical specialties,
p.(None): 2. homeopathic medicinal specialties within the meaning of § 11 paragraph 1, provided that their registration is not
p.(None): to be rejected in accordance with Section 11 (4),
p.(None): 3. Pharmacy-owned pharmaceutical specialties within the meaning of Section 11a (1), unless their registration
p.(None): is to be rejected in accordance with Section 11a (3),
p.(None): 4. traditional vegetable medicinal specialties within the meaning of § 12, provided that their registration is not in accordance with
p.(None): § 13 paragraph 2 is to be rejected,
p.(None): to be entered under a consecutive number (registration or registration number). Medicinal specialties that
p.(None): are placed on the market on the basis of a license in accordance with § 10c
p.(None): Approval number of the corresponding approved or registered pharmaceutical specialty (reference approval)
p.(None): take. However, this is due to a reference to the fact of parallel import and its
p.(None): To complete the order.
p.(None): (2) Any change or cancellation of an authorization or
p.(None): Approval in accordance with § 10c as well as any change or cancellation of a registration in accordance with para. 1 no.2 to 4
p.(None): entered.
...
p.(None): The approval or registration holder can be heard in the publication.
p.(None): III. SECTION
p.(None): Clinical trial
p.(None): general requirements
p.(None): § 28. (1) Clinical trials may only be carried out if
p.(None): 1. as expected, they meet the objectives of section 2a (1),
p.(None): 2. Information about relevant physical and chemical data or biological properties as well
p.(None): about the applied pharmaceutical technology and
p.(None): 3. Meaningful results of non-clinical tests are available, which correspond to the respective
p.(None): State of the art.
p.(None): (2) The planning and implementation of clinical trials must comply with the regulations
p.(None): Federal law according to the state of the sciences and according to the principles of good clinical
p.(None): Practice. To interpret the principles of good clinical practice, those are generally accepted
p.(None): To use the principles and requirements set out in Volume 10 of the regulations for medicinal products in the
p.(None): European Union are published.
p.(None): § 29. (1) When planning, setting up and carrying out clinical trials, the health
p.(None): To keep risks and burdens for the test participant as low as possible.
p.(None): (2) The clinical trial of medicinal products may only be carried out if the risks associated with it for
p.(None): the test participants are connected, measured by the expected meaning of the result of the
p.(None): Examination for medicine are justifiable and the risk of impairment of the
p.(None): Examiner health
p.(None): 1. is not significant or
p.(None): 2. is outweighed by the benefit to be expected from the use of the drug
p.(None): Health.
p.(None): (3) The clinical trial of a medicinal product may only be carried out on patients if
p.(None): 1. Results of clinical trials on healthy volunteers are available, unless
p.(None): The investigational medicinal product may not be tested on healthy volunteers in accordance with paragraph 2 no
p.(None): no meaningful result can be expected from healthy subjects, and
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is to treat the disease or the patient on whom the clinical trial is to be performed
p.(None): to recognize their course, to heal or alleviate them or to prevent them from further illnesses
p.(None): protect.
p.(None): If there is meaningful data according to Z 1 and from clinical trials on patients, this may not be available
p.(None): the requirements of Z 2, a clinical trial on the patient can also be carried out if
p.(None): A certain illness of the test participant is a prerequisite for that for the in the test plan
p.(None): the relevant question is expected to result.
p.(None): (4) (Note: repealed by Federal Law Gazette I No. 35/2004)
p.(None): § 30. The clinical trial of medicinal products may be performed on women of childbearing potential, with the exception of cases of
p.(None): Section 44, can only be carried out or continued if before and in sufficient repetition during the
p.(None): clinical trial to determine the absence of pregnancy.
p.(None): Tasks, responsibilities and qualifications of sponsor, monitor and auditor
p.(None): § 31. The sponsor must develop detailed procedural rules (SOPs) and for their compliance
p.(None): To take care.
p.(None): § 32. (1) The sponsor has
p.(None): 1. the examiner taking into account his suitability and the local conditions and possibilities
p.(None): the test center to select
p.(None): 2. to ensure the approval of the investigator, the clinical trial in accordance with the study plan and the
p.(None): Implement provisions of this federal law,
p.(None): 3. assess the test plan and, if necessary, confirm it with his signature and at
p.(None): to proceed with any changes within the meaning of Section 37a,
...
p.(None): If the Federal Office for Safety in Health Care does not respond within 35 days, the
p.(None): Application subject to paragraph 4 as approved. These deadlines do not apply to clinical trials within the meaning of the
p.(None): Paragraph 6.
p.(None): (3) The Federal Office for Safety in Health Care has - if the in this federal law
p.(None): the above-mentioned requirements are not met - the conditions that are suitable for maintaining the requirements
p.(None): or stipulate conditions and allow a reasonable period for this. Can also by
p.(None): Prescribing conditions or conditions of compliance with the requirements of this federal law
p.(None): cannot be ensured, the authority has to carry out the clinical trial with the sponsor
p.(None): To prohibit decision.
p.(None): (4) If the ethics committee has no favorable opinion in the procedure pursuant to sections 41a and 41b
p.(None): submitted, the Federal Office for Safety in Health Care has carried out the clinical
p.(None): Prohibition exam if the sponsor does not object to the ethics committee's objections
p.(None): considered. The decision is from the Federal Office for Safety in Health Care without unnecessary
p.(None): Postponement, but no later than 60 days after submission of the application.
p.(None): (5) The Federal Office for Safety in Health Care can, if there are concerns about the
p.(None): the ethics committee has given its opinion correctly or is correct
p.(None): Instruct the drug advisory board to review the application for approval. If this is the implementation
p.(None): If the clinical trial is approved, a prohibition can be waived.
p.(None): (6) Conducting a clinical trial related to drugs for gene therapy and
p.(None): somatic cell therapy including xenogeneic cell therapy requires the approval of the
p.(None): Federal Office for Safety in Health Care.
p.(None): (7) The Federal Office for Safety in Health Care has applications according to paragraph 6 without unnecessary
p.(None): Postponement, but at the latest within 90 days after receipt of the application. In cases in
p.(None): to whom an advisory body is concerned, this period is extended by a further 90 days.
p.(None): (8) For a clinical trial in connection with drugs for gene therapy apply in addition to
p.(None): Provisions of this federal law meet the requirements of sections 74 to 79 of the Genetic Engineering Act.
p.(None): ethics committees
p.(None): Section 41. (1) The governor has clinical trials outside of hospitals
p.(None): To ensure that an ethics committee for the perception of the
p.(None): Tasks according to § 41a is set up and all necessary measures are taken to this
p.(None): Ethics committee to enable the work. The members of the ethics committee are allowed to participate in this
p.(None): Activity is not subject to any instructions.
p.(None): (2) The ethics committee has a balanced relationship between women and men
p.(None): to assemble and at least consist of:
p.(None): 1. a doctor who is authorized to practice the profession independently in Germany and is not the examiner,
...
p.(None): have occurred abroad and have resulted in a death or are life-threatening,
p.(None): recorded and the Federal Office for Safety in Health Care and the responsible authorities of all
p.(None): Contracting parties of the European Economic Area, in whose territory the clinical trial
p.(None): and the relevant ethics committees as soon as possible, but in any case within
p.(None): seven days after the sponsor becomes aware of the case, and
p.(None): that afterwards within a renewed period of eight days corresponding information about the further
p.(None): Measures are transmitted.
p.(None): (2) Any other suspected unexpected serious side effects arising from the
p.(None): the same clinical trial that has occurred in Germany or abroad are the authorities mentioned in paragraph 1
p.(None): and the relevant ethics committees as soon as possible, but in any case within 15 days of
p.(None): from the time the sponsor first became aware of it.
p.(None): (3) The sponsor has the other investigators of the same clinical trial information in the sense of
p.(None): To give paragraphs 1 and 2. The sponsor has once a year for the entire duration of the clinical trial
p.(None): a list of all the authorities mentioned in paragraph 1 and the relevant ethics committees
p.(None): suspected serious side effects that occurred during the entire exam period
p.(None): are to be submitted, as well as a report on the safety of the test participants.
p.(None): Protection of certain groups of people
p.(None): Section 42. (1) The clinical trial of a medicinal product may only be carried out on minors if
p.(None): 1. the drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in minors is intended and clinical trial for data validation,
p.(None): obtained in clinical trials on adults or using other research methods
p.(None): were absolutely necessary,
p.(None): 2. the use of the drug that is being tested, according to the knowledge of medical
p.(None): Science is indicated to be given to the minor on whom the clinical trial is being conducted
p.(None): will recognize, cure or alleviate diseases or protect them from diseases and the
p.(None): benefits for the test participant associated with inclusion in the clinical trial
p.(None): Risk outweighs
p.(None): 3. the consent of the legal guardian can be proven after appropriate clarification and
p.(None): was given in writing,
p.(None): 4. The minor before the start of the clinical trial by someone dealing with minors
p.(None): experienced auditor has received an explanation appropriate to his ability to understand this,
p.(None): 5. the consent of the minor who is able to understand the essence, the meaning, the
p.(None): To see the scope and risks of the clinical trial and to determine his will accordingly,
p.(None): has been demonstrably granted, and it is ensured that the expressly by a minor
p.(None): expressed desire not to take the clinical trial or take it at any time
p.(None): to be considered by the examiner
p.(None): 6. The consent can be withdrawn at any time without the minor being affected
p.(None): Disadvantage arises
p.(None): 7. with the participation in the clinical trial, no incentives or financial benefits
p.(None): Exception to an expense allowance,
...
p.(None): Condition, illness or disorder of the minor and thereby either
p.(None): Can benefit patients or the patient group to which the minor belongs, and
p.(None): 2. The clinical trial for the minor with only a minimal risk and minimal burden
p.(None): brings oneself; a clinical trial has minimal risk and minimal burden if
p.(None): it is to be expected that at most it will be a minor and merely temporary
p.(None): Impairment and the symptoms or inconvenience at best only
p.(None): could occur temporarily and will be very minor.
p.(None): § 43. (1) The clinical trial on an adult who is due to a mental illness or
p.(None): a comparable impairment of their ability to make decisions regarding representation regarding medical
p.(None): Treatments that have a legal representative (§ 1034 ABGB) may only be carried out if
p.(None): 1. the medicinal product being tested is intended to identify, cure, alleviate or prevent it
p.(None): and is the clinical trial for the confirmation of data used in clinical trials
p.(None): Consent obtained from persons capable of providing information or using other research methods
p.(None): were absolutely necessary,
p.(None): 2. the use of the drug that is being tested, according to the knowledge of medical
p.(None): Science is shown to work in the person who is suffering from a mental illness or an
p.(None): comparable impairment in their ability to make decisions is limited to this disease
p.(None): or to recognize impairment or its course, to heal or alleviate it or to prevent it
p.(None): to protect further diseases, and the associated with the inclusion in the clinical trial
p.(None): Benefit for the test subject outweighs the risk,
p.(None): 3. the consent of the legal representative after appropriate clarification demonstrably and
p.(None): was issued in writing; the presumed will of the test participant must be observed,
p.(None): 4. The test participant has also given evidence and in writing, provided that
p.(None): After appropriate information, he is able to understand the nature, meaning, scope and risks of the
p.(None): to inspect the clinical trial and then determine his will,
p.(None): 5. The consent can be withdrawn at any time without the exam participant
p.(None): Disadvantage arises
p.(None): 6. The candidate, depending on his ability to understand this, information regarding the
p.(None): Testing that has received risks and benefits
p.(None): 7. with the participation in the clinical trial, no incentives or financial benefits
p.(None): Exception to an expense allowance,
p.(None): 8. the clinical trial is planned so that it takes into account the disease and the
p.(None): Developmental stage with as little pain, discomfort, fear and others as possible
...
p.(None): Science stand.
p.(None): (2) If the person named in para. 1 has a legal representative for financial matters, then
p.(None): is also promptly informed of the participant's participation in the clinical trial and of the result
p.(None): inform associated insurance coverage.
p.(None): (3) Gives a person who is not able to make decisions to his or her proxy
p.(None): Adult representatives or the investigator to recognize that they are undergoing the clinical trial or their
p.(None): If the continuation is refused, this must be refrained from, unless the welfare of the person represented would otherwise be
p.(None): significantly at risk. The consent of the legal representative requires judicial approval.
p.(None): Section 43a. (1) A clinical trial, by its nature, can only be used in emergency situations in which appropriate
p.(None): Time no consent of the legal representative can be obtained, can be carried out at
p.(None): a person who is unable to consent to have a clinical trial performed if:
p.(None): 1. there are no indications that the patient refused the clinical trial or
p.(None): would refuse
p.(None): 2. Such research for the validation of data used in clinical trials for consent
p.(None): were obtained after informed persons or using other research methods,
p.(None): are absolutely necessary and can only be carried out in emergency situations,
p.(None): 3. The drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in an emergency situation is determined
p.(None): 4. the use of the drug that is being tested, according to the knowledge of medical
p.(None): Science is indicated to help the emergency patient develop an illness or its course
p.(None): recognize, heal or alleviate them or protect them from further diseases and the with
p.(None): the risk associated with the inclusion in the clinical trial for the trial subject
p.(None): predominates
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge of the
p.(None): Area of the disease concerned, in relation to the emergency situation and the affected
p.(None): Patient group or who deal with clinical and ethical issues in the field of
p.(None): related illness, in relation to the emergency situation and the affected patient group
p.(None): , expressly for the conduct of clinical trials in emergency situations on persons who
p.(None): are unable to give personal consent, have been approved, and
p.(None): 6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 38 and
p.(None): 39 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Education is given. Further processing of the personal data collected up to that point is required
p.(None): the express data protection consent.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 42 or § 43.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 44. (1) The clinical trial of a medicinal product may only be carried out on a pregnant woman if
p.(None): if
p.(None): 1. the drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in pregnant women or unborn children
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is with the pregnant woman on whom the clinical trial is being conducted or with her
p.(None): to recognize unborn child diseases or their course, to cure or to alleviate them or
p.(None): to protect them from diseases,
p.(None): 3. according to the knowledge of medical science, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): sufficient test results can be expected.
p.(None): (2) Paragraph 1 applies mutatis mutandis to clinical trials of medicinal products intended to be admission
p.(None): to allow pregnancy.
p.(None): Section 45. (1) The clinical trial of a medicinal product may be carried out on persons who have a presence or
p.(None): Provide training service, not be carried out.
p.(None): (2) The clinical trial of a medicinal product may be carried out on persons who are judicial or official
p.(None): Order stopped or accommodated according to the Accommodation Act, not carried out
p.(None): become.
p.(None): Dealing with data
p.(None): Section 46. (1) On the part of the sponsor, monitor and examiner, appropriate measures are necessary for careful
p.(None): and confidential handling of all data resulting from a clinical trial.
p.(None): (2) The test plan, the documentation, the agreements made between the investigator and sponsor and
p.(None): all other documents related to the clinical trial must be reviewed by
...
p.(None): this federal law prescribed standard with regard to planning, implementation and evaluation
p.(None): clinical trials are complied with. An ethics committee inspection may also aim to:
p.(None): by means of an objective, independent review to determine whether the ethics committee is performing its tasks
p.(None): this federal law in accordance with the state of the art.
p.(None): (7a) If an inspection determines that a clinical trial is contrary to the requirements of this
p.(None): Federal law is carried out, or concerns about the safety or arise
p.(None): scientific basis of clinical testing and thereby the life or health of
p.(None): Exam participants at risk, the Federal Office for Safety in Health Care can take measures in the
p.(None): Within the meaning of Section 41c (1) without prior procedure or before issuing a decision;
p.(None): however, a written notification must be issued within two weeks, otherwise the
p.(None): the measure taken is deemed to be canceled.
p.(None): (8) Will the Federal Office for Safety in Health Care come into being when an inspection is carried out
p.(None): clinical trial cash expenses are to be invoiced to the sponsor, unless the investigator
p.(None): performs the duties of the sponsor within the meaning of section 2a (16).
p.(None): Section 47a. Ethics committees are required, all of them to the Federal Office for Safety in Health Care
p.(None): To provide information and to send documents that this to perform its duties under this
p.(None): Section needed.
p.(None): statutory authorization
p.(None): § 48. (1) Insofar as this is necessary with regard to drug safety, the Federal Minister for
p.(None): Health and environmental protection through regulation more detailed provisions on the requirements and
p.(None): Conduct clinical trial and non-clinical trial of medicines.
p.(None): (2) Without prejudice to the Animal Testing Act 2012, Federal Law Gazette I, the Federal Minister of Health
p.(None): № 114/2012, taking into account Directive 81/852 / EEC, more detailed provisions on clinical
p.(None): To be tested on animals.
p.(None): (3) The Federal Minister of Health, if this is for reasons of drug safety, to
p.(None): Compliance with international scientific standards or obligations under Community law or
p.(None): to verify compliance with the provisions of Section V is required by ordinance
p.(None): Regulations on the conduct of non-interventional studies, a reporting obligation for non-
p.(None): interventional studies, which are required to report, the scope of the reporting obligation and management
p.(None): a register for non-interventional studies including a part that may be accessible to the public
p.(None): of this register.
p.(None): IV. SECTION
p.(None): Pharmaceutical Advisory Board and Delimitation Advisory Board
p.(None): Pharmaceutical Advisory Board
p.(None): Section 49. (1) For advice to the Federal Minister for Health and Women and the Federal Office for
p.(None): Healthcare security in pharmaceutical matters and to prepare expert reports in
p.(None): Matters of this federal law are one with the Federal Ministry of Health and Women
p.(None): Commission (drug advisory council).
p.(None): (2) The Pharmaceutical Advisory Board must have permanent members: one representative from each of the areas
p.(None): 1. pharmaceutical technology,
p.(None): 2. Internal medicine,
p.(None): 3. clinical pharmacology,
p.(None): 4. pharmacology and toxicology,
p.(None): 5. Pharmaceutical chemistry
p.(None): 6. gene technology or gene therapy and somatic cell therapy and
p.(None): 7. Biometrics.
p.(None): (3) Depending on the type of object to be treated, the advice of the Medicines Advisory Board can be given in the
p.(None): In individual cases, non-permanent members of relevant, technically suitable persons are involved.
p.(None): (4) The permanent members of the Pharmaceutical Advisory Board mentioned in paragraph 2 are from the Federal Minister for
p.(None): Order health and women for a period of five years.
p.(None): (5) The Federal Minister of Health and Women has a servant for the period mentioned in paragraph 4
p.(None): (Note: correct: staff) to entrust his ministry with the chairmanship of the pharmaceutical advisory board.
p.(None): (6) A deputy must be appointed for each member and the chairman.
p.(None): (7) All members as well as the chairman and their deputies have a casting vote.
p.(None): Representatives have such a right to vote only if the persons they represent are prevented.
p.(None): (8) Certain tasks can be assigned to committees. Experts who
p.(None): The Committee of the Drugs Advisory Board, who are not members in accordance with paragraph 2, are dated
p.(None): Federal Minister of Health and Women as committee members for the period specified in paragraph 4
p.(None): to order.
...
p.(None): take that a balanced cast with regard to the demarcation (note: correct: demarcation) in
p.(None): Considered coming product groups is guaranteed.
p.(None): (3) The deliberations of the delimitation advisory board can depend on the type of object to be treated
p.(None): in individual cases, as non-permanent members, relevant, technically suitable persons are involved.
p.(None): (4) The Federal Minister of Health and Women has a member of staff for the period specified in paragraph 2
p.(None): its ministry to chair the delimitation advisory board.
p.(None): (5) A deputy must be appointed for each member and the chairman.
p.(None): (6) All members as well as the chairman and their deputies have a casting vote.
p.(None): Representatives have such a right to vote only if the persons they represent are prevented.
p.(None): (7) The work of the Delimitation Advisory Board is carried out by the Federal Minister of Health and
p.(None): Women led to rules of procedure to be adopted.
p.(None): (8) The work in the delimitation advisory board is voluntary. Any travel expenses are the members of the
p.(None): Demarcation Advisory Board, its deputies and experts involved according to the highest fee level
p.(None): of the 1955 Travel Fee Regulation, Federal Law Gazette No. 133.
p.(None): V. SECTION
p.(None): advertising restrictions
p.(None): General provisions
p.(None): Section 50. (1) All measures for information, for market research, are considered "advertising for pharmaceuticals"
p.(None): and market cultivation and creation of incentives with the aim of prescribing, dispensing,
p.(None): Promote sales or consumption of medicines. In particular, it includes:
p.(None): 1. drug advertising intended for consumers (lay advertising),
p.(None): 2. The drug advertising for people who prescribe or dispense drugs
p.(None): are authorized (specialist advertising),
p.(None): 3. Visiting pharmaceutical officers for people who prescribe or dispense
p.(None): Medicinal products are authorized
p.(None): 4. the supply of medical samples,
p.(None): 5. Incentives to prescribe or dispense drugs by granting, offering or
p.(None): Promise of financial or material benefits,
p.(None): 6. the sponsorship of sales promotion events in which people who participate in the
p.(None): Are authorized to prescribe or dispense medicinal products,
p.(None): 7. The assumption of travel and subsistence costs and participation fees in connection with
p.(None): professional science events for people who are prescribing or prescribing
p.(None): Dispensing of medicinal products are authorized.
p.(None): (2) This section does not apply
p.(None): 1. the correspondence and, if applicable, all documents which are not used for advertising purposes and which are used for
p.(None): Answering a specific query about a particular drug is required
p.(None): 2. Sales catalogs and price lists, provided they do not contain any information about medicinal products,
p.(None): 3. Information about the health or diseases of humans and animals, if not therein, too
p.(None): not indirectly referring to a drug.
p.(None): (3) The approved technical information, instructions for use and labeling are not subject to the
p.(None): Provisions of this section insofar as they fulfill the requirements of §§ 15 Paragraph 1, 16 Paragraph 1, 16a Paragraph 1,
p.(None): Paragraphs 1 and 17a paragraph 1 serve obligations.
p.(None): § 50a. (1) Advertising for medicinal products is only allowed for
p.(None): 1. approved pharmaceutical specialties,
p.(None): 2. Registered traditional herbal and registered pharmacy specialties
p.(None): 3. registered homeopathic medicinal specialties,
p.(None): 4. medicinal products for which a license for distribution in parallel import has been granted, and
p.(None): 5. Medicinal specialties according to § 7 paragraph 2
p.(None): operate.
p.(None): (2) Advertising for registered homeopathic medicinal specialties may only contain information that is in § 17a
p.(None): are listed.
p.(None): (3) Advertising for medicinal products must objectively and without the properties of the medicinal product
p.(None): Exaggerate and may not contain statements or images that
p.(None): 1. add an effect to the medicinal product that goes beyond its actual effect,
p.(None): 2. Incorrectly give the impression that success can be expected regularly, or
p.(None): 3. not with labeling, instructions for use or specialist information (summary of the
p.(None): Product properties - SmPC) are compatible.
p.(None): (4) Lay advertising may not contain any statements that refer to labeling, use or
p.(None): Specialist information (summary of product characteristics - SmPC) go beyond. Specialized advertising may
p.(None): Contain statements that contain the statements in labeling, instructions for use or specialist information
p.(None): (Summary of product properties - SmPC) add if they are not in with these statements
p.(None): Contradict, but confirm these statements or in a meaning to be agreed with them
p.(None): specify without falsifying them.
p.(None): § 50b. (1) Sections 50a and 51 to 56 do not apply to medicinal products within the meaning of Section 7 (4).
p.(None): (2) Section 50a (1) does not apply to specialist advertising within the meaning of Section 54 in the context of scientific
p.(None): Events whose participants come mainly from abroad.
p.(None): lay Advertising
p.(None): § 51. (1) Lay advertising may not for
p.(None): 1. Medicinal specialties that are subject to prescription,
p.(None): 2. Medicinal specialties that are not subject to prescription, but whose name is the same
p.(None): Fancy word or the same scientifically common expression as the name of a
p.(None): contains prescription drug, and
p.(None): 3. registered homeopathic medicinal specialties,
p.(None): operate.
p.(None): (2) The prohibition according to Paragraph 1 No. 1 does not apply to those implemented or supported by local authorities
p.(None): Vaccination campaigns.
p.(None): Section 52. (1) Lay advertising must be designed in such a way that the advertising character is clearly expressed
p.(None): and the product is clearly represented as a drug. Advertising and editorial contributions are clear
p.(None): to separate.
p.(None): (2) Unless otherwise specified in Paragraph 4, lay advertising has at least the following information:
p.(None): contain:
p.(None): 1. the name of the pharmaceutical specialty and the scientifically common name of the active ingredient, if
p.(None): the medicinal product contains only one active substance,
p.(None): 2. the information essential for the sensible application of the medicinal product and
p.(None): 3. A clearly perceptible indication that medicinal products are not only effects
p.(None): can cause undesirable effects and therefore the package leaflet exactly
p.(None): or consult a doctor or pharmacist. The advertising is done via
p.(None): acoustic or audiovisual media, this notice must be clearly audible.
p.(None): (3) In addition to para. 2, lay advertising for traditional herbal medicinal specialties has a written one
p.(None): Note to contain that this is a traditional herbal medicinal specialty for use in a
p.(None): specific area of application or certain areas of application exclusively due to long-term
p.(None): Use.
p.(None): (4) lay advertising does not have to meet the requirements of paragraph 2 if the advertising
p.(None): consists exclusively of the name of a medicinal specialty (souvenir advertising), unless it acts
p.(None): are advertising for pharmaceutical specialties that serve to increase athletic performance. The notice according to
p.(None): Paragraph 2 no. 3 is to be included if the reminder advertising is via posters, advertisements or acoustic or
p.(None): audiovisual media.
p.(None): Section 53. (1) Lay advertising may not contain any elements that
p.(None): 1. pictorial representations in connection with members of the health professions or institutions of the
p.(None): Health care,
p.(None): 2. make a medical examination or a surgical procedure seem superfluous,
p.(None): in particular by offering a diagnosis or treatment on the
p.(None): Recommend correspondence,
p.(None): 3. suggest that the effect of the drug is guaranteed without side effects or one
p.(None): corresponds to or is superior to another treatment or another medicinal product,
p.(None): 4. suggest that the normal good health of the patient through the use of the drug
p.(None): could be improved
p.(None): 5. suggest that the normal good health of the patient in the event of non-use of the
p.(None): Drug could be affected
p.(None): 6. are intended exclusively or mainly for children,
p.(None): 7. on the recommendation of scientists, health professionals or
p.(None): Refer to people who, based on their popularity, could stimulate drug consumption,
p.(None): 8. The medicinal product is a food, cosmetic product or other consumer goods
p.(None): equate
p.(None): 9. suggest that the safety or efficacy of the medicine is due to the fact that it is
p.(None): act as a "natural product",
p.(None): 10. through a detailed description or presentation of the medical history of a wrong one
p.(None): Could lead to self-diagnosis,
p.(None): 11. Abusive, worrying, or misleading
p.(None): Get recovery certificates,
p.(None): 12. Abusive, worrying or misleading images of the
p.(None): Changes in the human or animal body due to diseases or
p.(None): Damage or the effect of a drug in the human body or in parts of the body
p.(None): use,
p.(None): 13. work towards obtaining prescription drugs at a distance.
p.(None): (2) Lay advertising may contain a reference to the admission or registration, provided that
p.(None): only the fact of admission or registration is referred to and such
p.(None): Note is not likely to mislead consumers in terms of safety and security
p.(None): Effectiveness of the medicinal product in question.
p.(None): (3) The supply of samples or samples of medicinal products or vouchers for this is not permitted.
p.(None): Likewise, the running of competitions is not permitted, provided that this is in connection with the
p.(None): Dispensing of drugs are available.
p.(None): professional advertising
p.(None): Section 54. (1) Pharmaceutical advertising intended for those authorized to use and dispense
p.(None): is, provided it
p.(None): 1. is operated for a medicinal specialty for which a specialist information (summary
p.(None): the product properties - SmPC) is to be published, and
p.(None): 2. takes place in printed matter, via electronic carrier media or by means of telecommunications,
p.(None): in a clearly legible form the essential information about the pharmaceutical specialty in accordance with the
p.(None): Technical information (summary of product properties - SmPC) included.
p.(None): (2) The Federal Minister of Health and Women has an ordinance pursuant to Section 15 (7)
p.(None): determine which information and in what form in drug advertising within the meaning of paragraph 1
p.(None): are to be included.
p.(None): Section 55. (1) All documents relating to a medicinal specialty that are part of the sales promotion for this
p.(None): Medicinal product must be given to the person authorized to prescribe or dispense it
p.(None): in addition to the information specified in Section 54 (1), the time at which the documents were created
p.(None): or last changed.
p.(None): (2) All information contained in the documents mentioned in paragraph 1 must be accurate, current,
p.(None): be verifiable and complete enough to give the recipient the opportunity to personally get an idea
p.(None): of the therapeutic value of the drug.
p.(None): (3) The quotes, tables and other representations taken from the specialist literature, which are described in the
p.(None): Paragraph 1 documents used must be taken over word for word; there is the
p.(None): specify exact source.
p.(None): (4) If reference is made to specialist literature in the documents mentioned in Paragraph 1, then this is
p.(None): reproduce essential content objectively with the source.
p.(None): Section 55a. (1) As part of the sales promotion for medicinal products for prescription or dispensing
p.(None): Authorized persons are prohibited from granting them a premium, fi nancial or material benefits,
p.(None): to offer or promise unless these are of little value and for medical or
p.(None): pharmaceutical practice of concern.
p.(None): (2) The representation effort in connection with sales promotion events must
p.(None): always strictly limited to their main purpose and may not be other than the person
p.(None): Prescription or persons authorized to dispense apply.
p.(None): (3) The provisions of paragraph 1 stand for the direct or indirect takeover of reasonable
p.(None): Travel and subsistence costs and participation fees for work-related only
p.(None): not opposed to scientific events; the representation effort must always be strict on the
p.(None): main scientific purpose of the event should be limited; the assumption of travel and
p.(None): Living expenses and participation fees as well as representation expenses must not be allowed to others
p.(None): Persons are regarded as persons authorized to prescribe or dispense.
p.(None): (4) The person authorized to prescribe or dispense it is prohibited, contrary to para. 1 bis
p.(None): 3 to request a premium, financial or material benefits, to be promised or accepted.
p.(None): (5) The Federal Minister of Health and Women can issue more detailed regulations by ordinance
...
p.(None): (2) Is determined during a check in accordance with paragraph 1, or receives the Federal Office for Security in
p.(None): Healthcare otherwise aware that the provisions of this section are violated
p.(None): it must have all the measures required to establish a state in conformity with the law
p.(None): are.
p.(None): VI. SECTION
p.(None): distribution
p.(None): Dispensing of medicines
p.(None): Section 57. (1) Medicinal products may only be supplied by the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): are on
p.(None): 1. public pharmacies, institutional pharmacies and veterinary home pharmacies,
p.(None): 2. Druggists or other traders who, according to section 59 (3), dispense medicinal products
p.(None): are authorized
p.(None): 3. Manufacturer only for the purpose of the manufacture of medicinal products or insofar as they are in accordance with the
p.(None): Trade Regulations 1994 are authorized to trade in pharmaceuticals,
p.(None): 4. pharmaceutical wholesaler,
p.(None): 5. Local authorities
p.(None): a) in connection with tasks of vaccination prophylaxis or to fulfill them by law
p.(None): assigned tasks of disease control,
p.(None): b) humanitarian aid in connection with a disaster that occurred abroad
p.(None): or a serious accident,
p.(None): c) to maintain the supply of pharmaceuticals in Germany if this is in connection with a
p.(None): Catastrophe, terrorist threat, armed conflict or pandemic
p.(None): is absolutely necessary
p.(None): 5a. Businesses and organizations that maintain basic public services
p.(None): serve and based on a between the federal government or a state and a manufacturer,
p.(None): Depositeur or pharmaceutical wholesaler concluded contract to ensure the
p.(None): Maintenance of drug supplies related to a pandemic, warlike
p.(None): Conflict or terrorist threat, in turn, individual contracts for direct purchase
p.(None): have completed a drug for the needs of their own employees,
p.(None): 6. Institutions of the Austrian Armed Forces, the pharmaceutical supply of the Armed Forces
p.(None): serve,
p.(None): 6a. the Federal Ministry of the Interior, the authorities and childcare facilities subordinate to it
p.(None): for emergency care, prevention and care of operations, provided that the medicines for
p.(None): Need to perform their duties
p.(None): 7. Institutions, the provisional judicial safekeeping or arrests, judicial
p.(None): Prison sentences or preventive judicial measures related to deprivation of liberty
p.(None): Take measures if they need drugs to perform their tasks
p.(None): 8. scientific institutes and research institutes of the local authorities and the
p.(None): Universities and the Austrian Agency for Health and Food Security, if these
p.(None): Need medicines to perform their tasks
p.(None): 9. Organized emergency medical services, provided they are addictive substances, which they use for their emergency medical services
p.(None): Need activity, and
p.(None): 10. Have a doctor who is sufficiently familiar with questions of substance abuse
p.(None): Institutions according to § 15 of the Addictive Substances Act, Federal Law Gazette I № 112/1997, for evidence-based and
p.(None): quality-assured support for clients as part of damage minimization measures,
p.(None): except drugs containing addictive substances.
...
p.(None): Druggists or by traders who, according to the 1994 Trade Ordinance, manufacture medicinal products
p.(None): are entitled to be released.
p.(None): (4) Insofar as medicinal products in accordance with Paragraph 3 are contact lens fluids, they may
p.(None): are also given by traders who, according to the 1994 Industrial Code, on retail
p.(None): with contact lenses and the adaptation of contact lenses.
p.(None): (5) Medicinal products that contain only active ingredients that are specified in a regulation
p.(None): 3, may be submitted in accordance with paragraphs 3 and 4, unless the Federal Office
p.(None): for Healthcare Safety determined by notice that this is due to a
p.(None): Possibility of danger arising from the special composition or a certain
p.(None): Indication results, is reserved for pharmacies in retail sales.
p.(None): (6) The Federal Office for Safety in Health Care can apply to the authorization holder
p.(None): exempt pharmaceutical specialties that do not comply with Paragraph 5 from the pharmacy reservation,
p.(None): if there is no hazard due to the special composition or the intended indication
p.(None): to get. Such a decision must be revoked if it subsequently becomes known that the
p.(None): The requirements for this are not met.
p.(None): (7) Paragraphs 1 to 6 do not apply to medicinal products within the meaning of Section 7 paragraph 4.
p.(None): (7a) If it is medicinal products for animals intended for external use on the skin
p.(None): are, or are medicinal specialties for bees, due to the special composition
p.(None): or the intended indications of these medicinal specialties upon application by the marketing authorization holder
p.(None): Federal Office for Safety in Health Care through a notice outside of pharmacies and
p.(None): Provide drug stores. Such a decision must be revoked if it subsequently becomes known that the
p.(None): The requirements for this are not met.
p.(None): (8) Medical gases may also be supplied by traders who, in accordance with the
p.(None): Trade Regulations 1994 are authorized to supply compressed technical gases in retail sales.
p.(None): (9) The dispensing of medicines by self-service or by distance selling is prohibited.
p.(None): (10) The distance selling ban according to paragraph 9 does not apply to those who are not registered or registered in Austria
p.(None): prescription-only human medicinal products sold by distance selling
p.(None): 1. within Austria through public pharmacies, or
p.(None): 2. to Austria through pharmacies of another EEA contracting party, according to those applicable there
p.(None): Legislation are empowered to
p.(None): be delivered.
p.(None): (11) The distance selling ban in accordance with paragraph 9 does not apply to human medicinal products that comply with the national
p.(None): Legal requirements of another EEA contracting party correspond, provided that they do not require a prescription there
p.(None): are by means of distance selling through public pharmacies in the territory of this EEA Contracting Party
p.(None): be delivered.
p.(None): Note for the following provision
p.(None): For the entry into force cf. Section 13 (2) of the Distance Selling Ordinance, Federal Law Gazette II No. 105/2015, and Section 94i (3).
p.(None): distance Selling
p.(None): Section 59a. (1) The supply of human medicinal products by means of distance selling in accordance with Section 59 (10)
p.(None): Z 1 and Paragraph 11 may only be carried out by public pharmacies that meet the requirements of Paragraphs 2 and 3
p.(None): fulfill.
...
p.(None): provide at least the following information:
p.(None): 1. Information on the offer to the public for the sale of human medicinal products
p.(None): Legislation applicable through distance selling,
p.(None): 2. Information on the purpose of the common logo in accordance with Article 85c (3) of Directive 2001/83 / EC,
p.(None): 3. a list of public pharmacies in accordance with paragraph 1 and the addresses of their websites,
p.(None): 4. Information about the dangers to human health and life
p.(None): Human medicinal products illegally released to the public by distance selling
p.(None): be, and
p.(None): 5. A periodically updated overview of the EEA Contracting Parties in which for
p.(None): dispensing of medicinal products by distance selling is comparable to Austrian regulations
p.(None): Security standards exist.
p.(None): (5) Human medicinal products that are sold through distance selling may only be in one of the usual
p.(None): personal quantity will be shipped and are appropriate
p.(None): 1. to pack, transport and deliver so that their quality and effectiveness are not
p.(None): is affected, and
p.(None): 2. demonstrably to be followed by the person who pays the order to the respective public
p.(None): Pharmacy was notified.
p.(None): (6) As part of the ordering process, advice is also available on any interactions
p.(None): take place, whereby according to the technical availability also the e-medication according to § 16a
p.(None): Health Telematics Act 2012, Federal Law Gazette I № 111/2012. The Federal Minister of Health
p.(None): has to make more detailed regulations by ordinance, so that the technical availability is also related
p.(None): of drugs by distance selling in e-medication according to § 16a
p.(None): Health Telematics Act 2012 to be included.
p.(None): (7) The Federal Minister of Health has taken into account drug safety
p.(None): Ordinance specifies the requirements for the delivery of
p.(None): Human medicinal products through distance selling and at their dispatch, in particular over the
p.(None): Ordering process, packaging, transport, storage, delivery, collection, securing
p.(None): pharmaceutical advice and the need for a quality assurance system.
p.(None): demarcation Commission
p.(None): Section 60. (1) To advise the Federal Minister of Health and Environmental Protection and the Federal Minister
p.(None): for trade, commerce and industry in matters of the delimitation of sales rights within the meaning of § 59 is with
p.(None): Federal Ministry of Health and Environmental Protection a commission (delimitation commission)
p.(None): to set up.
p.(None): (2) The Delimitation Commission must belong as members:
p.(None): 1. the board of an Austrian university institute for pharmacology,
p.(None): 2. the board of an Austrian university institute for pharmacognosy,
p.(None): 3. two representatives of the Austrian Chamber of Commerce,
p.(None): 4. a representative of the Austrian Chamber of Pharmacists,
p.(None): 5. a representative of the Austrian Medical Association,
p.(None): 6. a representative of the Federal Chamber of Veterinarians in Austria,
p.(None): 7. a representative of the Federal Chamber of Labor,
p.(None): 8. a representative of the umbrella organization of social security institutions and
p.(None): 9. an expert staff member of the Austrian Agency for Health and Food Security.
p.(None): (3) The members of the demarcation commission are from the Federal Minister of Health and
p.(None): Order environmental protection for a period of five years. With regard to those mentioned in paragraph 2 nos. 3 to 8
...
p.(None): a license to handle radioactive substances in accordance with the Radiation Protection Act, Federal Law Gazette.
p.(None): No. 227/1969, last amended by Federal Law Gazette I No. 13/2006, and
p.(None): 9. Medical facilities of the Federal Army, in which for the medical care of relatives of the
p.(None): Bundesheeres medicinal products are manufactured.
p.(None): (2a) Provided that public pharmacies sell medicinal products to others beyond the usual pharmacy operation
p.(None): dispensing to public pharmacies, to institutional pharmacies or to hospitals, these require one
p.(None): Appropriate authorization according to § 63 paragraph 1. This also applies to institutional pharmacies that sell medicines
p.(None): other institutional pharmacies or hospitals, except for those operated by the respective institutional pharmacy,
p.(None): submit.
p.(None): (2b) When re-blistering medicinal products, an operating license in accordance with Section 63 (1) is required for
p.(None): Public pharmacies or institutional pharmacies are required, provided the newly blistered medicinal products are sold to a
p.(None): more than the usual number of pharmacies.
p.(None): (2c) When assessing the exceedance of the usual pharmacy operation in accordance with para. 2a and 2b is -
p.(None): if applicable - to be checked in particular:
p.(None): 1. the production and distribution volume of the pharmaceuticals,
p.(None): 2. the risk potential of the manufacturing process,
p.(None): 3. the frequency of deliveries of medicines, and
p.(None): 4. the number of people supplied with newly blistered medicines on average per year.
p.(None): The Federal Office for Safety in Health Care has taken drug safety into account
p.(None): and the professional and personal equipment of a public pharmacy or institutional pharmacy
p.(None): Ordinance to issue more detailed rules for the examination and assessment of the criteria according to Z 1 to 4.
p.(None): The regulation is on the homepage of the Federal Office for Safety in Health Care
p.(None): to make known. The Federal Office for Safety in Health Care has exceeded the usual
p.(None): Pharmacy company to determine this with notice.
p.(None): (3) The ordinance pursuant to Paragraph 1 shall contain in particular more detailed provisions on
p.(None): 1. Manufacture, placing on the market, import and export of medicinal products or active substances,
p.(None): 1a. Staffing and qualification,
p.(None): 2. type and scope of the control of drugs or active substances, such as the management of a control laboratory,
p.(None): 3. Hygiene requirements,
p.(None): 4. quality, size, equipment, dedication and location of the operating rooms and their furnishings,
p.(None): 5. Nature of the technical equipment,
p.(None): 6. quality of work clothing,
p.(None): 7. Nature and labeling of the containers,
p.(None): 8. Management and storage of reservations, records, reports, samples and others
p.(None): show
p.(None): 9. nature and keeping of the animals used in the manufacture of the medicinal products,
p.(None): 10. Readiness for duty for pharmaceutical wholesalers and pharmaceutical wholesalers,
p.(None): 11. Storage and storage as well as transport,
p.(None): 12. Withdrawal, labeling, separation or destruction of non-marketable goods
p.(None): Drugs.
p.(None): (3a) In the regulation pursuant to Paragraph 1, the Federal Minister of Health, in agreement with the
p.(None): Federal Minister of Finance for implementing Union law regulations
...
p.(None): Carry out a business check with the applicant. If the Federal Office for Security in
p.(None): Health care to the applicant within 60 days of receipt of the documents in accordance with paragraph 1
p.(None): Announces operational review, the activity may only after approval by the Federal Office for Security in the
p.(None): Healthcare will be included. The Federal Office for Safety in Healthcare comments
p.(None): not within 60 days, the application is considered approved. If the requirements for a permit
p.(None): are not fulfilled, the Federal Office for Safety in Health Care has to state this with a decision.
p.(None): (3) Any changes that affect the quality or safety of the manufactured, in circulation
p.(None): brought or controlled active ingredients, require a permit from the Federal Office for
p.(None): Healthcare security.
p.(None): (4) Sections 64 to 66a, 67 (1) regarding periodic reviews, 69 and 71 apply to companies
p.(None): in accordance with Paragraph 1.
p.(None): Section 64. (1) The permit pursuant to Section 63 (1) is to be issued if the operating rules are complied with
p.(None): and due to the equipment, the necessary for the health and life of humans or animals
p.(None): The quality of the pharmaceuticals or active ingredients is guaranteed.
p.(None): (2) The Federal Office for Safety in Health Care can also order a trial operation if
p.(None): this is necessary to assess the existence of the prerequisites within the meaning of paragraph 1.
p.(None): (3) If necessary, the license must be issued stipulating such conditions as to
p.(None): Fulfillment necessary for the protection of human and animal health and life
p.(None): Ensure the nature of the drug or active ingredients
p.(None): (4) The Federal Office for Safety in Health Care can also issue a restricted permit in the
p.(None): Issue within the meaning of section 63 (1) if the conditions for granting such a license are only given in
p.(None): to this limited extent.
p.(None): (5) The Federal Office for Safety in Health Care has the data on the authorization for
p.(None): Manufacture and placing on the market of medicinal products or active substances in accordance with section 63 (1) and section 63a (2)
p.(None): or 3 or Section 65 (1) in the Union database in accordance with Article 111 (6) of Directive 2001/83 / EC
p.(None): enter.
p.(None): Section 65. (1) Significant changes with regard to manufacturing, placing on the market or control
p.(None): the medicinal products or active substances, in particular with regard to the information in accordance with section 63 (2) lines 1 to 3, the
p.(None): Effects on the nature of drugs or active ingredients or the production or
p.(None): Distribution program require the approval of the Federal Office for Security in the
p.(None): Healthcare system within the meaning of Section 63 (1). The Federal Office for Healthcare Safety has over
p.(None): to decide a corresponding application within 30 days of receipt of the application. This
p.(None): In exceptional cases, the deadline can be extended to 90 days.
p.(None): (2) The Federal Office for Safety in Health Care can provide the applicant with additional information
p.(None): with regard to the requested change in accordance with paragraph 1. In this case, the deadlines are set according to
p.(None): Paragraph 1 inhibited until additional information is received.
p.(None): (3) The holder of the license pursuant to Section 63 (1) or Section 65 (1) has all intended changes
...
p.(None): to be done immediately.
p.(None): Section 66. If the license is granted in accordance with Section 63 (1) or Section 65 (1), it follows that
p.(None): Compliance with the prescribed requirements for the health and life of humans or animals
p.(None): required condition of the drugs or active ingredients is not sufficiently guaranteed, that has
p.(None): Federal Office for Safety in Health Care to prescribe other or additional requirements.
p.(None): Section 66a. The license pursuant to Section 63 (1) or Section 65 (1) must be withdrawn if subsequently
p.(None): it is known that the requirements have not been met. It must be revoked if the
p.(None): Requirements no longer exist. Instead of the cancellation, the whole or partial
p.(None): Suspension of the permit will be ordered if the reason for the revocation may be within
p.(None): can be removed at an appropriate time by the holder of the operating license. The Federal Office for
p.(None): Healthcare safety has the other contracting parties to the Agreement on the European
p.(None): Economic area, Switzerland and the Commission to be informed immediately.
p.(None): Section 66b. The license pursuant to Section 63 (1) or Section 63a (2) or Section 3 or Section 65 (1) must be revoked.
p.(None): if the holder of the operating license waives this.
p.(None): Operations Review
p.(None): Section 67. (1) The Federal Office for Safety in Health Care plans companies in accordance with Section 62 (1)
p.(None): Granting a license in accordance with section 63 (1) or, if necessary, before granting a license in accordance
p.(None): Section 65 (1) and subsequently periodically to check whether the
p.(None): Provisions of this section or the regulations issued on the basis of this section
p.(None): is complied with and is necessary for the health and life of humans or animals
p.(None): Condition of the drug or active ingredients is guaranteed. The Federal Minister of Health can
p.(None): authorize the provincial governors to regulate such types of businesses
p.(None): Check state where this is due to the product range with regard to
p.(None): Drug safety appears justified.
p.(None): (1a) The Federal Office for Safety in Health Care has the Federal Minister of Health
p.(None): a risk-based inspection and sample plan for the implementation of the
p.(None): Operational reviews and the controls according to § 76 for the following calendar year for approval
p.(None): required. The approval is deemed to have been granted if no objections are raised within three months of receipt
p.(None): become. The Federal Office for Safety in Health Care has approved the
p.(None): Inspection and rehearsal plan to be submitted to the Federal Ministry of Health by March 31 of
p.(None): report on the execution of the following calendar year.
p.(None): (2) The reviews of companies that manufacture or control pharmaceuticals or active ingredients are
p.(None): at least once in three years, from establishments that provide human blood or blood components, provided that
p.(None): intended for transfusion, processed, stored or distributed, once in two years, by others
p.(None): Operate at least once every five years. You are in default unless there is a danger or if
p.(None): there is a reasonable assumption that the effectiveness of the official act is impaired,
p.(None): to announce in advance. Checks according to Art. 8 of Directive 96/22 / EC are without prior notice
p.(None): perform.
p.(None): (3) The Federal Minister of Health and Environmental Protection is authorized to deal with the highest
p.(None): Health authorities of those countries to which drugs or active substances are exported or from which drugs are exported
p.(None): or active substances are to be imported, administrative convention regarding the review of the
p.(None): Establishments in which these medicinal products or active substances are manufactured, mutual recognition
p.(None): to complete these reviews and exchange of information about these establishments.
p.(None): (4) The Federal Office for Safety in Health Care may carry out operational reviews by third countries
p.(None): Perform drug manufacturers to determine if they are manufactured according to standards and
p.(None): have been checked in accordance with the standards of good manufacturing practice set by the European Union
p.(None): are at least equivalent. The Federal Office for Safety in Health Care can
p.(None): Suspicion of a violation of the requirements of this section or based on this
p.(None): Section decrees for manufacturers or distributors of third-party countries
p.(None): Carry out active ingredient checks. The Federal Office for Safety in Health Care has contributed
p.(None): Co-ordinate operational reviews in third countries with the Agency and these
p.(None): to inform about planned and carried out operational reviews.
p.(None): (5) The Federal Office for Safety in Health Care can, if there are suspicion reasons
p.(None): Violation of the provisions of this section or those adopted on the basis of this section
p.(None): Regulations for companies that manufacture or import auxiliary materials, carry out company reviews.
p.(None): The Federal Office for Safety in Health Care can also in the premises of
p.(None): Marketing authorization holders, registration holders or pharmaceutical intermediaries
p.(None): carry out.
p.(None): (6) Operational reviews in accordance with paragraphs 1 and 4 and operational reviews in accordance with paragraph 5 of
p.(None): Companies that manufacture or import auxiliary materials can, at the request of another Member State,
p.(None): the European Commission or the Agency. Without prejudice to any agreements
p.(None): between the European Union and countries that are not parties to the Agreement on the
p.(None): Are European Economic Area, the Federal Office for Safety in Health Care one
...
p.(None): (7) The Federal Office for Safety in Health Care has company reviews of companies that
p.(None): 1. Human medicinal products or
p.(None): 2. Active ingredients
p.(None): manufacture, control or place on the market according to the guidelines of the European Commission
p.(None): Art. 111a of Directive 2001/83 / EC and the collection of the
p.(None): To carry out Community procedures for inspections and the exchange of information, with the
p.(None): Agency by exchanging information about planned and carried out operational reviews
p.(None): together.
p.(None): (8) The Federal Office for Safety in Health Care introduces its inspection activities
p.(None): professionally designed quality system, by the organs of the Federal Office and by this
p.(None): consulted experts in these activities. The quality system is closed if necessary
p.(None): To update.
p.(None): Section 68. (1) The organs of the Federal Ministry of Health and Women and of the bodies under Section 67 (1)
p.(None): authorized the governor, the organs of the Federal Office for Safety in Health Care as well
p.(None): by the Federal Minister for Health and Women or the Federal Office for Security in the
p.(None): Healthcare experts are authorized to
p.(None): 1. Companies in accordance with § 62 Paragraph 1 and
p.(None): 2. Facilities and means of transport of such companies that are operated by companies in accordance with Section 62 (1) with
p.(None): Storage or transport have been commissioned, provided that they are for storage or transport
p.(None): of drugs or active ingredients can serve
p.(None): to enter, to visit, to check and to take samples in the quantity required for an examination
p.(None): and to inspect the records of the company, which according to drug law
p.(None): Regulations are to be kept, and copies thereof as well as photographs and video recordings in the company
p.(None): to be made if this is necessary to preserve evidence. You can also inspect the certificate
p.(None): the necessary business license according to the trade regulations 1994 taken
p.(None): become. These official acts are, except in the event of imminent danger, during the operating hours
p.(None): perform.
p.(None): (2) The organs and experts within the meaning of paragraph 1 must take care that each
p.(None): disruption or obstruction of the operation that is not absolutely necessary is avoided.
p.(None): (3) No compensation is due for the samples taken in accordance with paragraph 1.
p.(None): (4) A record according to §§ 14f AVG and its content is to be recorded for each company audit
p.(None): from the Federal Office for Safety in Health Care to the holder of the operating license
p.(None): bring is. In terms of content, the minutes are based on those of the European Commission
p.(None): published guidelines in accordance with Art. 51 of Directive 2001/82 / EC or Art. 111a of Directive 2001/83 / EC
p.(None): to orient. Upon reasoned request from another party to the Agreement on the European
p.(None): Economic area or Switzerland, the Federal Office for Safety in Health Care has this
p.(None): Send the record to the requesting state.
p.(None): (5) The Federal Office for Safety in Health Care has within 90 days of completion
p.(None): to issue a certificate of an operational audit if the operational audit has shown
p.(None): that the operation complies with the provisions of this section, those adopted on the basis of this section
p.(None): Regulations and the operating license. The form and content of the certi fi cate are those of the
...
p.(None): The Federal Office for Safety in Health Care also has information about companies that database
p.(None): the provisions of this federal law or ordinances issued on the basis of this federal law
p.(None): do not correspond to enter. This also applies to the registration and deletion of pharmaceutical intermediaries.
p.(None): Section 69. (1) In cases of imminent danger to human or animal health caused by medicinal products
p.(None): Federal Office for Safety in Health Care according to the extent of the risk
p.(None): 1. the complete or partial closure of the business, the decommissioning of technical facilities or
p.(None): other measures to prevent the placing on the market of medicinal products or substances
p.(None): or
p.(None): 2. To impose requirements to ensure compliance with the provisions of this federal law or on grounds
p.(None): to ensure ordinances enacted by this federal law.
p.(None): (2) In cases of imminent danger from drugs, measures in accordance with paragraph 1 can also be taken
p.(None): be carried out on the spot without prior procedure or before issuing a decision;
p.(None): however, a written notification must be issued within two weeks, otherwise the one that has been passed
p.(None): Measure is deemed canceled.
p.(None): personal requirements
p.(None): Section 69a. (1) In a company within the meaning of Section 62 (1) may perform the tasks of a knowledgeable person
p.(None): and with the management of the manufacture of pharmaceuticals only people with the necessary scientific
p.(None): Vocational training and appropriate practical training.
p.(None): (2) The Federal Minister of Health and Women has issued an ordinance with regard to the
p.(None): Drug safety more detailed regulations on scientific professional training and practical
p.(None): Training of the competent person and the production manager.
p.(None): Section 70. (1) Only persons may be entrusted with the management of a control laboratory within the meaning of Section 62 (3) no
p.(None): who obtain the required scientific professional training and a corresponding one
p.(None): have completed practical training.
p.(None): (2) The Federal Minister of Health and Women, taking into account the necessary
p.(None): Knowledge and experience with regard to drug safety through prescribing more detailed regulations
p.(None): to enact what scientific professional training and practical training the head of a
p.(None): Has to prove control laboratories.
p.(None): Section 71. (1) Persons who are employed in a company within the meaning of Section 62 (1) and with medicinal products,
p.(None): in contact with their containers or materials used to manufacture medicinal products
p.(None): come, must immediately notify the manager of the company or his deputy if
p.(None): 1. they can adversely affect the nature of the medicinal products through illness,
p.(None): 2. They are infected by an illness, even if only to a limited extent, which is notifiable or notifiable
p.(None): have been exposed or are at risk of spreading such a disease,
p.(None): or
p.(None): 3. they are suspected of having an illness as defined in Z 1 or 2.
p.(None): They may only resume their work if the manager of the company or his deputy
p.(None): on the basis of a medical certificate has convinced that the nature of the
p.(None): Medicinal product is not adversely affected.
p.(None): (2) The manager of the company or his deputy must ensure that the persons mentioned in paragraph 1
p.(None): Individuals before starting work and then undergoing a medical examination once a year
p.(None): are subjected, in particular to the presence of diseases and circumstances within the meaning of
p.(None): Paragraph 1 is to be observed.
p.(None): (3) The persons named in paragraph 1 are at the beginning of their employment via paragraphs 1 and 2 as well
p.(None): to be instructed by the employer about § 83 Z 7.
p.(None): drug agent
p.(None): Section 71a. (1) A medication broker who is based in Austria has the Federal Office for Security in
p.(None): Healthcare to report his name, company name and permanent address. each
p.(None): The mediator must report any changes to this data immediately. The Federal Office for Security
p.(None): in the healthcare sector, a register has to be kept of reports from pharmaceutical intermediaries. This is
p.(None): on the website of the Federal Office for Safety in Health Care.
p.(None): (2) The Federal Office for Safety in Health Care has on application for registration
p.(None): to issue a confirmation. The registration must be denied or deleted if the in
p.(None): this federal law or on the basis of an ordinance issued under this federal law
p.(None): specified requirements have not been met or have subsequently ceased to apply.
p.(None): (3) The Federal Minister of Health may, by ordinance, provide more detailed provisions regarding the
p.(None): Issue requirements for the mediation of medicinal products, in particular via
p.(None): Documentation requirements and quality assurance measures.
p.(None): VIII. SECTION
p.(None): Pharmareferent
p.(None): qualification
p.(None): Section 72. (1) The activity of a pharmaceutical representative may only be carried out by persons who:
p.(None): 1. a university course in human medicine, dentistry, veterinary medicine
p.(None): or pharmacy in Austria or in another party to the Agreement on the
p.(None): European Economic Area or successful in the Swiss Confederation
p.(None): have completed or have the qualifications of a competent person,
p.(None): 2. have demonstrated by means of an examination that their vocational training with a view to the activity of a
p.(None): Pharmaceutical officers are to be equated with professional training according to Z 1.
...
p.(None): Section 74. Pharmaceutical officers may not place orders for medicinal products when performing their duties
p.(None): answer.
p.(None): IX. SECTION
p.(None): Market surveillance and pharmacovigilance
p.(None): General principles
p.(None): § 75. (1) For the interpretation of the principles of pharmacovigilance are the generally recognized
p.(None): scientific principles and requirements set out in the by the European Commission
p.(None): guidelines on good practice in the field of pharmacovigilance are included.
p.(None): (2) To the extent that authorization holders are addressed in this section, these provisions also apply
p.(None): for holders of a registration of a traditional herbal medicinal specialty.
p.(None): (3) The Federal Office for Safety in Health Care must operate a system that prevents
p.(None): to ensure that medicinal products that are suspected to be hazardous to health reach patients.
p.(None): Note for the following provision
p.(None): For the reference period cf. § 94h.
p.(None): statutory authorization
p.(None): Section 75a. The Federal Minister of Health has issued an ordinance, insofar as this is considered
p.(None): the requirements for in-depth and rapid information and the functioning of the pharmacovigilance system
p.(None): it is necessary to issue more detailed provisions on
p.(None): 1. the categories to be reported with regard to their frequency, severity and scientific relevance
p.(None): of side effects and
p.(None): 2. Content, scope and form of the report.
p.(None): Note for the following provision
p.(None): For the reference period cf. § 94h.
p.(None): Pharmacovigilance system of the Federal Office for Safety in Health Care
p.(None): Section 75b. (1) The Federal Office for Safety in Health Care has a pharmacovigilance system too
p.(None): lead the collection of important information for drug monitoring and their
p.(None): scientific evaluation and participation in pharmacovigilance activities of the European Union
p.(None): serves.
p.(None): (2) The pharmacovigilance system contains information about the risks of medicinal products for health
p.(None): of the patient or public health. Concerning this information
p.(None): especially side effects of human medicinal products including side effects related
p.(None): with professional exposure to the drug specialty. Furthermore, side effects of
p.(None): Veterinary drugs and human side effects related to the use of
p.(None): To collect veterinary medicinal products.
p.(None): (3) The Federal Office for Safety in Health Care must within the framework of pharmacovigilance
p.(None): Systems scientifically evaluate all information, options for risk minimization and -
p.(None): Check avoidance and, if necessary, measures with regard to approvals or registrations
p.(None): to meet.
p.(None): (4) The pharmacovigilance system must be effective and appropriate for its purpose
p.(None): Quality system.
p.(None): (5) The Federal Office for Safety in Health Care has regular audits of its
p.(None): Pharmacovigilance system for medicinal products for human use and the Commission
p.(None): Report on September 21, 2013 and thereafter every two years.
p.(None): (6) The Federal Office for Safety in Health Care has at least the agency and the commission
p.(None): 24 hours prior to a public notice regarding pharmacovigilance concerns regarding the
p.(None): To inform application of a medicinal product, unless that to protect public health
p.(None): prompt public communications are required.
p.(None): Section 75c. (1) Within the framework of pharmacovigilance, the Federal Office for Safety in Health Care
p.(None): Systems ensure that the following information is available on the Internet portal for medicinal products (§ 27)
p.(None): to be published:
p.(None): 1. Important information about pharmacovigilance concerns related to the application
p.(None): of a drug; these must be made available to the public in a timely manner
p.(None): remove any personal or confidential information of a commercial nature, unless
p.(None): it must be opened to protect public health; before release
p.(None): if applicable, to hear the authorization or registration holder;
p.(None): 2. Summaries of the risk management plan for each drug specialty;
p.(None): 3. the list of medicinal products in accordance with Article 23 of Regulation (EC) No. 726/2004 and
p.(None): 4. Information about the different ways of reporting suspected side effects
p.(None): Healthcare professionals and patients including those intended for it
p.(None): Internet forms.
p.(None): (2) Those affected by a publication in accordance with Paragraph 1 no. 1 may review the legality
p.(None): the publication in a procedure to be completed at the Federal Office for Security in
p.(None): Apply for healthcare. In this case, the Federal Office initiated the initiation of such a procedure in
p.(None): to make known in the same way. If the illegality of the
p.(None): Publication, the Federal Office must correct the publication or at the request of the
p.(None): Either withdraw the data subject or remove them from the Internet portal.
p.(None): Section 75d. (1) The Federal Office for Safety in Health Care has all suspected side effects that
p.(None): have performed in Austria and received it from health professionals or patients
p.(None): Be brought to grasp. If necessary, as part of tracking this
p.(None): Messages the information will be completed.
p.(None): (2) The Federal Office for Safety in Health Care has the reports mentioned in paragraph 1 above
p.(None): serious suspected adverse reactions are reported electronically within 15 days of their receipt
p.(None): Submit eudravigilance database. It does not have the reports mentioned in paragraph 1
p.(None): serious suspected adverse reactions are reported electronically within 90 days of receipt
p.(None): Submit eudravigilance database. If necessary, the Federal Office also has the authorization holder
p.(None): to inform.
p.(None): (3) The Federal Office for Safety in Health Care has by using methods for
p.(None): Gathering information and, if necessary, tracking reports of suspected
...
p.(None): To order. If the remedy order is not fulfilled, the Federal Office has
p.(None): To take measures according to § 23.
p.(None): (5) In cases of paragraph 4, the Federal Office for Safety in Health Care has the agency, the
p.(None): To inform the Commission and the other Member States of the Union, if they are
p.(None): Human medicinal products deals.
p.(None): (6) The Federal Office for Safety in Health Care has carried out the inspections in accordance with the guidelines of
p.(None): Commission under Article 111a of Directive 2001/83 / EC and with the agency
p.(None): Exchange information on planned and carried out inspections.
p.(None): Duties of health professionals
p.(None): Section 75g. (1) Doctors, dentists, veterinarians, dentists, midwives and, insofar as they are not required to report
p.(None): According to § 75j, pharmacists and traders who are registered according to the 1994 Industrial Code
p.(None): Manufacture of medicinal products or wholesalers of medicinal products, and have drugstores
p.(None): 1. suspected side effects or
p.(None): 2. suspected side effects in humans or
p.(None): 3. the lack of the expected effectiveness or
p.(None): 4. insufficient waiting times
p.(None): of medicinal products that have occurred domestically and are known to them due to their professional activity
p.(None): to the Federal Office for Security in accordance with a regulation pursuant to Section 75a
p.(None): to report in healthcare.
p.(None): (2) Those who are obliged to report in accordance with paragraph 1 have all to the Federal Office for Safety in Health Care
p.(None): Share observations and data that may be important for drug safety. The
p.(None): The transmission of personal data is only permitted in a pseudonymized form.
p.(None): § 75h. Persons who are not subject to the reporting obligation in accordance with sections 75g and 75j, in particular patients,
p.(None): have the opportunity to report suspected side effects of medicines to the Federal Office for Safety
p.(None): Healthcare via the Internet portal for medicinal products or by post.
p.(None): Obligations of the authorization holder
p.(None): Pharmacovigilance system
p.(None): Section 75i. (1) The authorization holder of a pharmaceutical specialty has a pharmacovigilance system for its
p.(None): Operate medicinal specialties.
p.(None): (2) As part of the pharmacovigilance system, the marketing authorization holder must
p.(None): 1. constantly and continuously via a person responsible for pharmacovigilance, accordingly
p.(None): qualified person (person responsible for pharmacovigilance),
p.(None): 2. Maintain pharmacovigilance master documentation and request this from the Federal Office of
p.(None): Provide healthcare security at any time within seven days
p.(None): 3. a risk management system
p.(None): (a) for each individual human specialty and
p.(None): (b) for a veterinary specialty, provided this is in view of the identified and potential risks of the
p.(None): Drug specialty is required
p.(None): 4. Monitor the results of risk mitigation measures that are part of the
p.(None): Risk management plans are or which according to §§ 18 paragraph 3, 19 paragraph 4 and 19b paragraph 1 and 2 as
p.(None): Conditions or conditions of approval have been prescribed,
p.(None): 5. Make updates to the risk management system and
p.(None): 6. Monitor pharmacovigilance data to determine if there are new risks to existing ones
p.(None): Risks have changed or the benefit-risk ratio of pharmaceutical specialties has changed.
p.(None): (3) The marketing authorization holder must provide all information within the framework of the pharmacovigilance system
p.(None): evaluate scientifically, examine ways of minimizing and avoiding risks and
p.(None): Take appropriate measures if necessary.
p.(None): (4) The marketing authorization holder is obliged to conduct regular audits of his pharmacovigilance system
p.(None): undergo. The main results of the audits can be found in his pharmacovigilance master documentation
p.(None): noted. According to the audit results, he has an action plan to remedy the deficiency
p.(None): to work out and to follow. If the remedial measures are complete
p.(None): the note can be deleted from the pharmacovigilance master documentation.
p.(None): (5) The person responsible for pharmacovigilance must be resident and active in the European Economic Area
p.(None): and has to set up and run the pharmacovigilance system. The marketing authorization holder has the
p.(None): Federal Office for Safety in Health Care and the agency the name and contact details of the
p.(None): Report pharmacovigilance managers and any change in this data immediately.
...
p.(None): The agency is not monitored according to Art. 27 of Regulation (EC) № 726/2004
p.(None): obligates the suspected side effects that appear in the medical literature listed in the list
p.(None): to be submitted to the eudravigilance database.
p.(None): (5) The marketing authorization holder is obliged to introduce procedures through the accurate and verifiable
p.(None): Data obtained for the scientific evaluation of reports of suspected side effects
p.(None): can be. He must collect and track information related to these reports
p.(None): submit the updated information to the eudravigilance database.
p.(None): (6) The license holder is obliged to communicate with the agency and the Federal Office for Security in
p.(None): Healthcare with a view to detecting double entries of suspected reports
p.(None): Side effects work together.
p.(None): (7) The marketing authorization holder has regularly checked the reports pursuant to Section 75g by means of
p.(None): Inform the eudravigilance database.
p.(None): (8) The Federal Office for Safety in Health Care has the license holder only then
p.(None): to prescribe additional obligations regarding the reporting of suspected side effects if this occurs
p.(None): Pharmacovigilance reasons is required.
p.(None): Note for the following provision
p.(None): Paragraphs 1 and 2: For entry into force cf. Section 94h (11).
p.(None): Regularly updated report on the safety of medicinal products (PSUR)
p.(None): § 75k. (1) The marketing authorization holder is obliged to provide regularly updated reports on the
p.(None): Harmlessness of drugs to the data archive for the regularly updated
p.(None): Submit safety reports electronically. These must include the following:
p.(None): 1. Summaries of data needed to assess the benefits and risks of a
p.(None): Drug specialty of interest, including the results of all studies, are the possible ones
p.(None): Have an impact on approval,
p.(None): 2. a scientific assessment of the benefit-risk ratio of the pharmaceutical specialty and
p.(None): 3. All data related to the sales volume of the medicinal product as well as all of it
p.(None): available data related to prescription volume, including one
p.(None): Estimate of the number of people using the medicinal product.
p.(None): The assessment according to Z 2 must be based on all available data, including data from
p.(None): clinical trials for indications and populations that are not approval
p.(None): correspond.
p.(None): (2) Notwithstanding Paragraph 1, the marketing authorization holder must be approved as a generic or after
p.(None): § 10a and the holder of a registration as a traditional herbal medicinal specialty regular
p.(None): Updated safety reports only to the data archive for the regularly updated
p.(None): Submit safety reports if
p.(None): 1. such an obligation as a condition or obligation for the approval to be granted or
p.(None): Registration has been prescribed or
p.(None): 2. a submission from the Federal Office for Safety in Health Care due to concerns in
p.(None): Relation to pharmacovigilance data or due to concerns about the absence
p.(None): Regularly updated reports on the safety of medicinal products for an active ingredient
p.(None): is arranged after approval or registration.
p.(None): (3) The Federal Office for Safety in Health Care must prescribe in the letter of admission in
p.(None): the rhythm of the regularly updated safety reports. Appointment
p.(None): for the submission is calculated according to the prescribed rhythm from the legal force of the
p.(None): Admission notice.
...
p.(None): which are the subject of a notification in accordance with paragraph 1, effective and verifiable from the distribution
p.(None): can be withdrawn.
p.(None): (3) The head of a blood deposit within the meaning of Section 8f KAKuG and the one issued in each case
p.(None): Implementing provisions or, if such does not exist, the medical director of the hospital as well
p.(None): Resident doctors, including group practices, are required to have serious incidents at the
p.(None): Storage or distribution of blood and blood components occur and the quality and safety
p.(None): can affect as well as serious undesirable reactions that occur during or after the transfusion
p.(None): and can be attributed to the quality and safety of blood or blood components
p.(None): Federal Office for Safety in Health Care to report immediately.
p.(None): (4) The Federal Minister of Health and Women can, insofar as this is with regard to uniformity
p.(None): and the information content of the reports is required, by means of ordinance, more detailed provisions on
p.(None): Issue the content, scope and form of the reports in accordance with paragraphs 1 and 3.
p.(None): (5) If a report in accordance with paragraph 1 concerns a specific blood donation facility, the Federal Office for
p.(None): Healthcare security to inform the blood donation facility concerned.
p.(None): § 75o. Exceptions to the reporting obligations of sections 75a to 75c are those cases in which a
p.(None): serious adverse event or serious adverse reaction according to
p.(None): Sections 17 or 32 Tissue Safety Act must be reported.
p.(None): § 75p. (1) The traceability requirements apply to medicinal products in accordance with Section 7 (6a)
p.(None): Sections 5 (4) and 16 (5) of the Tissue Safety Act, even if the drug cells
p.(None): or tissues of animal origin.
p.(None): (2) For medicinal products according to § 7 paragraph 6a, the reporting obligations according to §§ 17 and 32 des
p.(None): Tissue Safety Act, even if the drug cells or tissues of animal origin
p.(None): contain.
p.(None): Quality defects, counterfeit medicines
p.(None): § 75q. (1) Quality defects are
p.(None): 1. Defects within the meaning of § 4 and
p.(None): 2. deficiencies of a medicinal product placed on the market with regard to commercial packs,
p.(None): Composition or nature,
p.(None): if this poses a risk to the life or health of humans or animals.
p.(None): (2) Receive doctors, dentists, veterinarians, dentists, midwives and, insofar as they are not subject to the reporting obligation
p.(None): According to § 75j, pharmacists and traders who are registered according to the 1994 Industrial Code
p.(None): Manufacture of medicinal products or wholesale pharmaceuticals, and drugstores
p.(None): Because of their professional activities, information about quality defects that have occurred in Germany, so
p.(None): they must immediately inform the Federal Office for Safety in Health Care about this.
p.(None): (3) The marketing authorization holder has quality defects that have occurred in Germany and, according to para
p.(None): Have been brought to the knowledge or have otherwise come to the knowledge, to be recorded and the Federal Office of
p.(None): Healthcare security promptly, but no later than 15 days after
p.(None): Become known to report. The marketing authorization holder has the original wording of the refund
p.(None): to document the relevant notification and keep it for five years and to the Federal Office of
p.(None): Communicate healthcare security promptly upon request.
p.(None): (4) If, due to the lack of quality, there is an immediate risk to life or serious and
p.(None): If there is a significant risk to health, the report must be sent to the Federal Office for Security
...
p.(None): becomes.
p.(None): (10) With regard to the costs of an investigation, § 381 (1) 3 StPO applies in criminal proceedings. in the
p.(None): Administrative criminal proceedings are punitive in the penalty of reimbursement of the cost of the investigation
p.(None): to prescribe the respective research institute.
p.(None): Section 76c. (1) Before recovery of the goods that have been expired, the authority must inform the accused and the
p.(None): to give the person affected by the decay the opportunity to make a statement.
p.(None): (2) The expired goods are to be used in a useful manner. The expired goods are at the expense of
p.(None): Accused or destroy the person affected by the forfeiture if there is a useful recovery
p.(None): is not possible or the exploitation of the goods does not lead to the expectation that the achievable proceeds will
p.(None): Recovery costs will exceed. The destruction of the expired goods is by the accused or
p.(None): permitted by the person affected by the forfeiture at his own expense under the supervision of a supervisory body.
p.(None): (3) The proceeds of the exploitation are after deduction of the associated expenses and any
p.(None): irrecoverable costs of the criminal proceedings as well as the burden on the case
p.(None): To transfer liabilities to the federal government.
p.(None): Surveillance and protective measures
p.(None): Section 77. Is determined during a check in accordance with Section 76 or is the Federal Office for Security receiving
p.(None): Healthcare otherwise aware that a drug or active ingredient is subject to this federal law or to
p.(None): Does not comply with regulations or other administrative acts enacted on the basis of this federal law
p.(None): the Federal Office for Safety in Health Care to take measures to place the product on the market
p.(None): hinder or restrict. If applicable, section 76b (10) applies.
p.(None): Section 78. (1) The Federal Office for Safety in Health Care becomes aware of facts
p.(None): The reason for concern is that a medicinal product or active substance on the market is a hazard
p.(None): represents the life or health of humans or animals, the Federal Office for Security has
p.(None): To have all necessary measures in accordance with the extent of the risk,
p.(None): which prevent the placing on the market of the medicinal product or active substance or the use of the medicinal product
p.(None): or restrict.
p.(None): (2) In the event of imminent danger from a drug or an active ingredient, measures in accordance with Paragraph 1
p.(None): 1. even without previous procedure or
p.(None): 2. be made before issuing a decision.
p.(None): In the case of Z 2, however, is from the Federal Office for Safety in Health Care within two weeks
p.(None): to issue a written notice, otherwise the measure taken is deemed to have been revoked.
p.(None): (3) The Federal Office for Safety in Health Care has the drug it has confiscated
p.(None): or to declare the seized active ingredient verf as a precautionary measure if it has one
p.(None): serious and significant danger to humans or animals and the person entitled to dispose does not
p.(None): ensures that the drug or active substance is not placed on the market after its release.
p.(None): Preliminary seizure
p.(None): Section 78a. Organs of the Federal Office for Safety in Health Care have considered
p.(None): to temporarily confiscate the protective objectives of this federal law on medicinal products or active substances if the
p.(None): there is reasonable suspicion that this
p.(None): 1. contrary to the provisions of this federal law or regulations based thereon or
p.(None): other administrative acts are placed on the market and
p.(None): 2. pose a threat to the life or health of humans or animals.
p.(None): The regulations of § 76b on the provisional seizure by supervisory bodies and on measures
p.(None): the district administrative authorities in administrative criminal proceedings as well as § 76c are to be applied.
p.(None): Section 78b applies to the enforcement of a provisional seizure.
p.(None): Section 78b. The business owner or his / her authorized representative refuses to act after this
p.(None): Tolerating surveillance or protective measures provided for by federal law can enforce them
p.(None): become.
p.(None): X. SECTION
p.(None): fees
p.(None): Section 79. (1) The Federal Minister of Health and Consumer Protection, in agreement with the
p.(None): Federal Minister of Finance Fees for the permits to be issued under this Federal Act and
p.(None): other activities of federal agencies whose necessity changes
p.(None): 1. from this Federal Act and the ordinances issued on the basis thereof or
p.(None): 2. relevant legal acts of the European Union
p.(None): results, according to experience, from the average growing costs in a tariff
p.(None): set. The tariff and its changes are to be published in the “Official Gazette of the Wiener Zeitung”.
p.(None): Copies of the tariff are from the Federal Ministry (correct: Federal Ministry) for health and
p.(None): To provide consumer protection on request against reimbursement of costs.
p.(None): (2) Is the result of this Federal Act, the regulations issued on the basis thereof
p.(None): or the legal acts within the meaning of paragraph 1 no. 2 the necessity of activities of departments of the
p.(None): Federal government for which a tariff has not been set, the costs actually incurred must be stipulated.
p.(None): (3) The Federal Minister of Health and Consumer Protection can distance himself from this in individual cases
p.(None): to collect fees for certain activities if these are based on a party request
p.(None): are to be carried out and the interests of public health in this application are party interest
p.(None): significantly exceed.
p.(None): (4) For cash expenses, the party, regardless of the fees specified in the tariff in accordance with § 76 of the
p.(None): General Administrative Procedure Act 1991, Federal Law Gazette No. 51.
p.(None): XI. SECTION
p.(None): Automation-supported data traffic
p.(None): § 80. (1) To ensure drug safety and to ensure the protection of
p.(None): Life and health of humans and animals may be required for the implementation of this federal law
p.(None): personal data about pharmaceutical companies and users of pharmaceuticals in the
p.(None): Relation to the manufacture, control, distribution and use of medicinal products by
p.(None): processed by the Federal Office for Safety in Health Care.
p.(None): (2) To ensure drug safety and to ensure the protection of life and
p.(None): Human and animal health are allowed for the enforcement of this federal law with regard to
p.(None): Medicinal product monitoring requires personal data related to patients
p.(None): Use of medicinal products by the reporting agents are transmitted pseudonymized. The
p.(None): Processing by the Federal Office for Safety in Health Care has increased in pseudonymized form
p.(None): as long as the data is required in this form for the purposes of drug monitoring.
p.(None): (3) The Federal Office for Safety in Health Care is authorized to process the data in accordance with paragraphs 1 and 2
p.(None): to be transmitted with automation support
p.(None): 1. the Federal Ministry of Health and Women and subordinate authorities for purposes in the sense
p.(None): paragraphs 1 and 2,
p.(None): 2. the Austrian Agency for Health and Food Security, the Medicines Advisory Board, the
p.(None): Delimitation commission as well as experts, insofar as they are in execution of this federal law
p.(None): Tasks are assigned that correspond to the intended use of paragraphs 1 and 2,
p.(None): 3. die Gesundheit Österreich GesmbH, university institutes and other research institutions
p.(None): Institutions, insofar as they work in the interest of public health, for tasks in the sense of
p.(None): Purpose of paragraphs 1 and 2,
p.(None): 4. the Austrian Chamber of Pharmacists, the Austrian Chamber of Physicians, the Austrian
p.(None): Dental Association, the Austrian Veterinary Association and the umbrella organization of the
p.(None): Social insurance institutions, insofar as this data is an essential prerequisite for the fulfillment of
p.(None): form legally assigned tasks,
p.(None): 5. the World Health Organization as defined in paragraphs 1 and 2, and
p.(None): 6. the Agency, the European Commission and the parties to the Agreement on the
p.(None): European Economic Area, the European Directorate for the Quality of Medicines (EDQM), the
p.(None): Council of Europe and foreign authorities under a mutual agreement
p.(None): Acknowledgment of inspections if there is an obligation to transmit the data to them
p.(None): consists.
p.(None): (4) The Federal Office for Safety in Health Care is also authorized to provide personal data
p.(None): to be transmitted with automation support
p.(None): 1. Hospitals, health resorts, doctors, veterinarians, dentists and other freelance professionals
p.(None): Healthcare professionals and pharmacists insofar as they place medicinal products on the market or
p.(None): apply and the safe use or protection of life or human health
p.(None): or animal require it, and
p.(None): 2. international organizations, provided there is an international legal obligation to transmit the data
p.(None): to this exists.
p.(None): (5) The Federal Office for Safety in Health Care and the Federal Ministry of Health are
p.(None): - insofar as this is in the relevant drug-related guidelines and regulations of the European Union
p.(None): is envisaged - further authorized
p.(None): 1. Enter data in the European databases provided there and
p.(None): 2. Information to the competent authorities of the member states of the European Union, the agency
p.(None): and forward to the European Commission.
p.(None): Section 81. The copies of the notices and
p.(None): Certificates issued by electronic data processing equipment or in a similar process
p.(None): manufactured, require neither a signature nor a certification.
p.(None): Section 81a. The Federal Office for Safety in Health Care is in accordance with the technical
p.(None): Authorized possibilities to provide by ordinance that the according to this federal law, according to
p.(None): Pharmaceuticals Imports Act 2010, the Blood Safety Act, the Prescription Law, the
p.(None): Medical device law and the tissue safety law applications, notifications and notifications
p.(None): must be done in electronic form. In this regulation there are exceptions for hardship cases
p.(None): provided.
p.(None): XII. SECTION
p.(None): Confidentiality and transparency
p.(None): § 82. All persons entrusted with tasks in the implementation of this Federal Act are
p.(None): unless otherwise stipulated by law, secrecy about all of them exclusively from this
p.(None): Committed to facts that have become known, the confidentiality of which is in the interest of a
p.(None): Local authority or the parties is required.
p.(None): Section 82a. (1) The Federal Office for Safety in Health Care and the Austrian Agency for
p.(None): With regard to independence and transparency, health and food security ensure that
...
p.(None): XIII. SECTION
p.(None): sanctions
p.(None): Acts punishable by law
p.(None): Section 82b. (1) Anyone who falsifies medicinal products, active substances or auxiliary substances with the intention (§ 1 para. 25 and 26) that
p.(None): if they are handed over to another, they are punished with imprisonment for up to three years.
p.(None): (2) Anyone who falsifies medicinal products, active substances or auxiliary substances must also be punished
p.(None): offers, exports or surrenders or keeps with the intent, executes or introduces that one
p.(None): left to others.
p.(None): (3) Anyone who is a criminal offense under paragraph 1 or 2 as a doctor, dentist, veterinarian, pharmacist, dentist or midwife
p.(None): commits is punishable by imprisonment for up to five years.
p.(None): (4) Anyone who commits a crime under paragraph 1 or 2 with the intention of enforcing his
p.(None): recurring inspection to miss a continuous intake, and already because of a
p.(None): such a crime has been convicted.
p.(None): (5) Anyone who committed the offense (para. 4) as a doctor, dentist, veterinarian, pharmacist, dentist or midwife
p.(None): commits is punishable by imprisonment for up to ten years.
p.(None): (6) If the offense referred to in paragraphs 1 or 2 results in the death of a person or serious physical injury (Section 84
p.(None): Paragraph 1 of the Criminal Code) results in a larger number of people, the perpetrator is sentenced to imprisonment from five to
p.(None): punish fifteen years.
p.(None): (7) Who the commercial pack or other document that relates to a drug, an active ingredient
p.(None): or obtains an auxiliary material with the intent to forge or falsify that the document uses it
p.(None): to pass on counterfeit medicines, active ingredients or auxiliary substances to another - provided that the perpetrator
p.(None): is not to be punished according to paragraph 1 or 2 - punishable by imprisonment up to one year.
p.(None): (8) Anyone who induces another person or otherwise contributes to him or him or a relative
p.(None): (§ 72 StGB) falsified medicines so that they can be used by him or his family,
p.(None): is not to be punished according to paragraphs 1 to 7.
p.(None): collection
p.(None): § 82c. (1) Counterfeit drugs, active ingredients, auxiliary substances and documents (§ 82b (7)) are - provided
p.(None): the conditions for confiscation according to Section 26 of the Criminal Code have not already been met - also to confiscate if none
p.(None): certain person can be persecuted or convicted of an offense pursuant to Section 82b, unless the or
p.(None): the person entitled to dispose makes a legitimate intended use credible and guarantees that
p.(None): that the drug, the active substance, the excipient or the document is not placed on the market.
p.(None): (2) Sections 443 to 446 of the Code of Criminal Procedure 1975 (StPO), BGBl. Apply to the procedure.
p.(None): No. 631/1975, accordingly. For the application of the StPO are counterfeit medicines, active substances, auxiliary substances
p.(None): and treat documents as items the possession of which is generally prohibited.
p.(None): Authorization to provide security and duty to inform the customs authorities
p.(None): § 82d. (1) If certain facts indicate that counterfeit medicinal products, active substances,
p.(None): Auxiliary materials or documents (Section 82b (7)) are transported to or from Austria are the customs organs
p.(None): authorized to ensure this. From the seizure you have the responsible immediately
p.(None): Prosecutor to report. Declares that the conditions for a guarantee (§ 110 StPO)
p.(None): if there is no such security, it must be canceled immediately.
p.(None): (2) In connection with the control of counterfeit medicines, active ingredients, auxiliary substances or
p.(None): Documents may be processed by the customs authorities personal data (Art. 4 Z 2 data protection
p.(None): Basic regulation) and transmit this to the responsible law enforcement authorities, insofar as this is to be fulfilled
p.(None): whose legal role is required.
p.(None): administrative Penalties
p.(None): § 83. (1) Who
p.(None): 1. places medicinal products on the market contrary to Section 15 or a regulation pursuant to Section 15 (7),
p.(None): 2. Medicinal specialties contrary to §§ 16 to 16b or a regulation according to § 16 paragraph 6, § 16a
p.(None): 4 or Section 26, Section 8,
...
p.(None): 19. the Biocidal Products Act, Federal Law Gazette I No. 105/2000.
p.(None): § 87. Examinations and assessments according to this federal law are by the Austrian
p.(None): Agency for Health and Food Security or other experts who:
p.(None): by the Federal Office for Safety in Health Care or the Federal Ministry of Health and
p.(None): Women are commissioned.
p.(None): Section 88. (1) Those approved in accordance with Section 7 of the Specialties Ordinance, Federal Law Gazette № 99/1947
p.(None): Medicinal products for which an approval according to § 88 Paragraph 3 of the
p.(None): Drugs Act in the version of Federal Law Gazette No. 185/1983 has been applied for are considered approved in the sense
p.(None): of the Medicinal Products Act.
p.(None): (2) About applications pursuant to Section 88 (3) of the Medicinal Products Act in the Federal Law Gazette No. 185/1983
p.(None): not to issue a decision.
p.(None): (3) Unless notified in this regard before this provision comes into force
p.(None): the license holder has the labeling, instructions for use and specialist information in accordance with sections 7 to 10
p.(None): to design and their texts before the first use, but no later than December 31, 1991, the
p.(None): Submitted to the Federal Chancellery.
p.(None): (4) When creating the labeling, instructions for use and specialist information within the meaning of paragraph 3
p.(None): Deviations in content from signature and package insert in the approved according to the specialty regulations
p.(None): Form, unless it is a change
p.(None): 1. the fantasy word or the scientifically usual expression in the name of the
p.(None): Medicinal product,
p.(None): 2. with a view to expanding the areas of application or
p.(None): 3. the dosage of the drug specialty.
p.(None): These changes require approval by the Federal Chancellor. You will need this after it comes into effect
p.(None): Determination to be requested separately. This also applies to applications in accordance with § 24 Para
p.(None): Applications within the meaning of Section 88 (3) of the Medicinal Products Act as amended by Federal Law Gazette № 185/1983
p.(None): were.
p.(None): (5) The following applies to changes in labeling, instructions for use or specialist information
p.(None): § 24.
p.(None): (6) Entries in accordance with paragraphs 3 and 4 together with the required supplements are exempt from fees.
p.(None): Section 89. (1) At the time this Federal Act comes into force
p.(None): Pharmaceutical specialties that are subject to approval and which are subject to prior approval of this Federal Act
p.(None): Specialties regulations that were not subject to approval are considered approved in the sense of this
p.(None): Federal law.
p.(None): (2) An approval that is valid according to paragraph 1 expires
p.(None): 1. for medicinal specialties within the meaning of Section 26 (1) and for medicinal specialties that
p.(None): Feed medicines or feed premixes are, as of March 31, 1990,
p.(None): 2. for radioactive pharmaceutical specialties as of March 31, 1991,
p.(None): 3. for pharmacy specialties from March 31, 1992,
p.(None): 4. for medicinal products not listed in items 1 to 3 or 5, as of March 31, 1994 and
p.(None): 5. for homeopathic medicinal specialties as of March 31, 1995,
p.(None): unless an application for admission according to § 13 is made before the relevant deadline.
p.(None): (3) Paragraph 1 applies mutatis mutandis to medicinal products within the meaning of § 11a. The valid approval expires with
p.(None): March 31, 1991 unless an application for admission is made before the expiry of this period.
p.(None): (4) An approval valid in accordance with Paragraph 1 expires for products which are in accordance with Directive 93/42 / EEC, OJ.
p.(None): No.L 169 of July 12, 1993, to be classified as medical devices, at the end of June 13, 1998.
p.(None): (5) Products that are classified as medical devices according to Directive 93/42 / EEC and that have a CE
p.(None): Labeling within the meaning of Directive 92/43 / EEC are not subject to the
p.(None): Admission according to § 7.
p.(None): (6) Homeopathic medicinal specialties that are considered approved according to paragraph 1 are homeopathic
p.(None): Equal to pharmaceutical specialties that are approved by decision. The applications within the meaning of paragraph 2
p.(None): therefore do not require an official settlement. A refund of the minimum fee paid for
p.(None): there is no need for specialist investigations.
p.(None): § 89a. At the time of entry into force of the Medicinal Products Act in the version of the Federal Act
p.(None): BGBl. № 107/1994 medicinal specialties in circulation within the meaning of § 17b are considered to be approved in
p.(None): Meaning of the drug law. The current approval expires on March 31, 1996, unless it becomes available
p.(None): An application for admission has been made within this period.
p.(None): Section 90. (1) Medicinal products that are considered approved in accordance with Section 88 may also bear the signature and
p.(None): the package insert in the form approved in accordance with the specialty regulations
p.(None): 1. from the domestic manufacturer within one year of the date of submission to the
p.(None): Federal Chancellery within the meaning of Section 88 (3) are established,
p.(None): 2. by the depositeur within one year of the date of submission to the Federal Chancellery in
p.(None): Imported to Austria within the meaning of section 88 (3) and
p.(None): 3. placed on the market by the respective expiry date.
p.(None): (2) Medicinal products that are considered approved according to § 89 are not subject to § § 7 to 10. You
p.(None): may be placed on the market with the previous labeling and package leaflet.
p.(None): Section 91. (1) Applications for approval of a medicinal product that are in accordance with the provisions of
p.(None): Specialties regulations were put in place before the entry into force of this federal law and at the time
p.(None): of the entry into force of this federal law has not been decided as applications within the meaning of § 13
p.(None): to treat.
p.(None): (2) The applications within the meaning of paragraph 1 must be submitted in accordance with § 15 paragraph 1 lines 4 to 6.
p.(None): Otherwise, the decision on these applications must be based on the documents that are in accordance with the
p.(None): Provisions of the special order were sufficient.
p.(None): Section 92. (1) Establishments within the meaning of Section 62 (1) in which at the time of entry into force
p.(None): Federal law activities within the meaning of Section 63 (1) are deemed to have been approved in accordance with Section 63.
p.(None): (2) A license valid in accordance with paragraph 1 expires on July 1, 1999, unless it is canceled before the expiry of the
p.(None): June 30, 1999 an application for authorization was made.
p.(None): (3) Paragraph 2 does not apply to drugstores within the meaning of Section 216 of the 1994 Trade Code.
p.(None): Section 93. (1) The Federal Minister of Health and Environmental Protection can direct the head of a control laboratory
p.(None): Requirement for academic professional training in accordance with section 70 or a regulation in accordance with section 70 (2)
p.(None): see if this
p.(None): 1. can prove that he has been in the last five years before the entry into force of this federal law
p.(None): has performed the activity of the head of a control laboratory within the meaning of Section 62 (3) (2),
p.(None): 2. can demonstrate scientific professional training and practical training on the ground
p.(None): who does not interfere with drug safety through his work as head of a
p.(None): Control laboratory is expected, and
p.(None): 3. the granting of leniency within six months after the entry into force of this federal law
p.(None): has requested.
p.(None): (2) The head of a control laboratory may make a decision on his application submitted in good time
p.(None): continue to carry out his activity to the extent previously possible.
p.(None): Section 94. Pharmaceutical officers who do not meet the requirements of Section 72 (1) are allowed to work
p.(None): continue exercising if they
p.(None): 1. can demonstrate that they are in the last year before the entry into force of this
p.(None): Have acted as a pharmaceutical officer, and
p.(None): 2. the further pursuit of their work as a pharmaceutical officer to the Federal Ministry of Health and
p.(None): Report environmental protection within six months of the entry into force of this federal law.
p.(None): § 94a. (1) For medicinal products that were amended before the Medicinal Products Act came into force
p.(None): Federal Law BGBl. № 107/1994 must be approved until the first submission according to § 19a
p.(None): Labeling as well as the instructions for use and specialist information on the provisions of this federal law and
p.(None): of the regulations adopted on the basis thereof.
p.(None): (2) For medicinal products that were amended before the Medicinal Products Act came into force
p.(None): Federal Law Gazette No. 107/1994, the documents according to § 19a are not three to
p.(None): to be submitted six months before the expiry of five years after the approval notice has become final. For this
p.(None): The Federal Minister of Health and Women can submit medicinal specialties at any time by notice
p.(None): order if it does not appear certain that the information contained in the approval documents
p.(None): Evidence of the quality, effectiveness and harmlessness of the latest scientific
p.(None): Insights correspond.
p.(None): (3) Clinical trials that take place before the entry into force of the Medicinal Products Act in the version of the
p.(None): Federal Law Gazette No. 107/1994 started, may according to the legal situation before entry into force
p.(None): of the Medicinal Products Act in the version of the Federal Law Gazette No. 107/1994.
p.(None): (4) For medicinal products that were amended before the Medicinal Products Act came into force
p.(None): Federal Law Gazette № 379/1996 have been approved, must be until the first submission according to § 19a
p.(None): Technical information to the provisions of § 10 in the version of the Federal Law BGBl. № 379/1996 and
p.(None): the ordinance issued in accordance with section 10 (5) in the version of the Federal Law Gazette No. 379/1996
p.(None): be adjusted.
p.(None): (5) Clinical trials that take place before the drug law in the version of the
p.(None): Federal Law BGBl. I № 35/2004 started, may according to the legal situation before entry into force
p.(None): Entering the drug law in the version of the federal law BGBl. I No. 35/2004 to be continued.
p.(None): (6) Bumps or preparations made from bumps within the meaning of Section 1 (3) 8, provided that they are always in advance in
p.(None): manufactured in the same composition and under the same name in a for delivery in
p.(None): Retail sales certain form are placed on the market, which according to § 11b in the version of the
p.(None): Federal Law Gazette No. 748/1988 have been reported, may continue until the end of December 31, 2013
p.(None): delivered in Germany or kept ready for delivery in Germany, unless, § 3, the analogous
p.(None): this applies to these products.
p.(None): § 94b. As far as this federal law refers to other federal laws, these provisions are in
p.(None): applicable version.
p.(None): Transitional regulations to amendment BGBl. I No. 153/2005
p.(None): § 94c. (1) Sto oder e or preparations from Sto ff en in the sense of § 1 Paragraph 3 No. 9, the reporting of
p.(None): Section 11c (1) in the version prior to the entry into force of this Federal Act in the version of the
p.(None): Federal Law BGBl. I № 153/2005 from the Federal Minister for Health and Women under the award of a
p.(None): consecutive number has been confirmed, may remain unchanged until December 31, 2008
p.(None): be placed on the market with the number.
p.(None): (2) The technical and package leaflet of specialty medicinal products prior to the entry into force of this
p.(None): Federal law in the version of the federal law BGBl. I № 153/2005 approved or registered
p.(None): have the §§ 15, 16 and 16a as soon as possible, at the latest by January 1, 2011
p.(None): correspond.
p.(None): (3) Is the change of technical or usage information only to adapt the in §§ 15, 16
...
p.(None): if the necessary supply of the population would otherwise be seriously and significantly endangered by
p.(None): Ordinance Regulations on supply and provision obligations for marketing authorization holders,
p.(None): Depositeurs, manufacturers, pharmaceutical wholesalers, pharmaceutical wholesalers and public pharmacies
p.(None): adopted if and as long as this is necessary due to the special situation.
p.(None): (3) A regulation pursuant to Paragraph 1 or Paragraph 2 applies for a maximum of six months.
p.(None): § 94e. (1) As long as the World Health Organization (WHO) has declared a pandemic of influenza
p.(None): 1. A license that is in accordance with the provisions of this federal law and approved for Austria
p.(None): Vaccine for vaccination against New Influenza A (H1N1) directly from the manufacturer or marketing authorization holder
p.(None): on
p.(None): (a) local authorities, and
p.(None): b) by the public sector (local authorities, health insurance providers and
p.(None): Health care facilities) certain distribution centers
p.(None): be delivered and
p.(None): 2. the vaccine by means of the local authorities or distribution centers to from the public
p.(None): Hand (local authorities, health insurance providers and health care institutions)
p.(None): certain vaccination sites are given. For the distribution of the vaccine, the
p.(None): Manufacturers, marketing authorization holders who serve local authorities and third-party distribution centers.
p.(None): (2) Medicines used in the event of a disaster, terrorist threat, martial
p.(None): Confrontation, epidemic, pandemic or other crisis situation to those in § 57 Paragraph 1 Numbers 5 and 5a
p.(None): given to maintain the drug supply and from these to
p.(None): Averting the danger posed by such a crisis situation may be kept in
p.(None): of their intended commercial packaging or original packaging to manufacturers, depositors, pharmaceutical
p.(None): Wholesalers, public pharmacies and institutional pharmacies are sold.
p.(None): (3) Pharmaceutical specialties that are available through a regional authority or on behalf of a regional authority
p.(None): Averting from a catastrophe, terrorist threat, armed conflict,
p.(None): Epidemic, pandemic or other crisis situation pending dangerous situation held in stock
p.(None): may be kept in stock even after the expiry date has passed and for stockpiling
p.(None): be handed in as well as given when the specific danger occurs, if on a professional basis
p.(None): Investigations by the Federal Office for Safety in Health Care have found that their
p.(None): Quality and impact are still guaranteed.
p.(None): § 94f. (1) Pharmacy proprietary medicinal products, which according to § 9d in the version before the entry into force
p.(None): of this federal law in the version of the federal law BGBl. I № 63/2009 have been approved
p.(None): as registered pharmacy specialties according to § 11a of this federal law in the version of the
p.(None): Federal Law BGBl. I No. 63/2009.
p.(None): (2) At the time of entry into force of this Federal Act in the version of the Federal Law BGBl. I
p.(None): №63 / 2009 pending applications for approval as a pharmacy proprietary medicinal product count as registrations
p.(None): for registration as pharmacy specialties.
p.(None): (3) The change in the package leaflet and labeling of pharmacy proprietary medicinal products,
...
p.(None): Marketing authorization holder or registration holder of the obligation to operate a pharmacovigilance
p.(None): Master documentation from the legal validity of the extension of the admission or registration, at the latest however
p.(None): as of July 21, 2015.
p.(None): (3) (Note: repealed by Federal Law Gazette I No. 162/2013)
p.(None): (4) The technical information and instructions for use of medicinal specialties that were published before this came into force
p.(None): Federal law in the version of the federal law BGBl. I № 110/2012 approved or registered
p.(None): have the §§ 15 paragraph 2 line 14 and 16 paragraph 2 line 20 at the earliest possible time, but at the latest
p.(None): to comply with July 1, 2014.
p.(None): (5) If the change of technical or usage information is only for the adjustment according to paragraph 3 or 4, see above
p.(None): is the change of the authorization holder or the holder of a registration to the Federal Office for
p.(None): Health Safety Report.
p.(None): (6) Section 20 (2) in the version of the Federal Law BGBl. I № 110/2012 applies to medicinal specialties,
p.(None): their approval or registration would end after April 21, 2013.
p.(None): (7) Sections 75a (3) and (4) and (75b) in the version prior to the amendment apply to veterinary specialties
p.(None): BGBl. I No. 110/2012.
p.(None): (8) Sections 75a (3) and (4) and (75b) apply to registered pharmacy specialties
p.(None): Version before the amendment BGBl. I No. 110/2012.
p.(None): (9) Section 75b (1) and (2) in the version before the amendment BGBl. I № 110/2012 also applies mutatis mutandis to the
p.(None): Holder of a license for distribution in parallel import. Relates to a report according to § 75g
p.(None): Drug specialty based on a license for parallel import sales to Austria
p.(None): the Federal Office for Safety in Health Care has the holder of the permit
p.(None): for sales in parallel import immediately, but no later than 15 days after becoming known
p.(None): inform. The information must be given anonymously.
p.(None): (10) Section 75j (3) in the version of the Federal Law BGBl. I № 110/2012 occurs six months later
p.(None): Announcement of the agency on its web portal that the eudravigilance database on the corresponding
p.(None): Features has in place. Until then, Section 75j (3) applies, with the proviso that the reports to the
p.(None): Federal Office for Safety in Health Care have to take place and all suspected not
p.(None): serious side effects of immunological medicinal products, medicinal products listed below
p.(None): Using human blood or blood plasma as a source and
p.(None): Medicinal products that are on the list according to Art. 23 of Regulation (EC) № 726/2004, which are listed in
p.(None): Austria occurred within 90 days after the license holder became aware of it
p.(None): has to be reported to the Federal Office for Safety in Health Care.
p.(None): (11) Section 75k (1) and (2) in the version of the Federal Law BGBl. I № 110/2012 occurs with regard to the
p.(None): Obligation to electronically submit regular, updated reports on safety
p.(None): of medicines twelve months after the agency announced on its web portal that the data archive
p.(None): has the appropriate functions for the regularly updated safety reports, in
p.(None): Force. Until then, the regularly updated reports on the safety of medicines
p.(None): to be submitted to the Federal Office for Safety in Health Care.
p.(None): (12) The Federal Office for Safety in Health Care informed the Commission by 22 July 2013 about the
p.(None): To provide details of the system in accordance with section 75 (3).
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Searching for indicator influence:
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p.(None): BGBl. I No. 108/2012 (NR: GP XXIV RV 1935 AB 1980 p. 179. BR: 8814 AB 8819 p. 815.)
p.(None): [CELEX No .: 32010L0053]
p.(None): BGBl. I No. 110/2012 (NR: GP XXIV RV 1898 AB 1982 p. 179. BR: AB 8821 p. 815.)
p.(None): [CELEX No .: 32010L0084]
p.(None): BGBl. I No. 114/2012 (NR: GP XXIV RV 2016 AB 2080 p. 185. BR: 8831 AB 8853 p. 816.)
p.(None): [CELEX No .: 32010L0063]
p.(None): BGBl. I No. 48/2013 (NR: GP XXIV RV 2010 AB 2103 p. 185. BR: AB 8875 p. 816.)
p.(None): [CELEX No .: 32011L0062]
p.(None): BGBl. I No. 162/2013 (NR: GP XXIV RV 2446 AB 2560 p. 213. BR: AB 9071 p. 823.)
p.(None): [CELEX-No .: 32011L0024, 32012L0026]
p.(None): BGBl. II No. 105/2015 (V via Idat)
p.(None): BGBl. I No. 40/2017 (NR: GP XXV RV 1457 AB 1569 p. 171. BR: 9747 AB 9752 p. 866.)
p.(None): [CELEX No .: 32009L0031]
p.(None): BGBl. I No. 37/2018 (NR: GP XXVI RV 108 AB 139 P. 23. BR: 9967 AB 9970 P. 880.)
p.(None): [CELEX-No .: 32017L2399, 32017L1572]
p.(None): BGBl. I No. 59/2018 (NR: GP XXVI RV 191 AB 231 S. 36. BR: 10001 AB 10017 S. 883.)
p.(None): BGBl. I No. 100/2018 (NR: GP XXVI RV 329 AB 413 p. 57. BR: 10079 AB 10082 p. 888.)
p.(None): BGBl. I No. 104/2019 (NR: GP XXVI IA 985 / A AB 692 p. 88. BR: AB 10252 p. 897.)
p.(None): text
p.(None): I. SECTION
p.(None): General provisions
p.(None): definitions
p.(None): § 1. (1) "Medicinal products" are substances or preparations from substances that
p.(None): 1. for use in or on the human or animal body and as an agent with properties for
p.(None): Cure or to alleviate or prevent human or animal diseases or
p.(None): pathological complaints are determined, or
p.(None): 2. applied in or on the human or animal body or a human or an animal
p.(None): can be administered to either
p.(None): a) the physiological functions through a pharmacological, immunological or metabolic
p.(None): Restore, correct or influence the effect, or
p.(None): b) to serve as the basis for a medical diagnosis.
p.(None): (2) Objects that contain a medicinal product or on which a medicinal product is considered a medicinal product
p.(None): is applied and which are intended for use on or in the human or animal body.
p.(None): (3) Are no drugs
p.(None): 1. Foodstuffs according to Art. 2 Para. 1 and 2 of Regulation (EC) № 178/2002 establishing the
p.(None): general principles and requirements of food law to establish the European
p.(None): Authority for Food Safety and for Establishing Food Safety Procedures, OJ.
p.(None): № L 31, 1.2.2002 p. 1, last amended by regulation (EG) № 596/2009, OJ. № L 188 from
p.(None): 18.7.2009 p. 14,
p.(None): 2. Utility articles and food additives in accordance with food law provisions,
p.(None): 3. cosmetic products in accordance with food law provisions, provided that they are used and
p.(None): Effects are restricted to the area of the skin and its appendages and the oral cavity,
p.(None): 4. Tobacco products according to the Tobacco Act, Federal Law Gazette No. 431/1995,
p.(None): 5. Feed, feed additives and premixes in accordance with the feed law regulations,
p.(None): 6. Materials or preparations made of materials used in dentistry and physically
p.(None): stable state have no pharmacological effect,
p.(None): 7. Natural healing deposits and products from a natural healing deposit in accordance with Section 42a (2)
p.(None): of the Federal Act on Hospitals and Health Centers, Federal Law Gazette № 1/1957, unless their
p.(None): Composition was changed by the addition of substances with an influence on the effectiveness,
p.(None): or, based on the sciences, undesirable even when used as intended
p.(None): Effects in humans are expected
p.(None): 8. Materials or preparations made from materials that are used only for prophylactic purposes
p.(None): To ward off, eliminate or harm pathogens, parasites or foreign substances
p.(None): to make, provided their application and effect on healthy skin and its appendages
p.(None): are limited and unless they are for use on patients before surgery or others
p.(None): medical interventions that require skin disinfection are intended,
p.(None): 9. Materials or preparations made from materials that are intended exclusively for
p.(None): complementary medical methods to be used, provided that they neither serve nor
p.(None): are intended to fulfill the purpose of paragraph 1, unless it concerns
p.(None): Stumps or preparations from stumps that are made according to homeopathic principles and
p.(None): Process technologies are produced,
p.(None): 10. Substances or preparations made from substances intended for use on animals and
p.(None): a) for cleaning, grooming, imparting certain odor impressions to the animal, influencing the
p.(None): Look or serve to protect the skin and
p.(None): b) do not contain any substances that are in accordance with food law provisions in cosmetic products
p.(None): may not be included
p.(None): 11. Medical devices in the sense of the Medical Devices Act, Federal Law Gazette No. 657/1996 and
p.(None): 12. Organs or parts of organs within the meaning of the Organ Transplantation Act, Federal Law Gazette I No. 108/2012.
p.(None): (3a) A product fulfills both the definition of the medicinal product in accordance with paras. 1 to 3 and the definition
...
p.(None): medical science is justifiable.
p.(None): (15) “Consumers” are physical or legal persons who take medicinal products for their own use
p.(None): purchase.
p.(None): (15a) "Mediation of medicinal products" includes all activities, with the exception of wholesale, in the
p.(None): Connection with the sale or purchase of medicinal products for human use, which consist of self-employed and in
p.(None): Negotiate the name of another legal or natural person without using these drugs
p.(None): Acquiring property or physically handling these medicines.
p.(None): (16) “Expiry date” is the term after which the shelf life of a medicine
p.(None): is no longer guaranteed.
p.(None): (17) Waiting time is the period between the last administration of a drug to animals under
p.(None): Compliance with drug regulations and the time up to which these animals are not available
p.(None): Extraction of food or medicinal products may be used, must be observed and the
p.(None): ensures that residues of the substances administered in these foods comply with the
p.(None): Regulation (EEC) № 2377/90 maximum permissible quantities for pharmacologically active substances
p.(None): do not exceed.
p.(None): (18) "Efficacy" is the suitability of a drug, the intended uses mentioned in § 1 Paragraph 1
p.(None): to fulfill.
p.(None): (19) "Effect" is an influenceable influence of the
p.(None): Condition or function of a biological object.
p.(None): (20) 'Central procedure' is one for the Member States of the European Union through the Regulation
p.(None): (EG) № 726/2004, OJ. № L 136/1 of March 31, 2004, established procedure for the approval of certain
p.(None): Medicinal specialties, that for medicinal products covered by the annex to the aforementioned regulation
p.(None): compulsory for pharmaceutical specialties covered by Article 3 Paragraph 2 of the Ordinance on request as required
p.(None): the requirements mentioned there apply.
p.(None): (21) 'Intermediate' is a medicinal product that is still in one or more manufacturing phases
p.(None): needs to become bulk goods.
p.(None): Definitions regarding clinical trials
p.(None): § 2a. (1) "Clinical Trial" is a systematic examination of a drug on one
p.(None): Test taker that is conducted with the goal
p.(None): 1. to research or prove the effects of investigational medicinal products,
p.(None): 2. determine side effects of investigational medicinal products, or
p.(None): 3. absorption, distribution, metabolism and excretion of investigational medicinal products
p.(None): investigate.
p.(None): This includes clinical trials conducted in one or more test centers in one or more
p.(None): Contracting parties to the European Economic Area. No clinical trial is one
p.(None): Non-interventional study within the meaning of paragraph 3.
p.(None): (2) “Multicentre clinical trial” is a clinical trial conducted under a single trial plan
p.(None): Examination that takes place in more than one test center and is therefore carried out by more than one examiner
...
p.(None): 13. Indication of the quality criteria of the components of the medicinal product used,
p.(None): 14. A declaration that the substance samples required to carry out technical examinations
p.(None): be made available on official request
p.(None): 15. Indication of scientific knowledge and practical experience on the
p.(None): Harmlessness of the components of the medicinal product used,
p.(None): 16. Indication of the quality characteristics and properties of the packing elements, which with the
p.(None): Drug specialty come into contact, as well as specification of the test instructions for this
p.(None): Packing elements,
p.(None): 17. Test reports on the shelf life in the intended retail pack,
p.(None): 18. Information on the appropriateness of the dosage form,
p.(None): 19. non-clinical data,
p.(None): 20. clinical data,
p.(None): 21. Information on areas of application, contraindications, side effects, dosage (if necessary for
p.(None): each target species), type and form of application, if this is not in the documents according to Z 6 to 8
p.(None): are included
p.(None): 22. The risk management plan for the pharmaceutical specialty concerned, including a summary
p.(None): In accordance with paragraph 4,
p.(None): 23. Proof that the manufacturer has a license pursuant to Section 63 or a
p.(None): Manufacturer approval from the competent authority of another state for the manufacture of medicinal products
p.(None): has,
p.(None): 24. in the case of medicinal specialties that contain several components, the influence on the efficacy or the
p.(None): Have tolerance, information about the suitability of the combination of these components,
p.(None): 25. for medicinal products with antimicrobial activity, the specification of the test instructions of
p.(None): antimicrobial effectiveness, if chemical-physical tests are not sufficient,
p.(None): 26. for medicinal products, the safe and safe use of which requires sterility
p.(None): the sterilization method,
p.(None): 27. for pharmaceutical specialties, their safe and harmless use an examination for pyrogenic
p.(None): Substances required, the specification of the test specification,
p.(None): 28. for medicinal products for animals, results of safety and residue tests and
p.(None): of tests to assess the possible environmental risks,
p.(None): 29. for medicinal products that are feed medicinal products, proof that the product contains
p.(None): Proportion of feed is a feed that complies with the Feed Act,
p.(None): 30. for medicinal products that are premixes of feed medicinal products, proof that
p.(None): the proportion of feed contained is a feed that complies with the Feed Act,
p.(None): 31. in the case of medicinal specialties for use on animals which are used to obtain medicinal products or
p.(None): Food, documents on the waiting time,
p.(None): 32. in pharmaceutical specialties for use on animals, for the production of food or
p.(None): Medicinal products are intended to be a proof of at least six months ago
p.(None): Valid application to set the maximum residue limit according to Regulation (EEC)
p.(None): No. 2377/90, provided the active substances for the target species concerned are not yet listed in Annex I, II or
p.(None): III of Regulation (EEC) № 2377/90 are included; this does not apply if the target species is equidae
p.(None): provided they are in accordance with Commission Decision 92/623 / EEC of 20 October 1993 on
...
p.(None): (2) For homeopathic medicinal products, which are produced by dilution of only one substance
p.(None): a single application is sufficient for the substance and its dilutions.
p.(None): § 9c. An application for approval of a pharmaceutical specialty, which is a monograph of the pharmacopoeia in the
p.(None): The meaning of Section 1 of the Pharmacopoeia Act 2012 does not, however, meet the requirements of Section 7 (2)
p.(None): fulfilled, is not mentioned in Section 7 (9) and is not subject to registration in accordance with Section 12, documents must be provided
p.(None): 8, 12 to 15, 18 to 21, 24 to 27 and 29 to 31 may not be added in accordance with Section 9a (1) no. documents
p.(None): According to § 9a para. 1 no. 5 and 11, the application only has to be attached if during the production and
p.(None): Testing other methods or devices are used than described in the pharmacopoeia
p.(None): are.
p.(None): § 9d. Section 9a does not apply to medicinal specialties within the meaning of Section 7 (9) lines 2 and 3, which are based on a monograph of
p.(None): Pharmacopoeia in the sense of § 1 of the Pharmacopoeia Act. An application for admission to a
p.(None): such a medicinal product, documents according to § 9a paragraph 1 lines 1 to 9 as well as 14 and 15 are to be attached.
p.(None): § 9e. An application for approval of a generator must be submitted in addition to the documents pursuant to Section 9a
p.(None): to connect the following documents:
p.(None): 1. a general description of the system with a detailed description of the components of the
p.(None): Systems that can influence the composition or quality of the daughter nuclide preparation
p.(None): and
p.(None): 2. Information on the qualitative and quantitative peculiarities of the eluate or sublimate.
p.(None): Reference approval
p.(None): Section 10. (1) Notwithstanding Section 9a (1) lines 19, 20 and 28, the applicant is not obliged to:
p.(None): Results of non-clinical trials and clinical trials or trials and the results of
p.(None): Submit safety and residue tests if he can prove that it is
p.(None): Medicinal product is a generic of a reference medicinal product and
p.(None): 1. initial approval in a contracting party to the Agreement on the European
p.(None): Economic area at least eight years ago, or
p.(None): 2. the authorization holder of the reference medicinal product has a reference to that of the authorization
p.(None): the underlying documents have been irrevocably approved in writing.
p.(None): (2) A generic drug that has been authorized in accordance with paragraph 1 may only be used after ten years
p.(None): First authorization for the reference medicinal product to be placed on the market.
p.(None): (3) If the marketing authorization holder of a reference human medicinal product within the first eight years
p.(None): After granting the first approval, approval of one or more new areas of application
p.(None): the scientific evaluation prior to its approval by the Federal Office for Security in
p.(None): Healthcare according to paragraph 14 as of significant clinical benefit compared to the existing ones
p.(None): Therapies are considered, the period provided for in paragraph 2 is extended to 11 years.
p.(None): (4) The period specified in paragraph 2 is extended for medicinal products
...
p.(None): and confidential handling of all data resulting from a clinical trial.
p.(None): (2) The test plan, the documentation, the agreements made between the investigator and sponsor and
p.(None): all other documents related to the clinical trial must be reviewed by
p.(None): the sponsor for a period of 15 years after completion or termination of the clinical trial
p.(None): be kept.
p.(None): (3) The examiner must ensure that the documents relate to pseudonymization for
p.(None): kept for a period of 15 years after completion or termination of the clinical trial.
p.(None): (4) Without prejudice to the duty of storage in accordance with paragraph 2, the final report must be submitted by the sponsor
p.(None): or later marketing authorization holder, are kept 5 years longer than the pharmaceutical specialty in Austria
p.(None): is allowed.
p.(None): (4a) With regard to the deadlines specified in paragraphs 2 to 4, the right under Art.
p.(None): Basic regulation excluded.
p.(None): (5) All data and documents relevant to the clinical trial must be submitted to the
p.(None): Federal Office for Safety in Health Care be made available. The transmission
p.(None): Personal data is only permitted in pseudonymised form. A transmission directly
p.(None): Personal data of a test participant is only permitted if this is the case in a specific individual case
p.(None): Protecting the life or health of a test subject is essential.
p.(None): Section 46a. The clinical trial of a medicinal product may be made to conscripts who are on duty,
p.(None): not be carried out.
p.(None): Quality control and quality assurance
p.(None): Section 47. (1) To achieve the goal of a clinical trial that is optimally carried out in the interest of all participants
p.(None): the sponsor must organize itself in such a way that the technical, administrative and
p.(None): ethical factors that influence the quality of the clinical trial are controlled. All
p.(None): Control measures must aim to prevent inadequate quality. Responsibility and
p.(None): Authorization for any quality-effective activity must be clearly defined. The sponsor has an adequate one
p.(None): To put the quality assurance system into effect and apply it.
p.(None): (2) A quality assurance system within the meaning of paragraph 1 consists of the organizational structure, the allocation
p.(None): of responsibilities, the planned procedural steps, the documentation and the means for the
p.(None): Realization of quality management.
p.(None): (3) All observations and findings must be fully understandable. This is
p.(None): in particular to ensure that the conclusions presented are correct from the raw data
p.(None): derive. The verification methods must be described in detail and justified.
p.(None): (4) A quality control must be provided for every step of the handling of the data in order to
p.(None): ensure that the data is reliable and that it has been processed correctly.
p.(None): (5) An audit initiated by the sponsor must be carried out by bodies that are independent of those for the
p.(None): clinical trial are responsible.
p.(None): (6) In addition, all the facilities mentioned in § 2a (7) second sentence as well as any kind of
p.(None): Make data available for inspection at any time. Test centers including laboratories as well as each
p.(None): The type of data must also be made available for an audit at any time.
p.(None): (7) The aim of an inspection is to determine, by means of objective, independent verification, whether the in
p.(None): this federal law prescribed standard with regard to planning, implementation and evaluation
p.(None): clinical trials are complied with. An ethics committee inspection may also aim to:
...
p.(None): (3) The provisions of paragraph 1 stand for the direct or indirect takeover of reasonable
p.(None): Travel and subsistence costs and participation fees for work-related only
p.(None): not opposed to scientific events; the representation effort must always be strict on the
p.(None): main scientific purpose of the event should be limited; the assumption of travel and
p.(None): Living expenses and participation fees as well as representation expenses must not be allowed to others
p.(None): Persons are regarded as persons authorized to prescribe or dispense.
p.(None): (4) The person authorized to prescribe or dispense it is prohibited, contrary to para. 1 bis
p.(None): 3 to request a premium, financial or material benefits, to be promised or accepted.
p.(None): (5) The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): enacted
p.(None): 1. when to assume a low value of premiums or fi nancial or material benefits
p.(None): is
p.(None): 2. With regard to the type and scope of the permissible representation effort in connection with
p.(None): Sales promotion events including choice of venue and location
p.(None): hosting,
p.(None): 3. What criteria an event must meet in order to be considered exclusively professional
p.(None): scientific event within the meaning of paragraph 3 apply,
p.(None): 4. With regard to the adequacy of travel and subsistence costs for work-related
p.(None): scientific events, and
p.(None): 5. With regard to the type and scope of the permissible representation effort in connection with
p.(None): job-related scientific events including the choice of the venue.
p.(None): In doing so, particular care must be taken to ensure that any appearance of improper influence from the
p.(None): Prescribing and dispensing authorized persons in their therapy decision or recommendation
p.(None): is avoided.
p.(None): free goods
p.(None): Section 55b. (1) Granting, offering and promising free goods for prescription
p.(None): or the supply of authorized persons is prohibited if it concerns medicinal products which
p.(None): Umbrella Association of Social Insurance Institutions issued reimbursement code are included.
p.(None): (2) Demanding, which can be promised or accepting those covered by paragraph 1
p.(None): In-kind discounts by persons authorized to prescribe or dispense are prohibited.
p.(None): information officer
p.(None): Section 56. (1) The authorization holder or holder of a registration must ensure that
p.(None): 1. any advertising for medicinal products complies with this section
p.(None): 2. the pharmaceutical officers employed by his company have the qualifications required in § 72
p.(None): and comply with the obligations incumbent on them in accordance with Section 73f,
p.(None): 3. Every popular advertising material is available and a directory of all recipient groups and the
p.(None): Distribution type is carried out, and
p.(None): 4. the orders of the authorities responsible for the control of pharmaceutical advertising
p.(None): be followed immediately and fully.
p.(None): (2) The authorization holder or holder of a registration is obliged, a person who is responsible for the
p.(None): required expertise and experience to mandate the task of scientific
p.(None): Information on the medicinal products placed on the market by the marketing authorization holder
p.(None): perceive (information officer) and these with the necessary powers to fulfill them
...
p.(None): as well as information about an application of the medicinal product that goes beyond the provisions of the approval
p.(None): goes beyond that. Furthermore, conclusions from evaluations and recommendations are given
p.(None): according to Art. 26 of the Regulation (EG) № 726/2004 on the European internet portal for medicinal products
p.(None): to be published. Marketing authorization holders are furthermore obligated, all immediately
p.(None): Restrictions and prohibitions by the competent authorities of each state in which the medicinal product is in
p.(None): Is placed on the market.
p.(None): (2) Marketing authorization holders have submitted to the Federal Office for Safety in Health Care and the Agency in
p.(None): In the event of an application for cancellation of the authorization or the non - application for an extension of the
p.(None): Authorization to state the reasons for this measure, in particular whether this measure derives from the in
p.(None): Art. 116 or 117 (1) of Directive 2001/83 / EC is given.
p.(None): (3) Marketing authorization holders are obliged to the Federal Office for Safety in Health Care and the
p.(None): Agency also any temporary or permanent cessation of placing the medicinal product on the market
p.(None): and any application for cancellation of an authorization or non-application for an extension of an authorization
p.(None): announce that in a third country from Art. 116 or 117 paragraph 1 of Directive 2001/83 / EC
p.(None): reasons mentioned.
p.(None): hemovigilance
p.(None): Section 75n. (1) Any establishment that uses human blood or blood components, provided these are for transfusion
p.(None): Are destined, processed, stored or distributed, is committed to serious incidents related to the
p.(None): Processing, storage and distribution of blood or blood components that affect quality and safety
p.(None): can influence to report immediately to the Federal Office for safety in the health service.
p.(None): (2) Any establishment that produces human blood or blood components, provided that they are intended for transfusion
p.(None): , processed, stored or distributed, must have a process through which blood and blood components,
p.(None): which are the subject of a notification in accordance with paragraph 1, effective and verifiable from the distribution
p.(None): can be withdrawn.
p.(None): (3) The head of a blood deposit within the meaning of Section 8f KAKuG and the one issued in each case
p.(None): Implementing provisions or, if such does not exist, the medical director of the hospital as well
p.(None): Resident doctors, including group practices, are required to have serious incidents at the
p.(None): Storage or distribution of blood and blood components occur and the quality and safety
p.(None): can affect as well as serious undesirable reactions that occur during or after the transfusion
p.(None): and can be attributed to the quality and safety of blood or blood components
p.(None): Federal Office for Safety in Health Care to report immediately.
p.(None): (4) The Federal Minister of Health and Women can, insofar as this is with regard to uniformity
p.(None): and the information content of the reports is required, by means of ordinance, more detailed provisions on
p.(None): Issue the content, scope and form of the reports in accordance with paragraphs 1 and 3.
p.(None): (5) If a report in accordance with paragraph 1 concerns a specific blood donation facility, the Federal Office for
p.(None): Healthcare security to inform the blood donation facility concerned.
p.(None): § 75o. Exceptions to the reporting obligations of sections 75a to 75c are those cases in which a
p.(None): serious adverse event or serious adverse reaction according to
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Searching for indicator substance:
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p.(None): Apply provisions of this federal law.
p.(None): (3b) At the request of a person who has a product in
p.(None): To market to determine whether a product falls under the definition of a drug. The Federal Office
p.(None): Healthcare Safety may also determine ex officio whether a product is under the
p.(None): De fi nition of the drug falls. As part of these procedures, there may be an opinion from the Delimitation Advisory Board
p.(None): Obtain according to § 49a.
p.(None): (4) are "substances"
p.(None): 1. chemical elements, natural chemical substances and synthetic processing
p.(None): chemical compounds obtained,
p.(None): 2. Plants, parts of plants and plant components in any form, including by extraction
p.(None): obtained substances,
p.(None): 3. Animal bodies as well as body parts, components and metabolic products of humans or animals in
p.(None): of any shape and
p.(None): 4. Microorganisms and viruses and their components or products.
p.(None): (4a) "Active substances" are substances or mixtures of substances which are intended to be used in the manufacture
p.(None): of a drug to be used and when used in drug manufacturing
p.(None): to become medicinally active components of the drug.
p.(None): (4b) "Auxiliary substance" is every component of a medicinal product with the exception of the active substance and the
p.(None): Packaging material.
p.(None): (5) “Medicinal specialties” are medicinal products that are always prepared in advance in the same composition
p.(None): and under the same name in one intended for delivery to the consumer or user
p.(None): Be placed on the market and medicinal products for distribution to consumers or users
p.(None): whose manufacture otherwise uses an industrial process or which is manufactured commercially
p.(None): become.
p.(None): (6) "Pharmacy proprietary medicinal products" are medicinal products that, unless they are
p.(None): Components within the meaning of paragraph 2 no. 2 are only manufactured from components that are in the
p.(None): Austrian medical taxes are listed, which are not of the dosage and type of application
p.(None): Prescriptions are subject to prescription and are only available in the pharmacy in which they are wholly or predominantly
p.(None): getting produced.
p.(None): (6a) “Medicinal products for novel therapies” are gene therapeutics and somatic cell therapeutics according to
p.(None): Part IV of Annex I to Directive 2001/83 / EC of the European Parliament and of the Council of 6 November
p.(None): 2001 on the creation of a Community code for medicinal products for human use, most recently amended by the directive
p.(None): 2009/120 / EG, as well as biotechnologically processed tissue products in accordance with Article 2 Paragraph 1 lit. b the
p.(None): Regulation (EC) № 1394/2007 of the European Parliament and of the Council of November 13, 2007 on
p.(None): Medicinal products for novel therapies and amending Directive 2001/83 / EC and Regulation (EC)
p.(None): No. 726/2004.
p.(None): (7) "Dental medicinal products" are medicinal products that are intended exclusively for use in dentistry
p.(None): are.
p.(None): (8) 'Feed medicinal products' are mixtures of one or more veterinary medicinal products and one or
...
p.(None): become. A homeopathic medicine can also contain several active substances.
p.(None): (11) 'Radioactive medicinal products' are medicinal products which, when ready for use, contain one or more for
p.(None): contain radionuclides (radioactive isotopes) recorded for medical purposes.
p.(None): (11a) “Biological medicinal products” are medicinal products whose active ingredient is a biological agent. On
p.(None): biological shock is a shock that is of biological origin or from biological origin material
p.(None): is generated and for its characterization and quality determination physical, chemical and
p.(None): biological tests and the assessment of the production process and its control are required.
p.(None): Biological medicines include immunological medicinal products, medicinal products listed below
p.(None): Using human blood or blood plasma as a source,
p.(None): Pharmaceutical specialties according to Z 1 and 1a of the Annex to Regulation (EC) № 726/2004 for the definition of
p.(None): Community procedure for the authorization and surveillance of medicinal products for human and veterinary use and
p.(None): Establishment of a European Medicines Agency, OJ. № L 136 from 04/30/2004 p. 1, last changed
p.(None): by Regulation (EU) No. 1235/2010, OJ. L 348 from December 31, 2010 p. 1.
p.(None): (12) "Generator" is a system with a fixed parent radionuclide, on the basis of which a
p.(None): Daughter radionuclide is generated, which is extracted by elution or another method and in one
p.(None): radioactive medicine is used.
p.(None): (13) "Kit" is a preparation that - usually before its administration - is in the final
p.(None): radioactive drugs are newly formed or combined with radionuclides.
p.(None): (14) “Precursor” is another one, for radiolabelling another substance before administration
p.(None): produced radionuclide.
p.(None): (15) "Name of the medicinal product" is the name that is either not to be confused with the
p.(None): common name leading fancy name or a common or scientific name in
p.(None): May be associated with a trademark or the name of the marketing authorization holder.
p.(None): (16) "Strength of the medicinal product" is, depending on the form of administration, the amount of active ingredient per dose,
p.(None): Unit of volume or weight.
p.(None): (17) 'primary packaging' means the container or any other form of pharmaceutical packaging which
p.(None): comes into direct contact with the medicine.
p.(None): (18) "Agency" is the European Medicinal Products Agency established by Regulation (EC) № 726/2004
p.(None): Agency.
p.(None): (19) 'Generic' is a medicinal product that has the same qualitative and quantitative composition
p.(None): Active ingredients and the same dosage form as the reference drug and its
p.(None): Bioequivalence with the reference medicinal product has been demonstrated by means of suitable bioavailability studies.
p.(None): The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of one
p.(None): Active ingredients are considered to be one and the same active ingredient, unless their properties differ significantly
p.(None): in terms of safety or effectiveness. In this case, the applicant must provide additional data
p.(None): be presented, the safety or effectiveness of the various salts, esters or derivatives of a
p.(None): prove approved active ingredient. The different oral dosage forms with immediate
p.(None): Drug release is considered one and the same dosage form.
...
p.(None): Parts of plants, algae, fungi, lichens in unprocessed condition, usually in the dried form, but
p.(None): sometimes also fresh. Certain plant excretions that have not undergone any special treatment
p.(None): were also considered herbal substances. Vegetable substances are due to the plant part and
p.(None): the botanical name according to the binomial system (genus, art. variety and author) is precisely defined.
p.(None): (22) 'Vegetable preparations' are preparations which are made by
p.(None): Impact treatments such as extraction, distillation, pressing, fractionation, purification, concentration or
p.(None): Undergo fermentation. These include grated or powdered plant matter,
p.(None): Tinctures, extracts, essential oils, press juices and processed plant excretions.
p.(None): (23) “Plant-based medicinal products” are all medicinal products that act exclusively as one or more active substances
p.(None): vegetable substances or one or more vegetable preparations or one or more such
p.(None): contain vegetable substances in combination with one or more such herbal preparations.
p.(None): (24) "Traditional herbal medicinal product specialty" is a herbal medicinal product that complies with the requirements of § 12
p.(None): specified conditions met.
p.(None): (25) 'Counterfeit medicinal product' means any medicinal product that has been counterfeited:
p.(None): 1. its identity, including its packaging and labeling, its name or its
p.(None): Composition related to any ingredient, including excipients and content
p.(None): of these components, or
p.(None): 2. its origin, including manufacturer, country of manufacture, country of origin and marketing authorization holder, or
p.(None): Registration holder, or
p.(None): 3. the records and documents related to the distribution channels used.
p.(None): (26) 'Counterfeit active substance' is an active substance in which the following has been falsified:
p.(None): 1. its labeling on the container with regard to the actual content, or
p.(None): 2. the records and documents in connection with the manufacturers involved or the
p.(None): distribution channels used.
p.(None): § 2. (1) "Users" are doctors, dentists, veterinarians, dentists, midwives, members of the
p.(None): Nursing, medical and technical services and first aid services and
p.(None): Legal entities of hospitals without their own institutional pharmacy and other medical facilities, insofar as
p.(None): need these medicines to do their job.
p.(None): (2) "pharmaceutical wholesaler" is a trader who, based on the 1994 Industrial Code,
p.(None): Federal Law Gazette № 194, is entitled to wholesale pharmaceuticals and has a corresponding license
p.(None): in accordance with section 63 (1), as well as a pharmaceutical company of another contracting party of the
p.(None): Agreement on the European Economic Area, which is authorized to wholesale pharmaceuticals
p.(None): float.
p.(None): (3) "pharmaceutical wholesaler" is a pharmaceutical wholesaler, according to which sufficient
p.(None): Warehousing, a corresponding assortment design and a corresponding
p.(None): Willingness, regularity and intensity of care, capable of supplying drugs in the sense
p.(None): of § 57 in a certain area.
p.(None): (3a) "Mediator" is one in a contracting party to the European Economic Area
p.(None): resident person authorized to act as a mediator of medicinal products for human use.
p.(None): (3b) "Bulkware" is a medicinal product that only needs to be filled or packaged to
p.(None): To become the final product.
...
p.(None): commissioned and responsible for monitoring and reporting on the progress of the study and review of the
p.(None): Data is responsible.
p.(None): (9) "Proper permit application and proper change request" is a
p.(None): Application for approval or modification, which is based on generally accepted scientific principles and
p.(None): Meets requirements. These generally accepted scientific principles and requirements
p.(None): can be found in the detailed reports adopted by the Commission in accordance with Article 9 of Directive 2001/20 / EC
p.(None): Instructions for applying.
p.(None): (10) “Test Sheet” is a document that contains data and other information about the test plan
p.(None): contains each individual subject included in the clinical trial.
p.(None): (11) "Examiner" is a doctor or dentist who is authorized to practice his or her profession in Austria
p.(None): is responsible for conducting the clinical trial in a trial center. Will an exam in
p.(None): a test center carried out by a team, the examiner is the responsible head of the team.
p.(None): (12) "Examiner Information" is a compilation of the information for the investigations with investigational medicinal products on
p.(None): Human relevant clinical and non-clinical data on the preparations concerned.
p.(None): (13) "Test plan" is the entirety of the documents in which objectives, planning, methodology,
p.(None): statistical considerations and organization of an examination are described. The term “test plan” relates
p.(None): the test plan itself and its subsequent versions and changes.
p.(None): (14) "investigational medicinal product" is a pharmaceutical form of an active ingredient or placebo that is contained in a
p.(None): clinical trial or used as a reference substance; also an approved one
p.(None): Pharmaceutical specialty when used or provided in a form other than that authorized or for
p.(None): used an unauthorized area of application or to receive additional information on the
p.(None): approved form is used.
p.(None): (15) "Examiner" (healthy subject or patient) is a person who is either the recipient
p.(None): of the investigational medicinal product or as a member of a control group takes part in a clinical trial.
p.(None): (16) "Sponsor" is any physical or legal person who is responsible for planning the
p.(None): Initiation, supervision and funding of a clinical trial. The sponsor or be
p.(None): Authorized representatives must be established in a contracting party to the European Economic Area.
p.(None): The auditor has to assume the additional duties and responsibilities of the sponsor if he has one
p.(None): conducts clinical trials independently of the manufacturer of the medicinal product and under their own responsibility.
p.(None): (17) "Standard Operating Procedures (SOPs)" are standardized, detailed, written
p.(None): Procedural rules of the sponsor for all activities related to the clinical trial
p.(None): are necessary.
p.(None): (18) “Adverse event” is any harmful event that occurs to a subject
p.(None): happens and that is not necessarily causally related to the clinical trial.
p.(None): (19) “Side effect” is any harmful and unintended reaction to an investigational medicinal product.
p.(None): (20) "Serious adverse event or serious side effect" is a
p.(None): adverse event or side effect that is fatal or irrespective of the dose
p.(None): is life-threatening, requires inpatient treatment or its extension to become one
...
p.(None): if there is an INN for the medicinal product or the relevant chemical name,
p.(None): 4. Assessment of the possible environmental risks of the pharmaceutical specialty; precautions must be taken if necessary
p.(None): to provide and justify their limitation,
p.(None): 5. Information about the manufacturing process,
p.(None): 6. Draft of the intended labeling according to § 17 (mock-up),
p.(None): 7. Draft the intended package leaflet according to § 16,
p.(None): 8. Technical information (summary of product properties - SmPC) according to § 15,
p.(None): 9. at the request of the authority, a sample of the outer packaging,
p.(None): 10. reasons for possible precautionary and safety measures when storing the medicinal product,
p.(None): their administration to patients and the disposal of the waste products (together with an indication
p.(None): potential risks that the pharmaceutical specialty poses to the environment),
p.(None): 11. information on the controls envisaged during manufacture,
p.(None): 11a. in the case of human medicinal products, a written confirmation from the manufacturer that he has audited the
p.(None): Compliance with the good manufacturing practice for active ingredients checked by the active ingredient manufacturer on site
p.(None): and has determined; the confirmation must also include the date of the audits,
p.(None): 12. Fully developed, reproducible analysis and standardization regulations for
p.(None): Starting and intermediate products and for the end product, optionally a complete one
p.(None): elaborated, reproducible analytical method for the detection of
p.(None): residues,
p.(None): 13. Indication of the quality criteria of the components of the medicinal product used,
p.(None): 14. A declaration that the substance samples required to carry out technical examinations
p.(None): be made available on official request
p.(None): 15. Indication of scientific knowledge and practical experience on the
p.(None): Harmlessness of the components of the medicinal product used,
p.(None): 16. Indication of the quality characteristics and properties of the packing elements, which with the
p.(None): Drug specialty come into contact, as well as specification of the test instructions for this
p.(None): Packing elements,
p.(None): 17. Test reports on the shelf life in the intended retail pack,
p.(None): 18. Information on the appropriateness of the dosage form,
p.(None): 19. non-clinical data,
p.(None): 20. clinical data,
p.(None): 21. Information on areas of application, contraindications, side effects, dosage (if necessary for
p.(None): each target species), type and form of application, if this is not in the documents according to Z 6 to 8
p.(None): are included
p.(None): 22. The risk management plan for the pharmaceutical specialty concerned, including a summary
p.(None): In accordance with paragraph 4,
p.(None): 23. Proof that the manufacturer has a license pursuant to Section 63 or a
p.(None): Manufacturer approval from the competent authority of another state for the manufacture of medicinal products
p.(None): has,
p.(None): 24. in the case of medicinal specialties that contain several components, the influence on the efficacy or the
p.(None): Have tolerance, information about the suitability of the combination of these components,
...
p.(None): 3. copies of those proposed by the applicant or by the competent national authorities
p.(None): Approved Summary of Product Features (SmPC) and Package Leaflet;
p.(None): 4. The details of all decisions to refuse approval in another
p.(None): Contracting party to the European Economic Area or in a third country and the reasons for this
p.(None): Decision and
p.(None): 5. the copy of the designation of the medicinal product as an orphan medicinal product according to the
p.(None): Regulation (EC) № 141/2000 on orphan medicinal products, OJ. № L 18 from 01/22/2000 p.
p.(None): 1, as amended by Regulation (EC) No. 596/2009, OJ. L 188 from 07/18/2009 p. 14.
p.(None): (6) If the medicinal product is only to be exported, the applicant must contact
p.(None): Submitting the application in writing to make a declaration that the medicinal product is not domestically in
p.(None): Is placed on the market.
p.(None): (7) The applicant is responsible for the accuracy of the information provided and the documents submitted
p.(None): responsible.
p.(None): § 9b. (1) An application for approval of a homeopathic medicinal specialty must include documents
p.(None): according to § 9a paragraph 1 lines 18 to 20 are not included. Furthermore, documents according to Section 9a (2) are not
p.(None): enclosed, however
p.(None): 1. documents that are important for the toxicological assessment of the medicinal product, and
p.(None): 2. Documents on the speci fi c homeopathic or, if applicable, on the speci fi c one
p.(None): anthroposophical effectiveness
p.(None): to join.
p.(None): (2) For homeopathic medicinal products, which are produced by dilution of only one substance
p.(None): a single application is sufficient for the substance and its dilutions.
p.(None): § 9c. An application for approval of a pharmaceutical specialty, which is a monograph of the pharmacopoeia in the
p.(None): The meaning of Section 1 of the Pharmacopoeia Act 2012 does not, however, meet the requirements of Section 7 (2)
p.(None): fulfilled, is not mentioned in Section 7 (9) and is not subject to registration in accordance with Section 12, documents must be provided
p.(None): 8, 12 to 15, 18 to 21, 24 to 27 and 29 to 31 may not be added in accordance with Section 9a (1) no. documents
p.(None): According to § 9a para. 1 no. 5 and 11, the application only has to be attached if during the production and
p.(None): Testing other methods or devices are used than described in the pharmacopoeia
p.(None): are.
p.(None): § 9d. Section 9a does not apply to medicinal specialties within the meaning of Section 7 (9) lines 2 and 3, which are based on a monograph of
p.(None): Pharmacopoeia in the sense of § 1 of the Pharmacopoeia Act. An application for admission to a
p.(None): such a medicinal product, documents according to § 9a paragraph 1 lines 1 to 9 as well as 14 and 15 are to be attached.
p.(None): § 9e. An application for approval of a generator must be submitted in addition to the documents pursuant to Section 9a
p.(None): to connect the following documents:
p.(None): 1. a general description of the system with a detailed description of the components of the
p.(None): Systems that can influence the composition or quality of the daughter nuclide preparation
p.(None): and
p.(None): 2. Information on the qualitative and quantitative peculiarities of the eluate or sublimate.
p.(None): Reference approval
p.(None): Section 10. (1) Notwithstanding Section 9a (1) lines 19, 20 and 28, the applicant is not obliged to:
...
p.(None): Agreement on the European Economic Area to specify in which the reference medicinal product
p.(None): is or has been approved. In this case, the Federal Office for Safety in Health Care has the
p.(None): competent authority of the other party to the Agreement on the European Economic Area
p.(None): request within a month to send confirmation that the reference medicinal product
p.(None): is or has been approved, as well as the full composition of the reference medicine and others
p.(None): Documents if required for the approval of the generic. If the
p.(None): The Federal Office for Safety in Health Care asks the agency for the
p.(None): corresponding information and documents.
p.(None): (6) Were in an amendment for a new area of application of a human medicinal product in
p.(None): Regarding an already well-established drug related to non-clinical or clinical studies
p.(None): the new area of application carried out by the Federal Office for Safety in Health Care
p.(None): Paragraph 14 were considered to be significant, so with an application according to § 10 or according to the
p.(None): Regulation (EC) № 1234/2008 on the examination of changes in the authorization of human and
p.(None): Veterinary medicinal products, OJ. № L 334 of 12.12.2008 p. 7 as amended by Regulation (EU) № 712/2012, OJ.
p.(None): № L 209, 4.8.2012 p. 4, one year not to refer to this data. This
p.(None): Exclusive period is not cumulative.
p.(None): (7) If the approval or its modification of a veterinary specialty, its active substance or active substances
p.(None): used for veterinary purposes in the Union for at least ten years, for another for
p.(None): Obtaining food certain target animal species, and will be new residue attempts
p.(None): according to Regulation (EEC) № 2377/90 and submitted new clinical trials, so can apply
p.(None): in accordance with section 10 or section 24, no reference is made to this data for three years.
p.(None): (8) A medicinal product that is similar to a biological reference medicine fulfills the definition
p.(None): of the generic not because in particular the raw materials or the manufacturing process of the biological
p.(None): Drug differ from that of the reference biological drug, so the results are
p.(None): suitable non-clinical trials or clinical trials or trials regarding these differences
p.(None): required. The type and number of additional data to be submitted must be in Annex I to the Directive
p.(None): 2001/83 / EG, in the version of the directives 2004/24 / EG and 2004/27 / EG or the directive 2001/82 / EG, in
p.(None): comply with the version of Directive 2004/28 / EC.
p.(None): (9) If the medicinal product does not fall under the definition of a generic or the bioequivalence can
p.(None): not demonstrated by bioavailability studies, as well as in the event of a change in the active ingredient or
p.(None): the active ingredients, the areas of application, the strength, the dosage form or the route of administration
p.(None): compared to the reference medicine, are the results of the corresponding non-clinical trials or
p.(None): clinical trials or trials as well as the results of the corresponding safety and
...
p.(None): a corresponding decision by the Commission after referral to the Standing Committee on
p.(None): Veterinary medicines for the adaptation of the guidelines for the removal of technical barriers to trade
p.(None): technical progress in the field of veterinary medicines.
p.(None): (13) With regard to the implementation of the required to obtain an authorization according to paragraph 1 and a
p.(None): Modification of an approval required studies and experiments and the resulting practical
p.(None): Requirements apply to § 22 Paragraph 1 Patent Act 1970 and § 4 Paragraph 1 Utility Model Act.
p.(None): (14) As part of the examination of an amendment for a new area of application, the
p.(None): Federal Office for Safety in Health Care to decide on application
p.(None): 1. whether the new application areas of significant clinical benefit compared to the
p.(None): existing therapies are to be viewed and
p.(None): 2. whether significant non-clinical or clinical studies in an already well-established active ingredient
p.(None): In connection with the new area of application.
p.(None): (15) The protection periods contained in this provision in accordance with paragraphs 1, 2, 3, 4 and 12 apply to applications
p.(None): on the authorization of a reference medicinal product for which the application for authorization has expired after the expiry of the
p.(None): October 30, 2005.
p.(None): § 10a. (1) In deviation from Section 9a (1) nos. 19 and 20, the applicant is not obliged to submit the results
p.(None): the non-clinical trials or the clinical trials or trials or in deviation from Section 9a (1)
p.(None): Item 28 does not undertake to submit the results of the safety and residue tests if it
p.(None): can prove by means of detailed bibliographical documents that
p.(None): 1. the active substance or substances of the medicinal specialty in the Union for at least ten years
p.(None): generally used medicinally or veterinary and
p.(None): 2. the efficacy and safety of the medicinal product recognized for approval are given
p.(None): is.
p.(None): (2) The assessment report issued by the Agency after the assessment of an application for the fixing of
p.(None): Maximum residue levels according to Regulation (EEC) № 2377/90 can be published in
p.(None): appropriately as a corresponding bibliographical document, especially for
p.(None): Safety tests are used.
p.(None): § 10b. In the case of a new pharmaceutical specialty, which consists of known ingredients within the meaning of § 10a,
p.(None): which have so far not been approved in this combination are the results of new non-clinical trials
p.(None): or clinical trials or trials and, if applicable, the results of safety and
p.(None): Residue tests only for this combination, but not for the individual components.
p.(None): Authorization for distribution in parallel import
p.(None): § 10c. (1) medicinal specialties,
p.(None): 1. the one approved or registered in Austria on the basis of this federal law
p.(None): Pharmaceutical specialty (approval),
p.(None): 2. from another party to the Agreement on the European Economic Area
p.(None): be introduced, and
p.(None): 3. in which the assessment of the already approved or registered pharmaceutical specialty
p.(None): Safety and effectiveness can be used for health protection without any risk
p.(None): can
p.(None): may only be placed on the market if the Federal Office for Safety in Health Care
p.(None): Has given approval for sales in parallel imports.
...
p.(None): described route of administration are determined,
p.(None): 3. no specific therapeutic indication in the name, labeling or, if applicable, in the
p.(None): Have package leaflet, and
p.(None): 4. are only given in dilutions that guarantee the safety of the medicinal product.
p.(None): Above all, the medicinal product must not contain more than one part per ten thousand of the mother tincture,
p.(None): or not more than one hundredth of the smallest dose that may be used in allopathy
p.(None): those active ingredients in the presence of which in an allopathic medicinal product, the latter
p.(None): requires a prescription.
p.(None): (2) Homeopathic medicinal specialties within the meaning of paragraph 1 may only be sold in Germany or for the
p.(None): Levy will be kept available when registered with the Federal Office for Safety in Health Care
p.(None): and have been registered in accordance with section 27 (1) 2. Section 9 (1) applies to the authorization to register
p.(None): If necessary, registration is to be issued subject to the stipulation of requirements, the fulfillment of which protects
p.(None): to ensure human or animal health or drug safety. Such conditions
p.(None): can also be prescribed subsequently.
p.(None): (3) The following documents must be enclosed with a registration in accordance with paragraph 2:
p.(None): 1. Name or company name and registered office of the applicant and if the applicant is not with the manufacturer
p.(None): is identical, name or company and registered office of the manufacturer, as well as proof of authorization to
p.(None): Application,
p.(None): 2. scientific or other name of the homeopathic name contained in a pharmacopoeia
p.(None): Original substance or substances with details of the various uses and
p.(None): dilutions
p.(None): 3. Documents in which the extraction and control of the original substance or substances
p.(None): described and their homeopathic use using appropriate bibliographic
p.(None): Documents are documented; contains the pharmaceutical specialty biological substances, also documents on the
p.(None): Measures taken to ensure their freedom from pathogens
p.(None): 4.Documents for the preparation and control of the dosage form and description of the dilution
p.(None): and dynamization method,
p.(None): 5. Evidence that the manufacturer has a license pursuant to Section 63 or a
p.(None): Manufacturer approval from the competent authority of another state for the manufacture of medicinal products
p.(None): has,
p.(None): 6. Copy of, where applicable, in other contracting parties to the Agreement on the European
p.(None): Economic area for registrations or permits received for the same drug,
p.(None): 7. Draft of the labeling according to § 17a (mock-up) and a sample of the at the request of the authority
p.(None): Outer packaging,
p.(None): 8. Information on the shelf life of the pharmaceutical specialty and
p.(None): 9. Justification for the proposed waiting period.
p.(None): The application can extend to a series of medicinal specialties made from the same or the same
p.(None): homeopathic original substance or original substances have been obtained.
p.(None): (4) Does the homeopathic medicinal specialty not comply with the provisions of paragraph 1 or are they
p.(None): Documents within the meaning of paragraph 3 incomplete or incorrect, the Federal Office for Security in
p.(None): Healthcare to refuse registration by notice.
p.(None): (5) Paragraph 1 does not apply to
p.(None): 1. pharmaceutical specialties within the meaning of § 26,
p.(None): 2. sterile, pyrogen-free rinsing liquids,
p.(None): 3. radioactive pharmaceutical specialties and
p.(None): 4. Medicinal specialties that are in accordance with § 2 Paragraph 1 of the Prescription Law or for addictive law
p.(None): Provisions are subject to prescription requirements.
p.(None): Registration of pharmacy specialties
p.(None): § 11a. (1) A registration for the registration of a pharmacy proprietary specialty must be
p.(None): Documents in accordance with section 9a (1) 8, 12, 18 to 20, and 23 and section 9a (2) cannot be attached. The
p.(None): Registration must also be attached:
p.(None): 1. Information on the specification of the finished pharmaceutical specialty and
p.(None): 2. a commenting and evaluating scientific summary of each
p.(None): a) pharmaceutical data contained in the registration documents,
p.(None): b) taken from the specialist literature and for the assessment of the pharmacy-specific pharmaceutical specialty
p.(None): required non-clinical pharmacological and toxicological data and
p.(None): c) taken from the specialist literature and for the assessment of the pharmacy-specific pharmaceutical specialty
p.(None): required results of clinical trials.
p.(None): (2) Documents in accordance with Section 9a (1) no. 16 do not have to be submitted if the medicinal product is for
p.(None): is intended for external use or the packaging elements with the medicinal product are not fully attached
...
p.(None): Medicated feed,
p.(None): 3. radioactive pharmaceutical specialties, generators, kits or precursors of radioactive pharmaceutical specialties
p.(None): Precautions to be taken by the user and the patient during preparation and
p.(None): Administration of the product, as well as special precautions for the
p.(None): Disposal of the transport container and its unused content,
p.(None): 4. Medicinal specialties, the banned active substances according to § 1 para. 2 of the anti-doping
p.(None): Federal Law 2007, Federal Law Gazette I № 30, contain the following note: “The application of the
p.(None): Medicinal product [use the name of the medicinal product] can be positive in doping controls
p.(None): Results. " May result from misuse of the medicinal product for doping purposes
p.(None): If there is a risk to health, this must also be stated. These obligations do not apply to
p.(None): Medicinal specialties according to § 9b.
p.(None): (6) If this is necessary with regard to drug safety, the Federal Minister for
p.(None): Health and women through regulation more detailed provisions on content, type, shape, size and
p.(None): The nature of the information specified in paras. 2 to 5.
p.(None): Instructions for use for registered homeopathic medicinal specialties
p.(None): § 16a. (1) Medicinal products that are registered in accordance with § 11 may only be placed on the market
p.(None): if the retail pack contains instructions for use in German.
p.(None): (2) The package leaflet has the following information in the following order in general
p.(None): to contain understandable form:
p.(None): 1. scientific name of the original substance or substances and dilution; the are in
p.(None): European pharmacopoeia or, in the absence thereof, in one currently in use
p.(None): Pharmacopoeias of the parties to the Agreement on the European Economic Area
p.(None): to use the symbols it contains
p.(None): 2. Name and address of the registration holder,
p.(None): 3. Name and address of the manufacturer,
p.(None): 4. type and, if necessary, route of administration,
p.(None): 5. expiry date (month / year),
p.(None): 6. capacity of the primary packaging,
p.(None): 7. if necessary, special precautionary measures for storage,
p.(None): 8. special warnings,
p.(None): 9. batch number,
p.(None): 10. Registration number,
p.(None): 11. the note “Homeopathic medicinal specialty without approved therapeutic
p.(None): Application areas",
p.(None): 12. the indication that a doctor should be consulted if symptoms of illness persist, and
p.(None): 13. the date of creation of the package leaflet, in the case of a change the date of the last
p.(None): Modification.
p.(None): (3) The Federal Office for Safety in Health Care can request an exception from one
p.(None): Grant requirement according to paragraphs 1 and 2 if this is necessary for reasons of expediency, especially in
p.(None): With regard to the type of pharmaceutical specialty and its primary or outer packaging offered and with the
p.(None): Principles of drug safety is compatible.
p.(None): (4) If this is for the sake of expediency, in particular with regard to the type of
p.(None): Pharmaceutical specialty and its primary or outer packaging is offered and it with the principles of
...
p.(None): (7) The primary packaging in the form of blister packs must at least have the short name
p.(None): the name and authorization holder as well as the batch number and expiry date
p.(None): his. It must be ensured that the name is legible until the last dosage unit is removed
p.(None): is.
p.(None): (8) Small primary packaging - if an outer packaging is available - only with the
p.(None): Information according to paragraph 1 Z 1, 7, 10, 13 and content by weight, volume or dosage units, and the
p.(None): Short name of the authorization holder. The name must include the
p.(None): Do not include dosage form if this does not affect the safety of the drug.
p.(None): (9) The Federal Minister of Health and Women may, if for reasons of expediency,
p.(None): especially with regard to the type of medicinal product, its primary or outer packaging offered and
p.(None): it is compatible with the principles of drug safety, taking into account the requirements
p.(None): the protection of human or animal health by regulation for certain types of
p.(None): Pharmaceutical specialties Exceptions to the labeling requirements of paras 1 to 5a and § 17a
p.(None): Paragraph 1 and, if necessary, additional labeling requirements.
p.(None): Labeling of registered homeopathic medicinal specialties
p.(None): § 17a. (1) Registered homeopathic medicinal products may only be placed on the market if
p.(None): The following information is contained in German on the outer packaging and the primary packaging:
p.(None): 1. scientific name of the original substance or substances and dilution; the are in
p.(None): European pharmacopoeia or, in the absence thereof, in one currently in use
p.(None): Pharmacopoeias of the parties to the Agreement on the European Economic Area
p.(None): use included symbols; the medicinal product consists of two or more original substances
p.(None): together, the scientific name of the original substances can be identified by an imaginary name
p.(None): be replaced,
p.(None): 2. Name and address of the registration holder,
p.(None): 3. Name and address of the manufacturer,
p.(None): 4. type and, if necessary, route of administration,
p.(None): 5. expiry date (month / year),
p.(None): 6. capacity of the primary packaging,
p.(None): 7. if necessary, special precautionary measures for storage,
p.(None): 8. special warnings,
p.(None): 9. Registration number,
p.(None): 10. batch number,
p.(None): 11. the note “Homeopathic medicinal specialty without approved therapeutic
p.(None): Areas of application ”, and
p.(None): 12. the indication that a doctor should be consulted if symptoms of illness persist.
p.(None): (2) The Federal Office for Safety in Health Care may, on request, exceptions to the
p.(None): Grant requirements according to para. 1 nos. 3, 11 and 12.
p.(None): Procedure for applications and registrations
p.(None): § 18. (1) Considering the requirements of an immediate and quick examination of
p.(None): Applications for approval and registrations for the registration of pharmaceutical specialties
p.(None): the Federal Office for Safety in Health Care without unnecessary postponement, but at the latest
p.(None): 1. seven months after receipt of the application for admission or registration for registration
p.(None): a pharmaceutical specialty and
...
p.(None): Health Safety Report.
p.(None): (6) Those documents are an application in accordance with paragraph 2 or 3 and a notification in accordance with paragraph 5
p.(None): connect that allow an assessment of the change.
p.(None): (7) Changes to homeopathic medicinal specialties within the meaning of Section 11 (1) are the responsibility of the Federal Office for
p.(None): Healthcare reporting unless changes to the
p.(None): Composition with regard to therapeutically relevant components or changes in name,
p.(None): unless these changes are necessary due to the current state of science. Are a message
p.(None): to attach those documents that allow an assessment of the change. Changes in
p.(None): Composition with regard to therapeutically relevant components or the name, if any
p.(None): Changes that are not necessary due to the state of science are subject to one
p.(None): New registration according to § 11.
p.(None): (8) Any change in the data that was decisive for the prescription status of a medicinal product,
p.(None): must be reported to the Federal Office for Security immediately. Changes to the prescription requirement require
p.(None): Approval from the Federal Office for Safety in Health Care, unless it is a
p.(None): Prescription exemption, which is due to the invalidation of the prescription obligation according to § 2 Paragraph 1 of the
p.(None): Prescription Law, Federal Law Gazette No. 413/1972.
p.(None): (9) If an application for prescription exemption due to significant non-clinical or clinical
p.(None): Trials approved by the Federal Office for Safety in Health Care can be done within a year
p.(None): after this decision has become final, a prescription exemption for medicinal specialties based on this data
p.(None): other marketing authorization holder with the same active substance.
p.(None): § 24a. (1) The approval of a change in accordance with Regulation (EC) № 1234/2008 or in accordance with Section 24
p.(None): is
p.(None): 1. if there is a reason in accordance with § 19 paragraphs 1 and 2 or
p.(None): 2. in the event of changes that affect the basic nature of the medicinal product,
p.(None): to fail.
p.(None): (2) The approval of the change of a pharmaceutical specialty is, if necessary, prescribed
p.(None): To impose obligations, the fulfillment of which protects the health of humans or animals or the
p.(None): To ensure drug safety.
p.(None): § 24b. (1) The authorization holder or holder of a registration must ensure that in his
p.(None): Company complete documentation of everything related to approval or registration
p.(None): standing documents, their changes, as well as all notices and official notifications in
p.(None): Connection with this specialty drug is available at all times. This applies analogously to the
p.(None): Holder of a license for distribution in parallel import in accordance with § 10c.
p.(None): (2) The authorization holder or the holder of a registration has, in particular for the purposes of
p.(None): Pharmacovigilance, the Federal Ministry of Health and Women on its mandate all data
p.(None): in connection with the sales and sales volume of the pharmaceutical specialty as well as all available to it
p.(None): Provide data related to prescription volume. The authorization holder
p.(None): or the holder of a registration has furthermore for the purposes of pharmacovigilance the Federal Office for
p.(None): Healthcare security by ordering all data related to the health care system
...
p.(None): § 31. The sponsor must develop detailed procedural rules (SOPs) and for their compliance
p.(None): To take care.
p.(None): § 32. (1) The sponsor has
p.(None): 1. the examiner taking into account his suitability and the local conditions and possibilities
p.(None): the test center to select
p.(None): 2. to ensure the approval of the investigator, the clinical trial in accordance with the study plan and the
p.(None): Implement provisions of this federal law,
p.(None): 3. assess the test plan and, if necessary, confirm it with his signature and at
p.(None): to proceed with any changes within the meaning of Section 37a,
p.(None): 4. The investigator also about non-clinical and possibly existing clinical data and results
p.(None): to inform in writing, whereby the obligation to provide immediate information also with regard to
p.(None): any relevant new information that becomes available during the course of the clinical trial,
p.(None): consists,
p.(None): 5. Before the clinical trial begins, a proper application for approval of the clinical trial
p.(None): To pass the examination in accordance with Section 40 (1), to deal with the ethics committee and to end the
p.(None): clinical examination, the Federal Office for Safety in Health Care and the Ethics Committee
p.(None): within 90 days, with early termination within 15 days with clear indication
p.(None): all reasons for canceling to report
p.(None): 6. the conduct of the clinical trial at a hospital before it begins and its
p.(None): To report termination to the medical director of the hospital,
p.(None): 7. the sufficiently characterized and labeled investigational medicinal product, the production of which after a
p.(None): Works regulations according to § 62 or, if the test substance was not manufactured in Austria,
p.(None): in any case according to the internationally recognized standards, in accordance with paragraph 3
p.(None): to provide,
p.(None): 8. to ensure that professionally qualified monitors and, if necessary, supportive
p.(None): ResearchXstaff are available
p.(None): 9. Document all undesirable events in accordance with Section 41d (4) together with the examiner
p.(None): to evaluate immediately and to take the appropriate measures in accordance with Section 37a (4),
p.(None): as well as to report suspected unexpected serious side effects in accordance with Section 41e,
p.(None): 10. the completion of a summary final report of the clinical trial
p.(None): ensure
p.(None): 11. Taking into account paragraph 2, take out personal injury insurance covering all damages
p.(None): covers the life and health of the test subject through the tests performed on them
p.(None): Clinical trial measures may be caused and for which the investigator would be liable,
p.(None): if he was at fault (§ 1295 ABGB), with the exception of damage due to
p.(None): Changes in genetic material in germline cells,
p.(None): 12. In the event that the sponsor is not the examiner at the same time, clarify whether the examiner is a
p.(None): has sufficient liability and legal protection insurance, if necessary the auditor from the
p.(None): the increase in risk associated with the clinical trial incurs additional costs for your own
p.(None): To adequately replace insurance or suitable insurance for your own account
p.(None): in favor of the examiner,
p.(None): 13. with the auditor on the distribution of responsibilities regarding the referral of the
p.(None): Ethics Committee, data transmission and storage, biometric evaluation,
p.(None): Reporting and publication modalities to make appropriate agreements and
p.(None): 14. to ensure that the test participant has a contact point at which the
p.(None): Exam participants independently or with the help of the patient's attorney
p.(None): can catch up, and
p.(None): 15. To pay a cost contribution for the assessment to be made by the ethics committee.
p.(None): (2) Personal injury insurance (Paragraph 1 No. 11) is based on the following principles
p.(None): complete:
p.(None): 1. The sponsor has policyholders, the test participant has independent entitlement
p.(None): To be insured.
p.(None): 2. Austrian law must apply to the insurance contract.
p.(None): 3. The insurance claims must be enforceable in Austria.
p.(None): 4. The enforceability of an Austrian execution title abroad must, if necessary
p.(None): be secured.
p.(None): 5. The scope of insurance must be proportionate to that with the clinical
p.(None): Related risks. More information can be obtained by decree from the Federal Minister for
p.(None): Health and women are determined. This is particularly the result of the number of
p.(None): Trial participants and trial sites, the type of clinical trial and the nature of the
p.(None): Test substance to be taken into account.
p.(None): (3) The sponsor must ensure that neither the test participants nor the Austrian
p.(None): Social insurance institutions incur costs from the provision of the investigational medicinal product (para. 1 no. 7)
p.(None): because that
p.(None): 1. the investigational medicinal product is a pharmaceutical specialty approved in Austria,
p.(None): 2. the use of which is primarily associated with individual benefit insofar as it serves to ward off one
p.(None): Life threatening or serious health damage is urgently needed and
p.(None): compared to available pharmaceutical specialties approved in the relevant indication area
p.(None): substantial increase in chances of success (note: correct: chances of success) seriously expected
p.(None): 3. the social security institution information about the investigational medicinal product and the clinical trial
p.(None): have been made available, and
p.(None): 4. This on the basis of these documents, after assessing the existence of the requirements of Z 1 bis
p.(None): 3 has approved an application for the assumption of costs.
p.(None): (4) The sponsor may delegate all or part of its duties or obligations to external parties
p.(None): delegate scientific institutions.
p.(None): monitor
p.(None): § 33. The monitor must establish communication between the sponsor and the clinical investigator. The
p.(None): Monitor must have the quali fi cations that give it expert supervision of the clinical trial
p.(None): allows.
p.(None): § 34. The monitor has
p.(None): 1. To work according to the SOP, the investigator before, during and after the completion of the clinical
p.(None): Attend testing to check compliance with test plan and ensure that everyone
p.(None): Data is correctly and completely recorded and recorded,
p.(None): 2. to check whether the inspection body has sufficient space, facilities, equipment and personnel,
...
p.(None): Contradict, but confirm these statements or in a meaning to be agreed with them
p.(None): specify without falsifying them.
p.(None): § 50b. (1) Sections 50a and 51 to 56 do not apply to medicinal products within the meaning of Section 7 (4).
p.(None): (2) Section 50a (1) does not apply to specialist advertising within the meaning of Section 54 in the context of scientific
p.(None): Events whose participants come mainly from abroad.
p.(None): lay Advertising
p.(None): § 51. (1) Lay advertising may not for
p.(None): 1. Medicinal specialties that are subject to prescription,
p.(None): 2. Medicinal specialties that are not subject to prescription, but whose name is the same
p.(None): Fancy word or the same scientifically common expression as the name of a
p.(None): contains prescription drug, and
p.(None): 3. registered homeopathic medicinal specialties,
p.(None): operate.
p.(None): (2) The prohibition according to Paragraph 1 No. 1 does not apply to those implemented or supported by local authorities
p.(None): Vaccination campaigns.
p.(None): Section 52. (1) Lay advertising must be designed in such a way that the advertising character is clearly expressed
p.(None): and the product is clearly represented as a drug. Advertising and editorial contributions are clear
p.(None): to separate.
p.(None): (2) Unless otherwise specified in Paragraph 4, lay advertising has at least the following information:
p.(None): contain:
p.(None): 1. the name of the pharmaceutical specialty and the scientifically common name of the active ingredient, if
p.(None): the medicinal product contains only one active substance,
p.(None): 2. the information essential for the sensible application of the medicinal product and
p.(None): 3. A clearly perceptible indication that medicinal products are not only effects
p.(None): can cause undesirable effects and therefore the package leaflet exactly
p.(None): or consult a doctor or pharmacist. The advertising is done via
p.(None): acoustic or audiovisual media, this notice must be clearly audible.
p.(None): (3) In addition to para. 2, lay advertising for traditional herbal medicinal specialties has a written one
p.(None): Note to contain that this is a traditional herbal medicinal specialty for use in a
p.(None): specific area of application or certain areas of application exclusively due to long-term
p.(None): Use.
p.(None): (4) lay advertising does not have to meet the requirements of paragraph 2 if the advertising
p.(None): consists exclusively of the name of a medicinal specialty (souvenir advertising), unless it acts
p.(None): are advertising for pharmaceutical specialties that serve to increase athletic performance. The notice according to
p.(None): Paragraph 2 no. 3 is to be included if the reminder advertising is via posters, advertisements or acoustic or
p.(None): audiovisual media.
p.(None): Section 53. (1) Lay advertising may not contain any elements that
p.(None): 1. pictorial representations in connection with members of the health professions or institutions of the
p.(None): Health care,
p.(None): 2. make a medical examination or a surgical procedure seem superfluous,
p.(None): in particular by offering a diagnosis or treatment on the
p.(None): Recommend correspondence,
p.(None): 3. suggest that the effect of the drug is guaranteed without side effects or one
p.(None): corresponds to or is superior to another treatment or another medicinal product,
...
p.(None): Conflict or terrorist threat, in turn, individual contracts for direct purchase
p.(None): have completed a drug for the needs of their own employees,
p.(None): 6. Institutions of the Austrian Armed Forces, the pharmaceutical supply of the Armed Forces
p.(None): serve,
p.(None): 6a. the Federal Ministry of the Interior, the authorities and childcare facilities subordinate to it
p.(None): for emergency care, prevention and care of operations, provided that the medicines for
p.(None): Need to perform their duties
p.(None): 7. Institutions, the provisional judicial safekeeping or arrests, judicial
p.(None): Prison sentences or preventive judicial measures related to deprivation of liberty
p.(None): Take measures if they need drugs to perform their tasks
p.(None): 8. scientific institutes and research institutes of the local authorities and the
p.(None): Universities and the Austrian Agency for Health and Food Security, if these
p.(None): Need medicines to perform their tasks
p.(None): 9. Organized emergency medical services, provided they are addictive substances, which they use for their emergency medical services
p.(None): Need activity, and
p.(None): 10. Have a doctor who is sufficiently familiar with questions of substance abuse
p.(None): Institutions according to § 15 of the Addictive Substances Act, Federal Law Gazette I № 112/1997, for evidence-based and
p.(None): quality-assured support for clients as part of damage minimization measures,
p.(None): except drugs containing addictive substances.
p.(None): (2) At hospitals without institutional pharmacies, the manufacturer, depositeur or pharmaceutical
p.(None): Wholesalers are given:
p.(None): 1. whole blood preserves, suspensions of cellular or corpuscular blood components,
p.(None): Single donor preparations,
p.(None): 2. native human or animal tissue.
p.(None): (3) Paragraphs 1 and 2 do not apply to radioactive medicinal products. These may be from the manufacturer, depositeur
p.(None): or pharmaceutical wholesalers only to holders of a license to handle radioactive materials
p.(None): according to the Radiation Protection Act, Federal Law Gazette No. 227/1969.
p.(None): (4) Feed medicines may be purchased from the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): Prescription of the treating veterinarian can be given directly to consumers. The repeated
p.(None): Delivery on a prescription is not permitted.
p.(None): (5) Paragraph 1 does not apply to pharmaceutical specialties according to § 7 Paragraph 4 and § 59 Paragraph 7a.
p.(None): (6) From the manufacturer, depositeur or pharmaceutical wholesaler, medicinal products whose delivery in
p.(None): Retail sales are not reserved for pharmacies, directly to bandagists, orthopedic shoemakers,
p.(None): Orthopedic technician, dental technician, podiatrist, holder of a hoof and
p.(None): Claw fittings and massage therapists are given, provided they are medicinal products
...
p.(None): to give the person affected by the decay the opportunity to make a statement.
p.(None): (2) The expired goods are to be used in a useful manner. The expired goods are at the expense of
p.(None): Accused or destroy the person affected by the forfeiture if there is a useful recovery
p.(None): is not possible or the exploitation of the goods does not lead to the expectation that the achievable proceeds will
p.(None): Recovery costs will exceed. The destruction of the expired goods is by the accused or
p.(None): permitted by the person affected by the forfeiture at his own expense under the supervision of a supervisory body.
p.(None): (3) The proceeds of the exploitation are after deduction of the associated expenses and any
p.(None): irrecoverable costs of the criminal proceedings as well as the burden on the case
p.(None): To transfer liabilities to the federal government.
p.(None): Surveillance and protective measures
p.(None): Section 77. Is determined during a check in accordance with Section 76 or is the Federal Office for Security receiving
p.(None): Healthcare otherwise aware that a drug or active ingredient is subject to this federal law or to
p.(None): Does not comply with regulations or other administrative acts enacted on the basis of this federal law
p.(None): the Federal Office for Safety in Health Care to take measures to place the product on the market
p.(None): hinder or restrict. If applicable, section 76b (10) applies.
p.(None): Section 78. (1) The Federal Office for Safety in Health Care becomes aware of facts
p.(None): The reason for concern is that a medicinal product or active substance on the market is a hazard
p.(None): represents the life or health of humans or animals, the Federal Office for Security has
p.(None): To have all necessary measures in accordance with the extent of the risk,
p.(None): which prevent the placing on the market of the medicinal product or active substance or the use of the medicinal product
p.(None): or restrict.
p.(None): (2) In the event of imminent danger from a drug or an active ingredient, measures in accordance with Paragraph 1
p.(None): 1. even without previous procedure or
p.(None): 2. be made before issuing a decision.
p.(None): In the case of Z 2, however, is from the Federal Office for Safety in Health Care within two weeks
p.(None): to issue a written notice, otherwise the measure taken is deemed to have been revoked.
p.(None): (3) The Federal Office for Safety in Health Care has the drug it has confiscated
p.(None): or to declare the seized active ingredient verf as a precautionary measure if it has one
p.(None): serious and significant danger to humans or animals and the person entitled to dispose does not
p.(None): ensures that the drug or active substance is not placed on the market after its release.
p.(None): Preliminary seizure
p.(None): Section 78a. Organs of the Federal Office for Safety in Health Care have considered
p.(None): to temporarily confiscate the protective objectives of this federal law on medicinal products or active substances if the
p.(None): there is reasonable suspicion that this
p.(None): 1. contrary to the provisions of this federal law or regulations based thereon or
p.(None): other administrative acts are placed on the market and
p.(None): 2. pose a threat to the life or health of humans or animals.
p.(None): The regulations of § 76b on the provisional seizure by supervisory bodies and on measures
p.(None): the district administrative authorities in administrative criminal proceedings as well as § 76c are to be applied.
p.(None): Section 78b applies to the enforcement of a provisional seizure.
p.(None): Section 78b. The business owner or his / her authorized representative refuses to act after this
p.(None): Tolerating surveillance or protective measures provided for by federal law can enforce them
p.(None): become.
p.(None): X. SECTION
p.(None): fees
p.(None): Section 79. (1) The Federal Minister of Health and Consumer Protection, in agreement with the
p.(None): Federal Minister of Finance Fees for the permits to be issued under this Federal Act and
p.(None): other activities of federal agencies whose necessity changes
p.(None): 1. from this Federal Act and the ordinances issued on the basis thereof or
p.(None): 2. relevant legal acts of the European Union
p.(None): results, according to experience, from the average growing costs in a tariff
...
p.(None): Paragraph 1 of the Criminal Code) results in a larger number of people, the perpetrator is sentenced to imprisonment from five to
p.(None): punish fifteen years.
p.(None): (7) Who the commercial pack or other document that relates to a drug, an active ingredient
p.(None): or obtains an auxiliary material with the intent to forge or falsify that the document uses it
p.(None): to pass on counterfeit medicines, active ingredients or auxiliary substances to another - provided that the perpetrator
p.(None): is not to be punished according to paragraph 1 or 2 - punishable by imprisonment up to one year.
p.(None): (8) Anyone who induces another person or otherwise contributes to him or him or a relative
p.(None): (§ 72 StGB) falsified medicines so that they can be used by him or his family,
p.(None): is not to be punished according to paragraphs 1 to 7.
p.(None): collection
p.(None): § 82c. (1) Counterfeit drugs, active ingredients, auxiliary substances and documents (§ 82b (7)) are - provided
p.(None): the conditions for confiscation according to Section 26 of the Criminal Code have not already been met - also to confiscate if none
p.(None): certain person can be persecuted or convicted of an offense pursuant to Section 82b, unless the or
p.(None): the person entitled to dispose makes a legitimate intended use credible and guarantees that
p.(None): that the drug, the active substance, the excipient or the document is not placed on the market.
p.(None): (2) Sections 443 to 446 of the Code of Criminal Procedure 1975 (StPO), BGBl. Apply to the procedure.
p.(None): No. 631/1975, accordingly. For the application of the StPO are counterfeit medicines, active substances, auxiliary substances
p.(None): and treat documents as items the possession of which is generally prohibited.
p.(None): Authorization to provide security and duty to inform the customs authorities
p.(None): § 82d. (1) If certain facts indicate that counterfeit medicinal products, active substances,
p.(None): Auxiliary materials or documents (Section 82b (7)) are transported to or from Austria are the customs organs
p.(None): authorized to ensure this. From the seizure you have the responsible immediately
p.(None): Prosecutor to report. Declares that the conditions for a guarantee (§ 110 StPO)
p.(None): if there is no such security, it must be canceled immediately.
p.(None): (2) In connection with the control of counterfeit medicines, active ingredients, auxiliary substances or
p.(None): Documents may be processed by the customs authorities personal data (Art. 4 Z 2 data protection
p.(None): Basic regulation) and transmit this to the responsible law enforcement authorities, insofar as this is to be fulfilled
p.(None): whose legal role is required.
p.(None): administrative Penalties
p.(None): § 83. (1) Who
p.(None): 1. places medicinal products on the market contrary to Section 15 or a regulation pursuant to Section 15 (7),
p.(None): 2. Medicinal specialties contrary to §§ 16 to 16b or a regulation according to § 16 paragraph 6, § 16a
p.(None): 4 or Section 26, Section 8,
p.(None): 3. Medicinal specialties contrary to § 17 or § 17a or a regulation according to § 17 paragraph 5a or 9 in
p.(None): Brings traffic,
...
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p.(None): 26. for medicinal products, the safe and safe use of which requires sterility
p.(None): the sterilization method,
p.(None): 27. for pharmaceutical specialties, their safe and harmless use an examination for pyrogenic
p.(None): Substances required, the specification of the test specification,
p.(None): 28. for medicinal products for animals, results of safety and residue tests and
p.(None): of tests to assess the possible environmental risks,
p.(None): 29. for medicinal products that are feed medicinal products, proof that the product contains
p.(None): Proportion of feed is a feed that complies with the Feed Act,
p.(None): 30. for medicinal products that are premixes of feed medicinal products, proof that
p.(None): the proportion of feed contained is a feed that complies with the Feed Act,
p.(None): 31. in the case of medicinal specialties for use on animals which are used to obtain medicinal products or
p.(None): Food, documents on the waiting time,
p.(None): 32. in pharmaceutical specialties for use on animals, for the production of food or
p.(None): Medicinal products are intended to be a proof of at least six months ago
p.(None): Valid application to set the maximum residue limit according to Regulation (EEC)
p.(None): No. 2377/90, provided the active substances for the target species concerned are not yet listed in Annex I, II or
p.(None): III of Regulation (EEC) № 2377/90 are included; this does not apply if the target species is equidae
p.(None): provided they are in accordance with Commission Decision 92/623 / EEC of 20 October 1993 on
p.(None): the document for the identification of registered equidae (equine passport) and the decision
p.(None): Commission 2000/68 / EC of 22 December 1999 amending Decision 93/623 / EEC
p.(None): and to establish a procedure for identifying breeding and usage as not
p.(None): Slaughter intended for human consumption,
p.(None): 33. A statement that clinical trials are outside the European Economic Area
p.(None): have been carried out that are equivalent to the ethical requirements of Directive 2001/20 / EC,
p.(None): 34. for veterinary specialties, proof that the applicant has a
p.(None): Pharmacovigilance managers and the necessary infrastructure to each
p.(None): Side effect, its occurrence within the European Economic Area or in a third country
p.(None): is suspected to report. For human medicinal products, a summary of the
p.(None): The applicant's pharmacovigilance system, which must include:
p.(None): a) proof that the applicant has a pharmacovigilance officer,
p.(None): b) the place of residence and activity of the person responsible for pharmacovigilance in the European Union
p.(None): Economic Area,
p.(None): (c) the declaration signed by the applicant that he has the necessary resources to:
p.(None): fulfill its obligations under Section IX and
p.(None): d) the location of the place where the pharmacovigilance master documentation is kept.
p.(None): (2) An application for admission is also each a commenting and evaluating scientific
p.(None): Summary of those contained in the documents pursuant to Paragraph 1
p.(None): 1. pharmaceutical data,
p.(None): 2. Results of the non-clinical pharmacological and toxicological experiments and
p.(None): 3. Results of the clinical trials or clinical trials
p.(None): to add. This must contain all information relevant to the evaluation, whether cheap or unfavorable.
p.(None): This also applies to incomplete or canceled pharmacological or toxicological tests or
...
p.(None): (6) Bumps or preparations made from bumps within the meaning of Section 1 (3) 8, provided that they are always in advance in
p.(None): manufactured in the same composition and under the same name in a for delivery in
p.(None): Retail sales certain form are placed on the market, which according to § 11b in the version of the
p.(None): Federal Law Gazette No. 748/1988 have been reported, may continue until the end of December 31, 2013
p.(None): delivered in Germany or kept ready for delivery in Germany, unless, § 3, the analogous
p.(None): this applies to these products.
p.(None): § 94b. As far as this federal law refers to other federal laws, these provisions are in
p.(None): applicable version.
p.(None): Transitional regulations to amendment BGBl. I No. 153/2005
p.(None): § 94c. (1) Sto oder e or preparations from Sto ff en in the sense of § 1 Paragraph 3 No. 9, the reporting of
p.(None): Section 11c (1) in the version prior to the entry into force of this Federal Act in the version of the
p.(None): Federal Law BGBl. I № 153/2005 from the Federal Minister for Health and Women under the award of a
p.(None): consecutive number has been confirmed, may remain unchanged until December 31, 2008
p.(None): be placed on the market with the number.
p.(None): (2) The technical and package leaflet of specialty medicinal products prior to the entry into force of this
p.(None): Federal law in the version of the federal law BGBl. I № 153/2005 approved or registered
p.(None): have the §§ 15, 16 and 16a as soon as possible, at the latest by January 1, 2011
p.(None): correspond.
p.(None): (3) Is the change of technical or usage information only to adapt the in §§ 15, 16
p.(None): and 16a provided order, their change is the authorization holder or the holder of a
p.(None): Report registration to the Federal Office for Safety in Health Care.
p.(None): (4) Section 16c (1) applies to medicinal products that are listed in the before the entry into force of this federal law
p.(None): Version of the Federal Law BGBl. I № 153/2005 were approved or registered, with the proviso
p.(None): that these formats must be available as soon as possible, but no later than January 1, 2011. Section 16c (2)
p.(None): does not apply to medicinal products that were amended before the entry into force of this Federal Act
p.(None): Federal Law Gazette I No. 153/2005 were approved or registered.
p.(None): (5) Pharmaceutical specialties that were issued before the entry into force of this Federal Act in the version of the
p.(None): Federal Law BGBl. I № 153/2005 have been approved, provided for in § 17 (5)
p.(None): Labeling as soon as possible, at the latest by 1 January 2011.
p.(None): (6) The labeling of a commercial pack already in circulation does not correspond to that
p.(None): Regulations of § 17 paragraph 5, these may still be passed on.
p.(None): (7) If the change in the marking serves to fulfill the obligation in accordance with Section 17 (5), then:
p.(None): this change to the Federal Office for Safety in Health Care on presentation of a model of
p.(None): Report outer packaging.
p.(None): (7a) Applications for approval of pharmaceutical specialties in accordance with § 17a of this Federal Act in the version
p.(None): before the entry into force of Federal Law BGBl. I No. 153/2005, which were pending on January 2, 2006
p.(None): according to the legal situation before the entry into force of the Federal Law BGBl. I № 153/2005 and
p.(None): complete.
...
p.(None): § 94g. The change in the package leaflet for specialty medicinal products prior to the entry into force of this
p.(None): Federal law in the version of the federal law BGBl. I № 146/2009 approved or registered
p.(None): , and which serves to adapt to Section 16 (5) (4), has until December 31 at the latest
p.(None): To take place in 2010. This change is deemed to be a reportable change in accordance with Section 24 (6).
p.(None): Transitional right to amendment BGBl. I No. 110/2012
p.(None): § 94h. (1) Section 9a (1) no.22 in the version of the Federal Law BGBl. I № 110/2012 does not apply to
p.(None): Approvals or registrations of pharmaceutical specialties before the entry into force of this federal law
p.(None): in the version of the Federal Law BGBl. I No. 110/2012.
p.(None): (2) Section 9a (1) No. 34 in the version of the Federal Law BGBl. I No. 110/2012 does not apply to approvals
p.(None): or registrations of medicinal products for human use that were published in the
p.(None): Version of the Federal Law BGBl. I № 110/2012 have been requested. In these cases they have
p.(None): Marketing authorization holder or registration holder of the obligation to operate a pharmacovigilance
p.(None): Master documentation from the legal validity of the extension of the admission or registration, at the latest however
p.(None): as of July 21, 2015.
p.(None): (3) (Note: repealed by Federal Law Gazette I No. 162/2013)
p.(None): (4) The technical information and instructions for use of medicinal specialties that were published before this came into force
p.(None): Federal law in the version of the federal law BGBl. I № 110/2012 approved or registered
p.(None): have the §§ 15 paragraph 2 line 14 and 16 paragraph 2 line 20 at the earliest possible time, but at the latest
p.(None): to comply with July 1, 2014.
p.(None): (5) If the change of technical or usage information is only for the adjustment according to paragraph 3 or 4, see above
p.(None): is the change of the authorization holder or the holder of a registration to the Federal Office for
p.(None): Health Safety Report.
p.(None): (6) Section 20 (2) in the version of the Federal Law BGBl. I № 110/2012 applies to medicinal specialties,
p.(None): their approval or registration would end after April 21, 2013.
p.(None): (7) Sections 75a (3) and (4) and (75b) in the version prior to the amendment apply to veterinary specialties
p.(None): BGBl. I No. 110/2012.
p.(None): (8) Sections 75a (3) and (4) and (75b) apply to registered pharmacy specialties
p.(None): Version before the amendment BGBl. I No. 110/2012.
p.(None): (9) Section 75b (1) and (2) in the version before the amendment BGBl. I № 110/2012 also applies mutatis mutandis to the
p.(None): Holder of a license for distribution in parallel import. Relates to a report according to § 75g
p.(None): Drug specialty based on a license for parallel import sales to Austria
p.(None): the Federal Office for Safety in Health Care has the holder of the permit
p.(None): for sales in parallel import immediately, but no later than 15 days after becoming known
p.(None): inform. The information must be given anonymously.
p.(None): (10) Section 75j (3) in the version of the Federal Law BGBl. I № 110/2012 occurs six months later
p.(None): Announcement of the agency on its web portal that the eudravigilance database on the corresponding
p.(None): Features has in place. Until then, Section 75j (3) applies, with the proviso that the reports to the
p.(None): Federal Office for Safety in Health Care have to take place and all suspected not
p.(None): serious side effects of immunological medicinal products, medicinal products listed below
...
Health / Healthy People
Searching for indicator healthy volunteers:
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p.(None): 1. as expected, they meet the objectives of section 2a (1),
p.(None): 2. Information about relevant physical and chemical data or biological properties as well
p.(None): about the applied pharmaceutical technology and
p.(None): 3. Meaningful results of non-clinical tests are available, which correspond to the respective
p.(None): State of the art.
p.(None): (2) The planning and implementation of clinical trials must comply with the regulations
p.(None): Federal law according to the state of the sciences and according to the principles of good clinical
p.(None): Practice. To interpret the principles of good clinical practice, those are generally accepted
p.(None): To use the principles and requirements set out in Volume 10 of the regulations for medicinal products in the
p.(None): European Union are published.
p.(None): § 29. (1) When planning, setting up and carrying out clinical trials, the health
p.(None): To keep risks and burdens for the test participant as low as possible.
p.(None): (2) The clinical trial of medicinal products may only be carried out if the risks associated with it for
p.(None): the test participants are connected, measured by the expected meaning of the result of the
p.(None): Examination for medicine are justifiable and the risk of impairment of the
p.(None): Examiner health
p.(None): 1. is not significant or
p.(None): 2. is outweighed by the benefit to be expected from the use of the drug
p.(None): Health.
p.(None): (3) The clinical trial of a medicinal product may only be carried out on patients if
p.(None): 1. Results of clinical trials on healthy volunteers are available, unless
p.(None): The investigational medicinal product may not be tested on healthy volunteers in accordance with paragraph 2 no
p.(None): no meaningful result can be expected from healthy subjects, and
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is to treat the disease or the patient on whom the clinical trial is to be performed
p.(None): to recognize their course, to heal or alleviate them or to prevent them from further illnesses
p.(None): protect.
p.(None): If there is meaningful data according to Z 1 and from clinical trials on patients, this may not be available
p.(None): the requirements of Z 2, a clinical trial on the patient can also be carried out if
p.(None): A certain illness of the test participant is a prerequisite for that for the in the test plan
p.(None): the relevant question is expected to result.
p.(None): (4) (Note: repealed by Federal Law Gazette I No. 35/2004)
p.(None): § 30. The clinical trial of medicinal products may be performed on women of childbearing potential, with the exception of cases of
p.(None): Section 44, can only be carried out or continued if before and in sufficient repetition during the
p.(None): clinical trial to determine the absence of pregnancy.
p.(None): Tasks, responsibilities and qualifications of sponsor, monitor and auditor
p.(None): § 31. The sponsor must develop detailed procedural rules (SOPs) and for their compliance
p.(None): To take care.
p.(None): § 32. (1) The sponsor has
p.(None): 1. the examiner taking into account his suitability and the local conditions and possibilities
p.(None): the test center to select
p.(None): 2. to ensure the approval of the investigator, the clinical trial in accordance with the study plan and the
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.(None): Postponement, but at the latest within 90 days after receipt of the application. In cases in
p.(None): to whom an advisory body is concerned, this period is extended by a further 90 days.
p.(None): (8) For a clinical trial in connection with drugs for gene therapy apply in addition to
p.(None): Provisions of this federal law meet the requirements of sections 74 to 79 of the Genetic Engineering Act.
p.(None): ethics committees
p.(None): Section 41. (1) The governor has clinical trials outside of hospitals
p.(None): To ensure that an ethics committee for the perception of the
p.(None): Tasks according to § 41a is set up and all necessary measures are taken to this
p.(None): Ethics committee to enable the work. The members of the ethics committee are allowed to participate in this
p.(None): Activity is not subject to any instructions.
p.(None): (2) The ethics committee has a balanced relationship between women and men
p.(None): to assemble and at least consist of:
p.(None): 1. a doctor who is authorized to practice the profession independently in Germany and is not the examiner,
p.(None): 2. a specialist in whose specialty the respective clinical trial falls, or, if applicable, one
p.(None): Dentist, and who are not examiners,
p.(None): 3. a representative of the superior service for health and nursing,
p.(None): 4. a lawyer,
p.(None): 5. a pharmacist,
p.(None): 6. a patient representative,
p.(None): 7. a representative of a representative organization for the disabled and a representative of the elderly,
p.(None): which belongs to a senior citizen organization in accordance with the Federal Senior Citizens Act, Federal Law Gazette I No. 84/1998,
p.(None): 8. a person with biometric expertise and
p.(None): 9. Another person who does not fall under Z 1 to 8 and who is concerned with pastoral care
p.(None): Is entrusted with matters or otherwise has the appropriate ethical competence.
p.(None): An equally qualified representative must be appointed for each member.
p.(None): (3) The members of the ethics committee and their representatives have any relationships with
p.(None): pharmaceutical industry completely open to the governor. You have yours
p.(None): To act in the ethics committee in all matters involving a relationship with
p.(None): pharmaceutical industry is likely to question its full impartiality.
p.(None): (4) The governor is entitled to a contribution from the sponsor in accordance with the
p.(None): Experience has shown that the costs of an assessment in the context of a clinical assessment are on average
p.(None): To request examination.
p.(None): Section 41a. (1) The in execution of § 8c of the Federal Act on Hospitals and Health Centers
p.(None): according to state law provisions, those according to university law provisions and those according to § 41
p.(None): Ethics committees set up have the rules on the procedure contained in paras. 2 to 7
p.(None): to be observed and in particular to be taken into account in their comments:
p.(None): 1. the relevance of the clinical trial and its planning,
p.(None): 2. the adequacy of the assessment of the expected benefits and the
p.(None): expected risks,
p.(None): 3. the test plan,
...
Searching for indicator disability:
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p.(None): Pharmaceutical specialty when used or provided in a form other than that authorized or for
p.(None): used an unauthorized area of application or to receive additional information on the
p.(None): approved form is used.
p.(None): (15) "Examiner" (healthy subject or patient) is a person who is either the recipient
p.(None): of the investigational medicinal product or as a member of a control group takes part in a clinical trial.
p.(None): (16) "Sponsor" is any physical or legal person who is responsible for planning the
p.(None): Initiation, supervision and funding of a clinical trial. The sponsor or be
p.(None): Authorized representatives must be established in a contracting party to the European Economic Area.
p.(None): The auditor has to assume the additional duties and responsibilities of the sponsor if he has one
p.(None): conducts clinical trials independently of the manufacturer of the medicinal product and under their own responsibility.
p.(None): (17) "Standard Operating Procedures (SOPs)" are standardized, detailed, written
p.(None): Procedural rules of the sponsor for all activities related to the clinical trial
p.(None): are necessary.
p.(None): (18) “Adverse event” is any harmful event that occurs to a subject
p.(None): happens and that is not necessarily causally related to the clinical trial.
p.(None): (19) “Side effect” is any harmful and unintended reaction to an investigational medicinal product.
p.(None): (20) "Serious adverse event or serious side effect" is a
p.(None): adverse event or side effect that is fatal or irrespective of the dose
p.(None): is life-threatening, requires inpatient treatment or its extension to become one
p.(None): permanent or serious disability or disability or a congenital anomaly or
p.(None): is a birth defect.
p.(None): (21) "Unexpected side effect" is a side effect that depends on the type or severity due to the
p.(None): available product information is not expected.
p.(None): (22) "Pediatric investigation concept" is a research and development program that ensures
p.(None): the data that is required to determine the prerequisites should be developed,
p.(None): among which a drug will be approved for treatment in the pediatric population
p.(None): can. The pediatric population includes people from birth to the age of 18.
p.(None): Birthday.
p.(None): Definitions regarding drug monitoring (pharmacovigilance)
p.(None): § 2 B. (1) “Side effect” of a medicinal product for human use is a harmful and unintended reaction to
p.(None): the Medicine. “Side effect” of a veterinary medicinal product is a harmful and unintended reaction to
p.(None): the medicinal product that occurs at doses normally used in animals for prophylaxis, diagnosis or
p.(None): Therapy for diseases or for changing a physiological function.
p.(None): (2) "Side effect in humans" is a reaction that is harmful and unintentional and in
p.(None): People experience exposure to a veterinary drug.
p.(None): (3) "Serious side effect of a human medicinal product" is a side effect that is fatal or
p.(None): is life-threatening, requires inpatient treatment or its extension, more permanent
p.(None): or severe disability or disability or a congenital anomaly or
p.(None): Birth defect is.
p.(None): (4) "Serious side effect of a veterinary medicinal product" is a side effect that is fatal or
p.(None): is life-threatening, leads to significant disability or disability, congenital anomalies or
p.(None): Causes birth defects in the following generation or in the treated animals constantly occurring or
p.(None): causes long-lasting symptoms.
p.(None): (5) "Misuse of a drug" is the intended, permanent or sporadic excessive
p.(None): Use of a drug with physical or mental damage as a result.
p.(None): (6) "Improper use" is the use of a veterinary medicinal product contrary to
p.(None): Information about the summary of product characteristics, including the improper one
p.(None): Use or serious abuse.
p.(None): (7) “Risk management system” is a series of pharmacovigilance activities and measures that
p.(None): identified, described, avoided or minimized by the risks associated with pharmaceutical specialties
p.(None): should be; this also includes evaluating the effectiveness of such activities and measures.
p.(None): (8) “Risk Management Plan” is a detailed description of the risk management system.
p.(None): (9) “Pharmacovigilance system” is a system that the marketing authorization holder or holder of a
p.(None): Registration and the Federal Office for Safety in Health Care apply to the in Section IX
p.(None): to carry out the tasks and duties mentioned and the surveillance of the safety of authorized
p.(None): or registered pharmaceutical specialties and the discovery of all changes in the benefit-risk
p.(None): Relationship serves.
p.(None): (10) “Pharmacovigilance Master Documentation (Pharmacovigilance Master File)” is a detailed one
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): left to others.
p.(None): (3) Anyone who is a criminal offense under paragraph 1 or 2 as a doctor, dentist, veterinarian, pharmacist, dentist or midwife
p.(None): commits is punishable by imprisonment for up to five years.
p.(None): (4) Anyone who commits a crime under paragraph 1 or 2 with the intention of enforcing his
p.(None): recurring inspection to miss a continuous intake, and already because of a
p.(None): such a crime has been convicted.
p.(None): (5) Anyone who committed the offense (para. 4) as a doctor, dentist, veterinarian, pharmacist, dentist or midwife
p.(None): commits is punishable by imprisonment for up to ten years.
p.(None): (6) If the offense referred to in paragraphs 1 or 2 results in the death of a person or serious physical injury (Section 84
p.(None): Paragraph 1 of the Criminal Code) results in a larger number of people, the perpetrator is sentenced to imprisonment from five to
p.(None): punish fifteen years.
p.(None): (7) Who the commercial pack or other document that relates to a drug, an active ingredient
p.(None): or obtains an auxiliary material with the intent to forge or falsify that the document uses it
p.(None): to pass on counterfeit medicines, active ingredients or auxiliary substances to another - provided that the perpetrator
p.(None): is not to be punished according to paragraph 1 or 2 - punishable by imprisonment up to one year.
p.(None): (8) Anyone who induces another person or otherwise contributes to him or him or a relative
p.(None): (§ 72 StGB) falsified medicines so that they can be used by him or his family,
p.(None): is not to be punished according to paragraphs 1 to 7.
p.(None): collection
p.(None): § 82c. (1) Counterfeit drugs, active ingredients, auxiliary substances and documents (§ 82b (7)) are - provided
p.(None): the conditions for confiscation according to Section 26 of the Criminal Code have not already been met - also to confiscate if none
p.(None): certain person can be persecuted or convicted of an offense pursuant to Section 82b, unless the or
p.(None): the person entitled to dispose makes a legitimate intended use credible and guarantees that
p.(None): that the drug, the active substance, the excipient or the document is not placed on the market.
p.(None): (2) Sections 443 to 446 of the Code of Criminal Procedure 1975 (StPO), BGBl. Apply to the procedure.
p.(None): No. 631/1975, accordingly. For the application of the StPO are counterfeit medicines, active substances, auxiliary substances
p.(None): and treat documents as items the possession of which is generally prohibited.
p.(None): Authorization to provide security and duty to inform the customs authorities
p.(None): § 82d. (1) If certain facts indicate that counterfeit medicinal products, active substances,
p.(None): Auxiliary materials or documents (Section 82b (7)) are transported to or from Austria are the customs organs
p.(None): authorized to ensure this. From the seizure you have the responsible immediately
p.(None): Prosecutor to report. Declares that the conditions for a guarantee (§ 110 StPO)
p.(None): if there is no such security, it must be canceled immediately.
...
Health / Physically Disabled
Searching for indicator illness:
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p.(None): is needed and the success of this treatment with an approved and available
p.(None): Pharmaceutical specialty cannot be achieved according to the state of the art, or
p.(None): 4. the pharmaceutical specialty to prevent or in connection with a disaster,
p.(None): terrorist threat or armed conflict
p.(None): should be applied and the success with an approved and available pharmaceutical specialty
p.(None): the state of the art cannot be achieved, or
p.(None): 5. the medicinal product for use by doctors or paramedics related to a
p.(None): national major event according to § 26a Sanitary Act, Federal Law Gazette I № 30/2002, from abroad
p.(None): coming to work temporarily in Austria.
p.(None): (2) If an application for reimbursement of a pharmaceutical specialty not approved in Austria is submitted to
p.(None): an Austrian social security institution, the domestic manufacturer or the
p.(None): Applicant for an import license according to the Pharmaceuticals Imports Act 2010 or for
p.(None): Notification according to the Pharmaceutical Imports Act 2010 entitled to the Austrian social security institution
p.(None): upon request to provide the information immediately and free of charge that at least
p.(None): correspond to the information in the technical information.
p.(None): § 8a. (1) Pharmaceutical specialties that meet the requirements of Article 3 Paragraph 1 or 2 of Regulation (EC)
p.(None): № 726/2004 meet no approval if the Federal Office for Health Safety
p.(None): under the conditions specified in Article 83 of Regulation (EC) № 726/2004, approval for
p.(None): which they have placed on the market as part of a "compassionate use program". The program is for
p.(None): to define a defined group of patients who have a chronic or
p.(None): suffer from serious illness or whose illness is life-threatening and who has an approved and
p.(None): available medicinal product cannot be treated satisfactorily.
p.(None): (2) Is entitled to apply for a permit in accordance with paragraph 1
p.(None): 1. the manufacturer if he sponsors an approved clinical trial for the medicinal product in question
p.(None): is, or
p.(None): 2. the applicant for a marketing authorization pursuant to Article 6 of the Regulation
p.(None): No. 726/2004 for the medicinal product in question.
p.(None): (3) The Federal Minister of Health may, by ordinance, provide more detailed regulations on the procedure
p.(None): to authorize the placing on the market of a medicinal product as part of a “Compassionate use
p.(None): Program ”as far as this is necessary to protect the health of patients.
p.(None): (4) The holder of an authorization for the implementation of a "Compassionate use program"
p.(None): ensure that the medicinal product is included in the patients included in the program even after the
p.(None): Granting of marketing authorization until the actual marketing is available
p.(None): is provided.
p.(None): Application for Admission
p.(None): § 9. (1) The following are entitled to apply for approval or to register a pharmaceutical specialty:
p.(None): 1. a trader who, on the basis of the 1994 Trade Ordinance, is responsible for the manufacture of the
p.(None): Is wholesaling with the pharmaceutical specialty in question, or
p.(None): 2. an operator of a domestic public pharmacy, or
p.(None): 3. one in another party to the Agreement on the European Economic Area
p.(None): resident pharmaceutical entrepreneur who is authorized to sell the pharmaceutical specialty in question
p.(None): To bring traffic.
...
p.(None): Medicinal specialties according to § 9b.
p.(None): (6) If this is necessary with regard to drug safety, the Federal Minister for
p.(None): Health and women through regulation more detailed provisions on content, type, shape, size and
p.(None): The nature of the information specified in paras. 2 to 5.
p.(None): Instructions for use for registered homeopathic medicinal specialties
p.(None): § 16a. (1) Medicinal products that are registered in accordance with § 11 may only be placed on the market
p.(None): if the retail pack contains instructions for use in German.
p.(None): (2) The package leaflet has the following information in the following order in general
p.(None): to contain understandable form:
p.(None): 1. scientific name of the original substance or substances and dilution; the are in
p.(None): European pharmacopoeia or, in the absence thereof, in one currently in use
p.(None): Pharmacopoeias of the parties to the Agreement on the European Economic Area
p.(None): to use the symbols it contains
p.(None): 2. Name and address of the registration holder,
p.(None): 3. Name and address of the manufacturer,
p.(None): 4. type and, if necessary, route of administration,
p.(None): 5. expiry date (month / year),
p.(None): 6. capacity of the primary packaging,
p.(None): 7. if necessary, special precautionary measures for storage,
p.(None): 8. special warnings,
p.(None): 9. batch number,
p.(None): 10. Registration number,
p.(None): 11. the note “Homeopathic medicinal specialty without approved therapeutic
p.(None): Application areas",
p.(None): 12. the indication that a doctor should be consulted if symptoms of illness persist, and
p.(None): 13. the date of creation of the package leaflet, in the case of a change the date of the last
p.(None): Modification.
p.(None): (3) The Federal Office for Safety in Health Care can request an exception from one
p.(None): Grant requirement according to paragraphs 1 and 2 if this is necessary for reasons of expediency, especially in
p.(None): With regard to the type of pharmaceutical specialty and its primary or outer packaging offered and with the
p.(None): Principles of drug safety is compatible.
p.(None): (4) If this is for the sake of expediency, in particular with regard to the type of
p.(None): Pharmaceutical specialty and its primary or outer packaging is offered and it with the principles of
p.(None): Pharmaceutical safety is compatible, the Federal Minister of Health and Women can by ordinance
p.(None): considering the requirements of protecting human or animal health exceptions
p.(None): issued from the requirements of paragraphs 1 and 2.
p.(None): Obligations in connection with the package leaflet
p.(None): § 16c. (1) The authorization holder or the holder of a registration must ensure that the
p.(None): Package leaflet is available at the request of patient organizations in formats suitable for blind and
p.(None): visually impaired people are suitable.
p.(None): (2) The package leaflet has the results of cooperation with patient target groups
p.(None): reflect. The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): adopted to ensure the readability, clarity and user-friendliness of the package leaflet.
p.(None): Note for the following provision
...
p.(None): the protection of human or animal health by regulation for certain types of
p.(None): Pharmaceutical specialties Exceptions to the labeling requirements of paras 1 to 5a and § 17a
p.(None): Paragraph 1 and, if necessary, additional labeling requirements.
p.(None): Labeling of registered homeopathic medicinal specialties
p.(None): § 17a. (1) Registered homeopathic medicinal products may only be placed on the market if
p.(None): The following information is contained in German on the outer packaging and the primary packaging:
p.(None): 1. scientific name of the original substance or substances and dilution; the are in
p.(None): European pharmacopoeia or, in the absence thereof, in one currently in use
p.(None): Pharmacopoeias of the parties to the Agreement on the European Economic Area
p.(None): use included symbols; the medicinal product consists of two or more original substances
p.(None): together, the scientific name of the original substances can be identified by an imaginary name
p.(None): be replaced,
p.(None): 2. Name and address of the registration holder,
p.(None): 3. Name and address of the manufacturer,
p.(None): 4. type and, if necessary, route of administration,
p.(None): 5. expiry date (month / year),
p.(None): 6. capacity of the primary packaging,
p.(None): 7. if necessary, special precautionary measures for storage,
p.(None): 8. special warnings,
p.(None): 9. Registration number,
p.(None): 10. batch number,
p.(None): 11. the note “Homeopathic medicinal specialty without approved therapeutic
p.(None): Areas of application ”, and
p.(None): 12. the indication that a doctor should be consulted if symptoms of illness persist.
p.(None): (2) The Federal Office for Safety in Health Care may, on request, exceptions to the
p.(None): Grant requirements according to para. 1 nos. 3, 11 and 12.
p.(None): Procedure for applications and registrations
p.(None): § 18. (1) Considering the requirements of an immediate and quick examination of
p.(None): Applications for approval and registrations for the registration of pharmaceutical specialties
p.(None): the Federal Office for Safety in Health Care without unnecessary postponement, but at the latest
p.(None): 1. seven months after receipt of the application for admission or registration for registration
p.(None): a pharmaceutical specialty and
p.(None): 2. 45 days after receipt of an application for approval for sales in parallel import
p.(None): to issue a decision.
p.(None): (2) Notification of the result of the investigation to the applicant or applicant
p.(None): and the order to improve the application or registration or the application or
p.(None): Registration documents inhibit the deadline according to paragraph 1 until the opinion of the
p.(None): Applicant or applicant or the improvement.
p.(None): (3) The approval or registration of a pharmaceutical specialty is subject to conditions
p.(None): or to impose orders if these protect human or animal health, for which
p.(None): Drug safety or effective disease control are required. These can in particular
p.(None): Include the following:
p.(None): 1. Certain measures contained in the risk management system to ensure safe
p.(None): Application of the drug specialty,
p.(None): 2. Conducting safety studies after approval,
...
p.(None): To keep risks and burdens for the test participant as low as possible.
p.(None): (2) The clinical trial of medicinal products may only be carried out if the risks associated with it for
p.(None): the test participants are connected, measured by the expected meaning of the result of the
p.(None): Examination for medicine are justifiable and the risk of impairment of the
p.(None): Examiner health
p.(None): 1. is not significant or
p.(None): 2. is outweighed by the benefit to be expected from the use of the drug
p.(None): Health.
p.(None): (3) The clinical trial of a medicinal product may only be carried out on patients if
p.(None): 1. Results of clinical trials on healthy volunteers are available, unless
p.(None): The investigational medicinal product may not be tested on healthy volunteers in accordance with paragraph 2 no
p.(None): no meaningful result can be expected from healthy subjects, and
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is to treat the disease or the patient on whom the clinical trial is to be performed
p.(None): to recognize their course, to heal or alleviate them or to prevent them from further illnesses
p.(None): protect.
p.(None): If there is meaningful data according to Z 1 and from clinical trials on patients, this may not be available
p.(None): the requirements of Z 2, a clinical trial on the patient can also be carried out if
p.(None): A certain illness of the test participant is a prerequisite for that for the in the test plan
p.(None): the relevant question is expected to result.
p.(None): (4) (Note: repealed by Federal Law Gazette I No. 35/2004)
p.(None): § 30. The clinical trial of medicinal products may be performed on women of childbearing potential, with the exception of cases of
p.(None): Section 44, can only be carried out or continued if before and in sufficient repetition during the
p.(None): clinical trial to determine the absence of pregnancy.
p.(None): Tasks, responsibilities and qualifications of sponsor, monitor and auditor
p.(None): § 31. The sponsor must develop detailed procedural rules (SOPs) and for their compliance
p.(None): To take care.
p.(None): § 32. (1) The sponsor has
p.(None): 1. the examiner taking into account his suitability and the local conditions and possibilities
p.(None): the test center to select
p.(None): 2. to ensure the approval of the investigator, the clinical trial in accordance with the study plan and the
p.(None): Implement provisions of this federal law,
p.(None): 3. assess the test plan and, if necessary, confirm it with his signature and at
p.(None): to proceed with any changes within the meaning of Section 37a,
p.(None): 4. The investigator also about non-clinical and possibly existing clinical data and results
p.(None): to inform in writing, whereby the obligation to provide immediate information also with regard to
p.(None): any relevant new information that becomes available during the course of the clinical trial,
p.(None): consists,
p.(None): 5. Before the clinical trial begins, a proper application for approval of the clinical trial
p.(None): To pass the examination in accordance with Section 40 (1), to deal with the ethics committee and to end the
...
p.(None): has been demonstrably granted, and it is ensured that the expressly by a minor
p.(None): expressed desire not to take the clinical trial or take it at any time
p.(None): to be considered by the examiner
p.(None): 6. The consent can be withdrawn at any time without the minor being affected
p.(None): Disadvantage arises
p.(None): 7. with the participation in the clinical trial, no incentives or financial benefits
p.(None): Exception to an expense allowance,
p.(None): 8. the clinical trial is planned so that it takes into account the disease and the
p.(None): Developmental stage of the minor with as little pain, discomfort, fear and
p.(None): other predictable risks, including the risk threshold as well as the
p.(None): Degree of exposure specifically defined and constantly checked,
p.(None): 9. The test plan by an ethics committee that has knowledge in the field of children and
p.(None): Juvenile medicine or who deals with clinical, ethical and psychosocial issues on the
p.(None): Had been advised in the area of pediatrics and adolescent medicine, and was approved
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of
p.(None): Science stand.
p.(None): (2) Deviating from Paragraph 1 No. 2, a clinical trial on minors is also permitted if
p.(None): 1. The clinical trial is an essential extension of the scientific understanding of the
p.(None): Condition, illness or disorder of the minor and thereby either
p.(None): Can benefit patients or the patient group to which the minor belongs, and
p.(None): 2. The clinical trial for the minor with only a minimal risk and minimal burden
p.(None): brings oneself; a clinical trial has minimal risk and minimal burden if
p.(None): it is to be expected that at most it will be a minor and merely temporary
p.(None): Impairment and the symptoms or inconvenience at best only
p.(None): could occur temporarily and will be very minor.
p.(None): § 43. (1) The clinical trial on an adult who is due to a mental illness or
p.(None): a comparable impairment of their ability to make decisions regarding representation regarding medical
p.(None): Treatments that have a legal representative (§ 1034 ABGB) may only be carried out if
p.(None): 1. the medicinal product being tested is intended to identify, cure, alleviate or prevent it
p.(None): and is the clinical trial for the confirmation of data used in clinical trials
p.(None): Consent obtained from persons capable of providing information or using other research methods
p.(None): were absolutely necessary,
p.(None): 2. the use of the drug that is being tested, according to the knowledge of medical
p.(None): Science is shown to work in the person who is suffering from a mental illness or an
p.(None): comparable impairment in their ability to make decisions is limited to this disease
p.(None): or to recognize impairment or its course, to heal or alleviate it or to prevent it
p.(None): to protect further diseases, and the associated with the inclusion in the clinical trial
p.(None): Benefit for the test subject outweighs the risk,
p.(None): 3. the consent of the legal representative after appropriate clarification demonstrably and
p.(None): was issued in writing; the presumed will of the test participant must be observed,
p.(None): 4. The test participant has also given evidence and in writing, provided that
p.(None): After appropriate information, he is able to understand the nature, meaning, scope and risks of the
p.(None): to inspect the clinical trial and then determine his will,
p.(None): 5. The consent can be withdrawn at any time without the exam participant
p.(None): Disadvantage arises
p.(None): 6. The candidate, depending on his ability to understand this, information regarding the
p.(None): Testing that has received risks and benefits
p.(None): 7. with the participation in the clinical trial, no incentives or financial benefits
p.(None): Exception to an expense allowance,
p.(None): 8. the clinical trial is planned so that it takes into account the disease and the
p.(None): Developmental stage with as little pain, discomfort, fear and others as possible
p.(None): predictable risks are associated; Both the risk threshold and the degree of exposure must be
...
p.(None): If the continuation is refused, this must be refrained from, unless the welfare of the person represented would otherwise be
p.(None): significantly at risk. The consent of the legal representative requires judicial approval.
p.(None): Section 43a. (1) A clinical trial, by its nature, can only be used in emergency situations in which appropriate
p.(None): Time no consent of the legal representative can be obtained, can be carried out at
p.(None): a person who is unable to consent to have a clinical trial performed if:
p.(None): 1. there are no indications that the patient refused the clinical trial or
p.(None): would refuse
p.(None): 2. Such research for the validation of data used in clinical trials for consent
p.(None): were obtained after informed persons or using other research methods,
p.(None): are absolutely necessary and can only be carried out in emergency situations,
p.(None): 3. The drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in an emergency situation is determined
p.(None): 4. the use of the drug that is being tested, according to the knowledge of medical
p.(None): Science is indicated to help the emergency patient develop an illness or its course
p.(None): recognize, heal or alleviate them or protect them from further diseases and the with
p.(None): the risk associated with the inclusion in the clinical trial for the trial subject
p.(None): predominates
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge of the
p.(None): Area of the disease concerned, in relation to the emergency situation and the affected
p.(None): Patient group or who deal with clinical and ethical issues in the field of
p.(None): related illness, in relation to the emergency situation and the affected patient group
p.(None): , expressly for the conduct of clinical trials in emergency situations on persons who
p.(None): are unable to give personal consent, have been approved, and
p.(None): 6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 38 and
p.(None): 39 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Education is given. Further processing of the personal data collected up to that point is required
p.(None): the express data protection consent.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
...
p.(None): Measure is deemed canceled.
p.(None): personal requirements
p.(None): Section 69a. (1) In a company within the meaning of Section 62 (1) may perform the tasks of a knowledgeable person
p.(None): and with the management of the manufacture of pharmaceuticals only people with the necessary scientific
p.(None): Vocational training and appropriate practical training.
p.(None): (2) The Federal Minister of Health and Women has issued an ordinance with regard to the
p.(None): Drug safety more detailed regulations on scientific professional training and practical
p.(None): Training of the competent person and the production manager.
p.(None): Section 70. (1) Only persons may be entrusted with the management of a control laboratory within the meaning of Section 62 (3) no
p.(None): who obtain the required scientific professional training and a corresponding one
p.(None): have completed practical training.
p.(None): (2) The Federal Minister of Health and Women, taking into account the necessary
p.(None): Knowledge and experience with regard to drug safety through prescribing more detailed regulations
p.(None): to enact what scientific professional training and practical training the head of a
p.(None): Has to prove control laboratories.
p.(None): Section 71. (1) Persons who are employed in a company within the meaning of Section 62 (1) and with medicinal products,
p.(None): in contact with their containers or materials used to manufacture medicinal products
p.(None): come, must immediately notify the manager of the company or his deputy if
p.(None): 1. they can adversely affect the nature of the medicinal products through illness,
p.(None): 2. They are infected by an illness, even if only to a limited extent, which is notifiable or notifiable
p.(None): have been exposed or are at risk of spreading such a disease,
p.(None): or
p.(None): 3. they are suspected of having an illness as defined in Z 1 or 2.
p.(None): They may only resume their work if the manager of the company or his deputy
p.(None): on the basis of a medical certificate has convinced that the nature of the
p.(None): Medicinal product is not adversely affected.
p.(None): (2) The manager of the company or his deputy must ensure that the persons mentioned in paragraph 1
p.(None): Individuals before starting work and then undergoing a medical examination once a year
p.(None): are subjected, in particular to the presence of diseases and circumstances within the meaning of
p.(None): Paragraph 1 is to be observed.
p.(None): (3) The persons named in paragraph 1 are at the beginning of their employment via paragraphs 1 and 2 as well
p.(None): to be instructed by the employer about § 83 Z 7.
p.(None): drug agent
p.(None): Section 71a. (1) A medication broker who is based in Austria has the Federal Office for Security in
p.(None): Healthcare to report his name, company name and permanent address. each
p.(None): The mediator must report any changes to this data immediately. The Federal Office for Security
p.(None): in the healthcare sector, a register has to be kept of reports from pharmaceutical intermediaries. This is
p.(None): on the website of the Federal Office for Safety in Health Care.
p.(None): (2) The Federal Office for Safety in Health Care has on application for registration
p.(None): to issue a confirmation. The registration must be denied or deleted if the in
p.(None): this federal law or on the basis of an ordinance issued under this federal law
p.(None): specified requirements have not been met or have subsequently ceased to apply.
p.(None): (3) The Federal Minister of Health may, by ordinance, provide more detailed provisions regarding the
p.(None): Issue requirements for the mediation of medicinal products, in particular via
...
Searching for indicator physically:
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p.(None): Cure or to alleviate or prevent human or animal diseases or
p.(None): pathological complaints are determined, or
p.(None): 2. applied in or on the human or animal body or a human or an animal
p.(None): can be administered to either
p.(None): a) the physiological functions through a pharmacological, immunological or metabolic
p.(None): Restore, correct or influence the effect, or
p.(None): b) to serve as the basis for a medical diagnosis.
p.(None): (2) Objects that contain a medicinal product or on which a medicinal product is considered a medicinal product
p.(None): is applied and which are intended for use on or in the human or animal body.
p.(None): (3) Are no drugs
p.(None): 1. Foodstuffs according to Art. 2 Para. 1 and 2 of Regulation (EC) № 178/2002 establishing the
p.(None): general principles and requirements of food law to establish the European
p.(None): Authority for Food Safety and for Establishing Food Safety Procedures, OJ.
p.(None): № L 31, 1.2.2002 p. 1, last amended by regulation (EG) № 596/2009, OJ. № L 188 from
p.(None): 18.7.2009 p. 14,
p.(None): 2. Utility articles and food additives in accordance with food law provisions,
p.(None): 3. cosmetic products in accordance with food law provisions, provided that they are used and
p.(None): Effects are restricted to the area of the skin and its appendages and the oral cavity,
p.(None): 4. Tobacco products according to the Tobacco Act, Federal Law Gazette No. 431/1995,
p.(None): 5. Feed, feed additives and premixes in accordance with the feed law regulations,
p.(None): 6. Materials or preparations made of materials used in dentistry and physically
p.(None): stable state have no pharmacological effect,
p.(None): 7. Natural healing deposits and products from a natural healing deposit in accordance with Section 42a (2)
p.(None): of the Federal Act on Hospitals and Health Centers, Federal Law Gazette № 1/1957, unless their
p.(None): Composition was changed by the addition of substances with an influence on the effectiveness,
p.(None): or, based on the sciences, undesirable even when used as intended
p.(None): Effects in humans are expected
p.(None): 8. Materials or preparations made from materials that are used only for prophylactic purposes
p.(None): To ward off, eliminate or harm pathogens, parasites or foreign substances
p.(None): to make, provided their application and effect on healthy skin and its appendages
p.(None): are limited and unless they are for use on patients before surgery or others
p.(None): medical interventions that require skin disinfection are intended,
p.(None): 9. Materials or preparations made from materials that are intended exclusively for
p.(None): complementary medical methods to be used, provided that they neither serve nor
p.(None): are intended to fulfill the purpose of paragraph 1, unless it concerns
p.(None): Stumps or preparations from stumps that are made according to homeopathic principles and
p.(None): Process technologies are produced,
p.(None): 10. Substances or preparations made from substances intended for use on animals and
p.(None): a) for cleaning, grooming, imparting certain odor impressions to the animal, influencing the
p.(None): Look or serve to protect the skin and
p.(None): b) do not contain any substances that are in accordance with food law provisions in cosmetic products
p.(None): may not be included
...
p.(None): that is not done on humans.
p.(None): (13) Pharmaceutical officers are persons who are doctors, dentists, veterinarians, dentists, midwives,
p.(None): Visit pharmacists or traders mentioned in section 59 (3), (4) and (8) to find out about medicines
p.(None): to provide technical information.
p.(None): (13a) "Marketing Authorization Holder" is a party to the Agreement on the
p.(None): European Economic Area (EEA Agreement) resident entrepreneur who is entitled to
p.(None): To market, manufacture or wholesale pharmaceuticals or active ingredients under his name
p.(None): to drive.
p.(None): (13b) "Expert person" is a person as defined in Article 48 of Directive 2001/83 / EC, as amended
p.(None): of Directives 2004/24 / EC and 2004/27 / EC, or Article 52 of Directive 2001/82 / EC, in the version of the
p.(None): Directive 2004/28 / EC, or Article 13 (1) of Directive 2001/20 / EC.
p.(None): (14) "Harmlessness" means that when used as intended, the foreseeable risk
p.(None): undesirable effects in consideration of the effectiveness or purpose according to the knowledge
p.(None): medical science is justifiable.
p.(None): (15) “Consumers” are physical or legal persons who take medicinal products for their own use
p.(None): purchase.
p.(None): (15a) "Mediation of medicinal products" includes all activities, with the exception of wholesale, in the
p.(None): Connection with the sale or purchase of medicinal products for human use, which consist of self-employed and in
p.(None): Negotiate the name of another legal or natural person without using these drugs
p.(None): Acquiring property or physically handling these medicines.
p.(None): (16) “Expiry date” is the term after which the shelf life of a medicine
p.(None): is no longer guaranteed.
p.(None): (17) Waiting time is the period between the last administration of a drug to animals under
p.(None): Compliance with drug regulations and the time up to which these animals are not available
p.(None): Extraction of food or medicinal products may be used, must be observed and the
p.(None): ensures that residues of the substances administered in these foods comply with the
p.(None): Regulation (EEC) № 2377/90 maximum permissible quantities for pharmacologically active substances
p.(None): do not exceed.
p.(None): (18) "Efficacy" is the suitability of a drug, the intended uses mentioned in § 1 Paragraph 1
p.(None): to fulfill.
p.(None): (19) "Effect" is an influenceable influence of the
p.(None): Condition or function of a biological object.
p.(None): (20) 'Central procedure' is one for the Member States of the European Union through the Regulation
p.(None): (EG) № 726/2004, OJ. № L 136/1 of March 31, 2004, established procedure for the approval of certain
p.(None): Medicinal specialties, that for medicinal products covered by the annex to the aforementioned regulation
p.(None): compulsory for pharmaceutical specialties covered by Article 3 Paragraph 2 of the Ordinance on request as required
p.(None): the requirements mentioned there apply.
p.(None): (21) 'Intermediate' is a medicinal product that is still in one or more manufacturing phases
p.(None): needs to become bulk goods.
p.(None): Definitions regarding clinical trials
...
Health / Pregnant
Searching for indicator pregnant:
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p.(None): 6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 38 and
p.(None): 39 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Education is given. Further processing of the personal data collected up to that point is required
p.(None): the express data protection consent.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 42 or § 43.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 44. (1) The clinical trial of a medicinal product may only be carried out on a pregnant woman if
p.(None): if
p.(None): 1. the drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in pregnant women or unborn children
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is with the pregnant woman on whom the clinical trial is being conducted or with her
p.(None): to recognize unborn child diseases or their course, to cure or to alleviate them or
p.(None): to protect them from diseases,
p.(None): 3. according to the knowledge of medical science, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): sufficient test results can be expected.
p.(None): (2) Paragraph 1 applies mutatis mutandis to clinical trials of medicinal products intended to be admission
p.(None): to allow pregnancy.
p.(None): Section 45. (1) The clinical trial of a medicinal product may be carried out on persons who have a presence or
p.(None): Provide training service, not be carried out.
p.(None): (2) The clinical trial of a medicinal product may be carried out on persons who are judicial or official
p.(None): Order stopped or accommodated according to the Accommodation Act, not carried out
p.(None): become.
p.(None): Dealing with data
p.(None): Section 46. (1) On the part of the sponsor, monitor and examiner, appropriate measures are necessary for careful
p.(None): and confidential handling of all data resulting from a clinical trial.
p.(None): (2) The test plan, the documentation, the agreements made between the investigator and sponsor and
p.(None): all other documents related to the clinical trial must be reviewed by
p.(None): the sponsor for a period of 15 years after completion or termination of the clinical trial
p.(None): be kept.
p.(None): (3) The examiner must ensure that the documents relate to pseudonymization for
p.(None): kept for a period of 15 years after completion or termination of the clinical trial.
p.(None): (4) Without prejudice to the duty of storage in accordance with paragraph 2, the final report must be submitted by the sponsor
p.(None): or later marketing authorization holder, are kept 5 years longer than the pharmaceutical specialty in Austria
p.(None): is allowed.
p.(None): (4a) With regard to the deadlines specified in paragraphs 2 to 4, the right under Art.
p.(None): Basic regulation excluded.
p.(None): (5) All data and documents relevant to the clinical trial must be submitted to the
...
Health / patients in emergency situations
Searching for indicator emergency situation:
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p.(None): is also promptly informed of the participant's participation in the clinical trial and of the result
p.(None): inform associated insurance coverage.
p.(None): (3) Gives a person who is not able to make decisions to his or her proxy
p.(None): Adult representatives or the investigator to recognize that they are undergoing the clinical trial or their
p.(None): If the continuation is refused, this must be refrained from, unless the welfare of the person represented would otherwise be
p.(None): significantly at risk. The consent of the legal representative requires judicial approval.
p.(None): Section 43a. (1) A clinical trial, by its nature, can only be used in emergency situations in which appropriate
p.(None): Time no consent of the legal representative can be obtained, can be carried out at
p.(None): a person who is unable to consent to have a clinical trial performed if:
p.(None): 1. there are no indications that the patient refused the clinical trial or
p.(None): would refuse
p.(None): 2. Such research for the validation of data used in clinical trials for consent
p.(None): were obtained after informed persons or using other research methods,
p.(None): are absolutely necessary and can only be carried out in emergency situations,
p.(None): 3. The drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in an emergency situation is determined
p.(None): 4. the use of the drug that is being tested, according to the knowledge of medical
p.(None): Science is indicated to help the emergency patient develop an illness or its course
p.(None): recognize, heal or alleviate them or protect them from further diseases and the with
p.(None): the risk associated with the inclusion in the clinical trial for the trial subject
p.(None): predominates
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge of the
p.(None): Area of the disease concerned, in relation to the emergency situation and the affected
p.(None): Patient group or who deal with clinical and ethical issues in the field of
p.(None): related illness, in relation to the emergency situation and the affected patient group
p.(None): , expressly for the conduct of clinical trials in emergency situations on persons who
p.(None): are unable to give personal consent, have been approved, and
p.(None): 6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 38 and
p.(None): 39 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Education is given. Further processing of the personal data collected up to that point is required
p.(None): the express data protection consent.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 42 or § 43.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 44. (1) The clinical trial of a medicinal product may only be carried out on a pregnant woman if
p.(None): if
p.(None): 1. the drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in pregnant women or unborn children
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is with the pregnant woman on whom the clinical trial is being conducted or with her
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): the Federal Office for Safety in Health Care sends to all other member states of the
p.(None): European Economic Area and all possible actors in the domestic supply chain
p.(None): Quick warning. It can be assumed that the medicinal product has already reached patients and
p.(None): there is reasonable suspicion that there is an immediate risk to life or serious and
p.(None): the Federal Office for Safety in the
p.(None): Health care immediately, but at the latest within 24 hours, information to the public
p.(None): about the lack of quality and the resulting dangers. Any from
p.(None): Approval holders have already taken measures to be taken into account. Section 75c (2) applies
p.(None): analogous.
p.(None): (8) Paragraphs 2 to 4, 6 and 7 apply analogously to counterfeit medicinal products.
p.(None): sampling
p.(None): Section 76. (1) Medicines are issued by organs of the Federal Ministry of Health and Women
p.(None): Organs of the Federal Office for Safety in Health Care or commissioned by them
p.(None): Control experts.
p.(None): (2) The control has by sampling in the company of the 1st manufacturer,
p.(None): 2. Depositeurs,
p.(None): 3. pharmaceutical wholesaler or
p.(None): 4. Pharmaceutical retailer
p.(None): to take place during operating hours.
p.(None): (3) Feed medicinal products can also be checked by the consumer.
p.(None): (3a) Radioactive medicinal products can also be checked by the user.
p.(None): (4) The organs of the Federal Ministry of Health and Women are responsible for carrying out the control
p.(None): and the Federal Office for Safety in Health Care or experts commissioned by them
p.(None): To grant access to the companies mentioned in paragraph 2 and the necessary sampling. this applies
p.(None): analogously also for the control of feed medicinal products at the consumer and of radioactive ones
p.(None): Medicines for the user.
p.(None): (5) The sample taken is, insofar as this is possible by nature and therefore not hers
p.(None): faultless assessment is frustrated to be divided into two equal parts that are officially closed. On
p.(None): Part is to be left to the party for evidence.
p.(None): (6) No compensation is due for the samples taken. Are the samples in factories according to
p.(None): Paragraph 2 no. 3 or 4, taken from the consumer according to Paragraph 3 or from the user according to Paragraph 3a
p.(None): the manufacturer or depositeur must provide replacement by providing the same pieces.
p.(None): Section 76a. (1) Monitoring food traffic suspected of being
p.(None): Medicinal products are or banned active substances in accordance with Section 1 (2) (1) of the 2007 Anti-Doping Act
p.(None): included (hereinafter referred to as "goods") is the responsibility of the governor.
p.(None): (2) The governor has chosen to perform this task as specially trained bodies
p.(None): To use supervisory bodies. The following are considered specially trained:
p.(None): 1. Doctors who have passed the physics examination and
p.(None): 2. People who meet the training requirement in accordance with Section 24 (3) LMSVG.
p.(None): (3) Supervisory bodies are entitled to inspect wherever goods are placed on the market
p.(None): hold and take samples. For this purpose, they must be granted access to all places where
p.(None): are goods. The review is, apart from the control of means of transport or at
p.(None): Danger of being delayed during normal business or operating hours. The disturbance of the
p.(None): Business operations should be avoided if possible.
p.(None): (4) The sample taken is, insofar as this is possible by nature and therefore not hers
p.(None): faultless assessment is frustrated to be divided into two equal parts that are officially closed. On
p.(None): Part is to be left as a cross-check of the party for evidence purposes. If a division is not possible, it has
p.(None): Supervisory body to supply the sample without prior division of the investigation. For the samples taken
p.(None): no compensation is due.
p.(None): (5) On the occasion of the sampling, the supervisory body must issue a cover letter and everyone
p.(None): Include part of the sample in which the observations and observations are noteworthy for the assessor
p.(None): of the organ are included. The Federal Minister is responsible for the details of the sample accompanying letter
p.(None): for health and women.
p.(None): (6) The sample taken is to be sent to the investigating institution. This
p.(None): The investigation institute has to examine the sample and to produce findings and expert opinions. findings
p.(None): and reports are to be sent immediately to the sampling agency. If the
p.(None): Investigation center comes to a reasoned opinion that the suspicion of the violation of
p.(None): Legislation is in place, so it has to determine this in its report and the responsible person
p.(None): To inform the authority immediately.
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Social / Age
Searching for indicator age:
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p.(None): The auditor has to assume the additional duties and responsibilities of the sponsor if he has one
p.(None): conducts clinical trials independently of the manufacturer of the medicinal product and under their own responsibility.
p.(None): (17) "Standard Operating Procedures (SOPs)" are standardized, detailed, written
p.(None): Procedural rules of the sponsor for all activities related to the clinical trial
p.(None): are necessary.
p.(None): (18) “Adverse event” is any harmful event that occurs to a subject
p.(None): happens and that is not necessarily causally related to the clinical trial.
p.(None): (19) “Side effect” is any harmful and unintended reaction to an investigational medicinal product.
p.(None): (20) "Serious adverse event or serious side effect" is a
p.(None): adverse event or side effect that is fatal or irrespective of the dose
p.(None): is life-threatening, requires inpatient treatment or its extension to become one
p.(None): permanent or serious disability or disability or a congenital anomaly or
p.(None): is a birth defect.
p.(None): (21) "Unexpected side effect" is a side effect that depends on the type or severity due to the
p.(None): available product information is not expected.
p.(None): (22) "Pediatric investigation concept" is a research and development program that ensures
p.(None): the data that is required to determine the prerequisites should be developed,
p.(None): among which a drug will be approved for treatment in the pediatric population
p.(None): can. The pediatric population includes people from birth to the age of 18.
p.(None): Birthday.
p.(None): Definitions regarding drug monitoring (pharmacovigilance)
p.(None): § 2 B. (1) “Side effect” of a medicinal product for human use is a harmful and unintended reaction to
p.(None): the Medicine. “Side effect” of a veterinary medicinal product is a harmful and unintended reaction to
p.(None): the medicinal product that occurs at doses normally used in animals for prophylaxis, diagnosis or
p.(None): Therapy for diseases or for changing a physiological function.
p.(None): (2) "Side effect in humans" is a reaction that is harmful and unintentional and in
p.(None): People experience exposure to a veterinary drug.
p.(None): (3) "Serious side effect of a human medicinal product" is a side effect that is fatal or
p.(None): is life-threatening, requires inpatient treatment or its extension, more permanent
p.(None): or severe disability or disability or a congenital anomaly or
p.(None): Birth defect is.
p.(None): (4) "Serious side effect of a veterinary medicinal product" is a side effect that is fatal or
p.(None): is life-threatening, leads to significant disability or disability, congenital anomalies or
p.(None): Causes birth defects in the following generation or in the treated animals constantly occurring or
p.(None): causes long-lasting symptoms.
p.(None): (5) "Misuse of a drug" is the intended, permanent or sporadic excessive
p.(None): Use of a drug with physical or mental damage as a result.
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Social / Child
Searching for indicator child:
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p.(None): 39 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Education is given. Further processing of the personal data collected up to that point is required
p.(None): the express data protection consent.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 42 or § 43.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 44. (1) The clinical trial of a medicinal product may only be carried out on a pregnant woman if
p.(None): if
p.(None): 1. the drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in pregnant women or unborn children
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is with the pregnant woman on whom the clinical trial is being conducted or with her
p.(None): to recognize unborn child diseases or their course, to cure or to alleviate them or
p.(None): to protect them from diseases,
p.(None): 3. according to the knowledge of medical science, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): sufficient test results can be expected.
p.(None): (2) Paragraph 1 applies mutatis mutandis to clinical trials of medicinal products intended to be admission
p.(None): to allow pregnancy.
p.(None): Section 45. (1) The clinical trial of a medicinal product may be carried out on persons who have a presence or
p.(None): Provide training service, not be carried out.
p.(None): (2) The clinical trial of a medicinal product may be carried out on persons who are judicial or official
p.(None): Order stopped or accommodated according to the Accommodation Act, not carried out
p.(None): become.
p.(None): Dealing with data
p.(None): Section 46. (1) On the part of the sponsor, monitor and examiner, appropriate measures are necessary for careful
p.(None): and confidential handling of all data resulting from a clinical trial.
p.(None): (2) The test plan, the documentation, the agreements made between the investigator and sponsor and
p.(None): all other documents related to the clinical trial must be reviewed by
p.(None): the sponsor for a period of 15 years after completion or termination of the clinical trial
p.(None): be kept.
p.(None): (3) The examiner must ensure that the documents relate to pseudonymization for
p.(None): kept for a period of 15 years after completion or termination of the clinical trial.
p.(None): (4) Without prejudice to the duty of storage in accordance with paragraph 2, the final report must be submitted by the sponsor
p.(None): or later marketing authorization holder, are kept 5 years longer than the pharmaceutical specialty in Austria
p.(None): is allowed.
p.(None): (4a) With regard to the deadlines specified in paragraphs 2 to 4, the right under Art.
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Searching for indicator children:
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p.(None): Authority of another contracting party to the Agreement on the European Economic Area on request
p.(None): every negative decision about the registration and the reasons for it.
p.(None): statutory authorization
p.(None): § 14. The Federal Minister of Health and Women may consider the requirements
p.(None): an in-depth and rapid examination of the application and the admission and registration documents
p.(None): by regulation, more detailed provisions on applications and notifications as well as on content, scope, form,
p.(None): Issue the nature and submission of the samples and documents in accordance with sections 9a to 12a and 24.
p.(None): Product Information
p.(None): Technical information (summary of product characteristics - SMPC)
p.(None): § 15. (1) About medicinal specialties that are in accordance with § 7 of the approval or in accordance with § 12 of the registration
p.(None): is subject to doctors, dentists, dentists, midwives, veterinarians, pharmacists and those in § 59 para. 3
p.(None): to make available technical information in German to the traders mentioned, provided that it
p.(None): are not pharmaceutical specialties according to § 9c.
p.(None): (2) The subject information must contain at least the following information in the following order:
p.(None): 1. Name of the pharmaceutical specialty, followed by the strength and the dosage form,
p.(None): 2. Qualitative and quantitative composition according to active ingredients using the usual
p.(None): common or chemical name,
p.(None): 3. pharmaceutical form,
p.(None): 4. Clinical information:
p.(None): a) fields of application,
p.(None): b) dosage and type of use in adults and, if necessary, in children,
p.(None): c) contraindications,
p.(None): d) special warnings and cautions for use and in immunological
p.(None): Medicinal products all special precautions taken by people with
p.(None): immunological medicines and those dealing with these medicinal products
p.(None): Administer patients who are to be met, as well as all where necessary to be met by the patient
p.(None): Precautions,
p.(None): e) interactions with other drugs or other agents,
p.(None): f) use during pregnancy and lactation,
p.(None): (g) effects on the ability to operate machines and to operate
p.(None): Motor vehicles
p.(None): h) side effects that may occur when used as intended,
p.(None): i) overdose (symptoms, emergency measures, antidotes),
p.(None): 5. Pharmacological properties:
p.(None): a) pharmacodynamic properties,
p.(None): b) pharmacokinetic properties,
p.(None): c) non-clinical safety data;
p.(None): 6. Pharmaceutical information:
p.(None): a) list of auxiliary substances,
p.(None): b) major incompatibilities,
p.(None): c) Shelf life, if necessary after reconstitution of the medicinal product or at
p.(None): first opening of the primary packaging,
p.(None): d) special precautions for storage,
p.(None): e) type and content of the container,
p.(None): f) if necessary, special precautionary measures for the disposal of opened ones
p.(None): Pharmaceutical specialties or the waste materials derived from them,
p.(None): 7. Name or company name and seat of the authorization holder,
p.(None): 8. approval number,
p.(None): 9. Date of first approval or extension of approval,
p.(None): 10. Date of revision of the text,
p.(None): 11. for radioactive pharmaceutical specialties all additional details of the internal radiation dosimetry,
p.(None): 12. For radioactive pharmaceutical specialties, additional detailed instructions for the ex-temporane
...
p.(None): the placing on the market of a generic still fell under patent law.
p.(None): (6) The subject information as well as any changes to the subject information in accordance with Regulation (EC)
p.(None): № 1234/2008 or according to §§ 24 or 25 are from the Austrian Chamber of Pharmacists under
p.(None): To publish the participation of the Austrian Medical Association. The publication has the date of
p.(None): Creation of the subject information, in the event of a change in the subject information, the date of the last change
p.(None): exhibit.
p.(None): (7) The Federal Minister of Health and Women has to determine by decree which others
p.(None): Information that is important for the application must be included in the specialist information and
p.(None): more detailed provisions on the type of publication and the availability of the specialist information as well as on
p.(None): Changes to the same and, if necessary with regard to drug safety, about content,
p.(None): To issue the type and form of the information specified in paras. 2 and 3.
p.(None): leaflet
p.(None): Section 16. (1) Medicinal specialties that are in accordance with Section 7 of the approval or in accordance with Section 11a of the registration
p.(None): may only be placed on the market if the commercial pack is in accordance with
p.(None): In the summary of the product characteristics, instructions for use in German
p.(None): contains.
p.(None): (2) The package leaflet for medicinal products for human use has the following information in the following
p.(None): To contain the order in a generally understandable form:
p.(None): 1. the name of the medicinal product, followed by the strength and the dosage form; possibly
p.(None): whether it is intended for use by infants, children or adults; the
p.(None): Common names must be given if the medicinal product contains only one active ingredient
p.(None): and her name is a fancy name,
p.(None): 2. the pharmaceutical-therapeutic class or mode of action in one easy for the patient
p.(None): understandable form,
p.(None): 3. the areas of application,
p.(None): 4. Contraindications
p.(None): 5. appropriate precautions for use,
p.(None): 6. Interactions with other medicinal products and other interactions that affect the
p.(None): Effect of the drug specialty can impair,
p.(None): 7. special warnings,
p.(None): 8. The usual instructions required for proper use, in particular:
p.(None): a) Dosage (if necessary with the indication that it is only valid if the doctor or
p.(None): Dentist does not prescribe otherwise),
p.(None): b) the type and route of administration, if necessary,
p.(None): c) frequency of administration, if necessary with indication of the exact time at which the
p.(None): Drug specialty can or must be administered,
p.(None): d) duration of treatment, if this has to be limited,
p.(None): e) measures in the event of an overdose (e.g. symptoms, first aid measures),
p.(None): f) measures in the event that the administration of one or more doses has been omitted,
p.(None): g) where appropriate, indication of the risk that the withdrawal of the medicinal product
p.(None): Can trigger withdrawal symptoms,
p.(None): h) the express recommendation, if necessary the doctor or pharmacist to clarify the
p.(None): To consult the use of the medicinal product,
p.(None): 9. a description of the side effects that can occur when used as intended,
p.(None): and any countermeasures to be taken,
p.(None): 10. Reference to the expiry date stated on the packaging, as well
...
p.(None): Pharmaceutical safety is compatible, the Federal Minister of Health and Women can by ordinance
p.(None): considering the requirements of protecting human or animal health exceptions
p.(None): issued from the requirements of paragraphs 1 and 2.
p.(None): Obligations in connection with the package leaflet
p.(None): § 16c. (1) The authorization holder or the holder of a registration must ensure that the
p.(None): Package leaflet is available at the request of patient organizations in formats suitable for blind and
p.(None): visually impaired people are suitable.
p.(None): (2) The package leaflet has the results of cooperation with patient target groups
p.(None): reflect. The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): adopted to ensure the readability, clarity and user-friendliness of the package leaflet.
p.(None): Note for the following provision
p.(None): For the entry into force cf. Section 38 (2) of the Medicinal Products Regulations 2009, Federal Law Gazette II No. 41/2019 and Section 94i (2).
p.(None): Labelling
p.(None): Section 17. (1) Pharmaceutical specialties that are in accordance with Section 7 of the approval or in accordance with Section 11a of the registration
p.(None): are only allowed to be placed on the market unless they are radioactive pharmaceutical specialties
p.(None): if the following information is in German on the outer packaging and the primary packaging
p.(None): are included:
p.(None): 1. Name of the medicinal product, followed by the strength and the dosage form; where appropriate
p.(None): Indication of whether it is intended for use by infants, children or adults; contains the
p.(None): Pharmaceutical specialty up to three active ingredients, the international free name (INN) must be listed
p.(None): or, if this does not exist, the common name; this applies to veterinary specialties
p.(None): However, there is an obligation for such pharmaceutical specialties that do not contain more than one active ingredient
p.(None): 2. Name and address of the authorization holder,
p.(None): 3. approval number,
p.(None): 4. qualitative and quantitative composition of active ingredients according to dosage unit or depending on
p.(None): Form of administration for a given volume or weight using the
p.(None): common names,
p.(None): 5. pharmaceutical form and content according to weight, volume or dosage units,
p.(None): 6. List of auxiliary substances with known mode of action; for injectables, topical preparations
p.(None): or eye drops, however, all auxiliary substances must be specified,
p.(None): 7. Type and, if necessary, route of administration, with space for the prescription
p.(None): Provide dosing,
p.(None): 8. Special warning that the medicinal product is outside the reach and sight of
p.(None): To be kept by children
p.(None): 9. Special warning if this is required for the medicinal product in question,
p.(None): 10. unencrypted expiry date (month / year),
p.(None): 11. special precautions for storage, if applicable,
p.(None): 12. If necessary, special precautions for the disposal of unused ones
p.(None): Pharmaceutical specialties or the waste of pharmaceutical specialties as well as a reference to existing ones
p.(None): suitable collection systems,
p.(None): 13. batch name,
p.(None): 14. Areas of application for non-prescription medicinal products.
p.(None): (2) In addition to the information in paragraph 1, the marking of
p.(None): 1. Medicinal products for exclusive use on animals, a reference to it, and the
p.(None): Target species,
p.(None): 2. Medicinal specialties for use on animals from which medicinal products or foods are obtained
p.(None): the waiting time or the indication that no waiting time is required; the indication of the
p.(None): Waiting time for each affected animal species and for all affected foods, including
p.(None): those for which there is no waiting time to take place
p.(None): 3. Medicinal products for exclusive use on animals, from which no medicinal products or
p.(None): Foods are obtained, indicating that the medicinal product is only used on animals
p.(None): that are not used for the production of pharmaceuticals or food,
p.(None): to contain.
p.(None): (3) In addition to the information in accordance with Paragraphs 1 and 2, the label must contain at
p.(None): 1. Medicinal specialties, which according to the prescription law, BGBl. № 413/1972, only on prescription
p.(None): an indication that
p.(None): 2. Medicinal specialties, which may only be dispensed on a small scale in pharmacies, an indication that
p.(None): 3. Medicinal specialties that are only available in small pharmacies and from those mentioned in section 59 (3)
p.(None): Traders may be given an indication that
...
p.(None): Federal Office for Safety in Health Care, provided Austria at the request of the applicant as
p.(None): Reference Member State within the meaning of Article 28 (1) of Directive 2001/83 / EC, as amended by the
p.(None): Directives 2004/24 / EC and 2004/27 / EC, or Article 32 of Directive 2001/82 / EC, in the version of the
p.(None): Directive 2004/28 / EC, acts, an assessment report, a draft of the package leaflet and for
p.(None): to produce the label and to the applicant and the parties to the Agreement on the
p.(None): European Economic Area, to which the registration documents have been submitted.
p.(None): (5) The registration for registration concerns a traditional herbal medicinal specialty for which the
p.(None): Committee for Plant Medicinal Products a Community plant monograph in accordance with Article 16h (3)
p.(None): Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or
p.(None): a vegetable crop, a vegetable preparation, or a combination thereof, in the list
p.(None): vegetable substances, vegetable preparations or combinations thereof for use in traditional
p.(None): herbal medicinal products in accordance with Article 16f (1) of Directive 2001/83 / EC, as amended by the Directives
p.(None): 2004/24 / EG and 2004/27 / EG, are included, paragraphs 1 and 2 apply.
p.(None): § 18b. (1) The competent national authority within the meaning of Regulation (EC) № 726/2004 is the Federal Office
p.(None): for healthcare security.
p.(None): (2) Competent national authority within the meaning of Regulation (EC) № 1901/2006 of the European
p.(None): Parliament and of the Council of 12 December 2006 on medicinal products for children and amending the
p.(None): Regulation (EEC) № 1768/92, the directives 2001/20 / EG and 2001/83 / EG as well as the regulation (EG)
p.(None): No. 726/2004 is the Federal Office for Safety in Health Care.
p.(None): (3) Does the Federal Office for Safety in Health Care get into the procedure for approval or
p.(None): the change in the approval of a pharmaceutical specialty to the conclusion that the submitted documents are not included
p.(None): this is the same as the pediatric investigation plan approved by the Agency's Pediatric Committee
p.(None): with notice. If necessary, an opinion of the Pediatric Committee is required
p.(None): Article 23 of Regulation (EC) No. 1901/2006 to be taken into account.
p.(None): (4) Competent national authority within the meaning of Regulation (EC) № 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and
p.(None): Amendment to Directive 2001/83 / EC is the Federal Office for Safety in Health Care.
p.(None): Rejection of an application for admission
p.(None): § 19. (1) An application for approval of a pharmaceutical specialty is by the Federal Office for Security in the
p.(None): Health care refuse if
p.(None): 1. the applicant is not entitled to apply in accordance with § 9,
p.(None): 2. the application contains incorrect or incomplete information or the information provided in §§ 9a to 9f
p.(None): approval documents to be provided contain incorrect information, prove to be incomplete or for
p.(None): the assessment of the pharmaceutical specialty proves to be insufficient,
p.(None): 3. it according to the current state of scientific knowledge and the practical
p.(None): Experience does not appear to be certain that the medicinal specialty even when used as intended
...
p.(None): required notices
p.(None): required. After these statements have been received by the Federal Office for Safety in Health Care, the
p.(None): Authorized in the sense of Z 2 as authorization holder or registration holder of the pharmaceutical specialty. He kicks
p.(None): in all rights and obligations in connection with the admission or registration of the
p.(None): Drug specialty available.
p.(None): Selling periods after change or transfer of rights
p.(None): Section 25a. (1) Medicinal products to which changes according to Regulation (EC) № 1234/2008 or
p.(None): 24 or 25 may be carried out without this change
p.(None): 1. by the pharmaceutical company within one year after official approval or
p.(None): Notification of this change,
p.(None): 2. by others authorized to dispense until the expiry date of the medicinal product
p.(None): placed on the market unless this transition period is for reasons of medicinal product safety
p.(None): not justifiable.
p.(None): (2) Holders of a license for distribution in parallel import have all to protect the
p.(None): Conformity within the meaning of § 10c necessary changes within the period that the
p.(None): pharmaceutical entrepreneurs according to paragraph 1 is granted to understand.
p.(None): batch release
p.(None): § 26. (1) The batch release is subject to the following intended for use on or in humans
p.(None): Proprietary Medicinal Products:
p.(None): 1. Medicinal products that use human blood or blood plasma as a source ff
p.(None): were produced, as well
p.(None): 2. immunological medicinal specialties consisting of vaccines, toxins, sera or allergens,
p.(None): as far as this is concerned
p.(None): a) live vaccines,
p.(None): b) used for primary immunization of young children or other risk groups
p.(None): Drug,
p.(None): c) used in immunization programs in the context of public health
p.(None): Medicines, or um
p.(None): d) deals with medicinal products that are newly approved or manufactured using new techniques
p.(None): or are new to a particular manufacturer. These medicinal specialties are subject to the
p.(None): Batch release for a transition period to be specified.
p.(None): For medicinal specialties of Z 2 lit. d has the Federal Office for Safety in Health Care by notice
p.(None): to determine whether the respective pharmaceutical specialties are new and for what period or what number of
p.(None): Batches are subject to batch inspection.
p.(None): (2) Batch release is subject to certain immunological conditions for use on or in animals
p.(None): Medicinal specialties that consist of vaccines, toxins, sera or allergens and for the defense against
p.(None): Notifiable animal diseases according to § 16 animal diseases law, RGBl. No. 177/1909.
p.(None): (3) Pharmaceutical specialties in accordance with paragraphs 1 and 2 may be without prejudice to the provisions on approval
p.(None): of medicinal products in Germany can only be delivered or kept ready for delivery if by a
p.(None): a testing institute designated by the Federal Minister for Health and Women was determined,
p.(None): that the batch conforms to the speci fi cations approved in the approval, in the case of non-approved
p.(None): Medicinal specialties correspond to the state of the art in science and technology. The decision has been made by
p.(None): the designated institute within 60 days of submitting an application and the
p.(None): necessary documents to be made. The applicant must be informed immediately. comes
...
p.(None): was given in writing,
p.(None): 4. The minor before the start of the clinical trial by someone dealing with minors
p.(None): experienced auditor has received an explanation appropriate to his ability to understand this,
p.(None): 5. the consent of the minor who is able to understand the essence, the meaning, the
p.(None): To see the scope and risks of the clinical trial and to determine his will accordingly,
p.(None): has been demonstrably granted, and it is ensured that the expressly by a minor
p.(None): expressed desire not to take the clinical trial or take it at any time
p.(None): to be considered by the examiner
p.(None): 6. The consent can be withdrawn at any time without the minor being affected
p.(None): Disadvantage arises
p.(None): 7. with the participation in the clinical trial, no incentives or financial benefits
p.(None): Exception to an expense allowance,
p.(None): 8. the clinical trial is planned so that it takes into account the disease and the
p.(None): Developmental stage of the minor with as little pain, discomfort, fear and
p.(None): other predictable risks, including the risk threshold as well as the
p.(None): Degree of exposure specifically defined and constantly checked,
p.(None): 9. The test plan by an ethics committee that has knowledge in the field of children and
p.(None): Juvenile medicine or who deals with clinical, ethical and psychosocial issues on the
p.(None): Had been advised in the area of pediatrics and adolescent medicine, and was approved
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of
p.(None): Science stand.
p.(None): (2) Deviating from Paragraph 1 No. 2, a clinical trial on minors is also permitted if
p.(None): 1. The clinical trial is an essential extension of the scientific understanding of the
p.(None): Condition, illness or disorder of the minor and thereby either
p.(None): Can benefit patients or the patient group to which the minor belongs, and
p.(None): 2. The clinical trial for the minor with only a minimal risk and minimal burden
p.(None): brings oneself; a clinical trial has minimal risk and minimal burden if
p.(None): it is to be expected that at most it will be a minor and merely temporary
p.(None): Impairment and the symptoms or inconvenience at best only
p.(None): could occur temporarily and will be very minor.
p.(None): § 43. (1) The clinical trial on an adult who is due to a mental illness or
p.(None): a comparable impairment of their ability to make decisions regarding representation regarding medical
...
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 38 and
p.(None): 39 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Education is given. Further processing of the personal data collected up to that point is required
p.(None): the express data protection consent.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 42 or § 43.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 44. (1) The clinical trial of a medicinal product may only be carried out on a pregnant woman if
p.(None): if
p.(None): 1. the drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in pregnant women or unborn children
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is with the pregnant woman on whom the clinical trial is being conducted or with her
p.(None): to recognize unborn child diseases or their course, to cure or to alleviate them or
p.(None): to protect them from diseases,
p.(None): 3. according to the knowledge of medical science, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): sufficient test results can be expected.
p.(None): (2) Paragraph 1 applies mutatis mutandis to clinical trials of medicinal products intended to be admission
p.(None): to allow pregnancy.
p.(None): Section 45. (1) The clinical trial of a medicinal product may be carried out on persons who have a presence or
p.(None): Provide training service, not be carried out.
p.(None): (2) The clinical trial of a medicinal product may be carried out on persons who are judicial or official
p.(None): Order stopped or accommodated according to the Accommodation Act, not carried out
p.(None): become.
p.(None): Dealing with data
p.(None): Section 46. (1) On the part of the sponsor, monitor and examiner, appropriate measures are necessary for careful
p.(None): and confidential handling of all data resulting from a clinical trial.
...
p.(None): (3) In addition to para. 2, lay advertising for traditional herbal medicinal specialties has a written one
p.(None): Note to contain that this is a traditional herbal medicinal specialty for use in a
p.(None): specific area of application or certain areas of application exclusively due to long-term
p.(None): Use.
p.(None): (4) lay advertising does not have to meet the requirements of paragraph 2 if the advertising
p.(None): consists exclusively of the name of a medicinal specialty (souvenir advertising), unless it acts
p.(None): are advertising for pharmaceutical specialties that serve to increase athletic performance. The notice according to
p.(None): Paragraph 2 no. 3 is to be included if the reminder advertising is via posters, advertisements or acoustic or
p.(None): audiovisual media.
p.(None): Section 53. (1) Lay advertising may not contain any elements that
p.(None): 1. pictorial representations in connection with members of the health professions or institutions of the
p.(None): Health care,
p.(None): 2. make a medical examination or a surgical procedure seem superfluous,
p.(None): in particular by offering a diagnosis or treatment on the
p.(None): Recommend correspondence,
p.(None): 3. suggest that the effect of the drug is guaranteed without side effects or one
p.(None): corresponds to or is superior to another treatment or another medicinal product,
p.(None): 4. suggest that the normal good health of the patient through the use of the drug
p.(None): could be improved
p.(None): 5. suggest that the normal good health of the patient in the event of non-use of the
p.(None): Drug could be affected
p.(None): 6. are intended exclusively or mainly for children,
p.(None): 7. on the recommendation of scientists, health professionals or
p.(None): Refer to people who, based on their popularity, could stimulate drug consumption,
p.(None): 8. The medicinal product is a food, cosmetic product or other consumer goods
p.(None): equate
p.(None): 9. suggest that the safety or efficacy of the medicine is due to the fact that it is
p.(None): act as a "natural product",
p.(None): 10. through a detailed description or presentation of the medical history of a wrong one
p.(None): Could lead to self-diagnosis,
p.(None): 11. Abusive, worrying, or misleading
p.(None): Get recovery certificates,
p.(None): 12. Abusive, worrying or misleading images of the
p.(None): Changes in the human or animal body due to diseases or
p.(None): Damage or the effect of a drug in the human body or in parts of the body
p.(None): use,
p.(None): 13. work towards obtaining prescription drugs at a distance.
p.(None): (2) Lay advertising may contain a reference to the admission or registration, provided that
p.(None): only the fact of admission or registration is referred to and such
p.(None): Note is not likely to mislead consumers in terms of safety and security
p.(None): Effectiveness of the medicinal product in question.
p.(None): (3) The supply of samples or samples of medicinal products or vouchers for this is not permitted.
p.(None): Likewise, the running of competitions is not permitted, provided that this is in connection with the
p.(None): Dispensing of drugs are available.
p.(None): professional advertising
p.(None): Section 54. (1) Pharmaceutical advertising intended for those authorized to use and dispense
p.(None): is, provided it
p.(None): 1. is operated for a medicinal specialty for which a specialist information (summary
...
Social / Elderly
Searching for indicator elderly:
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p.(None): to whom an advisory body is concerned, this period is extended by a further 90 days.
p.(None): (8) For a clinical trial in connection with drugs for gene therapy apply in addition to
p.(None): Provisions of this federal law meet the requirements of sections 74 to 79 of the Genetic Engineering Act.
p.(None): ethics committees
p.(None): Section 41. (1) The governor has clinical trials outside of hospitals
p.(None): To ensure that an ethics committee for the perception of the
p.(None): Tasks according to § 41a is set up and all necessary measures are taken to this
p.(None): Ethics committee to enable the work. The members of the ethics committee are allowed to participate in this
p.(None): Activity is not subject to any instructions.
p.(None): (2) The ethics committee has a balanced relationship between women and men
p.(None): to assemble and at least consist of:
p.(None): 1. a doctor who is authorized to practice the profession independently in Germany and is not the examiner,
p.(None): 2. a specialist in whose specialty the respective clinical trial falls, or, if applicable, one
p.(None): Dentist, and who are not examiners,
p.(None): 3. a representative of the superior service for health and nursing,
p.(None): 4. a lawyer,
p.(None): 5. a pharmacist,
p.(None): 6. a patient representative,
p.(None): 7. a representative of a representative organization for the disabled and a representative of the elderly,
p.(None): which belongs to a senior citizen organization in accordance with the Federal Senior Citizens Act, Federal Law Gazette I No. 84/1998,
p.(None): 8. a person with biometric expertise and
p.(None): 9. Another person who does not fall under Z 1 to 8 and who is concerned with pastoral care
p.(None): Is entrusted with matters or otherwise has the appropriate ethical competence.
p.(None): An equally qualified representative must be appointed for each member.
p.(None): (3) The members of the ethics committee and their representatives have any relationships with
p.(None): pharmaceutical industry completely open to the governor. You have yours
p.(None): To act in the ethics committee in all matters involving a relationship with
p.(None): pharmaceutical industry is likely to question its full impartiality.
p.(None): (4) The governor is entitled to a contribution from the sponsor in accordance with the
p.(None): Experience has shown that the costs of an assessment in the context of a clinical assessment are on average
p.(None): To request examination.
p.(None): Section 41a. (1) The in execution of § 8c of the Federal Act on Hospitals and Health Centers
p.(None): according to state law provisions, those according to university law provisions and those according to § 41
p.(None): Ethics committees set up have the rules on the procedure contained in paras. 2 to 7
p.(None): to be observed and in particular to be taken into account in their comments:
p.(None): 1. the relevance of the clinical trial and its planning,
p.(None): 2. the adequacy of the assessment of the expected benefits and the
p.(None): expected risks,
p.(None): 3. the test plan,
...
Social / Incarcerated
Searching for indicator restricted:
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p.(None): BGBl. I No. 100/2018 (NR: GP XXVI RV 329 AB 413 p. 57. BR: 10079 AB 10082 p. 888.)
p.(None): BGBl. I No. 104/2019 (NR: GP XXVI IA 985 / A AB 692 p. 88. BR: AB 10252 p. 897.)
p.(None): text
p.(None): I. SECTION
p.(None): General provisions
p.(None): definitions
p.(None): § 1. (1) "Medicinal products" are substances or preparations from substances that
p.(None): 1. for use in or on the human or animal body and as an agent with properties for
p.(None): Cure or to alleviate or prevent human or animal diseases or
p.(None): pathological complaints are determined, or
p.(None): 2. applied in or on the human or animal body or a human or an animal
p.(None): can be administered to either
p.(None): a) the physiological functions through a pharmacological, immunological or metabolic
p.(None): Restore, correct or influence the effect, or
p.(None): b) to serve as the basis for a medical diagnosis.
p.(None): (2) Objects that contain a medicinal product or on which a medicinal product is considered a medicinal product
p.(None): is applied and which are intended for use on or in the human or animal body.
p.(None): (3) Are no drugs
p.(None): 1. Foodstuffs according to Art. 2 Para. 1 and 2 of Regulation (EC) № 178/2002 establishing the
p.(None): general principles and requirements of food law to establish the European
p.(None): Authority for Food Safety and for Establishing Food Safety Procedures, OJ.
p.(None): № L 31, 1.2.2002 p. 1, last amended by regulation (EG) № 596/2009, OJ. № L 188 from
p.(None): 18.7.2009 p. 14,
p.(None): 2. Utility articles and food additives in accordance with food law provisions,
p.(None): 3. cosmetic products in accordance with food law provisions, provided that they are used and
p.(None): Effects are restricted to the area of the skin and its appendages and the oral cavity,
p.(None): 4. Tobacco products according to the Tobacco Act, Federal Law Gazette No. 431/1995,
p.(None): 5. Feed, feed additives and premixes in accordance with the feed law regulations,
p.(None): 6. Materials or preparations made of materials used in dentistry and physically
p.(None): stable state have no pharmacological effect,
p.(None): 7. Natural healing deposits and products from a natural healing deposit in accordance with Section 42a (2)
p.(None): of the Federal Act on Hospitals and Health Centers, Federal Law Gazette № 1/1957, unless their
p.(None): Composition was changed by the addition of substances with an influence on the effectiveness,
p.(None): or, based on the sciences, undesirable even when used as intended
p.(None): Effects in humans are expected
p.(None): 8. Materials or preparations made from materials that are used only for prophylactic purposes
p.(None): To ward off, eliminate or harm pathogens, parasites or foreign substances
p.(None): to make, provided their application and effect on healthy skin and its appendages
p.(None): are limited and unless they are for use on patients before surgery or others
p.(None): medical interventions that require skin disinfection are intended,
p.(None): 9. Materials or preparations made from materials that are intended exclusively for
p.(None): complementary medical methods to be used, provided that they neither serve nor
p.(None): are intended to fulfill the purpose of paragraph 1, unless it concerns
p.(None): Stumps or preparations from stumps that are made according to homeopathic principles and
p.(None): Process technologies are produced,
...
p.(None): Health care to the applicant within 60 days of receipt of the documents in accordance with paragraph 1
p.(None): Announces operational review, the activity may only after approval by the Federal Office for Security in the
p.(None): Healthcare will be included. The Federal Office for Safety in Healthcare comments
p.(None): not within 60 days, the application is considered approved. If the requirements for a permit
p.(None): are not fulfilled, the Federal Office for Safety in Health Care has to state this with a decision.
p.(None): (3) Any changes that affect the quality or safety of the manufactured, in circulation
p.(None): brought or controlled active ingredients, require a permit from the Federal Office for
p.(None): Healthcare security.
p.(None): (4) Sections 64 to 66a, 67 (1) regarding periodic reviews, 69 and 71 apply to companies
p.(None): in accordance with Paragraph 1.
p.(None): Section 64. (1) The permit pursuant to Section 63 (1) is to be issued if the operating rules are complied with
p.(None): and due to the equipment, the necessary for the health and life of humans or animals
p.(None): The quality of the pharmaceuticals or active ingredients is guaranteed.
p.(None): (2) The Federal Office for Safety in Health Care can also order a trial operation if
p.(None): this is necessary to assess the existence of the prerequisites within the meaning of paragraph 1.
p.(None): (3) If necessary, the license must be issued stipulating such conditions as to
p.(None): Fulfillment necessary for the protection of human and animal health and life
p.(None): Ensure the nature of the drug or active ingredients
p.(None): (4) The Federal Office for Safety in Health Care can also issue a restricted permit in the
p.(None): Issue within the meaning of section 63 (1) if the conditions for granting such a license are only given in
p.(None): to this limited extent.
p.(None): (5) The Federal Office for Safety in Health Care has the data on the authorization for
p.(None): Manufacture and placing on the market of medicinal products or active substances in accordance with section 63 (1) and section 63a (2)
p.(None): or 3 or Section 65 (1) in the Union database in accordance with Article 111 (6) of Directive 2001/83 / EC
p.(None): enter.
p.(None): Section 65. (1) Significant changes with regard to manufacturing, placing on the market or control
p.(None): the medicinal products or active substances, in particular with regard to the information in accordance with section 63 (2) lines 1 to 3, the
p.(None): Effects on the nature of drugs or active ingredients or the production or
p.(None): Distribution program require the approval of the Federal Office for Security in the
p.(None): Healthcare system within the meaning of Section 63 (1). The Federal Office for Healthcare Safety has over
p.(None): to decide a corresponding application within 30 days of receipt of the application. This
p.(None): In exceptional cases, the deadline can be extended to 90 days.
p.(None): (2) The Federal Office for Safety in Health Care can provide the applicant with additional information
p.(None): with regard to the requested change in accordance with paragraph 1. In this case, the deadlines are set according to
p.(None): Paragraph 1 inhibited until additional information is received.
p.(None): (3) The holder of the license pursuant to Section 63 (1) or Section 65 (1) has all intended changes
p.(None): in relation to the knowledgeable person to the Federal Office for Health Safety in advance
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): Pharmaceutical specialty is authorized or registered and in which it is distributed (home Member State),
p.(None): 5. the name and the approval or registration number of the medicinal product in the
p.(None): Member State of origin
p.(None): 6. the name and address of the authorization holder in the home Member State,
p.(None): 7. where applicable, the name and address of the manufacturer in the home Member State,
p.(None): 8. the type of packaging of the imported medicinal product,
p.(None): 9. the pack sizes intended for distribution in Austria,
p.(None): 10. the description of the process of re-labeling or repacking,
p.(None): 11. the name and address of the person who will carry out the re-labeling or repackaging
p.(None): company
p.(None): 12. A statement that the texts for the outer packaging, primary packaging, and where appropriate
p.(None): Package leaflet and technical information except for speci fi c information as well as information on
p.(None): Avoidance of senselessness no textual deviations from the labeling,
p.(None): where applicable, package leaflet and specialist information for those authorized or
p.(None): have registered pharmaceutical specialty and
p.(None): 13. A description of the pharmacovigilance and, if necessary, the risk management system
p.(None): the applicant will introduce.
p.(None): (4) Pharmaceutical specialties that have been granted an authorization in accordance with Regulation (EC) № 726/2004 and
p.(None): Paragraph 1 lines 2 and 3 may only be placed on the market if they are in German
p.(None): Labeling and instructions for use are provided and there is German-language technical information
p.(None): and a notification to the agency and the Federal Office for Safety in Health Care has been made beforehand.
p.(None): This message must contain:
p.(None): 1. proof of the right to apply in accordance with § 9,
p.(None): 2. Name and registration number of those approved according to Regulation (EEC) № 726/2004
p.(None): Medicinal product,
p.(None): 3. the party to the Agreement on the European Economic Area in which the imported
p.(None): Drug specialty is distributed (home Member State),
p.(None): 4. the name and address of the authorization holder,
p.(None): 5. the name and address of the manufacturer,
p.(None): 6. the pack sizes intended for distribution in Austria,
p.(None): 7. A declaration that the texts for outer packaging, primary packaging, instructions for use and
p.(None): Specialist information, apart from company-specific information, no textual deviations from the
p.(None): Labeling, instructions for use and specialist information according to the regulation (EWG)
p.(None): No. 726/2004 approved pharmaceutical specialty.
p.(None): To the agency is a fee for checking compliance with the conditions set out in Union law
p.(None): Medicines and are specified in the marketing authorizations. their
p.(None): Dimensioning is based on Union law regulations.
p.(None): (5) The applicant is obliged to submit the application pursuant to paragraph 3 to the authorization holder
p.(None): or owner of the registration. The same applies to the notification according to paragraph 4.
...
Social / Marital Status
Searching for indicator single:
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p.(None): to fulfill.
p.(None): (19) "Effect" is an influenceable influence of the
p.(None): Condition or function of a biological object.
p.(None): (20) 'Central procedure' is one for the Member States of the European Union through the Regulation
p.(None): (EG) № 726/2004, OJ. № L 136/1 of March 31, 2004, established procedure for the approval of certain
p.(None): Medicinal specialties, that for medicinal products covered by the annex to the aforementioned regulation
p.(None): compulsory for pharmaceutical specialties covered by Article 3 Paragraph 2 of the Ordinance on request as required
p.(None): the requirements mentioned there apply.
p.(None): (21) 'Intermediate' is a medicinal product that is still in one or more manufacturing phases
p.(None): needs to become bulk goods.
p.(None): Definitions regarding clinical trials
p.(None): § 2a. (1) "Clinical Trial" is a systematic examination of a drug on one
p.(None): Test taker that is conducted with the goal
p.(None): 1. to research or prove the effects of investigational medicinal products,
p.(None): 2. determine side effects of investigational medicinal products, or
p.(None): 3. absorption, distribution, metabolism and excretion of investigational medicinal products
p.(None): investigate.
p.(None): This includes clinical trials conducted in one or more test centers in one or more
p.(None): Contracting parties to the European Economic Area. No clinical trial is one
p.(None): Non-interventional study within the meaning of paragraph 3.
p.(None): (2) “Multicentre clinical trial” is a clinical trial conducted under a single trial plan
p.(None): Examination that takes place in more than one test center and is therefore carried out by more than one examiner
p.(None): the test centers are located in a single or in several contracting parties to the European
p.(None): Economic area or in contracting parties and third countries.
p.(None): (3) "Non-interventional study" is a systematic examination of approved pharmaceutical specialties
p.(None): to patients, provided
p.(None): 1. the pharmaceutical specialty only among those mentioned in the approval or registration
p.(None): Conditions is used
p.(None): 2. The non-interventional study does not require additional diagnostic or therapeutic measures
p.(None): makes necessary and does not involve any additional burdens on the patient, and
p.(None): 3. The application of a particular treatment strategy is not set out in advance in a test plan
p.(None): it corresponds to medical practice and the decision to prescribe the
p.(None): Drug specialty is clearly separated from the decision to include a patient in the study.
p.(None): Epidemiological methods are used to analyze the data collected. Not-
p.(None): interventional studies are to be planned and carried out according to the state of the art in science.
p.(None): (4) "Final Report" is a complete and detailed account of the clinical trial
p.(None): their termination.
p.(None): (5) "Audit" is a comparison of the raw data with the corresponding records in the test sheets
p.(None): to determine whether the raw data were reported correctly and the conduct of the clinical trial
p.(None): was carried out in accordance with the test plan and the standard operating procedures (SOPs).
p.(None): An audit must be carried out either by an internal sponsor unit, but independently of that unit
p.(None): that is responsible for clinical research or through an external scientific
p.(None): Establishment to be carried out.
p.(None): (6) "Ethics Committee" is an independent body consisting of members of
...
p.(None): 1. the manufacturer if he sponsors an approved clinical trial for the medicinal product in question
p.(None): is, or
p.(None): 2. the applicant for a marketing authorization pursuant to Article 6 of the Regulation
p.(None): No. 726/2004 for the medicinal product in question.
p.(None): (3) The Federal Minister of Health may, by ordinance, provide more detailed regulations on the procedure
p.(None): to authorize the placing on the market of a medicinal product as part of a “Compassionate use
p.(None): Program ”as far as this is necessary to protect the health of patients.
p.(None): (4) The holder of an authorization for the implementation of a "Compassionate use program"
p.(None): ensure that the medicinal product is included in the patients included in the program even after the
p.(None): Granting of marketing authorization until the actual marketing is available
p.(None): is provided.
p.(None): Application for Admission
p.(None): § 9. (1) The following are entitled to apply for approval or to register a pharmaceutical specialty:
p.(None): 1. a trader who, on the basis of the 1994 Trade Ordinance, is responsible for the manufacture of the
p.(None): Is wholesaling with the pharmaceutical specialty in question, or
p.(None): 2. an operator of a domestic public pharmacy, or
p.(None): 3. one in another party to the Agreement on the European Economic Area
p.(None): resident pharmaceutical entrepreneur who is authorized to sell the pharmaceutical specialty in question
p.(None): To bring traffic.
p.(None): (2) A separate application is required for each pharmaceutical form, composition, strength and type of application
p.(None): put.
p.(None): (3) For radioactive medicinal products containing a radionuclide, a single application is for one
p.(None): Range of radioactivity levels sufficient.
p.(None): (4) For medicinal products that are dental medicines and are only in color
p.(None): Make a difference, provided that the respective color does not affect the effectiveness, durability or
p.(None): A single application is sufficient to tolerate the medicinal product.
p.(None): Note for the following provision
p.(None): For the reference period cf. § 94h.
p.(None): Approval documents
p.(None): § 9a. (1) The following must be attached to an application for admission:
p.(None): 1. Name or company name and registered office of the applicant and if the applicant is not with the manufacturer
p.(None): is identical, name or company and registered office of the manufacturer, as well as proof of authorization to
p.(None): Application,
p.(None): 2. Name of the pharmaceutical specialty,
p.(None): 3. Composition by type and amount of all components of the medicinal product, including the
p.(None): Mention of the international free name (INN) recommended by the World Health Organization,
p.(None): if there is an INN for the medicinal product or the relevant chemical name,
p.(None): 4. Assessment of the possible environmental risks of the pharmaceutical specialty; precautions must be taken if necessary
p.(None): to provide and justify their limitation,
p.(None): 5. Information about the manufacturing process,
p.(None): 6. Draft of the intended labeling according to § 17 (mock-up),
p.(None): 7. Draft the intended package leaflet according to § 16,
p.(None): 8. Technical information (summary of product properties - SmPC) according to § 15,
p.(None): 9. at the request of the authority, a sample of the outer packaging,
p.(None): 10. reasons for possible precautionary and safety measures when storing the medicinal product,
p.(None): their administration to patients and the disposal of the waste products (together with an indication
p.(None): potential risks that the pharmaceutical specialty poses to the environment),
p.(None): 11. information on the controls envisaged during manufacture,
...
p.(None): Approved Summary of Product Features (SmPC) and Package Leaflet;
p.(None): 4. The details of all decisions to refuse approval in another
p.(None): Contracting party to the European Economic Area or in a third country and the reasons for this
p.(None): Decision and
p.(None): 5. the copy of the designation of the medicinal product as an orphan medicinal product according to the
p.(None): Regulation (EC) № 141/2000 on orphan medicinal products, OJ. № L 18 from 01/22/2000 p.
p.(None): 1, as amended by Regulation (EC) No. 596/2009, OJ. L 188 from 07/18/2009 p. 14.
p.(None): (6) If the medicinal product is only to be exported, the applicant must contact
p.(None): Submitting the application in writing to make a declaration that the medicinal product is not domestically in
p.(None): Is placed on the market.
p.(None): (7) The applicant is responsible for the accuracy of the information provided and the documents submitted
p.(None): responsible.
p.(None): § 9b. (1) An application for approval of a homeopathic medicinal specialty must include documents
p.(None): according to § 9a paragraph 1 lines 18 to 20 are not included. Furthermore, documents according to Section 9a (2) are not
p.(None): enclosed, however
p.(None): 1. documents that are important for the toxicological assessment of the medicinal product, and
p.(None): 2. Documents on the speci fi c homeopathic or, if applicable, on the speci fi c one
p.(None): anthroposophical effectiveness
p.(None): to join.
p.(None): (2) For homeopathic medicinal products, which are produced by dilution of only one substance
p.(None): a single application is sufficient for the substance and its dilutions.
p.(None): § 9c. An application for approval of a pharmaceutical specialty, which is a monograph of the pharmacopoeia in the
p.(None): The meaning of Section 1 of the Pharmacopoeia Act 2012 does not, however, meet the requirements of Section 7 (2)
p.(None): fulfilled, is not mentioned in Section 7 (9) and is not subject to registration in accordance with Section 12, documents must be provided
p.(None): 8, 12 to 15, 18 to 21, 24 to 27 and 29 to 31 may not be added in accordance with Section 9a (1) no. documents
p.(None): According to § 9a para. 1 no. 5 and 11, the application only has to be attached if during the production and
p.(None): Testing other methods or devices are used than described in the pharmacopoeia
p.(None): are.
p.(None): § 9d. Section 9a does not apply to medicinal specialties within the meaning of Section 7 (9) lines 2 and 3, which are based on a monograph of
p.(None): Pharmacopoeia in the sense of § 1 of the Pharmacopoeia Act. An application for admission to a
p.(None): such a medicinal product, documents according to § 9a paragraph 1 lines 1 to 9 as well as 14 and 15 are to be attached.
p.(None): § 9e. An application for approval of a generator must be submitted in addition to the documents pursuant to Section 9a
p.(None): to connect the following documents:
p.(None): 1. a general description of the system with a detailed description of the components of the
p.(None): Systems that can influence the composition or quality of the daughter nuclide preparation
p.(None): and
p.(None): 2. Information on the qualitative and quantitative peculiarities of the eluate or sublimate.
p.(None): Reference approval
p.(None): Section 10. (1) Notwithstanding Section 9a (1) lines 19, 20 and 28, the applicant is not obliged to:
...
p.(None): Application for approval has been received and the sponsor immediately, but at the latest within five working days
p.(None): to inform about it after receipt of the application.
p.(None): (4) The Ethics Committee must give the sponsor the opportunity to attend the
p.(None): Submit an opinion to the assessment fields mentioned in paragraph 1.
p.(None): (5) The Ethics Committee has sent its reasoned opinion to the sponsor within 35
p.(None): Days from the reporting date. The ethics committee has to ensure that the in
p.(None): Paragraph 6 deadline is met. This does not apply to applications within the meaning of Section 40 (6).
p.(None): (6) The Ethics Committee has the sponsor within 60 days and the Federal Office for
p.(None): Healthcare safety within 50 days of receiving a proper application
p.(None): to provide a reasoned opinion. For applications within the meaning of section 40 (6), the
p.(None): Deadlines in accordance with Section 40 (7).
p.(None): (7) During the examination of the application, the ethics committee may only make one additional decision
p.(None): Request information on the information already submitted by the applicant. The in paragraphs 5 and 6
p.(None): scheduled deadlines will be delayed until additional information is received.
p.(None): Multi-center exams
p.(None): Section 41b. (1) For multicentre examinations, the opinion of a single Austrian
p.(None): Ethics committee sufficient. The sponsor has to deal with an ethics committee that the through
p.(None): Ordinance of the Federal Minister of Health and Women meets specific requirements.
p.(None): This regulation has in particular
p.(None): 1. the organizational framework,
p.(None): 2. the circumstances relevant to the assessment of the necessary extensive experience, and
p.(None): 3. the internal quality assurance measures
p.(None): to consider.
p.(None): (2) Ethics committees that aim to work in the context of multicentre examinations have this
p.(None): the Federal Ministry of Health and Women with proof of the required according to paragraph 1
p.(None): Prerequisites to report. The Federal Minister of Health and Women has the ethics committees that
p.(None): meet the requirements set out in paragraph 1 of publishing in the official gazette of the Wiener Zeitung.
p.(None): (3) In the case of a multi-center examination, the sponsor has one of those announced in accordance with paragraph 2
p.(None): Select ethics committees that are responsible for one of the test centers. Is not one of the paragraph 2
p.(None): made known ethics committees responsible for one of these test centers or refuses to accept them
p.(None): of an application in accordance with paragraph 4, the sponsor can use the information published in accordance with paragraph 2
...
p.(None): serve,
p.(None): 6a. the Federal Ministry of the Interior, the authorities and childcare facilities subordinate to it
p.(None): for emergency care, prevention and care of operations, provided that the medicines for
p.(None): Need to perform their duties
p.(None): 7. Institutions, the provisional judicial safekeeping or arrests, judicial
p.(None): Prison sentences or preventive judicial measures related to deprivation of liberty
p.(None): Take measures if they need drugs to perform their tasks
p.(None): 8. scientific institutes and research institutes of the local authorities and the
p.(None): Universities and the Austrian Agency for Health and Food Security, if these
p.(None): Need medicines to perform their tasks
p.(None): 9. Organized emergency medical services, provided they are addictive substances, which they use for their emergency medical services
p.(None): Need activity, and
p.(None): 10. Have a doctor who is sufficiently familiar with questions of substance abuse
p.(None): Institutions according to § 15 of the Addictive Substances Act, Federal Law Gazette I № 112/1997, for evidence-based and
p.(None): quality-assured support for clients as part of damage minimization measures,
p.(None): except drugs containing addictive substances.
p.(None): (2) At hospitals without institutional pharmacies, the manufacturer, depositeur or pharmaceutical
p.(None): Wholesalers are given:
p.(None): 1. whole blood preserves, suspensions of cellular or corpuscular blood components,
p.(None): Single donor preparations,
p.(None): 2. native human or animal tissue.
p.(None): (3) Paragraphs 1 and 2 do not apply to radioactive medicinal products. These may be from the manufacturer, depositeur
p.(None): or pharmaceutical wholesalers only to holders of a license to handle radioactive materials
p.(None): according to the Radiation Protection Act, Federal Law Gazette No. 227/1969.
p.(None): (4) Feed medicines may be purchased from the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): Prescription of the treating veterinarian can be given directly to consumers. The repeated
p.(None): Delivery on a prescription is not permitted.
p.(None): (5) Paragraph 1 does not apply to pharmaceutical specialties according to § 7 Paragraph 4 and § 59 Paragraph 7a.
p.(None): (6) From the manufacturer, depositeur or pharmaceutical wholesaler, medicinal products whose delivery in
p.(None): Retail sales are not reserved for pharmacies, directly to bandagists, orthopedic shoemakers,
p.(None): Orthopedic technician, dental technician, podiatrist, holder of a hoof and
p.(None): Claw fittings and massage therapists are given, provided they are medicinal products
p.(None): Traders need for the exercise of their activity.
p.(None): (7) From the manufacturer, depositeur or pharmaceutical wholesaler, dental medicinal products that
p.(None): 1. are not subject to the prescription requirement and
p.(None): 2. are exclusively intended by dentists, specialists in dentistry, oral and maxillofacial medicine
p.(None): or being applied to the patient by dentists,
p.(None): are given directly to them and to dental outpatients.
p.(None): (8) Medical gases may come from the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): Hospitals without a pharmacy and to traders who are in accordance with the
...
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p.(None): (23) “Plant-based medicinal products” are all medicinal products that act exclusively as one or more active substances
p.(None): vegetable substances or one or more vegetable preparations or one or more such
p.(None): contain vegetable substances in combination with one or more such herbal preparations.
p.(None): (24) "Traditional herbal medicinal product specialty" is a herbal medicinal product that complies with the requirements of § 12
p.(None): specified conditions met.
p.(None): (25) 'Counterfeit medicinal product' means any medicinal product that has been counterfeited:
p.(None): 1. its identity, including its packaging and labeling, its name or its
p.(None): Composition related to any ingredient, including excipients and content
p.(None): of these components, or
p.(None): 2. its origin, including manufacturer, country of manufacture, country of origin and marketing authorization holder, or
p.(None): Registration holder, or
p.(None): 3. the records and documents related to the distribution channels used.
p.(None): (26) 'Counterfeit active substance' is an active substance in which the following has been falsified:
p.(None): 1. its labeling on the container with regard to the actual content, or
p.(None): 2. the records and documents in connection with the manufacturers involved or the
p.(None): distribution channels used.
p.(None): § 2. (1) "Users" are doctors, dentists, veterinarians, dentists, midwives, members of the
p.(None): Nursing, medical and technical services and first aid services and
p.(None): Legal entities of hospitals without their own institutional pharmacy and other medical facilities, insofar as
p.(None): need these medicines to do their job.
p.(None): (2) "pharmaceutical wholesaler" is a trader who, based on the 1994 Industrial Code,
p.(None): Federal Law Gazette № 194, is entitled to wholesale pharmaceuticals and has a corresponding license
p.(None): in accordance with section 63 (1), as well as a pharmaceutical company of another contracting party of the
p.(None): Agreement on the European Economic Area, which is authorized to wholesale pharmaceuticals
p.(None): float.
p.(None): (3) "pharmaceutical wholesaler" is a pharmaceutical wholesaler, according to which sufficient
p.(None): Warehousing, a corresponding assortment design and a corresponding
p.(None): Willingness, regularity and intensity of care, capable of supplying drugs in the sense
p.(None): of § 57 in a certain area.
p.(None): (3a) "Mediator" is one in a contracting party to the European Economic Area
p.(None): resident person authorized to act as a mediator of medicinal products for human use.
p.(None): (3b) "Bulkware" is a medicinal product that only needs to be filled or packaged to
p.(None): To become the final product.
p.(None): (4) “Batch” is the quantity of a drug manufactured in the course of a uniform manufacturing process.
p.(None): (5) "Batch name" is a characteristic combination of digits or letters used to
p.(None): serves to clearly identify a batch.
p.(None): (5a) "Compassionate Use Program" is the placing on the market of a medicinal product within the meaning of Art. 83
p.(None): of Regulation (EC) No. 726/2004.
p.(None): (6) “Depositeur” is
p.(None): 1. a trader who, on the basis of the 1994 Industrial Code, deals in the wholesale sale of medicines
p.(None): is entitled and has a corresponding license pursuant to Section 63 (1), or
p.(None): 2. the operator of a domestic public pharmacy,
...
p.(None): always strictly limited to their main purpose and may not be other than the person
p.(None): Prescription or persons authorized to dispense apply.
p.(None): (3) The provisions of paragraph 1 stand for the direct or indirect takeover of reasonable
p.(None): Travel and subsistence costs and participation fees for work-related only
p.(None): not opposed to scientific events; the representation effort must always be strict on the
p.(None): main scientific purpose of the event should be limited; the assumption of travel and
p.(None): Living expenses and participation fees as well as representation expenses must not be allowed to others
p.(None): Persons are regarded as persons authorized to prescribe or dispense.
p.(None): (4) The person authorized to prescribe or dispense it is prohibited, contrary to para. 1 bis
p.(None): 3 to request a premium, financial or material benefits, to be promised or accepted.
p.(None): (5) The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): enacted
p.(None): 1. when to assume a low value of premiums or fi nancial or material benefits
p.(None): is
p.(None): 2. With regard to the type and scope of the permissible representation effort in connection with
p.(None): Sales promotion events including choice of venue and location
p.(None): hosting,
p.(None): 3. What criteria an event must meet in order to be considered exclusively professional
p.(None): scientific event within the meaning of paragraph 3 apply,
p.(None): 4. With regard to the adequacy of travel and subsistence costs for work-related
p.(None): scientific events, and
p.(None): 5. With regard to the type and scope of the permissible representation effort in connection with
p.(None): job-related scientific events including the choice of the venue.
p.(None): In doing so, particular care must be taken to ensure that any appearance of improper influence from the
p.(None): Prescribing and dispensing authorized persons in their therapy decision or recommendation
p.(None): is avoided.
p.(None): free goods
p.(None): Section 55b. (1) Granting, offering and promising free goods for prescription
p.(None): or the supply of authorized persons is prohibited if it concerns medicinal products which
p.(None): Umbrella Association of Social Insurance Institutions issued reimbursement code are included.
p.(None): (2) Demanding, which can be promised or accepting those covered by paragraph 1
p.(None): In-kind discounts by persons authorized to prescribe or dispense are prohibited.
p.(None): information officer
p.(None): Section 56. (1) The authorization holder or holder of a registration must ensure that
p.(None): 1. any advertising for medicinal products complies with this section
p.(None): 2. the pharmaceutical officers employed by his company have the qualifications required in § 72
p.(None): and comply with the obligations incumbent on them in accordance with Section 73f,
p.(None): 3. Every popular advertising material is available and a directory of all recipient groups and the
p.(None): Distribution type is carried out, and
p.(None): 4. the orders of the authorities responsible for the control of pharmaceutical advertising
p.(None): be followed immediately and fully.
p.(None): (2) The authorization holder or holder of a registration is obliged, a person who is responsible for the
p.(None): required expertise and experience to mandate the task of scientific
p.(None): Information on the medicinal products placed on the market by the marketing authorization holder
p.(None): perceive (information officer) and these with the necessary powers to fulfill them
p.(None): To equip tasks. The appointment of the information officer and every change of the same is the
p.(None): To bring the Federal Office for Safety in Healthcare to the attention immediately.
p.(None): control
p.(None): Section 56a. (1) The Federal Office for Safety in Health Care is responsible for checking this section.
p.(None): Upon request, all documents that the Federal Office believes are to be sent to the latter
p.(None): Control of compliance with this section are required. This also includes all documents about
p.(None): Sales promotion events and job-related scientific events. Organs of the
p.(None): Federal Office for Safety in Health Care and the experts commissioned by it
p.(None): authorized to enter all rooms and to inspect all documents and copies thereof
p.(None): make as necessary to control the provisions of this section. The controls are
p.(None): except in the event of imminent danger to be carried out during operating hours.
p.(None): (2) Is determined during a check in accordance with paragraph 1, or receives the Federal Office for Security in
p.(None): Healthcare otherwise aware that the provisions of this section are violated
p.(None): it must have all the measures required to establish a state in conformity with the law
p.(None): are.
p.(None): VI. SECTION
p.(None): distribution
p.(None): Dispensing of medicines
p.(None): Section 57. (1) Medicinal products may only be supplied by the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): are on
p.(None): 1. public pharmacies, institutional pharmacies and veterinary home pharmacies,
p.(None): 2. Druggists or other traders who, according to section 59 (3), dispense medicinal products
p.(None): are authorized
p.(None): 3. Manufacturer only for the purpose of the manufacture of medicinal products or insofar as they are in accordance with the
p.(None): Trade Regulations 1994 are authorized to trade in pharmaceuticals,
p.(None): 4. pharmaceutical wholesaler,
p.(None): 5. Local authorities
p.(None): a) in connection with tasks of vaccination prophylaxis or to fulfill them by law
p.(None): assigned tasks of disease control,
p.(None): b) humanitarian aid in connection with a disaster that occurred abroad
p.(None): or a serious accident,
p.(None): c) to maintain the supply of pharmaceuticals in Germany if this is in connection with a
...
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p.(None): Use of a drug with physical or mental damage as a result.
p.(None): (6) "Improper use" is the use of a veterinary medicinal product contrary to
p.(None): Information about the summary of product characteristics, including the improper one
p.(None): Use or serious abuse.
p.(None): (7) “Risk management system” is a series of pharmacovigilance activities and measures that
p.(None): identified, described, avoided or minimized by the risks associated with pharmaceutical specialties
p.(None): should be; this also includes evaluating the effectiveness of such activities and measures.
p.(None): (8) “Risk Management Plan” is a detailed description of the risk management system.
p.(None): (9) “Pharmacovigilance system” is a system that the marketing authorization holder or holder of a
p.(None): Registration and the Federal Office for Safety in Health Care apply to the in Section IX
p.(None): to carry out the tasks and duties mentioned and the surveillance of the safety of authorized
p.(None): or registered pharmaceutical specialties and the discovery of all changes in the benefit-risk
p.(None): Relationship serves.
p.(None): (10) “Pharmacovigilance Master Documentation (Pharmacovigilance Master File)” is a detailed one
p.(None): Description of the system of pharmacovigilance that the marketing authorization holder applies to one or more
p.(None): uses authorized medicinal products.
p.(None): (11) "Pharmacovigilance Officer" is a person responsible for drug monitoring,
p.(None): suitably qualified person.
p.(None): (12) "Regularly updated report on the safety of medicinal products (PSUR)" is a
p.(None): Report with those specified in Art. 75 of Directive 2001/82 / EC or Art. 107b of Directive 2001/83 / EC
p.(None): Records.
p.(None): (13) “Post-approval safety study” is any clinical trial or non-interventional
p.(None): Study on an approved or registered medicinal product that is being carried out to
p.(None): Identifying, describing or quantifying the safety risk is the safety profile of a medicinal product
p.(None): to confirm or measure the efficiency of risk management measures.
p.(None): (14) "Pharmacovigilance Risk Assessment Committee (PRAC)" is the one at the agency
p.(None): Committee set up under Article 56 of Regulation (EC) No 726/2004.
p.(None): (15) "Eudravigilance database" is the database operated by the Agency in accordance with Art. 24 of the
p.(None): Regulation (EC) No. 726/2004.
p.(None): (16) "Data archive for the regularly updated safety reports" is that of the agency
p.(None): Data archive operated in accordance with Art. 25a of Regulation (EC) No. 726/2004.
p.(None): Pharmaceutical requirements
p.(None): Section 3
p.(None): scientific knowledge and based on practical experience does not appear to be certain that it
p.(None): When used as intended, they have no harmful effect beyond what is known
p.(None): that is acceptable to medical science.
p.(None): (2) It is also prohibited to place veterinary medicinal products on the market if, according to the respective status of the
p.(None): scientific knowledge and based on practical experience it does not appear certain that
...
p.(None): the proportion of feed contained is a feed that complies with the Feed Act,
p.(None): 31. in the case of medicinal specialties for use on animals which are used to obtain medicinal products or
p.(None): Food, documents on the waiting time,
p.(None): 32. in pharmaceutical specialties for use on animals, for the production of food or
p.(None): Medicinal products are intended to be a proof of at least six months ago
p.(None): Valid application to set the maximum residue limit according to Regulation (EEC)
p.(None): No. 2377/90, provided the active substances for the target species concerned are not yet listed in Annex I, II or
p.(None): III of Regulation (EEC) № 2377/90 are included; this does not apply if the target species is equidae
p.(None): provided they are in accordance with Commission Decision 92/623 / EEC of 20 October 1993 on
p.(None): the document for the identification of registered equidae (equine passport) and the decision
p.(None): Commission 2000/68 / EC of 22 December 1999 amending Decision 93/623 / EEC
p.(None): and to establish a procedure for identifying breeding and usage as not
p.(None): Slaughter intended for human consumption,
p.(None): 33. A statement that clinical trials are outside the European Economic Area
p.(None): have been carried out that are equivalent to the ethical requirements of Directive 2001/20 / EC,
p.(None): 34. for veterinary specialties, proof that the applicant has a
p.(None): Pharmacovigilance managers and the necessary infrastructure to each
p.(None): Side effect, its occurrence within the European Economic Area or in a third country
p.(None): is suspected to report. For human medicinal products, a summary of the
p.(None): The applicant's pharmacovigilance system, which must include:
p.(None): a) proof that the applicant has a pharmacovigilance officer,
p.(None): b) the place of residence and activity of the person responsible for pharmacovigilance in the European Union
p.(None): Economic Area,
p.(None): (c) the declaration signed by the applicant that he has the necessary resources to:
p.(None): fulfill its obligations under Section IX and
p.(None): d) the location of the place where the pharmacovigilance master documentation is kept.
p.(None): (2) An application for admission is also each a commenting and evaluating scientific
p.(None): Summary of those contained in the documents pursuant to Paragraph 1
p.(None): 1. pharmaceutical data,
p.(None): 2. Results of the non-clinical pharmacological and toxicological experiments and
p.(None): 3. Results of the clinical trials or clinical trials
p.(None): to add. This must contain all information relevant to the evaluation, whether cheap or unfavorable.
p.(None): This also applies to incomplete or canceled pharmacological or toxicological tests or
p.(None): clinical trials or clinical trials of the drug. These documents are from individuals too
p.(None): create that have the required professional quali fi cation. This is with the application for admission
p.(None): to be demonstrated by means of a curriculum vitae.
p.(None): (3) An application for approval of a veterinary specialty is also a commenting and
p.(None): Assessing scientific summary of those contained in the documents in accordance with paragraph 1
p.(None): 1. Safety and residue tests and
p.(None): 2. Tests to assess the possible environmental risks
p.(None): to add. Submission of the results of clinical trials and safety and
p.(None): Residue tests are not required for immunological veterinary specialties if they are in
...
p.(None): (4) With regard to the authorization to register, Section 9 (1) applies. Registration documents
p.(None): § 12a. (1) Registration for registration are those in § 9a (1) 1 to 11, 13, 14, 17, 21 and 23
p.(None): The documents mentioned must be enclosed, whereby the specialist information does not have to contain any non-clinical information.
p.(None): There are also copies of all permits and registrations that the applicant has in another
p.(None): Contracting party to the Agreement on the European Economic Area or in a third country
p.(None): and details of any decision to refuse authorization or registration in another
p.(None): Contracting party to the Agreement on the European Economic Area or in a third country and the
p.(None): Submit reasons for this decision.
p.(None): (2) A registration for registration are also
p.(None): 1. a commenting and evaluating scientific summary of those in the documents
p.(None): pharmaceutical data contained in paragraph 1,
p.(None): 2. Bibliographical information on traditional plant use or reports from
p.(None): Experts from which it appears that the relevant or a corresponding drug
p.(None): at least 30 years at the time of application, including at least 15 years in
p.(None): European Economic Area, used medicinally, the drug among the specified
p.(None): Conditions of use is harmless and the pharmacological effect or effectiveness
p.(None): are plausible due to many years of application and experience,
p.(None): 3. A bibliographical overview of the information on safety with a scientific
p.(None): Rating,
p.(None): 4. Evidence that the applicant has a pharmacovigilance officer and
p.(None): necessary infrastructure has to any side effect, their occurrence within the European
p.(None): Economic area or in a third country is suspected, and
p.(None): 5. A description of the pharmacovigilance and, if necessary, the risk management system
p.(None): the registrant will introduce
p.(None): to add. To the extent that the Federal Office for Safety in Health Care to assess the
p.(None): The information required for their assessment is also considered to be harmless
p.(None): to add.
p.(None): (3) A medicinal product is deemed to be corresponding within the meaning of para. 2 no. 2 if it
p.(None): used auxiliary substances contains the same active substances and, the same or a similar one
p.(None): Intended use, an equivalent strength and dosage and the same or a similar one
p.(None): Has route of administration.
p.(None): (4) In the case of combinations within the meaning of Section 12 (3) or if the medicinal product has more than one
p.(None): plant active ingredient, the information on traditional use and the safety for
p.(None): submit the combination. Is the traditional application of the individual active ingredients of these combinations
p.(None): not documented, information on these individual active substances must also be provided.
p.(None): (5) It is not necessary to submit information and documents in accordance with paragraph 2 nos. 2 and 3 if there is a
p.(None): Community plant monograph prepared by the Committee for Herbal Medicinal Products in accordance with Article 16h
p.(None): Paragraph 3 of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, reference
p.(None): is taken. Regarding registration for registration, a plant-based crop, a plant-based one
p.(None): Preparation or a combination thereof which is in the list of plant substances, plant preparations or
...
p.(None): (5) The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): enacted
p.(None): 1. when to assume a low value of premiums or fi nancial or material benefits
p.(None): is
p.(None): 2. With regard to the type and scope of the permissible representation effort in connection with
p.(None): Sales promotion events including choice of venue and location
p.(None): hosting,
p.(None): 3. What criteria an event must meet in order to be considered exclusively professional
p.(None): scientific event within the meaning of paragraph 3 apply,
p.(None): 4. With regard to the adequacy of travel and subsistence costs for work-related
p.(None): scientific events, and
p.(None): 5. With regard to the type and scope of the permissible representation effort in connection with
p.(None): job-related scientific events including the choice of the venue.
p.(None): In doing so, particular care must be taken to ensure that any appearance of improper influence from the
p.(None): Prescribing and dispensing authorized persons in their therapy decision or recommendation
p.(None): is avoided.
p.(None): free goods
p.(None): Section 55b. (1) Granting, offering and promising free goods for prescription
p.(None): or the supply of authorized persons is prohibited if it concerns medicinal products which
p.(None): Umbrella Association of Social Insurance Institutions issued reimbursement code are included.
p.(None): (2) Demanding, which can be promised or accepting those covered by paragraph 1
p.(None): In-kind discounts by persons authorized to prescribe or dispense are prohibited.
p.(None): information officer
p.(None): Section 56. (1) The authorization holder or holder of a registration must ensure that
p.(None): 1. any advertising for medicinal products complies with this section
p.(None): 2. the pharmaceutical officers employed by his company have the qualifications required in § 72
p.(None): and comply with the obligations incumbent on them in accordance with Section 73f,
p.(None): 3. Every popular advertising material is available and a directory of all recipient groups and the
p.(None): Distribution type is carried out, and
p.(None): 4. the orders of the authorities responsible for the control of pharmaceutical advertising
p.(None): be followed immediately and fully.
p.(None): (2) The authorization holder or holder of a registration is obliged, a person who is responsible for the
p.(None): required expertise and experience to mandate the task of scientific
p.(None): Information on the medicinal products placed on the market by the marketing authorization holder
p.(None): perceive (information officer) and these with the necessary powers to fulfill them
p.(None): To equip tasks. The appointment of the information officer and every change of the same is the
p.(None): To bring the Federal Office for Safety in Healthcare to the attention immediately.
p.(None): control
p.(None): Section 56a. (1) The Federal Office for Safety in Health Care is responsible for checking this section.
p.(None): Upon request, all documents that the Federal Office believes are to be sent to the latter
p.(None): Control of compliance with this section are required. This also includes all documents about
p.(None): Sales promotion events and job-related scientific events. Organs of the
p.(None): Federal Office for Safety in Health Care and the experts commissioned by it
p.(None): authorized to enter all rooms and to inspect all documents and copies thereof
p.(None): make as necessary to control the provisions of this section. The controls are
p.(None): except in the event of imminent danger to be carried out during operating hours.
p.(None): (2) Is determined during a check in accordance with paragraph 1, or receives the Federal Office for Security in
p.(None): Healthcare otherwise aware that the provisions of this section are violated
p.(None): it must have all the measures required to establish a state in conformity with the law
p.(None): are.
p.(None): VI. SECTION
p.(None): distribution
p.(None): Dispensing of medicines
p.(None): Section 57. (1) Medicinal products may only be supplied by the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): are on
p.(None): 1. public pharmacies, institutional pharmacies and veterinary home pharmacies,
p.(None): 2. Druggists or other traders who, according to section 59 (3), dispense medicinal products
p.(None): are authorized
p.(None): 3. Manufacturer only for the purpose of the manufacture of medicinal products or insofar as they are in accordance with the
...
p.(None): (3) The Federal Minister of Health and Environmental Protection has more detailed regulations by ordinance
p.(None): about the composition of the examination board, the examination subjects, the examination requirements and
p.(None): to issue the conduct of the test.
p.(None): (4) In any case, the ordinance pursuant to para. 3 must stipulate that
p.(None): 1. the examination committee to be appointed as members by the Federal Minister for Health and Women
p.(None): Experts from the areas mentioned in Z 2, as well as one representative of each
p.(None): Austrian Chamber of Commerce, the Federal Chamber of Labor and the Austrian Medical Association as
p.(None): Assessors have to belong
p.(None): 2. the exam at least the subjects
p.(None): a) General principles of physics and chemistry,
p.(None): b) anatomy and physiology,
p.(None): c) pathology,
p.(None): d) hygiene, medical microbiology and parasitology,
p.(None): e) pharmacology and pharmaceutical technology,
p.(None): (f) pharmaceutical chemistry and pharmacognosy; and
p.(None): g) Pharmaceutical Law
p.(None): has to include, and
p.(None): 3. The prerequisite for taking the exam is at least the general university entrance qualification
p.(None): or represents a professional qualification in the higher service for health and nursing.
p.(None): (5) Nationals of a contracting party to the Agreement on the European Economic Area
p.(None): or the Swiss Confederation, who have a certificate of competence within the meaning of the directive
p.(None): 2005/36 / EG on the recognition of professional qualifications, which is necessary for the practice of
p.(None): Authorized to work as a pharmaceutical officer, the Federal Minister of Health has granted approval for
p.(None): To exercise a profession as a pharmaceutical officer.
p.(None): (6) Admission to practice is conditional on the successful completion of a
p.(None): Aptitude test to be linked if it can be proven by submitting the relevant documents
p.(None): Knowledge of the applicant differ significantly from the required Austrian knowledge.
p.(None): (7) The decision on admission to practice has to be made within four months of submission
p.(None): of these documents.
p.(None): (8) More detailed regulations on the documents to be submitted by the applicant and on the
p.(None): The Federal Minister of Health and Women has carried out and assessed the aptitude test in
p.(None): of a regulation in accordance with paragraph 3.
p.(None): obligations
p.(None): Section 73. (1) Pharmaceutical officers have the information in the exercise of their activity that the specialist information
p.(None): according to § 15, must convey without restriction. Statements made by the content of the
p.(None): Subject information that is not covered is not permitted.
p.(None): (2) Pharmaceutical officers are obliged to provide them with information in accordance with Section 75a
p.(None): to be sent to your client immediately.
p.(None): Section 74. Pharmaceutical officers may not place orders for medicinal products when performing their duties
p.(None): answer.
p.(None): IX. SECTION
p.(None): Market surveillance and pharmacovigilance
p.(None): General principles
p.(None): § 75. (1) For the interpretation of the principles of pharmacovigilance are the generally recognized
p.(None): scientific principles and requirements set out in the by the European Commission
p.(None): guidelines on good practice in the field of pharmacovigilance are included.
p.(None): (2) To the extent that authorization holders are addressed in this section, these provisions also apply
p.(None): for holders of a registration of a traditional herbal medicinal specialty.
...
p.(None): (2) A license valid in accordance with paragraph 1 expires on July 1, 1999, unless it is canceled before the expiry of the
p.(None): June 30, 1999 an application for authorization was made.
p.(None): (3) Paragraph 2 does not apply to drugstores within the meaning of Section 216 of the 1994 Trade Code.
p.(None): Section 93. (1) The Federal Minister of Health and Environmental Protection can direct the head of a control laboratory
p.(None): Requirement for academic professional training in accordance with section 70 or a regulation in accordance with section 70 (2)
p.(None): see if this
p.(None): 1. can prove that he has been in the last five years before the entry into force of this federal law
p.(None): has performed the activity of the head of a control laboratory within the meaning of Section 62 (3) (2),
p.(None): 2. can demonstrate scientific professional training and practical training on the ground
p.(None): who does not interfere with drug safety through his work as head of a
p.(None): Control laboratory is expected, and
p.(None): 3. the granting of leniency within six months after the entry into force of this federal law
p.(None): has requested.
p.(None): (2) The head of a control laboratory may make a decision on his application submitted in good time
p.(None): continue to carry out his activity to the extent previously possible.
p.(None): Section 94. Pharmaceutical officers who do not meet the requirements of Section 72 (1) are allowed to work
p.(None): continue exercising if they
p.(None): 1. can demonstrate that they are in the last year before the entry into force of this
p.(None): Have acted as a pharmaceutical officer, and
p.(None): 2. the further pursuit of their work as a pharmaceutical officer to the Federal Ministry of Health and
p.(None): Report environmental protection within six months of the entry into force of this federal law.
p.(None): § 94a. (1) For medicinal products that were amended before the Medicinal Products Act came into force
p.(None): Federal Law BGBl. № 107/1994 must be approved until the first submission according to § 19a
p.(None): Labeling as well as the instructions for use and specialist information on the provisions of this federal law and
p.(None): of the regulations adopted on the basis thereof.
p.(None): (2) For medicinal products that were amended before the Medicinal Products Act came into force
p.(None): Federal Law Gazette No. 107/1994, the documents according to § 19a are not three to
p.(None): to be submitted six months before the expiry of five years after the approval notice has become final. For this
p.(None): The Federal Minister of Health and Women can submit medicinal specialties at any time by notice
p.(None): order if it does not appear certain that the information contained in the approval documents
p.(None): Evidence of the quality, effectiveness and harmlessness of the latest scientific
p.(None): Insights correspond.
p.(None): (3) Clinical trials that take place before the entry into force of the Medicinal Products Act in the version of the
p.(None): Federal Law Gazette No. 107/1994 started, may according to the legal situation before entry into force
p.(None): of the Medicinal Products Act in the version of the Federal Law Gazette No. 107/1994.
p.(None): (4) For medicinal products that were amended before the Medicinal Products Act came into force
p.(None): Federal Law Gazette № 379/1996 have been approved, must be until the first submission according to § 19a
...
p.(None): Multiples of five years from the date of approval. No application will be made at this time
p.(None): If the authorization is extended, the medicinal product can continue to be marketed until January 1, 2011
p.(None): brought, an extension of the approval according to § 20 is no longer possible.
p.(None): (12) For registered homeopathic medicinal specialties, the time of submission is calculated according to
p.(None): Section 20 (2) and (3) from a multiple of five years from the date of registration. The template has
p.(None): no earlier than June 30, 2012.
p.(None): (13) The marketing authorization holder of a medicinal product that is in effect at the time of entry into force
p.(None): Federal law in the version of the federal law BGBl. I № 153/2005 was approved, must
p.(None): otherwise expiry of the approval by the Federal Office for Safety in Health Care at the latest
p.(None): December 31, 2008 report whether the medicinal product was actually placed on the market on January 1, 2006,
p.(None): whether it is actually still in circulation or from what point in time it is no longer actually in
p.(None): Traffic was. It must also be announced whether the approval is only for the purposes of Section 9a (5)
p.(None): is used.
p.(None): (13a) For applications for the authorization of a reference medicinal product for which the application for an authorization before
p.(None): At the end of October 30, 2005, the protection periods in § 15a of the Medicinal Products Act apply
p.(None): the version before the amendment to Federal Law Gazette I No. 153/2005.
p.(None): (14) Promotional material up to January 1, 2007 in the version of the requirements of this federal law
p.(None): of the Federal Law BGBl. I № 153/2005. The information officer is the Federal Office
p.(None): for Healthcare Safety to be announced by July 1, 2006 at the latest.
p.(None): (15) Homeopathic medicinal specialties that were published in the. Before the entry into force of this federal law
p.(None): Version BGBl. I № 153/2005 have been registered, as long as § 3 does not conflict with this, in
p.(None): To be placed on the market.
p.(None): Special provisions in connection with crisis situations
p.(None): § 94d. (1) In case of disaster, epidemic, pandemic, terrorist threat, martial
p.(None): The Federal Minister of Health and Women has a dispute or other crisis situation, if
p.(None): the necessary care of the population would otherwise be seriously and significantly endangered by regulation
p.(None): Exceptions to § 4, the provisions of II., VI. and VII. Section of this Federal Law and the
p.(None): to comply with the relevant ordinances issued on the basis of this federal law, to the extent and for as long
p.(None): this is necessary due to the special situation and the protection of life and health of
p.(None): Humans and animals are protected.
p.(None): (2) In the event of a disaster, epidemic, pandemic, terrorist threat, martial
p.(None): The Federal Minister of Health and Women,
p.(None): if the necessary supply of the population would otherwise be seriously and significantly endangered by
p.(None): Ordinance Regulations on supply and provision obligations for marketing authorization holders,
p.(None): Depositeurs, manufacturers, pharmaceutical wholesalers, pharmaceutical wholesalers and public pharmacies
p.(None): adopted if and as long as this is necessary due to the special situation.
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Social / Property Ownership
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p.(None): or clinical trials or trials and, if applicable, the results of safety and
p.(None): Residue tests only for this combination, but not for the individual components.
p.(None): Authorization for distribution in parallel import
p.(None): § 10c. (1) medicinal specialties,
p.(None): 1. the one approved or registered in Austria on the basis of this federal law
p.(None): Pharmaceutical specialty (approval),
p.(None): 2. from another party to the Agreement on the European Economic Area
p.(None): be introduced, and
p.(None): 3. in which the assessment of the already approved or registered pharmaceutical specialty
p.(None): Safety and effectiveness can be used for health protection without any risk
p.(None): can
p.(None): may only be placed on the market if the Federal Office for Safety in Health Care
p.(None): Has given approval for sales in parallel imports.
p.(None): (2) With regard to the application for approval for sales in parallel import, § 9 Paragraph 1 and
p.(None): Section 9a (1) 1 accordingly.
p.(None): (3) The application for approval for distribution in parallel import must contain:
p.(None): 1. proof of the right to apply in accordance with § 9,
p.(None): 2. the name and registration or registration number of the licensed or registered in Austria
p.(None): registered pharmaceutical specialty,
p.(None): 3. the composition according to the type and amount of the active ingredients,
p.(None): 4. the party to the Agreement on the European Economic Area in which the imported
p.(None): Pharmaceutical specialty is authorized or registered and in which it is distributed (home Member State),
p.(None): 5. the name and the approval or registration number of the medicinal product in the
p.(None): Member State of origin
p.(None): 6. the name and address of the authorization holder in the home Member State,
p.(None): 7. where applicable, the name and address of the manufacturer in the home Member State,
p.(None): 8. the type of packaging of the imported medicinal product,
p.(None): 9. the pack sizes intended for distribution in Austria,
p.(None): 10. the description of the process of re-labeling or repacking,
p.(None): 11. the name and address of the person who will carry out the re-labeling or repackaging
p.(None): company
p.(None): 12. A statement that the texts for the outer packaging, primary packaging, and where appropriate
p.(None): Package leaflet and technical information except for speci fi c information as well as information on
p.(None): Avoidance of senselessness no textual deviations from the labeling,
p.(None): where applicable, package leaflet and specialist information for those authorized or
p.(None): have registered pharmaceutical specialty and
p.(None): 13. A description of the pharmacovigilance and, if necessary, the risk management system
p.(None): the applicant will introduce.
p.(None): (4) Pharmaceutical specialties that have been granted an authorization in accordance with Regulation (EC) № 726/2004 and
p.(None): Paragraph 1 lines 2 and 3 may only be placed on the market if they are in German
p.(None): Labeling and instructions for use are provided and there is German-language technical information
p.(None): and a notification to the agency and the Federal Office for Safety in Health Care has been made beforehand.
p.(None): This message must contain:
p.(None): 1. proof of the right to apply in accordance with § 9,
p.(None): 2. Name and registration number of those approved according to Regulation (EEC) № 726/2004
p.(None): Medicinal product,
p.(None): 3. the party to the Agreement on the European Economic Area in which the imported
p.(None): Drug specialty is distributed (home Member State),
p.(None): 4. the name and address of the authorization holder,
p.(None): 5. the name and address of the manufacturer,
p.(None): 6. the pack sizes intended for distribution in Austria,
p.(None): 7. A declaration that the texts for outer packaging, primary packaging, instructions for use and
p.(None): Specialist information, apart from company-specific information, no textual deviations from the
p.(None): Labeling, instructions for use and specialist information according to the regulation (EWG)
p.(None): No. 726/2004 approved pharmaceutical specialty.
p.(None): To the agency is a fee for checking compliance with the conditions set out in Union law
p.(None): Medicines and are specified in the marketing authorizations. their
p.(None): Dimensioning is based on Union law regulations.
p.(None): (5) The applicant is obliged to submit the application pursuant to paragraph 3 to the authorization holder
p.(None): or owner of the registration. The same applies to the notification according to paragraph 4.
p.(None): (6) If this is necessary for reasons of drug safety, with the consent of the
p.(None): Federal Office for Safety in Health Care of the requirements for labeling in paragraph 3
p.(None): Z 12 can be deviated with regard to the primary packaging.
p.(None): Registration of homeopathic medicinal specialties
p.(None): § 11. (1) Homeopathic medicinal products are not subject to the authorization requirement according to § 7 if
p.(None): she
p.(None): 1. are intended as a human medicinal product for external or oral use,
p.(None): 2. as a veterinary specialty for administration according to the European Pharmacopoeia or in
...
p.(None): perceive (information officer) and these with the necessary powers to fulfill them
p.(None): To equip tasks. The appointment of the information officer and every change of the same is the
p.(None): To bring the Federal Office for Safety in Healthcare to the attention immediately.
p.(None): control
p.(None): Section 56a. (1) The Federal Office for Safety in Health Care is responsible for checking this section.
p.(None): Upon request, all documents that the Federal Office believes are to be sent to the latter
p.(None): Control of compliance with this section are required. This also includes all documents about
p.(None): Sales promotion events and job-related scientific events. Organs of the
p.(None): Federal Office for Safety in Health Care and the experts commissioned by it
p.(None): authorized to enter all rooms and to inspect all documents and copies thereof
p.(None): make as necessary to control the provisions of this section. The controls are
p.(None): except in the event of imminent danger to be carried out during operating hours.
p.(None): (2) Is determined during a check in accordance with paragraph 1, or receives the Federal Office for Security in
p.(None): Healthcare otherwise aware that the provisions of this section are violated
p.(None): it must have all the measures required to establish a state in conformity with the law
p.(None): are.
p.(None): VI. SECTION
p.(None): distribution
p.(None): Dispensing of medicines
p.(None): Section 57. (1) Medicinal products may only be supplied by the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): are on
p.(None): 1. public pharmacies, institutional pharmacies and veterinary home pharmacies,
p.(None): 2. Druggists or other traders who, according to section 59 (3), dispense medicinal products
p.(None): are authorized
p.(None): 3. Manufacturer only for the purpose of the manufacture of medicinal products or insofar as they are in accordance with the
p.(None): Trade Regulations 1994 are authorized to trade in pharmaceuticals,
p.(None): 4. pharmaceutical wholesaler,
p.(None): 5. Local authorities
p.(None): a) in connection with tasks of vaccination prophylaxis or to fulfill them by law
p.(None): assigned tasks of disease control,
p.(None): b) humanitarian aid in connection with a disaster that occurred abroad
p.(None): or a serious accident,
p.(None): c) to maintain the supply of pharmaceuticals in Germany if this is in connection with a
p.(None): Catastrophe, terrorist threat, armed conflict or pandemic
p.(None): is absolutely necessary
p.(None): 5a. Businesses and organizations that maintain basic public services
p.(None): serve and based on a between the federal government or a state and a manufacturer,
p.(None): Depositeur or pharmaceutical wholesaler concluded contract to ensure the
p.(None): Maintenance of drug supplies related to a pandemic, warlike
p.(None): Conflict or terrorist threat, in turn, individual contracts for direct purchase
p.(None): have completed a drug for the needs of their own employees,
p.(None): 6. Institutions of the Austrian Armed Forces, the pharmaceutical supply of the Armed Forces
p.(None): serve,
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p.(None): of Regulation (EC) No. 726/2004.
p.(None): (6) “Depositeur” is
p.(None): 1. a trader who, on the basis of the 1994 Industrial Code, deals in the wholesale sale of medicines
p.(None): is entitled and has a corresponding license pursuant to Section 63 (1), or
p.(None): 2. the operator of a domestic public pharmacy,
p.(None): who markets a medicinal product manufactured abroad in its name on the domestic market.
p.(None): (6a) "End product" is a medicinal product that has gone through all the stages of manufacture but not yet
p.(None): released by a knowledgeable person.
p.(None): (7) "Mutual recognition procedure" and "decentralized procedure" are for the
p.(None): Contracting parties to the Agreement on the European Economic Area through Chapter 4 of the Directive
p.(None): 2001/83 / EG, in the version of the guidelines 2004/24 / EG and 2004/27 / EG, as well as in chapter 4 of the guideline
p.(None): 2001/82 / EG, in the version of the directive 2004/28 / EG, specified procedures.
p.(None): (7a) "Distance selling" means entering into a contract using only one or
p.(None): several means of distance communication.
p.(None): (7b) "Long-distance communication means" are means of communication that are used to conclude a contract without
p.(None): simultaneous physical presence of the parties can be used, especially with printed matter
p.(None): or without address, catalogs, press advertising with order form, pre-made standard letters,
p.(None): Long-distance calls with people or machines as conversation partners, radio, videophone, fax,
p.(None): Teleshopping as well as publicly accessible electronic media that allow individual communication
p.(None): enable, such as the Internet or electronic mail.
p.(None): (8) "Shelf life" is the property of a medicinal product during a certain period of time
p.(None): proper storage, its quality, especially with regard to quality and effect, not
p.(None): to change.
p.(None): (9) "Retail package" is the container, as well as all package elements including package inserts and all
p.(None): Components with which the medicinal product is placed on the market with the respective labels.
p.(None): (10) "Manufacturing" is the extraction, the making, the preparation, the working or processing, the
p.(None): Decanting including the filling and packaging of drugs or active ingredients as well as the
p.(None): Labeling of medicinal specialties and investigational medicinal products.
p.(None): (10a) "Maximum amounts of residues" are those pursuant to Article 1 (1) lit. b of Regulation (EEC)
p.(None): № 2377/90 establishing a Community procedure for the setting of quantitative limits for
p.(None): Veterinary drug residues in food of animal origin, OJ. № L 224 of August 18, 1990,
p.(None): defined quantities.
p.(None): (11) "Placing on the market" means holding stock, holding it for sale or dispensing medicinal products or
p.(None): Wirksto ff s. A placing on the market does not exist if it is ensured by suitable measures that a
p.(None): Medicines that do not comply with the law do not reach consumers or users.
p.(None): (11a) "Magistral preparation" means any medicinal product that is available in a pharmacy on the basis of a
p.(None): medical or dental prescription for a specific patient or by veterinary
p.(None): Prescription is made for a particular animal.
p.(None): (11b) "O ffi zinal preparation" means any drug that is in a pharmacy after a monograph
p.(None): the pharmacopoeia is produced in accordance with § 1 of the Pharmacopoeia Act and is intended to be used in pharmacies,
...
p.(None): (12) "Non-clinical investigation" is the pharmacological or toxicological examination of a medicinal product,
p.(None): that is not done on humans.
p.(None): (13) Pharmaceutical officers are persons who are doctors, dentists, veterinarians, dentists, midwives,
p.(None): Visit pharmacists or traders mentioned in section 59 (3), (4) and (8) to find out about medicines
p.(None): to provide technical information.
p.(None): (13a) "Marketing Authorization Holder" is a party to the Agreement on the
p.(None): European Economic Area (EEA Agreement) resident entrepreneur who is entitled to
p.(None): To market, manufacture or wholesale pharmaceuticals or active ingredients under his name
p.(None): to drive.
p.(None): (13b) "Expert person" is a person as defined in Article 48 of Directive 2001/83 / EC, as amended
p.(None): of Directives 2004/24 / EC and 2004/27 / EC, or Article 52 of Directive 2001/82 / EC, in the version of the
p.(None): Directive 2004/28 / EC, or Article 13 (1) of Directive 2001/20 / EC.
p.(None): (14) "Harmlessness" means that when used as intended, the foreseeable risk
p.(None): undesirable effects in consideration of the effectiveness or purpose according to the knowledge
p.(None): medical science is justifiable.
p.(None): (15) “Consumers” are physical or legal persons who take medicinal products for their own use
p.(None): purchase.
p.(None): (15a) "Mediation of medicinal products" includes all activities, with the exception of wholesale, in the
p.(None): Connection with the sale or purchase of medicinal products for human use, which consist of self-employed and in
p.(None): Negotiate the name of another legal or natural person without using these drugs
p.(None): Acquiring property or physically handling these medicines.
p.(None): (16) “Expiry date” is the term after which the shelf life of a medicine
p.(None): is no longer guaranteed.
p.(None): (17) Waiting time is the period between the last administration of a drug to animals under
p.(None): Compliance with drug regulations and the time up to which these animals are not available
p.(None): Extraction of food or medicinal products may be used, must be observed and the
p.(None): ensures that residues of the substances administered in these foods comply with the
p.(None): Regulation (EEC) № 2377/90 maximum permissible quantities for pharmacologically active substances
p.(None): do not exceed.
p.(None): (18) "Efficacy" is the suitability of a drug, the intended uses mentioned in § 1 Paragraph 1
p.(None): to fulfill.
p.(None): (19) "Effect" is an influenceable influence of the
p.(None): Condition or function of a biological object.
p.(None): (20) 'Central procedure' is one for the Member States of the European Union through the Regulation
p.(None): (EG) № 726/2004, OJ. № L 136/1 of March 31, 2004, established procedure for the approval of certain
p.(None): Medicinal specialties, that for medicinal products covered by the annex to the aforementioned regulation
p.(None): compulsory for pharmaceutical specialties covered by Article 3 Paragraph 2 of the Ordinance on request as required
p.(None): the requirements mentioned there apply.
p.(None): (21) 'Intermediate' is a medicinal product that is still in one or more manufacturing phases
p.(None): needs to become bulk goods.
...
p.(None): exempt from a regulation in accordance with paragraph 1, if this results from the latest state of medical
p.(None): Science a threat to drug safety cannot be feared.
p.(None): (3) The Federal Minister of Health and Women may consider an opinion
p.(None): of Article 27 of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or the
p.(None): in Art. 31 Directive 2001/82 / EC, as amended by Directive 2004/28 / EC
p.(None): Coordinating group of medicinal specialties that are based on a regulation issued on the basis of paragraph 1
p.(None): not comply, by decision exempt from the scope of this regulation if after the
p.(None): state of the art in medical science not to worry about a threat to drug safety
p.(None): is. Such notice is to be revoked if it subsequently becomes known that the requirements for this
p.(None): are not given.
p.(None): misleading
p.(None): § 6. (1) It is forbidden to place medicinal products or active substances on the market which are not the facts
p.(None): corresponding information or other misleading designations or packaging
p.(None): exhibit.
p.(None): (2) It is also prohibited in connection with the placing on the market of medicinal products or
p.(None): Effective about this information that does not correspond to the facts or is misleading
p.(None): do.
p.(None): (3) A misleading situation exists in particular if
p.(None): 1. The medicinal products are considered to have an efficacy or the active substances have a property that
p.(None): according to the current state of scientific knowledge or practical
p.(None): Experience is not sufficiently documented, or
p.(None): 2. the impression is incorrectly given that success is to be expected with certainty or that after
p.(None): Intended or prolonged use, no harmful effects occur, or
p.(None): 3. the name or presentation is suitable for confusion.
p.(None): (4) It is also prohibited to announce or place objects on the market that are to be used
p.(None): are determined on or in the human body and which are based on the type and form of the announcement or the
p.(None): Placing on the market are likely to mislead consumers to expect these items
p.(None): are themselves medicinal or medicinally effective, or contain medicinal products or would be compatible with them
p.(None): Medicines applied.
p.(None): Section II
p.(None): Proprietary medicinal Products
p.(None): Approval of pharmaceutical specialties
p.(None): § 7. (1) Medicinal products may only be delivered in Germany or kept ready for delivery in Germany
p.(None): if they are approved by the Federal Office for Safety in Health Care, unless it
p.(None): is about
p.(None): 1. in accordance with Regulation (EC) № 726/2004, Regulation (EC) № 726/2004 in conjunction with the
p.(None): Regulation (EG) № 1901/2006, or the regulation (EG) № 1394/2007 approved
p.(None): Proprietary Medicinal Products,
p.(None): 2. Medicinal specialties, their transfer or import according to the Pharmaceuticals Import Law 2010, Federal Law Gazette I
p.(None): No. 79/2010, or
p.(None): 3. Medicinal specialties for which a license according to § 12 Animal Disease Act, RGBl. № 177/1909,
p.(None): was granted.
p.(None): (2) Medicinal specialties that correspond to a monograph of the pharmacopoeia within the meaning of § 1 of the
p.(None): Comply with the Pharmacopoeia Act, are manufactured in a pharmacy and are intended to be used in the
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p.(None): § 4. (1) It is forbidden to manufacture medicinal products or active substances or to place them on the market in their
p.(None): Quality does not correspond to the current state of science.
p.(None): (2) The quality of pharmaceuticals or active ingredients corresponds to the current state of science
p.(None): especially not if they
p.(None): 1. the quality requirements of the pharmacopoeia within the meaning of Section 1 of the Pharmacopoeia Act 2012,
p.(None): BGBl. I № 44/2012, or the quality requirements of the pharmacopoeia of another contracting party
p.(None): the European Economic Area,
p.(None): 2. the quality requirements of other pharmacopoeias, the standard of which corresponds to that of the pharmacopoeia
p.(None): § 1 of the Pharmacopoeia Act 2012 can be kept the same, provided there are no standards in accordance with Z 1,
p.(None): 3. Other existing internationally recognized minimum standards, provided there are no standards according to
p.(None): Z 1 and 2 exist, or
p.(None): 4. the standards set by the manufacturer himself according to the current state of science, if
p.(None): there are no standards according to Z 1 to 3,
p.(None): do not match.
p.(None): (3) It is prohibited to place medicinal products on the market
p.(None): 1. whose durability is no longer given,
p.(None): 2. whose expiry date has passed,
p.(None): 3. whose commercial packs can have an adverse effect on the quality of the medicinal product,
p.(None): or
p.(None): 4. which are intended for use on animals, which serve for the production of food and their
p.(None): pharmacologically active ingredients not in Annexes I to III of Regulation (EEC)
p.(None): No. 2377/90 are included.
p.(None): (4) Pharmaceutical specialties whose expiry date has passed may be used if the
p.(None): Federal Armed Forces in accordance with Section 2 (1) lit. a of the Wehrgesetzes 1990, Federal Law Gazette № 305, are placed on the market,
p.(None): if this is essential for the supply of medicinal products and research has shown that
p.(None): the protection of human and animal health is maintained.
p.(None): § 5. (1) The Federal Minister of Health and Environmental Protection has to ensure the
p.(None): Drug safety, to prevent harmful effects within the meaning of § 3 and to secure the
p.(None): Quality in the sense of § 4 by ordinance, more detailed provisions on the use of certain substances,
p.(None): Preparations from materials, processes or articles for the manufacture and control of medicinal products
p.(None): or active substances and on the placing on the market, import and use of medicinal products or
p.(None): To adopt active substances.
p.(None): (2) The Federal Minister of Health and Women may consider an application in accordance with
p.(None): § 18a or according to Art. 3 of Regulation (EC) № 726/2004 medicinal specialties from the area of application
p.(None): exempt from a regulation in accordance with paragraph 1, if this results from the latest state of medical
p.(None): Science a threat to drug safety cannot be feared.
p.(None): (3) The Federal Minister of Health and Women may consider an opinion
p.(None): of Article 27 of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or the
...
p.(None): are on
p.(None): 1. public pharmacies, institutional pharmacies and veterinary home pharmacies,
p.(None): 2. Druggists or other traders who, according to section 59 (3), dispense medicinal products
p.(None): are authorized
p.(None): 3. Manufacturer only for the purpose of the manufacture of medicinal products or insofar as they are in accordance with the
p.(None): Trade Regulations 1994 are authorized to trade in pharmaceuticals,
p.(None): 4. pharmaceutical wholesaler,
p.(None): 5. Local authorities
p.(None): a) in connection with tasks of vaccination prophylaxis or to fulfill them by law
p.(None): assigned tasks of disease control,
p.(None): b) humanitarian aid in connection with a disaster that occurred abroad
p.(None): or a serious accident,
p.(None): c) to maintain the supply of pharmaceuticals in Germany if this is in connection with a
p.(None): Catastrophe, terrorist threat, armed conflict or pandemic
p.(None): is absolutely necessary
p.(None): 5a. Businesses and organizations that maintain basic public services
p.(None): serve and based on a between the federal government or a state and a manufacturer,
p.(None): Depositeur or pharmaceutical wholesaler concluded contract to ensure the
p.(None): Maintenance of drug supplies related to a pandemic, warlike
p.(None): Conflict or terrorist threat, in turn, individual contracts for direct purchase
p.(None): have completed a drug for the needs of their own employees,
p.(None): 6. Institutions of the Austrian Armed Forces, the pharmaceutical supply of the Armed Forces
p.(None): serve,
p.(None): 6a. the Federal Ministry of the Interior, the authorities and childcare facilities subordinate to it
p.(None): for emergency care, prevention and care of operations, provided that the medicines for
p.(None): Need to perform their duties
p.(None): 7. Institutions, the provisional judicial safekeeping or arrests, judicial
p.(None): Prison sentences or preventive judicial measures related to deprivation of liberty
p.(None): Take measures if they need drugs to perform their tasks
p.(None): 8. scientific institutes and research institutes of the local authorities and the
p.(None): Universities and the Austrian Agency for Health and Food Security, if these
p.(None): Need medicines to perform their tasks
p.(None): 9. Organized emergency medical services, provided they are addictive substances, which they use for their emergency medical services
p.(None): Need activity, and
p.(None): 10. Have a doctor who is sufficiently familiar with questions of substance abuse
p.(None): Institutions according to § 15 of the Addictive Substances Act, Federal Law Gazette I № 112/1997, for evidence-based and
p.(None): quality-assured support for clients as part of damage minimization measures,
p.(None): except drugs containing addictive substances.
p.(None): (2) At hospitals without institutional pharmacies, the manufacturer, depositeur or pharmaceutical
p.(None): Wholesalers are given:
p.(None): 1. whole blood preserves, suspensions of cellular or corpuscular blood components,
p.(None): Single donor preparations,
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p.(None): the documents that are sufficient for the assessment of the intended end products are to be enclosed.
p.(None): § 7b. (1) If there is no authorization and no application for authorization for a human medicinal product,
p.(None): the Federal Minister of Health and Women may do so in another party to the agreement
p.(None): Medicinal product approved for use in the European Economic Area for public reasons
p.(None): Allow health.
p.(None): (2) The Federal Minister of Health and Women may, by ordinance, specify further provisions on
p.(None): the procedure to be used, in particular with regard to the selection of the authorization holder,
p.(None): adopted. It is particularly important to ensure that the marketing authorization holder is informed about the
p.(None): necessary organizational and technical prerequisites for fulfilling him after a possible
p.(None): Approval according to this federal law.
p.(None): § 8. (1) Medicinal products do not require approval if
p.(None): 1. these to conduct non-clinical or clinical trials or clinical trials
p.(None): are determined, or
p.(None): 2. certifies a doctor, dentist or veterinarian who is authorized to practice his profession independently in Germany,
p.(None): that the drug specialty to ward off a life threatening or serious health
p.(None): Damage is urgently needed and this success with an approved and available
p.(None): Pharmaceutical specialty probably cannot be achieved according to the state of the art, or
p.(None): 3. the pharmaceutical specialty for medical treatment
p.(None): a) in the event of deployment of the Federal Army in accordance with Section 2 (1) lit. a of the Defense Act 2001,
p.(None): BGBl. I No. 146, or
p.(None): b) in preparation for a posting under the Federal Constitutional Law on Cooperation and
p.(None): Solidarity when sending units and individuals abroad (KSE-BVG),
p.(None): BGBl. I No. 38/1997, or in the context of such a posting
p.(None): is needed and the success of this treatment with an approved and available
p.(None): Pharmaceutical specialty cannot be achieved according to the state of the art, or
p.(None): 4. the pharmaceutical specialty to prevent or in connection with a disaster,
p.(None): terrorist threat or armed conflict
p.(None): should be applied and the success with an approved and available pharmaceutical specialty
p.(None): the state of the art cannot be achieved, or
p.(None): 5. the medicinal product for use by doctors or paramedics related to a
p.(None): national major event according to § 26a Sanitary Act, Federal Law Gazette I № 30/2002, from abroad
p.(None): coming to work temporarily in Austria.
p.(None): (2) If an application for reimbursement of a pharmaceutical specialty not approved in Austria is submitted to
p.(None): an Austrian social security institution, the domestic manufacturer or the
p.(None): Applicant for an import license according to the Pharmaceuticals Imports Act 2010 or for
p.(None): Notification according to the Pharmaceutical Imports Act 2010 entitled to the Austrian social security institution
p.(None): upon request to provide the information immediately and free of charge that at least
p.(None): correspond to the information in the technical information.
p.(None): § 8a. (1) Pharmaceutical specialties that meet the requirements of Article 3 Paragraph 1 or 2 of Regulation (EC)
p.(None): № 726/2004 meet no approval if the Federal Office for Health Safety
...
p.(None): manufacture, control or place on the market,
p.(None): 2. Institutional pharmacies operating within the scope of normal pharmacy operations in accordance with
p.(None): Pharmacy Works Regulations 2005 Manufacture, control or market pharmaceuticals,
p.(None): 3. Institutional pharmacies with regard to the manufacture of investigational medicinal products, insofar as it involves transferring
p.(None): including filling, packaging and labeling, and the investigational medicinal products
p.(None): Are intended for use in a hospital,
p.(None): 4. Public pharmacies with regard to the manufacture of investigational medicinal products, insofar as it involves transferring
p.(None): including filling, packaging and labeling, and the investigational medicinal products
p.(None): Use in the hospital supplied by the public pharmacy in accordance with § 20 of the
p.(None): Federal Act on Hospitals and Health Centers (KAKuG), Federal Law Gazette № 1/1957, last
p.(None): amended by Federal Law Gazette I No. 49/2008, are determined,
p.(None): 5. medical and veterinary pharmacies,
p.(None): 6. Tissue banks, insofar as their activity according to § 1 of the Tissue Security Act exclusively in
p.(None): whose scope falls
p.(None): 7.Companies that are authorized to dispose of medicinal products in accordance with section 59 subsections 3, 4, 7a and 8,
p.(None): 8. Nuclear medical institutions or laboratories that use radioactive medicines exclusively for
p.(None): Manufacture for direct use to patients or these medicines to holders
p.(None): a license to handle radioactive substances in accordance with the Radiation Protection Act, Federal Law Gazette.
p.(None): No. 227/1969, last amended by Federal Law Gazette I No. 13/2006, and
p.(None): 9. Medical facilities of the Federal Army, in which for the medical care of relatives of the
p.(None): Bundesheeres medicinal products are manufactured.
p.(None): (2a) Provided that public pharmacies sell medicinal products to others beyond the usual pharmacy operation
p.(None): dispensing to public pharmacies, to institutional pharmacies or to hospitals, these require one
p.(None): Appropriate authorization according to § 63 paragraph 1. This also applies to institutional pharmacies that sell medicines
p.(None): other institutional pharmacies or hospitals, except for those operated by the respective institutional pharmacy,
p.(None): submit.
p.(None): (2b) When re-blistering medicinal products, an operating license in accordance with Section 63 (1) is required for
p.(None): Public pharmacies or institutional pharmacies are required, provided the newly blistered medicinal products are sold to a
p.(None): more than the usual number of pharmacies.
p.(None): (2c) When assessing the exceedance of the usual pharmacy operation in accordance with para. 2a and 2b is -
p.(None): if applicable - to be checked in particular:
p.(None): 1. the production and distribution volume of the pharmaceuticals,
p.(None): 2. the risk potential of the manufacturing process,
p.(None): 3. the frequency of deliveries of medicines, and
p.(None): 4. the number of people supplied with newly blistered medicines on average per year.
p.(None): The Federal Office for Safety in Health Care has taken drug safety into account
p.(None): and the professional and personal equipment of a public pharmacy or institutional pharmacy
p.(None): Ordinance to issue more detailed rules for the examination and assessment of the criteria according to Z 1 to 4.
p.(None): The regulation is on the homepage of the Federal Office for Safety in Health Care
...
Social / Threat of Stigma
Searching for indicator threat:
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p.(None): or
p.(None): 4. which are intended for use on animals, which serve for the production of food and their
p.(None): pharmacologically active ingredients not in Annexes I to III of Regulation (EEC)
p.(None): No. 2377/90 are included.
p.(None): (4) Pharmaceutical specialties whose expiry date has passed may be used if the
p.(None): Federal Armed Forces in accordance with Section 2 (1) lit. a of the Wehrgesetzes 1990, Federal Law Gazette № 305, are placed on the market,
p.(None): if this is essential for the supply of medicinal products and research has shown that
p.(None): the protection of human and animal health is maintained.
p.(None): § 5. (1) The Federal Minister of Health and Environmental Protection has to ensure the
p.(None): Drug safety, to prevent harmful effects within the meaning of § 3 and to secure the
p.(None): Quality in the sense of § 4 by ordinance, more detailed provisions on the use of certain substances,
p.(None): Preparations from materials, processes or articles for the manufacture and control of medicinal products
p.(None): or active substances and on the placing on the market, import and use of medicinal products or
p.(None): To adopt active substances.
p.(None): (2) The Federal Minister of Health and Women may consider an application in accordance with
p.(None): § 18a or according to Art. 3 of Regulation (EC) № 726/2004 medicinal specialties from the area of application
p.(None): exempt from a regulation in accordance with paragraph 1, if this results from the latest state of medical
p.(None): Science a threat to drug safety cannot be feared.
p.(None): (3) The Federal Minister of Health and Women may consider an opinion
p.(None): of Article 27 of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or the
p.(None): in Art. 31 Directive 2001/82 / EC, as amended by Directive 2004/28 / EC
p.(None): Coordinating group of medicinal specialties that are based on a regulation issued on the basis of paragraph 1
p.(None): not comply, by decision exempt from the scope of this regulation if after the
p.(None): state of the art in medical science not to worry about a threat to drug safety
p.(None): is. Such notice is to be revoked if it subsequently becomes known that the requirements for this
p.(None): are not given.
p.(None): misleading
p.(None): § 6. (1) It is forbidden to place medicinal products or active substances on the market which are not the facts
p.(None): corresponding information or other misleading designations or packaging
p.(None): exhibit.
p.(None): (2) It is also prohibited in connection with the placing on the market of medicinal products or
p.(None): Effective about this information that does not correspond to the facts or is misleading
p.(None): do.
p.(None): (3) A misleading situation exists in particular if
p.(None): 1. The medicinal products are considered to have an efficacy or the active substances have a property that
p.(None): according to the current state of scientific knowledge or practical
p.(None): Experience is not sufficiently documented, or
p.(None): 2. the impression is incorrectly given that success is to be expected with certainty or that after
p.(None): Intended or prolonged use, no harmful effects occur, or
p.(None): 3. the name or presentation is suitable for confusion.
p.(None): (4) It is also prohibited to announce or place objects on the market that are to be used
p.(None): are determined on or in the human body and which are based on the type and form of the announcement or the
p.(None): Placing on the market are likely to mislead consumers to expect these items
p.(None): are themselves medicinal or medicinally effective, or contain medicinal products or would be compatible with them
p.(None): Medicines applied.
p.(None): Section II
p.(None): Proprietary medicinal Products
p.(None): Approval of pharmaceutical specialties
...
p.(None): the procedure to be used, in particular with regard to the selection of the authorization holder,
p.(None): adopted. It is particularly important to ensure that the marketing authorization holder is informed about the
p.(None): necessary organizational and technical prerequisites for fulfilling him after a possible
p.(None): Approval according to this federal law.
p.(None): § 8. (1) Medicinal products do not require approval if
p.(None): 1. these to conduct non-clinical or clinical trials or clinical trials
p.(None): are determined, or
p.(None): 2. certifies a doctor, dentist or veterinarian who is authorized to practice his profession independently in Germany,
p.(None): that the drug specialty to ward off a life threatening or serious health
p.(None): Damage is urgently needed and this success with an approved and available
p.(None): Pharmaceutical specialty probably cannot be achieved according to the state of the art, or
p.(None): 3. the pharmaceutical specialty for medical treatment
p.(None): a) in the event of deployment of the Federal Army in accordance with Section 2 (1) lit. a of the Defense Act 2001,
p.(None): BGBl. I No. 146, or
p.(None): b) in preparation for a posting under the Federal Constitutional Law on Cooperation and
p.(None): Solidarity when sending units and individuals abroad (KSE-BVG),
p.(None): BGBl. I No. 38/1997, or in the context of such a posting
p.(None): is needed and the success of this treatment with an approved and available
p.(None): Pharmaceutical specialty cannot be achieved according to the state of the art, or
p.(None): 4. the pharmaceutical specialty to prevent or in connection with a disaster,
p.(None): terrorist threat or armed conflict
p.(None): should be applied and the success with an approved and available pharmaceutical specialty
p.(None): the state of the art cannot be achieved, or
p.(None): 5. the medicinal product for use by doctors or paramedics related to a
p.(None): national major event according to § 26a Sanitary Act, Federal Law Gazette I № 30/2002, from abroad
p.(None): coming to work temporarily in Austria.
p.(None): (2) If an application for reimbursement of a pharmaceutical specialty not approved in Austria is submitted to
p.(None): an Austrian social security institution, the domestic manufacturer or the
p.(None): Applicant for an import license according to the Pharmaceuticals Imports Act 2010 or for
p.(None): Notification according to the Pharmaceutical Imports Act 2010 entitled to the Austrian social security institution
p.(None): upon request to provide the information immediately and free of charge that at least
p.(None): correspond to the information in the technical information.
p.(None): § 8a. (1) Pharmaceutical specialties that meet the requirements of Article 3 Paragraph 1 or 2 of Regulation (EC)
p.(None): № 726/2004 meet no approval if the Federal Office for Health Safety
p.(None): under the conditions specified in Article 83 of Regulation (EC) № 726/2004, approval for
p.(None): which they have placed on the market as part of a "compassionate use program". The program is for
p.(None): to define a defined group of patients who have a chronic or
p.(None): suffer from serious illness or whose illness is life-threatening and who has an approved and
p.(None): available medicinal product cannot be treated satisfactorily.
p.(None): (2) Is entitled to apply for a permit in accordance with paragraph 1
...
p.(None): Federal Office for Safety in Health Care and the experts commissioned by it
p.(None): authorized to enter all rooms and to inspect all documents and copies thereof
p.(None): make as necessary to control the provisions of this section. The controls are
p.(None): except in the event of imminent danger to be carried out during operating hours.
p.(None): (2) Is determined during a check in accordance with paragraph 1, or receives the Federal Office for Security in
p.(None): Healthcare otherwise aware that the provisions of this section are violated
p.(None): it must have all the measures required to establish a state in conformity with the law
p.(None): are.
p.(None): VI. SECTION
p.(None): distribution
p.(None): Dispensing of medicines
p.(None): Section 57. (1) Medicinal products may only be supplied by the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): are on
p.(None): 1. public pharmacies, institutional pharmacies and veterinary home pharmacies,
p.(None): 2. Druggists or other traders who, according to section 59 (3), dispense medicinal products
p.(None): are authorized
p.(None): 3. Manufacturer only for the purpose of the manufacture of medicinal products or insofar as they are in accordance with the
p.(None): Trade Regulations 1994 are authorized to trade in pharmaceuticals,
p.(None): 4. pharmaceutical wholesaler,
p.(None): 5. Local authorities
p.(None): a) in connection with tasks of vaccination prophylaxis or to fulfill them by law
p.(None): assigned tasks of disease control,
p.(None): b) humanitarian aid in connection with a disaster that occurred abroad
p.(None): or a serious accident,
p.(None): c) to maintain the supply of pharmaceuticals in Germany if this is in connection with a
p.(None): Catastrophe, terrorist threat, armed conflict or pandemic
p.(None): is absolutely necessary
p.(None): 5a. Businesses and organizations that maintain basic public services
p.(None): serve and based on a between the federal government or a state and a manufacturer,
p.(None): Depositeur or pharmaceutical wholesaler concluded contract to ensure the
p.(None): Maintenance of drug supplies related to a pandemic, warlike
p.(None): Conflict or terrorist threat, in turn, individual contracts for direct purchase
p.(None): have completed a drug for the needs of their own employees,
p.(None): 6. Institutions of the Austrian Armed Forces, the pharmaceutical supply of the Armed Forces
p.(None): serve,
p.(None): 6a. the Federal Ministry of the Interior, the authorities and childcare facilities subordinate to it
p.(None): for emergency care, prevention and care of operations, provided that the medicines for
p.(None): Need to perform their duties
p.(None): 7. Institutions, the provisional judicial safekeeping or arrests, judicial
p.(None): Prison sentences or preventive judicial measures related to deprivation of liberty
p.(None): Take measures if they need drugs to perform their tasks
p.(None): 8. scientific institutes and research institutes of the local authorities and the
p.(None): Universities and the Austrian Agency for Health and Food Security, if these
p.(None): Need medicines to perform their tasks
p.(None): 9. Organized emergency medical services, provided they are addictive substances, which they use for their emergency medical services
p.(None): Need activity, and
p.(None): 10. Have a doctor who is sufficiently familiar with questions of substance abuse
p.(None): Institutions according to § 15 of the Addictive Substances Act, Federal Law Gazette I № 112/1997, for evidence-based and
p.(None): quality-assured support for clients as part of damage minimization measures,
...
p.(None): To have all necessary measures in accordance with the extent of the risk,
p.(None): which prevent the placing on the market of the medicinal product or active substance or the use of the medicinal product
p.(None): or restrict.
p.(None): (2) In the event of imminent danger from a drug or an active ingredient, measures in accordance with Paragraph 1
p.(None): 1. even without previous procedure or
p.(None): 2. be made before issuing a decision.
p.(None): In the case of Z 2, however, is from the Federal Office for Safety in Health Care within two weeks
p.(None): to issue a written notice, otherwise the measure taken is deemed to have been revoked.
p.(None): (3) The Federal Office for Safety in Health Care has the drug it has confiscated
p.(None): or to declare the seized active ingredient verf as a precautionary measure if it has one
p.(None): serious and significant danger to humans or animals and the person entitled to dispose does not
p.(None): ensures that the drug or active substance is not placed on the market after its release.
p.(None): Preliminary seizure
p.(None): Section 78a. Organs of the Federal Office for Safety in Health Care have considered
p.(None): to temporarily confiscate the protective objectives of this federal law on medicinal products or active substances if the
p.(None): there is reasonable suspicion that this
p.(None): 1. contrary to the provisions of this federal law or regulations based thereon or
p.(None): other administrative acts are placed on the market and
p.(None): 2. pose a threat to the life or health of humans or animals.
p.(None): The regulations of § 76b on the provisional seizure by supervisory bodies and on measures
p.(None): the district administrative authorities in administrative criminal proceedings as well as § 76c are to be applied.
p.(None): Section 78b applies to the enforcement of a provisional seizure.
p.(None): Section 78b. The business owner or his / her authorized representative refuses to act after this
p.(None): Tolerating surveillance or protective measures provided for by federal law can enforce them
p.(None): become.
p.(None): X. SECTION
p.(None): fees
p.(None): Section 79. (1) The Federal Minister of Health and Consumer Protection, in agreement with the
p.(None): Federal Minister of Finance Fees for the permits to be issued under this Federal Act and
p.(None): other activities of federal agencies whose necessity changes
p.(None): 1. from this Federal Act and the ordinances issued on the basis thereof or
p.(None): 2. relevant legal acts of the European Union
p.(None): results, according to experience, from the average growing costs in a tariff
p.(None): set. The tariff and its changes are to be published in the “Official Gazette of the Wiener Zeitung”.
p.(None): Copies of the tariff are from the Federal Ministry (correct: Federal Ministry) for health and
p.(None): To provide consumer protection on request against reimbursement of costs.
p.(None): (2) Is the result of this Federal Act, the regulations issued on the basis thereof
p.(None): or the legal acts within the meaning of paragraph 1 no. 2 the necessity of activities of departments of the
...
p.(None): no earlier than June 30, 2012.
p.(None): (13) The marketing authorization holder of a medicinal product that is in effect at the time of entry into force
p.(None): Federal law in the version of the federal law BGBl. I № 153/2005 was approved, must
p.(None): otherwise expiry of the approval by the Federal Office for Safety in Health Care at the latest
p.(None): December 31, 2008 report whether the medicinal product was actually placed on the market on January 1, 2006,
p.(None): whether it is actually still in circulation or from what point in time it is no longer actually in
p.(None): Traffic was. It must also be announced whether the approval is only for the purposes of Section 9a (5)
p.(None): is used.
p.(None): (13a) For applications for the authorization of a reference medicinal product for which the application for an authorization before
p.(None): At the end of October 30, 2005, the protection periods in § 15a of the Medicinal Products Act apply
p.(None): the version before the amendment to Federal Law Gazette I No. 153/2005.
p.(None): (14) Promotional material up to January 1, 2007 in the version of the requirements of this federal law
p.(None): of the Federal Law BGBl. I № 153/2005. The information officer is the Federal Office
p.(None): for Healthcare Safety to be announced by July 1, 2006 at the latest.
p.(None): (15) Homeopathic medicinal specialties that were published in the. Before the entry into force of this federal law
p.(None): Version BGBl. I № 153/2005 have been registered, as long as § 3 does not conflict with this, in
p.(None): To be placed on the market.
p.(None): Special provisions in connection with crisis situations
p.(None): § 94d. (1) In case of disaster, epidemic, pandemic, terrorist threat, martial
p.(None): The Federal Minister of Health and Women has a dispute or other crisis situation, if
p.(None): the necessary care of the population would otherwise be seriously and significantly endangered by regulation
p.(None): Exceptions to § 4, the provisions of II., VI. and VII. Section of this Federal Law and the
p.(None): to comply with the relevant ordinances issued on the basis of this federal law, to the extent and for as long
p.(None): this is necessary due to the special situation and the protection of life and health of
p.(None): Humans and animals are protected.
p.(None): (2) In the event of a disaster, epidemic, pandemic, terrorist threat, martial
p.(None): The Federal Minister of Health and Women,
p.(None): if the necessary supply of the population would otherwise be seriously and significantly endangered by
p.(None): Ordinance Regulations on supply and provision obligations for marketing authorization holders,
p.(None): Depositeurs, manufacturers, pharmaceutical wholesalers, pharmaceutical wholesalers and public pharmacies
p.(None): adopted if and as long as this is necessary due to the special situation.
p.(None): (3) A regulation pursuant to Paragraph 1 or Paragraph 2 applies for a maximum of six months.
p.(None): § 94e. (1) As long as the World Health Organization (WHO) has declared a pandemic of influenza
p.(None): 1. A license that is in accordance with the provisions of this federal law and approved for Austria
p.(None): Vaccine for vaccination against New Influenza A (H1N1) directly from the manufacturer or marketing authorization holder
p.(None): on
p.(None): (a) local authorities, and
p.(None): b) by the public sector (local authorities, health insurance providers and
p.(None): Health care facilities) certain distribution centers
p.(None): be delivered and
p.(None): 2. the vaccine by means of the local authorities or distribution centers to from the public
p.(None): Hand (local authorities, health insurance providers and health care institutions)
p.(None): certain vaccination sites are given. For the distribution of the vaccine, the
p.(None): Manufacturers, marketing authorization holders who serve local authorities and third-party distribution centers.
p.(None): (2) Medicines used in the event of a disaster, terrorist threat, martial
p.(None): Confrontation, epidemic, pandemic or other crisis situation to those in § 57 Paragraph 1 Numbers 5 and 5a
p.(None): given to maintain the drug supply and from these to
p.(None): Averting the danger posed by such a crisis situation may be kept in
p.(None): of their intended commercial packaging or original packaging to manufacturers, depositors, pharmaceutical
p.(None): Wholesalers, public pharmacies and institutional pharmacies are sold.
p.(None): (3) Pharmaceutical specialties that are available through a regional authority or on behalf of a regional authority
p.(None): Averting from a catastrophe, terrorist threat, armed conflict,
p.(None): Epidemic, pandemic or other crisis situation pending dangerous situation held in stock
p.(None): may be kept in stock even after the expiry date has passed and for stockpiling
p.(None): be handed in as well as given when the specific danger occurs, if on a professional basis
p.(None): Investigations by the Federal Office for Safety in Health Care have found that their
p.(None): Quality and impact are still guaranteed.
p.(None): § 94f. (1) Pharmacy proprietary medicinal products, which according to § 9d in the version before the entry into force
p.(None): of this federal law in the version of the federal law BGBl. I № 63/2009 have been approved
p.(None): as registered pharmacy specialties according to § 11a of this federal law in the version of the
p.(None): Federal Law BGBl. I No. 63/2009.
p.(None): (2) At the time of entry into force of this Federal Act in the version of the Federal Law BGBl. I
p.(None): №63 / 2009 pending applications for approval as a pharmacy proprietary medicinal product count as registrations
p.(None): for registration as pharmacy specialties.
p.(None): (3) The change in the package leaflet and labeling of pharmacy proprietary medicinal products,
p.(None): which according to § 9d in the version before the entry into force of this Federal Act in the version of the
p.(None): Federal Law BGBl. I № 63/2009 were admitted, and which resulted from the switch to a
p.(None): Registration must be completed by December 31, 2014.
p.(None): (4) Pharmaceutical specialties which, in accordance with § 16b in the version prior to the entry into force of this Federal Act, in
p.(None): the version of the Federal Law BGBl. I № 63/2009 placed on the market without information for use
p.(None): until the end of December 31, 2014
p.(None): correspond to. The Federal Office for Safety in Health Care can do this on reasoned request
p.(None): Extend deadline.
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): medical science is justifiable.
p.(None): (15) “Consumers” are physical or legal persons who take medicinal products for their own use
p.(None): purchase.
p.(None): (15a) "Mediation of medicinal products" includes all activities, with the exception of wholesale, in the
p.(None): Connection with the sale or purchase of medicinal products for human use, which consist of self-employed and in
p.(None): Negotiate the name of another legal or natural person without using these drugs
p.(None): Acquiring property or physically handling these medicines.
p.(None): (16) “Expiry date” is the term after which the shelf life of a medicine
p.(None): is no longer guaranteed.
p.(None): (17) Waiting time is the period between the last administration of a drug to animals under
p.(None): Compliance with drug regulations and the time up to which these animals are not available
p.(None): Extraction of food or medicinal products may be used, must be observed and the
p.(None): ensures that residues of the substances administered in these foods comply with the
p.(None): Regulation (EEC) № 2377/90 maximum permissible quantities for pharmacologically active substances
p.(None): do not exceed.
p.(None): (18) "Efficacy" is the suitability of a drug, the intended uses mentioned in § 1 Paragraph 1
p.(None): to fulfill.
p.(None): (19) "Effect" is an influenceable influence of the
p.(None): Condition or function of a biological object.
p.(None): (20) 'Central procedure' is one for the Member States of the European Union through the Regulation
p.(None): (EG) № 726/2004, OJ. № L 136/1 of March 31, 2004, established procedure for the approval of certain
p.(None): Medicinal specialties, that for medicinal products covered by the annex to the aforementioned regulation
p.(None): compulsory for pharmaceutical specialties covered by Article 3 Paragraph 2 of the Ordinance on request as required
p.(None): the requirements mentioned there apply.
p.(None): (21) 'Intermediate' is a medicinal product that is still in one or more manufacturing phases
p.(None): needs to become bulk goods.
p.(None): Definitions regarding clinical trials
p.(None): § 2a. (1) "Clinical Trial" is a systematic examination of a drug on one
p.(None): Test taker that is conducted with the goal
p.(None): 1. to research or prove the effects of investigational medicinal products,
p.(None): 2. determine side effects of investigational medicinal products, or
p.(None): 3. absorption, distribution, metabolism and excretion of investigational medicinal products
p.(None): investigate.
p.(None): This includes clinical trials conducted in one or more test centers in one or more
p.(None): Contracting parties to the European Economic Area. No clinical trial is one
p.(None): Non-interventional study within the meaning of paragraph 3.
p.(None): (2) “Multicentre clinical trial” is a clinical trial conducted under a single trial plan
p.(None): Examination that takes place in more than one test center and is therefore carried out by more than one examiner
p.(None): the test centers are located in a single or in several contracting parties to the European
p.(None): Economic area or in contracting parties and third countries.
...
p.(None): Food, documents on the waiting time,
p.(None): 32. in pharmaceutical specialties for use on animals, for the production of food or
p.(None): Medicinal products are intended to be a proof of at least six months ago
p.(None): Valid application to set the maximum residue limit according to Regulation (EEC)
p.(None): No. 2377/90, provided the active substances for the target species concerned are not yet listed in Annex I, II or
p.(None): III of Regulation (EEC) № 2377/90 are included; this does not apply if the target species is equidae
p.(None): provided they are in accordance with Commission Decision 92/623 / EEC of 20 October 1993 on
p.(None): the document for the identification of registered equidae (equine passport) and the decision
p.(None): Commission 2000/68 / EC of 22 December 1999 amending Decision 93/623 / EEC
p.(None): and to establish a procedure for identifying breeding and usage as not
p.(None): Slaughter intended for human consumption,
p.(None): 33. A statement that clinical trials are outside the European Economic Area
p.(None): have been carried out that are equivalent to the ethical requirements of Directive 2001/20 / EC,
p.(None): 34. for veterinary specialties, proof that the applicant has a
p.(None): Pharmacovigilance managers and the necessary infrastructure to each
p.(None): Side effect, its occurrence within the European Economic Area or in a third country
p.(None): is suspected to report. For human medicinal products, a summary of the
p.(None): The applicant's pharmacovigilance system, which must include:
p.(None): a) proof that the applicant has a pharmacovigilance officer,
p.(None): b) the place of residence and activity of the person responsible for pharmacovigilance in the European Union
p.(None): Economic Area,
p.(None): (c) the declaration signed by the applicant that he has the necessary resources to:
p.(None): fulfill its obligations under Section IX and
p.(None): d) the location of the place where the pharmacovigilance master documentation is kept.
p.(None): (2) An application for admission is also each a commenting and evaluating scientific
p.(None): Summary of those contained in the documents pursuant to Paragraph 1
p.(None): 1. pharmaceutical data,
p.(None): 2. Results of the non-clinical pharmacological and toxicological experiments and
p.(None): 3. Results of the clinical trials or clinical trials
p.(None): to add. This must contain all information relevant to the evaluation, whether cheap or unfavorable.
p.(None): This also applies to incomplete or canceled pharmacological or toxicological tests or
p.(None): clinical trials or clinical trials of the drug. These documents are from individuals too
p.(None): create that have the required professional quali fi cation. This is with the application for admission
p.(None): to be demonstrated by means of a curriculum vitae.
p.(None): (3) An application for approval of a veterinary specialty is also a commenting and
p.(None): Assessing scientific summary of those contained in the documents in accordance with paragraph 1
p.(None): 1. Safety and residue tests and
p.(None): 2. Tests to assess the possible environmental risks
p.(None): to add. Submission of the results of clinical trials and safety and
p.(None): Residue tests are not required for immunological veterinary specialties if they are in
p.(None): duly substantiated cases, in particular based on European Union legislation,
p.(None): cannot be carried out. These documents are to be prepared by persons who are responsible for the
p.(None): have the required professional quali fi cation. This is with the application for admission via resume
p.(None): demonstrated.
p.(None): (4) The risk management system must be proportionate to the identified and
p.(None): potential risks of the pharmaceutical specialty and the need for data on the safety after approval
p.(None): or registration. For veterinary specialties, in deviation from para. 1 no
p.(None): Submit risk management plan only if this is in view of the identified and potential
p.(None): Risks of the drug specialty is required.
p.(None): (5) In addition to the information according to paragraphs 1 to 4, an application for admission may be required
p.(None): to add:
p.(None): 1. Copies of all in another Contracting Party to the Agreement on the European
p.(None): Economic area or a third country granted marketing authorizations for the
p.(None): related pharmaceutical specialty, along with a list of parties to the agreement
p.(None): the European Economic Area in which a according to Directive 2001/83 / EC or Directive
p.(None): 2001/82 / EG application for approval is examined;
p.(None): 2. For human medicinal products, a summary of the safety data including the
p.(None): available data from the regularly updated reports on the safety of
p.(None): Medicines and reports of suspected side effects from other parties to the
p.(None): Agreement on the European Economic Area or a third country;
p.(None): 3. copies of those proposed by the applicant or by the competent national authorities
...
p.(None): Results of non-clinical trials and clinical trials or trials and the results of
p.(None): Submit safety and residue tests if he can prove that it is
p.(None): Medicinal product is a generic of a reference medicinal product and
p.(None): 1. initial approval in a contracting party to the Agreement on the European
p.(None): Economic area at least eight years ago, or
p.(None): 2. the authorization holder of the reference medicinal product has a reference to that of the authorization
p.(None): the underlying documents have been irrevocably approved in writing.
p.(None): (2) A generic drug that has been authorized in accordance with paragraph 1 may only be used after ten years
p.(None): First authorization for the reference medicinal product to be placed on the market.
p.(None): (3) If the marketing authorization holder of a reference human medicinal product within the first eight years
p.(None): After granting the first approval, approval of one or more new areas of application
p.(None): the scientific evaluation prior to its approval by the Federal Office for Security in
p.(None): Healthcare according to paragraph 14 as of significant clinical benefit compared to the existing ones
p.(None): Therapies are considered, the period provided for in paragraph 2 is extended to 11 years.
p.(None): (4) The period specified in paragraph 2 is extended for medicinal products
p.(None): 1. which are intended for use in fish or bees, for 13 years, and
p.(None): 2. which are intended for use in one or more animal species which are intended for the extraction of
p.(None): Serve food, and which contain a new active ingredient, which will expire on April 30, 2004
p.(None): was not authorized in the Union with each change to another animal, the extraction of
p.(None): Serves food that is obtained within five years of first approval, each by
p.(None): a year. However, this period can be a maximum of 13 years.
p.(None): However, the extension mentioned in Z 2 only takes place if the license holder originally also
p.(None): the establishment of maximum residue levels in accordance with Regulation (EEC) № 2377/90 for those of
p.(None): Has requested a change in the approval of the animal species concerned.
p.(None): (5) Paragraph 1 also applies if the reference medicinal product is not authorized in Austria
p.(None): if it is in another party to the Agreement on the European Economic Area
p.(None): was approved. In this case, the applicant has the name of the contracting party of the
p.(None): Agreement on the European Economic Area to specify in which the reference medicinal product
p.(None): is or has been approved. In this case, the Federal Office for Safety in Health Care has the
p.(None): competent authority of the other party to the Agreement on the European Economic Area
p.(None): request within a month to send confirmation that the reference medicinal product
p.(None): is or has been approved, as well as the full composition of the reference medicine and others
p.(None): Documents if required for the approval of the generic. If the
p.(None): The Federal Office for Safety in Health Care asks the agency for the
p.(None): corresponding information and documents.
p.(None): (6) Were in an amendment for a new area of application of a human medicinal product in
p.(None): Regarding an already well-established drug related to non-clinical or clinical studies
p.(None): the new area of application carried out by the Federal Office for Safety in Health Care
p.(None): Paragraph 14 were considered to be significant, so with an application according to § 10 or according to the
p.(None): Regulation (EC) № 1234/2008 on the examination of changes in the authorization of human and
p.(None): Veterinary medicinal products, OJ. № L 334 of 12.12.2008 p. 7 as amended by Regulation (EU) № 712/2012, OJ.
p.(None): № L 209, 4.8.2012 p. 4, one year not to refer to this data. This
p.(None): Exclusive period is not cumulative.
p.(None): (7) If the approval or its modification of a veterinary specialty, its active substance or active substances
p.(None): used for veterinary purposes in the Union for at least ten years, for another for
p.(None): Obtaining food certain target animal species, and will be new residue attempts
p.(None): according to Regulation (EEC) № 2377/90 and submitted new clinical trials, so can apply
p.(None): in accordance with section 10 or section 24, no reference is made to this data for three years.
p.(None): (8) A medicinal product that is similar to a biological reference medicine fulfills the definition
p.(None): of the generic not because in particular the raw materials or the manufacturing process of the biological
p.(None): Drug differ from that of the reference biological drug, so the results are
p.(None): suitable non-clinical trials or clinical trials or trials regarding these differences
p.(None): required. The type and number of additional data to be submitted must be in Annex I to the Directive
p.(None): 2001/83 / EG, in the version of the directives 2004/24 / EG and 2004/27 / EG or the directive 2001/82 / EG, in
p.(None): comply with the version of Directive 2004/28 / EC.
p.(None): (9) If the medicinal product does not fall under the definition of a generic or the bioequivalence can
p.(None): not demonstrated by bioavailability studies, as well as in the event of a change in the active ingredient or
p.(None): the active ingredients, the areas of application, the strength, the dosage form or the route of administration
p.(None): compared to the reference medicine, are the results of the corresponding non-clinical trials or
p.(None): clinical trials or trials as well as the results of the corresponding safety and
p.(None): To present residue tests.
p.(None): (10) If an authorization according to § 7 has been granted for a pharmaceutical specialty, then for the purposes of
...
p.(None): technical progress in the field of veterinary medicines.
p.(None): (13) With regard to the implementation of the required to obtain an authorization according to paragraph 1 and a
p.(None): Modification of an approval required studies and experiments and the resulting practical
p.(None): Requirements apply to § 22 Paragraph 1 Patent Act 1970 and § 4 Paragraph 1 Utility Model Act.
p.(None): (14) As part of the examination of an amendment for a new area of application, the
p.(None): Federal Office for Safety in Health Care to decide on application
p.(None): 1. whether the new application areas of significant clinical benefit compared to the
p.(None): existing therapies are to be viewed and
p.(None): 2. whether significant non-clinical or clinical studies in an already well-established active ingredient
p.(None): In connection with the new area of application.
p.(None): (15) The protection periods contained in this provision in accordance with paragraphs 1, 2, 3, 4 and 12 apply to applications
p.(None): on the authorization of a reference medicinal product for which the application for authorization has expired after the expiry of the
p.(None): October 30, 2005.
p.(None): § 10a. (1) In deviation from Section 9a (1) nos. 19 and 20, the applicant is not obliged to submit the results
p.(None): the non-clinical trials or the clinical trials or trials or in deviation from Section 9a (1)
p.(None): Item 28 does not undertake to submit the results of the safety and residue tests if it
p.(None): can prove by means of detailed bibliographical documents that
p.(None): 1. the active substance or substances of the medicinal specialty in the Union for at least ten years
p.(None): generally used medicinally or veterinary and
p.(None): 2. the efficacy and safety of the medicinal product recognized for approval are given
p.(None): is.
p.(None): (2) The assessment report issued by the Agency after the assessment of an application for the fixing of
p.(None): Maximum residue levels according to Regulation (EEC) № 2377/90 can be published in
p.(None): appropriately as a corresponding bibliographical document, especially for
p.(None): Safety tests are used.
p.(None): § 10b. In the case of a new pharmaceutical specialty, which consists of known ingredients within the meaning of § 10a,
p.(None): which have so far not been approved in this combination are the results of new non-clinical trials
p.(None): or clinical trials or trials and, if applicable, the results of safety and
p.(None): Residue tests only for this combination, but not for the individual components.
p.(None): Authorization for distribution in parallel import
p.(None): § 10c. (1) medicinal specialties,
p.(None): 1. the one approved or registered in Austria on the basis of this federal law
p.(None): Pharmaceutical specialty (approval),
p.(None): 2. from another party to the Agreement on the European Economic Area
p.(None): be introduced, and
p.(None): 3. in which the assessment of the already approved or registered pharmaceutical specialty
p.(None): Safety and effectiveness can be used for health protection without any risk
p.(None): can
p.(None): may only be placed on the market if the Federal Office for Safety in Health Care
p.(None): Has given approval for sales in parallel imports.
p.(None): (2) With regard to the application for approval for sales in parallel import, § 9 Paragraph 1 and
p.(None): Section 9a (1) 1 accordingly.
...
p.(None): the applicant will introduce.
p.(None): (4) Pharmaceutical specialties that have been granted an authorization in accordance with Regulation (EC) № 726/2004 and
p.(None): Paragraph 1 lines 2 and 3 may only be placed on the market if they are in German
p.(None): Labeling and instructions for use are provided and there is German-language technical information
p.(None): and a notification to the agency and the Federal Office for Safety in Health Care has been made beforehand.
p.(None): This message must contain:
p.(None): 1. proof of the right to apply in accordance with § 9,
p.(None): 2. Name and registration number of those approved according to Regulation (EEC) № 726/2004
p.(None): Medicinal product,
p.(None): 3. the party to the Agreement on the European Economic Area in which the imported
p.(None): Drug specialty is distributed (home Member State),
p.(None): 4. the name and address of the authorization holder,
p.(None): 5. the name and address of the manufacturer,
p.(None): 6. the pack sizes intended for distribution in Austria,
p.(None): 7. A declaration that the texts for outer packaging, primary packaging, instructions for use and
p.(None): Specialist information, apart from company-specific information, no textual deviations from the
p.(None): Labeling, instructions for use and specialist information according to the regulation (EWG)
p.(None): No. 726/2004 approved pharmaceutical specialty.
p.(None): To the agency is a fee for checking compliance with the conditions set out in Union law
p.(None): Medicines and are specified in the marketing authorizations. their
p.(None): Dimensioning is based on Union law regulations.
p.(None): (5) The applicant is obliged to submit the application pursuant to paragraph 3 to the authorization holder
p.(None): or owner of the registration. The same applies to the notification according to paragraph 4.
p.(None): (6) If this is necessary for reasons of drug safety, with the consent of the
p.(None): Federal Office for Safety in Health Care of the requirements for labeling in paragraph 3
p.(None): Z 12 can be deviated with regard to the primary packaging.
p.(None): Registration of homeopathic medicinal specialties
p.(None): § 11. (1) Homeopathic medicinal products are not subject to the authorization requirement according to § 7 if
p.(None): she
p.(None): 1. are intended as a human medicinal product for external or oral use,
p.(None): 2. as a veterinary specialty for administration according to the European Pharmacopoeia or in
p.(None): Lack of this, according to the pharmacopoeia of the Member States currently in use
p.(None): described route of administration are determined,
p.(None): 3. no specific therapeutic indication in the name, labeling or, if applicable, in the
p.(None): Have package leaflet, and
p.(None): 4. are only given in dilutions that guarantee the safety of the medicinal product.
p.(None): Above all, the medicinal product must not contain more than one part per ten thousand of the mother tincture,
p.(None): or not more than one hundredth of the smallest dose that may be used in allopathy
p.(None): those active ingredients in the presence of which in an allopathic medicinal product, the latter
p.(None): requires a prescription.
p.(None): (2) Homeopathic medicinal specialties within the meaning of paragraph 1 may only be sold in Germany or for the
p.(None): Levy will be kept available when registered with the Federal Office for Safety in Health Care
...
p.(None): (2) The Federal Office for Safety in Health Care may for reasons of health protection
p.(None): or, for animal health reasons, provide for exceptions from paragraph 1.
p.(None): (3) Paragraphs 1 and 2 do not apply to approvals for purposes according to § 9a paragraph 5.
p.(None): (4) The period mentioned in paragraph 1 begins in cases in which the actual placing on the market only occurs
p.(None): Due to conflicting patent law, it is not possible until this ceases to exist
p.(None): Obstacle to run. Proof of this must be provided on presentation of suitable documents.
p.(None): repeal
p.(None): § 23. (1) The approval of a pharmaceutical specialty is to be revoked if
p.(None): 1. it becomes known that there was a reason for refusal in accordance with Section 19 (1) to (3) upon admission
p.(None): or has occurred subsequently, and the protection of human or animal health by
p.(None): Subsequent stipulation of requirements within the meaning of Section 18 (3) does not appear to be guaranteed,
p.(None): or
p.(None): 2. the medicinal product without fulfilling the requirements issued in accordance with section 18 (3) or section 24a (2)
p.(None): Marketing authorization holder is placed on the market and a marketing authorization is revoked to protect the
p.(None): Human or animal health appears appropriate, or
p.(None): 3. the license holder waives the license.
p.(None): (2) The approval of a veterinary specialty shall also be revoked if this is due to a change
p.(None): in the Annexes to Regulation (EEC) № 2377/90 is required. This has to be done within 60 days of
p.(None): Publication of the amendments to the Annexes to the said Regulation in the Official Journal of the European Union
p.(None): to take place.
p.(None): (3) If there is a reason for annulment pursuant to Paragraph 1 No. 1 or 2, this may be
p.(None): can be removed by the license holder within a reasonable time, the Federal Office of
p.(None): Healthcare security has the rest of approval.
p.(None): (4) The authorization for distribution in parallel import is to be revoked if
p.(None): 1. it becomes known that when granting the approval, a reason for refusal pursuant to Section 10c (3)
p.(None): was present or such occurred subsequently, or
p.(None): 2. the medicinal product is placed on the market without fulfilling the requirements given in accordance with Section 18 (5),
p.(None): or
p.(None): 3. the license holder waives the license.
p.(None): (5) Registration of a homeopathic medicinal specialty should be canceled if
p.(None): 1. it becomes known that when deciding on the registration a reason for rejection according to § 11
p.(None): Paragraph 4 has existed or occurred subsequently, and the protection of human health
p.(None): or animal by subsequently stipulating requirements within the meaning of Section 11 (2)
p.(None): appears guaranteed, or
p.(None): 2. the pharmaceutical specialty without fulfilling the obligations given in accordance with § 11 paragraph 2 by the owner of a
p.(None): Registration is placed on the market and a deregistration to protect the
p.(None): Human or animal health appears appropriate, or
p.(None): 3. the owner of the registration waives the registration.
p.(None): (6) The registration of a pharmacy proprietary medicinal product should be canceled if
p.(None): 1. it becomes known that when deciding on the registration a reason for refusal in accordance with § 11a
...
p.(None): To ensure pharmaceutical specialty in accordance with the requirements on which the approval is based.
p.(None): (2) In the case of bulk goods or intermediate products that are approved for manufacturing in Austria
p.(None): Medicinal products are used and imported from outside the European Economic Area
p.(None): each batch, regardless of whether it was manufactured in the European Economic Area, from
p.(None): pharmaceutical entrepreneurs a full qualitative and quantitative analysis, at least in the
p.(None): With regard to effective components, as well as all other tests or tests,
p.(None): which are required to ensure the quality of the bulk goods or the intermediate product in accordance with the
p.(None): To ensure approval based on requirements.
p.(None): (3) For investigational medicinal products imported from outside the European Economic Area
p.(None): each batch, regardless of whether it was manufactured in the European Economic Area, from
p.(None): pharmaceutical entrepreneurs to undergo all the necessary analyzes and tests to ensure quality
p.(None): the investigational medicinal products in accordance with the basis for the proper application for approval in accordance with Section 40
p.(None): Ensure information. This also applies to investigational medicinal products that are considered in a clinical trial
p.(None): Comparative medicinal products are to be used in a country that is not a party to the
p.(None): Agreement on the European Economic Area is made, manufactured and placed on the market there
p.(None): may be imported from outside the European Economic Area, if none
p.(None): Documents are available to confirm that each batch has been manufactured to standards that comply with the
p.(None): standards set by the European Union are at least equivalent.
p.(None): (4) In another party to the Agreement on the European Economic Area pursuant to
p.(None): Paragraphs 1 to 3 checked batches are exempt from the above-mentioned checks when imported into Austria,
p.(None): if signed by the competent person of the pharmaceutical company
p.(None): Control reports are attached.
p.(None): (5) If appropriate agreements between the European Union and the exporting country
p.(None): have been taken to ensure that the manufacturer of the drug is in the process of manufacture
p.(None): Followed rules that are at least those under Community law
p.(None): comply with the stipulated regulations, and that the controls according to paragraphs 1 to 3 are already in the exporting country
p.(None): have been carried out, the pharmaceutical entrepreneur is exempt from the obligation according to paragraphs 1 to 3
p.(None): freed.
p.(None): Internet portal for pharmaceuticals and pharmaceutical specialty registers
p.(None): Section 27. (1) In a register to be kept at the Federal Office for Safety in Health Care
p.(None): (Pharmaceutical Specialty Register)
p.(None): 1. approved pharmaceutical specialties,
p.(None): 2. homeopathic medicinal specialties within the meaning of § 11 paragraph 1, provided that their registration is not
p.(None): to be rejected in accordance with Section 11 (4),
p.(None): 3. Pharmacy-owned pharmaceutical specialties within the meaning of Section 11a (1), unless their registration
p.(None): is to be rejected in accordance with Section 11a (3),
p.(None): 4. traditional vegetable medicinal specialties within the meaning of § 12, provided that their registration is not in accordance with
p.(None): § 13 paragraph 2 is to be rejected,
p.(None): to be entered under a consecutive number (registration or registration number). Medicinal specialties that
p.(None): are placed on the market on the basis of a license in accordance with § 10c
p.(None): Approval number of the corresponding approved or registered pharmaceutical specialty (reference approval)
p.(None): take. However, this is due to a reference to the fact of parallel import and its
p.(None): To complete the order.
p.(None): (2) Any change or cancellation of an authorization or
...
p.(None): clinical trials or trials, the assessment of the risk management system and the
p.(None): Summary of the pharmacovigilance system and, where appropriate, the safety and
p.(None): Residue tests) for each requested area of application, after all for commercial reasons in the
p.(None): The party's confidentiality interests have been removed immediately, but at the latest
p.(None): generally accessible three months after the notification in full text on the Internet portal for medicinal products
p.(None): to publish. The assessment report is a generally understandable summary
p.(None): publish, which must in particular contain a section on the conditions of the application. In front
p.(None): The approval or registration holder can be heard in the publication.
p.(None): III. SECTION
p.(None): Clinical trial
p.(None): general requirements
p.(None): § 28. (1) Clinical trials may only be carried out if
p.(None): 1. as expected, they meet the objectives of section 2a (1),
p.(None): 2. Information about relevant physical and chemical data or biological properties as well
p.(None): about the applied pharmaceutical technology and
p.(None): 3. Meaningful results of non-clinical tests are available, which correspond to the respective
p.(None): State of the art.
p.(None): (2) The planning and implementation of clinical trials must comply with the regulations
p.(None): Federal law according to the state of the sciences and according to the principles of good clinical
p.(None): Practice. To interpret the principles of good clinical practice, those are generally accepted
p.(None): To use the principles and requirements set out in Volume 10 of the regulations for medicinal products in the
p.(None): European Union are published.
p.(None): § 29. (1) When planning, setting up and carrying out clinical trials, the health
p.(None): To keep risks and burdens for the test participant as low as possible.
p.(None): (2) The clinical trial of medicinal products may only be carried out if the risks associated with it for
p.(None): the test participants are connected, measured by the expected meaning of the result of the
p.(None): Examination for medicine are justifiable and the risk of impairment of the
p.(None): Examiner health
p.(None): 1. is not significant or
p.(None): 2. is outweighed by the benefit to be expected from the use of the drug
p.(None): Health.
p.(None): (3) The clinical trial of a medicinal product may only be carried out on patients if
p.(None): 1. Results of clinical trials on healthy volunteers are available, unless
p.(None): The investigational medicinal product may not be tested on healthy volunteers in accordance with paragraph 2 no
p.(None): no meaningful result can be expected from healthy subjects, and
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is to treat the disease or the patient on whom the clinical trial is to be performed
p.(None): to recognize their course, to heal or alleviate them or to prevent them from further illnesses
p.(None): protect.
p.(None): If there is meaningful data according to Z 1 and from clinical trials on patients, this may not be available
p.(None): the requirements of Z 2, a clinical trial on the patient can also be carried out if
...
p.(None): and the professional and personal equipment of a public pharmacy or institutional pharmacy
p.(None): Ordinance to issue more detailed rules for the examination and assessment of the criteria according to Z 1 to 4.
p.(None): The regulation is on the homepage of the Federal Office for Safety in Health Care
p.(None): to make known. The Federal Office for Safety in Health Care has exceeded the usual
p.(None): Pharmacy company to determine this with notice.
p.(None): (3) The ordinance pursuant to Paragraph 1 shall contain in particular more detailed provisions on
p.(None): 1. Manufacture, placing on the market, import and export of medicinal products or active substances,
p.(None): 1a. Staffing and qualification,
p.(None): 2. type and scope of the control of drugs or active substances, such as the management of a control laboratory,
p.(None): 3. Hygiene requirements,
p.(None): 4. quality, size, equipment, dedication and location of the operating rooms and their furnishings,
p.(None): 5. Nature of the technical equipment,
p.(None): 6. quality of work clothing,
p.(None): 7. Nature and labeling of the containers,
p.(None): 8. Management and storage of reservations, records, reports, samples and others
p.(None): show
p.(None): 9. nature and keeping of the animals used in the manufacture of the medicinal products,
p.(None): 10. Readiness for duty for pharmaceutical wholesalers and pharmaceutical wholesalers,
p.(None): 11. Storage and storage as well as transport,
p.(None): 12. Withdrawal, labeling, separation or destruction of non-marketable goods
p.(None): Drugs.
p.(None): (3a) In the regulation pursuant to Paragraph 1, the Federal Minister of Health, in agreement with the
p.(None): Federal Minister of Finance for implementing Union law regulations
p.(None): Monitoring measures on the import and export of active substances to ensure that
p.(None): these correspond to the good manufacturing and sales practice for active ingredients. It can also be provided
p.(None): which active ingredients within the meaning of Regulation (EEC) № 2658/87 on customs and statistical
p.(None): Nomenclature and the Common Customs Tariff, OJ. № L 256 of September 7, 1987 S 1, last changed by
p.(None): the Implementing Regulation (EU) № 155/2012, OJ. № L 50 from 02/23/2012 p. 1, for surveillance
p.(None): through the customs offices.
p.(None): (4) The Federal Minister of Health and Women can further specify by ordinance
p.(None): Provisions regarding the requirements for wholesalers of pharmaceuticals, in particular
p.(None): with regard to sufficient storage, assortment design, availability,
p.(None): Supply intensity, regularity of supply and operational obligations taking into account the
p.(None): supplying area. A procedure for their recognition can also be provided.
p.(None): Section 62a. (1) As far as it is necessary to ensure the health and life of humans or animals
p.(None): To ensure the required quality of the medicinal products and the supply of medicinal products, the
p.(None): Federal Minister of Health, Sport and Consumer Protection by ordinance an operating regulation for
p.(None): to enact the operation of pharmacies.
p.(None): (2) A regulation in accordance with paragraph 1 must contain in particular more detailed provisions on:
p.(None): 1. the minimum size, dedication, location, quality, equipment and furnishings of the
p.(None): Pharmacies operating rooms,
p.(None): 2. Devices and magistral workplaces,
p.(None): 3. the nature and labeling of the containers,
...
p.(None): (3) Any changes that affect the quality or safety of the manufactured, in circulation
p.(None): brought or controlled active ingredients, require a permit from the Federal Office for
p.(None): Healthcare security.
p.(None): (4) Sections 64 to 66a, 67 (1) regarding periodic reviews, 69 and 71 apply to companies
p.(None): in accordance with Paragraph 1.
p.(None): Section 64. (1) The permit pursuant to Section 63 (1) is to be issued if the operating rules are complied with
p.(None): and due to the equipment, the necessary for the health and life of humans or animals
p.(None): The quality of the pharmaceuticals or active ingredients is guaranteed.
p.(None): (2) The Federal Office for Safety in Health Care can also order a trial operation if
p.(None): this is necessary to assess the existence of the prerequisites within the meaning of paragraph 1.
p.(None): (3) If necessary, the license must be issued stipulating such conditions as to
p.(None): Fulfillment necessary for the protection of human and animal health and life
p.(None): Ensure the nature of the drug or active ingredients
p.(None): (4) The Federal Office for Safety in Health Care can also issue a restricted permit in the
p.(None): Issue within the meaning of section 63 (1) if the conditions for granting such a license are only given in
p.(None): to this limited extent.
p.(None): (5) The Federal Office for Safety in Health Care has the data on the authorization for
p.(None): Manufacture and placing on the market of medicinal products or active substances in accordance with section 63 (1) and section 63a (2)
p.(None): or 3 or Section 65 (1) in the Union database in accordance with Article 111 (6) of Directive 2001/83 / EC
p.(None): enter.
p.(None): Section 65. (1) Significant changes with regard to manufacturing, placing on the market or control
p.(None): the medicinal products or active substances, in particular with regard to the information in accordance with section 63 (2) lines 1 to 3, the
p.(None): Effects on the nature of drugs or active ingredients or the production or
p.(None): Distribution program require the approval of the Federal Office for Security in the
p.(None): Healthcare system within the meaning of Section 63 (1). The Federal Office for Healthcare Safety has over
p.(None): to decide a corresponding application within 30 days of receipt of the application. This
p.(None): In exceptional cases, the deadline can be extended to 90 days.
p.(None): (2) The Federal Office for Safety in Health Care can provide the applicant with additional information
p.(None): with regard to the requested change in accordance with paragraph 1. In this case, the deadlines are set according to
p.(None): Paragraph 1 inhibited until additional information is received.
p.(None): (3) The holder of the license pursuant to Section 63 (1) or Section 65 (1) has all intended changes
p.(None): in relation to the knowledgeable person to the Federal Office for Health Safety in advance
p.(None): tell. In the event of an unforeseen change in relation to the knowledgeable person, the notice
p.(None): to be done immediately.
p.(None): Section 66. If the license is granted in accordance with Section 63 (1) or Section 65 (1), it follows that
p.(None): Compliance with the prescribed requirements for the health and life of humans or animals
p.(None): required condition of the drugs or active ingredients is not sufficiently guaranteed, that has
p.(None): Federal Office for Safety in Health Care to prescribe other or additional requirements.
...
p.(None): Inspection and rehearsal plan to be submitted to the Federal Ministry of Health by March 31 of
p.(None): report on the execution of the following calendar year.
p.(None): (2) The reviews of companies that manufacture or control pharmaceuticals or active ingredients are
p.(None): at least once in three years, from establishments that provide human blood or blood components, provided that
p.(None): intended for transfusion, processed, stored or distributed, once in two years, by others
p.(None): Operate at least once every five years. You are in default unless there is a danger or if
p.(None): there is a reasonable assumption that the effectiveness of the official act is impaired,
p.(None): to announce in advance. Checks according to Art. 8 of Directive 96/22 / EC are without prior notice
p.(None): perform.
p.(None): (3) The Federal Minister of Health and Environmental Protection is authorized to deal with the highest
p.(None): Health authorities of those countries to which drugs or active substances are exported or from which drugs are exported
p.(None): or active substances are to be imported, administrative convention regarding the review of the
p.(None): Establishments in which these medicinal products or active substances are manufactured, mutual recognition
p.(None): to complete these reviews and exchange of information about these establishments.
p.(None): (4) The Federal Office for Safety in Health Care may carry out operational reviews by third countries
p.(None): Perform drug manufacturers to determine if they are manufactured according to standards and
p.(None): have been checked in accordance with the standards of good manufacturing practice set by the European Union
p.(None): are at least equivalent. The Federal Office for Safety in Health Care can
p.(None): Suspicion of a violation of the requirements of this section or based on this
p.(None): Section decrees for manufacturers or distributors of third-party countries
p.(None): Carry out active ingredient checks. The Federal Office for Safety in Health Care has contributed
p.(None): Co-ordinate operational reviews in third countries with the Agency and these
p.(None): to inform about planned and carried out operational reviews.
p.(None): (5) The Federal Office for Safety in Health Care can, if there are suspicion reasons
p.(None): Violation of the provisions of this section or those adopted on the basis of this section
p.(None): Regulations for companies that manufacture or import auxiliary materials, carry out company reviews.
p.(None): The Federal Office for Safety in Health Care can also in the premises of
p.(None): Marketing authorization holders, registration holders or pharmaceutical intermediaries
p.(None): carry out.
p.(None): (6) Operational reviews in accordance with paragraphs 1 and 4 and operational reviews in accordance with paragraph 5 of
p.(None): Companies that manufacture or import auxiliary materials can, at the request of another Member State,
p.(None): the European Commission or the Agency. Without prejudice to any agreements
p.(None): between the European Union and countries that are not parties to the Agreement on the
p.(None): Are European Economic Area, the Federal Office for Safety in Health Care one
p.(None): Manufacturer in the country that is not a contracting state to the Agreement on the European Economic Area,
p.(None): request to undergo an operational review in accordance with the requirements of the European Union
p.(None): (7) The Federal Office for Safety in Health Care has company reviews of companies that
p.(None): 1. Human medicinal products or
p.(None): 2. Active ingredients
p.(None): manufacture, control or place on the market according to the guidelines of the European Commission
p.(None): Art. 111a of Directive 2001/83 / EC and the collection of the
p.(None): To carry out Community procedures for inspections and the exchange of information, with the
p.(None): Agency by exchanging information about planned and carried out operational reviews
p.(None): together.
p.(None): (8) The Federal Office for Safety in Health Care introduces its inspection activities
p.(None): professionally designed quality system, by the organs of the Federal Office and by this
p.(None): consulted experts in these activities. The quality system is closed if necessary
p.(None): To update.
p.(None): Section 68. (1) The organs of the Federal Ministry of Health and Women and of the bodies under Section 67 (1)
p.(None): authorized the governor, the organs of the Federal Office for Safety in Health Care as well
p.(None): by the Federal Minister for Health and Women or the Federal Office for Security in the
p.(None): Healthcare experts are authorized to
p.(None): 1. Companies in accordance with § 62 Paragraph 1 and
p.(None): 2. Facilities and means of transport of such companies that are operated by companies in accordance with Section 62 (1) with
p.(None): Storage or transport have been commissioned, provided that they are for storage or transport
p.(None): of drugs or active ingredients can serve
p.(None): to enter, to visit, to check and to take samples in the quantity required for an examination
p.(None): and to inspect the records of the company, which according to drug law
...
p.(None): (3) No compensation is due for the samples taken in accordance with paragraph 1.
p.(None): (4) A record according to §§ 14f AVG and its content is to be recorded for each company audit
p.(None): from the Federal Office for Safety in Health Care to the holder of the operating license
p.(None): bring is. In terms of content, the minutes are based on those of the European Commission
p.(None): published guidelines in accordance with Art. 51 of Directive 2001/82 / EC or Art. 111a of Directive 2001/83 / EC
p.(None): to orient. Upon reasoned request from another party to the Agreement on the European
p.(None): Economic area or Switzerland, the Federal Office for Safety in Health Care has this
p.(None): Send the record to the requesting state.
p.(None): (5) The Federal Office for Safety in Health Care has within 90 days of completion
p.(None): to issue a certificate of an operational audit if the operational audit has shown
p.(None): that the operation complies with the provisions of this section, those adopted on the basis of this section
p.(None): Regulations and the operating license. The form and content of the certi fi cate are those of the
p.(None): European Commission published guidelines according to Art. 51 of Directive 2001/82 / EC and Art. 111a
p.(None): of Directive 2001/83 / EC. If these requirements are not met, that has
p.(None): Federal Office for Safety in Health Care with notice within the specified period
p.(None): determine. The certi fi cate is to be withdrawn if it subsequently becomes known that the requirements
p.(None): did not exist. It must be revoked if the requirements are no longer met.
p.(None): (6) The Federal Office for Safety in Health Care has the certificates it has issued in accordance with
p.(None): Paragraph 5 in the Union database in accordance with Art. 111 Paragraph 6 of Directive 2001/83 / EC. In these
p.(None): The Federal Office for Safety in Health Care also has information about companies that database
p.(None): the provisions of this federal law or ordinances issued on the basis of this federal law
p.(None): do not correspond to enter. This also applies to the registration and deletion of pharmaceutical intermediaries.
p.(None): Section 69. (1) In cases of imminent danger to human or animal health caused by medicinal products
p.(None): Federal Office for Safety in Health Care according to the extent of the risk
p.(None): 1. the complete or partial closure of the business, the decommissioning of technical facilities or
p.(None): other measures to prevent the placing on the market of medicinal products or substances
p.(None): or
p.(None): 2. To impose requirements to ensure compliance with the provisions of this federal law or on grounds
p.(None): to ensure ordinances enacted by this federal law.
p.(None): (2) In cases of imminent danger from drugs, measures in accordance with paragraph 1 can also be taken
p.(None): be carried out on the spot without prior procedure or before issuing a decision;
p.(None): however, a written notification must be issued within two weeks, otherwise the one that has been passed
p.(None): Measure is deemed canceled.
p.(None): personal requirements
p.(None): Section 69a. (1) In a company within the meaning of Section 62 (1) may perform the tasks of a knowledgeable person
p.(None): and with the management of the manufacture of pharmaceuticals only people with the necessary scientific
p.(None): Vocational training and appropriate practical training.
p.(None): (2) The Federal Minister of Health and Women has issued an ordinance with regard to the
...
p.(None): Market surveillance and pharmacovigilance
p.(None): General principles
p.(None): § 75. (1) For the interpretation of the principles of pharmacovigilance are the generally recognized
p.(None): scientific principles and requirements set out in the by the European Commission
p.(None): guidelines on good practice in the field of pharmacovigilance are included.
p.(None): (2) To the extent that authorization holders are addressed in this section, these provisions also apply
p.(None): for holders of a registration of a traditional herbal medicinal specialty.
p.(None): (3) The Federal Office for Safety in Health Care must operate a system that prevents
p.(None): to ensure that medicinal products that are suspected to be hazardous to health reach patients.
p.(None): Note for the following provision
p.(None): For the reference period cf. § 94h.
p.(None): statutory authorization
p.(None): Section 75a. The Federal Minister of Health has issued an ordinance, insofar as this is considered
p.(None): the requirements for in-depth and rapid information and the functioning of the pharmacovigilance system
p.(None): it is necessary to issue more detailed provisions on
p.(None): 1. the categories to be reported with regard to their frequency, severity and scientific relevance
p.(None): of side effects and
p.(None): 2. Content, scope and form of the report.
p.(None): Note for the following provision
p.(None): For the reference period cf. § 94h.
p.(None): Pharmacovigilance system of the Federal Office for Safety in Health Care
p.(None): Section 75b. (1) The Federal Office for Safety in Health Care has a pharmacovigilance system too
p.(None): lead the collection of important information for drug monitoring and their
p.(None): scientific evaluation and participation in pharmacovigilance activities of the European Union
p.(None): serves.
p.(None): (2) The pharmacovigilance system contains information about the risks of medicinal products for health
p.(None): of the patient or public health. Concerning this information
p.(None): especially side effects of human medicinal products including side effects related
p.(None): with professional exposure to the drug specialty. Furthermore, side effects of
p.(None): Veterinary drugs and human side effects related to the use of
p.(None): To collect veterinary medicinal products.
p.(None): (3) The Federal Office for Safety in Health Care must within the framework of pharmacovigilance
p.(None): Systems scientifically evaluate all information, options for risk minimization and -
p.(None): Check avoidance and, if necessary, measures with regard to approvals or registrations
p.(None): to meet.
p.(None): (4) The pharmacovigilance system must be effective and appropriate for its purpose
p.(None): Quality system.
p.(None): (5) The Federal Office for Safety in Health Care has regular audits of its
p.(None): Pharmacovigilance system for medicinal products for human use and the Commission
p.(None): Report on September 21, 2013 and thereafter every two years.
p.(None): (6) The Federal Office for Safety in Health Care has at least the agency and the commission
p.(None): 24 hours prior to a public notice regarding pharmacovigilance concerns regarding the
p.(None): To inform application of a medicinal product, unless that to protect public health
p.(None): prompt public communications are required.
p.(None): Section 75c. (1) Within the framework of pharmacovigilance, the Federal Office for Safety in Health Care
p.(None): Systems ensure that the following information is available on the Internet portal for medicinal products (§ 27)
...
p.(None): 3. It evaluates the data in the eudravigilance database to determine whether it was new or changed
p.(None): There are risks and whether the benefit-risk balance of drugs is affected.
p.(None): (2) The Federal Office for Safety in Health Care has affected license holders and the
p.(None): To inform the agency if it is recognized that new or changed risks exist or that this is happening
p.(None): Risk-benefit ratio of pharmaceutical specialties has changed.
p.(None): Pharmakovigilanzinspektionen
p.(None): § 75f. (1) The Federal Office for Safety in Health Care has companies in accordance with Section 62 Paragraph 1 and of
p.(None): periodically with these pharmacovigilance officers with regard to compliance with the obligations
p.(None): check this section.
p.(None): (2) Section 68 subsections 1 to 3 apply mutatis mutandis.
p.(None): (3) A record of every pharmacovigilance inspection must be recorded in accordance with §§ 14f AVG, the
p.(None): To bring the license holder's content to the attention of the Federal Office for Safety in Health Care
p.(None): is.
p.(None): (4) Does the pharmacovigilance inspection conclude that the marketing authorization holder meets the requirements
p.(None): of this section has not been met, the Federal Office for Safety in Health Care
p.(None): After obtaining an opinion on the identified deficiencies, the authorization holder can rectify them
p.(None): To order. If the remedy order is not fulfilled, the Federal Office has
p.(None): To take measures according to § 23.
p.(None): (5) In cases of paragraph 4, the Federal Office for Safety in Health Care has the agency, the
p.(None): To inform the Commission and the other Member States of the Union, if they are
p.(None): Human medicinal products deals.
p.(None): (6) The Federal Office for Safety in Health Care has carried out the inspections in accordance with the guidelines of
p.(None): Commission under Article 111a of Directive 2001/83 / EC and with the agency
p.(None): Exchange information on planned and carried out inspections.
p.(None): Duties of health professionals
p.(None): Section 75g. (1) Doctors, dentists, veterinarians, dentists, midwives and, insofar as they are not required to report
p.(None): According to § 75j, pharmacists and traders who are registered according to the 1994 Industrial Code
p.(None): Manufacture of medicinal products or wholesalers of medicinal products, and have drugstores
p.(None): 1. suspected side effects or
p.(None): 2. suspected side effects in humans or
p.(None): 3. the lack of the expected effectiveness or
p.(None): 4. insufficient waiting times
p.(None): of medicinal products that have occurred domestically and are known to them due to their professional activity
p.(None): to the Federal Office for Security in accordance with a regulation pursuant to Section 75a
p.(None): to report in healthcare.
p.(None): (2) Those who are obliged to report in accordance with paragraph 1 have all to the Federal Office for Safety in Health Care
p.(None): Share observations and data that may be important for drug safety. The
p.(None): The transmission of personal data is only permitted in a pseudonymized form.
p.(None): § 75h. Persons who are not subject to the reporting obligation in accordance with sections 75g and 75j, in particular patients,
p.(None): have the opportunity to report suspected side effects of medicines to the Federal Office for Safety
p.(None): Healthcare via the Internet portal for medicinal products or by post.
p.(None): Obligations of the authorization holder
p.(None): Pharmacovigilance system
...
p.(None): Submit medicinal products to the Federal Office for Safety in Health Care in accordance with the following requirements:
p.(None): 1. if the medicinal product has not yet been placed on the market: at least every six months
p.(None): after approval,
p.(None): 2. if the medicinal product has been placed on the market: at least every six months during the
p.(None): first two years after first placing on the market, once a year for the next two years
p.(None): and then every three years and
p.(None): 3. Immediately after being requested by the Federal Office for Safety in Health Care.
p.(None): The requirements according to Z 1 and 2 apply until a change in the approval or in accordance with paragraph 6 or 7
p.(None): a different rhythm or other submission dates have been set.
p.(None): (5) Paragraph 4 also applies to medicinal products that are only approved in Austria and not under
p.(None): Paragraph 6 fall.
p.(None): (6) For medicinal products that contain the same active ingredient or the same combination of active ingredients,
p.(None): but are subject to different approvals, and in which the rhythm and the dates for submission
p.(None): the regularly updated reports on the safety of medicinal products have been harmonized,
p.(None): what has been made public by the agency via the European internet portal for medicinal products,
p.(None): , affected marketing authorization holders have given the Federal Office for Safety in Health Care the change to the
p.(None): Report admission. Changes to the approval are effective six months after publication
p.(None): put.
p.(None): (7) Marketing authorization holders can refer to the Committee for Medicinal Products for Human Use for:
p.(None): Art. 5 of Regulation (EC) № 726/2004 or in the coordination group according to Art. 27 of the Directive
p.(None): 2001/83 / EC request that a deadline be set in the Union or the rhythm of the submission
p.(None): Regularly updated reports on the safety of medicinal products are changed:
p.(None): 1. for reasons of public health,
p.(None): 2. to avoid double assessments or
p.(None): 3. With a view to international harmonization.
p.(None): Such applications must be made in writing and justified. Any change in the key dates or
p.(None): Rhythm of submitting regular updated reports on the safety of medicinal products
p.(None): published by the agency on the European internet portal for medicinal products. Betro ff ene
p.(None): Authorization holders have the Federal Office for Safety in Health Care to change the authorization
p.(None): Report to. Changes to the approval are effective six months after publication.
p.(None): § 75l. After reviewing and assessing the regularly updated safety report
p.(None): the Federal Office for Safety has medicines with a view to a changed benefit-risk ratio
p.(None): in the health care system according to the extent of any possible danger
p.(None): if necessary, stipulate requirements or have to cancel the admission or put it at rest.
p.(None): This also applies in the case of a uniform assessment according to Art. 107e of Directive 2001/83 / EC.
p.(None): § 75m. (1) Marketing authorization holders are obliged to the Federal Office for Safety in Health Care and
p.(None): to inform the agency if there are new or changed risks or if it is recognized that the
p.(None): Risk-benefit ratio of pharmaceutical specialties has changed. There are both positive and negative
p.(None): Results of clinical trials that affect not only those listed in the approval, but all
p.(None): Areas of application and population groups can relate, and from non-interventional studies
...
p.(None): ensures that the drug or active substance is not placed on the market after its release.
p.(None): Preliminary seizure
p.(None): Section 78a. Organs of the Federal Office for Safety in Health Care have considered
p.(None): to temporarily confiscate the protective objectives of this federal law on medicinal products or active substances if the
p.(None): there is reasonable suspicion that this
p.(None): 1. contrary to the provisions of this federal law or regulations based thereon or
p.(None): other administrative acts are placed on the market and
p.(None): 2. pose a threat to the life or health of humans or animals.
p.(None): The regulations of § 76b on the provisional seizure by supervisory bodies and on measures
p.(None): the district administrative authorities in administrative criminal proceedings as well as § 76c are to be applied.
p.(None): Section 78b applies to the enforcement of a provisional seizure.
p.(None): Section 78b. The business owner or his / her authorized representative refuses to act after this
p.(None): Tolerating surveillance or protective measures provided for by federal law can enforce them
p.(None): become.
p.(None): X. SECTION
p.(None): fees
p.(None): Section 79. (1) The Federal Minister of Health and Consumer Protection, in agreement with the
p.(None): Federal Minister of Finance Fees for the permits to be issued under this Federal Act and
p.(None): other activities of federal agencies whose necessity changes
p.(None): 1. from this Federal Act and the ordinances issued on the basis thereof or
p.(None): 2. relevant legal acts of the European Union
p.(None): results, according to experience, from the average growing costs in a tariff
p.(None): set. The tariff and its changes are to be published in the “Official Gazette of the Wiener Zeitung”.
p.(None): Copies of the tariff are from the Federal Ministry (correct: Federal Ministry) for health and
p.(None): To provide consumer protection on request against reimbursement of costs.
p.(None): (2) Is the result of this Federal Act, the regulations issued on the basis thereof
p.(None): or the legal acts within the meaning of paragraph 1 no. 2 the necessity of activities of departments of the
p.(None): Federal government for which a tariff has not been set, the costs actually incurred must be stipulated.
p.(None): (3) The Federal Minister of Health and Consumer Protection can distance himself from this in individual cases
p.(None): to collect fees for certain activities if these are based on a party request
p.(None): are to be carried out and the interests of public health in this application are party interest
p.(None): significantly exceed.
p.(None): (4) For cash expenses, the party, regardless of the fees specified in the tariff in accordance with § 76 of the
p.(None): General Administrative Procedure Act 1991, Federal Law Gazette No. 51.
p.(None): XI. SECTION
p.(None): Automation-supported data traffic
p.(None): § 80. (1) To ensure drug safety and to ensure the protection of
p.(None): Life and health of humans and animals may be required for the implementation of this federal law
...
p.(None): Purpose of paragraphs 1 and 2,
p.(None): 4. the Austrian Chamber of Pharmacists, the Austrian Chamber of Physicians, the Austrian
p.(None): Dental Association, the Austrian Veterinary Association and the umbrella organization of the
p.(None): Social insurance institutions, insofar as this data is an essential prerequisite for the fulfillment of
p.(None): form legally assigned tasks,
p.(None): 5. the World Health Organization as defined in paragraphs 1 and 2, and
p.(None): 6. the Agency, the European Commission and the parties to the Agreement on the
p.(None): European Economic Area, the European Directorate for the Quality of Medicines (EDQM), the
p.(None): Council of Europe and foreign authorities under a mutual agreement
p.(None): Acknowledgment of inspections if there is an obligation to transmit the data to them
p.(None): consists.
p.(None): (4) The Federal Office for Safety in Health Care is also authorized to provide personal data
p.(None): to be transmitted with automation support
p.(None): 1. Hospitals, health resorts, doctors, veterinarians, dentists and other freelance professionals
p.(None): Healthcare professionals and pharmacists insofar as they place medicinal products on the market or
p.(None): apply and the safe use or protection of life or human health
p.(None): or animal require it, and
p.(None): 2. international organizations, provided there is an international legal obligation to transmit the data
p.(None): to this exists.
p.(None): (5) The Federal Office for Safety in Health Care and the Federal Ministry of Health are
p.(None): - insofar as this is in the relevant drug-related guidelines and regulations of the European Union
p.(None): is envisaged - further authorized
p.(None): 1. Enter data in the European databases provided there and
p.(None): 2. Information to the competent authorities of the member states of the European Union, the agency
p.(None): and forward to the European Commission.
p.(None): Section 81. The copies of the notices and
p.(None): Certificates issued by electronic data processing equipment or in a similar process
p.(None): manufactured, require neither a signature nor a certification.
p.(None): Section 81a. The Federal Office for Safety in Health Care is in accordance with the technical
p.(None): Authorized possibilities to provide by ordinance that the according to this federal law, according to
p.(None): Pharmaceuticals Imports Act 2010, the Blood Safety Act, the Prescription Law, the
p.(None): Medical device law and the tissue safety law applications, notifications and notifications
p.(None): must be done in electronic form. In this regulation there are exceptions for hardship cases
p.(None): provided.
p.(None): XII. SECTION
p.(None): Confidentiality and transparency
p.(None): § 82. All persons entrusted with tasks in the implementation of this Federal Act are
p.(None): unless otherwise stipulated by law, secrecy about all of them exclusively from this
p.(None): Committed to facts that have become known, the confidentiality of which is in the interest of a
p.(None): Local authority or the parties is required.
p.(None): Section 82a. (1) The Federal Office for Safety in Health Care and the Austrian Agency for
p.(None): With regard to independence and transparency, health and food security ensure that
p.(None): all members and substitute members of the Federal Office mentioned as well as all in connection with the
p.(None): Tasks according to § 8 paragraph 2 lines 13 to 16 of the Health and Food Security Act, Federal Law Gazette I
p.(None): № 63/2002, or staff involved in surveillance or by the Federal Office for Security in the
p.(None): Healthcare does not mandate experts with fi nancial or other interests in the
...
p.(None): (2) The Federal Office for Safety in Health Care can issue a license in accordance with Section 63 (1)
p.(None): revoke if the license holder at least three times because of one and the same in § 84 Z 24 to 28
p.(None): and 32 the above-mentioned violation.
p.(None): (3) The Federal Office for Safety and Health Care may appoint a knowledgeable person on time or
p.(None): permanently prohibit the authorization to carry out the work of a competent person if they
p.(None): has been punished at least three times for violations of medicinal product regulations.
p.(None): injunctions
p.(None): Section 85a. (1) Anyone who advertises that does not comply with sections 50 to 56 can file an injunction
p.(None): become. There is no risk of a corresponding breach if the entrepreneur receives a warning
p.(None): by an institution entitled to bring an action within a reasonable period of time, within a reasonable time
p.(None): Conventional penalty (§ 1336 ABGB) provides for a cease and desist declaration.
p.(None): (2) The claim can be made by the Austrian Chamber of Commerce, the Federal Chamber of Labor, the
p.(None): Austrian Chamber of Agricultural Workers, the Presidents' Conference of the Chambers of Agriculture
p.(None): Austria, the umbrella organization of social security institutions, the Austrian Federation of Trade Unions, the
p.(None): Patient advocacy, the association for consumer information, the Austrian senior council, the
p.(None): Pharmig (Association of Pharmaceutical Entrepreneurs), the Austrian Medical Association and the
p.(None): Austrian Chamber of Pharmacists.
p.(None): (3) If the origin of the violation within the meaning of paragraph 1 is in Austria, the claim can also be made by
p.(None): each of the Commission in the Official Journal of the European Union pursuant to Art
p.(None): 2009/22 / EC of April 23, 2009 on injunctions for the protection of consumer interests, OJ.
p.(None): № L 110 of 1 May 2009 p. 30, published bodies and organizations of another member state
p.(None): of the European Union, if
p.(None): 1. the interests protected by that body are adversely affected in that Member State; and
p.(None): 2. the purpose of the institution stated in the publication justifies this action.
p.(None): (4) The publication within the meaning of paragraph 3 must be demonstrated when the action is brought.
p.(None): (5) Section 24, Section 25 paras. 3 to 7 and Section 26 of the Federal Act against Unfair Competition 1984 apply
p.(None): analogous.
p.(None): (6) The jurisdiction in litigation according to paragraph 1 is exercised by the commercial courts. § 51
p.(None): Paragraph 2 No. 10 and Section 83c of the jurisdiction standard apply mutatis mutandis.
p.(None): Involvement of the organs of the public security service
p.(None): Section 85b. The organs of the public security service have the Federal Office for Security in
p.(None): Healthcare and the organs according to § 76a about their requests to ensure the exercise of
p.(None): Powers pursuant to sections 47 subsections 6 and 7a, 56a, 67 to 69, 75f, 76 to 76b, 77 to 78b within the scope of their
p.(None): to provide legal scope.
p.(None): XIV. SECTION
p.(None): Transitional and final provisions
p.(None): Section 86. (1) With the entry into force of this Federal Act
p.(None): 1. the specialty regulations, BGBl. No. 99/1947, and
p.(None): 2. Section 224 (1) to (3) of the 1973 Industrial Code
p.(None): inoperative.
p.(None): (2) With the entry into force of the ordinance pursuant to Section 59 (3), the demarcation ordinances, RGBl.
p.(None): No. 152/1883, RGBl. No. 97/1886 and RGBl. No. 188/1895, no longer applicable.
p.(None): (3) With the entry into force of the ordinance pursuant to § 62a (1), the Pharmacy Works Ordinance, Federal Law Gazette II
p.(None): № 171/1934, in the version of the ordinances BGBl. № 24/1936, dRGBl. I S 1611/1938, dRGBl. I S
p.(None): 47/1941 and Federal Law Gazette No. 240/1991 no longer apply.
...
p.(None): to be submitted to the Federal Office for Safety in Health Care.
p.(None): (12) The Federal Office for Safety in Health Care informed the Commission by 22 July 2013 about the
p.(None): To provide details of the system in accordance with section 75 (3).
p.(None): Transitional regulations to amendment BGBl. I No. 48/2013
p.(None): § 94i. (1) For medicinal products that were amended before the entry into force of this Federal Act in the version of the
p.(None): Federal Law BGBl. I № 48/2013 were approved as a pharmacopoeia monograph according to § 9c and the
p.(None): Requirements for registration as a traditional herbal medicinal specialty according to § 12 must be met
p.(None): the documents according to § 12a if the approval otherwise expires the Federal Office for Security in the
p.(None): Healthcare must be submitted by 2 January 2016 at the latest. If there is no timely submission,
p.(None): the products may be placed on the market until December 31, 2016. The
p.(None): The Federal Office for Safety in Health Care has to determine the expiry by notice. Does the
p.(None): Marketing authorization holders must submit an application for registration as a traditional vegetable by January 2, 2016
p.(None): Medicinal product, the authorization remains until the decision of the Federal Office for Security in
p.(None): Health care valid through registration for registration. Already in traffic at this time
p.(None): brought medicinal products may continue until the expiry date of the medicinal product
p.(None): be delivered.
p.(None): (2) Section 17 (5a) in the version of the Federal Law BGBl. I № 48/2013 occurs three years after the
p.(None): Publication of the European Commission delegated act in accordance with Article 54a of the Directive
p.(None): 2001/83 / EC in force in the Official Journal of the European Union. The Federal Minister of Health has through
p.(None): Regulation the date of publication of the delegated act and the date of the
p.(None): Announcement of the entry into force of Section 17 (5a) in the Federal Law Gazette Part II.
p.(None): (3) Sections 59 (10) (1) and 59a (1) to (4) in the version of the Federal Law Gazette I No. 48/2013
p.(None): occur one year after the publication of the implementing acts of the European Commission
p.(None): Article 85c (3) of Directive 2001/83 / EC in the Official Journal of the European Union. The Federal Minister
p.(None): for health has, by regulation, the date of publication of implementing acts and the
p.(None): Date of entry into force of Sections 59 (10) (1) and 59a (1) to (4) in the Federal Law Gazette Part II
p.(None): to make known.
p.(None): (4) Companies within the meaning of Section 62 (1) that manufacture, control, or place active ingredients on the market and
p.(None): before the entry into force of this Federal Act in the version of the Federal Law BGBl. I № 48/2013 in accordance with
p.(None): Section 63 (1) has been approved are deemed to have been approved in accordance with Section 63a (2).
p.(None): (5) Pharmaceutical intermediaries who cease their activity before the entry into force of this Federal Act in the version of the
p.(None): Federal Law BGBl. I № 48/2013 have started within two months after
p.(None): Announcement of the Federal Law BGBl. I № 48/2013 at the Federal Office for Security in the
p.(None): Have healthcare registered in accordance with Section 71a.
p.(None): Section 95. (1) This Federal Act comes into effect one year after the first day of the month following its publication
p.(None): Force.
p.(None): (2) Section 1 (3) 7 to 10, Section 1 (11) to (14), Section 2 (2), Section 2 (6) 1, Section 2 (7), Section 2 (8) to 11, Section 2
p.(None): Paragraph 20, § 4 Paragraph 2 No. 1, § 5, the introductory sentence of § 7 Paragraph 1, § 7 Paragraph 1 No. 5, § 7 Paragraph 2 No. 15, § 7 Paragraph 3 bis
p.(None): 5, § 8 paragraph 1, § 8 paragraph 2 line 8, § 8 paragraph 3 lines 8 and 9, § 9a, § 10, § 11 paragraph 1 and 2, § 11 paragraph 2a line 1, § 11 Paragraph 3
p.(None): Section 1, Section 11 (4), Section 11 (8), Section 11 (9) Section 1, Section 11c, Section 12 Section 1 Section 3, Section 14 Section 1, Section 15 Section 1 Sections 2 and 3, Section 15
...
p.(None): Federal Law as amended by Federal Law Gazette I No. 59/2018 will come into force on July 1, 2018.
p.(None): (18) Section 62 (3a) in the version of the Federal Law Gazette I No. 104/2019 comes into force on July 1, 2020.
p.(None): Section 95a. The applies to all personal names used in this federal law
p.(None): chosen form for both genders.
p.(None): Section 96. (1) Unless otherwise stipulated in paragraph 2, the enforcement of this Federal Act shall mean that
p.(None): Federal Minister of Health and Women
p.(None): 1. With regard to Section 59 (3) and Section 60 (7) in agreement with the Federal Minister for
p.(None): Economy and work,
p.(None): 2. with regard to Section 79 (1) in agreement with the Federal Minister of Finance,
p.(None): 3. with regard to § 84a in agreement with the Federal Minister of Finance, and
p.(None): 4. With regard to Section 85b in agreement with the Federal Minister of the Interior.
p.(None): (2) With completion
p.(None): 1. of § 76a paragraphs 6 and 7 - insofar as it concerns the investigation for clashes within the meaning of § 1 paragraph 2 line 1
p.(None): of the 2007 Federal Anti-Doping Act - is the Federal Chancellor;
p.(None): 2. of § 76b - if it concerns a seizure or seizure in the procedure according to
p.(None): Criminal Procedure Code 1975 (StPO), BGBl. № 631, acts - and the §§ 82b, 82c and 85a this
p.(None): Federal law is the Federal Minister of Justice,
p.(None): 3. of § 82d is the Federal Minister of Finance
p.(None): entrusted.
p.(None): Section 97. The following directives of the European Union are implemented by this federal law:
p.(None): 1. Council Directive 65/65 / EEC of 26 January 1965 on the approximation of the legal and
p.(None): Administrative provisions on medicinal products (OJ No L 22, 9.2.2965);
p.(None): 2. Council Directive 75/318 / EEC of 20 May 1975 on the approximation of the laws and regulations
p.(None): Administrative provisions of the Member States on analytical, toxicological-pharmacological
p.(None): and medical or clinical regulations and evidence of trials with medicinal products (OJ.
p.(None): L 147, June 9, 1975);
p.(None): 3. Council Directive 75/319 / EEC of 20 May 1975 on the approximation of the laws and regulations
p.(None): Administrative provisions on medicinal products (OJ No L 147, 9. 6. 1975);
p.(None): 4. Council Directive 81/851 / EEC of 28 September 1981 on the approximation of laws
p.(None): of the Member States on veterinary medicinal products (OJ No L 317, 6.11.1981);
p.(None): 5. Council Directive 81/852 / EEC of 28 September 1981 on analytical, toxicological and
p.(None): pharmacological and veterinary or clinical regulations and evidence of experiments with
p.(None): Veterinary medicinal products (OJ No L 317, 6.11.1981);
p.(None): 6. Council Directive 83/570 / EEC of 26 October 1983 amending Directives 65/65 / EEC,
p.(None): 75/318 / EEC and 75/319 / EEC to approximate the laws, regulations and administrative provisions relating to
p.(None): Medicinal specialties (OJ No. L 332, 11/28/1983);
p.(None): 7. Council Directive 87/21 / EEC of 22 December 1986 amending Directive 65/65 / EEC on
p.(None): Approximation of laws, regulations and administrative provisions on pharmaceutical specialties (OJ № L 15, 17.
p.(None): 1. 1987);
p.(None): 8. Council Directive 89/341 / EEC of 3 May 1989 amending Directives 65/65 / EEC,
p.(None): 75/318 / EEC and 75/319 / EEC to approximate the laws, regulations and administrative provisions relating to
...
p.(None): Tests with medicinal products for human use (OJ No L 121, 1.5.2001).
p.(None): 24. Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on
p.(None): Creation of a Community code for medicinal products for human use, as last amended by the Directive
p.(None): 2004/24 EG and the directive 2004/27 / EG,
p.(None): 25. Directive 2001/82 / EC of the European Parliament and of the Council of 6 November 2001 on
p.(None): Creation of a Community code for veterinary medicinal products, as last amended by the directive
p.(None): 2004/28 / EC,
p.(None): 26. Council Directive 96/22 / EC of 29 April 1996 prohibiting the use of certain substances
p.(None): with hormonal or thyreostatic effects and by ß-agonists in animal production and
p.(None): repealing Directives 81/602 / EEC, 88/146 / EEC and 88/299 / EEC,
p.(None): 27. The Directive of the European Parliament and of the Council of 7 September 2005 on the
p.(None): Recognition of professional qualifications, OJ. № L 255 of September 30, 2005 p. 22, last
p.(None): Modified by Council Directive 2006/100 / EC of November 20, 2006 on adaptation
p.(None): certain directives in the area of free movement on the occasion of the accession of Bulgaria and Romania,
p.(None): OJ. L 363 of December 20, 2006, p. 141,
p.(None): 28. the agreement between the European Community and its Member States, of the one part, and the
p.(None): Swiss Confederation, on the other hand, on the free movement of persons, OJ. № L 114/6 from
p.(None): 30 April 2002, Federal Law Gazette III No. 133/2002, in the version of the protocol with a view to the inclusion of the
p.(None): Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and
p.(None): Slovakia as contracting parties following their accession to the European Union, OJ № L 89/30 from
p.(None): March 28, 2006, Federal Law Gazette III No. 162/2006,
p.(None): 29. Directive 2010/84 / EU of the European Parliament and of the Council of December 15, 2010 on
p.(None): Amendment to Directive 2001/83 / EC creating a Community code for
p.(None): Human medicinal products with regard to pharmacovigilance, OJ. № L 348 of December 31, 2010, p 74, in
p.(None): the version of the correction No.L 21 dated January 25, 2011, page 8,
p.(None): 30. Directive 2011/62 / EU of the European Parliament and of the Council of 8 June 2011 on
p.(None): Amendment to Directive 2001/83 / EC creating a Community code for
p.(None): Medicinal products for human use to prevent the entry of counterfeit medicinal products into the
p.(None): legal supply chain, OJ No.L 174 from 01.07.2011 S 74,
p.(None): 31. Directive 2012/26 / EU of the European Parliament and of the Council of October 25, 2012 on
p.(None): Amendment to Directive 2011/83 / EC with regard to pharmacovigilance, OJ. L No. 299 of October 27
p.(None): 2012, S 1,
p.(None): 32nd Commission Directive (EU) 2017/1572 supplementing Directive 2001/83 / EC with regard to
p.(None): Principles and guidelines of good manufacturing practice for medicinal products for human use (OJ No L 238,
p.(None): 16.09.2017).
p.(None): Article 6
p.(None): final provision
p.(None): (Note: from BGBl. I No. 78/1998, § 60, BGBl. No. 185/1983)
p.(None): Any change in the legal form of the Federal Institute for Drugs remains its own
p.(None): Federal law reserved.
p.(None): Article XXIV
p.(None): Transitional provision
p.(None): (Note: from BGBl. I No. 112/2007, §§ 76b and 96, BGBl. No. 185/1983)
p.(None): The penal provisions amended by this federal law are not applicable in criminal matters
p.(None): who were given a judgment in the first instance before their entry into force. After a judgment has been set aside
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.(None): the Medicine. “Side effect” of a veterinary medicinal product is a harmful and unintended reaction to
p.(None): the medicinal product that occurs at doses normally used in animals for prophylaxis, diagnosis or
p.(None): Therapy for diseases or for changing a physiological function.
p.(None): (2) "Side effect in humans" is a reaction that is harmful and unintentional and in
p.(None): People experience exposure to a veterinary drug.
p.(None): (3) "Serious side effect of a human medicinal product" is a side effect that is fatal or
p.(None): is life-threatening, requires inpatient treatment or its extension, more permanent
p.(None): or severe disability or disability or a congenital anomaly or
p.(None): Birth defect is.
p.(None): (4) "Serious side effect of a veterinary medicinal product" is a side effect that is fatal or
p.(None): is life-threatening, leads to significant disability or disability, congenital anomalies or
p.(None): Causes birth defects in the following generation or in the treated animals constantly occurring or
p.(None): causes long-lasting symptoms.
p.(None): (5) "Misuse of a drug" is the intended, permanent or sporadic excessive
p.(None): Use of a drug with physical or mental damage as a result.
p.(None): (6) "Improper use" is the use of a veterinary medicinal product contrary to
p.(None): Information about the summary of product characteristics, including the improper one
p.(None): Use or serious abuse.
p.(None): (7) “Risk management system” is a series of pharmacovigilance activities and measures that
p.(None): identified, described, avoided or minimized by the risks associated with pharmaceutical specialties
p.(None): should be; this also includes evaluating the effectiveness of such activities and measures.
p.(None): (8) “Risk Management Plan” is a detailed description of the risk management system.
p.(None): (9) “Pharmacovigilance system” is a system that the marketing authorization holder or holder of a
p.(None): Registration and the Federal Office for Safety in Health Care apply to the in Section IX
p.(None): to carry out the tasks and duties mentioned and the surveillance of the safety of authorized
p.(None): or registered pharmaceutical specialties and the discovery of all changes in the benefit-risk
p.(None): Relationship serves.
p.(None): (10) “Pharmacovigilance Master Documentation (Pharmacovigilance Master File)” is a detailed one
p.(None): Description of the system of pharmacovigilance that the marketing authorization holder applies to one or more
p.(None): uses authorized medicinal products.
p.(None): (11) "Pharmacovigilance Officer" is a person responsible for drug monitoring,
p.(None): suitably qualified person.
p.(None): (12) "Regularly updated report on the safety of medicinal products (PSUR)" is a
p.(None): Report with those specified in Art. 75 of Directive 2001/82 / EC or Art. 107b of Directive 2001/83 / EC
p.(None): Records.
p.(None): (13) “Post-approval safety study” is any clinical trial or non-interventional
...
p.(None): Maintenance of drug supplies related to a pandemic, warlike
p.(None): Conflict or terrorist threat, in turn, individual contracts for direct purchase
p.(None): have completed a drug for the needs of their own employees,
p.(None): 6. Institutions of the Austrian Armed Forces, the pharmaceutical supply of the Armed Forces
p.(None): serve,
p.(None): 6a. the Federal Ministry of the Interior, the authorities and childcare facilities subordinate to it
p.(None): for emergency care, prevention and care of operations, provided that the medicines for
p.(None): Need to perform their duties
p.(None): 7. Institutions, the provisional judicial safekeeping or arrests, judicial
p.(None): Prison sentences or preventive judicial measures related to deprivation of liberty
p.(None): Take measures if they need drugs to perform their tasks
p.(None): 8. scientific institutes and research institutes of the local authorities and the
p.(None): Universities and the Austrian Agency for Health and Food Security, if these
p.(None): Need medicines to perform their tasks
p.(None): 9. Organized emergency medical services, provided they are addictive substances, which they use for their emergency medical services
p.(None): Need activity, and
p.(None): 10. Have a doctor who is sufficiently familiar with questions of substance abuse
p.(None): Institutions according to § 15 of the Addictive Substances Act, Federal Law Gazette I № 112/1997, for evidence-based and
p.(None): quality-assured support for clients as part of damage minimization measures,
p.(None): except drugs containing addictive substances.
p.(None): (2) At hospitals without institutional pharmacies, the manufacturer, depositeur or pharmaceutical
p.(None): Wholesalers are given:
p.(None): 1. whole blood preserves, suspensions of cellular or corpuscular blood components,
p.(None): Single donor preparations,
p.(None): 2. native human or animal tissue.
p.(None): (3) Paragraphs 1 and 2 do not apply to radioactive medicinal products. These may be from the manufacturer, depositeur
p.(None): or pharmaceutical wholesalers only to holders of a license to handle radioactive materials
p.(None): according to the Radiation Protection Act, Federal Law Gazette No. 227/1969.
p.(None): (4) Feed medicines may be purchased from the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): Prescription of the treating veterinarian can be given directly to consumers. The repeated
p.(None): Delivery on a prescription is not permitted.
p.(None): (5) Paragraph 1 does not apply to pharmaceutical specialties according to § 7 Paragraph 4 and § 59 Paragraph 7a.
p.(None): (6) From the manufacturer, depositeur or pharmaceutical wholesaler, medicinal products whose delivery in
p.(None): Retail sales are not reserved for pharmacies, directly to bandagists, orthopedic shoemakers,
p.(None): Orthopedic technician, dental technician, podiatrist, holder of a hoof and
p.(None): Claw fittings and massage therapists are given, provided they are medicinal products
p.(None): Traders need for the exercise of their activity.
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): there are no standards according to Z 1 to 3,
p.(None): do not match.
p.(None): (3) It is prohibited to place medicinal products on the market
p.(None): 1. whose durability is no longer given,
p.(None): 2. whose expiry date has passed,
p.(None): 3. whose commercial packs can have an adverse effect on the quality of the medicinal product,
p.(None): or
p.(None): 4. which are intended for use on animals, which serve for the production of food and their
p.(None): pharmacologically active ingredients not in Annexes I to III of Regulation (EEC)
p.(None): No. 2377/90 are included.
p.(None): (4) Pharmaceutical specialties whose expiry date has passed may be used if the
p.(None): Federal Armed Forces in accordance with Section 2 (1) lit. a of the Wehrgesetzes 1990, Federal Law Gazette № 305, are placed on the market,
p.(None): if this is essential for the supply of medicinal products and research has shown that
p.(None): the protection of human and animal health is maintained.
p.(None): § 5. (1) The Federal Minister of Health and Environmental Protection has to ensure the
p.(None): Drug safety, to prevent harmful effects within the meaning of § 3 and to secure the
p.(None): Quality in the sense of § 4 by ordinance, more detailed provisions on the use of certain substances,
p.(None): Preparations from materials, processes or articles for the manufacture and control of medicinal products
p.(None): or active substances and on the placing on the market, import and use of medicinal products or
p.(None): To adopt active substances.
p.(None): (2) The Federal Minister of Health and Women may consider an application in accordance with
p.(None): § 18a or according to Art. 3 of Regulation (EC) № 726/2004 medicinal specialties from the area of application
p.(None): exempt from a regulation in accordance with paragraph 1, if this results from the latest state of medical
p.(None): Science a threat to drug safety cannot be feared.
p.(None): (3) The Federal Minister of Health and Women may consider an opinion
p.(None): of Article 27 of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or the
p.(None): in Art. 31 Directive 2001/82 / EC, as amended by Directive 2004/28 / EC
p.(None): Coordinating group of medicinal specialties that are based on a regulation issued on the basis of paragraph 1
p.(None): not comply, by decision exempt from the scope of this regulation if after the
p.(None): state of the art in medical science not to worry about a threat to drug safety
p.(None): is. Such notice is to be revoked if it subsequently becomes known that the requirements for this
p.(None): are not given.
p.(None): misleading
p.(None): § 6. (1) It is forbidden to place medicinal products or active substances on the market which are not the facts
p.(None): corresponding information or other misleading designations or packaging
p.(None): exhibit.
p.(None): (2) It is also prohibited in connection with the placing on the market of medicinal products or
p.(None): Effective about this information that does not correspond to the facts or is misleading
p.(None): do.
p.(None): (3) A misleading situation exists in particular if
p.(None): 1. The medicinal products are considered to have an efficacy or the active substances have a property that
p.(None): according to the current state of scientific knowledge or practical
p.(None): Experience is not sufficiently documented, or
p.(None): 2. the impression is incorrectly given that success is to be expected with certainty or that after
p.(None): Intended or prolonged use, no harmful effects occur, or
p.(None): 3. the name or presentation is suitable for confusion.
...
p.(None): 7. is not intended for intrathecal use.
p.(None): The Federal Office for Safety in Health Care has to revoke this decision if one of these
p.(None): Requirements no longer exist or were not originally met. The frequency of
p.(None): The Federal Office for Safety in Health Care is used by pharmaceutical companies
p.(None): to be documented annually.
p.(None): (9) Paragraph 2 does not apply to
p.(None): 1. pharmaceutical specialties within the meaning of § 26,
p.(None): 2. Pharmaceutical specialties for injection,
p.(None): 3. sterile, pyrogen-free rinsing liquids,
p.(None): 4. radioactive pharmaceutical specialties and
p.(None): 5. Medicinal specialties that are in accordance with § 2 Paragraph 1 of the Prescription Law or for addictive law
p.(None): Provisions are subject to prescription requirements.
p.(None): § 7a. (1) Medicines containing antigens or semi-antigens and the detection of speci fi c ones
p.(None): Defense and protective substances, desensitization or hyposensitization may, if they
p.(None): not always made in advance in the same composition and under the same name in one
p.(None): placed on the market for supply to the consumer or user, domestically only
p.(None): delivered or kept ready for delivery in Germany if the Federal Office for Security in
p.(None): Healthcare the manufacturing process to be used with this drug
p.(None): including chemical pharmaceutical documentation has been approved by notice.
p.(None): (2) Sections 8 to 25 apply mutatis mutandis to procedures in accordance with para
p.(None): the documents that are sufficient for the assessment of the intended end products are to be enclosed.
p.(None): § 7b. (1) If there is no authorization and no application for authorization for a human medicinal product,
p.(None): the Federal Minister of Health and Women may do so in another party to the agreement
p.(None): Medicinal product approved for use in the European Economic Area for public reasons
p.(None): Allow health.
p.(None): (2) The Federal Minister of Health and Women may, by ordinance, specify further provisions on
p.(None): the procedure to be used, in particular with regard to the selection of the authorization holder,
p.(None): adopted. It is particularly important to ensure that the marketing authorization holder is informed about the
p.(None): necessary organizational and technical prerequisites for fulfilling him after a possible
p.(None): Approval according to this federal law.
p.(None): § 8. (1) Medicinal products do not require approval if
p.(None): 1. these to conduct non-clinical or clinical trials or clinical trials
p.(None): are determined, or
p.(None): 2. certifies a doctor, dentist or veterinarian who is authorized to practice his profession independently in Germany,
p.(None): that the drug specialty to ward off a life threatening or serious health
p.(None): Damage is urgently needed and this success with an approved and available
p.(None): Pharmaceutical specialty probably cannot be achieved according to the state of the art, or
p.(None): 3. the pharmaceutical specialty for medical treatment
p.(None): a) in the event of deployment of the Federal Army in accordance with Section 2 (1) lit. a of the Defense Act 2001,
p.(None): BGBl. I No. 146, or
p.(None): b) in preparation for a posting under the Federal Constitutional Law on Cooperation and
p.(None): Solidarity when sending units and individuals abroad (KSE-BVG),
p.(None): BGBl. I No. 38/1997, or in the context of such a posting
p.(None): is needed and the success of this treatment with an approved and available
p.(None): Pharmaceutical specialty cannot be achieved according to the state of the art, or
p.(None): 4. the pharmaceutical specialty to prevent or in connection with a disaster,
p.(None): terrorist threat or armed conflict
...
p.(None): Drug differ from that of the reference biological drug, so the results are
p.(None): suitable non-clinical trials or clinical trials or trials regarding these differences
p.(None): required. The type and number of additional data to be submitted must be in Annex I to the Directive
p.(None): 2001/83 / EG, in the version of the directives 2004/24 / EG and 2004/27 / EG or the directive 2001/82 / EG, in
p.(None): comply with the version of Directive 2004/28 / EC.
p.(None): (9) If the medicinal product does not fall under the definition of a generic or the bioequivalence can
p.(None): not demonstrated by bioavailability studies, as well as in the event of a change in the active ingredient or
p.(None): the active ingredients, the areas of application, the strength, the dosage form or the route of administration
p.(None): compared to the reference medicine, are the results of the corresponding non-clinical trials or
p.(None): clinical trials or trials as well as the results of the corresponding safety and
p.(None): To present residue tests.
p.(None): (10) If an authorization according to § 7 has been granted for a pharmaceutical specialty, then for the purposes of
p.(None): Paragraphs 1 to 9 and 12 all other approved strengths, dosage forms, routes of administration and
p.(None): Forms of administration, as well as all changes and extensions as part of the same comprehensive
p.(None): Viewed approval.
p.(None): (11) The applicant may be required to submit the bioavailability studies if he:
p.(None): can demonstrate that the generic meets the relevant criteria based on the current state of science
p.(None): Proof of bioequivalence does not appear to be necessary.
p.(None): (12) The Federal Minister of Health and Women has additional animal species by decree
p.(None): determine for which the protection period is extended to 13 years within the meaning of para. 4 no.1 if they are in
p.(None): a corresponding decision by the Commission after referral to the Standing Committee on
p.(None): Veterinary medicines for the adaptation of the guidelines for the removal of technical barriers to trade
p.(None): technical progress in the field of veterinary medicines.
p.(None): (13) With regard to the implementation of the required to obtain an authorization according to paragraph 1 and a
p.(None): Modification of an approval required studies and experiments and the resulting practical
p.(None): Requirements apply to § 22 Paragraph 1 Patent Act 1970 and § 4 Paragraph 1 Utility Model Act.
p.(None): (14) As part of the examination of an amendment for a new area of application, the
p.(None): Federal Office for Safety in Health Care to decide on application
p.(None): 1. whether the new application areas of significant clinical benefit compared to the
p.(None): existing therapies are to be viewed and
p.(None): 2. whether significant non-clinical or clinical studies in an already well-established active ingredient
p.(None): In connection with the new area of application.
p.(None): (15) The protection periods contained in this provision in accordance with paragraphs 1, 2, 3, 4 and 12 apply to applications
p.(None): on the authorization of a reference medicinal product for which the application for authorization has expired after the expiry of the
p.(None): October 30, 2005.
p.(None): § 10a. (1) In deviation from Section 9a (1) nos. 19 and 20, the applicant is not obliged to submit the results
p.(None): the non-clinical trials or the clinical trials or trials or in deviation from Section 9a (1)
...
p.(None): herbal preparations or combinations for use in traditional herbal medicinal products
p.(None): in accordance with Article 16f (1) of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and
p.(None): 2004/27 / EG, deleted, the registration has to be canceled, if not within three months
p.(None): Deletion of the registration holder's documents in accordance with section 12a (1) last sentence and section 12a (2) no.2
p.(None): and 3 submitted.
p.(None): (4) The Federal Office for Safety in Health Care may appoint the Committee for Plant Medicinal Products
p.(None): request an opinion on the evidence of traditional use if in doubt in the
p.(None): With regard to the existence of the requirements according to § 12a para. 2 no.2.
p.(None): (5) If the medicinal product has been in the European Economic Area for less than 15 years
p.(None): has been used, but otherwise the requirements for registration according to § 12 and § 12a
p.(None): are available, the Federal Office for Safety in Health Care has that in accordance with Article 16c (4) of the
p.(None): Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC
p.(None): with the participation of the Committee for Herbal Medicinal Products.
p.(None): (6) The Federal Office for Safety in Health Care notifies the Commission and everyone responsible
p.(None): Authority of another contracting party to the Agreement on the European Economic Area on request
p.(None): every negative decision about the registration and the reasons for it.
p.(None): statutory authorization
p.(None): § 14. The Federal Minister of Health and Women may consider the requirements
p.(None): an in-depth and rapid examination of the application and the admission and registration documents
p.(None): by regulation, more detailed provisions on applications and notifications as well as on content, scope, form,
p.(None): Issue the nature and submission of the samples and documents in accordance with sections 9a to 12a and 24.
p.(None): Product Information
p.(None): Technical information (summary of product characteristics - SMPC)
p.(None): § 15. (1) About medicinal specialties that are in accordance with § 7 of the approval or in accordance with § 12 of the registration
p.(None): is subject to doctors, dentists, dentists, midwives, veterinarians, pharmacists and those in § 59 para. 3
p.(None): to make available technical information in German to the traders mentioned, provided that it
p.(None): are not pharmaceutical specialties according to § 9c.
p.(None): (2) The subject information must contain at least the following information in the following order:
p.(None): 1. Name of the pharmaceutical specialty, followed by the strength and the dosage form,
p.(None): 2. Qualitative and quantitative composition according to active ingredients using the usual
p.(None): common or chemical name,
p.(None): 3. pharmaceutical form,
p.(None): 4. Clinical information:
p.(None): a) fields of application,
p.(None): b) dosage and type of use in adults and, if necessary, in children,
p.(None): c) contraindications,
p.(None): d) special warnings and cautions for use and in immunological
p.(None): Medicinal products all special precautions taken by people with
p.(None): immunological medicines and those dealing with these medicinal products
p.(None): Administer patients who are to be met, as well as all where necessary to be met by the patient
p.(None): Precautions,
p.(None): e) interactions with other drugs or other agents,
...
p.(None): c) contraindications,
p.(None): d) special warnings regarding each target species,
p.(None): e) special warnings and cautions for use and in immunological
p.(None): Medicinal products all special precautions taken by people with
p.(None): immunological medicines and those dealing with these medicinal products
p.(None): Administer animals to be met
p.(None): f) side effects,
p.(None): g) use in pregnancy, egg or milk production,
p.(None): h) interactions with other medicinal products and other interactions,
p.(None): i) dosage and type of application,
p.(None): j) overdose (symptoms, emergency measures, antidotes),
p.(None): k) Waiting time for all foods, including those for which there is no waiting time.
p.(None): The information in accordance with para. 2 no. 5 lit. c and Z 14 are omitted.
p.(None): (4) The information in the technical information for a traditional herbal medicinal specialty is omitted
p.(None): Paragraph 2 No. 5.
p.(None): (5) For approvals according to § 10, the parts of the specialist information for the reference medicinal product that are
p.(None): refer to the areas of application, dosages or other subject matter of a patent which at the time
p.(None): the placing on the market of a generic still fell under patent law.
p.(None): (6) The subject information as well as any changes to the subject information in accordance with Regulation (EC)
p.(None): № 1234/2008 or according to §§ 24 or 25 are from the Austrian Chamber of Pharmacists under
p.(None): To publish the participation of the Austrian Medical Association. The publication has the date of
p.(None): Creation of the subject information, in the event of a change in the subject information, the date of the last change
p.(None): exhibit.
p.(None): (7) The Federal Minister of Health and Women has to determine by decree which others
p.(None): Information that is important for the application must be included in the specialist information and
p.(None): more detailed provisions on the type of publication and the availability of the specialist information as well as on
p.(None): Changes to the same and, if necessary with regard to drug safety, about content,
p.(None): To issue the type and form of the information specified in paras. 2 and 3.
p.(None): leaflet
p.(None): Section 16. (1) Medicinal specialties that are in accordance with Section 7 of the approval or in accordance with Section 11a of the registration
p.(None): may only be placed on the market if the commercial pack is in accordance with
p.(None): In the summary of the product characteristics, instructions for use in German
p.(None): contains.
p.(None): (2) The package leaflet for medicinal products for human use has the following information in the following
p.(None): To contain the order in a generally understandable form:
p.(None): 1. the name of the medicinal product, followed by the strength and the dosage form; possibly
p.(None): whether it is intended for use by infants, children or adults; the
p.(None): Common names must be given if the medicinal product contains only one active ingredient
p.(None): and her name is a fancy name,
p.(None): 2. the pharmaceutical-therapeutic class or mode of action in one easy for the patient
p.(None): understandable form,
p.(None): 3. the areas of application,
p.(None): 4. Contraindications
p.(None): 5. appropriate precautions for use,
p.(None): 6. Interactions with other medicinal products and other interactions that affect the
p.(None): Effect of the drug specialty can impair,
p.(None): 7. special warnings,
...
p.(None): disagree.
p.(None): (5) In addition to the information in accordance with paragraphs 2 and 4, the instructions for use must also include
p.(None): 1. Medicinal products that are feed medicines, the labeling according to
p.(None): Feed Act, a reference to the fact that it is a feed medicine, and a
p.(None): Directions for use,
p.(None): 2. Medicinal products that are feed premixes, the labeling according to the
p.(None): Feed Act, information on the type and amount of the ingredients contained in the feed,
p.(None): an indication that it is a feed premix that:
p.(None): Mixing instruction and the feeding instruction for that made from the premix
p.(None): Medicated feed,
p.(None): 3. radioactive pharmaceutical specialties, generators, kits or precursors of radioactive pharmaceutical specialties
p.(None): Precautions to be taken by the user and the patient during preparation and
p.(None): Administration of the product, as well as special precautions for the
p.(None): Disposal of the transport container and its unused content,
p.(None): 4. Medicinal specialties, the banned active substances according to § 1 para. 2 of the anti-doping
p.(None): Federal Law 2007, Federal Law Gazette I № 30, contain the following note: “The application of the
p.(None): Medicinal product [use the name of the medicinal product] can be positive in doping controls
p.(None): Results. " May result from misuse of the medicinal product for doping purposes
p.(None): If there is a risk to health, this must also be stated. These obligations do not apply to
p.(None): Medicinal specialties according to § 9b.
p.(None): (6) If this is necessary with regard to drug safety, the Federal Minister for
p.(None): Health and women through regulation more detailed provisions on content, type, shape, size and
p.(None): The nature of the information specified in paras. 2 to 5.
p.(None): Instructions for use for registered homeopathic medicinal specialties
p.(None): § 16a. (1) Medicinal products that are registered in accordance with § 11 may only be placed on the market
p.(None): if the retail pack contains instructions for use in German.
p.(None): (2) The package leaflet has the following information in the following order in general
p.(None): to contain understandable form:
p.(None): 1. scientific name of the original substance or substances and dilution; the are in
p.(None): European pharmacopoeia or, in the absence thereof, in one currently in use
p.(None): Pharmacopoeias of the parties to the Agreement on the European Economic Area
p.(None): to use the symbols it contains
p.(None): 2. Name and address of the registration holder,
p.(None): 3. Name and address of the manufacturer,
p.(None): 4. type and, if necessary, route of administration,
p.(None): 5. expiry date (month / year),
p.(None): 6. capacity of the primary packaging,
p.(None): 7. if necessary, special precautionary measures for storage,
p.(None): 8. special warnings,
p.(None): 9. batch number,
p.(None): 10. Registration number,
p.(None): 11. the note “Homeopathic medicinal specialty without approved therapeutic
p.(None): Application areas",
p.(None): 12. the indication that a doctor should be consulted if symptoms of illness persist, and
p.(None): 13. the date of creation of the package leaflet, in the case of a change the date of the last
p.(None): Modification.
p.(None): (3) The Federal Office for Safety in Health Care can request an exception from one
p.(None): Grant requirement according to paragraphs 1 and 2 if this is necessary for reasons of expediency, especially in
p.(None): With regard to the type of pharmaceutical specialty and its primary or outer packaging offered and with the
p.(None): Principles of drug safety is compatible.
p.(None): (4) If this is for the sake of expediency, in particular with regard to the type of
p.(None): Pharmaceutical specialty and its primary or outer packaging is offered and it with the principles of
p.(None): Pharmaceutical safety is compatible, the Federal Minister of Health and Women can by ordinance
p.(None): considering the requirements of protecting human or animal health exceptions
p.(None): issued from the requirements of paragraphs 1 and 2.
p.(None): Obligations in connection with the package leaflet
p.(None): § 16c. (1) The authorization holder or the holder of a registration must ensure that the
p.(None): Package leaflet is available at the request of patient organizations in formats suitable for blind and
p.(None): visually impaired people are suitable.
p.(None): (2) The package leaflet has the results of cooperation with patient target groups
p.(None): reflect. The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): adopted to ensure the readability, clarity and user-friendliness of the package leaflet.
p.(None): Note for the following provision
p.(None): For the entry into force cf. Section 38 (2) of the Medicinal Products Regulations 2009, Federal Law Gazette II No. 41/2019 and Section 94i (2).
p.(None): Labelling
p.(None): Section 17. (1) Pharmaceutical specialties that are in accordance with Section 7 of the approval or in accordance with Section 11a of the registration
p.(None): are only allowed to be placed on the market unless they are radioactive pharmaceutical specialties
p.(None): if the following information is in German on the outer packaging and the primary packaging
p.(None): are included:
p.(None): 1. Name of the medicinal product, followed by the strength and the dosage form; where appropriate
p.(None): Indication of whether it is intended for use by infants, children or adults; contains the
p.(None): Pharmaceutical specialty up to three active ingredients, the international free name (INN) must be listed
p.(None): or, if this does not exist, the common name; this applies to veterinary specialties
p.(None): However, there is an obligation for such pharmaceutical specialties that do not contain more than one active ingredient
p.(None): 2. Name and address of the authorization holder,
p.(None): 3. approval number,
p.(None): 4. qualitative and quantitative composition of active ingredients according to dosage unit or depending on
p.(None): Form of administration for a given volume or weight using the
p.(None): common names,
p.(None): 5. pharmaceutical form and content according to weight, volume or dosage units,
p.(None): 6. List of auxiliary substances with known mode of action; for injectables, topical preparations
p.(None): or eye drops, however, all auxiliary substances must be specified,
...
p.(None): Information about
p.(None): 5. Sera, details of the type of living being that served as the donor,
p.(None): 6. Homeopathic medicinal specialties, an indication that it is a homeopathic
p.(None): Drug specialty,
p.(None): 7. Pharmaceutical specialties that are subject to Section 26, information about batch release,
p.(None): 8. Medicinal products that are feed medicinal products, the labeling according to
p.(None): Feed Act as well as a note that it is a medicated feed,
p.(None): 9. Medicinal products that are feed premixes, the labeling according to the
p.(None): Feed Act, information on the type and quantity of the components contained in the feed
p.(None): and an indication that it is a feed premix, and
p.(None): 10. Dental medicinal products an indication that they are dental medicinal products.
p.(None): (4) The labeling of traditional herbal medicinal specialties has in addition to the information
p.(None): according to paragraphs 1 and 3 to contain the note that the product is a traditional herbal medicinal specialty
p.(None): for use in a specific area or areas of application only
p.(None): due to long-term use and that the consumer is a doctor, possibly a dentist,
p.(None): should consult if the symptoms persist when using the medicinal product or other than
p.(None): side effects mentioned in the package leaflet occur; provided the Federal Office for Security in
p.(None): Health care providers that require this when registering must also indicate the type of tradition concerned.
p.(None): (5) The outer packaging of the medicinal product must be in addition to that mentioned in paras. 1 to 4
p.(None): Information on the name of the medicinal product and the strength included in Braille. The Federal Minister for
p.(None): Health and women's health can be regulated by regulation regarding patient safety
p.(None): adopt the type and detailed form of the labeling obligation mentioned in the first sentence.
p.(None): (5a) On the outer packaging of medicinal products that are intended for use in humans,
p.(None): are security features and a device for detecting a possible manipulation of the
p.(None): Attach outer packaging, provided this is done by Art. 54a of Directive 2001/83 / EC to create a
p.(None): Community codes for medicinal products for human use, OJ. № L 311 from 11/28/2001 S 67, last changed by
p.(None): Directive 2011/62 / EU, OJ. № L 174 dated 01.07.2011 p. 74, prescribed or based on Art. 54a
p.(None): of Directive 2001/83 / EC. The Federal Minister of Health, if for reasons
p.(None): drug safety or to comply with EU law obligations, more details
p.(None): To issue provisions on the security features, in particular on which ones
p.(None): Human medicinal products carry safety features or do not have to carry them, as well as the type,
p.(None): Condition, properties, speci fi cations and other with the review of the security features in
p.(None): Related requirements.
p.(None): (6) Paragraphs 1 to 3, 5 and 5a do not apply to radioactive, subject to paragraph 1 of this paragraph
p.(None): Proprietary Medicinal Products. These must be identified by the following information:
p.(None): 1. The marking on the shielding must contain the information specified in Paragraph 1. Also has
p.(None): the labeling on the shielding indicates the coding used on the vials in plain text
p.(None): explain and if necessary at a given time and date the radioactivity amount per
p.(None): Dose or per vial and the number of capsules or, for liquids, the amount of milliliters in the
p.(None): Specify container.
p.(None): 2. The following information must be given on vials:
p.(None): a) Name or code of the medicinal product with the name or chemical formula of the
p.(None): radionuclide
p.(None): b) operational control number and expiry date,
p.(None): c) international symbol for radioactivity,
p.(None): (d) the name of the manufacturer and
p.(None): e) Amount of radioactivity according to Z 1.
p.(None): 3. The outer packaging and container of medicinal products containing radionuclides are in accordance with
p.(None): to mark the provisions on the transport of dangerous goods.
p.(None): (7) The primary packaging in the form of blister packs must at least have the short name
p.(None): the name and authorization holder as well as the batch number and expiry date
p.(None): his. It must be ensured that the name is legible until the last dosage unit is removed
p.(None): is.
p.(None): (8) Small primary packaging - if an outer packaging is available - only with the
p.(None): Information according to paragraph 1 Z 1, 7, 10, 13 and content by weight, volume or dosage units, and the
p.(None): Short name of the authorization holder. The name must include the
p.(None): Do not include dosage form if this does not affect the safety of the drug.
p.(None): (9) The Federal Minister of Health and Women may, if for reasons of expediency,
p.(None): especially with regard to the type of medicinal product, its primary or outer packaging offered and
p.(None): it is compatible with the principles of drug safety, taking into account the requirements
p.(None): the protection of human or animal health by regulation for certain types of
p.(None): Pharmaceutical specialties Exceptions to the labeling requirements of paras 1 to 5a and § 17a
p.(None): Paragraph 1 and, if necessary, additional labeling requirements.
p.(None): Labeling of registered homeopathic medicinal specialties
p.(None): § 17a. (1) Registered homeopathic medicinal products may only be placed on the market if
p.(None): The following information is contained in German on the outer packaging and the primary packaging:
p.(None): 1. scientific name of the original substance or substances and dilution; the are in
p.(None): European pharmacopoeia or, in the absence thereof, in one currently in use
p.(None): Pharmacopoeias of the parties to the Agreement on the European Economic Area
p.(None): use included symbols; the medicinal product consists of two or more original substances
p.(None): together, the scientific name of the original substances can be identified by an imaginary name
p.(None): be replaced,
p.(None): 2. Name and address of the registration holder,
p.(None): 3. Name and address of the manufacturer,
p.(None): 4. type and, if necessary, route of administration,
p.(None): 5. expiry date (month / year),
p.(None): 6. capacity of the primary packaging,
p.(None): 7. if necessary, special precautionary measures for storage,
p.(None): 8. special warnings,
p.(None): 9. Registration number,
p.(None): 10. batch number,
...
p.(None): Prescription Law, Federal Law Gazette No. 413/1972.
p.(None): (9) If an application for prescription exemption due to significant non-clinical or clinical
p.(None): Trials approved by the Federal Office for Safety in Health Care can be done within a year
p.(None): after this decision has become final, a prescription exemption for medicinal specialties based on this data
p.(None): other marketing authorization holder with the same active substance.
p.(None): § 24a. (1) The approval of a change in accordance with Regulation (EC) № 1234/2008 or in accordance with Section 24
p.(None): is
p.(None): 1. if there is a reason in accordance with § 19 paragraphs 1 and 2 or
p.(None): 2. in the event of changes that affect the basic nature of the medicinal product,
p.(None): to fail.
p.(None): (2) The approval of the change of a pharmaceutical specialty is, if necessary, prescribed
p.(None): To impose obligations, the fulfillment of which protects the health of humans or animals or the
p.(None): To ensure drug safety.
p.(None): § 24b. (1) The authorization holder or holder of a registration must ensure that in his
p.(None): Company complete documentation of everything related to approval or registration
p.(None): standing documents, their changes, as well as all notices and official notifications in
p.(None): Connection with this specialty drug is available at all times. This applies analogously to the
p.(None): Holder of a license for distribution in parallel import in accordance with § 10c.
p.(None): (2) The authorization holder or the holder of a registration has, in particular for the purposes of
p.(None): Pharmacovigilance, the Federal Ministry of Health and Women on its mandate all data
p.(None): in connection with the sales and sales volume of the pharmaceutical specialty as well as all available to it
p.(None): Provide data related to prescription volume. The authorization holder
p.(None): or the holder of a registration has furthermore for the purposes of pharmacovigilance the Federal Office for
p.(None): Healthcare security by ordering all data related to the health care system
p.(None): To provide sales volume of the drug specialty.
p.(None): (3) The authorization holder of a veterinary specialty is obliged, on request to the Federal Office for
p.(None): Healthcare safety free of charge Samples of the medicinal product in sufficient quantities for
p.(None): To provide that controls to identify residues of the medicinal product in question
p.(None): can be carried out. The license holder is also obliged to do so at the request of the Federal Office
p.(None): for healthcare safety to make the specialist knowledge available to him available to the
p.(None): Implementation of the analytical detection method for the determination of veterinary drug residues by the
p.(None): according to Council Directive 92/23 / EC of 29 April 1996 on control measures for certain
p.(None): Sto und e and their residues in live animals and animal products certain national
p.(None): To facilitate the reference laboratory.
p.(None): Transfer of rights
p.(None): § 25. The rights to an approved or registered pharmaceutical specialty go through legal transactions
p.(None): among the living or through inheritance from the license holder or registration holder to another
p.(None): according to § 9 for the application for approval or registration for the registration of this medicinal product
p.(None): Entitled over, are the Federal Office for Health Safety
...
p.(None): Proprietary Medicinal Products:
p.(None): 1. Medicinal products that use human blood or blood plasma as a source ff
p.(None): were produced, as well
p.(None): 2. immunological medicinal specialties consisting of vaccines, toxins, sera or allergens,
p.(None): as far as this is concerned
p.(None): a) live vaccines,
p.(None): b) used for primary immunization of young children or other risk groups
p.(None): Drug,
p.(None): c) used in immunization programs in the context of public health
p.(None): Medicines, or um
p.(None): d) deals with medicinal products that are newly approved or manufactured using new techniques
p.(None): or are new to a particular manufacturer. These medicinal specialties are subject to the
p.(None): Batch release for a transition period to be specified.
p.(None): For medicinal specialties of Z 2 lit. d has the Federal Office for Safety in Health Care by notice
p.(None): to determine whether the respective pharmaceutical specialties are new and for what period or what number of
p.(None): Batches are subject to batch inspection.
p.(None): (2) Batch release is subject to certain immunological conditions for use on or in animals
p.(None): Medicinal specialties that consist of vaccines, toxins, sera or allergens and for the defense against
p.(None): Notifiable animal diseases according to § 16 animal diseases law, RGBl. No. 177/1909.
p.(None): (3) Pharmaceutical specialties in accordance with paragraphs 1 and 2 may be without prejudice to the provisions on approval
p.(None): of medicinal products in Germany can only be delivered or kept ready for delivery if by a
p.(None): a testing institute designated by the Federal Minister for Health and Women was determined,
p.(None): that the batch conforms to the speci fi cations approved in the approval, in the case of non-approved
p.(None): Medicinal specialties correspond to the state of the art in science and technology. The decision has been made by
p.(None): the designated institute within 60 days of submitting an application and the
p.(None): necessary documents to be made. The applicant must be informed immediately. comes
p.(None): there is no positive opinion within 60 days, the applicant can contact the
p.(None): Federal Office for Safety in Health Care submit an application for a decision by the Federal Office.
p.(None): (4) The Federal Office for Safety in Health Care has an exception to the requirement upon application
p.(None): the batch release within the meaning of paragraph 3 if this is with regard to the special
p.(None): Condition, type of application or area of application of this medicinal specialty without
p.(None): Impairment of drug safety is justified. The exception must be revoked if the
p.(None): There are no prerequisites for this. Foreign medicinal specialties that are intended for a specific purpose in the
p.(None): 12 to 14 and 14 to 14 of the 2010 Medicinal Products Imports Act
p.(None): not batch release. Drug specialties by the state testing agency of another contracting party
p.(None): of the Agreement on the European Economic Area checked and approved in Austria
p.(None): Compliant specifications are also not subject to batch release.
p.(None): (5) The following principles apply when assessing the batch:
p.(None): 1. The testing institute named by ordinance of the Federal Minister for Health and Women can
p.(None): submit an assessment without performing an additional analytical test if
p.(None): Manufacturing and control methods the required quality, safety and harmlessness
p.(None): guarantee.
p.(None): 2. If the named test institute carries out an analytical test, this is based on the information provided in the frame
p.(None): of the admission procedure and if necessary available in the course of the application
p.(None): provided samples of the end product or samples of certain intermediate products (bulk
p.(None): Batches). It is important to ensure that the product meets the approval requirements
p.(None): approved specifications.
p.(None): 3. Can the testing institute named by the Federal Minister for Health and Women be approved on the basis of the
p.(None): submitted control reports and, if applicable, the analytical results obtained in the
p.(None): If the approval documents do not confirm the defined quality, the institute has the test report with it
p.(None): Justification to be forwarded immediately to the Federal Office for Safety in Health Care. This
p.(None): has in the case of an application for decision by the Federal Office for Security in the
p.(None): Healthcare to hear the applicant and within 30 days of receiving the application
p.(None): to decide on the batch release by notice. Results from the test report and the
p.(None): Justification the need to carry out an additional analytical test
p.(None): this 30-day period was inhibited for the duration of this test.
p.(None): (6) The export of medicinal products for which no examination according to paragraphs 3 to 5 has been requested is only
p.(None): permitted if the health authority of the country of destination decides not to
p.(None): Batch inspection in Austria has been informed and demonstrably takes note of this fact.
p.(None): (7) The Federal Minister of Health and Women may consider the
p.(None): Drug safety enact more detailed provisions on batch release.
p.(None): (8) If this appears necessary considering the safety of the drug, the
p.(None): Federal Minister of Health and Women by prescription pharmaceutical specialties in accordance with paragraphs 1 and 2 or
p.(None): to determine other biological medicinal products that may only be placed on the market if the
p.(None): Retail pack contains a number of adhesive labels corresponding to the number of pharmaceuticals contained therein
p.(None): is attached to enable the medicinal product and the respective batch to be identified. The
p.(None): Ordinance also has more detailed provisions on the content, shape, size and nature as well as the type of
p.(None): Include the adhesive labels.
p.(None): import analysis
p.(None): Section 26a. (1) For pharmaceutical specialties that are approved in Austria and from outside the
p.(None): European Economic Area, every batch, regardless of whether it is in the
p.(None): European Economic Area has been produced by a full pharmaceutical entrepreneur
p.(None): qualitative and quantitative analysis, at least with regard to effective components, as well as all
p.(None): other tests or examinations that are necessary to check the quality of the
p.(None): To ensure pharmaceutical specialty in accordance with the requirements on which the approval is based.
p.(None): (2) In the case of bulk goods or intermediate products that are approved for manufacturing in Austria
p.(None): Medicinal products are used and imported from outside the European Economic Area
p.(None): each batch, regardless of whether it was manufactured in the European Economic Area, from
p.(None): pharmaceutical entrepreneurs a full qualitative and quantitative analysis, at least in the
p.(None): With regard to effective components, as well as all other tests or tests,
p.(None): which are required to ensure the quality of the bulk goods or the intermediate product in accordance with the
p.(None): To ensure approval based on requirements.
p.(None): (3) For investigational medicinal products imported from outside the European Economic Area
...
p.(None): comply with the stipulated regulations, and that the controls according to paragraphs 1 to 3 are already in the exporting country
p.(None): have been carried out, the pharmaceutical entrepreneur is exempt from the obligation according to paragraphs 1 to 3
p.(None): freed.
p.(None): Internet portal for pharmaceuticals and pharmaceutical specialty registers
p.(None): Section 27. (1) In a register to be kept at the Federal Office for Safety in Health Care
p.(None): (Pharmaceutical Specialty Register)
p.(None): 1. approved pharmaceutical specialties,
p.(None): 2. homeopathic medicinal specialties within the meaning of § 11 paragraph 1, provided that their registration is not
p.(None): to be rejected in accordance with Section 11 (4),
p.(None): 3. Pharmacy-owned pharmaceutical specialties within the meaning of Section 11a (1), unless their registration
p.(None): is to be rejected in accordance with Section 11a (3),
p.(None): 4. traditional vegetable medicinal specialties within the meaning of § 12, provided that their registration is not in accordance with
p.(None): § 13 paragraph 2 is to be rejected,
p.(None): to be entered under a consecutive number (registration or registration number). Medicinal specialties that
p.(None): are placed on the market on the basis of a license in accordance with § 10c
p.(None): Approval number of the corresponding approved or registered pharmaceutical specialty (reference approval)
p.(None): take. However, this is due to a reference to the fact of parallel import and its
p.(None): To complete the order.
p.(None): (2) Any change or cancellation of an authorization or
p.(None): Approval in accordance with § 10c as well as any change or cancellation of a registration in accordance with para. 1 no.2 to 4
p.(None): entered.
p.(None): (3) The Federal Minister for Health and Women has more detailed regulations on the
p.(None): Maintaining the register of medicinal products, type and scope of entries and the type of
p.(None): To issue publication.
p.(None): (4) The Federal Office for Safety in Health Care has an internet portal for medicines
p.(None): operate. This serves to inform the public and the involved public about pharmaceuticals and
p.(None): is closed with the European Internet portal set up according to Art. 26 of the Regulation (EG) № 726/2004
p.(None): to link.
p.(None): (5) In this portal, every admission, every registration within the meaning of para. 1 nos. 2 to 4, each
p.(None): Approval according to § 10c and any change of a medicinal product that is necessary for its identification by the
p.(None): Users or pharmacists can be of importance immediately, but no later than two months after their
p.(None): Publish enactment in a generally accessible manner. The Federal Office for Security in
p.(None): Healthcare the approved specialist information and the approved package leaflet and their
p.(None): approved changes and any conditions or requirements for admission according to §§ 18 Para. 3,
p.(None): 19 paragraphs 4 and 19a paragraphs 1 and 2, which were carried out for pharmacovigilance reasons, and the deadlines for their
p.(None): Publish compliance publicly available. Before publication, the approval or
p.(None): Hear registry holder.
p.(None): (6) The Federal Office for Safety in Health Care is obliged, each in connection with
p.(None): Every application for approval and registration for registration (expert report as well as
p.(None): the opinion on the results of the
p.(None): pharmaceutical, non-clinical pharmacological and toxicological trials and the results of
p.(None): clinical trials or trials, the assessment of the risk management system and the
...
p.(None): Examiner health
p.(None): 1. is not significant or
p.(None): 2. is outweighed by the benefit to be expected from the use of the drug
p.(None): Health.
p.(None): (3) The clinical trial of a medicinal product may only be carried out on patients if
p.(None): 1. Results of clinical trials on healthy volunteers are available, unless
p.(None): The investigational medicinal product may not be tested on healthy volunteers in accordance with paragraph 2 no
p.(None): no meaningful result can be expected from healthy subjects, and
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is to treat the disease or the patient on whom the clinical trial is to be performed
p.(None): to recognize their course, to heal or alleviate them or to prevent them from further illnesses
p.(None): protect.
p.(None): If there is meaningful data according to Z 1 and from clinical trials on patients, this may not be available
p.(None): the requirements of Z 2, a clinical trial on the patient can also be carried out if
p.(None): A certain illness of the test participant is a prerequisite for that for the in the test plan
p.(None): the relevant question is expected to result.
p.(None): (4) (Note: repealed by Federal Law Gazette I No. 35/2004)
p.(None): § 30. The clinical trial of medicinal products may be performed on women of childbearing potential, with the exception of cases of
p.(None): Section 44, can only be carried out or continued if before and in sufficient repetition during the
p.(None): clinical trial to determine the absence of pregnancy.
p.(None): Tasks, responsibilities and qualifications of sponsor, monitor and auditor
p.(None): § 31. The sponsor must develop detailed procedural rules (SOPs) and for their compliance
p.(None): To take care.
p.(None): § 32. (1) The sponsor has
p.(None): 1. the examiner taking into account his suitability and the local conditions and possibilities
p.(None): the test center to select
p.(None): 2. to ensure the approval of the investigator, the clinical trial in accordance with the study plan and the
p.(None): Implement provisions of this federal law,
p.(None): 3. assess the test plan and, if necessary, confirm it with his signature and at
p.(None): to proceed with any changes within the meaning of Section 37a,
p.(None): 4. The investigator also about non-clinical and possibly existing clinical data and results
p.(None): to inform in writing, whereby the obligation to provide immediate information also with regard to
p.(None): any relevant new information that becomes available during the course of the clinical trial,
p.(None): consists,
p.(None): 5. Before the clinical trial begins, a proper application for approval of the clinical trial
p.(None): To pass the examination in accordance with Section 40 (1), to deal with the ethics committee and to end the
p.(None): clinical examination, the Federal Office for Safety in Health Care and the Ethics Committee
p.(None): within 90 days, with early termination within 15 days with clear indication
p.(None): all reasons for canceling to report
p.(None): 6. the conduct of the clinical trial at a hospital before it begins and its
...
p.(None): has sufficient liability and legal protection insurance, if necessary the auditor from the
p.(None): the increase in risk associated with the clinical trial incurs additional costs for your own
p.(None): To adequately replace insurance or suitable insurance for your own account
p.(None): in favor of the examiner,
p.(None): 13. with the auditor on the distribution of responsibilities regarding the referral of the
p.(None): Ethics Committee, data transmission and storage, biometric evaluation,
p.(None): Reporting and publication modalities to make appropriate agreements and
p.(None): 14. to ensure that the test participant has a contact point at which the
p.(None): Exam participants independently or with the help of the patient's attorney
p.(None): can catch up, and
p.(None): 15. To pay a cost contribution for the assessment to be made by the ethics committee.
p.(None): (2) Personal injury insurance (Paragraph 1 No. 11) is based on the following principles
p.(None): complete:
p.(None): 1. The sponsor has policyholders, the test participant has independent entitlement
p.(None): To be insured.
p.(None): 2. Austrian law must apply to the insurance contract.
p.(None): 3. The insurance claims must be enforceable in Austria.
p.(None): 4. The enforceability of an Austrian execution title abroad must, if necessary
p.(None): be secured.
p.(None): 5. The scope of insurance must be proportionate to that with the clinical
p.(None): Related risks. More information can be obtained by decree from the Federal Minister for
p.(None): Health and women are determined. This is particularly the result of the number of
p.(None): Trial participants and trial sites, the type of clinical trial and the nature of the
p.(None): Test substance to be taken into account.
p.(None): (3) The sponsor must ensure that neither the test participants nor the Austrian
p.(None): Social insurance institutions incur costs from the provision of the investigational medicinal product (para. 1 no. 7)
p.(None): because that
p.(None): 1. the investigational medicinal product is a pharmaceutical specialty approved in Austria,
p.(None): 2. the use of which is primarily associated with individual benefit insofar as it serves to ward off one
p.(None): Life threatening or serious health damage is urgently needed and
p.(None): compared to available pharmaceutical specialties approved in the relevant indication area
p.(None): substantial increase in chances of success (note: correct: chances of success) seriously expected
p.(None): 3. the social security institution information about the investigational medicinal product and the clinical trial
p.(None): have been made available, and
p.(None): 4. This on the basis of these documents, after assessing the existence of the requirements of Z 1 bis
p.(None): 3 has approved an application for the assumption of costs.
p.(None): (4) The sponsor may delegate all or part of its duties or obligations to external parties
p.(None): delegate scientific institutions.
p.(None): monitor
p.(None): § 33. The monitor must establish communication between the sponsor and the clinical investigator. The
p.(None): Monitor must have the quali fi cations that give it expert supervision of the clinical trial
p.(None): allows.
p.(None): § 34. The monitor has
p.(None): 1. To work according to the SOP, the investigator before, during and after the completion of the clinical
...
p.(None): Instruct the drug advisory board to review the application for approval. If this is the implementation
p.(None): If the clinical trial is approved, a prohibition can be waived.
p.(None): (6) Conducting a clinical trial related to drugs for gene therapy and
p.(None): somatic cell therapy including xenogeneic cell therapy requires the approval of the
p.(None): Federal Office for Safety in Health Care.
p.(None): (7) The Federal Office for Safety in Health Care has applications according to paragraph 6 without unnecessary
p.(None): Postponement, but at the latest within 90 days after receipt of the application. In cases in
p.(None): to whom an advisory body is concerned, this period is extended by a further 90 days.
p.(None): (8) For a clinical trial in connection with drugs for gene therapy apply in addition to
p.(None): Provisions of this federal law meet the requirements of sections 74 to 79 of the Genetic Engineering Act.
p.(None): ethics committees
p.(None): Section 41. (1) The governor has clinical trials outside of hospitals
p.(None): To ensure that an ethics committee for the perception of the
p.(None): Tasks according to § 41a is set up and all necessary measures are taken to this
p.(None): Ethics committee to enable the work. The members of the ethics committee are allowed to participate in this
p.(None): Activity is not subject to any instructions.
p.(None): (2) The ethics committee has a balanced relationship between women and men
p.(None): to assemble and at least consist of:
p.(None): 1. a doctor who is authorized to practice the profession independently in Germany and is not the examiner,
p.(None): 2. a specialist in whose specialty the respective clinical trial falls, or, if applicable, one
p.(None): Dentist, and who are not examiners,
p.(None): 3. a representative of the superior service for health and nursing,
p.(None): 4. a lawyer,
p.(None): 5. a pharmacist,
p.(None): 6. a patient representative,
p.(None): 7. a representative of a representative organization for the disabled and a representative of the elderly,
p.(None): which belongs to a senior citizen organization in accordance with the Federal Senior Citizens Act, Federal Law Gazette I No. 84/1998,
p.(None): 8. a person with biometric expertise and
p.(None): 9. Another person who does not fall under Z 1 to 8 and who is concerned with pastoral care
p.(None): Is entrusted with matters or otherwise has the appropriate ethical competence.
p.(None): An equally qualified representative must be appointed for each member.
p.(None): (3) The members of the ethics committee and their representatives have any relationships with
p.(None): pharmaceutical industry completely open to the governor. You have yours
p.(None): To act in the ethics committee in all matters involving a relationship with
p.(None): pharmaceutical industry is likely to question its full impartiality.
p.(None): (4) The governor is entitled to a contribution from the sponsor in accordance with the
p.(None): Experience has shown that the costs of an assessment in the context of a clinical assessment are on average
p.(None): To request examination.
...
p.(None): (5) The Ethics Committee has sent its reasoned opinion to the sponsor within 35
p.(None): Days from the reporting date. The ethics committee has to ensure that the in
p.(None): Paragraph 6 deadline is met. This does not apply to applications within the meaning of Section 40 (6).
p.(None): (6) The Ethics Committee has the sponsor within 60 days and the Federal Office for
p.(None): Healthcare safety within 50 days of receiving a proper application
p.(None): to provide a reasoned opinion. For applications within the meaning of section 40 (6), the
p.(None): Deadlines in accordance with Section 40 (7).
p.(None): (7) During the examination of the application, the ethics committee may only make one additional decision
p.(None): Request information on the information already submitted by the applicant. The in paragraphs 5 and 6
p.(None): scheduled deadlines will be delayed until additional information is received.
p.(None): Multi-center exams
p.(None): Section 41b. (1) For multicentre examinations, the opinion of a single Austrian
p.(None): Ethics committee sufficient. The sponsor has to deal with an ethics committee that the through
p.(None): Ordinance of the Federal Minister of Health and Women meets specific requirements.
p.(None): This regulation has in particular
p.(None): 1. the organizational framework,
p.(None): 2. the circumstances relevant to the assessment of the necessary extensive experience, and
p.(None): 3. the internal quality assurance measures
p.(None): to consider.
p.(None): (2) Ethics committees that aim to work in the context of multicentre examinations have this
p.(None): the Federal Ministry of Health and Women with proof of the required according to paragraph 1
p.(None): Prerequisites to report. The Federal Minister of Health and Women has the ethics committees that
p.(None): meet the requirements set out in paragraph 1 of publishing in the official gazette of the Wiener Zeitung.
p.(None): (3) In the case of a multi-center examination, the sponsor has one of those announced in accordance with paragraph 2
p.(None): Select ethics committees that are responsible for one of the test centers. Is not one of the paragraph 2
p.(None): made known ethics committees responsible for one of these test centers or refuses to accept them
p.(None): of an application in accordance with paragraph 4, the sponsor can use the information published in accordance with paragraph 2
p.(None): Free choice of ethics committees.
p.(None): (4) In the event of temporary work overload, the elected ethics committee is entitled to
p.(None): Temporarily refuse to accept an application. This is immediately with the applicant
p.(None): Notify application in writing.
p.(None): (5) The sponsor has the ethics committees responsible for the proposed trial centers in the event
p.(None): of a monocentric clinical trial would be responsible locally, all documents simultaneously with the
p.(None): Submit the application to the ethics committee announced in accordance with paragraph 2. Any local
p.(None): The ethics committee has the suitability of the auditor and his staff and the adequacy of the
...
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 38 and
p.(None): 39 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Education is given. Further processing of the personal data collected up to that point is required
p.(None): the express data protection consent.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 42 or § 43.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 44. (1) The clinical trial of a medicinal product may only be carried out on a pregnant woman if
p.(None): if
p.(None): 1. the drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in pregnant women or unborn children
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is with the pregnant woman on whom the clinical trial is being conducted or with her
p.(None): to recognize unborn child diseases or their course, to cure or to alleviate them or
p.(None): to protect them from diseases,
p.(None): 3. according to the knowledge of medical science, the conduct of the clinical trial
p.(None): is not expected to pose any risks to the unborn child and
p.(None): 4. The clinical trial according to the knowledge of medical science only on pregnant women
p.(None): sufficient test results can be expected.
p.(None): (2) Paragraph 1 applies mutatis mutandis to clinical trials of medicinal products intended to be admission
p.(None): to allow pregnancy.
p.(None): Section 45. (1) The clinical trial of a medicinal product may be carried out on persons who have a presence or
p.(None): Provide training service, not be carried out.
p.(None): (2) The clinical trial of a medicinal product may be carried out on persons who are judicial or official
p.(None): Order stopped or accommodated according to the Accommodation Act, not carried out
p.(None): become.
p.(None): Dealing with data
p.(None): Section 46. (1) On the part of the sponsor, monitor and examiner, appropriate measures are necessary for careful
p.(None): and confidential handling of all data resulting from a clinical trial.
p.(None): (2) The test plan, the documentation, the agreements made between the investigator and sponsor and
p.(None): all other documents related to the clinical trial must be reviewed by
p.(None): the sponsor for a period of 15 years after completion or termination of the clinical trial
p.(None): be kept.
p.(None): (3) The examiner must ensure that the documents relate to pseudonymization for
p.(None): kept for a period of 15 years after completion or termination of the clinical trial.
p.(None): (4) Without prejudice to the duty of storage in accordance with paragraph 2, the final report must be submitted by the sponsor
p.(None): or later marketing authorization holder, are kept 5 years longer than the pharmaceutical specialty in Austria
p.(None): is allowed.
p.(None): (4a) With regard to the deadlines specified in paragraphs 2 to 4, the right under Art.
p.(None): Basic regulation excluded.
p.(None): (5) All data and documents relevant to the clinical trial must be submitted to the
p.(None): Federal Office for Safety in Health Care be made available. The transmission
...
p.(None): Section 47a. Ethics committees are required, all of them to the Federal Office for Safety in Health Care
p.(None): To provide information and to send documents that this to perform its duties under this
p.(None): Section needed.
p.(None): statutory authorization
p.(None): § 48. (1) Insofar as this is necessary with regard to drug safety, the Federal Minister for
p.(None): Health and environmental protection through regulation more detailed provisions on the requirements and
p.(None): Conduct clinical trial and non-clinical trial of medicines.
p.(None): (2) Without prejudice to the Animal Testing Act 2012, Federal Law Gazette I, the Federal Minister of Health
p.(None): № 114/2012, taking into account Directive 81/852 / EEC, more detailed provisions on clinical
p.(None): To be tested on animals.
p.(None): (3) The Federal Minister of Health, if this is for reasons of drug safety, to
p.(None): Compliance with international scientific standards or obligations under Community law or
p.(None): to verify compliance with the provisions of Section V is required by ordinance
p.(None): Regulations on the conduct of non-interventional studies, a reporting obligation for non-
p.(None): interventional studies, which are required to report, the scope of the reporting obligation and management
p.(None): a register for non-interventional studies including a part that may be accessible to the public
p.(None): of this register.
p.(None): IV. SECTION
p.(None): Pharmaceutical Advisory Board and Delimitation Advisory Board
p.(None): Pharmaceutical Advisory Board
p.(None): Section 49. (1) For advice to the Federal Minister for Health and Women and the Federal Office for
p.(None): Healthcare security in pharmaceutical matters and to prepare expert reports in
p.(None): Matters of this federal law are one with the Federal Ministry of Health and Women
p.(None): Commission (drug advisory council).
p.(None): (2) The Pharmaceutical Advisory Board must have permanent members: one representative from each of the areas
p.(None): 1. pharmaceutical technology,
p.(None): 2. Internal medicine,
p.(None): 3. clinical pharmacology,
p.(None): 4. pharmacology and toxicology,
p.(None): 5. Pharmaceutical chemistry
p.(None): 6. gene technology or gene therapy and somatic cell therapy and
p.(None): 7. Biometrics.
p.(None): (3) Depending on the type of object to be treated, the advice of the Medicines Advisory Board can be given in the
p.(None): In individual cases, non-permanent members of relevant, technically suitable persons are involved.
p.(None): (4) The permanent members of the Pharmaceutical Advisory Board mentioned in paragraph 2 are from the Federal Minister for
p.(None): Order health and women for a period of five years.
p.(None): (5) The Federal Minister of Health and Women has a servant for the period mentioned in paragraph 4
p.(None): (Note: correct: staff) to entrust his ministry with the chairmanship of the pharmaceutical advisory board.
p.(None): (6) A deputy must be appointed for each member and the chairman.
p.(None): (7) All members as well as the chairman and their deputies have a casting vote.
p.(None): Representatives have such a right to vote only if the persons they represent are prevented.
p.(None): (8) Certain tasks can be assigned to committees. Experts who
p.(None): The Committee of the Drugs Advisory Board, who are not members in accordance with paragraph 2, are dated
p.(None): Federal Minister of Health and Women as committee members for the period specified in paragraph 4
p.(None): to order.
p.(None): (9) The work of the Drugs Advisory Board is carried out by the Federal Minister for Health and Women
p.(None): led to the rules of procedure.
p.(None): (10) Without prejudice to Paragraph 11, the work on the Medicines Advisory Board is voluntary. Any travel expenses
p.(None): are the members of the Pharmaceutical Advisory Board, their deputies and experts involved after the
p.(None): highest fee level of the travel fee regulation 1955, Federal Law Gazette No. 133.
p.(None): (11) The members of the Pharmaceutical Advisory Board, which are appointed by the Federal Office for Security in
p.(None): Health care with the preparation of reports in connection with procedures according to the
p.(None): Medicines Act were due in terms of effort and time
p.(None): reasonable compensation to be paid by the applicant.
p.(None): demarcation Advisory Board
p.(None): Section 49a. (1) To advise the Federal Minister for Health and Women and the Federal Office for
p.(None): Healthcare safety issues related to the differentiation of drugs from other products as well
p.(None): to provide advice on whether a product meets the definition of the medicinal product and therefore -
p.(None): regardless of the question of whether the definition of a product regulated in another federal law
p.(None): are met - on this product in accordance with Section 1 (3a) only the provisions of this Federal Act
p.(None): a commission must be applied to the Federal Ministry of Health and Women
p.(None): (Delimitation advisory board).
p.(None): (1a) In order to clarify issues of demarcation between medicinal products and medical devices, the Advisory Board must in accordance with
p.(None): Paragraph 1 in a joint meeting with the Advisory Board in accordance with Section 5b of the Medical Devices Act (Demarcation and
p.(None): Classification Advisory Board).
p.(None): (2) The Federal Minister of Health and Women has technically suitable persons as permanent
p.(None): Members to be appointed for a period of five years. Care should be taken with the composition
p.(None): take that a balanced cast with regard to the demarcation (note: correct: demarcation) in
p.(None): Considered coming product groups is guaranteed.
p.(None): (3) The deliberations of the delimitation advisory board can depend on the type of object to be treated
p.(None): in individual cases, as non-permanent members, relevant, technically suitable persons are involved.
p.(None): (4) The Federal Minister of Health and Women has a member of staff for the period specified in paragraph 2
p.(None): its ministry to chair the delimitation advisory board.
p.(None): (5) A deputy must be appointed for each member and the chairman.
p.(None): (6) All members as well as the chairman and their deputies have a casting vote.
p.(None): Representatives have such a right to vote only if the persons they represent are prevented.
p.(None): (7) The work of the Delimitation Advisory Board is carried out by the Federal Minister of Health and
p.(None): Women led to rules of procedure to be adopted.
p.(None): (8) The work in the delimitation advisory board is voluntary. Any travel expenses are the members of the
p.(None): Demarcation Advisory Board, its deputies and experts involved according to the highest fee level
p.(None): of the 1955 Travel Fee Regulation, Federal Law Gazette No. 133.
p.(None): V. SECTION
p.(None): advertising restrictions
p.(None): General provisions
p.(None): Section 50. (1) All measures for information, for market research, are considered "advertising for pharmaceuticals"
p.(None): and market cultivation and creation of incentives with the aim of prescribing, dispensing,
p.(None): Promote sales or consumption of medicines. In particular, it includes:
p.(None): 1. drug advertising intended for consumers (lay advertising),
p.(None): 2. The drug advertising for people who prescribe or dispense drugs
p.(None): are authorized (specialist advertising),
p.(None): 3. Visiting pharmaceutical officers for people who prescribe or dispense
p.(None): Medicinal products are authorized
p.(None): 4. the supply of medical samples,
p.(None): 5. Incentives to prescribe or dispense drugs by granting, offering or
p.(None): Promise of financial or material benefits,
p.(None): 6. the sponsorship of sales promotion events in which people who participate in the
p.(None): Are authorized to prescribe or dispense medicinal products,
p.(None): 7. The assumption of travel and subsistence costs and participation fees in connection with
p.(None): professional science events for people who are prescribing or prescribing
p.(None): Dispensing of medicinal products are authorized.
p.(None): (2) This section does not apply
p.(None): 1. the correspondence and, if applicable, all documents which are not used for advertising purposes and which are used for
...
p.(None): act as a "natural product",
p.(None): 10. through a detailed description or presentation of the medical history of a wrong one
p.(None): Could lead to self-diagnosis,
p.(None): 11. Abusive, worrying, or misleading
p.(None): Get recovery certificates,
p.(None): 12. Abusive, worrying or misleading images of the
p.(None): Changes in the human or animal body due to diseases or
p.(None): Damage or the effect of a drug in the human body or in parts of the body
p.(None): use,
p.(None): 13. work towards obtaining prescription drugs at a distance.
p.(None): (2) Lay advertising may contain a reference to the admission or registration, provided that
p.(None): only the fact of admission or registration is referred to and such
p.(None): Note is not likely to mislead consumers in terms of safety and security
p.(None): Effectiveness of the medicinal product in question.
p.(None): (3) The supply of samples or samples of medicinal products or vouchers for this is not permitted.
p.(None): Likewise, the running of competitions is not permitted, provided that this is in connection with the
p.(None): Dispensing of drugs are available.
p.(None): professional advertising
p.(None): Section 54. (1) Pharmaceutical advertising intended for those authorized to use and dispense
p.(None): is, provided it
p.(None): 1. is operated for a medicinal specialty for which a specialist information (summary
p.(None): the product properties - SmPC) is to be published, and
p.(None): 2. takes place in printed matter, via electronic carrier media or by means of telecommunications,
p.(None): in a clearly legible form the essential information about the pharmaceutical specialty in accordance with the
p.(None): Technical information (summary of product properties - SmPC) included.
p.(None): (2) The Federal Minister of Health and Women has an ordinance pursuant to Section 15 (7)
p.(None): determine which information and in what form in drug advertising within the meaning of paragraph 1
p.(None): are to be included.
p.(None): Section 55. (1) All documents relating to a medicinal specialty that are part of the sales promotion for this
p.(None): Medicinal product must be given to the person authorized to prescribe or dispense it
p.(None): in addition to the information specified in Section 54 (1), the time at which the documents were created
p.(None): or last changed.
p.(None): (2) All information contained in the documents mentioned in paragraph 1 must be accurate, current,
p.(None): be verifiable and complete enough to give the recipient the opportunity to personally get an idea
p.(None): of the therapeutic value of the drug.
p.(None): (3) The quotes, tables and other representations taken from the specialist literature, which are described in the
p.(None): Paragraph 1 documents used must be taken over word for word; there is the
p.(None): specify exact source.
p.(None): (4) If reference is made to specialist literature in the documents mentioned in Paragraph 1, then this is
p.(None): reproduce essential content objectively with the source.
p.(None): Section 55a. (1) As part of the sales promotion for medicinal products for prescription or dispensing
p.(None): Authorized persons are prohibited from granting them a premium, fi nancial or material benefits,
p.(None): to offer or promise unless these are of little value and for medical or
p.(None): pharmaceutical practice of concern.
p.(None): (2) The representation effort in connection with sales promotion events must
p.(None): always strictly limited to their main purpose and may not be other than the person
p.(None): Prescription or persons authorized to dispense apply.
p.(None): (3) The provisions of paragraph 1 stand for the direct or indirect takeover of reasonable
p.(None): Travel and subsistence costs and participation fees for work-related only
p.(None): not opposed to scientific events; the representation effort must always be strict on the
p.(None): main scientific purpose of the event should be limited; the assumption of travel and
p.(None): Living expenses and participation fees as well as representation expenses must not be allowed to others
p.(None): Persons are regarded as persons authorized to prescribe or dispense.
p.(None): (4) The person authorized to prescribe or dispense it is prohibited, contrary to para. 1 bis
p.(None): 3 to request a premium, financial or material benefits, to be promised or accepted.
p.(None): (5) The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): enacted
p.(None): 1. when to assume a low value of premiums or fi nancial or material benefits
p.(None): is
p.(None): 2. With regard to the type and scope of the permissible representation effort in connection with
p.(None): Sales promotion events including choice of venue and location
p.(None): hosting,
p.(None): 3. What criteria an event must meet in order to be considered exclusively professional
p.(None): scientific event within the meaning of paragraph 3 apply,
p.(None): 4. With regard to the adequacy of travel and subsistence costs for work-related
p.(None): scientific events, and
p.(None): 5. With regard to the type and scope of the permissible representation effort in connection with
p.(None): job-related scientific events including the choice of the venue.
p.(None): In doing so, particular care must be taken to ensure that any appearance of improper influence from the
p.(None): Prescribing and dispensing authorized persons in their therapy decision or recommendation
p.(None): is avoided.
p.(None): free goods
p.(None): Section 55b. (1) Granting, offering and promising free goods for prescription
p.(None): or the supply of authorized persons is prohibited if it concerns medicinal products which
p.(None): Umbrella Association of Social Insurance Institutions issued reimbursement code are included.
p.(None): (2) Demanding, which can be promised or accepting those covered by paragraph 1
p.(None): In-kind discounts by persons authorized to prescribe or dispense are prohibited.
p.(None): information officer
p.(None): Section 56. (1) The authorization holder or holder of a registration must ensure that
p.(None): 1. any advertising for medicinal products complies with this section
...
p.(None): 1. are not subject to the prescription requirement and
p.(None): 2. are exclusively intended by dentists, specialists in dentistry, oral and maxillofacial medicine
p.(None): or being applied to the patient by dentists,
p.(None): are given directly to them and to dental outpatients.
p.(None): (8) Medical gases may come from the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): Hospitals without a pharmacy and to traders who are in accordance with the
p.(None): Trade regulations 1994 are authorized to deliver compressed technical gases.
p.(None): (9) Medicinal products for clinical testing may be used by the manufacturer, depositeur and pharmaceutical wholesaler
p.(None): also be given directly to hospitals without a pharmacy and to examiners.
p.(None): (10) Rescue and ambulance services of a local authority may use medicinal products that they
p.(None): need to perform their rescue and ambulance duties from those
p.(None): Obtain pharmacies that are operated by hospitals, whose sponsors these
p.(None): Local authority is.
p.(None): Ensuring the supply
p.(None): Section 57a. (1) The authorization holder or the holder of a registration for a medicinal product and the
p.(None): Pharmaceutical wholesalers and pharmaceutical wholesalers who actually placed them on the market
p.(None): Selling medicinal products have an appropriate and within the scope of their respective responsibilities
p.(None): Continuous provision of the medicinal product for dispensing by pharmacies or for other dispensing
p.(None): 59 entitled persons to ensure that the needs of patients are met domestically.
p.(None): (2) The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): with regard to the scope of the obligations mentioned in paragraph 1 and the measures taken in relation to them
p.(None): Failure to enact, if necessary, to ensure the care of patients in the
p.(None): To ensure domestic.
p.(None): Section 57b. This section does not apply to the delivery of human cells and tissues for use
p.(None): in humans, insofar as they fall under the Tissue Safety Act, Federal Law Gazette I No. 49/2008.
p.(None): Submission of medical samples
p.(None): Section 58. (1) Marketing authorization holders may submit samples of approved pharmaceutical specialties to doctors, dentists,
p.(None): Veterinarians and dentists only by written request, only free of charge and after
p.(None): Application of the clearly legible and non-removable note "unsalable doctor's sample" in one
p.(None): Do not dispose of a package larger than the smallest commercially available in accordance with paragraph 2. This
p.(None): Samples may also only be passed on by the recipients free of charge. The submission of
p.(None): Medical specimens of medicinal specialties that contain psychotropic substances or narcotics are prohibited.
p.(None): (2) The supply of unsellable medical samples to recipients in accordance with paragraph 1
p.(None): 1. within a period of one year after the first delivery of the medicinal product in the sense
p.(None): of Section 57 in a number that is used to assess the success of treatment in a maximum of ten patients
p.(None): is sufficient, but in total no more than 30 medical samples of a pharmaceutical specialty each
p.(None): Receiver, and
p.(None): 2. after the expiry of the period specified in Z 1 per request, to a maximum of 2
p.(None): Medical samples, to a recipient but not more than five medical samples one
p.(None): Medicinal specialty take place in the year.
p.(None): (3) About the recipients of unsalable medical samples and about the type, scope and time of the
p.(None): Submission of the same must be documented and, if requested, submitted to the Federal Office for Security in the
p.(None): Submit health care. By ordinance, the Federal Minister has laid down more detailed provisions on Art
p.(None): and form of evidence.
p.(None): Note for the following provision
p.(None): For the entry into force cf. Section 13 (2) of the Distance Selling Ordinance, Federal Law Gazette II No. 105/2015, and Section 94i (3).
p.(None): Small-scale delivery
p.(None): Section 59. (1) Pharmaceuticals may only be dispensed by pharmacies, provided that in sections 57 and 58 or in
p.(None): following nothing else is determined.
p.(None): (2) Pharmacy specialties may only be dispensed by the pharmacy in which they are
p.(None): are wholly or predominantly manufactured and their operators are registered owners of these
p.(None): pharmacy proprietary medicinal product.
p.(None): (3) The Federal Minister for Health and Women, in agreement with the Federal Minister for
p.(None): Economy and labor by regulation to determine those medicines that are even in one after the
p.(None): Experience of everyday life foreseeable improper use none
p.(None): Let health or life endanger human or animal and therefore by
p.(None): Druggists or by traders who, according to the 1994 Trade Ordinance, manufacture medicinal products
p.(None): are entitled to be released.
p.(None): (4) Insofar as medicinal products in accordance with Paragraph 3 are contact lens fluids, they may
p.(None): are also given by traders who, according to the 1994 Industrial Code, on retail
p.(None): with contact lenses and the adaptation of contact lenses.
p.(None): (5) Medicinal products that contain only active ingredients that are specified in a regulation
p.(None): 3, may be submitted in accordance with paragraphs 3 and 4, unless the Federal Office
p.(None): for Healthcare Safety determined by notice that this is due to a
p.(None): Possibility of danger arising from the special composition or a certain
p.(None): Indication results, is reserved for pharmacies in retail sales.
p.(None): (6) The Federal Office for Safety in Health Care can apply to the authorization holder
p.(None): exempt pharmaceutical specialties that do not comply with Paragraph 5 from the pharmacy reservation,
p.(None): if there is no hazard due to the special composition or the intended indication
p.(None): to get. Such a decision must be revoked if it subsequently becomes known that the
p.(None): The requirements for this are not met.
p.(None): (7) Paragraphs 1 to 6 do not apply to medicinal products within the meaning of Section 7 paragraph 4.
p.(None): (7a) If it is medicinal products for animals intended for external use on the skin
p.(None): are, or are medicinal specialties for bees, due to the special composition
...
p.(None): to set up.
p.(None): (2) The Delimitation Commission must belong as members:
p.(None): 1. the board of an Austrian university institute for pharmacology,
p.(None): 2. the board of an Austrian university institute for pharmacognosy,
p.(None): 3. two representatives of the Austrian Chamber of Commerce,
p.(None): 4. a representative of the Austrian Chamber of Pharmacists,
p.(None): 5. a representative of the Austrian Medical Association,
p.(None): 6. a representative of the Federal Chamber of Veterinarians in Austria,
p.(None): 7. a representative of the Federal Chamber of Labor,
p.(None): 8. a representative of the umbrella organization of social security institutions and
p.(None): 9. an expert staff member of the Austrian Agency for Health and Food Security.
p.(None): (3) The members of the demarcation commission are from the Federal Minister of Health and
p.(None): Order environmental protection for a period of five years. With regard to those mentioned in paragraph 2 nos. 3 to 8
p.(None): Representatives have the right to propose to the institutions concerned.
p.(None): (4) The Federal Minister of Health and Environmental Protection has one for the period specified in paragraph 3
p.(None): To entrust ministry officials with the chairmanship of the demarcation commission.
p.(None): (5) A deputy is to be appointed for each member of the demarcation committee and for the chairman
p.(None): to order.
p.(None): (6) All members as well as the chairman and their deputies have a casting vote.
p.(None): Representatives have such a right to vote only if the persons they represent are prevented.
p.(None): (7) The deliberations of the delimitation commission are based on a by the Federal Minister for Health and
p.(None): Women to adopt rules of procedure in agreement with the Federal Minister of Economics and Labor
p.(None): respectively.
p.(None): (8) The work in the demarcation committee is voluntary. Any travel expenses are
p.(None): Members of the demarcation committee or their deputies according to the highest fee level of the
p.(None): Replace 1955 Travel Fee Regulation.
p.(None): Delivered in retail packs
p.(None): Section 61. (1) Pharmaceutical specialties may only be used in those provided by the manufacturer or depositeur
p.(None): Commercial packs are given. The following are excluded:
p.(None): 1. delivery on the basis of a special order by the doctor, dentist or veterinarian,
p.(None): 2. delivery in institutional pharmacies for the needs of the hospital to be supplied,
p.(None): 3. the supply of medicinal products for feeding in batches,
p.(None): 4. the delivery of medical gases,
p.(None): 5. dispensing by pharmacies after re-blistering based on a special order by the doctor
p.(None): or on behalf of the patient and
p.(None): 6. the delivery in accordance with section 57 (1) 10 by institutions in accordance with section 15 of the Narcotics Act.
p.(None): (2) When dispensing according to paragraph 1 no. 1, it must be ensured that the type and amount of the medicinal product are available at all times
p.(None): can be determined.
p.(None): (3) The consumer or user is to be accompanied by an accompanying document when submitting items in accordance with Paragraph 1 Numbers 3 and 4
p.(None): handed over the text of the labeling (sections 17 and 17a) and the instructions for use (sections 16 and 16a)
p.(None): must contain.
p.(None): VII. SECTION
p.(None): operating rules
p.(None): operating Rules
p.(None): § 62. (1) As far as it is necessary to protect the health and life of humans or animals
...
p.(None): 1. Manufacture, placing on the market, import and export of medicinal products or active substances,
p.(None): 1a. Staffing and qualification,
p.(None): 2. type and scope of the control of drugs or active substances, such as the management of a control laboratory,
p.(None): 3. Hygiene requirements,
p.(None): 4. quality, size, equipment, dedication and location of the operating rooms and their furnishings,
p.(None): 5. Nature of the technical equipment,
p.(None): 6. quality of work clothing,
p.(None): 7. Nature and labeling of the containers,
p.(None): 8. Management and storage of reservations, records, reports, samples and others
p.(None): show
p.(None): 9. nature and keeping of the animals used in the manufacture of the medicinal products,
p.(None): 10. Readiness for duty for pharmaceutical wholesalers and pharmaceutical wholesalers,
p.(None): 11. Storage and storage as well as transport,
p.(None): 12. Withdrawal, labeling, separation or destruction of non-marketable goods
p.(None): Drugs.
p.(None): (3a) In the regulation pursuant to Paragraph 1, the Federal Minister of Health, in agreement with the
p.(None): Federal Minister of Finance for implementing Union law regulations
p.(None): Monitoring measures on the import and export of active substances to ensure that
p.(None): these correspond to the good manufacturing and sales practice for active ingredients. It can also be provided
p.(None): which active ingredients within the meaning of Regulation (EEC) № 2658/87 on customs and statistical
p.(None): Nomenclature and the Common Customs Tariff, OJ. № L 256 of September 7, 1987 S 1, last changed by
p.(None): the Implementing Regulation (EU) № 155/2012, OJ. № L 50 from 02/23/2012 p. 1, for surveillance
p.(None): through the customs offices.
p.(None): (4) The Federal Minister of Health and Women can further specify by ordinance
p.(None): Provisions regarding the requirements for wholesalers of pharmaceuticals, in particular
p.(None): with regard to sufficient storage, assortment design, availability,
p.(None): Supply intensity, regularity of supply and operational obligations taking into account the
p.(None): supplying area. A procedure for their recognition can also be provided.
p.(None): Section 62a. (1) As far as it is necessary to ensure the health and life of humans or animals
p.(None): To ensure the required quality of the medicinal products and the supply of medicinal products, the
p.(None): Federal Minister of Health, Sport and Consumer Protection by ordinance an operating regulation for
p.(None): to enact the operation of pharmacies.
p.(None): (2) A regulation in accordance with paragraph 1 must contain in particular more detailed provisions on:
p.(None): 1. the minimum size, dedication, location, quality, equipment and furnishings of the
p.(None): Pharmacies operating rooms,
p.(None): 2. Devices and magistral workplaces,
p.(None): 3. the nature and labeling of the containers,
p.(None): 4. Storage, testing, magistral production (recipe and recipe stock) and production
p.(None): pharmacy-owned pharmaceutical specialties, re-blistering and dispensing of pharmaceuticals,
p.(None): 4a. Ensuring pharmaceutical information and advice on site when supplying
p.(None): immobile residents of old people's homes, nursing homes or other care facilities
p.(None): Medicines by pharmacists of the supplying pharmacy,
p.(None): 5. the maintenance and storage of reservations and records and
p.(None): 6. the operational review.
p.(None): Section 62b. (1) The Federal Minister of Health and Women can, in addition to those in § 62 and § 62a
p.(None): Regulations mentioned, by ordinance enact more detailed regulations for establishments that use human blood
p.(None): or process, store and distribute blood components, provided they are intended for transfusion.
p.(None): (2) The ordinance pursuant to paragraph 1 has a high level of health protection for donors
p.(None): and recipient in particular the requirements for staffing as well as the quality and
p.(None): To regulate safety requirements.
p.(None): approval
p.(None): Section 63. (1) In companies within the meaning of Section 62 (1), manufacturing, placing on the market and
p.(None): Control of medicinal products or medicinal products and active substances only on the basis of an authorization from the
p.(None): Federal Office for Safety in Health Care.
p.(None): (2) The application for the authorization are all for assessing the existence of the
p.(None): Requirements according to § 64 paragraph 1 required documents, especially about
p.(None): 1. type, scope and location of the intended activity,
p.(None): 2. quality, size, equipment, dedication and location of the operating rooms and their furnishings,
p.(None): 3. Condition of the technical equipment, and
p.(None): 4. the competent person, if necessary,
p.(None): to join.
p.(None): (3) The Federal Office for Safety in Health Care has received applications in accordance with paragraph 2 within
p.(None): To decide 90 days after receipt of the application.
p.(None): (4) The Federal Office for Safety in Health Care can provide the applicant with additional information
p.(None): with regard to the documents in accordance with paragraph 2. In this case, the deadline according to para
p.(None): Additional information inhibited.
...
p.(None): carry out.
p.(None): (6) Operational reviews in accordance with paragraphs 1 and 4 and operational reviews in accordance with paragraph 5 of
p.(None): Companies that manufacture or import auxiliary materials can, at the request of another Member State,
p.(None): the European Commission or the Agency. Without prejudice to any agreements
p.(None): between the European Union and countries that are not parties to the Agreement on the
p.(None): Are European Economic Area, the Federal Office for Safety in Health Care one
p.(None): Manufacturer in the country that is not a contracting state to the Agreement on the European Economic Area,
p.(None): request to undergo an operational review in accordance with the requirements of the European Union
p.(None): (7) The Federal Office for Safety in Health Care has company reviews of companies that
p.(None): 1. Human medicinal products or
p.(None): 2. Active ingredients
p.(None): manufacture, control or place on the market according to the guidelines of the European Commission
p.(None): Art. 111a of Directive 2001/83 / EC and the collection of the
p.(None): To carry out Community procedures for inspections and the exchange of information, with the
p.(None): Agency by exchanging information about planned and carried out operational reviews
p.(None): together.
p.(None): (8) The Federal Office for Safety in Health Care introduces its inspection activities
p.(None): professionally designed quality system, by the organs of the Federal Office and by this
p.(None): consulted experts in these activities. The quality system is closed if necessary
p.(None): To update.
p.(None): Section 68. (1) The organs of the Federal Ministry of Health and Women and of the bodies under Section 67 (1)
p.(None): authorized the governor, the organs of the Federal Office for Safety in Health Care as well
p.(None): by the Federal Minister for Health and Women or the Federal Office for Security in the
p.(None): Healthcare experts are authorized to
p.(None): 1. Companies in accordance with § 62 Paragraph 1 and
p.(None): 2. Facilities and means of transport of such companies that are operated by companies in accordance with Section 62 (1) with
p.(None): Storage or transport have been commissioned, provided that they are for storage or transport
p.(None): of drugs or active ingredients can serve
p.(None): to enter, to visit, to check and to take samples in the quantity required for an examination
p.(None): and to inspect the records of the company, which according to drug law
p.(None): Regulations are to be kept, and copies thereof as well as photographs and video recordings in the company
p.(None): to be made if this is necessary to preserve evidence. You can also inspect the certificate
p.(None): the necessary business license according to the trade regulations 1994 taken
p.(None): become. These official acts are, except in the event of imminent danger, during the operating hours
p.(None): perform.
p.(None): (2) The organs and experts within the meaning of paragraph 1 must take care that each
p.(None): disruption or obstruction of the operation that is not absolutely necessary is avoided.
p.(None): (3) No compensation is due for the samples taken in accordance with paragraph 1.
p.(None): (4) A record according to §§ 14f AVG and its content is to be recorded for each company audit
p.(None): from the Federal Office for Safety in Health Care to the holder of the operating license
p.(None): bring is. In terms of content, the minutes are based on those of the European Commission
p.(None): published guidelines in accordance with Art. 51 of Directive 2001/82 / EC or Art. 111a of Directive 2001/83 / EC
...
p.(None): Paragraph 5 in the Union database in accordance with Art. 111 Paragraph 6 of Directive 2001/83 / EC. In these
p.(None): The Federal Office for Safety in Health Care also has information about companies that database
p.(None): the provisions of this federal law or ordinances issued on the basis of this federal law
p.(None): do not correspond to enter. This also applies to the registration and deletion of pharmaceutical intermediaries.
p.(None): Section 69. (1) In cases of imminent danger to human or animal health caused by medicinal products
p.(None): Federal Office for Safety in Health Care according to the extent of the risk
p.(None): 1. the complete or partial closure of the business, the decommissioning of technical facilities or
p.(None): other measures to prevent the placing on the market of medicinal products or substances
p.(None): or
p.(None): 2. To impose requirements to ensure compliance with the provisions of this federal law or on grounds
p.(None): to ensure ordinances enacted by this federal law.
p.(None): (2) In cases of imminent danger from drugs, measures in accordance with paragraph 1 can also be taken
p.(None): be carried out on the spot without prior procedure or before issuing a decision;
p.(None): however, a written notification must be issued within two weeks, otherwise the one that has been passed
p.(None): Measure is deemed canceled.
p.(None): personal requirements
p.(None): Section 69a. (1) In a company within the meaning of Section 62 (1) may perform the tasks of a knowledgeable person
p.(None): and with the management of the manufacture of pharmaceuticals only people with the necessary scientific
p.(None): Vocational training and appropriate practical training.
p.(None): (2) The Federal Minister of Health and Women has issued an ordinance with regard to the
p.(None): Drug safety more detailed regulations on scientific professional training and practical
p.(None): Training of the competent person and the production manager.
p.(None): Section 70. (1) Only persons may be entrusted with the management of a control laboratory within the meaning of Section 62 (3) no
p.(None): who obtain the required scientific professional training and a corresponding one
p.(None): have completed practical training.
p.(None): (2) The Federal Minister of Health and Women, taking into account the necessary
p.(None): Knowledge and experience with regard to drug safety through prescribing more detailed regulations
p.(None): to enact what scientific professional training and practical training the head of a
p.(None): Has to prove control laboratories.
p.(None): Section 71. (1) Persons who are employed in a company within the meaning of Section 62 (1) and with medicinal products,
p.(None): in contact with their containers or materials used to manufacture medicinal products
p.(None): come, must immediately notify the manager of the company or his deputy if
p.(None): 1. they can adversely affect the nature of the medicinal products through illness,
p.(None): 2. They are infected by an illness, even if only to a limited extent, which is notifiable or notifiable
p.(None): have been exposed or are at risk of spreading such a disease,
p.(None): or
p.(None): 3. they are suspected of having an illness as defined in Z 1 or 2.
p.(None): They may only resume their work if the manager of the company or his deputy
p.(None): on the basis of a medical certificate has convinced that the nature of the
p.(None): Medicinal product is not adversely affected.
p.(None): (2) The manager of the company or his deputy must ensure that the persons mentioned in paragraph 1
p.(None): Individuals before starting work and then undergoing a medical examination once a year
p.(None): are subjected, in particular to the presence of diseases and circumstances within the meaning of
p.(None): Paragraph 1 is to be observed.
p.(None): (3) The persons named in paragraph 1 are at the beginning of their employment via paragraphs 1 and 2 as well
...
p.(None): (3) The Federal Minister of Health may, by ordinance, provide more detailed provisions regarding the
p.(None): Issue requirements for the mediation of medicinal products, in particular via
p.(None): Documentation requirements and quality assurance measures.
p.(None): VIII. SECTION
p.(None): Pharmareferent
p.(None): qualification
p.(None): Section 72. (1) The activity of a pharmaceutical representative may only be carried out by persons who:
p.(None): 1. a university course in human medicine, dentistry, veterinary medicine
p.(None): or pharmacy in Austria or in another party to the Agreement on the
p.(None): European Economic Area or successful in the Swiss Confederation
p.(None): have completed or have the qualifications of a competent person,
p.(None): 2. have demonstrated by means of an examination that their vocational training with a view to the activity of a
p.(None): Pharmaceutical officers are to be equated with professional training according to Z 1.
p.(None): (2) The examination in accordance with paragraph 1 no. 2 is to be taken at the Federal Ministry of Health and
p.(None): Examination committee to be set up for environmental protection.
p.(None): (3) The Federal Minister of Health and Environmental Protection has more detailed regulations by ordinance
p.(None): about the composition of the examination board, the examination subjects, the examination requirements and
p.(None): to issue the conduct of the test.
p.(None): (4) In any case, the ordinance pursuant to para. 3 must stipulate that
p.(None): 1. the examination committee to be appointed as members by the Federal Minister for Health and Women
p.(None): Experts from the areas mentioned in Z 2, as well as one representative of each
p.(None): Austrian Chamber of Commerce, the Federal Chamber of Labor and the Austrian Medical Association as
p.(None): Assessors have to belong
p.(None): 2. the exam at least the subjects
p.(None): a) General principles of physics and chemistry,
p.(None): b) anatomy and physiology,
p.(None): c) pathology,
p.(None): d) hygiene, medical microbiology and parasitology,
p.(None): e) pharmacology and pharmaceutical technology,
p.(None): (f) pharmaceutical chemistry and pharmacognosy; and
p.(None): g) Pharmaceutical Law
p.(None): has to include, and
p.(None): 3. The prerequisite for taking the exam is at least the general university entrance qualification
p.(None): or represents a professional qualification in the higher service for health and nursing.
p.(None): (5) Nationals of a contracting party to the Agreement on the European Economic Area
p.(None): or the Swiss Confederation, who have a certificate of competence within the meaning of the directive
p.(None): 2005/36 / EG on the recognition of professional qualifications, which is necessary for the practice of
p.(None): Authorized to work as a pharmaceutical officer, the Federal Minister of Health has granted approval for
p.(None): To exercise a profession as a pharmaceutical officer.
p.(None): (6) Admission to practice is conditional on the successful completion of a
p.(None): Aptitude test to be linked if it can be proven by submitting the relevant documents
p.(None): Knowledge of the applicant differ significantly from the required Austrian knowledge.
p.(None): (7) The decision on admission to practice has to be made within four months of submission
p.(None): of these documents.
p.(None): (8) More detailed regulations on the documents to be submitted by the applicant and on the
p.(None): The Federal Minister of Health and Women has carried out and assessed the aptitude test in
p.(None): of a regulation in accordance with paragraph 3.
p.(None): obligations
p.(None): Section 73. (1) Pharmaceutical officers have the information in the exercise of their activity that the specialist information
p.(None): according to § 15, must convey without restriction. Statements made by the content of the
p.(None): Subject information that is not covered is not permitted.
p.(None): (2) Pharmaceutical officers are obliged to provide them with information in accordance with Section 75a
p.(None): to be sent to your client immediately.
p.(None): Section 74. Pharmaceutical officers may not place orders for medicinal products when performing their duties
p.(None): answer.
p.(None): IX. SECTION
p.(None): Market surveillance and pharmacovigilance
p.(None): General principles
p.(None): § 75. (1) For the interpretation of the principles of pharmacovigilance are the generally recognized
p.(None): scientific principles and requirements set out in the by the European Commission
p.(None): guidelines on good practice in the field of pharmacovigilance are included.
p.(None): (2) To the extent that authorization holders are addressed in this section, these provisions also apply
p.(None): for holders of a registration of a traditional herbal medicinal specialty.
p.(None): (3) The Federal Office for Safety in Health Care must operate a system that prevents
p.(None): to ensure that medicinal products that are suspected to be hazardous to health reach patients.
p.(None): Note for the following provision
p.(None): For the reference period cf. § 94h.
p.(None): statutory authorization
p.(None): Section 75a. The Federal Minister of Health has issued an ordinance, insofar as this is considered
p.(None): the requirements for in-depth and rapid information and the functioning of the pharmacovigilance system
p.(None): it is necessary to issue more detailed provisions on
...
p.(None): announce that in a third country from Art. 116 or 117 paragraph 1 of Directive 2001/83 / EC
p.(None): reasons mentioned.
p.(None): hemovigilance
p.(None): Section 75n. (1) Any establishment that uses human blood or blood components, provided these are for transfusion
p.(None): Are destined, processed, stored or distributed, is committed to serious incidents related to the
p.(None): Processing, storage and distribution of blood or blood components that affect quality and safety
p.(None): can influence to report immediately to the Federal Office for safety in the health service.
p.(None): (2) Any establishment that produces human blood or blood components, provided that they are intended for transfusion
p.(None): , processed, stored or distributed, must have a process through which blood and blood components,
p.(None): which are the subject of a notification in accordance with paragraph 1, effective and verifiable from the distribution
p.(None): can be withdrawn.
p.(None): (3) The head of a blood deposit within the meaning of Section 8f KAKuG and the one issued in each case
p.(None): Implementing provisions or, if such does not exist, the medical director of the hospital as well
p.(None): Resident doctors, including group practices, are required to have serious incidents at the
p.(None): Storage or distribution of blood and blood components occur and the quality and safety
p.(None): can affect as well as serious undesirable reactions that occur during or after the transfusion
p.(None): and can be attributed to the quality and safety of blood or blood components
p.(None): Federal Office for Safety in Health Care to report immediately.
p.(None): (4) The Federal Minister of Health and Women can, insofar as this is with regard to uniformity
p.(None): and the information content of the reports is required, by means of ordinance, more detailed provisions on
p.(None): Issue the content, scope and form of the reports in accordance with paragraphs 1 and 3.
p.(None): (5) If a report in accordance with paragraph 1 concerns a specific blood donation facility, the Federal Office for
p.(None): Healthcare security to inform the blood donation facility concerned.
p.(None): § 75o. Exceptions to the reporting obligations of sections 75a to 75c are those cases in which a
p.(None): serious adverse event or serious adverse reaction according to
p.(None): Sections 17 or 32 Tissue Safety Act must be reported.
p.(None): § 75p. (1) The traceability requirements apply to medicinal products in accordance with Section 7 (6a)
p.(None): Sections 5 (4) and 16 (5) of the Tissue Safety Act, even if the drug cells
p.(None): or tissues of animal origin.
p.(None): (2) For medicinal products according to § 7 paragraph 6a, the reporting obligations according to §§ 17 and 32 des
p.(None): Tissue Safety Act, even if the drug cells or tissues of animal origin
p.(None): contain.
p.(None): Quality defects, counterfeit medicines
p.(None): § 75q. (1) Quality defects are
p.(None): 1. Defects within the meaning of § 4 and
p.(None): 2. deficiencies of a medicinal product placed on the market with regard to commercial packs,
p.(None): Composition or nature,
p.(None): if this poses a risk to the life or health of humans or animals.
p.(None): (2) Receive doctors, dentists, veterinarians, dentists, midwives and, insofar as they are not subject to the reporting obligation
p.(None): According to § 75j, pharmacists and traders who are registered according to the 1994 Industrial Code
...
p.(None): If there is a significant risk to health, the report must be sent to the Federal Office for Security
p.(None): in healthcare immediately.
p.(None): (5) Paragraphs 1 to 4 apply mutatis mutandis to the holder of a registration as a pharmacy own or
p.(None): homeopathic medicinal specialty.
p.(None): (6) Paragraphs 1 to 4 apply mutatis mutandis to the holder of an authorization for distribution in the
p.(None): Parallel imports. Furthermore, the holder of a license for parallel import sales within the
p.(None): period mentioned the authorization holder or the holder of a registration as a pharmacy own or
p.(None): inform herbal traditional herbal medicinal product about this message.
p.(None): (7) If there is a considerable risk to public health due to the lack of quality,
p.(None): the Federal Office for Safety in Health Care sends to all other member states of the
p.(None): European Economic Area and all possible actors in the domestic supply chain
p.(None): Quick warning. It can be assumed that the medicinal product has already reached patients and
p.(None): there is reasonable suspicion that there is an immediate risk to life or serious and
p.(None): the Federal Office for Safety in the
p.(None): Health care immediately, but at the latest within 24 hours, information to the public
p.(None): about the lack of quality and the resulting dangers. Any from
p.(None): Approval holders have already taken measures to be taken into account. Section 75c (2) applies
p.(None): analogous.
p.(None): (8) Paragraphs 2 to 4, 6 and 7 apply analogously to counterfeit medicinal products.
p.(None): sampling
p.(None): Section 76. (1) Medicines are issued by organs of the Federal Ministry of Health and Women
p.(None): Organs of the Federal Office for Safety in Health Care or commissioned by them
p.(None): Control experts.
p.(None): (2) The control has by sampling in the company of the 1st manufacturer,
p.(None): 2. Depositeurs,
p.(None): 3. pharmaceutical wholesaler or
p.(None): 4. Pharmaceutical retailer
p.(None): to take place during operating hours.
p.(None): (3) Feed medicinal products can also be checked by the consumer.
p.(None): (3a) Radioactive medicinal products can also be checked by the user.
p.(None): (4) The organs of the Federal Ministry of Health and Women are responsible for carrying out the control
p.(None): and the Federal Office for Safety in Health Care or experts commissioned by them
p.(None): To grant access to the companies mentioned in paragraph 2 and the necessary sampling. this applies
p.(None): analogously also for the control of feed medicinal products at the consumer and of radioactive ones
p.(None): Medicines for the user.
p.(None): (5) The sample taken is, insofar as this is possible by nature and therefore not hers
p.(None): faultless assessment is frustrated to be divided into two equal parts that are officially closed. On
p.(None): Part is to be left to the party for evidence.
p.(None): (6) No compensation is due for the samples taken. Are the samples in factories according to
p.(None): Paragraph 2 no. 3 or 4, taken from the consumer according to Paragraph 3 or from the user according to Paragraph 3a
p.(None): the manufacturer or depositeur must provide replacement by providing the same pieces.
p.(None): Section 76a. (1) Monitoring food traffic suspected of being
p.(None): Medicinal products are or banned active substances in accordance with Section 1 (2) (1) of the 2007 Anti-Doping Act
p.(None): included (hereinafter referred to as "goods") is the responsibility of the governor.
p.(None): (2) The governor has chosen to perform this task as specially trained bodies
p.(None): To use supervisory bodies. The following are considered specially trained:
p.(None): 1. Doctors who have passed the physics examination and
p.(None): 2. People who meet the training requirement in accordance with Section 24 (3) LMSVG.
p.(None): (3) Supervisory bodies are entitled to inspect wherever goods are placed on the market
p.(None): hold and take samples. For this purpose, they must be granted access to all places where
p.(None): are goods. The review is, apart from the control of means of transport or at
p.(None): Danger of being delayed during normal business or operating hours. The disturbance of the
p.(None): Business operations should be avoided if possible.
p.(None): (4) The sample taken is, insofar as this is possible by nature and therefore not hers
p.(None): faultless assessment is frustrated to be divided into two equal parts that are officially closed. On
p.(None): Part is to be left as a cross-check of the party for evidence purposes. If a division is not possible, it has
p.(None): Supervisory body to supply the sample without prior division of the investigation. For the samples taken
p.(None): no compensation is due.
p.(None): (5) On the occasion of the sampling, the supervisory body must issue a cover letter and everyone
p.(None): Include part of the sample in which the observations and observations are noteworthy for the assessor
p.(None): of the organ are included. The Federal Minister is responsible for the details of the sample accompanying letter
p.(None): for health and women.
p.(None): (6) The sample taken is to be sent to the investigating institution. This
p.(None): The investigation institute has to examine the sample and to produce findings and expert opinions. findings
p.(None): and reports are to be sent immediately to the sampling agency. If the
p.(None): Investigation center comes to a reasoned opinion that the suspicion of the violation of
p.(None): Legislation is in place, so it has to determine this in its report and the responsible person
p.(None): To inform the authority immediately.
p.(None): (7) The Federal Minister of Health and Women has the one in question by ordinance
p.(None): Investigation facility or the relevant investigation facilities in accordance with Paragraph 6 - if there is
p.(None): to carry out investigations into bumps within the meaning of Section 1 (2) (1) of the Anti-Doping
p.(None): Federal Act 2007 acts in agreement with the Federal Chancellor.
p.(None): Section 76b. (1) Supervisory bodies pursuant to Section 76a (2) have to confiscate the goods temporarily or securely
p.(None): if there is reasonable suspicion that these substances within the meaning of section 1 (2) no.
p.(None): Federal doping law 2007 contains, or this a danger to the life or health of
p.(None): Represent human or animal.
p.(None): (2) The supervisory body has so far been informed of the provisional confiscation or seizure
p.(None): Hand over a certificate to those entitled to dispose, stating the location and type and
p.(None): The quantity of the seized or seized goods must be stated.
p.(None): (3) In the event of a preliminary seizure, the supervisory body must immediately notify the
p.(None): District administrative authority, but in the case of seizure the public prosecutor through the
p.(None): Ensuring reporting, depending on whether the violation is likely to be a criminal offense
p.(None): or represents an administrative violation. The provision expires in the event of an administrative offense
p.(None): Seizure, unless a seizure notice is not issued within four weeks.
p.(None): (4) The right to dispose of the goods which have been temporarily confiscated or seized is initially in place
p.(None): the authority to which the supervisory body belongs and if the violation constitutes an administrative violation,
...
p.(None): significantly exceed.
p.(None): (4) For cash expenses, the party, regardless of the fees specified in the tariff in accordance with § 76 of the
p.(None): General Administrative Procedure Act 1991, Federal Law Gazette No. 51.
p.(None): XI. SECTION
p.(None): Automation-supported data traffic
p.(None): § 80. (1) To ensure drug safety and to ensure the protection of
p.(None): Life and health of humans and animals may be required for the implementation of this federal law
p.(None): personal data about pharmaceutical companies and users of pharmaceuticals in the
p.(None): Relation to the manufacture, control, distribution and use of medicinal products by
p.(None): processed by the Federal Office for Safety in Health Care.
p.(None): (2) To ensure drug safety and to ensure the protection of life and
p.(None): Human and animal health are allowed for the enforcement of this federal law with regard to
p.(None): Medicinal product monitoring requires personal data related to patients
p.(None): Use of medicinal products by the reporting agents are transmitted pseudonymized. The
p.(None): Processing by the Federal Office for Safety in Health Care has increased in pseudonymized form
p.(None): as long as the data is required in this form for the purposes of drug monitoring.
p.(None): (3) The Federal Office for Safety in Health Care is authorized to process the data in accordance with paragraphs 1 and 2
p.(None): to be transmitted with automation support
p.(None): 1. the Federal Ministry of Health and Women and subordinate authorities for purposes in the sense
p.(None): paragraphs 1 and 2,
p.(None): 2. the Austrian Agency for Health and Food Security, the Medicines Advisory Board, the
p.(None): Delimitation commission as well as experts, insofar as they are in execution of this federal law
p.(None): Tasks are assigned that correspond to the intended use of paragraphs 1 and 2,
p.(None): 3. die Gesundheit Österreich GesmbH, university institutes and other research institutions
p.(None): Institutions, insofar as they work in the interest of public health, for tasks in the sense of
p.(None): Purpose of paragraphs 1 and 2,
p.(None): 4. the Austrian Chamber of Pharmacists, the Austrian Chamber of Physicians, the Austrian
p.(None): Dental Association, the Austrian Veterinary Association and the umbrella organization of the
p.(None): Social insurance institutions, insofar as this data is an essential prerequisite for the fulfillment of
p.(None): form legally assigned tasks,
p.(None): 5. the World Health Organization as defined in paragraphs 1 and 2, and
p.(None): 6. the Agency, the European Commission and the parties to the Agreement on the
p.(None): European Economic Area, the European Directorate for the Quality of Medicines (EDQM), the
p.(None): Council of Europe and foreign authorities under a mutual agreement
p.(None): Acknowledgment of inspections if there is an obligation to transmit the data to them
p.(None): consists.
p.(None): (4) The Federal Office for Safety in Health Care is also authorized to provide personal data
p.(None): to be transmitted with automation support
p.(None): 1. Hospitals, health resorts, doctors, veterinarians, dentists and other freelance professionals
p.(None): Healthcare professionals and pharmacists insofar as they place medicinal products on the market or
p.(None): apply and the safe use or protection of life or human health
...
p.(None): (4) This Federal Act does not affect:
p.(None): 1. the Pharmacy Act, RGBl. No. 5/1907,
p.(None): 2. the Pharmacopoeia Act, Federal Law Gazette No. 195/1980,
p.(None): 3. the Prescription Obligation Act, Federal Law Gazette No. 413/1972,
p.(None): 4. the Addictive Substances Act, Federal Law Gazette I No. 112/1997,
p.(None): 5. the Radiation Protection Act, Federal Law Gazette No. 227/1969,
p.(None): 6. the Pharmaceuticals Imports Act 2010,
p.(None): 7. The Feed Act, Federal Law Gazette I No. 139/1999,
p.(None): 8. the Price Act, Federal Law Gazette No. 145/1992,
p.(None): 9. Animal Testing Act 2012, Federal Law Gazette I No. 114/2012,
p.(None): 10. the law on the defense and eradication of animal diseases, RGBl. No. 177/1909,
p.(None): 11. the Federal Law against Unfair Competition, Federal Law Gazette No. 448/1984,
p.(None): 12. the Trademark Protection Act, Federal Law Gazette No. 260/1970,
p.(None): 13. the Musterschutzgesetz 1990, Federal Law Gazette No. 479/1990,
p.(None): 14. the Medical Devices Act, Federal Law Gazette No. 657/1996,
p.(None): 15. the Chemicals Act, Federal Law Gazette I No. 53/1997,
p.(None): 16. the Physicians Act 1998, Federal Law Gazette I No. 169/1998,
p.(None): 17. The Midwives Act, Federal Law Gazette No. 310/1994,
p.(None): 18. the New Psychoactive Substances Act, Federal Law Gazette I No. 146/2011,
p.(None): 19. the Biocidal Products Act, Federal Law Gazette I No. 105/2000.
p.(None): § 87. Examinations and assessments according to this federal law are by the Austrian
p.(None): Agency for Health and Food Security or other experts who:
p.(None): by the Federal Office for Safety in Health Care or the Federal Ministry of Health and
p.(None): Women are commissioned.
p.(None): Section 88. (1) Those approved in accordance with Section 7 of the Specialties Ordinance, Federal Law Gazette № 99/1947
p.(None): Medicinal products for which an approval according to § 88 Paragraph 3 of the
p.(None): Drugs Act in the version of Federal Law Gazette No. 185/1983 has been applied for are considered approved in the sense
p.(None): of the Medicinal Products Act.
p.(None): (2) About applications pursuant to Section 88 (3) of the Medicinal Products Act in the Federal Law Gazette No. 185/1983
p.(None): not to issue a decision.
p.(None): (3) Unless notified in this regard before this provision comes into force
p.(None): the license holder has the labeling, instructions for use and specialist information in accordance with sections 7 to 10
p.(None): to design and their texts before the first use, but no later than December 31, 1991, the
p.(None): Submitted to the Federal Chancellery.
p.(None): (4) When creating the labeling, instructions for use and specialist information within the meaning of paragraph 3
p.(None): Deviations in content from signature and package insert in the approved according to the specialty regulations
p.(None): Form, unless it is a change
p.(None): 1. the fantasy word or the scientifically usual expression in the name of the
p.(None): Medicinal product,
p.(None): 2. with a view to expanding the areas of application or
p.(None): 3. the dosage of the drug specialty.
p.(None): These changes require approval by the Federal Chancellor. You will need this after it comes into effect
p.(None): Determination to be requested separately. This also applies to applications in accordance with § 24 Para
p.(None): Applications within the meaning of Section 88 (3) of the Medicinal Products Act as amended by Federal Law Gazette № 185/1983
p.(None): were.
...
p.(None): Control laboratory is expected, and
p.(None): 3. the granting of leniency within six months after the entry into force of this federal law
p.(None): has requested.
p.(None): (2) The head of a control laboratory may make a decision on his application submitted in good time
p.(None): continue to carry out his activity to the extent previously possible.
p.(None): Section 94. Pharmaceutical officers who do not meet the requirements of Section 72 (1) are allowed to work
p.(None): continue exercising if they
p.(None): 1. can demonstrate that they are in the last year before the entry into force of this
p.(None): Have acted as a pharmaceutical officer, and
p.(None): 2. the further pursuit of their work as a pharmaceutical officer to the Federal Ministry of Health and
p.(None): Report environmental protection within six months of the entry into force of this federal law.
p.(None): § 94a. (1) For medicinal products that were amended before the Medicinal Products Act came into force
p.(None): Federal Law BGBl. № 107/1994 must be approved until the first submission according to § 19a
p.(None): Labeling as well as the instructions for use and specialist information on the provisions of this federal law and
p.(None): of the regulations adopted on the basis thereof.
p.(None): (2) For medicinal products that were amended before the Medicinal Products Act came into force
p.(None): Federal Law Gazette No. 107/1994, the documents according to § 19a are not three to
p.(None): to be submitted six months before the expiry of five years after the approval notice has become final. For this
p.(None): The Federal Minister of Health and Women can submit medicinal specialties at any time by notice
p.(None): order if it does not appear certain that the information contained in the approval documents
p.(None): Evidence of the quality, effectiveness and harmlessness of the latest scientific
p.(None): Insights correspond.
p.(None): (3) Clinical trials that take place before the entry into force of the Medicinal Products Act in the version of the
p.(None): Federal Law Gazette No. 107/1994 started, may according to the legal situation before entry into force
p.(None): of the Medicinal Products Act in the version of the Federal Law Gazette No. 107/1994.
p.(None): (4) For medicinal products that were amended before the Medicinal Products Act came into force
p.(None): Federal Law Gazette № 379/1996 have been approved, must be until the first submission according to § 19a
p.(None): Technical information to the provisions of § 10 in the version of the Federal Law BGBl. № 379/1996 and
p.(None): the ordinance issued in accordance with section 10 (5) in the version of the Federal Law Gazette No. 379/1996
p.(None): be adjusted.
p.(None): (5) Clinical trials that take place before the drug law in the version of the
p.(None): Federal Law BGBl. I № 35/2004 started, may according to the legal situation before entry into force
p.(None): Entering the drug law in the version of the federal law BGBl. I No. 35/2004 to be continued.
p.(None): (6) Bumps or preparations made from bumps within the meaning of Section 1 (3) 8, provided that they are always in advance in
p.(None): manufactured in the same composition and under the same name in a for delivery in
p.(None): Retail sales certain form are placed on the market, which according to § 11b in the version of the
p.(None): Federal Law Gazette No. 748/1988 have been reported, may continue until the end of December 31, 2013
p.(None): delivered in Germany or kept ready for delivery in Germany, unless, § 3, the analogous
p.(None): this applies to these products.
p.(None): § 94b. As far as this federal law refers to other federal laws, these provisions are in
p.(None): applicable version.
p.(None): Transitional regulations to amendment BGBl. I No. 153/2005
p.(None): § 94c. (1) Sto oder e or preparations from Sto ff en in the sense of § 1 Paragraph 3 No. 9, the reporting of
p.(None): Section 11c (1) in the version prior to the entry into force of this Federal Act in the version of the
p.(None): Federal Law BGBl. I № 153/2005 from the Federal Minister for Health and Women under the award of a
p.(None): consecutive number has been confirmed, may remain unchanged until December 31, 2008
p.(None): be placed on the market with the number.
p.(None): (2) The technical and package leaflet of specialty medicinal products prior to the entry into force of this
p.(None): Federal law in the version of the federal law BGBl. I № 153/2005 approved or registered
p.(None): have the §§ 15, 16 and 16a as soon as possible, at the latest by January 1, 2011
p.(None): correspond.
p.(None): (3) Is the change of technical or usage information only to adapt the in §§ 15, 16
p.(None): and 16a provided order, their change is the authorization holder or the holder of a
p.(None): Report registration to the Federal Office for Safety in Health Care.
p.(None): (4) Section 16c (1) applies to medicinal products that are listed in the before the entry into force of this federal law
p.(None): Version of the Federal Law BGBl. I № 153/2005 were approved or registered, with the proviso
p.(None): that these formats must be available as soon as possible, but no later than January 1, 2011. Section 16c (2)
p.(None): does not apply to medicinal products that were amended before the entry into force of this Federal Act
p.(None): Federal Law Gazette I No. 153/2005 were approved or registered.
p.(None): (5) Pharmaceutical specialties that were issued before the entry into force of this Federal Act in the version of the
p.(None): Federal Law BGBl. I № 153/2005 have been approved, provided for in § 17 (5)
p.(None): Labeling as soon as possible, at the latest by 1 January 2011.
p.(None): (6) The labeling of a commercial pack already in circulation does not correspond to that
p.(None): Regulations of § 17 paragraph 5, these may still be passed on.
p.(None): (7) If the change in the marking serves to fulfill the obligation in accordance with Section 17 (5), then:
...
p.(None): be placed on the market more. If the marketing authorization holder submits one by October 30, 2010
p.(None): Application for approval or application for registration as a traditional herbal medicinal specialty remains the same
p.(None): Admission until the decision of the Federal Office for Safety in Health Care on the application for
p.(None): Admission or registration for registration valid.
p.(None): (9) The approval of pharmacy proprietary medicinal products, which take effect at the time of entry into force of this
p.(None): Federal law in the version of the Federal Law BGBl. I № 153/2005 were permitted remains
p.(None): upright, even if they are made from ingredients that are not in the Austrian medical tax
p.(None): are listed, but in a regulation according to § 17a of this federal law in the version before
p.(None): Entry into force of the Federal Law BGBl. I No. 153/2005.
p.(None): (10) Also pharmaceutical specialties that were amended before the entry into force of this Federal Act in the version of the
p.(None): Federal Law Gazette I № 153/2005 and the existence of
p.(None): Admission requirements already in accordance with § 19a of this federal law in the version before
p.(None): Entry into force of the Federal Law BGBl. I № 153/2005, was subject to the
p.(None): Provisions of section 20. The submission of the documents required in accordance with section 20 (2) or (3) has been requested by
p.(None): other expiry of the admission to take place no later than June 30, 2012. The Federal Office for Security
p.(None): in health care, the expiry has to be determined by notice. If there is no timely submission,
p.(None): the products may be placed on the market until December 31, 2012.
p.(None): (11) For the medicinal products mentioned in § 94a (2), the submission of which is not by decision of the
p.(None): Federal Minister of Health and Women has been ordered, otherwise the approval expires
p.(None): by 1 January 2011 at the latest, the application for an extension of the admission must be submitted, in accordance with Section 20 (2)
p.(None): and 3 mentioned documents can be requested. The time of application is calculated from a
p.(None): Multiples of five years from the date of approval. No application will be made at this time
p.(None): If the authorization is extended, the medicinal product can continue to be marketed until January 1, 2011
p.(None): brought, an extension of the approval according to § 20 is no longer possible.
p.(None): (12) For registered homeopathic medicinal specialties, the time of submission is calculated according to
p.(None): Section 20 (2) and (3) from a multiple of five years from the date of registration. The template has
p.(None): no earlier than June 30, 2012.
p.(None): (13) The marketing authorization holder of a medicinal product that is in effect at the time of entry into force
p.(None): Federal law in the version of the federal law BGBl. I № 153/2005 was approved, must
p.(None): otherwise expiry of the approval by the Federal Office for Safety in Health Care at the latest
p.(None): December 31, 2008 report whether the medicinal product was actually placed on the market on January 1, 2006,
p.(None): whether it is actually still in circulation or from what point in time it is no longer actually in
p.(None): Traffic was. It must also be announced whether the approval is only for the purposes of Section 9a (5)
p.(None): is used.
p.(None): (13a) For applications for the authorization of a reference medicinal product for which the application for an authorization before
p.(None): At the end of October 30, 2005, the protection periods in § 15a of the Medicinal Products Act apply
p.(None): the version before the amendment to Federal Law Gazette I No. 153/2005.
p.(None): (14) Promotional material up to January 1, 2007 in the version of the requirements of this federal law
p.(None): of the Federal Law BGBl. I № 153/2005. The information officer is the Federal Office
p.(None): for Healthcare Safety to be announced by July 1, 2006 at the latest.
p.(None): (15) Homeopathic medicinal specialties that were published in the. Before the entry into force of this federal law
p.(None): Version BGBl. I № 153/2005 have been registered, as long as § 3 does not conflict with this, in
p.(None): To be placed on the market.
p.(None): Special provisions in connection with crisis situations
p.(None): § 94d. (1) In case of disaster, epidemic, pandemic, terrorist threat, martial
p.(None): The Federal Minister of Health and Women has a dispute or other crisis situation, if
p.(None): the necessary care of the population would otherwise be seriously and significantly endangered by regulation
p.(None): Exceptions to § 4, the provisions of II., VI. and VII. Section of this Federal Law and the
p.(None): to comply with the relevant ordinances issued on the basis of this federal law, to the extent and for as long
p.(None): this is necessary due to the special situation and the protection of life and health of
p.(None): Humans and animals are protected.
p.(None): (2) In the event of a disaster, epidemic, pandemic, terrorist threat, martial
p.(None): The Federal Minister of Health and Women,
p.(None): if the necessary supply of the population would otherwise be seriously and significantly endangered by
p.(None): Ordinance Regulations on supply and provision obligations for marketing authorization holders,
p.(None): Depositeurs, manufacturers, pharmaceutical wholesalers, pharmaceutical wholesalers and public pharmacies
p.(None): adopted if and as long as this is necessary due to the special situation.
p.(None): (3) A regulation pursuant to Paragraph 1 or Paragraph 2 applies for a maximum of six months.
p.(None): § 94e. (1) As long as the World Health Organization (WHO) has declared a pandemic of influenza
p.(None): 1. A license that is in accordance with the provisions of this federal law and approved for Austria
p.(None): Vaccine for vaccination against New Influenza A (H1N1) directly from the manufacturer or marketing authorization holder
p.(None): on
p.(None): (a) local authorities, and
p.(None): b) by the public sector (local authorities, health insurance providers and
p.(None): Health care facilities) certain distribution centers
p.(None): be delivered and
p.(None): 2. the vaccine by means of the local authorities or distribution centers to from the public
p.(None): Hand (local authorities, health insurance providers and health care institutions)
p.(None): certain vaccination sites are given. For the distribution of the vaccine, the
p.(None): Manufacturers, marketing authorization holders who serve local authorities and third-party distribution centers.
p.(None): (2) Medicines used in the event of a disaster, terrorist threat, martial
p.(None): Confrontation, epidemic, pandemic or other crisis situation to those in § 57 Paragraph 1 Numbers 5 and 5a
p.(None): given to maintain the drug supply and from these to
...
p.(None): January 1, 2002, but not in force before the day following the announcement of the aforementioned law. The
p.(None): Proceedings pending at this time are to be continued according to the previously applicable legal situation.
p.(None): (8) Section 12 (1) 3 and 4 and Section 57 (1) 5 in the version of the Federal Law Gazette I No. 12/2003
p.(None): take effect on December 1, 2002.
p.(None): (8a) Section 2a (7), Section 11 (1), 2a and 9, Section 11a, Section 11c (1) and (3), Section 16a (2), Section 19a (1), Section 20a
p.(None): Paragraphs 1 and 4, Section 21 Paragraph 1, Section 22 Paragraphs 1, 3 and 4, Section 23 Paragraph 2, Section 24 Paragraph 1, 2 Z 6, 3, 5, and 9, Section 24a, Section 26
p.(None): Paragraphs 1, 3, 4 and 5, Section 27, Section 32 Section 1 No. 5, Section 35 Section 2, Section 37a Section 1, 3 and 4, Section 40, Section 41a Section 6, Section 41c Section 1,
p.(None): 3 and 4, Section 41e (1), Section 46 (5), Section 47 (8), Section 49 (1) and Section 11, Section 58 (3), Section 59 (5), 6 and 7a, Section 60
p.(None): Paragraph 2 No. 9, Section 63 Paragraph 1, Section 64 Paragraphs 2 and 4, Section 66, Section 67 Paragraph 1 and Section 1a, Section 68 Paragraph 1, Section 69 Paragraph 1, Section 70, Section 75
p.(None): Paragraphs 1, 2 and 3 and Section 75a Paragraphs 1, 2, 3, 4 and 8, Section 76 Paragraphs 1 and 4, Section 77, Section 78 Paragraphs 1 and 2, Section 80 Paragraphs 3 to 5,
p.(None): § 85 and § 87 in the version of the Federal Law BGBl. I No. 107/2005 come into force on 1st January 2006.
p.(None): (8b) At the end of December 31, 2005, pending proceedings according to those listed in Paragraph 8a
p.(None): Provisions are to be continued by the Federal Office for Safety in Health Care. The
p.(None): Administrative files are immediately from the Federal Ministry of Health and Women to the Federal Office
p.(None): for security in healthcare.
p.(None): (8c) § 1 paragraph 3, 3a, 3b, 6 to 10 and 15 to 24, § 2 paragraph 2, 3a, 6, 6a, 7, 10, 13b, 17, 20 and 21, § 2a
p.(None): Section 20, Section 2b, Section 3 Section 2, Section 5 Section 2 and 3, Section II, Section 37a Section 3, Section 41b Section 5, Section 48 Section 3, IV.
p.(None): Section, Section 5, Section 57 Paragraph 1, Section 57 Paragraph 5, Section 57a, Section 58 Paragraph 1 First Sentence, Section 59 Paragraph 7, Section 61 Paragraph 3,
p.(None): Section 62 (2), 3 (10) and (4), Section 63 (2), (3) and (4), Section 64 (5), Section 65 (note: Section 66 is missing from the list) Section 66a,
p.(None): Section 67 (1) and (2), Section 68 (4) to (6), Section 69a, the amendments to Section 73 (1) and (2), Section 75 to 75d, Section 76b (1),
p.(None): Section 80 (1), the changes in (3) 4 and 5, and (3) (6) XII. Section, the heading of XIII.
p.(None): Section, § 83, § 84, § 85, § 94c, § 94 d, § 95 Abs. 8a to 8d and § 97 Z 24 to 26 in the version of the
p.(None): Federal Law BGBl. I No. 153/2005 take effect on January 2, 2006.
p.(None): (8d) With the entry into force of this federal law in the version of the federal law BGBl. I
p.(None): No. 153/2005 expire:
p.(None): 1. the regulation on homeopathic medicinal specialties subject to registration, BGBl.
p.(None): No. 1011/1994,
p.(None): 2. the regulation concerns the facilitation of the approval of certain pharmaceutical specialties,
p.(None): Federal Law Gazette No. 541/1989, last changed by Federal Law Gazette No. 727/1992.
p.(None): (8e) Sections 76b and 96 in the version of the Federal Law, Federal Law Gazette I № 112/2007 come into effect on 1 January
p.(None): 2008 in force.
p.(None): (8f) Section 57b, Section 62 (2) and Section 75e in the version of the Federal Law BGBl. I № 49/2008 also come into play
...
p.(None): (13) Sections 10 (3), 4, 6, 13, 14 and 15, 15 (6), 20 (3a), 24, 24a, 25, 25a, 83 (1) (4), 84 (1)
p.(None): Z 5, 12, 14 and 15 of this federal law in the version of the federal law BGBl. I № 162/2013 occur
p.(None): effective August 4, 2013; at the same time, section 84 (1) no. 11 expires.
p.(None): (14) Section 57 (1) 8 to 10 and Section 61 (1) 4 to 6 in the version of the Deregulation Act 2017,
p.(None): BGBl. I No. 40/2017, come into force on the day following the announcement.
p.(None): (15) Data protection consent in connection with clinical trials that took place before the
p.(None): May 25, 2018, do not need to be renewed.
p.(None): (16) Section 36 lines 8 to 8c, Section 39 subsection 3, 3a to 3c, Section 43a subsections 3 and 5, Section 46 subsection 3, 4a and 5, Section 67 subsections 7 and 8,
p.(None): Section 75g, Section 80 (1) to (4) and Section 82d (2) in the version of the 2nd Material Data Protection Adjustment Act,
p.(None): BGBl. I No. 37/2018, come into force on May 25, 2018.
p.(None): (17) Section 39 subsection 4, the introductory sentence of Section 43 subsection 1, Section 43 subsection 1 lines 2 to 4 and Section 43 subsection 2 and 3 of this
p.(None): Federal Law as amended by Federal Law Gazette I No. 59/2018 will come into force on July 1, 2018.
p.(None): (18) Section 62 (3a) in the version of the Federal Law Gazette I No. 104/2019 comes into force on July 1, 2020.
p.(None): Section 95a. The applies to all personal names used in this federal law
p.(None): chosen form for both genders.
p.(None): Section 96. (1) Unless otherwise stipulated in paragraph 2, the enforcement of this Federal Act shall mean that
p.(None): Federal Minister of Health and Women
p.(None): 1. With regard to Section 59 (3) and Section 60 (7) in agreement with the Federal Minister for
p.(None): Economy and work,
p.(None): 2. with regard to Section 79 (1) in agreement with the Federal Minister of Finance,
p.(None): 3. with regard to § 84a in agreement with the Federal Minister of Finance, and
p.(None): 4. With regard to Section 85b in agreement with the Federal Minister of the Interior.
p.(None): (2) With completion
p.(None): 1. of § 76a paragraphs 6 and 7 - insofar as it concerns the investigation for clashes within the meaning of § 1 paragraph 2 line 1
p.(None): of the 2007 Federal Anti-Doping Act - is the Federal Chancellor;
p.(None): 2. of § 76b - if it concerns a seizure or seizure in the procedure according to
p.(None): Criminal Procedure Code 1975 (StPO), BGBl. № 631, acts - and the §§ 82b, 82c and 85a this
p.(None): Federal law is the Federal Minister of Justice,
p.(None): 3. of § 82d is the Federal Minister of Finance
p.(None): entrusted.
p.(None): Section 97. The following directives of the European Union are implemented by this federal law:
p.(None): 1. Council Directive 65/65 / EEC of 26 January 1965 on the approximation of the legal and
p.(None): Administrative provisions on medicinal products (OJ No L 22, 9.2.2965);
p.(None): 2. Council Directive 75/318 / EEC of 20 May 1975 on the approximation of the laws and regulations
p.(None): Administrative provisions of the Member States on analytical, toxicological-pharmacological
p.(None): and medical or clinical regulations and evidence of trials with medicinal products (OJ.
p.(None): L 147, June 9, 1975);
p.(None): 3. Council Directive 75/319 / EEC of 20 May 1975 on the approximation of the laws and regulations
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): that afterwards within a renewed period of eight days corresponding information about the further
p.(None): Measures are transmitted.
p.(None): (2) Any other suspected unexpected serious side effects arising from the
p.(None): the same clinical trial that has occurred in Germany or abroad are the authorities mentioned in paragraph 1
p.(None): and the relevant ethics committees as soon as possible, but in any case within 15 days of
p.(None): from the time the sponsor first became aware of it.
p.(None): (3) The sponsor has the other investigators of the same clinical trial information in the sense of
p.(None): To give paragraphs 1 and 2. The sponsor has once a year for the entire duration of the clinical trial
p.(None): a list of all the authorities mentioned in paragraph 1 and the relevant ethics committees
p.(None): suspected serious side effects that occurred during the entire exam period
p.(None): are to be submitted, as well as a report on the safety of the test participants.
p.(None): Protection of certain groups of people
p.(None): Section 42. (1) The clinical trial of a medicinal product may only be carried out on minors if
p.(None): 1. the drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in minors is intended and clinical trial for data validation,
p.(None): obtained in clinical trials on adults or using other research methods
p.(None): were absolutely necessary,
p.(None): 2. the use of the drug that is being tested, according to the knowledge of medical
p.(None): Science is indicated to be given to the minor on whom the clinical trial is being conducted
p.(None): will recognize, cure or alleviate diseases or protect them from diseases and the
p.(None): benefits for the test participant associated with inclusion in the clinical trial
p.(None): Risk outweighs
p.(None): 3. the consent of the legal guardian can be proven after appropriate clarification and
p.(None): was given in writing,
p.(None): 4. The minor before the start of the clinical trial by someone dealing with minors
p.(None): experienced auditor has received an explanation appropriate to his ability to understand this,
p.(None): 5. the consent of the minor who is able to understand the essence, the meaning, the
p.(None): To see the scope and risks of the clinical trial and to determine his will accordingly,
p.(None): has been demonstrably granted, and it is ensured that the expressly by a minor
p.(None): expressed desire not to take the clinical trial or take it at any time
p.(None): to be considered by the examiner
p.(None): 6. The consent can be withdrawn at any time without the minor being affected
p.(None): Disadvantage arises
p.(None): 7. with the participation in the clinical trial, no incentives or financial benefits
p.(None): Exception to an expense allowance,
p.(None): 8. the clinical trial is planned so that it takes into account the disease and the
p.(None): Developmental stage of the minor with as little pain, discomfort, fear and
p.(None): other predictable risks, including the risk threshold as well as the
p.(None): Degree of exposure specifically defined and constantly checked,
p.(None): 9. The test plan by an ethics committee that has knowledge in the field of children and
p.(None): Juvenile medicine or who deals with clinical, ethical and psychosocial issues on the
p.(None): Had been advised in the area of pediatrics and adolescent medicine, and was approved
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of
p.(None): Science stand.
p.(None): (2) Deviating from Paragraph 1 No. 2, a clinical trial on minors is also permitted if
p.(None): 1. The clinical trial is an essential extension of the scientific understanding of the
p.(None): Condition, illness or disorder of the minor and thereby either
p.(None): Can benefit patients or the patient group to which the minor belongs, and
p.(None): 2. The clinical trial for the minor with only a minimal risk and minimal burden
p.(None): brings oneself; a clinical trial has minimal risk and minimal burden if
p.(None): it is to be expected that at most it will be a minor and merely temporary
p.(None): Impairment and the symptoms or inconvenience at best only
p.(None): could occur temporarily and will be very minor.
p.(None): § 43. (1) The clinical trial on an adult who is due to a mental illness or
p.(None): a comparable impairment of their ability to make decisions regarding representation regarding medical
p.(None): Treatments that have a legal representative (§ 1034 ABGB) may only be carried out if
p.(None): 1. the medicinal product being tested is intended to identify, cure, alleviate or prevent it
p.(None): and is the clinical trial for the confirmation of data used in clinical trials
p.(None): Consent obtained from persons capable of providing information or using other research methods
p.(None): were absolutely necessary,
p.(None): 2. the use of the drug that is being tested, according to the knowledge of medical
p.(None): Science is shown to work in the person who is suffering from a mental illness or an
p.(None): comparable impairment in their ability to make decisions is limited to this disease
p.(None): or to recognize impairment or its course, to heal or alleviate it or to prevent it
p.(None): to protect further diseases, and the associated with the inclusion in the clinical trial
p.(None): Benefit for the test subject outweighs the risk,
p.(None): 3. the consent of the legal representative after appropriate clarification demonstrably and
p.(None): was issued in writing; the presumed will of the test participant must be observed,
...
Social / education
Searching for indicator education:
(return to top)
p.(None): analogous.
p.(None): (2) On the basis of the criteria and in § 41a (1), the responsible ethics committee
p.(None): in accordance with § 41b within a maximum of 35 days from the date of receipt of the
p.(None): to submit a correct proposal for an opinion.
p.(None): (3) If the ethics committee does not give a favorable opinion or does not exist from the perspective of the
p.(None): Federal Office for Safety in Health Care has other objections to the planned changes on
p.(None): Test plan, the Federal Office for Safety in Health Care has the change of the test plan for the case
p.(None): to prohibit the sponsor from taking the objections into account. The amendment is considered approved
p.(None): if the change is not made within 35 days of receipt of the proper change request
p.(None): is prohibited.
p.(None): (4) Without prejudice to paragraphs 1 to 3, the sponsor and the examiner have under certain circumstances:
p.(None): especially with any new circumstance regarding the course of the examination or the development of a
p.(None): Investigational medicinal product that can impair the safety of the test participants, the urgently needed
p.(None): Take security measures to protect the test participants from immediate danger. The
p.(None): The Federal Office for Health Safety immediately sponsors the new circumstances
p.(None): and to inform the measures taken and to ensure that at the same time the person responsible
p.(None): Ethics committee.
p.(None): Education and consent
p.(None): Section 38. (1) The clinical trial of a medicinal product may, unless sections 42, 43 and 43a otherwise
p.(None): determine to be performed only when the subject is examined by a doctor or dentist
p.(None): Nature, meaning, scope and risks of the clinical trial has been elucidated and the
p.(None): Exam participants have given their consent.
p.(None): (2) The consent within the meaning of paragraph 1 may be withdrawn at any time. Are responsible for carrying out the
p.(None): clinical trial requires multiple consents, the clinical trial may take place on this
p.(None): Exam participants will not continue if even one of these consents is withdrawn.
p.(None): Section 39. (1) Education and information must be given both verbally and in writing. The
p.(None): Information must clarify that the refusal to participate in the clinical trial or that
p.(None): Leaving the clinical trial at any time without adverse consequences,
p.(None): in particular for the further medical care of the test participant.
p.(None): (2) If a test participant agrees to participate after extensive information, his / her
p.(None): Consent must be recorded in writing. The consent must be dated and signed
p.(None): of the test participant. If the test participant is unable to do so,
p.(None): the consent must be given before a witness who gives the consent by his signature
p.(None): has confirmed.
p.(None): (3) The test participants are aware of the purpose and scope of the collection and use
p.(None): to inform personal data. The test participants are particularly keen on this
p.(None): point out that data
p.(None): 1. checked by the monitor, during an audit and during an inspection by the authority
p.(None): can be and
p.(None): 2. passed on to the sponsor in pseudonymized form.
p.(None): (3a) With the consent to take part in the clinical trial according to paragraph 2, the express is also
p.(None): obtain data protection consent. The withdrawal of consent has no effect on
p.(None): Activities that are carried out on the basis of informed consent prior to its revocation
...
p.(None): Area of the disease concerned, in relation to the emergency situation and the affected
p.(None): Patient group or who deal with clinical and ethical issues in the field of
p.(None): related illness, in relation to the emergency situation and the affected patient group
p.(None): , expressly for the conduct of clinical trials in emergency situations on persons who
p.(None): are unable to give personal consent, have been approved, and
p.(None): 6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 38 and
p.(None): 39 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Education is given. Further processing of the personal data collected up to that point is required
p.(None): the express data protection consent.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 42 or § 43.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 44. (1) The clinical trial of a medicinal product may only be carried out on a pregnant woman if
p.(None): if
p.(None): 1. the drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in pregnant women or unborn children
p.(None): 2. the use of the drug is indicated according to the knowledge of medical science
p.(None): is with the pregnant woman on whom the clinical trial is being conducted or with her
p.(None): to recognize unborn child diseases or their course, to cure or to alleviate them or
p.(None): to protect them from diseases,
p.(None): 3. according to the knowledge of medical science, the conduct of the clinical trial
...
Social / employees
Searching for indicator employees:
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p.(None): Austria is entitled, and
p.(None): 1. have appropriate knowledge and experience in the field of clinical trials of
p.(None): Medicines,
p.(None): 2. appropriate knowledge and experience in the intended indication area and
p.(None): 3. Knowledge of the relevant areas of non-clinical medicine, in particular also about
p.(None): Biometrics.
p.(None): (2) The examiner must provide the Federal Office of
p.(None): To provide security in healthcare as well as the sponsor. If the examiner is in one of the sub-areas
p.(None): according to paragraph 1 no. 3 does not have the appropriate knowledge and experience, he is relevant
p.(None): Involving experts in a responsible manner.
p.(None): § 36. The examiner has
p.(None): 1. to become thoroughly familiar with the properties of the investigational medicinal product,
p.(None): 2. Ensure that he can spend enough time to conduct the clinical trial
p.(None): and is expected to terminate or provide appropriate replacement that he
p.(None): sufficient staff and adequate facilities for the entire duration of the clinical trial
p.(None): can provide and ensure that appropriate adverse events
p.(None): Countermeasures within the meaning of Section 37a (4) can be taken,
p.(None): 3. Sign the test plan and, in addition, record in writing that it is the
p.(None): Has read and taken note of the test plan and the clinical test according to the test plan and
p.(None): will carry out the provisions of this federal law and this through his signature
p.(None): to confirm,
p.(None): 4. to proceed in the event of changes to the test plan within the meaning of Section 37a (4),
p.(None): 5. the consent after clarification before inclusion in the clinical trial according to § 38
p.(None): obtain,
p.(None): 6. All employees involved in the conduct of the clinical trial or in the supervision of the
p.(None): Exam participants are involved in making all relevant information available,
p.(None): 7. safe and separate storage and handling of the medicinal product
p.(None): To ensure investigational product, its delivery or application to test participants
p.(None): document and return unused investigational medication to the sponsor,
p.(None): 8. to process the data correctly, in particular to collect, record and transmit them,
p.(None): 8a. to pseudonymize the data as soon as possible, to document the pseudonymization, the
p.(None): Handle documentation with the utmost care and ensure that the assignment to a
p.(None): specific person concerned only under the circumstances specified in the test plan
p.(None): he follows,
p.(None): 8b. for the sponsor, the obligations under Art. 13, 15, 16 and 18 of Regulation (EU) 2016/679 for protection
p.(None): natural persons in the processing of personal data, on free data traffic and
p.(None): repealing Directive 95/46 / EC (General Data Protection Regulation), OJ. № L 119 from
p.(None): May 4, 2016 p. 1,
p.(None): 8c. in the event of violations of the protection of personal data, the test participant in accordance with Art. 34
p.(None): Notify the General Data Protection Regulation and inform the sponsor about it,
p.(None): 9. Report to the sponsor in accordance with § 41d immediately about serious adverse events
p.(None): and to take the necessary measures to protect the test participants,
p.(None): 10. All data related to the clinical trial for the purpose of an audit or a
p.(None): Make inspection accessible,
...
p.(None): which belongs to a senior citizen organization in accordance with the Federal Senior Citizens Act, Federal Law Gazette I No. 84/1998,
p.(None): 8. a person with biometric expertise and
p.(None): 9. Another person who does not fall under Z 1 to 8 and who is concerned with pastoral care
p.(None): Is entrusted with matters or otherwise has the appropriate ethical competence.
p.(None): An equally qualified representative must be appointed for each member.
p.(None): (3) The members of the ethics committee and their representatives have any relationships with
p.(None): pharmaceutical industry completely open to the governor. You have yours
p.(None): To act in the ethics committee in all matters involving a relationship with
p.(None): pharmaceutical industry is likely to question its full impartiality.
p.(None): (4) The governor is entitled to a contribution from the sponsor in accordance with the
p.(None): Experience has shown that the costs of an assessment in the context of a clinical assessment are on average
p.(None): To request examination.
p.(None): Section 41a. (1) The in execution of § 8c of the Federal Act on Hospitals and Health Centers
p.(None): according to state law provisions, those according to university law provisions and those according to § 41
p.(None): Ethics committees set up have the rules on the procedure contained in paras. 2 to 7
p.(None): to be observed and in particular to be taken into account in their comments:
p.(None): 1. the relevance of the clinical trial and its planning,
p.(None): 2. the adequacy of the assessment of the expected benefits and the
p.(None): expected risks,
p.(None): 3. the test plan,
p.(None): 4. the suitability of the auditor and his employees,
p.(None): 5. the auditor information,
p.(None): 6. the adequacy of the facilities,
p.(None): 7. the adequacy and completeness of the written information to be provided and the
p.(None): Procedures for informed consent and justification for research
p.(None): to people who are unable to give informed consent as to what they speci fi c
p.(None): Restrictions in accordance with sections 29, 38, 39, 42, 43 and 43a,
p.(None): 8. Personal injury insurance taken out in accordance with section 32 (1) no. 11 as well as any kind of
p.(None): Insurance or compensation to cover the liability of the auditor and sponsor,
p.(None): 9. the amounts and modalities for any remuneration or compensation for auditors and
p.(None): Exam participants and the relevant elements each between the sponsor and the
p.(None): Testing center envisaged contract, and
p.(None): 10. the modalities for the selection of the test participants.
p.(None): (2) The Ethics Committee has monthly meetings in one for one year in advance
p.(None): publishing schedule and deadlines for the submission of each meeting
p.(None): Applications. The ethics committee is responsible for determining the dates of the meetings and the related dates
p.(None): associated deadlines for submitting applications to ensure that the scheduled deadlines
p.(None): can be met.
p.(None): (3) After receipt of an application, the ethics committee has to check whether a proper one
p.(None): Application for approval has been received and the sponsor immediately, but at the latest within five working days
p.(None): to inform about it after receipt of the application.
...
p.(None): Dispensing of medicines
p.(None): Section 57. (1) Medicinal products may only be supplied by the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): are on
p.(None): 1. public pharmacies, institutional pharmacies and veterinary home pharmacies,
p.(None): 2. Druggists or other traders who, according to section 59 (3), dispense medicinal products
p.(None): are authorized
p.(None): 3. Manufacturer only for the purpose of the manufacture of medicinal products or insofar as they are in accordance with the
p.(None): Trade Regulations 1994 are authorized to trade in pharmaceuticals,
p.(None): 4. pharmaceutical wholesaler,
p.(None): 5. Local authorities
p.(None): a) in connection with tasks of vaccination prophylaxis or to fulfill them by law
p.(None): assigned tasks of disease control,
p.(None): b) humanitarian aid in connection with a disaster that occurred abroad
p.(None): or a serious accident,
p.(None): c) to maintain the supply of pharmaceuticals in Germany if this is in connection with a
p.(None): Catastrophe, terrorist threat, armed conflict or pandemic
p.(None): is absolutely necessary
p.(None): 5a. Businesses and organizations that maintain basic public services
p.(None): serve and based on a between the federal government or a state and a manufacturer,
p.(None): Depositeur or pharmaceutical wholesaler concluded contract to ensure the
p.(None): Maintenance of drug supplies related to a pandemic, warlike
p.(None): Conflict or terrorist threat, in turn, individual contracts for direct purchase
p.(None): have completed a drug for the needs of their own employees,
p.(None): 6. Institutions of the Austrian Armed Forces, the pharmaceutical supply of the Armed Forces
p.(None): serve,
p.(None): 6a. the Federal Ministry of the Interior, the authorities and childcare facilities subordinate to it
p.(None): for emergency care, prevention and care of operations, provided that the medicines for
p.(None): Need to perform their duties
p.(None): 7. Institutions, the provisional judicial safekeeping or arrests, judicial
p.(None): Prison sentences or preventive judicial measures related to deprivation of liberty
p.(None): Take measures if they need drugs to perform their tasks
p.(None): 8. scientific institutes and research institutes of the local authorities and the
p.(None): Universities and the Austrian Agency for Health and Food Security, if these
p.(None): Need medicines to perform their tasks
p.(None): 9. Organized emergency medical services, provided they are addictive substances, which they use for their emergency medical services
p.(None): Need activity, and
p.(None): 10. Have a doctor who is sufficiently familiar with questions of substance abuse
p.(None): Institutions according to § 15 of the Addictive Substances Act, Federal Law Gazette I № 112/1997, for evidence-based and
p.(None): quality-assured support for clients as part of damage minimization measures,
p.(None): except drugs containing addictive substances.
p.(None): (2) At hospitals without institutional pharmacies, the manufacturer, depositeur or pharmaceutical
p.(None): Wholesalers are given:
...
Social / orphan
Searching for indicator orphan:
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p.(None): potential risks of the pharmaceutical specialty and the need for data on the safety after approval
p.(None): or registration. For veterinary specialties, in deviation from para. 1 no
p.(None): Submit risk management plan only if this is in view of the identified and potential
p.(None): Risks of the drug specialty is required.
p.(None): (5) In addition to the information according to paragraphs 1 to 4, an application for admission may be required
p.(None): to add:
p.(None): 1. Copies of all in another Contracting Party to the Agreement on the European
p.(None): Economic area or a third country granted marketing authorizations for the
p.(None): related pharmaceutical specialty, along with a list of parties to the agreement
p.(None): the European Economic Area in which a according to Directive 2001/83 / EC or Directive
p.(None): 2001/82 / EG application for approval is examined;
p.(None): 2. For human medicinal products, a summary of the safety data including the
p.(None): available data from the regularly updated reports on the safety of
p.(None): Medicines and reports of suspected side effects from other parties to the
p.(None): Agreement on the European Economic Area or a third country;
p.(None): 3. copies of those proposed by the applicant or by the competent national authorities
p.(None): Approved Summary of Product Features (SmPC) and Package Leaflet;
p.(None): 4. The details of all decisions to refuse approval in another
p.(None): Contracting party to the European Economic Area or in a third country and the reasons for this
p.(None): Decision and
p.(None): 5. the copy of the designation of the medicinal product as an orphan medicinal product according to the
p.(None): Regulation (EC) № 141/2000 on orphan medicinal products, OJ. № L 18 from 01/22/2000 p.
p.(None): 1, as amended by Regulation (EC) No. 596/2009, OJ. L 188 from 07/18/2009 p. 14.
p.(None): (6) If the medicinal product is only to be exported, the applicant must contact
p.(None): Submitting the application in writing to make a declaration that the medicinal product is not domestically in
p.(None): Is placed on the market.
p.(None): (7) The applicant is responsible for the accuracy of the information provided and the documents submitted
p.(None): responsible.
p.(None): § 9b. (1) An application for approval of a homeopathic medicinal specialty must include documents
p.(None): according to § 9a paragraph 1 lines 18 to 20 are not included. Furthermore, documents according to Section 9a (2) are not
p.(None): enclosed, however
p.(None): 1. documents that are important for the toxicological assessment of the medicinal product, and
p.(None): 2. Documents on the speci fi c homeopathic or, if applicable, on the speci fi c one
p.(None): anthroposophical effectiveness
p.(None): to join.
p.(None): (2) For homeopathic medicinal products, which are produced by dilution of only one substance
p.(None): a single application is sufficient for the substance and its dilutions.
p.(None): § 9c. An application for approval of a pharmaceutical specialty, which is a monograph of the pharmacopoeia in the
p.(None): The meaning of Section 1 of the Pharmacopoeia Act 2012 does not, however, meet the requirements of Section 7 (2)
p.(None): fulfilled, is not mentioned in Section 7 (9) and is not subject to registration in accordance with Section 12, documents must be provided
p.(None): 8, 12 to 15, 18 to 21, 24 to 27 and 29 to 31 may not be added in accordance with Section 9a (1) no. documents
...
Social / parents
Searching for indicator parent:
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p.(None): Feeding medicines to be used.
p.(None): (10) "Homeopathic medicinal products" are medicinal products that are listed in the European Pharmacopoeia or
p.(None): in the absence of this, according to a pharmacopoeia of the
p.(None): Contracting parties to the Agreement on the European Economic Area described homeopathic
p.(None): Preparation processes have been made from substances called homeopathic primary substances
p.(None): become. A homeopathic medicine can also contain several active substances.
p.(None): (11) 'Radioactive medicinal products' are medicinal products which, when ready for use, contain one or more for
p.(None): contain radionuclides (radioactive isotopes) recorded for medical purposes.
p.(None): (11a) “Biological medicinal products” are medicinal products whose active ingredient is a biological agent. On
p.(None): biological shock is a shock that is of biological origin or from biological origin material
p.(None): is generated and for its characterization and quality determination physical, chemical and
p.(None): biological tests and the assessment of the production process and its control are required.
p.(None): Biological medicines include immunological medicinal products, medicinal products listed below
p.(None): Using human blood or blood plasma as a source,
p.(None): Pharmaceutical specialties according to Z 1 and 1a of the Annex to Regulation (EC) № 726/2004 for the definition of
p.(None): Community procedure for the authorization and surveillance of medicinal products for human and veterinary use and
p.(None): Establishment of a European Medicines Agency, OJ. № L 136 from 04/30/2004 p. 1, last changed
p.(None): by Regulation (EU) No. 1235/2010, OJ. L 348 from December 31, 2010 p. 1.
p.(None): (12) "Generator" is a system with a fixed parent radionuclide, on the basis of which a
p.(None): Daughter radionuclide is generated, which is extracted by elution or another method and in one
p.(None): radioactive medicine is used.
p.(None): (13) "Kit" is a preparation that - usually before its administration - is in the final
p.(None): radioactive drugs are newly formed or combined with radionuclides.
p.(None): (14) “Precursor” is another one, for radiolabelling another substance before administration
p.(None): produced radionuclide.
p.(None): (15) "Name of the medicinal product" is the name that is either not to be confused with the
p.(None): common name leading fancy name or a common or scientific name in
p.(None): May be associated with a trademark or the name of the marketing authorization holder.
p.(None): (16) "Strength of the medicinal product" is, depending on the form of administration, the amount of active ingredient per dose,
p.(None): Unit of volume or weight.
p.(None): (17) 'primary packaging' means the container or any other form of pharmaceutical packaging which
p.(None): comes into direct contact with the medicine.
p.(None): (18) "Agency" is the European Medicinal Products Agency established by Regulation (EC) № 726/2004
p.(None): Agency.
p.(None): (19) 'Generic' is a medicinal product that has the same qualitative and quantitative composition
p.(None): Active ingredients and the same dosage form as the reference drug and its
p.(None): Bioequivalence with the reference medicinal product has been demonstrated by means of suitable bioavailability studies.
p.(None): The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of one
p.(None): Active ingredients are considered to be one and the same active ingredient, unless their properties differ significantly
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): 9. Materials or preparations made from materials that are intended exclusively for
p.(None): complementary medical methods to be used, provided that they neither serve nor
p.(None): are intended to fulfill the purpose of paragraph 1, unless it concerns
p.(None): Stumps or preparations from stumps that are made according to homeopathic principles and
p.(None): Process technologies are produced,
p.(None): 10. Substances or preparations made from substances intended for use on animals and
p.(None): a) for cleaning, grooming, imparting certain odor impressions to the animal, influencing the
p.(None): Look or serve to protect the skin and
p.(None): b) do not contain any substances that are in accordance with food law provisions in cosmetic products
p.(None): may not be included
p.(None): 11. Medical devices in the sense of the Medical Devices Act, Federal Law Gazette No. 657/1996 and
p.(None): 12. Organs or parts of organs within the meaning of the Organ Transplantation Act, Federal Law Gazette I No. 108/2012.
p.(None): (3a) A product fulfills both the definition of the medicinal product in accordance with paras. 1 to 3 and the definition
p.(None): of a product regulated in another federal law, only that product is included in this product
p.(None): Apply provisions of this federal law.
p.(None): (3b) At the request of a person who has a product in
p.(None): To market to determine whether a product falls under the definition of a drug. The Federal Office
p.(None): Healthcare Safety may also determine ex officio whether a product is under the
p.(None): De fi nition of the drug falls. As part of these procedures, there may be an opinion from the Delimitation Advisory Board
p.(None): Obtain according to § 49a.
p.(None): (4) are "substances"
p.(None): 1. chemical elements, natural chemical substances and synthetic processing
p.(None): chemical compounds obtained,
p.(None): 2. Plants, parts of plants and plant components in any form, including by extraction
p.(None): obtained substances,
p.(None): 3. Animal bodies as well as body parts, components and metabolic products of humans or animals in
p.(None): of any shape and
p.(None): 4. Microorganisms and viruses and their components or products.
p.(None): (4a) "Active substances" are substances or mixtures of substances which are intended to be used in the manufacture
p.(None): of a drug to be used and when used in drug manufacturing
p.(None): to become medicinally active components of the drug.
p.(None): (4b) "Auxiliary substance" is every component of a medicinal product with the exception of the active substance and the
p.(None): Packaging material.
p.(None): (5) “Medicinal specialties” are medicinal products that are always prepared in advance in the same composition
p.(None): and under the same name in one intended for delivery to the consumer or user
p.(None): Be placed on the market and medicinal products for distribution to consumers or users
p.(None): whose manufacture otherwise uses an industrial process or which is manufactured commercially
p.(None): become.
p.(None): (6) "Pharmacy proprietary medicinal products" are medicinal products that, unless they are
p.(None): Components within the meaning of paragraph 2 no. 2 are only manufactured from components that are in the
...
p.(None): Drug specialty is clearly separated from the decision to include a patient in the study.
p.(None): Epidemiological methods are used to analyze the data collected. Not-
p.(None): interventional studies are to be planned and carried out according to the state of the art in science.
p.(None): (4) "Final Report" is a complete and detailed account of the clinical trial
p.(None): their termination.
p.(None): (5) "Audit" is a comparison of the raw data with the corresponding records in the test sheets
p.(None): to determine whether the raw data were reported correctly and the conduct of the clinical trial
p.(None): was carried out in accordance with the test plan and the standard operating procedures (SOPs).
p.(None): An audit must be carried out either by an internal sponsor unit, but independently of that unit
p.(None): that is responsible for clinical research or through an external scientific
p.(None): Establishment to be carried out.
p.(None): (6) "Ethics Committee" is an independent body consisting of members of
p.(None): Health professions and people working in non-medical areas and their
p.(None): The task is to protect the rights, security and welfare of the test takers
p.(None): secure and create public trust in this regard.
p.(None): (7) "Inspection" is one by the Federal Office for Safety in Health Care or by one of
p.(None): experts commissioned by him or carried out by a foreign health authority
p.(None): Review of documents, facilities, records, quality assurance systems and all
p.(None): other resources which, in the opinion of the Federal Office for Safety in Health Care or a
p.(None): foreign health authority related to the clinical trial. These can be
p.(None): in the test center, in the sponsor's or contract research institute's facilities or in
p.(None): other institutions (e.g. in laboratories, at ethics committees) which, in the opinion of the Federal Office for
p.(None): Health care or a foreign health agency to be inspected are located.
p.(None): (8) “Monitor” is a person hired by the sponsor or a contract research organization or
p.(None): commissioned and responsible for monitoring and reporting on the progress of the study and review of the
p.(None): Data is responsible.
p.(None): (9) "Proper permit application and proper change request" is a
p.(None): Application for approval or modification, which is based on generally accepted scientific principles and
p.(None): Meets requirements. These generally accepted scientific principles and requirements
p.(None): can be found in the detailed reports adopted by the Commission in accordance with Article 9 of Directive 2001/20 / EC
p.(None): Instructions for applying.
p.(None): (10) “Test Sheet” is a document that contains data and other information about the test plan
p.(None): contains each individual subject included in the clinical trial.
p.(None): (11) "Examiner" is a doctor or dentist who is authorized to practice his or her profession in Austria
p.(None): is responsible for conducting the clinical trial in a trial center. Will an exam in
p.(None): a test center carried out by a team, the examiner is the responsible head of the team.
p.(None): (12) "Examiner Information" is a compilation of the information for the investigations with investigational medicinal products on
p.(None): Human relevant clinical and non-clinical data on the preparations concerned.
p.(None): (13) "Test plan" is the entirety of the documents in which objectives, planning, methodology,
p.(None): statistical considerations and organization of an examination are described. The term “test plan” relates
p.(None): the test plan itself and its subsequent versions and changes.
...
p.(None): (4) Pharmaceutical specialties whose expiry date has passed may be used if the
p.(None): Federal Armed Forces in accordance with Section 2 (1) lit. a of the Wehrgesetzes 1990, Federal Law Gazette № 305, are placed on the market,
p.(None): if this is essential for the supply of medicinal products and research has shown that
p.(None): the protection of human and animal health is maintained.
p.(None): § 5. (1) The Federal Minister of Health and Environmental Protection has to ensure the
p.(None): Drug safety, to prevent harmful effects within the meaning of § 3 and to secure the
p.(None): Quality in the sense of § 4 by ordinance, more detailed provisions on the use of certain substances,
p.(None): Preparations from materials, processes or articles for the manufacture and control of medicinal products
p.(None): or active substances and on the placing on the market, import and use of medicinal products or
p.(None): To adopt active substances.
p.(None): (2) The Federal Minister of Health and Women may consider an application in accordance with
p.(None): § 18a or according to Art. 3 of Regulation (EC) № 726/2004 medicinal specialties from the area of application
p.(None): exempt from a regulation in accordance with paragraph 1, if this results from the latest state of medical
p.(None): Science a threat to drug safety cannot be feared.
p.(None): (3) The Federal Minister of Health and Women may consider an opinion
p.(None): of Article 27 of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or the
p.(None): in Art. 31 Directive 2001/82 / EC, as amended by Directive 2004/28 / EC
p.(None): Coordinating group of medicinal specialties that are based on a regulation issued on the basis of paragraph 1
p.(None): not comply, by decision exempt from the scope of this regulation if after the
p.(None): state of the art in medical science not to worry about a threat to drug safety
p.(None): is. Such notice is to be revoked if it subsequently becomes known that the requirements for this
p.(None): are not given.
p.(None): misleading
p.(None): § 6. (1) It is forbidden to place medicinal products or active substances on the market which are not the facts
p.(None): corresponding information or other misleading designations or packaging
p.(None): exhibit.
p.(None): (2) It is also prohibited in connection with the placing on the market of medicinal products or
p.(None): Effective about this information that does not correspond to the facts or is misleading
p.(None): do.
p.(None): (3) A misleading situation exists in particular if
p.(None): 1. The medicinal products are considered to have an efficacy or the active substances have a property that
p.(None): according to the current state of scientific knowledge or practical
p.(None): Experience is not sufficiently documented, or
p.(None): 2. the impression is incorrectly given that success is to be expected with certainty or that after
p.(None): Intended or prolonged use, no harmful effects occur, or
p.(None): 3. the name or presentation is suitable for confusion.
p.(None): (4) It is also prohibited to announce or place objects on the market that are to be used
...
p.(None): prove inadequate for the assessment of the pharmaceutical specialty,
p.(None): 3. the qualitative or quantitative composition does not correspond to the information or otherwise the
p.(None): pharmaceutical quality is not appropriate
p.(None): 4. The medicinal product meets the requirements for approval according to § 7 or registration according to
p.(None): § 11 fulfilled,
p.(None): 5. the requirements of section 12 (2) lines 1 to 5 have not been met,
p.(None): 6. the pharmaceutical specialty can be harmful when used,
p.(None): 7. the harmlessness of vitamins or minerals contained in the medicinal specialty,
p.(None): has not been proven, or the requirements of Section 12a (4) have not been met,
p.(None): 8. the information on traditional use is insufficient or pharmacological
p.(None): Effect or effectiveness are not plausible due to the long-term use and experience,
p.(None): or
p.(None): 9. the requirements of section 18a (5) are met.
p.(None): (3) If a registration has been made on the basis of Section 12a (5) second sentence, and subsequently the
p.(None): vegetable crop, the vegetable preparation or a combination thereof from the list of vegetable crops,
p.(None): herbal preparations or combinations for use in traditional herbal medicinal products
p.(None): in accordance with Article 16f (1) of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and
p.(None): 2004/27 / EG, deleted, the registration has to be canceled, if not within three months
p.(None): Deletion of the registration holder's documents in accordance with section 12a (1) last sentence and section 12a (2) no.2
p.(None): and 3 submitted.
p.(None): (4) The Federal Office for Safety in Health Care may appoint the Committee for Plant Medicinal Products
p.(None): request an opinion on the evidence of traditional use if in doubt in the
p.(None): With regard to the existence of the requirements according to § 12a para. 2 no.2.
p.(None): (5) If the medicinal product has been in the European Economic Area for less than 15 years
p.(None): has been used, but otherwise the requirements for registration according to § 12 and § 12a
p.(None): are available, the Federal Office for Safety in Health Care has that in accordance with Article 16c (4) of the
p.(None): Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC
p.(None): with the participation of the Committee for Herbal Medicinal Products.
p.(None): (6) The Federal Office for Safety in Health Care notifies the Commission and everyone responsible
p.(None): Authority of another contracting party to the Agreement on the European Economic Area on request
p.(None): every negative decision about the registration and the reasons for it.
p.(None): statutory authorization
p.(None): § 14. The Federal Minister of Health and Women may consider the requirements
p.(None): an in-depth and rapid examination of the application and the admission and registration documents
p.(None): by regulation, more detailed provisions on applications and notifications as well as on content, scope, form,
p.(None): Issue the nature and submission of the samples and documents in accordance with sections 9a to 12a and 24.
p.(None): Product Information
p.(None): Technical information (summary of product characteristics - SMPC)
p.(None): § 15. (1) About medicinal specialties that are in accordance with § 7 of the approval or in accordance with § 12 of the registration
p.(None): is subject to doctors, dentists, dentists, midwives, veterinarians, pharmacists and those in § 59 para. 3
...
p.(None): be replaced,
p.(None): 2. Name and address of the registration holder,
p.(None): 3. Name and address of the manufacturer,
p.(None): 4. type and, if necessary, route of administration,
p.(None): 5. expiry date (month / year),
p.(None): 6. capacity of the primary packaging,
p.(None): 7. if necessary, special precautionary measures for storage,
p.(None): 8. special warnings,
p.(None): 9. Registration number,
p.(None): 10. batch number,
p.(None): 11. the note “Homeopathic medicinal specialty without approved therapeutic
p.(None): Areas of application ”, and
p.(None): 12. the indication that a doctor should be consulted if symptoms of illness persist.
p.(None): (2) The Federal Office for Safety in Health Care may, on request, exceptions to the
p.(None): Grant requirements according to para. 1 nos. 3, 11 and 12.
p.(None): Procedure for applications and registrations
p.(None): § 18. (1) Considering the requirements of an immediate and quick examination of
p.(None): Applications for approval and registrations for the registration of pharmaceutical specialties
p.(None): the Federal Office for Safety in Health Care without unnecessary postponement, but at the latest
p.(None): 1. seven months after receipt of the application for admission or registration for registration
p.(None): a pharmaceutical specialty and
p.(None): 2. 45 days after receipt of an application for approval for sales in parallel import
p.(None): to issue a decision.
p.(None): (2) Notification of the result of the investigation to the applicant or applicant
p.(None): and the order to improve the application or registration or the application or
p.(None): Registration documents inhibit the deadline according to paragraph 1 until the opinion of the
p.(None): Applicant or applicant or the improvement.
p.(None): (3) The approval or registration of a pharmaceutical specialty is subject to conditions
p.(None): or to impose orders if these protect human or animal health, for which
p.(None): Drug safety or effective disease control are required. These can in particular
p.(None): Include the following:
p.(None): 1. Certain measures contained in the risk management system to ensure safe
p.(None): Application of the drug specialty,
p.(None): 2. Conducting safety studies after approval,
p.(None): 3. Obligations with regard to the recording or reporting of suspected side effects that are related to the
p.(None): the obligations set out in Section IX,
p.(None): 4. other conditions or restrictions regarding the safe and effective use of the
p.(None): Medicinal product,
p.(None): 5. Operating a risk-adequate pharmacovigilance system and
p.(None): 6. Conducting efficacy studies after approval, as far as concerns regarding individual
p.(None): There are aspects of the effectiveness of the medicinal product that are only assessed after it has been placed on the market
p.(None): can be.
p.(None): (4) If this is necessary in view of a therapy-appropriate application, the Federal Office can
p.(None): for safety in health care by stipulating that the marketing authorization holder holds the
p.(None): Medicinal product also available in certain pack sizes within a certain period of time
p.(None): has brought.
p.(None): (5) The authorization for parallel import is, if necessary, subject to mandatory conditions
...
p.(None): (5) The registration for registration concerns a traditional herbal medicinal specialty for which the
p.(None): Committee for Plant Medicinal Products a Community plant monograph in accordance with Article 16h (3)
p.(None): Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or
p.(None): a vegetable crop, a vegetable preparation, or a combination thereof, in the list
p.(None): vegetable substances, vegetable preparations or combinations thereof for use in traditional
p.(None): herbal medicinal products in accordance with Article 16f (1) of Directive 2001/83 / EC, as amended by the Directives
p.(None): 2004/24 / EG and 2004/27 / EG, are included, paragraphs 1 and 2 apply.
p.(None): § 18b. (1) The competent national authority within the meaning of Regulation (EC) № 726/2004 is the Federal Office
p.(None): for healthcare security.
p.(None): (2) Competent national authority within the meaning of Regulation (EC) № 1901/2006 of the European
p.(None): Parliament and of the Council of 12 December 2006 on medicinal products for children and amending the
p.(None): Regulation (EEC) № 1768/92, the directives 2001/20 / EG and 2001/83 / EG as well as the regulation (EG)
p.(None): No. 726/2004 is the Federal Office for Safety in Health Care.
p.(None): (3) Does the Federal Office for Safety in Health Care get into the procedure for approval or
p.(None): the change in the approval of a pharmaceutical specialty to the conclusion that the submitted documents are not included
p.(None): this is the same as the pediatric investigation plan approved by the Agency's Pediatric Committee
p.(None): with notice. If necessary, an opinion of the Pediatric Committee is required
p.(None): Article 23 of Regulation (EC) No. 1901/2006 to be taken into account.
p.(None): (4) Competent national authority within the meaning of Regulation (EC) № 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and
p.(None): Amendment to Directive 2001/83 / EC is the Federal Office for Safety in Health Care.
p.(None): Rejection of an application for admission
p.(None): § 19. (1) An application for approval of a pharmaceutical specialty is by the Federal Office for Security in the
p.(None): Health care refuse if
p.(None): 1. the applicant is not entitled to apply in accordance with § 9,
p.(None): 2. the application contains incorrect or incomplete information or the information provided in §§ 9a to 9f
p.(None): approval documents to be provided contain incorrect information, prove to be incomplete or for
p.(None): the assessment of the pharmaceutical specialty proves to be insufficient,
p.(None): 3. it according to the current state of scientific knowledge and the practical
p.(None): Experience does not appear to be certain that the medicinal specialty even when used as intended
p.(None): Use has no harmful effects beyond that according to medical knowledge
p.(None): Science goes beyond reasonable limits,
p.(None): 4. the pharmaceutical specialty contains substances or preparations from substances, the harmlessness of which
p.(None): scientific knowledge and not confirmed by practical experience,
p.(None): 5. the quality of the pharmaceutical specialty does not correspond to the current state of science,
p.(None): 6. the pharmaceutical specialty does not comply with an ordinance pursuant to Section 5 (1),
p.(None): 7. the name of the medicinal product or the information in the authorization documents to mislead
p.(None): are suitable,
...
p.(None): Drug,
p.(None): c) used in immunization programs in the context of public health
p.(None): Medicines, or um
p.(None): d) deals with medicinal products that are newly approved or manufactured using new techniques
p.(None): or are new to a particular manufacturer. These medicinal specialties are subject to the
p.(None): Batch release for a transition period to be specified.
p.(None): For medicinal specialties of Z 2 lit. d has the Federal Office for Safety in Health Care by notice
p.(None): to determine whether the respective pharmaceutical specialties are new and for what period or what number of
p.(None): Batches are subject to batch inspection.
p.(None): (2) Batch release is subject to certain immunological conditions for use on or in animals
p.(None): Medicinal specialties that consist of vaccines, toxins, sera or allergens and for the defense against
p.(None): Notifiable animal diseases according to § 16 animal diseases law, RGBl. No. 177/1909.
p.(None): (3) Pharmaceutical specialties in accordance with paragraphs 1 and 2 may be without prejudice to the provisions on approval
p.(None): of medicinal products in Germany can only be delivered or kept ready for delivery if by a
p.(None): a testing institute designated by the Federal Minister for Health and Women was determined,
p.(None): that the batch conforms to the speci fi cations approved in the approval, in the case of non-approved
p.(None): Medicinal specialties correspond to the state of the art in science and technology. The decision has been made by
p.(None): the designated institute within 60 days of submitting an application and the
p.(None): necessary documents to be made. The applicant must be informed immediately. comes
p.(None): there is no positive opinion within 60 days, the applicant can contact the
p.(None): Federal Office for Safety in Health Care submit an application for a decision by the Federal Office.
p.(None): (4) The Federal Office for Safety in Health Care has an exception to the requirement upon application
p.(None): the batch release within the meaning of paragraph 3 if this is with regard to the special
p.(None): Condition, type of application or area of application of this medicinal specialty without
p.(None): Impairment of drug safety is justified. The exception must be revoked if the
p.(None): There are no prerequisites for this. Foreign medicinal specialties that are intended for a specific purpose in the
p.(None): 12 to 14 and 14 to 14 of the 2010 Medicinal Products Imports Act
p.(None): not batch release. Drug specialties by the state testing agency of another contracting party
p.(None): of the Agreement on the European Economic Area checked and approved in Austria
p.(None): Compliant specifications are also not subject to batch release.
p.(None): (5) The following principles apply when assessing the batch:
p.(None): 1. The testing institute named by ordinance of the Federal Minister for Health and Women can
p.(None): submit an assessment without performing an additional analytical test if
p.(None): Manufacturing and control methods the required quality, safety and harmlessness
p.(None): guarantee.
p.(None): 2. If the named test institute carries out an analytical test, this is based on the information provided in the frame
p.(None): of the admission procedure and if necessary available in the course of the application
...
p.(None): Approval in accordance with § 10c as well as any change or cancellation of a registration in accordance with para. 1 no.2 to 4
p.(None): entered.
p.(None): (3) The Federal Minister for Health and Women has more detailed regulations on the
p.(None): Maintaining the register of medicinal products, type and scope of entries and the type of
p.(None): To issue publication.
p.(None): (4) The Federal Office for Safety in Health Care has an internet portal for medicines
p.(None): operate. This serves to inform the public and the involved public about pharmaceuticals and
p.(None): is closed with the European Internet portal set up according to Art. 26 of the Regulation (EG) № 726/2004
p.(None): to link.
p.(None): (5) In this portal, every admission, every registration within the meaning of para. 1 nos. 2 to 4, each
p.(None): Approval according to § 10c and any change of a medicinal product that is necessary for its identification by the
p.(None): Users or pharmacists can be of importance immediately, but no later than two months after their
p.(None): Publish enactment in a generally accessible manner. The Federal Office for Security in
p.(None): Healthcare the approved specialist information and the approved package leaflet and their
p.(None): approved changes and any conditions or requirements for admission according to §§ 18 Para. 3,
p.(None): 19 paragraphs 4 and 19a paragraphs 1 and 2, which were carried out for pharmacovigilance reasons, and the deadlines for their
p.(None): Publish compliance publicly available. Before publication, the approval or
p.(None): Hear registry holder.
p.(None): (6) The Federal Office for Safety in Health Care is obliged, each in connection with
p.(None): Every application for approval and registration for registration (expert report as well as
p.(None): the opinion on the results of the
p.(None): pharmaceutical, non-clinical pharmacological and toxicological trials and the results of
p.(None): clinical trials or trials, the assessment of the risk management system and the
p.(None): Summary of the pharmacovigilance system and, where appropriate, the safety and
p.(None): Residue tests) for each requested area of application, after all for commercial reasons in the
p.(None): The party's confidentiality interests have been removed immediately, but at the latest
p.(None): generally accessible three months after the notification in full text on the Internet portal for medicinal products
p.(None): to publish. The assessment report is a generally understandable summary
p.(None): publish, which must in particular contain a section on the conditions of the application. In front
p.(None): The approval or registration holder can be heard in the publication.
p.(None): III. SECTION
p.(None): Clinical trial
p.(None): general requirements
p.(None): § 28. (1) Clinical trials may only be carried out if
p.(None): 1. as expected, they meet the objectives of section 2a (1),
p.(None): 2. Information about relevant physical and chemical data or biological properties as well
p.(None): about the applied pharmaceutical technology and
p.(None): 3. Meaningful results of non-clinical tests are available, which correspond to the respective
p.(None): State of the art.
p.(None): (2) The planning and implementation of clinical trials must comply with the regulations
p.(None): Federal law according to the state of the sciences and according to the principles of good clinical
p.(None): Practice. To interpret the principles of good clinical practice, those are generally accepted
p.(None): To use the principles and requirements set out in Volume 10 of the regulations for medicinal products in the
...
p.(None): Later deviations from this planning must be described and justified in the final report.
p.(None): (5) The planning of the statistical analysis and its execution must be carried out accordingly
p.(None): qualified biometrics or statisticians. The possibility and the
p.(None): Circumstances of an interim evaluation must also be stated in the test plan.
p.(None): (6) The statistical analysis must provide information about missing, unused and incorrect data
p.(None): contain.
p.(None): (7) Every publication of a clinical trial must contain information about it; who sponsors this
p.(None): clinical trial was.
p.(None): Changes to the test plan
p.(None): Section 37a. (1) After the start of the clinical trial, the sponsor can make changes to the trial schedule
p.(None): make. If these changes are significant and affect the safety of the examinee
p.(None): impact or interpretation of the scientific documents on which the conduct of the exam
p.(None): supported, or if they are of any other importance
p.(None): are, the sponsor has the Federal Office for Safety in Health Care and the responsible
p.(None): Inform the ethics committee of all reasons and the content of the changes. It is
p.(None): the significant changes relating to the inclusion of new test centers, section 41b (5) applies with the proviso
p.(None): that any objections to the lead ethics committee must be reported within 30 days at the latest,
p.(None): analogous.
p.(None): (2) On the basis of the criteria and in § 41a (1), the responsible ethics committee
p.(None): in accordance with § 41b within a maximum of 35 days from the date of receipt of the
p.(None): to submit a correct proposal for an opinion.
p.(None): (3) If the ethics committee does not give a favorable opinion or does not exist from the perspective of the
p.(None): Federal Office for Safety in Health Care has other objections to the planned changes on
p.(None): Test plan, the Federal Office for Safety in Health Care has the change of the test plan for the case
p.(None): to prohibit the sponsor from taking the objections into account. The amendment is considered approved
p.(None): if the change is not made within 35 days of receipt of the proper change request
p.(None): is prohibited.
p.(None): (4) Without prejudice to paragraphs 1 to 3, the sponsor and the examiner have under certain circumstances:
p.(None): especially with any new circumstance regarding the course of the examination or the development of a
p.(None): Investigational medicinal product that can impair the safety of the test participants, the urgently needed
p.(None): Take security measures to protect the test participants from immediate danger. The
p.(None): The Federal Office for Health Safety immediately sponsors the new circumstances
p.(None): and to inform the measures taken and to ensure that at the same time the person responsible
p.(None): Ethics committee.
p.(None): Education and consent
p.(None): Section 38. (1) The clinical trial of a medicinal product may, unless sections 42, 43 and 43a otherwise
p.(None): determine to be performed only when the subject is examined by a doctor or dentist
p.(None): Nature, meaning, scope and risks of the clinical trial has been elucidated and the
p.(None): Exam participants have given their consent.
...
p.(None): obtain data protection consent. The withdrawal of consent has no effect on
p.(None): Activities that are carried out on the basis of informed consent prior to its revocation
p.(None): or on the processing of the data collected on this basis. The right under Art. 17 and
p.(None): 20 of the General Data Protection Regulation is excluded. This is in the course of obtaining consent
p.(None): enlighten.
p.(None): (3b) For further processing in accordance with Art. 9 Para. 2 lit. j of the General Data Protection Regulation, Section 2d applies
p.(None): Paragraph 3 of the Research Organization Act, Federal Law Gazette I No. 131/2015.
p.(None): (3c) Paragraphs 3a and 3b apply mutatis mutandis to non-interventional studies.
p.(None): (4) The test participants and, if applicable, the legal representatives (§ 1034 ABGB) must contact the
p.(None): Insurance coverage within the meaning of § 32 Paragraph 1 No. 11 are informed.
p.(None): Start of clinical trial
p.(None): Section 40. (1) The conduct of a clinical trial is only permitted if the Federal Office for Security
p.(None): in the healthcare system, the conduct of the clinical trial according to paragraph 3 or 4 is not prohibited or
p.(None): approved in accordance with paragraph 6. The sponsor must contact the Federal Office of Health before the clinical trial begins
p.(None): Healthcare safety to make a proper permit application, all for that
p.(None): Assessment of the clinical trial required documents and submit the opinion of
p.(None): Obtain an ethics committee. The sponsorship may be referred to the Ethics Committee before the
p.(None): Applications are submitted to the Federal Office or simultaneously with it.
p.(None): (2) The examination of an application by the Federal Office for Safety in Health Care has no
p.(None): unnecessary postponement, but at the latest within 35 days. The Federal Office for Security in
p.(None): Health care has the correctness of the application, the basic justification and
p.(None): Check the relevance of the project and the requirements for the manufacture of the investigational medicinal products.
p.(None): If the Federal Office for Safety in Health Care does not respond within 35 days, the
p.(None): Application subject to paragraph 4 as approved. These deadlines do not apply to clinical trials within the meaning of the
p.(None): Paragraph 6.
p.(None): (3) The Federal Office for Safety in Health Care has - if the in this federal law
p.(None): the above-mentioned requirements are not met - the conditions that are suitable for maintaining the requirements
p.(None): or stipulate conditions and allow a reasonable period for this. Can also by
p.(None): Prescribing conditions or conditions of compliance with the requirements of this federal law
p.(None): cannot be ensured, the authority has to carry out the clinical trial with the sponsor
p.(None): To prohibit decision.
p.(None): (4) If the ethics committee has no favorable opinion in the procedure pursuant to sections 41a and 41b
p.(None): submitted, the Federal Office for Safety in Health Care has carried out the clinical
p.(None): Prohibition exam if the sponsor does not object to the ethics committee's objections
p.(None): considered. The decision is from the Federal Office for Safety in Health Care without unnecessary
p.(None): Postponement, but no later than 60 days after submission of the application.
p.(None): (5) The Federal Office for Safety in Health Care can, if there are concerns about the
p.(None): the ethics committee has given its opinion correctly or is correct
p.(None): Instruct the drug advisory board to review the application for approval. If this is the implementation
p.(None): If the clinical trial is approved, a prohibition can be waived.
p.(None): (6) Conducting a clinical trial related to drugs for gene therapy and
p.(None): somatic cell therapy including xenogeneic cell therapy requires the approval of the
p.(None): Federal Office for Safety in Health Care.
p.(None): (7) The Federal Office for Safety in Health Care has applications according to paragraph 6 without unnecessary
p.(None): Postponement, but at the latest within 90 days after receipt of the application. In cases in
p.(None): to whom an advisory body is concerned, this period is extended by a further 90 days.
p.(None): (8) For a clinical trial in connection with drugs for gene therapy apply in addition to
p.(None): Provisions of this federal law meet the requirements of sections 74 to 79 of the Genetic Engineering Act.
p.(None): ethics committees
p.(None): Section 41. (1) The governor has clinical trials outside of hospitals
p.(None): To ensure that an ethics committee for the perception of the
p.(None): Tasks according to § 41a is set up and all necessary measures are taken to this
p.(None): Ethics committee to enable the work. The members of the ethics committee are allowed to participate in this
p.(None): Activity is not subject to any instructions.
p.(None): (2) The ethics committee has a balanced relationship between women and men
p.(None): to assemble and at least consist of:
...
p.(None): Procedures for informed consent and justification for research
p.(None): to people who are unable to give informed consent as to what they speci fi c
p.(None): Restrictions in accordance with sections 29, 38, 39, 42, 43 and 43a,
p.(None): 8. Personal injury insurance taken out in accordance with section 32 (1) no. 11 as well as any kind of
p.(None): Insurance or compensation to cover the liability of the auditor and sponsor,
p.(None): 9. the amounts and modalities for any remuneration or compensation for auditors and
p.(None): Exam participants and the relevant elements each between the sponsor and the
p.(None): Testing center envisaged contract, and
p.(None): 10. the modalities for the selection of the test participants.
p.(None): (2) The Ethics Committee has monthly meetings in one for one year in advance
p.(None): publishing schedule and deadlines for the submission of each meeting
p.(None): Applications. The ethics committee is responsible for determining the dates of the meetings and the related dates
p.(None): associated deadlines for submitting applications to ensure that the scheduled deadlines
p.(None): can be met.
p.(None): (3) After receipt of an application, the ethics committee has to check whether a proper one
p.(None): Application for approval has been received and the sponsor immediately, but at the latest within five working days
p.(None): to inform about it after receipt of the application.
p.(None): (4) The Ethics Committee must give the sponsor the opportunity to attend the
p.(None): Submit an opinion to the assessment fields mentioned in paragraph 1.
p.(None): (5) The Ethics Committee has sent its reasoned opinion to the sponsor within 35
p.(None): Days from the reporting date. The ethics committee has to ensure that the in
p.(None): Paragraph 6 deadline is met. This does not apply to applications within the meaning of Section 40 (6).
p.(None): (6) The Ethics Committee has the sponsor within 60 days and the Federal Office for
p.(None): Healthcare safety within 50 days of receiving a proper application
p.(None): to provide a reasoned opinion. For applications within the meaning of section 40 (6), the
p.(None): Deadlines in accordance with Section 40 (7).
p.(None): (7) During the examination of the application, the ethics committee may only make one additional decision
p.(None): Request information on the information already submitted by the applicant. The in paragraphs 5 and 6
p.(None): scheduled deadlines will be delayed until additional information is received.
p.(None): Multi-center exams
p.(None): Section 41b. (1) For multicentre examinations, the opinion of a single Austrian
p.(None): Ethics committee sufficient. The sponsor has to deal with an ethics committee that the through
p.(None): Ordinance of the Federal Minister of Health and Women meets specific requirements.
p.(None): This regulation has in particular
p.(None): 1. the organizational framework,
p.(None): 2. the circumstances relevant to the assessment of the necessary extensive experience, and
p.(None): 3. the internal quality assurance measures
p.(None): to consider.
p.(None): (2) Ethics committees that aim to work in the context of multicentre examinations have this
p.(None): the Federal Ministry of Health and Women with proof of the required according to paragraph 1
p.(None): Prerequisites to report. The Federal Minister of Health and Women has the ethics committees that
p.(None): meet the requirements set out in paragraph 1 of publishing in the official gazette of the Wiener Zeitung.
p.(None): (3) In the case of a multi-center examination, the sponsor has one of those announced in accordance with paragraph 2
p.(None): Select ethics committees that are responsible for one of the test centers. Is not one of the paragraph 2
p.(None): made known ethics committees responsible for one of these test centers or refuses to accept them
...
p.(None): of a monocentric clinical trial would be responsible locally, all documents simultaneously with the
p.(None): Submit the application to the ethics committee announced in accordance with paragraph 2. Any local
p.(None): The ethics committee has the suitability of the auditor and his staff and the adequacy of the
p.(None): Assess institutions in their area of responsibility and any objections from the lead ethics committee
p.(None): Notify at least five days before the meeting date in accordance with Section 41a (2). Be from a local
p.(None): Ethics Committee no objections to the conditions to be assessed up to this point
p.(None): raised, the lead ethics committee can from a positive assessment by the local ethics committee
p.(None): out.
p.(None): Suspension and prohibition of the clinical trial
p.(None): Section 41c. (1) Provided that the Federal Office for Safety in Health Care has objective reasons for acceptance
p.(None): has that the requirements of the application for approval pursuant to Section 40 (1) no longer exist,
p.(None): or has information regarding the safety or the scientific basis
p.(None): the clinical trial may raise concerns, it may suspend or prohibit the clinical trial. This
p.(None): applies in any case even if a clinical trial by the sponsor without compliance with the regulations of the
p.(None): § 40 is carried out.
p.(None): (2) Before the decision according to paragraph 1, except in the event of imminent danger, the sponsor and the
p.(None): To inform auditors. The sponsor must give his opinion within one week.
p.(None): (3) The Federal Office for Safety in Health Care has the other competent authorities of all
p.(None): Contracting parties of the European Economic Area, in whose territory the clinical trial
p.(None): is carried out by the relevant ethics committee, the European Agency for the Evaluation of
p.(None): Medicines and the Commission stating the reasons for its decision, the clinical trial
p.(None): suspend or prohibit, inform.
p.(None): (4) Has the Federal Office for Safety in Health Care (note: correct: health care) objective
p.(None): Reasons to believe that the sponsor or investigator or anyone else is participating in the clinical trial
p.(None): If the participant no longer fulfills his obligations, he must inform the person concerned immediately
p.(None): Giving opportunity to comment and then communicating to him an action plan that he will implement
p.(None): must to remedy the situation. This also applies if the clinical trial has already ended. The
p.(None): The Federal Office for Safety in Health Care has the other competent authorities of all contracting parties
p.(None): of the European Economic Area, in whose territory the clinical trial is carried out, the
p.(None): To notify the Ethics Committee and the Commission immediately of this action plan.
p.(None): Adverse event reports
p.(None): Section 41d. (1) The examiner must immediately report to the sponsor any serious undesirable effects
p.(None): Reimburse events, except for events beyond which, according to the audit plan or auditor information
p.(None): must be reported immediately. On the immediate reporting have detailed written
p.(None): Reports to follow. In the immediate reporting and in the follow-up reports are the
p.(None): Name test takers with a code number.
...
p.(None): Risk management plans are, and the conditions and obligations according to §§ 18 paragraph 3, 19 paragraph 4 and
p.(None): 19b paragraphs 1 and 2,
p.(None): 2. it assesses updates to the risk management system,
p.(None): 3. It evaluates the data in the eudravigilance database to determine whether it was new or changed
p.(None): There are risks and whether the benefit-risk balance of drugs is affected.
p.(None): (2) The Federal Office for Safety in Health Care has affected license holders and the
p.(None): To inform the agency if it is recognized that new or changed risks exist or that this is happening
p.(None): Risk-benefit ratio of pharmaceutical specialties has changed.
p.(None): Pharmakovigilanzinspektionen
p.(None): § 75f. (1) The Federal Office for Safety in Health Care has companies in accordance with Section 62 Paragraph 1 and of
p.(None): periodically with these pharmacovigilance officers with regard to compliance with the obligations
p.(None): check this section.
p.(None): (2) Section 68 subsections 1 to 3 apply mutatis mutandis.
p.(None): (3) A record of every pharmacovigilance inspection must be recorded in accordance with §§ 14f AVG, the
p.(None): To bring the license holder's content to the attention of the Federal Office for Safety in Health Care
p.(None): is.
p.(None): (4) Does the pharmacovigilance inspection conclude that the marketing authorization holder meets the requirements
p.(None): of this section has not been met, the Federal Office for Safety in Health Care
p.(None): After obtaining an opinion on the identified deficiencies, the authorization holder can rectify them
p.(None): To order. If the remedy order is not fulfilled, the Federal Office has
p.(None): To take measures according to § 23.
p.(None): (5) In cases of paragraph 4, the Federal Office for Safety in Health Care has the agency, the
p.(None): To inform the Commission and the other Member States of the Union, if they are
p.(None): Human medicinal products deals.
p.(None): (6) The Federal Office for Safety in Health Care has carried out the inspections in accordance with the guidelines of
p.(None): Commission under Article 111a of Directive 2001/83 / EC and with the agency
p.(None): Exchange information on planned and carried out inspections.
p.(None): Duties of health professionals
p.(None): Section 75g. (1) Doctors, dentists, veterinarians, dentists, midwives and, insofar as they are not required to report
p.(None): According to § 75j, pharmacists and traders who are registered according to the 1994 Industrial Code
p.(None): Manufacture of medicinal products or wholesalers of medicinal products, and have drugstores
p.(None): 1. suspected side effects or
p.(None): 2. suspected side effects in humans or
p.(None): 3. the lack of the expected effectiveness or
p.(None): 4. insufficient waiting times
p.(None): of medicinal products that have occurred domestically and are known to them due to their professional activity
p.(None): to the Federal Office for Security in accordance with a regulation pursuant to Section 75a
p.(None): to report in healthcare.
p.(None): (2) Those who are obliged to report in accordance with paragraph 1 have all to the Federal Office for Safety in Health Care
p.(None): Share observations and data that may be important for drug safety. The
...
p.(None): 2. People who meet the training requirement in accordance with Section 24 (3) LMSVG.
p.(None): (3) Supervisory bodies are entitled to inspect wherever goods are placed on the market
p.(None): hold and take samples. For this purpose, they must be granted access to all places where
p.(None): are goods. The review is, apart from the control of means of transport or at
p.(None): Danger of being delayed during normal business or operating hours. The disturbance of the
p.(None): Business operations should be avoided if possible.
p.(None): (4) The sample taken is, insofar as this is possible by nature and therefore not hers
p.(None): faultless assessment is frustrated to be divided into two equal parts that are officially closed. On
p.(None): Part is to be left as a cross-check of the party for evidence purposes. If a division is not possible, it has
p.(None): Supervisory body to supply the sample without prior division of the investigation. For the samples taken
p.(None): no compensation is due.
p.(None): (5) On the occasion of the sampling, the supervisory body must issue a cover letter and everyone
p.(None): Include part of the sample in which the observations and observations are noteworthy for the assessor
p.(None): of the organ are included. The Federal Minister is responsible for the details of the sample accompanying letter
p.(None): for health and women.
p.(None): (6) The sample taken is to be sent to the investigating institution. This
p.(None): The investigation institute has to examine the sample and to produce findings and expert opinions. findings
p.(None): and reports are to be sent immediately to the sampling agency. If the
p.(None): Investigation center comes to a reasoned opinion that the suspicion of the violation of
p.(None): Legislation is in place, so it has to determine this in its report and the responsible person
p.(None): To inform the authority immediately.
p.(None): (7) The Federal Minister of Health and Women has the one in question by ordinance
p.(None): Investigation facility or the relevant investigation facilities in accordance with Paragraph 6 - if there is
p.(None): to carry out investigations into bumps within the meaning of Section 1 (2) (1) of the Anti-Doping
p.(None): Federal Act 2007 acts in agreement with the Federal Chancellor.
p.(None): Section 76b. (1) Supervisory bodies pursuant to Section 76a (2) have to confiscate the goods temporarily or securely
p.(None): if there is reasonable suspicion that these substances within the meaning of section 1 (2) no.
p.(None): Federal doping law 2007 contains, or this a danger to the life or health of
p.(None): Represent human or animal.
p.(None): (2) The supervisory body has so far been informed of the provisional confiscation or seizure
p.(None): Hand over a certificate to those entitled to dispose, stating the location and type and
p.(None): The quantity of the seized or seized goods must be stated.
p.(None): (3) In the event of a preliminary seizure, the supervisory body must immediately notify the
p.(None): District administrative authority, but in the case of seizure the public prosecutor through the
p.(None): Ensuring reporting, depending on whether the violation is likely to be a criminal offense
p.(None): or represents an administrative violation. The provision expires in the event of an administrative offense
p.(None): Seizure, unless a seizure notice is not issued within four weeks.
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.(None): Section 59. (1) Pharmaceuticals may only be dispensed by pharmacies, provided that in sections 57 and 58 or in
p.(None): following nothing else is determined.
p.(None): (2) Pharmacy specialties may only be dispensed by the pharmacy in which they are
p.(None): are wholly or predominantly manufactured and their operators are registered owners of these
p.(None): pharmacy proprietary medicinal product.
p.(None): (3) The Federal Minister for Health and Women, in agreement with the Federal Minister for
p.(None): Economy and labor by regulation to determine those medicines that are even in one after the
p.(None): Experience of everyday life foreseeable improper use none
p.(None): Let health or life endanger human or animal and therefore by
p.(None): Druggists or by traders who, according to the 1994 Trade Ordinance, manufacture medicinal products
p.(None): are entitled to be released.
p.(None): (4) Insofar as medicinal products in accordance with Paragraph 3 are contact lens fluids, they may
p.(None): are also given by traders who, according to the 1994 Industrial Code, on retail
p.(None): with contact lenses and the adaptation of contact lenses.
p.(None): (5) Medicinal products that contain only active ingredients that are specified in a regulation
p.(None): 3, may be submitted in accordance with paragraphs 3 and 4, unless the Federal Office
p.(None): for Healthcare Safety determined by notice that this is due to a
p.(None): Possibility of danger arising from the special composition or a certain
p.(None): Indication results, is reserved for pharmacies in retail sales.
p.(None): (6) The Federal Office for Safety in Health Care can apply to the authorization holder
p.(None): exempt pharmaceutical specialties that do not comply with Paragraph 5 from the pharmacy reservation,
p.(None): if there is no hazard due to the special composition or the intended indication
p.(None): to get. Such a decision must be revoked if it subsequently becomes known that the
p.(None): The requirements for this are not met.
p.(None): (7) Paragraphs 1 to 6 do not apply to medicinal products within the meaning of Section 7 paragraph 4.
p.(None): (7a) If it is medicinal products for animals intended for external use on the skin
p.(None): are, or are medicinal specialties for bees, due to the special composition
p.(None): or the intended indications of these medicinal specialties upon application by the marketing authorization holder
p.(None): Federal Office for Safety in Health Care through a notice outside of pharmacies and
p.(None): Provide drug stores. Such a decision must be revoked if it subsequently becomes known that the
p.(None): The requirements for this are not met.
p.(None): (8) Medical gases may also be supplied by traders who, in accordance with the
p.(None): Trade Regulations 1994 are authorized to supply compressed technical gases in retail sales.
p.(None): (9) The dispensing of medicines by self-service or by distance selling is prohibited.
p.(None): (10) The distance selling ban according to paragraph 9 does not apply to those who are not registered or registered in Austria
p.(None): prescription-only human medicinal products sold by distance selling
p.(None): 1. within Austria through public pharmacies, or
p.(None): 2. to Austria through pharmacies of another EEA contracting party, according to those applicable there
p.(None): Legislation are empowered to
p.(None): be delivered.
p.(None): (11) The distance selling ban in accordance with paragraph 9 does not apply to human medicinal products that comply with the national
...
p.(None): to give the person affected by the decay the opportunity to make a statement.
p.(None): (2) The expired goods are to be used in a useful manner. The expired goods are at the expense of
p.(None): Accused or destroy the person affected by the forfeiture if there is a useful recovery
p.(None): is not possible or the exploitation of the goods does not lead to the expectation that the achievable proceeds will
p.(None): Recovery costs will exceed. The destruction of the expired goods is by the accused or
p.(None): permitted by the person affected by the forfeiture at his own expense under the supervision of a supervisory body.
p.(None): (3) The proceeds of the exploitation are after deduction of the associated expenses and any
p.(None): irrecoverable costs of the criminal proceedings as well as the burden on the case
p.(None): To transfer liabilities to the federal government.
p.(None): Surveillance and protective measures
p.(None): Section 77. Is determined during a check in accordance with Section 76 or is the Federal Office for Security receiving
p.(None): Healthcare otherwise aware that a drug or active ingredient is subject to this federal law or to
p.(None): Does not comply with regulations or other administrative acts enacted on the basis of this federal law
p.(None): the Federal Office for Safety in Health Care to take measures to place the product on the market
p.(None): hinder or restrict. If applicable, section 76b (10) applies.
p.(None): Section 78. (1) The Federal Office for Safety in Health Care becomes aware of facts
p.(None): The reason for concern is that a medicinal product or active substance on the market is a hazard
p.(None): represents the life or health of humans or animals, the Federal Office for Security has
p.(None): To have all necessary measures in accordance with the extent of the risk,
p.(None): which prevent the placing on the market of the medicinal product or active substance or the use of the medicinal product
p.(None): or restrict.
p.(None): (2) In the event of imminent danger from a drug or an active ingredient, measures in accordance with Paragraph 1
p.(None): 1. even without previous procedure or
p.(None): 2. be made before issuing a decision.
p.(None): In the case of Z 2, however, is from the Federal Office for Safety in Health Care within two weeks
p.(None): to issue a written notice, otherwise the measure taken is deemed to have been revoked.
p.(None): (3) The Federal Office for Safety in Health Care has the drug it has confiscated
p.(None): or to declare the seized active ingredient verf as a precautionary measure if it has one
p.(None): serious and significant danger to humans or animals and the person entitled to dispose does not
p.(None): ensures that the drug or active substance is not placed on the market after its release.
p.(None): Preliminary seizure
p.(None): Section 78a. Organs of the Federal Office for Safety in Health Care have considered
p.(None): to temporarily confiscate the protective objectives of this federal law on medicinal products or active substances if the
p.(None): there is reasonable suspicion that this
p.(None): 1. contrary to the provisions of this federal law or regulations based thereon or
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.(None): Product Information
p.(None): Technical information (summary of product characteristics - SMPC)
p.(None): § 15. (1) About medicinal specialties that are in accordance with § 7 of the approval or in accordance with § 12 of the registration
p.(None): is subject to doctors, dentists, dentists, midwives, veterinarians, pharmacists and those in § 59 para. 3
p.(None): to make available technical information in German to the traders mentioned, provided that it
p.(None): are not pharmaceutical specialties according to § 9c.
p.(None): (2) The subject information must contain at least the following information in the following order:
p.(None): 1. Name of the pharmaceutical specialty, followed by the strength and the dosage form,
p.(None): 2. Qualitative and quantitative composition according to active ingredients using the usual
p.(None): common or chemical name,
p.(None): 3. pharmaceutical form,
p.(None): 4. Clinical information:
p.(None): a) fields of application,
p.(None): b) dosage and type of use in adults and, if necessary, in children,
p.(None): c) contraindications,
p.(None): d) special warnings and cautions for use and in immunological
p.(None): Medicinal products all special precautions taken by people with
p.(None): immunological medicines and those dealing with these medicinal products
p.(None): Administer patients who are to be met, as well as all where necessary to be met by the patient
p.(None): Precautions,
p.(None): e) interactions with other drugs or other agents,
p.(None): f) use during pregnancy and lactation,
p.(None): (g) effects on the ability to operate machines and to operate
p.(None): Motor vehicles
p.(None): h) side effects that may occur when used as intended,
p.(None): i) overdose (symptoms, emergency measures, antidotes),
p.(None): 5. Pharmacological properties:
p.(None): a) pharmacodynamic properties,
p.(None): b) pharmacokinetic properties,
p.(None): c) non-clinical safety data;
p.(None): 6. Pharmaceutical information:
p.(None): a) list of auxiliary substances,
p.(None): b) major incompatibilities,
p.(None): c) Shelf life, if necessary after reconstitution of the medicinal product or at
p.(None): first opening of the primary packaging,
p.(None): d) special precautions for storage,
p.(None): e) type and content of the container,
p.(None): f) if necessary, special precautionary measures for the disposal of opened ones
p.(None): Pharmaceutical specialties or the waste materials derived from them,
p.(None): 7. Name or company name and seat of the authorization holder,
p.(None): 8. approval number,
p.(None): 9. Date of first approval or extension of approval,
p.(None): 10. Date of revision of the text,
p.(None): 11. for radioactive pharmaceutical specialties all additional details of the internal radiation dosimetry,
p.(None): 12. For radioactive pharmaceutical specialties, additional detailed instructions for the ex-temporane
p.(None): Preparation and quality control for this preparation and, if applicable, maximum storage time,
p.(None): during which an intermediate preparation such as an eluate or the ready-to-use radioactive
p.(None): Pharmaceutical meets its intended specifications,
p.(None): 13. for medicinal specialties that are on the list according to Art. 23 of Regulation (EC) № 726/2004
p.(None): find the following statement: "This medicinal product is subject to additional monitoring."
p.(None): Declaration must precede and enter the black symbol in accordance with Art. 23 of this regulation
p.(None): a suitable standardized explanatory sentence in accordance with Article 23 (5) of this Ordinance will follow, and
p.(None): 14. In the case of human medicinal product specialties, a note by doctors, dentists, dentists, midwives and
p.(None): Pharmacists, unless they are subject to the reporting obligation as a marketing authorization holder, expressly
p.(None): are asked to report suspected side effects to the Federal Office for Security
p.(None): Healthcare report.
p.(None): (3) Notwithstanding paragraph 2, line 4, line 4 of the specialist information for a veterinary medicinal product is:
p.(None): 4. Clinical information:
p.(None): a) each target species for which the medicinal product is to be used,
p.(None): b) information on use with particular reference to the target species,
p.(None): c) contraindications,
p.(None): d) special warnings regarding each target species,
p.(None): e) special warnings and cautions for use and in immunological
p.(None): Medicinal products all special precautions taken by people with
p.(None): immunological medicines and those dealing with these medicinal products
p.(None): Administer animals to be met
p.(None): f) side effects,
p.(None): g) use in pregnancy, egg or milk production,
p.(None): h) interactions with other medicinal products and other interactions,
p.(None): i) dosage and type of application,
p.(None): j) overdose (symptoms, emergency measures, antidotes),
p.(None): k) Waiting time for all foods, including those for which there is no waiting time.
p.(None): The information in accordance with para. 2 no. 5 lit. c and Z 14 are omitted.
p.(None): (4) The information in the technical information for a traditional herbal medicinal specialty is omitted
p.(None): Paragraph 2 No. 5.
p.(None): (5) For approvals according to § 10, the parts of the specialist information for the reference medicinal product that are
p.(None): refer to the areas of application, dosages or other subject matter of a patent which at the time
p.(None): the placing on the market of a generic still fell under patent law.
p.(None): (6) The subject information as well as any changes to the subject information in accordance with Regulation (EC)
p.(None): № 1234/2008 or according to §§ 24 or 25 are from the Austrian Chamber of Pharmacists under
p.(None): To publish the participation of the Austrian Medical Association. The publication has the date of
p.(None): Creation of the subject information, in the event of a change in the subject information, the date of the last change
p.(None): exhibit.
p.(None): (7) The Federal Minister of Health and Women has to determine by decree which others
p.(None): Information that is important for the application must be included in the specialist information and
p.(None): more detailed provisions on the type of publication and the availability of the specialist information as well as on
p.(None): Changes to the same and, if necessary with regard to drug safety, about content,
p.(None): To issue the type and form of the information specified in paras. 2 and 3.
p.(None): leaflet
p.(None): Section 16. (1) Medicinal specialties that are in accordance with Section 7 of the approval or in accordance with Section 11a of the registration
...
p.(None): 8. the clinical trial is planned so that it takes into account the disease and the
p.(None): Developmental stage with as little pain, discomfort, fear and others as possible
p.(None): predictable risks are associated; Both the risk threshold and the degree of exposure must be
p.(None): specifically defined and constantly checked,
p.(None): 9. The test plan from an ethics committee that has knowledge of the area concerned
p.(None): Disease and in relation to the affected patient group or in clinical, ethical
p.(None): and psychosocial issues in the field of the disease in question and in relation to the
p.(None): the affected patient group was advised, endorsed, and
p.(None): 10. In case of doubt, the interests of the patient always outweigh the public interests and the interests of
p.(None): Science stand.
p.(None): (2) If the person named in para. 1 has a legal representative for financial matters, then
p.(None): is also promptly informed of the participant's participation in the clinical trial and of the result
p.(None): inform associated insurance coverage.
p.(None): (3) Gives a person who is not able to make decisions to his or her proxy
p.(None): Adult representatives or the investigator to recognize that they are undergoing the clinical trial or their
p.(None): If the continuation is refused, this must be refrained from, unless the welfare of the person represented would otherwise be
p.(None): significantly at risk. The consent of the legal representative requires judicial approval.
p.(None): Section 43a. (1) A clinical trial, by its nature, can only be used in emergency situations in which appropriate
p.(None): Time no consent of the legal representative can be obtained, can be carried out at
p.(None): a person who is unable to consent to have a clinical trial performed if:
p.(None): 1. there are no indications that the patient refused the clinical trial or
p.(None): would refuse
p.(None): 2. Such research for the validation of data used in clinical trials for consent
p.(None): were obtained after informed persons or using other research methods,
p.(None): are absolutely necessary and can only be carried out in emergency situations,
p.(None): 3. The drug being tested to detect, cure, alleviate or prevent
p.(None): Diseases in an emergency situation is determined
p.(None): 4. the use of the drug that is being tested, according to the knowledge of medical
p.(None): Science is indicated to help the emergency patient develop an illness or its course
p.(None): recognize, heal or alleviate them or protect them from further diseases and the with
p.(None): the risk associated with the inclusion in the clinical trial for the trial subject
p.(None): predominates
p.(None): 5. the conduct of the test and the test plan by an ethics committee that has knowledge of the
p.(None): Area of the disease concerned, in relation to the emergency situation and the affected
p.(None): Patient group or who deal with clinical and ethical issues in the field of
p.(None): related illness, in relation to the emergency situation and the affected patient group
p.(None): , expressly for the conduct of clinical trials in emergency situations on persons who
p.(None): are unable to give personal consent, have been approved, and
p.(None): 6. In case of doubt, the interests of the patient always outweigh the public interests and the interests of the patient
p.(None): Science stand.
p.(None): (2) At the test center where a clinical trial in emergency situations is performed on people who are not in
p.(None): are able to consent, the public is appropriately informed about this
p.(None): To inform circumstance.
p.(None): (3) If the patient becomes able to give consent, he must be informed immediately that a
p.(None): clinical examination in an emergency situation was or will be carried out on him. It is in the sense of §§ 38 and
p.(None): 39 to clear up. A continuation of the clinical trial is only permitted if the consent is given after
p.(None): Education is given. Further processing of the personal data collected up to that point is required
p.(None): the express data protection consent.
p.(None): (4) As soon as the legal representative's consent can be obtained, it is continued
p.(None): the clinical trial is only permitted under the conditions of § 42 or § 43.
p.(None): (5) If the test participant dies before the time specified in paras. 3 and 4, they may until then
p.(None): processed data will be used for the purposes of this clinical trial.
p.(None): Section 44. (1) The clinical trial of a medicinal product may only be carried out on a pregnant woman if
p.(None): if
p.(None): 1. the drug being tested to detect, cure, alleviate or prevent
...
p.(None): are authorized
p.(None): 3. Manufacturer only for the purpose of the manufacture of medicinal products or insofar as they are in accordance with the
p.(None): Trade Regulations 1994 are authorized to trade in pharmaceuticals,
p.(None): 4. pharmaceutical wholesaler,
p.(None): 5. Local authorities
p.(None): a) in connection with tasks of vaccination prophylaxis or to fulfill them by law
p.(None): assigned tasks of disease control,
p.(None): b) humanitarian aid in connection with a disaster that occurred abroad
p.(None): or a serious accident,
p.(None): c) to maintain the supply of pharmaceuticals in Germany if this is in connection with a
p.(None): Catastrophe, terrorist threat, armed conflict or pandemic
p.(None): is absolutely necessary
p.(None): 5a. Businesses and organizations that maintain basic public services
p.(None): serve and based on a between the federal government or a state and a manufacturer,
p.(None): Depositeur or pharmaceutical wholesaler concluded contract to ensure the
p.(None): Maintenance of drug supplies related to a pandemic, warlike
p.(None): Conflict or terrorist threat, in turn, individual contracts for direct purchase
p.(None): have completed a drug for the needs of their own employees,
p.(None): 6. Institutions of the Austrian Armed Forces, the pharmaceutical supply of the Armed Forces
p.(None): serve,
p.(None): 6a. the Federal Ministry of the Interior, the authorities and childcare facilities subordinate to it
p.(None): for emergency care, prevention and care of operations, provided that the medicines for
p.(None): Need to perform their duties
p.(None): 7. Institutions, the provisional judicial safekeeping or arrests, judicial
p.(None): Prison sentences or preventive judicial measures related to deprivation of liberty
p.(None): Take measures if they need drugs to perform their tasks
p.(None): 8. scientific institutes and research institutes of the local authorities and the
p.(None): Universities and the Austrian Agency for Health and Food Security, if these
p.(None): Need medicines to perform their tasks
p.(None): 9. Organized emergency medical services, provided they are addictive substances, which they use for their emergency medical services
p.(None): Need activity, and
p.(None): 10. Have a doctor who is sufficiently familiar with questions of substance abuse
p.(None): Institutions according to § 15 of the Addictive Substances Act, Federal Law Gazette I № 112/1997, for evidence-based and
p.(None): quality-assured support for clients as part of damage minimization measures,
p.(None): except drugs containing addictive substances.
p.(None): (2) At hospitals without institutional pharmacies, the manufacturer, depositeur or pharmaceutical
p.(None): Wholesalers are given:
p.(None): 1. whole blood preserves, suspensions of cellular or corpuscular blood components,
p.(None): Single donor preparations,
p.(None): 2. native human or animal tissue.
p.(None): (3) Paragraphs 1 and 2 do not apply to radioactive medicinal products. These may be from the manufacturer, depositeur
p.(None): or pharmaceutical wholesalers only to holders of a license to handle radioactive materials
p.(None): according to the Radiation Protection Act, Federal Law Gazette No. 227/1969.
p.(None): (4) Feed medicines may be purchased from the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): Prescription of the treating veterinarian can be given directly to consumers. The repeated
p.(None): Delivery on a prescription is not permitted.
p.(None): (5) Paragraph 1 does not apply to pharmaceutical specialties according to § 7 Paragraph 4 and § 59 Paragraph 7a.
p.(None): (6) From the manufacturer, depositeur or pharmaceutical wholesaler, medicinal products whose delivery in
p.(None): Retail sales are not reserved for pharmacies, directly to bandagists, orthopedic shoemakers,
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): [CELEX-No .: 32011L0024, 32012L0026]
p.(None): BGBl. II No. 105/2015 (V via Idat)
p.(None): BGBl. I No. 40/2017 (NR: GP XXV RV 1457 AB 1569 p. 171. BR: 9747 AB 9752 p. 866.)
p.(None): [CELEX No .: 32009L0031]
p.(None): BGBl. I No. 37/2018 (NR: GP XXVI RV 108 AB 139 P. 23. BR: 9967 AB 9970 P. 880.)
p.(None): [CELEX-No .: 32017L2399, 32017L1572]
p.(None): BGBl. I No. 59/2018 (NR: GP XXVI RV 191 AB 231 S. 36. BR: 10001 AB 10017 S. 883.)
p.(None): BGBl. I No. 100/2018 (NR: GP XXVI RV 329 AB 413 p. 57. BR: 10079 AB 10082 p. 888.)
p.(None): BGBl. I No. 104/2019 (NR: GP XXVI IA 985 / A AB 692 p. 88. BR: AB 10252 p. 897.)
p.(None): text
p.(None): I. SECTION
p.(None): General provisions
p.(None): definitions
p.(None): § 1. (1) "Medicinal products" are substances or preparations from substances that
p.(None): 1. for use in or on the human or animal body and as an agent with properties for
p.(None): Cure or to alleviate or prevent human or animal diseases or
p.(None): pathological complaints are determined, or
p.(None): 2. applied in or on the human or animal body or a human or an animal
p.(None): can be administered to either
p.(None): a) the physiological functions through a pharmacological, immunological or metabolic
p.(None): Restore, correct or influence the effect, or
p.(None): b) to serve as the basis for a medical diagnosis.
p.(None): (2) Objects that contain a medicinal product or on which a medicinal product is considered a medicinal product
p.(None): is applied and which are intended for use on or in the human or animal body.
p.(None): (3) Are no drugs
p.(None): 1. Foodstuffs according to Art. 2 Para. 1 and 2 of Regulation (EC) № 178/2002 establishing the
p.(None): general principles and requirements of food law to establish the European
p.(None): Authority for Food Safety and for Establishing Food Safety Procedures, OJ.
p.(None): № L 31, 1.2.2002 p. 1, last amended by regulation (EG) № 596/2009, OJ. № L 188 from
p.(None): 18.7.2009 p. 14,
p.(None): 2. Utility articles and food additives in accordance with food law provisions,
p.(None): 3. cosmetic products in accordance with food law provisions, provided that they are used and
p.(None): Effects are restricted to the area of the skin and its appendages and the oral cavity,
p.(None): 4. Tobacco products according to the Tobacco Act, Federal Law Gazette No. 431/1995,
p.(None): 5. Feed, feed additives and premixes in accordance with the feed law regulations,
p.(None): 6. Materials or preparations made of materials used in dentistry and physically
p.(None): stable state have no pharmacological effect,
p.(None): 7. Natural healing deposits and products from a natural healing deposit in accordance with Section 42a (2)
p.(None): of the Federal Act on Hospitals and Health Centers, Federal Law Gazette № 1/1957, unless their
p.(None): Composition was changed by the addition of substances with an influence on the effectiveness,
p.(None): or, based on the sciences, undesirable even when used as intended
p.(None): Effects in humans are expected
p.(None): 8. Materials or preparations made from materials that are used only for prophylactic purposes
p.(None): To ward off, eliminate or harm pathogens, parasites or foreign substances
p.(None): to make, provided their application and effect on healthy skin and its appendages
p.(None): are limited and unless they are for use on patients before surgery or others
p.(None): medical interventions that require skin disinfection are intended,
...
p.(None): 3. The application of a particular treatment strategy is not set out in advance in a test plan
p.(None): it corresponds to medical practice and the decision to prescribe the
p.(None): Drug specialty is clearly separated from the decision to include a patient in the study.
p.(None): Epidemiological methods are used to analyze the data collected. Not-
p.(None): interventional studies are to be planned and carried out according to the state of the art in science.
p.(None): (4) "Final Report" is a complete and detailed account of the clinical trial
p.(None): their termination.
p.(None): (5) "Audit" is a comparison of the raw data with the corresponding records in the test sheets
p.(None): to determine whether the raw data were reported correctly and the conduct of the clinical trial
p.(None): was carried out in accordance with the test plan and the standard operating procedures (SOPs).
p.(None): An audit must be carried out either by an internal sponsor unit, but independently of that unit
p.(None): that is responsible for clinical research or through an external scientific
p.(None): Establishment to be carried out.
p.(None): (6) "Ethics Committee" is an independent body consisting of members of
p.(None): Health professions and people working in non-medical areas and their
p.(None): The task is to protect the rights, security and welfare of the test takers
p.(None): secure and create public trust in this regard.
p.(None): (7) "Inspection" is one by the Federal Office for Safety in Health Care or by one of
p.(None): experts commissioned by him or carried out by a foreign health authority
p.(None): Review of documents, facilities, records, quality assurance systems and all
p.(None): other resources which, in the opinion of the Federal Office for Safety in Health Care or a
p.(None): foreign health authority related to the clinical trial. These can be
p.(None): in the test center, in the sponsor's or contract research institute's facilities or in
p.(None): other institutions (e.g. in laboratories, at ethics committees) which, in the opinion of the Federal Office for
p.(None): Health care or a foreign health agency to be inspected are located.
p.(None): (8) “Monitor” is a person hired by the sponsor or a contract research organization or
p.(None): commissioned and responsible for monitoring and reporting on the progress of the study and review of the
p.(None): Data is responsible.
p.(None): (9) "Proper permit application and proper change request" is a
p.(None): Application for approval or modification, which is based on generally accepted scientific principles and
p.(None): Meets requirements. These generally accepted scientific principles and requirements
p.(None): can be found in the detailed reports adopted by the Commission in accordance with Article 9 of Directive 2001/20 / EC
p.(None): Instructions for applying.
p.(None): (10) “Test Sheet” is a document that contains data and other information about the test plan
p.(None): contains each individual subject included in the clinical trial.
p.(None): (11) "Examiner" is a doctor or dentist who is authorized to practice his or her profession in Austria
p.(None): is responsible for conducting the clinical trial in a trial center. Will an exam in
p.(None): a test center carried out by a team, the examiner is the responsible head of the team.
p.(None): (12) "Examiner Information" is a compilation of the information for the investigations with investigational medicinal products on
p.(None): Human relevant clinical and non-clinical data on the preparations concerned.
...
p.(None): put.
p.(None): (3) For radioactive medicinal products containing a radionuclide, a single application is for one
p.(None): Range of radioactivity levels sufficient.
p.(None): (4) For medicinal products that are dental medicines and are only in color
p.(None): Make a difference, provided that the respective color does not affect the effectiveness, durability or
p.(None): A single application is sufficient to tolerate the medicinal product.
p.(None): Note for the following provision
p.(None): For the reference period cf. § 94h.
p.(None): Approval documents
p.(None): § 9a. (1) The following must be attached to an application for admission:
p.(None): 1. Name or company name and registered office of the applicant and if the applicant is not with the manufacturer
p.(None): is identical, name or company and registered office of the manufacturer, as well as proof of authorization to
p.(None): Application,
p.(None): 2. Name of the pharmaceutical specialty,
p.(None): 3. Composition by type and amount of all components of the medicinal product, including the
p.(None): Mention of the international free name (INN) recommended by the World Health Organization,
p.(None): if there is an INN for the medicinal product or the relevant chemical name,
p.(None): 4. Assessment of the possible environmental risks of the pharmaceutical specialty; precautions must be taken if necessary
p.(None): to provide and justify their limitation,
p.(None): 5. Information about the manufacturing process,
p.(None): 6. Draft of the intended labeling according to § 17 (mock-up),
p.(None): 7. Draft the intended package leaflet according to § 16,
p.(None): 8. Technical information (summary of product properties - SmPC) according to § 15,
p.(None): 9. at the request of the authority, a sample of the outer packaging,
p.(None): 10. reasons for possible precautionary and safety measures when storing the medicinal product,
p.(None): their administration to patients and the disposal of the waste products (together with an indication
p.(None): potential risks that the pharmaceutical specialty poses to the environment),
p.(None): 11. information on the controls envisaged during manufacture,
p.(None): 11a. in the case of human medicinal products, a written confirmation from the manufacturer that he has audited the
p.(None): Compliance with the good manufacturing practice for active ingredients checked by the active ingredient manufacturer on site
p.(None): and has determined; the confirmation must also include the date of the audits,
p.(None): 12. Fully developed, reproducible analysis and standardization regulations for
p.(None): Starting and intermediate products and for the end product, optionally a complete one
p.(None): elaborated, reproducible analytical method for the detection of
p.(None): residues,
p.(None): 13. Indication of the quality criteria of the components of the medicinal product used,
p.(None): 14. A declaration that the substance samples required to carry out technical examinations
p.(None): be made available on official request
p.(None): 15. Indication of scientific knowledge and practical experience on the
p.(None): Harmlessness of the components of the medicinal product used,
p.(None): 16. Indication of the quality characteristics and properties of the packing elements, which with the
p.(None): Drug specialty come into contact, as well as specification of the test instructions for this
p.(None): Packing elements,
p.(None): 17. Test reports on the shelf life in the intended retail pack,
p.(None): 18. Information on the appropriateness of the dosage form,
p.(None): 19. non-clinical data,
p.(None): 20. clinical data,
p.(None): 21. Information on areas of application, contraindications, side effects, dosage (if necessary for
p.(None): each target species), type and form of application, if this is not in the documents according to Z 6 to 8
p.(None): are included
p.(None): 22. The risk management plan for the pharmaceutical specialty concerned, including a summary
p.(None): In accordance with paragraph 4,
p.(None): 23. Proof that the manufacturer has a license pursuant to Section 63 or a
p.(None): Manufacturer approval from the competent authority of another state for the manufacture of medicinal products
p.(None): has,
p.(None): 24. in the case of medicinal specialties that contain several components, the influence on the efficacy or the
p.(None): Have tolerance, information about the suitability of the combination of these components,
p.(None): 25. for medicinal products with antimicrobial activity, the specification of the test instructions of
p.(None): antimicrobial effectiveness, if chemical-physical tests are not sufficient,
p.(None): 26. for medicinal products, the safe and safe use of which requires sterility
p.(None): the sterilization method,
p.(None): 27. for pharmaceutical specialties, their safe and harmless use an examination for pyrogenic
p.(None): Substances required, the specification of the test specification,
p.(None): 28. for medicinal products for animals, results of safety and residue tests and
p.(None): of tests to assess the possible environmental risks,
p.(None): 29. for medicinal products that are feed medicinal products, proof that the product contains
p.(None): Proportion of feed is a feed that complies with the Feed Act,
p.(None): 30. for medicinal products that are premixes of feed medicinal products, proof that
p.(None): the proportion of feed contained is a feed that complies with the Feed Act,
p.(None): 31. in the case of medicinal specialties for use on animals which are used to obtain medicinal products or
p.(None): Food, documents on the waiting time,
p.(None): 32. in pharmaceutical specialties for use on animals, for the production of food or
p.(None): Medicinal products are intended to be a proof of at least six months ago
p.(None): Valid application to set the maximum residue limit according to Regulation (EEC)
p.(None): No. 2377/90, provided the active substances for the target species concerned are not yet listed in Annex I, II or
...
p.(None): Healthcare according to paragraph 14 as of significant clinical benefit compared to the existing ones
p.(None): Therapies are considered, the period provided for in paragraph 2 is extended to 11 years.
p.(None): (4) The period specified in paragraph 2 is extended for medicinal products
p.(None): 1. which are intended for use in fish or bees, for 13 years, and
p.(None): 2. which are intended for use in one or more animal species which are intended for the extraction of
p.(None): Serve food, and which contain a new active ingredient, which will expire on April 30, 2004
p.(None): was not authorized in the Union with each change to another animal, the extraction of
p.(None): Serves food that is obtained within five years of first approval, each by
p.(None): a year. However, this period can be a maximum of 13 years.
p.(None): However, the extension mentioned in Z 2 only takes place if the license holder originally also
p.(None): the establishment of maximum residue levels in accordance with Regulation (EEC) № 2377/90 for those of
p.(None): Has requested a change in the approval of the animal species concerned.
p.(None): (5) Paragraph 1 also applies if the reference medicinal product is not authorized in Austria
p.(None): if it is in another party to the Agreement on the European Economic Area
p.(None): was approved. In this case, the applicant has the name of the contracting party of the
p.(None): Agreement on the European Economic Area to specify in which the reference medicinal product
p.(None): is or has been approved. In this case, the Federal Office for Safety in Health Care has the
p.(None): competent authority of the other party to the Agreement on the European Economic Area
p.(None): request within a month to send confirmation that the reference medicinal product
p.(None): is or has been approved, as well as the full composition of the reference medicine and others
p.(None): Documents if required for the approval of the generic. If the
p.(None): The Federal Office for Safety in Health Care asks the agency for the
p.(None): corresponding information and documents.
p.(None): (6) Were in an amendment for a new area of application of a human medicinal product in
p.(None): Regarding an already well-established drug related to non-clinical or clinical studies
p.(None): the new area of application carried out by the Federal Office for Safety in Health Care
p.(None): Paragraph 14 were considered to be significant, so with an application according to § 10 or according to the
p.(None): Regulation (EC) № 1234/2008 on the examination of changes in the authorization of human and
p.(None): Veterinary medicinal products, OJ. № L 334 of 12.12.2008 p. 7 as amended by Regulation (EU) № 712/2012, OJ.
p.(None): № L 209, 4.8.2012 p. 4, one year not to refer to this data. This
p.(None): Exclusive period is not cumulative.
p.(None): (7) If the approval or its modification of a veterinary specialty, its active substance or active substances
p.(None): used for veterinary purposes in the Union for at least ten years, for another for
p.(None): Obtaining food certain target animal species, and will be new residue attempts
p.(None): according to Regulation (EEC) № 2377/90 and submitted new clinical trials, so can apply
...
p.(None): Levy will be kept available when registered with the Federal Office for Safety in Health Care
p.(None): and have been registered in accordance with section 27 (1) 2. Section 9 (1) applies to the authorization to register
p.(None): If necessary, registration is to be issued subject to the stipulation of requirements, the fulfillment of which protects
p.(None): to ensure human or animal health or drug safety. Such conditions
p.(None): can also be prescribed subsequently.
p.(None): (3) The following documents must be enclosed with a registration in accordance with paragraph 2:
p.(None): 1. Name or company name and registered office of the applicant and if the applicant is not with the manufacturer
p.(None): is identical, name or company and registered office of the manufacturer, as well as proof of authorization to
p.(None): Application,
p.(None): 2. scientific or other name of the homeopathic name contained in a pharmacopoeia
p.(None): Original substance or substances with details of the various uses and
p.(None): dilutions
p.(None): 3. Documents in which the extraction and control of the original substance or substances
p.(None): described and their homeopathic use using appropriate bibliographic
p.(None): Documents are documented; contains the pharmaceutical specialty biological substances, also documents on the
p.(None): Measures taken to ensure their freedom from pathogens
p.(None): 4.Documents for the preparation and control of the dosage form and description of the dilution
p.(None): and dynamization method,
p.(None): 5. Evidence that the manufacturer has a license pursuant to Section 63 or a
p.(None): Manufacturer approval from the competent authority of another state for the manufacture of medicinal products
p.(None): has,
p.(None): 6. Copy of, where applicable, in other contracting parties to the Agreement on the European
p.(None): Economic area for registrations or permits received for the same drug,
p.(None): 7. Draft of the labeling according to § 17a (mock-up) and a sample of the at the request of the authority
p.(None): Outer packaging,
p.(None): 8. Information on the shelf life of the pharmaceutical specialty and
p.(None): 9. Justification for the proposed waiting period.
p.(None): The application can extend to a series of medicinal specialties made from the same or the same
p.(None): homeopathic original substance or original substances have been obtained.
p.(None): (4) Does the homeopathic medicinal specialty not comply with the provisions of paragraph 1 or are they
p.(None): Documents within the meaning of paragraph 3 incomplete or incorrect, the Federal Office for Security in
p.(None): Healthcare to refuse registration by notice.
p.(None): (5) Paragraph 1 does not apply to
p.(None): 1. pharmaceutical specialties within the meaning of § 26,
p.(None): 2. sterile, pyrogen-free rinsing liquids,
p.(None): 3. radioactive pharmaceutical specialties and
p.(None): 4. Medicinal specialties that are in accordance with § 2 Paragraph 1 of the Prescription Law or for addictive law
p.(None): Provisions are subject to prescription requirements.
p.(None): Registration of pharmacy specialties
p.(None): § 11a. (1) A registration for the registration of a pharmacy proprietary specialty must be
p.(None): Documents in accordance with section 9a (1) 8, 12, 18 to 20, and 23 and section 9a (2) cannot be attached. The
p.(None): Registration must also be attached:
p.(None): 1. Information on the specification of the finished pharmaceutical specialty and
p.(None): 2. a commenting and evaluating scientific summary of each
p.(None): a) pharmaceutical data contained in the registration documents,
p.(None): b) taken from the specialist literature and for the assessment of the pharmacy-specific pharmaceutical specialty
p.(None): required non-clinical pharmacological and toxicological data and
...
p.(None): Effect or effectiveness are not plausible due to the long-term use and experience,
p.(None): or
p.(None): 9. the requirements of section 18a (5) are met.
p.(None): (3) If a registration has been made on the basis of Section 12a (5) second sentence, and subsequently the
p.(None): vegetable crop, the vegetable preparation or a combination thereof from the list of vegetable crops,
p.(None): herbal preparations or combinations for use in traditional herbal medicinal products
p.(None): in accordance with Article 16f (1) of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and
p.(None): 2004/27 / EG, deleted, the registration has to be canceled, if not within three months
p.(None): Deletion of the registration holder's documents in accordance with section 12a (1) last sentence and section 12a (2) no.2
p.(None): and 3 submitted.
p.(None): (4) The Federal Office for Safety in Health Care may appoint the Committee for Plant Medicinal Products
p.(None): request an opinion on the evidence of traditional use if in doubt in the
p.(None): With regard to the existence of the requirements according to § 12a para. 2 no.2.
p.(None): (5) If the medicinal product has been in the European Economic Area for less than 15 years
p.(None): has been used, but otherwise the requirements for registration according to § 12 and § 12a
p.(None): are available, the Federal Office for Safety in Health Care has that in accordance with Article 16c (4) of the
p.(None): Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC
p.(None): with the participation of the Committee for Herbal Medicinal Products.
p.(None): (6) The Federal Office for Safety in Health Care notifies the Commission and everyone responsible
p.(None): Authority of another contracting party to the Agreement on the European Economic Area on request
p.(None): every negative decision about the registration and the reasons for it.
p.(None): statutory authorization
p.(None): § 14. The Federal Minister of Health and Women may consider the requirements
p.(None): an in-depth and rapid examination of the application and the admission and registration documents
p.(None): by regulation, more detailed provisions on applications and notifications as well as on content, scope, form,
p.(None): Issue the nature and submission of the samples and documents in accordance with sections 9a to 12a and 24.
p.(None): Product Information
p.(None): Technical information (summary of product characteristics - SMPC)
p.(None): § 15. (1) About medicinal specialties that are in accordance with § 7 of the approval or in accordance with § 12 of the registration
p.(None): is subject to doctors, dentists, dentists, midwives, veterinarians, pharmacists and those in § 59 para. 3
p.(None): to make available technical information in German to the traders mentioned, provided that it
p.(None): are not pharmaceutical specialties according to § 9c.
p.(None): (2) The subject information must contain at least the following information in the following order:
p.(None): 1. Name of the pharmaceutical specialty, followed by the strength and the dosage form,
p.(None): 2. Qualitative and quantitative composition according to active ingredients using the usual
p.(None): common or chemical name,
p.(None): 3. pharmaceutical form,
p.(None): 4. Clinical information:
p.(None): a) fields of application,
p.(None): b) dosage and type of use in adults and, if necessary, in children,
p.(None): c) contraindications,
...
p.(None): has already been registered, the Federal Office for Safety in Health Care has this in Articles 28 and 29 (1)
p.(None): to 3 of Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or that in
p.(None): Articles 32 and 33 (1) to (3) of Directive 2001/82 / EC, as amended by Directive 2004/28 / EC
p.(None): Apply procedures and meet the deadlines specified there.
p.(None): (4) If the homeopathic medicinal product is not registered at the time of registration, this has
p.(None): Federal Office for Safety in Health Care, provided Austria at the request of the applicant as
p.(None): Reference Member State within the meaning of Article 28 (1) of Directive 2001/83 / EC, as amended by the
p.(None): Directives 2004/24 / EC and 2004/27 / EC, or Article 32 of Directive 2001/82 / EC, in the version of the
p.(None): Directive 2004/28 / EC, acts, an assessment report, a draft of the package leaflet and for
p.(None): to produce the label and to the applicant and the parties to the Agreement on the
p.(None): European Economic Area, to which the registration documents have been submitted.
p.(None): (5) The registration for registration concerns a traditional herbal medicinal specialty for which the
p.(None): Committee for Plant Medicinal Products a Community plant monograph in accordance with Article 16h (3)
p.(None): Directive 2001/83 / EC, as amended by Directives 2004/24 / EC and 2004/27 / EC, or
p.(None): a vegetable crop, a vegetable preparation, or a combination thereof, in the list
p.(None): vegetable substances, vegetable preparations or combinations thereof for use in traditional
p.(None): herbal medicinal products in accordance with Article 16f (1) of Directive 2001/83 / EC, as amended by the Directives
p.(None): 2004/24 / EG and 2004/27 / EG, are included, paragraphs 1 and 2 apply.
p.(None): § 18b. (1) The competent national authority within the meaning of Regulation (EC) № 726/2004 is the Federal Office
p.(None): for healthcare security.
p.(None): (2) Competent national authority within the meaning of Regulation (EC) № 1901/2006 of the European
p.(None): Parliament and of the Council of 12 December 2006 on medicinal products for children and amending the
p.(None): Regulation (EEC) № 1768/92, the directives 2001/20 / EG and 2001/83 / EG as well as the regulation (EG)
p.(None): No. 726/2004 is the Federal Office for Safety in Health Care.
p.(None): (3) Does the Federal Office for Safety in Health Care get into the procedure for approval or
p.(None): the change in the approval of a pharmaceutical specialty to the conclusion that the submitted documents are not included
p.(None): this is the same as the pediatric investigation plan approved by the Agency's Pediatric Committee
p.(None): with notice. If necessary, an opinion of the Pediatric Committee is required
p.(None): Article 23 of Regulation (EC) No. 1901/2006 to be taken into account.
p.(None): (4) Competent national authority within the meaning of Regulation (EC) № 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and
p.(None): Amendment to Directive 2001/83 / EC is the Federal Office for Safety in Health Care.
p.(None): Rejection of an application for admission
p.(None): § 19. (1) An application for approval of a pharmaceutical specialty is by the Federal Office for Security in the
p.(None): Health care refuse if
p.(None): 1. the applicant is not entitled to apply in accordance with § 9,
p.(None): 2. the application contains incorrect or incomplete information or the information provided in §§ 9a to 9f
p.(None): approval documents to be provided contain incorrect information, prove to be incomplete or for
p.(None): the assessment of the pharmaceutical specialty proves to be insufficient,
p.(None): 3. it according to the current state of scientific knowledge and the practical
p.(None): Experience does not appear to be certain that the medicinal specialty even when used as intended
p.(None): Use has no harmful effects beyond that according to medical knowledge
p.(None): Science goes beyond reasonable limits,
p.(None): 4. the pharmaceutical specialty contains substances or preparations from substances, the harmlessness of which
p.(None): scientific knowledge and not confirmed by practical experience,
p.(None): 5. the quality of the pharmaceutical specialty does not correspond to the current state of science,
p.(None): 6. the pharmaceutical specialty does not comply with an ordinance pursuant to Section 5 (1),
p.(None): 7. the name of the medicinal product or the information in the authorization documents to mislead
p.(None): are suitable,
p.(None): 8. the effectiveness of the medicinal product has not been sufficiently demonstrated by the applicant,
p.(None): 9. the pharmaceutical specialty with regard to its effectiveness, composition, strength, quality,
...
p.(None): 1. The testing institute named by ordinance of the Federal Minister for Health and Women can
p.(None): submit an assessment without performing an additional analytical test if
p.(None): Manufacturing and control methods the required quality, safety and harmlessness
p.(None): guarantee.
p.(None): 2. If the named test institute carries out an analytical test, this is based on the information provided in the frame
p.(None): of the admission procedure and if necessary available in the course of the application
p.(None): provided samples of the end product or samples of certain intermediate products (bulk
p.(None): Batches). It is important to ensure that the product meets the approval requirements
p.(None): approved specifications.
p.(None): 3. Can the testing institute named by the Federal Minister for Health and Women be approved on the basis of the
p.(None): submitted control reports and, if applicable, the analytical results obtained in the
p.(None): If the approval documents do not confirm the defined quality, the institute has the test report with it
p.(None): Justification to be forwarded immediately to the Federal Office for Safety in Health Care. This
p.(None): has in the case of an application for decision by the Federal Office for Security in the
p.(None): Healthcare to hear the applicant and within 30 days of receiving the application
p.(None): to decide on the batch release by notice. Results from the test report and the
p.(None): Justification the need to carry out an additional analytical test
p.(None): this 30-day period was inhibited for the duration of this test.
p.(None): (6) The export of medicinal products for which no examination according to paragraphs 3 to 5 has been requested is only
p.(None): permitted if the health authority of the country of destination decides not to
p.(None): Batch inspection in Austria has been informed and demonstrably takes note of this fact.
p.(None): (7) The Federal Minister of Health and Women may consider the
p.(None): Drug safety enact more detailed provisions on batch release.
p.(None): (8) If this appears necessary considering the safety of the drug, the
p.(None): Federal Minister of Health and Women by prescription pharmaceutical specialties in accordance with paragraphs 1 and 2 or
p.(None): to determine other biological medicinal products that may only be placed on the market if the
p.(None): Retail pack contains a number of adhesive labels corresponding to the number of pharmaceuticals contained therein
p.(None): is attached to enable the medicinal product and the respective batch to be identified. The
p.(None): Ordinance also has more detailed provisions on the content, shape, size and nature as well as the type of
p.(None): Include the adhesive labels.
p.(None): import analysis
p.(None): Section 26a. (1) For pharmaceutical specialties that are approved in Austria and from outside the
p.(None): European Economic Area, every batch, regardless of whether it is in the
p.(None): European Economic Area has been produced by a full pharmaceutical entrepreneur
p.(None): qualitative and quantitative analysis, at least with regard to effective components, as well as all
p.(None): other tests or examinations that are necessary to check the quality of the
p.(None): To ensure pharmaceutical specialty in accordance with the requirements on which the approval is based.
p.(None): (2) In the case of bulk goods or intermediate products that are approved for manufacturing in Austria
...
p.(None): Nature, meaning, scope and risks of the clinical trial has been elucidated and the
p.(None): Exam participants have given their consent.
p.(None): (2) The consent within the meaning of paragraph 1 may be withdrawn at any time. Are responsible for carrying out the
p.(None): clinical trial requires multiple consents, the clinical trial may take place on this
p.(None): Exam participants will not continue if even one of these consents is withdrawn.
p.(None): Section 39. (1) Education and information must be given both verbally and in writing. The
p.(None): Information must clarify that the refusal to participate in the clinical trial or that
p.(None): Leaving the clinical trial at any time without adverse consequences,
p.(None): in particular for the further medical care of the test participant.
p.(None): (2) If a test participant agrees to participate after extensive information, his / her
p.(None): Consent must be recorded in writing. The consent must be dated and signed
p.(None): of the test participant. If the test participant is unable to do so,
p.(None): the consent must be given before a witness who gives the consent by his signature
p.(None): has confirmed.
p.(None): (3) The test participants are aware of the purpose and scope of the collection and use
p.(None): to inform personal data. The test participants are particularly keen on this
p.(None): point out that data
p.(None): 1. checked by the monitor, during an audit and during an inspection by the authority
p.(None): can be and
p.(None): 2. passed on to the sponsor in pseudonymized form.
p.(None): (3a) With the consent to take part in the clinical trial according to paragraph 2, the express is also
p.(None): obtain data protection consent. The withdrawal of consent has no effect on
p.(None): Activities that are carried out on the basis of informed consent prior to its revocation
p.(None): or on the processing of the data collected on this basis. The right under Art. 17 and
p.(None): 20 of the General Data Protection Regulation is excluded. This is in the course of obtaining consent
p.(None): enlighten.
p.(None): (3b) For further processing in accordance with Art. 9 Para. 2 lit. j of the General Data Protection Regulation, Section 2d applies
p.(None): Paragraph 3 of the Research Organization Act, Federal Law Gazette I No. 131/2015.
p.(None): (3c) Paragraphs 3a and 3b apply mutatis mutandis to non-interventional studies.
p.(None): (4) The test participants and, if applicable, the legal representatives (§ 1034 ABGB) must contact the
p.(None): Insurance coverage within the meaning of § 32 Paragraph 1 No. 11 are informed.
p.(None): Start of clinical trial
p.(None): Section 40. (1) The conduct of a clinical trial is only permitted if the Federal Office for Security
p.(None): in the healthcare system, the conduct of the clinical trial according to paragraph 3 or 4 is not prohibited or
p.(None): approved in accordance with paragraph 6. The sponsor must contact the Federal Office of Health before the clinical trial begins
p.(None): Healthcare safety to make a proper permit application, all for that
p.(None): Assessment of the clinical trial required documents and submit the opinion of
p.(None): Obtain an ethics committee. The sponsorship may be referred to the Ethics Committee before the
p.(None): Applications are submitted to the Federal Office or simultaneously with it.
p.(None): (2) The examination of an application by the Federal Office for Safety in Health Care has no
p.(None): unnecessary postponement, but at the latest within 35 days. The Federal Office for Security in
p.(None): Health care has the correctness of the application, the basic justification and
p.(None): Check the relevance of the project and the requirements for the manufacture of the investigational medicinal products.
p.(None): If the Federal Office for Safety in Health Care does not respond within 35 days, the
p.(None): Application subject to paragraph 4 as approved. These deadlines do not apply to clinical trials within the meaning of the
p.(None): Paragraph 6.
p.(None): (3) The Federal Office for Safety in Health Care has - if the in this federal law
p.(None): the above-mentioned requirements are not met - the conditions that are suitable for maintaining the requirements
p.(None): or stipulate conditions and allow a reasonable period for this. Can also by
p.(None): Prescribing conditions or conditions of compliance with the requirements of this federal law
p.(None): cannot be ensured, the authority has to carry out the clinical trial with the sponsor
p.(None): To prohibit decision.
p.(None): (4) If the ethics committee has no favorable opinion in the procedure pursuant to sections 41a and 41b
p.(None): submitted, the Federal Office for Safety in Health Care has carried out the clinical
p.(None): Prohibition exam if the sponsor does not object to the ethics committee's objections
p.(None): considered. The decision is from the Federal Office for Safety in Health Care without unnecessary
p.(None): Postponement, but no later than 60 days after submission of the application.
p.(None): (5) The Federal Office for Safety in Health Care can, if there are concerns about the
p.(None): the ethics committee has given its opinion correctly or is correct
p.(None): Instruct the drug advisory board to review the application for approval. If this is the implementation
p.(None): If the clinical trial is approved, a prohibition can be waived.
p.(None): (6) Conducting a clinical trial related to drugs for gene therapy and
p.(None): somatic cell therapy including xenogeneic cell therapy requires the approval of the
p.(None): Federal Office for Safety in Health Care.
p.(None): (7) The Federal Office for Safety in Health Care has applications according to paragraph 6 without unnecessary
p.(None): Postponement, but at the latest within 90 days after receipt of the application. In cases in
p.(None): to whom an advisory body is concerned, this period is extended by a further 90 days.
p.(None): (8) For a clinical trial in connection with drugs for gene therapy apply in addition to
...
p.(None): (4) Feed medicines may be purchased from the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): Prescription of the treating veterinarian can be given directly to consumers. The repeated
p.(None): Delivery on a prescription is not permitted.
p.(None): (5) Paragraph 1 does not apply to pharmaceutical specialties according to § 7 Paragraph 4 and § 59 Paragraph 7a.
p.(None): (6) From the manufacturer, depositeur or pharmaceutical wholesaler, medicinal products whose delivery in
p.(None): Retail sales are not reserved for pharmacies, directly to bandagists, orthopedic shoemakers,
p.(None): Orthopedic technician, dental technician, podiatrist, holder of a hoof and
p.(None): Claw fittings and massage therapists are given, provided they are medicinal products
p.(None): Traders need for the exercise of their activity.
p.(None): (7) From the manufacturer, depositeur or pharmaceutical wholesaler, dental medicinal products that
p.(None): 1. are not subject to the prescription requirement and
p.(None): 2. are exclusively intended by dentists, specialists in dentistry, oral and maxillofacial medicine
p.(None): or being applied to the patient by dentists,
p.(None): are given directly to them and to dental outpatients.
p.(None): (8) Medical gases may come from the manufacturer, depositeur or pharmaceutical wholesaler
p.(None): Hospitals without a pharmacy and to traders who are in accordance with the
p.(None): Trade regulations 1994 are authorized to deliver compressed technical gases.
p.(None): (9) Medicinal products for clinical testing may be used by the manufacturer, depositeur and pharmaceutical wholesaler
p.(None): also be given directly to hospitals without a pharmacy and to examiners.
p.(None): (10) Rescue and ambulance services of a local authority may use medicinal products that they
p.(None): need to perform their rescue and ambulance duties from those
p.(None): Obtain pharmacies that are operated by hospitals, whose sponsors these
p.(None): Local authority is.
p.(None): Ensuring the supply
p.(None): Section 57a. (1) The authorization holder or the holder of a registration for a medicinal product and the
p.(None): Pharmaceutical wholesalers and pharmaceutical wholesalers who actually placed them on the market
p.(None): Selling medicinal products have an appropriate and within the scope of their respective responsibilities
p.(None): Continuous provision of the medicinal product for dispensing by pharmacies or for other dispensing
p.(None): 59 entitled persons to ensure that the needs of patients are met domestically.
p.(None): (2) The Federal Minister of Health and Women can issue more detailed regulations by ordinance
p.(None): with regard to the scope of the obligations mentioned in paragraph 1 and the measures taken in relation to them
p.(None): Failure to enact, if necessary, to ensure the care of patients in the
p.(None): To ensure domestic.
p.(None): Section 57b. This section does not apply to the delivery of human cells and tissues for use
p.(None): in humans, insofar as they fall under the Tissue Safety Act, Federal Law Gazette I No. 49/2008.
p.(None): Submission of medical samples
p.(None): Section 58. (1) Marketing authorization holders may submit samples of approved pharmaceutical specialties to doctors, dentists,
p.(None): Veterinarians and dentists only by written request, only free of charge and after
p.(None): Application of the clearly legible and non-removable note "unsalable doctor's sample" in one
p.(None): Do not dispose of a package larger than the smallest commercially available in accordance with paragraph 2. This
p.(None): Samples may also only be passed on by the recipients free of charge. The submission of
p.(None): Medical specimens of medicinal specialties that contain psychotropic substances or narcotics are prohibited.
...
p.(None): are goods. The review is, apart from the control of means of transport or at
p.(None): Danger of being delayed during normal business or operating hours. The disturbance of the
p.(None): Business operations should be avoided if possible.
p.(None): (4) The sample taken is, insofar as this is possible by nature and therefore not hers
p.(None): faultless assessment is frustrated to be divided into two equal parts that are officially closed. On
p.(None): Part is to be left as a cross-check of the party for evidence purposes. If a division is not possible, it has
p.(None): Supervisory body to supply the sample without prior division of the investigation. For the samples taken
p.(None): no compensation is due.
p.(None): (5) On the occasion of the sampling, the supervisory body must issue a cover letter and everyone
p.(None): Include part of the sample in which the observations and observations are noteworthy for the assessor
p.(None): of the organ are included. The Federal Minister is responsible for the details of the sample accompanying letter
p.(None): for health and women.
p.(None): (6) The sample taken is to be sent to the investigating institution. This
p.(None): The investigation institute has to examine the sample and to produce findings and expert opinions. findings
p.(None): and reports are to be sent immediately to the sampling agency. If the
p.(None): Investigation center comes to a reasoned opinion that the suspicion of the violation of
p.(None): Legislation is in place, so it has to determine this in its report and the responsible person
p.(None): To inform the authority immediately.
p.(None): (7) The Federal Minister of Health and Women has the one in question by ordinance
p.(None): Investigation facility or the relevant investigation facilities in accordance with Paragraph 6 - if there is
p.(None): to carry out investigations into bumps within the meaning of Section 1 (2) (1) of the Anti-Doping
p.(None): Federal Act 2007 acts in agreement with the Federal Chancellor.
p.(None): Section 76b. (1) Supervisory bodies pursuant to Section 76a (2) have to confiscate the goods temporarily or securely
p.(None): if there is reasonable suspicion that these substances within the meaning of section 1 (2) no.
p.(None): Federal doping law 2007 contains, or this a danger to the life or health of
p.(None): Represent human or animal.
p.(None): (2) The supervisory body has so far been informed of the provisional confiscation or seizure
p.(None): Hand over a certificate to those entitled to dispose, stating the location and type and
p.(None): The quantity of the seized or seized goods must be stated.
p.(None): (3) In the event of a preliminary seizure, the supervisory body must immediately notify the
p.(None): District administrative authority, but in the case of seizure the public prosecutor through the
p.(None): Ensuring reporting, depending on whether the violation is likely to be a criminal offense
p.(None): or represents an administrative violation. The provision expires in the event of an administrative offense
p.(None): Seizure, unless a seizure notice is not issued within four weeks.
p.(None): (4) The right to dispose of the goods which have been temporarily confiscated or seized is initially in place
p.(None): the authority to which the supervisory body belongs and if the violation constitutes an administrative violation,
p.(None): from the issuance of the confiscation notice by the authority that issued the confiscation notice,
p.(None): to. If the violation constitutes a criminal offense, the right to dispose of it is effective upon receipt
p.(None): of the report to the public prosecutor's office, to the court from the time the charge is brought.
p.(None): (5) The goods seized or seized must be left in the company. You are so
p.(None): to seal or to mark that a change without breaching the containers, the
p.(None): Packaging or labeling is not possible. The person who is previously authorized to dispose of the goods
p.(None): by the supervisory body in writing on the criminal consequences of the transfer or change of the
p.(None): confiscated or seized goods and the violation of the official seal
p.(None): do.
p.(None): (6) The preservation of the goods left in the company from damage is the responsibility of the previous one
p.(None): Person entitled. If special measures are required for this, he has the responsible authority
p.(None): to inform beforehand; at the expense of the person concerned, the latter has, if necessary, instructions regarding
p.(None): shipment, storage, sealing or labeling. The measures are, except
p.(None): in the event of imminent danger, in the presence of a supervisory body.
p.(None): (7) During the seizure or seizure, samples of the goods may only be ordered by the
p.(None): competent authority or the responsible public prosecutor.
p.(None): (8) The provisions of Sections 87 and 106 StPO apply mutatis mutandis.
p.(None): (9) The district administrative authority has forfeited the seized goods as a security measure
p.(None): to explain if there is a serious and significant danger to humans or animals and the
p.(None): Authorized party does not guarantee that the goods will not be placed on the market after their release
p.(None): becomes.
p.(None): (10) With regard to the costs of an investigation, § 381 (1) 3 StPO applies in criminal proceedings. in the
p.(None): Administrative criminal proceedings are punitive in the penalty of reimbursement of the cost of the investigation
p.(None): to prescribe the respective research institute.
p.(None): Section 76c. (1) Before recovery of the goods that have been expired, the authority must inform the accused and the
p.(None): to give the person affected by the decay the opportunity to make a statement.
p.(None): (2) The expired goods are to be used in a useful manner. The expired goods are at the expense of
p.(None): Accused or destroy the person affected by the forfeiture if there is a useful recovery
p.(None): is not possible or the exploitation of the goods does not lead to the expectation that the achievable proceeds will
p.(None): Recovery costs will exceed. The destruction of the expired goods is by the accused or
p.(None): permitted by the person affected by the forfeiture at his own expense under the supervision of a supervisory body.
p.(None): (3) The proceeds of the exploitation are after deduction of the associated expenses and any
p.(None): irrecoverable costs of the criminal proceedings as well as the burden on the case
p.(None): To transfer liabilities to the federal government.
p.(None): Surveillance and protective measures
p.(None): Section 77. Is determined during a check in accordance with Section 76 or is the Federal Office for Security receiving
p.(None): Healthcare otherwise aware that a drug or active ingredient is subject to this federal law or to
p.(None): Does not comply with regulations or other administrative acts enacted on the basis of this federal law
p.(None): the Federal Office for Safety in Health Care to take measures to place the product on the market
p.(None): hinder or restrict. If applicable, section 76b (10) applies.
p.(None): Section 78. (1) The Federal Office for Safety in Health Care becomes aware of facts
p.(None): The reason for concern is that a medicinal product or active substance on the market is a hazard
...
p.(None): to this exists.
p.(None): (5) The Federal Office for Safety in Health Care and the Federal Ministry of Health are
p.(None): - insofar as this is in the relevant drug-related guidelines and regulations of the European Union
p.(None): is envisaged - further authorized
p.(None): 1. Enter data in the European databases provided there and
p.(None): 2. Information to the competent authorities of the member states of the European Union, the agency
p.(None): and forward to the European Commission.
p.(None): Section 81. The copies of the notices and
p.(None): Certificates issued by electronic data processing equipment or in a similar process
p.(None): manufactured, require neither a signature nor a certification.
p.(None): Section 81a. The Federal Office for Safety in Health Care is in accordance with the technical
p.(None): Authorized possibilities to provide by ordinance that the according to this federal law, according to
p.(None): Pharmaceuticals Imports Act 2010, the Blood Safety Act, the Prescription Law, the
p.(None): Medical device law and the tissue safety law applications, notifications and notifications
p.(None): must be done in electronic form. In this regulation there are exceptions for hardship cases
p.(None): provided.
p.(None): XII. SECTION
p.(None): Confidentiality and transparency
p.(None): § 82. All persons entrusted with tasks in the implementation of this Federal Act are
p.(None): unless otherwise stipulated by law, secrecy about all of them exclusively from this
p.(None): Committed to facts that have become known, the confidentiality of which is in the interest of a
p.(None): Local authority or the parties is required.
p.(None): Section 82a. (1) The Federal Office for Safety in Health Care and the Austrian Agency for
p.(None): With regard to independence and transparency, health and food security ensure that
p.(None): all members and substitute members of the Federal Office mentioned as well as all in connection with the
p.(None): Tasks according to § 8 paragraph 2 lines 13 to 16 of the Health and Food Security Act, Federal Law Gazette I
p.(None): № 63/2002, or staff involved in surveillance or by the Federal Office for Security in the
p.(None): Healthcare does not mandate experts with fi nancial or other interests in the
p.(None): pharmaceutical industry that could affect their impartiality. These people are
p.(None): undertakes to submit an annual declaration to the Federal Office for Safety in Health Care that
p.(None): to be sent to the Federal Ministry of Health on request.
p.(None): (2) As part of the performance of its duties under this Federal Act, the Federal Office of
p.(None): Healthcare safety rules and the agendas and minutes of the
p.(None): Votings generally accessible on the Internet. More about the publication of the agendas and
p.(None): Protocols are regulated in the rules of procedure of the Federal Office.
p.(None): XIII. SECTION
p.(None): sanctions
p.(None): Acts punishable by law
p.(None): Section 82b. (1) Anyone who falsifies medicinal products, active substances or auxiliary substances with the intention (§ 1 para. 25 and 26) that
p.(None): if they are handed over to another, they are punished with imprisonment for up to three years.
p.(None): (2) Anyone who falsifies medicinal products, active substances or auxiliary substances must also be punished
p.(None): offers, exports or surrenders or keeps with the intent, executes or introduces that one
p.(None): left to others.
...
p.(None): (3) A regulation pursuant to Paragraph 1 or Paragraph 2 applies for a maximum of six months.
p.(None): § 94e. (1) As long as the World Health Organization (WHO) has declared a pandemic of influenza
p.(None): 1. A license that is in accordance with the provisions of this federal law and approved for Austria
p.(None): Vaccine for vaccination against New Influenza A (H1N1) directly from the manufacturer or marketing authorization holder
p.(None): on
p.(None): (a) local authorities, and
p.(None): b) by the public sector (local authorities, health insurance providers and
p.(None): Health care facilities) certain distribution centers
p.(None): be delivered and
p.(None): 2. the vaccine by means of the local authorities or distribution centers to from the public
p.(None): Hand (local authorities, health insurance providers and health care institutions)
p.(None): certain vaccination sites are given. For the distribution of the vaccine, the
p.(None): Manufacturers, marketing authorization holders who serve local authorities and third-party distribution centers.
p.(None): (2) Medicines used in the event of a disaster, terrorist threat, martial
p.(None): Confrontation, epidemic, pandemic or other crisis situation to those in § 57 Paragraph 1 Numbers 5 and 5a
p.(None): given to maintain the drug supply and from these to
p.(None): Averting the danger posed by such a crisis situation may be kept in
p.(None): of their intended commercial packaging or original packaging to manufacturers, depositors, pharmaceutical
p.(None): Wholesalers, public pharmacies and institutional pharmacies are sold.
p.(None): (3) Pharmaceutical specialties that are available through a regional authority or on behalf of a regional authority
p.(None): Averting from a catastrophe, terrorist threat, armed conflict,
p.(None): Epidemic, pandemic or other crisis situation pending dangerous situation held in stock
p.(None): may be kept in stock even after the expiry date has passed and for stockpiling
p.(None): be handed in as well as given when the specific danger occurs, if on a professional basis
p.(None): Investigations by the Federal Office for Safety in Health Care have found that their
p.(None): Quality and impact are still guaranteed.
p.(None): § 94f. (1) Pharmacy proprietary medicinal products, which according to § 9d in the version before the entry into force
p.(None): of this federal law in the version of the federal law BGBl. I № 63/2009 have been approved
p.(None): as registered pharmacy specialties according to § 11a of this federal law in the version of the
p.(None): Federal Law BGBl. I No. 63/2009.
p.(None): (2) At the time of entry into force of this Federal Act in the version of the Federal Law BGBl. I
p.(None): №63 / 2009 pending applications for approval as a pharmacy proprietary medicinal product count as registrations
p.(None): for registration as pharmacy specialties.
p.(None): (3) The change in the package leaflet and labeling of pharmacy proprietary medicinal products,
p.(None): which according to § 9d in the version before the entry into force of this Federal Act in the version of the
p.(None): Federal Law BGBl. I № 63/2009 were admitted, and which resulted from the switch to a
p.(None): Registration must be completed by December 31, 2014.
p.(None): (4) Pharmaceutical specialties which, in accordance with § 16b in the version prior to the entry into force of this Federal Act, in
p.(None): the version of the Federal Law BGBl. I № 63/2009 placed on the market without information for use
p.(None): until the end of December 31, 2014
...
General/Other / participants in a control group
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p.(None): Instructions for applying.
p.(None): (10) “Test Sheet” is a document that contains data and other information about the test plan
p.(None): contains each individual subject included in the clinical trial.
p.(None): (11) "Examiner" is a doctor or dentist who is authorized to practice his or her profession in Austria
p.(None): is responsible for conducting the clinical trial in a trial center. Will an exam in
p.(None): a test center carried out by a team, the examiner is the responsible head of the team.
p.(None): (12) "Examiner Information" is a compilation of the information for the investigations with investigational medicinal products on
p.(None): Human relevant clinical and non-clinical data on the preparations concerned.
p.(None): (13) "Test plan" is the entirety of the documents in which objectives, planning, methodology,
p.(None): statistical considerations and organization of an examination are described. The term “test plan” relates
p.(None): the test plan itself and its subsequent versions and changes.
p.(None): (14) "investigational medicinal product" is a pharmaceutical form of an active ingredient or placebo that is contained in a
p.(None): clinical trial or used as a reference substance; also an approved one
p.(None): Pharmaceutical specialty when used or provided in a form other than that authorized or for
p.(None): used an unauthorized area of application or to receive additional information on the
p.(None): approved form is used.
p.(None): (15) "Examiner" (healthy subject or patient) is a person who is either the recipient
p.(None): of the investigational medicinal product or as a member of a control group takes part in a clinical trial.
p.(None): (16) "Sponsor" is any physical or legal person who is responsible for planning the
p.(None): Initiation, supervision and funding of a clinical trial. The sponsor or be
p.(None): Authorized representatives must be established in a contracting party to the European Economic Area.
p.(None): The auditor has to assume the additional duties and responsibilities of the sponsor if he has one
p.(None): conducts clinical trials independently of the manufacturer of the medicinal product and under their own responsibility.
p.(None): (17) "Standard Operating Procedures (SOPs)" are standardized, detailed, written
p.(None): Procedural rules of the sponsor for all activities related to the clinical trial
p.(None): are necessary.
p.(None): (18) “Adverse event” is any harmful event that occurs to a subject
p.(None): happens and that is not necessarily causally related to the clinical trial.
p.(None): (19) “Side effect” is any harmful and unintended reaction to an investigational medicinal product.
p.(None): (20) "Serious adverse event or serious side effect" is a
p.(None): adverse event or side effect that is fatal or irrespective of the dose
p.(None): is life-threatening, requires inpatient treatment or its extension to become one
p.(None): permanent or serious disability or disability or a congenital anomaly or
p.(None): is a birth defect.
p.(None): (21) "Unexpected side effect" is a side effect that depends on the type or severity due to the
p.(None): available product information is not expected.
p.(None): (22) "Pediatric investigation concept" is a research and development program that ensures
p.(None): the data that is required to determine the prerequisites should be developed,
...
Searching for indicator placebo:
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p.(None): Health care or a foreign health agency to be inspected are located.
p.(None): (8) “Monitor” is a person hired by the sponsor or a contract research organization or
p.(None): commissioned and responsible for monitoring and reporting on the progress of the study and review of the
p.(None): Data is responsible.
p.(None): (9) "Proper permit application and proper change request" is a
p.(None): Application for approval or modification, which is based on generally accepted scientific principles and
p.(None): Meets requirements. These generally accepted scientific principles and requirements
p.(None): can be found in the detailed reports adopted by the Commission in accordance with Article 9 of Directive 2001/20 / EC
p.(None): Instructions for applying.
p.(None): (10) “Test Sheet” is a document that contains data and other information about the test plan
p.(None): contains each individual subject included in the clinical trial.
p.(None): (11) "Examiner" is a doctor or dentist who is authorized to practice his or her profession in Austria
p.(None): is responsible for conducting the clinical trial in a trial center. Will an exam in
p.(None): a test center carried out by a team, the examiner is the responsible head of the team.
p.(None): (12) "Examiner Information" is a compilation of the information for the investigations with investigational medicinal products on
p.(None): Human relevant clinical and non-clinical data on the preparations concerned.
p.(None): (13) "Test plan" is the entirety of the documents in which objectives, planning, methodology,
p.(None): statistical considerations and organization of an examination are described. The term “test plan” relates
p.(None): the test plan itself and its subsequent versions and changes.
p.(None): (14) "investigational medicinal product" is a pharmaceutical form of an active ingredient or placebo that is contained in a
p.(None): clinical trial or used as a reference substance; also an approved one
p.(None): Pharmaceutical specialty when used or provided in a form other than that authorized or for
p.(None): used an unauthorized area of application or to receive additional information on the
p.(None): approved form is used.
p.(None): (15) "Examiner" (healthy subject or patient) is a person who is either the recipient
p.(None): of the investigational medicinal product or as a member of a control group takes part in a clinical trial.
p.(None): (16) "Sponsor" is any physical or legal person who is responsible for planning the
p.(None): Initiation, supervision and funding of a clinical trial. The sponsor or be
p.(None): Authorized representatives must be established in a contracting party to the European Economic Area.
p.(None): The auditor has to assume the additional duties and responsibilities of the sponsor if he has one
p.(None): conducts clinical trials independently of the manufacturer of the medicinal product and under their own responsibility.
p.(None): (17) "Standard Operating Procedures (SOPs)" are standardized, detailed, written
p.(None): Procedural rules of the sponsor for all activities related to the clinical trial
p.(None): are necessary.
p.(None): (18) “Adverse event” is any harmful event that occurs to a subject
p.(None): happens and that is not necessarily causally related to the clinical trial.
p.(None): (19) “Side effect” is any harmful and unintended reaction to an investigational medicinal product.
p.(None): (20) "Serious adverse event or serious side effect" is a
p.(None): adverse event or side effect that is fatal or irrespective of the dose
...
Orphaned Trigger Words
p.(None): (4) Notwithstanding paragraph 1, an application for admission cannot be rejected if the applicant
p.(None): can prove that it is based on objectively comprehensible, listed in Annex I of Directive 2001/83 / EC
p.(None): No complete data on safety or effectiveness when used as intended
p.(None): can submit. Admission is to be granted under conditions or conditions that in particular the
p.(None): Safety of the pharmaceutical specialty, the obligation to inform the Federal Office for Safety in the
p.(None): Health care about all incidents related to its application and those to be taken
p.(None): Take measures. The approval must also be issued on condition that an annual
p.(None): Evaluation of the presence of the admission requirements has to be made as not complete data
p.(None): about safety and effectiveness. The authorization holder has submitted to the Federal Office for Security in
p.(None): Healthcare to submit all available updated data annually.
p.(None): § 19a. (1) Requirements or conditions according to § 18 paragraph 3 can be heard after hearing the approval or
p.(None): Registration holder may also be required subsequently.
p.(None): (2) The conduct of a safety study after admission must be prescribed if there are concerns
p.(None): exist with regard to the risks of the pharmaceutical specialty. Carrying out an effectiveness study after
p.(None): Admission must be prescribed if there is knowledge of the disease or the clinical methodology on it
p.(None): suggest that previous efficacy assessments may need to be significantly revised.
p.(None): In any case, the goals of the study, a time frame for its implementation and the submission of the
p.(None): To provide results.
p.(None): (3) The prescription of the obligations mentioned in Paragraph 2 applies as a change to the approval and with
p.(None): edition related to approval. The marketing authorization holder has his risk management system
p.(None): update accordingly.
p.(None): (4) If the concerns about the risks mentioned in para. 2 concern more than one medicinal product, that has
p.(None): Federal Office for Safety in Health Care the Committee for Risk Assessment in Pharmacovigilance
p.(None): (PRAC) to deal with. In accordance with the recommendation of this committee, the Federal Office sets all
p.(None): affected approval holders, a joint safety study after approval
p.(None): perform.
p.(None): (5) The Federal Minister of Health can issue more detailed regulations on implementation by ordinance
p.(None): of efficacy studies after approval, in particular with regard to the requirements, under
p.(None): to whom these can be prescribed.
p.(None): § 19b. The Federal Office for Safety in Health Care is committed, the agency above all
p.(None): Approvals that are subject to conditions or requirements in accordance with sections 18 subsection 3, 19 subsection 4 and 19a subsection 1 and 2
p.(None): have been given to teach.
p.(None): Note for the following provision
p.(None): For the reference period cf. § 94h.
p.(None): Validity of admission and registration
p.(None): Section 20. (1) Approval of a medicinal specialty and registration of a traditional herbal,
p.(None): homeopathic or pharmacy proprietary medicinal products are generally valid for five years.
p.(None): (2) The authorization holder of a human medicinal product or the registration holder of a
p.(None): Traditional herbal, homeopathic or pharmacy proprietary medicinal specialties can be obtained from the Federal Office
p.(None): for safety in healthcare at the earliest four years after the approval or
p.(None): Notification of registration up to nine months before the expiry of five years after the legal validity of the
p.(None): Admission or registration notice the application for extension of admission or registration
p.(None): if the admission or registration requirements according to the state of the art
p.(None): given are. For this purpose, the authorization or registration holder has a consolidated version
...
p.(None): to take place.
p.(None): (3) If there is a reason for annulment pursuant to Paragraph 1 No. 1 or 2, this may be
p.(None): can be removed by the license holder within a reasonable time, the Federal Office of
p.(None): Healthcare security has the rest of approval.
p.(None): (4) The authorization for distribution in parallel import is to be revoked if
p.(None): 1. it becomes known that when granting the approval, a reason for refusal pursuant to Section 10c (3)
p.(None): was present or such occurred subsequently, or
p.(None): 2. the medicinal product is placed on the market without fulfilling the requirements given in accordance with Section 18 (5),
p.(None): or
p.(None): 3. the license holder waives the license.
p.(None): (5) Registration of a homeopathic medicinal specialty should be canceled if
p.(None): 1. it becomes known that when deciding on the registration a reason for rejection according to § 11
p.(None): Paragraph 4 has existed or occurred subsequently, and the protection of human health
p.(None): or animal by subsequently stipulating requirements within the meaning of Section 11 (2)
p.(None): appears guaranteed, or
p.(None): 2. the pharmaceutical specialty without fulfilling the obligations given in accordance with § 11 paragraph 2 by the owner of a
p.(None): Registration is placed on the market and a deregistration to protect the
p.(None): Human or animal health appears appropriate, or
p.(None): 3. the owner of the registration waives the registration.
p.(None): (6) The registration of a pharmacy proprietary medicinal product should be canceled if
p.(None): 1. it becomes known that when deciding on the registration a reason for refusal in accordance with § 11a
p.(None): Paragraph 3 has existed or occurred subsequently, and the protection of human health
p.(None): or animal by subsequently stipulating requirements within the meaning of section 18 (3)
p.(None): appears guaranteed, or
p.(None): 2. the medicinal product without fulfilling the requirements issued in accordance with section 18 (3) or section 24a (2)
p.(None): Registration holder is placed on the market and a deregistration to protect the
p.(None): Human or animal health appears appropriate, or
p.(None): 3. the registration holder does not register.
p.(None): (7) Registration of a traditional herbal medicinal specialty should be revoked if
p.(None): 1. it becomes known that when deciding on the registration a reason for rejection according to § 13
p.(None): Paragraph 2 has existed or occurred subsequently, and the protection of human health
p.(None): or animal by subsequently stipulating requirements within the meaning of section 13 (1)
p.(None): appears guaranteed, or
p.(None): 2. the medicinal product without fulfilling the requirements given in accordance with section 13 (1) by the holder of a
p.(None): Registration is placed on the market and a deregistration to protect the
p.(None): Human or animal health appears appropriate, or
p.(None): 3. the owner of the registration waives the registration.
p.(None): (8) If a reason for annulment in accordance with paragraph 5 line 1 or 2, paragraph 6 line 1 or 2 or paragraph 7 line 1 or 2
p.(None): is present, but this may be within a reasonable time by the registration holder
p.(None): can be eliminated, the Federal Office for Safety in Health Care the resting of the
p.(None): Registration.
p.(None): Changes to registered pharmaceutical specialties and changes to the prescription status
...
p.(None): (5a) Section 45 (1) in the version of Federal Law BGBl. I No. 30/1998 comes into force on January 1, 1998.
p.(None): (6) Section 4 (4), Section 5a, Section 9a, Section 10 (1), Section 11 (3) 3 (note: correct: Section 11 (1) 2 and 3), Section 15 (1)
p.(None): Z 2 and 3, Section 20a, Section 21, Section 22 Paragraphs 4 and 5, the heading of Section 23, Section 23 Paragraphs 2 and 3, Section 24 Paragraph 7a, Section 24
p.(None): Paragraph 8, Section 26 Paragraphs 3 and 4, Section 27 Paragraphs 1 to 3, Section 56 Paragraph 1 Line 2, Section 57 Paragraph 1 Line 7 and 8, Section 68a, Section 71 Paragraphs 1 and 2,
p.(None): § 80, § 83 Z 3 (note: § 83 Z 3 not affected by the amendment BGBl. I № 33/2002), § 83 Z 7, § 84 Z 5c, the
p.(None): §§ 84a and 84b, § 85a, § 86 paragraph 4, § 87, § 89 paragraph 6, § 95a and §§ 96 and 97 in the version of the
p.(None): Federal Law BGBl. I № 33/2002 occur one month after the announcement of the Federal Law
p.(None): BGBl. I No. 33/2002 following the first day of the month. Section 11 (5) expires at the same time.
p.(None): (6a) (1) Section 2a, Section 29 (1) and (2), Section 30, Section 32 (1) 3, 5, 9, 11, 14 and 15, Section 32 (2) 1, Section 2 (2) 3
p.(None): (Note: correct: section 32 (3)), section 34 line 5, section 36 lines 2, 4, 9 and 12, section 37a, section 38, section 39, section 40, section 41, section 41a, section 41b, Section 41c,
p.(None): Section 41d, Section 41e, Section 42, Section 43, Section 43a, Section 45 Paragraph 2, Section 47 Paragraphs 6 and 8, Section 49 Paragraphs 1 and 11, Section 80 Paragraph 5 and Section 94a
p.(None): Paragraph 5 will enter into force on May 1, 2004. Section 29 (4) expires at the same time.
p.(None): (6b) Section 41b comes into force with the proviso that the notification according to Section 41b (2) is already immediate
p.(None): after announcement, the commencement of the work of these ethics committees according to § 41b only on May 1, 2004
p.(None): may take place.
p.(None): (7) Section 1 (3) 7 in the version of the Administrative Reform Act 2001, Federal Law Gazette I № 65/2002, also comes into effect
p.(None): January 1, 2002, but not in force before the day following the announcement of the aforementioned law. The
p.(None): Proceedings pending at this time are to be continued according to the previously applicable legal situation.
p.(None): (8) Section 12 (1) 3 and 4 and Section 57 (1) 5 in the version of the Federal Law Gazette I No. 12/2003
p.(None): take effect on December 1, 2002.
p.(None): (8a) Section 2a (7), Section 11 (1), 2a and 9, Section 11a, Section 11c (1) and (3), Section 16a (2), Section 19a (1), Section 20a
p.(None): Paragraphs 1 and 4, Section 21 Paragraph 1, Section 22 Paragraphs 1, 3 and 4, Section 23 Paragraph 2, Section 24 Paragraph 1, 2 Z 6, 3, 5, and 9, Section 24a, Section 26
p.(None): Paragraphs 1, 3, 4 and 5, Section 27, Section 32 Section 1 No. 5, Section 35 Section 2, Section 37a Section 1, 3 and 4, Section 40, Section 41a Section 6, Section 41c Section 1,
p.(None): 3 and 4, Section 41e (1), Section 46 (5), Section 47 (8), Section 49 (1) and Section 11, Section 58 (3), Section 59 (5), 6 and 7a, Section 60
p.(None): Paragraph 2 No. 9, Section 63 Paragraph 1, Section 64 Paragraphs 2 and 4, Section 66, Section 67 Paragraph 1 and Section 1a, Section 68 Paragraph 1, Section 69 Paragraph 1, Section 70, Section 75
p.(None): Paragraphs 1, 2 and 3 and Section 75a Paragraphs 1, 2, 3, 4 and 8, Section 76 Paragraphs 1 and 4, Section 77, Section 78 Paragraphs 1 and 2, Section 80 Paragraphs 3 to 5,
p.(None): § 85 and § 87 in the version of the Federal Law BGBl. I No. 107/2005 come into force on 1st January 2006.
p.(None): (8b) At the end of December 31, 2005, pending proceedings according to those listed in Paragraph 8a
...
p.(None): Veterinary medicinal products and for the establishment of additional regulations for immunological veterinary medicinal products
p.(None): (OJ No L 373, 31.12.1990);
p.(None): 15. Council Directive 92/25 / EEC of 31 March 1992 on the wholesale distribution of
p.(None): Medicinal products for human use (OJ No L 113, 30.4.1992);
p.(None): 16. Council Directive 92/27 / EEC of 31 March 1992 on the labeling and package leaflet of
p.(None): Medicinal products for human use (OJ No L 113, 30.4.1992);
p.(None): 17. Council Directive 92/28 / EEC of 31 March 1992 on the advertising of medicinal products for human use (OJ L
p.(None): No. L 113 of April 30, 1992);
p.(None): 18. Council Directive 92/73 / EEC of 22 September 1992 extending the
p.(None): Area of application of Directives 65/65 / EEC and 75/319 / EEC for the approximation of legal and
p.(None): Administrative provisions on medicines and laying down additional provisions for
p.(None): homeopathic medicinal products (OJ No. L 297, 13. 10. 1992);
p.(None): 19. Council Directive 92/74 / EEC of 22 September 1992 to extend the scope
p.(None): Directive 81/851 / EEC on the approximation of laws, regulations and administrative provisions on
p.(None): Veterinary medicinal products and to lay down additional regulations for homeopathic veterinary medicinal products
p.(None): (OJ No L 279, 13. 10. 1992);
p.(None): 20. Council Directive 93/39 / EEC of 14 June 1993 amending Directives 65/65 / EEC,
p.(None): 75/318 / EEC and 75/319 / EEC on medicinal products (OJ No L 214, 24.8.1993);
p.(None): 21. Council Directive 93/40 / EEC of 14 June 1993 amending Directives 81/851 / EEC and
p.(None): 81/852 / EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ
p.(None): L 214, 8/24/1993);
p.(None): 22. Directive 98/27 / EC of May 19, 1998 on injunctions for the protection of
p.(None): Consumer interests (OJ No L 166, 11.6.1998).
p.(None): 23. Directive 2001/20 / EC of April 4, 2001 on the approximation of the laws, regulations and administrative provisions of the
p.(None): Member States on the application of good clinical practice in the conduct of clinical
p.(None): Tests with medicinal products for human use (OJ No L 121, 1.5.2001).
p.(None): 24. Directive 2001/83 / EC of the European Parliament and of the Council of 6 November 2001 on
p.(None): Creation of a Community code for medicinal products for human use, as last amended by the Directive
p.(None): 2004/24 EG and the directive 2004/27 / EG,
p.(None): 25. Directive 2001/82 / EC of the European Parliament and of the Council of 6 November 2001 on
p.(None): Creation of a Community code for veterinary medicinal products, as last amended by the directive
p.(None): 2004/28 / EC,
p.(None): 26. Council Directive 96/22 / EC of 29 April 1996 prohibiting the use of certain substances
p.(None): with hormonal or thyreostatic effects and by ß-agonists in animal production and
p.(None): repealing Directives 81/602 / EEC, 88/146 / EEC and 88/299 / EEC,
p.(None): 27. The Directive of the European Parliament and of the Council of 7 September 2005 on the
p.(None): Recognition of professional qualifications, OJ. № L 255 of September 30, 2005 p. 22, last
p.(None): Modified by Council Directive 2006/100 / EC of November 20, 2006 on adaptation
p.(None): certain directives in the area of free movement on the occasion of the accession of Bulgaria and Romania,
p.(None): OJ. L 363 of December 20, 2006, p. 141,
p.(None): 28. the agreement between the European Community and its Member States, of the one part, and the
p.(None): Swiss Confederation, on the other hand, on the free movement of persons, OJ. № L 114/6 from
p.(None): 30 April 2002, Federal Law Gazette III No. 133/2002, in the version of the protocol with a view to the inclusion of the
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| armedXforces | Soldier |
| army | Soldier |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| control group | participants in a control group |
| crime | Illegal Activity |
| criminal | criminal |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| elderly | Elderly |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| employees | employees |
| family | Motherhood/Family |
| hazard | Natural Hazards |
| healthy volunteers | Healthy People |
| home | Property Ownership |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| influence | Drug Usage |
| job | Occupation |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| native | Indigenous |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| orphan | orphan |
| parent | parents |
| party | political affiliation |
| persecuted | Persecuted |
| physically | Physically Disabled |
| placebo | participants in a control group |
| pregnant | Pregnant |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| union | Trade Union Membership |
| usage | Drug Usage |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| armedXforces | ['army'] |
| army | ['armedXforces'] |
| child | ['children'] |
| children | ['child'] |
| control group | ['placebo'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| drug | ['influence', 'substance', 'usage'] |
| home | ['property'] |
| illness | ['physically'] |
| impaired | ['impairment'] |
| impairment | ['impaired'] |
| influence | ['drug', 'substance', 'usage'] |
| physically | ['illness'] |
| placebo | ['controlXgroup'] |
| property | ['home'] |
| substance | ['drug', 'influence', 'usage'] |
| usage | ['drug', 'influence', 'substance'] |
Trigger Words
capacity
consent
ethics
harm
justice
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input