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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalIllegal Activitycrime2
PoliticalIndigenousnative1
PoliticalPersecutedpersecuted2
Politicalcriminalcriminal18
Politicalpolitical affiliationparty44
HealthCognitive Impairmentimpaired2
HealthCognitive Impairmentimpairment6
HealthDrug Usagedrug134
HealthDrug Usageinfluence8
HealthDrug Usagesubstance25
HealthDrug Usageusage3
HealthHealthy Peoplehealthy volunteers2
HealthMentally Disableddisabled1
HealthMentally Disableddisability6
HealthMotherhood/Familyfamily1
HealthPhysically Disabledillness13
HealthPhysically Disabledphysically2
HealthPregnantpregnant4
Healthpatients in emergency situationsemergency situation4
SocialAccess to Social Goodsaccess2
SocialAgeage1
SocialChildchild2
SocialChildchildren9
SocialElderlyelderly1
SocialIncarceratedrestricted2
SocialLinguistic Proficiencylanguage1
SocialMarital Statussingle7
SocialOccupationjob3
SocialPolice Officerofficer11
SocialProperty Ownershiphome5
SocialProperty Ownershipproperty3
SocialSoldierarmedXforces3
SocialSoldierarmy2
SocialThreat of Stigmathreat10
SocialTrade Union Membershipunion30
SocialVictim of Abuseabuse2
SocialWomenwomen65
SocialYouth/Minorsminor11
Socialeducationeducation3
Socialemployeesemployees3
Socialorphanorphan2
Socialparentsparent1
Socialphilosophical differences/differences of opinionopinion21
General/OtherNatural Hazardshazard2
General/OtherPublic Emergencyemergency10
General/OtherRelationship to Authorityauthority28
General/Otherparticipants in a control groupcontrol group1
General/Otherparticipants in a control groupplacebo1

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:

(return to top)
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
...

Searching for indicator impairment:

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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).
...

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
...

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,
...

Searching for indicator usage:

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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.
...

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.
...

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.
...

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
...

Social / Occupation

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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
...

Social / Police Officer

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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