79C3C34C52B45572883A05D425EB0F82
Medicinal Products in Human Medicine Act (2017)
https://www.bda.bg/images/stories/documents/regulations/zakoni/ZLPHM_28122017.pdf
http://leaux.net/URLS/ConvertAPI Text Files/7E25D4979399332A86CD6EECF7F6D359.en.txt
Examining the file media/Synopses/7E25D4979399332A86CD6EECF7F6D359.html:
This file was generated: 2020-12-01 05:44:49
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator crime:
(return to top)
p.002017: (2) The orders under para. 1 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 280. (1) In finding violations of the provisions of Chapter Eleven,
p.002017: respectively of the ordinance under art. 249, the Executive Director of the BDA orders an order
p.002017: stop advertising from spreading.
p.002017: (2) With the order under para. 1, the BDA Director may oblige the advertiser to
p.002017: publish or distribute, in agreement with the BDA, a rebuttal of the allegations in the advertisement
p.002017: by the same means and in the same format and volume.
p.002017: (3) The order under para. 2 shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: Chapter fourteen.
p.002017: ADMINISTRATIVE PENALTY PROVISIONS
p.002017: Art. 281. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG, No. 102 of 2012)
p.002017: 01/02/2013) Who manufactures, imports, sells, stores or makes available for use in the Republic of Bulgaria
p.002017: medicinal products that are not authorized for use, except in cases under Art. 8, 9 and 10, as well as those with unknown
p.002017: origin if not more difficult
p.002017: shall be punished by a fine of BGN 25,000 to BGN 50,000.
p.002017: (2) The same punishment shall be imposed on the persons who produce, import, sell or
p.002017: allow non-compliant medicinal products to be used in the Republic of Bulgaria
p.002017: the requirements of the applicable pharmacopoeia and the conditions of their authorization.
p.002017: (3) When the violations under para. 1 and 2 are related to unauthorized medicinal products
p.002017: products containing narcotic substances, or when repeated, if the acts do not
p.002017: constitute a crime, the permit issued under this law shall be revoked.
p.002017: (4) Medical professionals who manufacture, sell or supply
p.002017: unauthorized medicinal products are deprived of the right to practice the profession
p.002017: your for a period of 6 months to two years.
p.002017: (5) The punishment under para. 4 shall be imposed by order of the Minister of Health under
p.002017: proposal of the BDA Executive Director.
p.002017: Art. 282. (1) Who sells medicinal products in packages or leaflets to the patient,
p.002017: who do not meet the requirements of this law shall be punished by a fine of BGN 750 up to BGN 1500;
p.002017: repeated infringement - with a fine from 1500 to 3000 BGN.
p.002017: (2) Whoever sells medicinal products without leaflets to the patient shall be liable to a fine of
p.002017: 750 to 1500 BGN, and in the case of repeated infringement - with a fine of 1500 to 3000 BGN.
p.002017: Art. 283. (1) Who imports, trades or makes available for use medicinal products with
p.002017: expired, is liable to a fine of BGN 10,000 to BGN 20,000.
p.002017: (2) Who breaks the primary / secondary packaging or sells / provides medicinal products
p.002017: products with broken primary / secondary packaging are punished with a fine of 750 to 1500 levs, and for
p.002017: repeated violation - with a fine from 1500 to 3000 BGN.
p.002017: Art. 284. (1) Who manufactures, imports or wholesale medicinal products or
p.002017: sells medicinal products without permission, is fined BGN 50,000.
p.002017: (2) (suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 02.01.2013)
p.002017: Who manufactures, imports or wholesale medicinal products or sells medicinal products in violation of
p.002017: the authorization is granted or the sale, storage or supply of medicinal products which are of unknown origin,
p.002017: shall be punished by a fine of 25
p.002017: 000 to 50 000 BGN
...
Searching for indicator illegal:
(return to top)
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
p.002017: 2. are often and very widely applied incorrectly and as a result can
p.002017: pose a danger to human health;
p.002017: 3. contain substances whose activity and / or undesirable effects require it
p.002017: subsequent follow-up study;
p.002017: 4. usually prescribed by a doctor for parenteral administration.
p.002017: Art. 174. Medicinal products shall be subject to special medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. contain narcotic substances within the meaning of the Drug Control Act
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
p.002017: the medicinal product is classified as a prescription only product.
p.002017: Art. 177. Medicinal products that do not meet the requirements of Art. 173, 174 and
...
p.002017: use or persons to whom he has assigned
p.002017: carrying out the activities of Chapter Eight;
p.002017: 6. (new - SG 102/2012, in force since 21.12.2012) to carry out a check on
p.002017: observance of the approved prices, the marginal prices or the registered prices at the sale of
p.002017: medical products;
p.002017: 7. (Renumbered from Item 6, SG No. 102/2012, effective 21.12.2012) to draw up acts for
p.002017: establishment of administrative violations.
p.002017: (2) (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002017: (3) (amend. - SG 98/10, in force from 01.01.2011) The Executive Director of
p.002017: The BDA or the relevant Director of the RIC, subject to the official's submission,
p.002017: having established the violation, has the right to:
p.002017: 1. order in writing the offender to suspend the violation under para. 1, Vol. 1;
p.002017: 2. requires the offender to declare that he will cease the violation under para. 1, item 1 and
p.002017: if necessary, oblige him to make the declaration public;
p.002017: 3. order the termination or prohibition of any violation under para. 1, item 1 and at
p.002017: the need to make an order for termination or prohibition of the infringement
p.002017: public domain.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) The chairman of the council under Art.
p.002017: 258, para. 1 has the right to order in writing the offender to cease the infringement,
p.002017: established during the inspection under para. 1, v. 6.
p.002017: Art. 271. (1) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: inspections shall have the right to:
p.002017: 1. stop construction and issue prescriptions when they find violations of hygiene standards and
p.002017: requirements in the construction execution process; illegal construction of facilities and facilities for
p.002017: manufacture, storage and sale of medicinal products shall notify the National Construction Control Directorate or
p.002017: the technical service of
p.002017: the municipality;
p.002017: 2. prohibit the commissioning and stop the operation of sites and
p.002017: facilities in violation of requirements and hygiene standards in production,
p.002017: storage and sale of medicinal products - until the elimination of the disorders;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008) block medicinal products in the presence of
p.002017: documented information on: non-compliance with quality requirements; medicinal products imported or
p.002017: produced in violation of this law; medicinal products that are available in packs of leaflets which do not
p.002017: meet the requirements of this one
p.002017: law; and send samples of them to the BDA;
p.002017: 4. give conclusions about the compliance of the objects of control with the normative
p.002017: the specified requirements;
p.002017: 5. issue orders, prescriptions and instructions within their competence,
p.002017: which are binding on all persons in the territory of the area concerned.
p.002017: (2) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: administrative measures under para. 1 or under Art. 270, para. 3 shall be imposed by an order of the director of the RII.
p.002017: (3) The orders under para. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 272. (1) The Executive Agency for Medicines shall:
p.002017: 1. (suppl. - SG 102/2012, in force from 02.01.2013) prohibits the commissioning and
p.002017: suspends the operation of sites and facilities in violation of the rules of Good Manufacturing Practice
p.002017: medicinal products and active substances as well as
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.002017: data with the regulatory authorities of other Member States, the European Commission and the European Commission
p.002017: drug agency.
p.002017: Art. 19a. (New, SG No. 60/2011, effective 05.08.2011) (1) The respective SICs shall also keep
p.002017: maintain public registers for the drugstore registration certificates they have issued.
p.002017: (2) Within 7 days from the issuance of a certificate for registration of a drugstore
p.002017: the respective RII sends to the Ministry of Health information on the issued act.
p.002017: (3) The Ministry of Health shall maintain and maintain on its website
p.002017: public national register of drugstore registration certificates issued.
p.002017: Section III.
p.002017: Financing
p.002017: Art. 20. (1) The activities of the BDA shall be financed by budgetary funds and revenues from
p.002017: own business.
p.002017: (2) (amend. - SG 15/2013, in force from 01.01.2014) The budgetary funds shall be
p.002017: provide a subsidy from the state budget through the budget of the Ministry of Finance
p.002017: healthcare.
p.002017: Art. 21. (1) The Executive Agency for Medicines shall be the revenue administrator of
p.002017: own activity, which are formed by:
p.002017: 1. chemical-pharmaceutical expertise;
p.002017: 2. laboratory analyzes and tests;
p.002017: 3. evaluation of documentation and issuance of permits, certificates, certificates and
p.002017: other documents specified in this law;
p.002017: 4. evaluation of the renewal, modification and deletion of the marketing authorization, and
p.002017: certificate of registration of a medicinal product;
p.002017: 5. maintenance of the marketing authorizations or the registration certificates of
p.002017: medicine;
p.002017: 6. fines and pecuniary sanctions imposed by criminal decrees issued for
p.002017: violations under this law;
p.002017: 7. consulting, publishing and research activities in the field of
p.002017: the medical sector;
p.002017: 8. coordination of investment projects for new construction and / or reconstruction
p.002017: existing facilities related to the manufacture of medicinal products;
p.002017: 9. carrying out inspections in relation to conformity assessment of the conditions of
p.002017: production with the requirements of Good Manufacturing Practice;
p.002017: 10. other sources.
p.002017: (2) In carrying out the activities under para. 1, items 1 - 5 and 7-9 the BDA collects fees in the amount,
p.002017: set in a tariff adopted by the Council of Ministers.
p.002017: (3) (New - SG 71/08, in force from 12.08.2008) In the tariff under para. 2 are defined as lower and different by
p.002017: amount of fees for carrying out the authorization procedures for the use, production and import of medicinal products
p.002017: products for small and medium - sized enterprises in
p.002017: pharmaceutical sector within the meaning of the Small and Medium Enterprises Act.
p.002017: Art. 22. (1) The financial resources under art. 21 is spent on:
p.002017: 1. the control activity of the BDA;
p.002017: 2. payment of activities under art. 21, para. 1, items 1 and 2, in cases where their implementation is
p.002017: assigned by the BDA under a contract to other persons;
p.002017: 3. (repealed, SG No. 38/2012, effective 01.07.2012)
p.002017: 4. creating, maintaining and maintaining the registers of art. 19, para. 1;
p.002017: 5. maintaining electronic data interchange systems with the regulatory authorities of
p.002017: the other Member States, the European Commission and the European Medicines Agency;
p.002017: 6. (suppl. - SG 102/2012, in force from 21.12.2012) information and publishing
p.002017: activity related to the quality, efficacy and safety of medicinal products and
...
p.002017: Art. 148. For obtaining a production permit the person under Art. 146 should
p.002017: has:
p.002017: 1. with appropriately qualified personnel, depending on the specifics of
p.002017: manufactured types of medicinal products and dosage forms;
p.002017: 2. at any one time with at least one qualified person who is eligible
p.002017: Art. 159;
p.002017: 3. premises for production, control and storage of medicinal products,
p.002017: provided with the necessary technical equipment and control laboratories.
p.002017: Art. 149. Managers of production and quality control of medicinal products
p.002017: products in manufacturing enterprises are persons:
p.002017: 1. who hold a Master's degree in a specialty
p.002017: "pharmacy", "chemistry" or "biology" and at least two years' practical experience in
p.002017: pharmaceutical production;
p.002017: 2. which meet the requirements of item 1 and have an additional recognized specialty in
p.002017: radiobiology or radiochemistry - for radiopharmaceuticals or for medicinal products,
p.002017: exposed to ionizing radiation;
p.002017: 3. with recognized specialty in clinical hematology, medical microbiology, virology or
p.002017: immunology - for the production of immunological medicinal products - vaccines, toxins, sera, for
p.002017: biotech products and for medicinal products derived from
p.002017: human plasma or human blood.
p.002017: Art. 150. (1) The person under art. 146 submits to the BDA an application in the form approved by
p.002017: the director of the agency.
p.002017: (2) Together with the application under para. 1 the applicant shall also submit:
p.002017: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002017: specialty, work record, criminal record or similar document, if not
p.002017: Bulgarian citizen, and employment contract for the persons under Art.
p.002017: 148, item 2 and art. 149;
p.002017: 2. copies of contracts for the assignment of production and / or control of the applications for
p.002017: production of products - in the cases of art. 151;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union,
p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
p.002017: production of radiopharmaceuticals or medicinal products subject to ionization
p.002017: radiation during their production;
p.002017: 8. permission to use the premises for production, control and storage,
p.002017: issued by the order of the Spatial Planning Act, or other substitute document;
p.002017: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 10. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) In the manufacture of narcotic substances and dosage forms containing
p.002017: such substances are also complied with the requirements of the Drug Control Act and
p.002017: precursors.
p.002017: (4) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 2, Vol. 1,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
p.002017: perform by contract in another object on the territory of the Republic of Bulgaria or outside it, the persons under art. 146
p.002017: are required to indicate the location of this
p.002017: an object and a copy of the contract setting out the responsibilities of each party in respect of
p.002017: compliance with the requirements of Good Manufacturing Practice of Medicinal Products
p.002017: products and obligations of the qualified person under Art. 148, Vol. 2.
p.002017: Art. 152. (amend. - SG 102/2012, in force from 02.01.2013) (1) The principles and requirements for
p.002017: Good manufacturing practice for all types of medicinal products, clinical medicinal products
p.002017: test and of the active substances are determined by the ordinance of
p.002017: the Minister of Health and with acts and guidelines adopted by the European Commission.
p.002017: (2) The principles and requirements for a formal risk assessment to establish the
p.002017: Good manufacturing practice for excipients shall be determined by the ordinance under para. 1 and p
p.002017: guidelines adopted by the European Commission.
p.002017: Art. 153. (1) Upon receipt of an application under Art. 150 BDA evaluates the submitted documentation and
p.002017: perform on-site inspection of the production, control and storage sites, including in the cases under Art.
p.002017: 151, to establish the correspondence between the submitted documentation and the conditions of production, control
p.002017: and storage of source materials for manufacturing and finished medicinal products and their compliance
p.002017: with the requirements of
...
p.002017: from a document certifying that it is manufactured and controlled in accordance with standards,
p.002017: equivalent to Good manufacturing practice, including when this medicinal product
p.002017: has been issued
p.002017: marketing authorization.
p.002017: (6) (amend. - SG 71/08, in force from 12.08.2008) It is not required to carry out control tests of
p.002017: the territory of the Republic of Bulgaria, when in another Member State the requirements of para. 4 or 5 and
p.002017: the medicinal product intended for clinical trial is accompanied by a certificate of release for
p.002017: the batch issued by another
p.002017: qualified person.
p.002017: (7) The qualified person under para. 1 shall keep records of each lot imported
p.002017: medicinal product for at least 5 years and present it at the request of the control authorities.
p.002017: (8) The holder of the import authorization shall provide and maintain a locking system and
p.002017: withdrawal from the market of medicinal products which have shown non - compliance with the requirements for
p.002017: quality.
p.002017: (9) The holder of an import authorization shall be obliged to block and withdraw the medicinal products
p.002017: products which have shown non - compliance with the safety and efficacy requirements according to
p.002017: the ordinance under Art. 274, para. 1.
p.002017: (10) (Amended, SG No. 12/2011, effective 08.02.2011) The provisions of Art. 160, para. 1, vol.
p.002017: 4 and 7 shall also apply to import license holders.
p.002017: (11) The holder of an import permit shall provide the qualified person under Art. 161,
p.002017: para. 2, item 1 the necessary conditions for the fulfillment of his duties and shall notify immediately
p.002017: the control authorities when it is changed.
p.002017: (12) When instituting administrative criminal proceedings for infringements committed under
p.002017: the fulfillment of the obligations of the qualified person, the BDA shall order the holder of the authorization for
p.002017: import to remove the temporarily qualified person from
p.002017: the position.
p.002017: Art. 163a. (New, SG No. 12/2011, effective 08.02.2011) (1) When the BDA establishes
p.002017: deficiencies and deficiencies in the documentation submitted, it shall notify the applicant in writing and provide
p.002017: written instructions.
p.002017: (2) In the cases of para. 1 the term under Art. 164, para. 1 stops running until
p.002017: documentation as required.
p.002017: Art. 164. (1) The BDA Executive Director shall issue an import permit within 30 days
p.002017: from the date of submission of the application under Art. 162 or reasonably refused.
p.002017: (2) The refusal under para. 1 shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: (3) The import permit shall be issued only for the medicinal products specified in the application
p.002017: products, their forms of active substances and for the intended medicinal products intended
p.002017: for the clinical trial and for the premises where the control and storage will be carried out.
p.002017: (4) The import authorization is open-ended.
p.002017: Art. 165. (1) The holder of an import permit from a third country shall submit to the BDA
p.002017: application when changing:
p.002017: 1. the person under art. 161, para. 2, Vol. 1;
p.002017: 2. (amend. - SG 102/02, in force from 02.01.2013) the medicinal products and
p.002017: the forms for which the import authorization has been granted;
p.002017: 3. the address of the laboratory under Art. 161, para. 2, Vol. 2;
p.002017: 4. the court registration of the trader.
p.002017: (2) To the application under para. 1, the documents related to the change specified shall be attached
...
p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
p.002017: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible master pharmacist under Art. 197, v. 2 and
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
p.002017: containing such substances, the requirements of the Control Act also apply
p.002017: drugs and precursors.
p.002017: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Agency
p.002017: for nuclear regulation.
p.002017: (5) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the person under para. 1, Vol. 3,
p.002017: when he is a Bulgarian citizen.
p.002017: Art. 200. The Drug Enforcement Agency evaluates the documentation and performs it
p.002017: on - the - spot verification of the sites indicated in the application for their compliance with
p.002017: requirements for Good Distribution Practice.
p.002017: Art. 201. (1) The Executive Agency for Medicines shall notify the applicant in writing,
p.002017: when it finds deficiencies in the documentation submitted.
p.002017: (2) In the cases of para. 1 the term under Art. 202, para. 1 stops running.
p.002017: Art. 202. (1) Within 90 days from the date of submission of the application under Art. 199, para. 1
p.002017: the Executive Director of the BDA issues the permit for wholesale trade or makes it motivated
p.002017: refusal.
p.002017: (2) The refusal under para. 1 shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: Art. 203. Within 15 days from the date of submission of the documentation under Art. 199, para. 2
p.002017: the BDA Executive Director issues a Wholesale Trade Registration Certificate to
p.002017: the territory of the Republic of Bulgaria of the person under Art. 195, para. 1.
p.002017: Art. 204. (1) The permit for wholesale of medicinal products shall be indefinite.
p.002017: (2) The authorization under Art. 202 or the certificate under Art. 203 is terminated if
p.002017: the holder requested this in writing from the BDA Executive Director.
p.002017: (3) The person under art. 195 is obliged to notify the BDA in writing within 7 days after the termination of
p.002017: its activity in the wholesale of medicinal products. In these cases, the BDA Executive Director
p.002017: terminates the issued marketing authorizations / certificates
p.002017: of medicines.
...
p.002017: The requirements for the location and the premises of the pharmacy are laid down in the ordinance of
p.002017: Art. 219, para. 2.
p.002017: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in
p.002017: (requirements from 05.08.2011) Requirements to the device and premises of pharmacies under Art. 228, para.
p.002017: 5 shall be determined in the ordinance under para. 1.
p.002017: Art. 228. (amend. - SG 71/08, in force from 26.07.2008) (1) (amend. - SG 60/11, in force from 26.07.2008)
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002017: director of the BDA on the basis of a model application to
p.002017: applicable:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a country Party
p.002017: Agreement on the European Economic Area - Document for the up - to - date registration of the European Economic Area
p.002017: national legislation issued by the competent authority of the relevant
p.002017: the state of the persons under art. 222, para. 1;
p.002017: 2. employment contract or contract for management of the pharmacy, concluded with the master pharmacist
p.002017: or with a pharmacist assistant;
p.002017: 3. a copy of the act for the creation of the persons under Art. 222, para. 4;
p.002017: 4. documents certifying that the requirements of Art. 224 Hours;
p.002017: 5. (suppl. - SG 103/07, in force from 01.01.2018) criminal record of
p.002017: Master of Pharmacy, respectively of the Assistant Pharmacist appointed as Head of Pharmacy,
p.002017: if they are not Bulgarian citizens;
p.002017: 6. medical certificate of the Master of Pharmacy, respectively
p.002017: assistant pharmacist appointed as pharmacy manager;
p.002017: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002017: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued
p.002017: from the relevant RI;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002017: medicinal products are checked to see if the diploma of the master pharmacist / assistant pharmacist is presented
p.002017: issued by the relevant competent authority
p.002017: institution.
p.002017: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies under Art.
p.002017: 222, para. 4 and 6 shall be opened and closed at the request of the person representing the medical establishment.
p.002017: (4) (Renumbered from Paragraph (3), SG No. 60/2011, effective 05.08.2011)
p.002017: pharmacy in which medicinal products containing narcotic substances are marketed
p.002017: and the requirements of the Drugs and Precursors Control Act.
p.002017: (5) (New - SG, iss. 102 in 2009, in force since 22.12.2009, previous para 4 - SG, iss. 60 in 2011, in force since
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy opened in a population
p.002017: a place with a population of less than 10,000 inhabitants is issued on the basis of
p.002017: application form to which shall be attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) the documents under para. 1, items 1 - 7a and
...
p.002017: 50 per cent of the fee determined in the tariff under Art. 21, para. 2 for the authorization of
p.002017: retail trade of medicinal products under Art. 222, para. 1.
p.002017: (6) (Renumbered from Paragraph (4), Suppl. - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 98)
p.002017: from 2010, in force from 01.01.2011, previous para. 5, amend. - SG, issue. 60 of 2011, effective 05.08.2011
p.002017: d.) The application and documents under para. 1 and 5 shall be submitted to the BDA.
p.002017: (7) (Renumbered from Paragraph (5), amend. - SG 102/09, in force from 22.12.2009, amended - SG, issue 98
p.002017: from 2010, in force from 01.01.2011, previous para. 6, amend. - SG, issue. 60 of 2011, effective 05.08.2011
p.002017: (d) Regional health inspections shall issue a hygienic conclusion within 14 days of the date
p.002017: of applying for it.
p.002017: (8) (New, SG No. 48/2015) On the day of receipt of the application under para. 1 and 5, the BDA shall send a request on its own motion
p.002017: to the Board of Directors of the Bulgarian Pharmaceutical Union for issuance of a certificate for registration in the national
p.002017: electronic register of the members of the Bulgarian Pharmaceutical Union - for the master pharmacist, head of
p.002017: pharmacy, as well as providing information on penalties imposed under the Commercial Law
p.002017: the organization of master pharmacists and the Health Act.
p.002017: (9) (New, SG No. 48/2015) The Managing Board shall submit the documents under para. 8th c
p.002017: 5 working days after receiving the request.
p.002017: (10) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 1, Vol. 5,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 229. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, repealed - SG No. 60/2011)
p.002017: (in force from 05.08.2011)
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 102/2009, effective 22.12.2009,
p.002017: ed. - SG, issue. 60 of 2011, in force since 05.08.2011, suppl. - SG, issue. 18 of 2014) Within one month from
p.002017: receipt of the documentation under Art. 228, para. 6 the Executive Director of the BDA after the opinion of
p.002017: The Expert Council for Retail Trade in Medicinal Products issues a marketing authorization
p.002017: retail with medicinal products at a pharmacy or make a motivated refusal to grant an authorization.
p.002017: The permit or refusal shall be
p.002017: served on the applicant.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation under Art.
p.002017: 228, para. 6 The BDA shall check the submitted documents and notify the applicant in writing of the established ones
p.002017: inconsistencies or incompleteness. In these cases
p.002017: the term under para. 2 shall cease to run from the day of notification until the deficiencies have been rectified.
p.002017: (4) (New - SG 71/08, in force from 12.08.2008) In case within 60 days from the date of notification
p.002017: under para. 3, the applicant has not remedied any inconsistencies or incompleteness found in the proceedings for the issuance of
p.002017: retail authorization for medicinal products
p.002017: products or for a change to an authorization is terminated.
p.002017: (5) (Renumbered from Paragraph (4), SG No. 71/2008, effective 12.08.2008, amended, SG No. 60/2008)
p.002017: 2011, effective 05.08.2011) The refusal of the BDA Executive Director to issue a
...
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
p.002017: registration of a drugstore or for making a change under Art. 242 the respective RIC collects fees
p.002017: in the amount determined by the tariff under Art. 21, para. 2.
p.002017: (6) (New - SG 103 2017, in force from 01.01.2018)
p.002017: food safety ex officio establishes the circumstances of a person 's criminal record
p.002017: para. 2, item 2, when he is a Bulgarian citizen.
p.002017: Art. 240. (amend. - SG 60/11, in force from 05.08.2011) (1) Within 14 days from
p.002017: performing the inspection under Art. 239, para. 3 or by eliminating the incompleteness of art. 239, para. 4
p.002017: the director of RII issues a certificate for registration of a drugstore or makes a reasoned refusal
p.002017: for its publication.
p.002017: (2) (New, SG No. 102/2012, effective 21.12.2012)
p.002017: refuses to issue a certificate of registration of the person under Art. 238, para. 2 when:
p.002017: 1. none of the documents under Art. 239, para. 2;
p.002017: 2. within the term of art. 239, para. 4 the applicant did not remove the incompleteness found.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) When, within the term of para. 1
p.002017: the director of RZI did not issue a certificate for registration of a drugstore or did not
p.002017: motivated refusal, it is considered that there is tacit consent.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 3 the applicant can start
p.002017: performing the requested activities in compliance with Art. 29 of the Administrative Restriction Act
p.002017: regulation and administrative control over the economic activity.
p.002017: (5) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012)
p.002017: of RZI under para. 1 shall be subject to appeal by the order of the Administrative Procedure Code.
p.002017: Art. 240a. (New, SG No. 102/2012, effective 21.12.2012) (1) The Director of
p.002017: the respective RZI shall terminate the registration of a drugstore by order:
p.002017: 1. at the request of the person who has received a certificate for registration of a drugstore;
p.002017: 2. by termination of the activity of the person under art. 238, para. 2, of which it notifies
...
p.002000: § 84. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: with the exception of § 65, which comes into force on 30 September 2011.
p.002000: Transitional and Final Provisions
p.002000: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002000: DRUGS AND PRECURSORS
p.002000: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002000: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002000: Transitional and Final Provisions
p.002000: TO THE LAW AMENDING AND SUPPLEMENTING THE STATE LAW
p.002000: EMPLOYEE
p.002000: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002000: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in
p.002000: "State Gazette":
p.002000: 1. The Council of Ministers shall bring the Classifier of posts in administration to
p.002000: compliance with this law;
p.002000: 2. the competent authorities shall bring the planning acts of the respective
p.002000: administration in accordance with this law.
p.002000: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002000: the independent financial audit, the Electronic Communications Act, the Financial Supervision Commission Act, the Access Act and
p.002000: disclosure of documents and declaring of belonging of Bulgarian citizens to the State Security and
p.002000: Intelligence Services of the Bulgarian People's Army, Law on Forfeiture in favor of the State of Property Acquired
p.002000: of criminal activity, the Conflict of Interest Prevention and Identification Act, the Code of Conduct
p.002000: social security, the Health Insurance Act, the Farmers Support Act, and
p.002000: The Roads Act is governed by the terms and procedures of § 36 of the transitional and final provisions of the Act
p.002000: amending and supplementing the
p.002000: the civil servant (State Gazette, issue 24 of 2006).
p.002000: (2) The act of appointment of the civil servant shall:
p.002000: 1. assigns the definitions in the Classifier of posts in the administration
p.002000: minimum rank for the position held, unless the employee holds a higher rank;
p.002000: 2. determines the individual basic monthly salary.
p.002000: (3) The additional necessary funds for social security contributions of the persons under para. 2 se
p.002000: provide, within the cost of wages, salaries and social security contributions,
p.002000: the budgets of the authorizing officers concerned.
p.002000: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account
p.002000: of the State Fund for Agriculture, resulting from this law.
p.002000: (5) The governing bodies of the National Social Security Institute and the National Social Security Institute
p.002000: Health Insurance Fund to make the necessary changes to the respective budgets,
p.002000: arising from this law.
p.002000: (6) Unused employment leave shall be maintained and shall not be maintained
p.002000: offset by cash benefits.
p.002000: § 86. (1) Within one month from the entry into force of this Act the individual basic monthly salary of the employee
p.002000: is determined so that the same, less the tax due and the mandatory social security contributions at the expense of
p.002000: the insured person, if they were owed, no lower than the gross monthly salary received so far,
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.002017: and retail, clinical trials, safety and advertising of medicinal products;
p.002017: 10. perform laboratory analysis on suspected quality deviation,
p.002017: the efficacy and safety of medicinal products and undertakes the legal provisions
p.002017: measures;
p.002017: 10a. (new, SG No. 102/2012, effective 21.12.2012) shall exercise the functions of
p.002017: a competent body for pharmacovigilance monitoring;
p.002017: 11. (amend. - SG 102/2012, in force from 21.12.2012) organize and maintain a system
p.002017: for pharmacovigilance monitoring;
p.002017: 12. issue certificates under the WHO certification scheme;
p.002017: 12a. (new, SG No. 18/2014) issue certificates of Good Distribution Practice;
p.002017: 13. issue certificates of Good Manufacturing Practice;
p.002017: 14. (amend. - SG 18/04) consult the investment projects for construction of
p.002017: new and / or redevelopment of existing facilities related to the manufacture of medicinal products
p.002017: products in accordance with the rules of Good Manufacturing Practice;
p.002017: 15. performs the functions of coordinator and advisory body on problems,
p.002017: related to the quality, efficacy and safety of medicinal products;
p.002017: 16. performs consulting, scientific, information and publishing activities in the field
p.002017: the medicines sector;
p.002017: 17. coordinates and participates in activities related to the European Pharmacopoeia and to the
p.002017: the development of the Bulgarian Pharmacopoeia;
p.002017: 18. participate in activities in the field of medicinal products related to the work of the European Agency
p.002017: on Medicines, European Directorate for Quality of Medicines and Health, international
p.002017: bodies and organizations as well as with the implementation of
p.002017: international treaties to which the Republic of Bulgaria is a party;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) participates in the international
p.002017: harmonization and standardization of technical measures related to traceability
p.002017: drug safety, coordinated by the European Medicines Agency;
p.002017: 18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain
p.002017: national internet portal for medicinal products;
p.002017: 19. performs other activities specified by law.
p.002017: (6) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: medicines coordinates its activities with regional health inspections (RICs) in the area of
p.002017: control of medicinal products.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under
p.002017: this law related to preventing the entry and distribution of counterfeit
p.002017: medicinal products, is carried out in cooperation between the BDA and the customs authorities.
p.002017: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health
p.002017: inspections issue certificates for registration of drugstores.
p.002017: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002017: retail of medicinal products, which includes three representatives of the Bulgarian
p.002017: pharmaceutical union, one representative of the faculties of pharmacy of the medical colleges and
p.002017: four BDA representatives. The composition of the Board is determined by an order of the Executive Director of the BDA,
p.002017: agreed with the Minister of
p.002017: healthcare.
p.002017: (2) The council under para. 1 is an advisory unit which:
p.002017: 1. prepares opinions on the applications and documents submitted to the BDA under Art. 228, para. 1 and 5,
...
p.002017: pharmaceutical production;
p.002017: 2. which meet the requirements of item 1 and have an additional recognized specialty in
p.002017: radiobiology or radiochemistry - for radiopharmaceuticals or for medicinal products,
p.002017: exposed to ionizing radiation;
p.002017: 3. with recognized specialty in clinical hematology, medical microbiology, virology or
p.002017: immunology - for the production of immunological medicinal products - vaccines, toxins, sera, for
p.002017: biotech products and for medicinal products derived from
p.002017: human plasma or human blood.
p.002017: Art. 150. (1) The person under art. 146 submits to the BDA an application in the form approved by
p.002017: the director of the agency.
p.002017: (2) Together with the application under para. 1 the applicant shall also submit:
p.002017: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002017: specialty, work record, criminal record or similar document, if not
p.002017: Bulgarian citizen, and employment contract for the persons under Art.
p.002017: 148, item 2 and art. 149;
p.002017: 2. copies of contracts for the assignment of production and / or control of the applications for
p.002017: production of products - in the cases of art. 151;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union,
p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
p.002017: production of radiopharmaceuticals or medicinal products subject to ionization
p.002017: radiation during their production;
p.002017: 8. permission to use the premises for production, control and storage,
p.002017: issued by the order of the Spatial Planning Act, or other substitute document;
p.002017: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 10. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) In the manufacture of narcotic substances and dosage forms containing
p.002017: such substances are also complied with the requirements of the Drug Control Act and
p.002017: precursors.
p.002017: (4) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 2, Vol. 1,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
p.002017: perform by contract in another object on the territory of the Republic of Bulgaria or outside it, the persons under art. 146
p.002017: are required to indicate the location of this
p.002017: an object and a copy of the contract setting out the responsibilities of each party in respect of
p.002017: compliance with the requirements of Good Manufacturing Practice of Medicinal Products
p.002017: products and obligations of the qualified person under Art. 148, Vol. 2.
p.002017: Art. 152. (amend. - SG 102/2012, in force from 02.01.2013) (1) The principles and requirements for
p.002017: Good manufacturing practice for all types of medicinal products, clinical medicinal products
p.002017: test and of the active substances are determined by the ordinance of
p.002017: the Minister of Health and with acts and guidelines adopted by the European Commission.
p.002017: (2) The principles and requirements for a formal risk assessment to establish the
p.002017: Good manufacturing practice for excipients shall be determined by the ordinance under para. 1 and p
p.002017: guidelines adopted by the European Commission.
p.002017: Art. 153. (1) Upon receipt of an application under Art. 150 BDA evaluates the submitted documentation and
p.002017: perform on-site inspection of the production, control and storage sites, including in the cases under Art.
p.002017: 151, to establish the correspondence between the submitted documentation and the conditions of production, control
p.002017: and storage of source materials for manufacturing and finished medicinal products and their compliance
p.002017: with the requirements of
p.002017: Good manufacturing practice.
p.002017: (2) The costs of carrying out on-site inspections under para. 1 shall be at the expense of the applicant.
p.002017: (3) For carrying out on-site inspections under para. 1 the applicant pays a fee of
p.002017: determined in the tariff under Art. 21, para. 2.
p.002017: Art. 154. (1) When the BDA establishes incompleteness in the submitted documentation and / or inconsistency between
...
p.002017: 5. (repealed, SG No. 12/2011, effective 08.02.2011)
p.002017: 6. notify immediately the control bodies in case of change of the qualified person
p.002017: under Art. 148, Vol. 2;
p.002017: 7. ensure at all times access of the control bodies to the premises and
p.002017: documentation;
p.002017: 8. provide to the qualified person under Art. 148, item 2 the necessary conditions for
p.002017: performance of his duties;
p.002017: 9. (new - SG 102/2012, in force from 02.01.2013) inform immediately the BDA and the holder of the permit for
p.002017: use if he / she receives information that the medicinal products fall within the scope of his authorization
p.002017: production, are falsified or there are doubts about falsification, regardless of whether these medicinal products
p.002017: products have been distributed within the legal supply chain or illegally,
p.002017: including through illicit sale through the information society services;
p.002017: 10. (new - SG 102/2012, in force from 02.01.2013) check whether
p.002017: the manufacturers, importers or traders from which it receives the active substances are
p.002017: registered by the competent authority of the Member State in which they are established;
p.002017: 11. (New, SG No. 102/2012, effective 02.01.2013) verify the authenticity and
p.002017: the quality of the active substances and of the excipients.
p.002017: (2) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing permit shall exercise
p.002017: audits at the sites for the production and marketing of active substances for compliance with Good Manufacturing
p.002017: practice and Good distribution practice. The holder of the manufacturing authorization may
p.002017: contract with a third party yes
p.002017: performed the audit on his behalf and on his behalf.
p.002017: (3) (New, SG No. 102/2012, effective 02.01.2013) The holder of the permit
p.002017: document the undertakings under para. 1, items 2 and 2a measures.
p.002017: (4) (Renumbered from Paragraph (2), SG No. 102/2012, effective 02.01.2013) The holder of a permit for
p.002017: manufacture keeps the samples and the documentation for the active medicinal products manufactured by him
p.002017: substances and medicinal products intended for clinical use
p.002017: tests, under the conditions and in the order specified in the ordinance under art. 152.
p.002017: (5) (Renumbered from Paragraph (3), SG No. 102/2012, in force from 02.01.2013) In the case of a medicinal product
p.002017: product for clinical trial, the holder of the manufacturing authorization shall ensure that
p.002017: all production operations shall be carried out in accordance with
p.002017: the information provided by the contracting authority to the BDA in accordance with the ordinance under Art. 82, para. 3.
p.002017: (6) (Renumbered from Paragraph (4), SG No. 102/2012, effective 02.01.2013)
p.002017: each transaction is kept for 5 years and contains the date, name of the medicinal product
p.002017: product, quantity delivered, name and address of consignee, and batch number.
p.002017: (7) (Renumbered from Paragraph (5), SG No. 102/2012, effective 02.01.2013)
p.002017: a production authorization provides and maintains a system for blocking and withdrawing from the market
p.002017: medicinal products that have shown non-compliance with quality requirements.
p.002017: (8) (Renumbered from Paragraph (6), SG No. 102/2012, effective 02.01.2013)
p.002017: a manufacturing authorization is required to block and withdraw the medicinal products shown
...
p.002017: Import of medicinal products (Title amend. - SG 102/02, in force from 02.01.2013)
p.002017: Art. 161. (1) (amend. - SG 102/02, in force from 02.01.2013) Imports into the territory of the Republic of Bulgaria from
p.002017: third country of all types of medicinal products and medicinal products intended for clinical use
p.002017: testing may only be carried out by natural or legal persons registered as traders under the legislation
p.002017: of a Member State that are
p.002017: have received an import permit issued by the BDA Executive Director.
p.002017: (2) In order to obtain an import permit, the person under para. 1 must have:
p.002017: 1. (amend. - SG 102/2012, in force from 02.01.2013) at any time with at least one
p.002017: a qualified person who meets the requirements of Art. 159, para. 2 and 10;
p.002017: 2. (amend. - SG 102/2012, in force from 02.01.2013) with a laboratory for quality control in
p.002017: compliance with the requirements of the ordinance under Art. 152 and storage facilities for medicinal products, and
p.002017: clinical trial medicinal products provided with
p.002017: the necessary technical equipment, in accordance with the requirements of the ordinance under Art. 198.
p.002017: Art. 162. (1) In order to obtain an import permit, the person under Art. 161, para. 1 submits to the BDA
p.002017: an application in accordance with a model approved by the Executive Director of the Agency.
p.002017: (2) To the application under para. 1 shall apply:
p.002017: 1. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: Economic Space - Document for current registration under national law, issued by
p.002017: competent
p.002017: authority of the country concerned;
p.002017: 2. (amend. - SG 102/02, in force from 02.01.2013) list of the medicinal products
p.002017: products and forms to be imported;
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) a copy of the production permit,
p.002017: issued by the regulatory authority of the exporting country and a certificate attesting the conformity of
p.002017: conditions for production, control and storage with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 4. documents certifying the circumstances under Art. 159, para. 1 and 2 for
p.002017: the qualified person;
p.002017: 5. data on the address of a laboratory on the territory of the Republic of Bulgaria for performing full quantitative and
p.002017: qualitative analysis of at least the active substances and of all other tests and verifications for the demonstration of
p.002017: the quality of each imported batch of medicinal product in accordance with the requirements of the marketing authorization
p.002017: use in accordance with this law and the address of
p.002017: storage facilities;
p.002017: 6. a contract which defines the responsibilities of each party in respect of compliance with
p.002017: the principles of Good Manufacturing Practice by the contractor and the manner in which the qualified person under Art.
p.002017: 161, para. 2, item 1 shall perform its duties in the cases,
p.002017: when the person under Art. 161, para. 1 does not have its own laboratory;
p.002017: 7. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 71/2008, effective 12.08.2008) Upon receipt of an application under para. 1 BDA evaluates the submitted
p.002017: documentation and perform on - site verification of the laboratory for
p.002017: control and storage facilities for medicinal products and medicinal products intended for use
p.002017: a clinical trial to determine their compliance with the requirements of
p.002017: Good manufacturing practice and Good distribution practice.
p.002017: (4) (Renumbered from Paragraph (3), SG No. 71/2008, effective 12.08.2008) Where manufacturing premises are located
p.002017: in a third country with which the European Community has signed an agreement on the mutual recognition of certificates of Good
p.002017: production practice, the persons under art. 161, para. 1 shall attach to the application the address of each premises for
p.002017: manufacture of medicinal products, active substances or medicinal products intended for clinical trial,
p.002017: name, registered office and management address of the person who has received the manufacturing authorization, certificate,
p.002017: certifying compliance of the production, control and storage conditions with standards equivalent to
p.002017: standards approved by the requirements of the Good
p.002017: manufacturing practice, and the name of the qualified person.
p.002017: (5) (Renumbered from Paragraph (4), amend. - SG 71/08, in force from 12.08.2008) In cases other than
...
p.002017: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may
p.002017: only wholesale medicinal products for which a marketing authorization has been granted
p.002017: production.
p.002017: (2) An importer of medicinal products within the meaning of this Act may perform
p.002017: wholesale only of medicinal products for which import authorization has been granted.
p.002017: Art. 197. The persons under art. 195 must have:
p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
p.002017: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible master pharmacist under Art. 197, v. 2 and
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
...
p.002017: for special medical purposes and infant formulas and follow-on formulas, and nutritional supplements, cosmetic and
p.002017: sanitary and hygienic
p.002017: funds.
p.002017: Art. 226. (1) On the territory of medical establishments for outpatient care may be
p.002017: open pharmacies to sell medicinal products to citizens.
p.002017: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, curative
p.002017: establishments for hospital care and medical establishments under art. 10 of the Law on medical establishments does not
p.002017: pharmacies can be opened to sell medicinal products to citizens.
p.002017: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009)
p.002017: The requirements for the location and the premises of the pharmacy are laid down in the ordinance of
p.002017: Art. 219, para. 2.
p.002017: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in
p.002017: (requirements from 05.08.2011) Requirements to the device and premises of pharmacies under Art. 228, para.
p.002017: 5 shall be determined in the ordinance under para. 1.
p.002017: Art. 228. (amend. - SG 71/08, in force from 26.07.2008) (1) (amend. - SG 60/11, in force from 26.07.2008)
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002017: director of the BDA on the basis of a model application to
p.002017: applicable:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a country Party
p.002017: Agreement on the European Economic Area - Document for the up - to - date registration of the European Economic Area
p.002017: national legislation issued by the competent authority of the relevant
p.002017: the state of the persons under art. 222, para. 1;
p.002017: 2. employment contract or contract for management of the pharmacy, concluded with the master pharmacist
p.002017: or with a pharmacist assistant;
p.002017: 3. a copy of the act for the creation of the persons under Art. 222, para. 4;
p.002017: 4. documents certifying that the requirements of Art. 224 Hours;
p.002017: 5. (suppl. - SG 103/07, in force from 01.01.2018) criminal record of
p.002017: Master of Pharmacy, respectively of the Assistant Pharmacist appointed as Head of Pharmacy,
p.002017: if they are not Bulgarian citizens;
p.002017: 6. medical certificate of the Master of Pharmacy, respectively
p.002017: assistant pharmacist appointed as pharmacy manager;
p.002017: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002017: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued
p.002017: from the relevant RI;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002017: medicinal products are checked to see if the diploma of the master pharmacist / assistant pharmacist is presented
p.002017: issued by the relevant competent authority
p.002017: institution.
p.002017: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies under Art.
...
p.002017: wholesale of medicines.
p.002017: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002017: prescription, can be sold in a drugstore. Drugstores can also sell products and
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
...
p.002017: (3) The orders under para. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 272a. (New, SG No. 102/2012, effective 02.01.2013) (1) By delegated acts under Art. 52b, paragraph
p.002017: 2 of Directive 2001/83 / EC lays down the necessary measures to prevent the placing on the market of
p.002017: medicinal products introduced into the European Union but not intended to be placed on the market in the European Union,
p.002017: for which there is enough
p.002017: grounds for suspecting that they have been falsified.
p.002017: (2) The Executive Agency for Medicinal Products shall take the necessary measures in accordance with the delegated ones
p.002017: acts under para. 1 to prevent the release of medicinal products introduced into the European Union
p.002017: union but not intended to be marketed
p.002017: of the European Union for which there are sufficient grounds for suspecting that they have been falsified.
p.002017: (3) The customs authorities shall notify the BDA of the introduction into the territory of the Republic
p.002017: Bulgaria of medicinal products under para. 1 with a view to taking measures under para. 2.
p.002017: Art. 273. (1) The conditions and the procedure for sampling, testing and
p.002017: their remuneration shall be determined in an ordinance of the Minister of Health.
p.002017: (2) When challenging the results of laboratory tests, they shall be made
p.002017: retesting. They shall be made upon written request from the interested party,
p.002017: made within 7 days from the date of receipt of the result of the original test.
p.002017: (3) The repeated tests under para. 2 shall be carried out by experts designated by
p.002017: the BDA's Executive Director, who did not participate in the initial test, c
p.002017: the presence of an authorized representative of the interested party.
p.002017: Art. 274. (1) The conditions and the order for blocking and withdrawal of medicinal products,
p.002017: have shown non - compliance with the requirements for quality, safety and efficacy, shall be defined in
p.002017: ordinance of the Minister of Health.
p.002017: (2) The conditions and procedure for the destruction, processing or use for others
p.002017: the goals of the medicinal products are set out in an ordinance of the Minister of Health.
p.002017: Art. Article 275. (1) In exercising control, the BDA shall take all necessary measures to ensure proper validation of
p.002017: the processes of production and purification of medicinal products derived from human blood or human plasma,
p.002017: consistency in batch quality and ensuring, as far as technology allows, the absence of
p.002017: specific viral
p.002017: contamination.
p.002017: (2) Manufacturers shall notify the BDA of the method used to reduce or
p.002017: removal of pathogenic viruses that can be transmitted through medicinal products,
p.002017: obtained from human blood or human plasma.
p.002017: (3) The Drug Enforcement Agency shall test or send for testing to another
p.002017: official laboratory for control of medicinal products in the Republic of Bulgaria or in another
p.002017: Member State samples of the bulk / non - spilled product and / or test product or
p.002017: in the course of evaluating an application for marketing authorization under Art. 46, para. 1, item 2 or after issue
p.002017: of the marketing authorization.
p.002017: Art. 276. The Executive Director of the BDA shall, by order, suspend, revoke,
p.002017: suspend or change the marketing authorization / registration,
p.002017: when it is established that:
p.002017: 1. there is an unacceptable side effect when used properly, or
p.002017: 2. lack of therapeutic efficacy (therapeutic efficacy is lacking when
...
p.002017: active substance are considered to be the same active substance, unless they differ significantly in their nature
p.002017: safety and / or efficiency.
p.002017: 10. "Principal Investigator" is the doctor or dentist appointed by the contracting authority, who direct
p.002017: the overall conduct of the clinical trial in accordance with the approved protocol and the Good Guideline
p.002017: clinical practice and responsible for the work of
p.002017: the researchers.
p.002017: 11. "Defined daily dose" is an average daily maintenance dose of a drug
p.002017: product for use in adults according to the primary indication of the medicinal product.
p.002017: 12. "Good clinical practice" is the set of internationally recognized ethical and
p.002017: scientific quality requirements to be met when planning, conducting, reporting and
p.002017: reporting of clinical trials.
p.002017: 13. "Good laboratory practice" is a system of internationally recognized rules
p.002017: in terms of planning conditions, processes of organizing, executing, tracking and
p.002017: documentation of laboratory tests.
p.002017: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers all
p.002017: production sides - personnel, premises, facilities, materials, documentation, quality control, and aims
p.002017: to ensure safety, efficiency and
p.002017: according to the specification.
p.002017: 15. (suppl. - SG 71/08, in force from 12.08.2008) "Member State" is a state,
p.002017: Member State of the European Union or a State Party to the Agreement on the European Union
p.002017: economic space.
p.002017: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002017: 17. "Immunological medicinal product" is a medicinal product containing vaccines, toxins, serums or allergens. IN
p.002017: the range of vaccines, toxins and serums include agents used to create active immunity or to
p.002017: establish a state of immunity or induce passive immunity. Allergens are medicinal products that are
p.002017: intended to identify or stimulate a specific targeted change in the immunological response
p.002017: to an allergic agent.
p.002017: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002017: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative, and
p.002017: when their bioavailability after application in the same
p.002017: the molar dose is similar to a degree which is a condition of equivalent efficacy and safety.
p.002017: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and extent of
p.002017: in which the active substance or the therapeutically significant portion of the test drug reaches
p.002017: from the dosage form to the systemic
p.002017: blood circulation.
p.002017: 20. "Tested medicinal product" means the dosage form of the active substance or placebo to be tested
p.002017: or used as a comparison in a clinical trial, including authorized products
p.002017: for use, but are used for unauthorized use or for the purpose of obtaining additional information on
p.002017: the authorized form, or they are
...
p.002017: diseases "is a product that:
p.002017: (a) is intended for the diagnosis, prophylaxis or treatment of life-threatening diseases
p.002017: diseases or progressive chronic diseases affecting no more than 5 in 10
p.002017: 000 people on the territory of the country, or
p.002017: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002017: health-damaging chronic conditions (diseases with a high incidence of incapacity for work and
p.002017: disability) and evidence was provided that the sale of the product did not provide a satisfactory one
p.002017: returns to justify the investment needed for R&D without
p.002017: incentives for
p.002017: the creator of the product, and
p.002017: (c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of
p.002017: the condition, or if there is one, the proposed medicinal product
p.002017: far more benefits than that and benefits for those affected by this condition.
p.002017: 30. A "dosage form" is an acceptable accepting structure containing the active substance (s) which
p.002017: may or may not include excipients obtained by the application of certain technological
p.002017: operations providing the desired healing effect and
p.002017: storage stability over the shelf life.
p.002017: 31. (amend. - SG 71/08, in force from 12.08.2008) "Person established in the territory of a Member State"
p.002017: is a legal entity registered under the civil or commercial law of a Member State or
p.002017: created by a legal act having its registered office and registered office in a Member State or in a State -
p.002017: Party to the Agreement on
p.002017: The European Economic Area.
p.002017: 32. "Highway formulation" is a prescription for a medicinal product made in a pharmacy under
p.002017: prescription from a healthcare professional or an approved prescription for a particular patient.
p.002017: 33. "International non-patent name" is the recommended name of
p.002017: the active substance approved and published by the WHO.
p.002017: 34. "Medical specialists" are doctors, doctors of dental medicine,
p.002017: master pharmacists, nurses, midwives, medical assistants, paramedics, and
p.002017: assistant pharmacist.
p.002017: 35. "Medical sales representative" is a person who has undergone special training and
p.002017: having the scientific knowledge to provide accurate and complete information on
p.002017: the medicinal product it advertises.
p.002017: 35a. (new - SG 1/2014, in force from 03.01.2014) "Medical prescription" is a prescription of
p.002017: medicinal product or medical device issued by a person practicing regulated medical
p.002017: profession within the meaning of § 1, item 1 of the additional provisions of the Law on the recognition of
p.002017: professional qualifications and what is legal
p.002017: the right to do so in the Member State where the medical prescription is issued.
p.002017: 36. "Multicenter Clinical Trial" is a clinical trial conducted under
p.002017: one protocol but in more than one center and more than one researcher. The research
p.002017: centers may be located in the territory of one Member State in more than one
p.002017: Member State and / or Member States and third countries.
p.002017: 37. "Name of a medicinal product" is the name given to the product which may
p.002017: be:
p.002017: a) freely chosen name (trade name);
p.002017: b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the commercial
...
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
...
p.002017: re-registration, to which shall apply:
p.002017: 1. application for authorization of retail trade of medicinal products from
p.002017: the persons under art. 222, para. 1, according to the model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration of the person under art. 222, para. 1;
p.002017: 3. a copy of the issued in accordance with the repealed Law on Medicines and Pharmacies in
p.002017: human medicine permit to open a pharmacy;
p.002017: 4. a certified copy of the employment contract or contract for management assignment
p.002017: the pharmacy manager - in cases where such is required;
p.002017: 5. declaration by the persons under art. 222, para. 1 that the conditions under which it was issued are preserved
p.002017: the permit for retail sale of medicinal products of the persons under para. 2;
p.002017: 6. document for a one-time fee of BGN 100
p.002017: § 67. Persons who have submitted prior to the entry into force of this Law applications for re-registration under
p.002017: the order of repeal of § 16 of the transitional and final provisions which will carry on their business
p.002017: according to the requirements of this law, submit to the Ministry of
p.002017: within three months of its entry into force, the following documents:
p.002017: 1. an application in accordance with a model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration or certified copy of a similar document under national law
p.002017: of a Member State of the European Union, or under the law of another State Party
p.002017: of the Agreement on the European Economic Area, Art. 222, para. 1;
p.002017: 3. employment contract or contract for the management of the pharmacy concluded with the master pharmacist
p.002017: or pharmacist assistant.
p.002017: § 68. (1) Master-pharmacist or assistant-pharmacist who has been authorized for
p.002017: opening a pharmacy under the repealed § 16 of the transitional and final provisions,
p.002017: may transfer his issued permit to a person under Art. 222, para. 1.
p.002017: (2) For carrying out the transfer the persons under para. 1 filed with the Ministry of
p.002017: healthcare application to which attach:
p.002017: 1. application for authorization of retail trade of medicinal products from
p.002017: the persons under art. 222, para. 1, according to the model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration of the person under art. 222, para. 1;
p.002017: 3. a copy of the issued in accordance with the repealed Law on Medicines and Pharmacies in
p.002017: human medicine permit to open a pharmacy or permit to re - register under
p.002017: the procedure for repealing § 16 of the transitional and final provisions;
p.002017: 4. a certified copy of the employment contract or management contract of the head of
p.002017: pharmacy;
p.002017: 5. declaration by the persons under art. 222, para. 1 that the conditions under which it was issued are preserved
p.002017: the permit for retail sale of medicinal products of the persons under para. 1.
p.002017: (3) The transfer under para. 1 may be completed within one year of its entry into force
p.002017: of this law.
p.002017: § 69. The drugstores welded upon the entry into force of this Act shall continue to be
p.002017: carry out their activities on the basis of the issued certificates of registration.
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.002017: (5) The consent of the minor, the parents or the guardian may be
p.002017: withdrawn at any time without negative consequences for the minor.
p.002017: (6) The express wish of the minor to withdraw at any time from
p.002017: the clinical trial must be considered by the investigator and, if necessary, by the
p.002017: the principal investigator.
p.002017: (7) The information of the test is provided to the minor or minor,
p.002017: about the potential risks and benefits of a physician who has experience with it in an understandable way
p.002017: minors.
p.002017: Art. 98. Informed consent to participate in a clinical trial is not required if
p.002017: imposes an immediate decision to save the person's life, and if at that moment that consent
p.002017: could not be received. The decision is made by at least two doctors who do not participate in
p.002017: the research team.
p.002017: Art. 99. (1) During the test the participant receives an additional upon request
p.002017: information from an independent entity.
p.002017: (2) The written information provided to the participants in the clinical trial of
p.002017: medicinal product, contains contact details of the independent person for additional
p.002017: information.
p.002017: Section II.
p.002017: A clinical trial with vulnerable patient groups
p.002017: Art. 100. A clinical trial of minors may be
p.002017: undertake, provided that:
p.002017: 1. the protocol is approved by the relevant ethics committee after discussion of the clinical,
p.002017: moral and psychosocial aspects of childhood, in which they participated no less than
p.002017: two pediatricians;
p.002017: 2. there is an expected direct benefit of the clinical trial for the group of patients who will
p.002017: be included;
p.002017: 3. the test is directly related to the clinical condition of the minor
p.002017: or the minor;
p.002017: 4. the investigational medicinal product is intended for diagnosis, treatment or
p.002017: prevention of diseases specific to minors;
p.002017: 5. the test is intended to be conducted on minors or minors;
p.002017: 6. the purpose of the test is to verify data obtained from clinical trials on
p.002017: persons who are able to give informed consent or data obtained through others
p.002017: research methods;
p.002017: 7. the results of clinical trials on adults and their results
p.002017: interpretations cannot be considered valid for both minors and minors;
p.002017: 8. the test is designed so that pain, discomfort, fear and other foreseeable risks
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: defined in advance and are constantly monitored by
p.002017: test time;
p.002017: 9. the study is planned and is conducted in accordance with the guidelines of
p.002017: The European Medicines Agency;
p.002017: 10. no financial or other incentives are given except compensation.
...
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.002017: measures;
p.002017: 10a. (new, SG No. 102/2012, effective 21.12.2012) shall exercise the functions of
p.002017: a competent body for pharmacovigilance monitoring;
p.002017: 11. (amend. - SG 102/2012, in force from 21.12.2012) organize and maintain a system
p.002017: for pharmacovigilance monitoring;
p.002017: 12. issue certificates under the WHO certification scheme;
p.002017: 12a. (new, SG No. 18/2014) issue certificates of Good Distribution Practice;
p.002017: 13. issue certificates of Good Manufacturing Practice;
p.002017: 14. (amend. - SG 18/04) consult the investment projects for construction of
p.002017: new and / or redevelopment of existing facilities related to the manufacture of medicinal products
p.002017: products in accordance with the rules of Good Manufacturing Practice;
p.002017: 15. performs the functions of coordinator and advisory body on problems,
p.002017: related to the quality, efficacy and safety of medicinal products;
p.002017: 16. performs consulting, scientific, information and publishing activities in the field
p.002017: the medicines sector;
p.002017: 17. coordinates and participates in activities related to the European Pharmacopoeia and to the
p.002017: the development of the Bulgarian Pharmacopoeia;
p.002017: 18. participate in activities in the field of medicinal products related to the work of the European Agency
p.002017: on Medicines, European Directorate for Quality of Medicines and Health, international
p.002017: bodies and organizations as well as with the implementation of
p.002017: international treaties to which the Republic of Bulgaria is a party;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) participates in the international
p.002017: harmonization and standardization of technical measures related to traceability
p.002017: drug safety, coordinated by the European Medicines Agency;
p.002017: 18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain
p.002017: national internet portal for medicinal products;
p.002017: 19. performs other activities specified by law.
p.002017: (6) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: medicines coordinates its activities with regional health inspections (RICs) in the area of
p.002017: control of medicinal products.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under
p.002017: this law related to preventing the entry and distribution of counterfeit
p.002017: medicinal products, is carried out in cooperation between the BDA and the customs authorities.
p.002017: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health
p.002017: inspections issue certificates for registration of drugstores.
p.002017: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002017: retail of medicinal products, which includes three representatives of the Bulgarian
p.002017: pharmaceutical union, one representative of the faculties of pharmacy of the medical colleges and
p.002017: four BDA representatives. The composition of the Board is determined by an order of the Executive Director of the BDA,
p.002017: agreed with the Minister of
p.002017: healthcare.
p.002017: (2) The council under para. 1 is an advisory unit which:
p.002017: 1. prepares opinions on the applications and documents submitted to the BDA under Art. 228, para. 1 and 5,
p.002017: which he presents to the Executive Director of the BDA;
p.002017: 2. make motivated proposals to the Minister of Health through
p.002017: the BDA's Executive Director for improving public access to medicines
...
p.002017: sole proprietors manufacturing, importing, wholesale or retail trade with
p.002017: medical products;
p.002017: 2. partners or shareholders holding more than 5 percent of the capital in commercial
p.002017: companies active in the manufacture, import, wholesale or retail of medicinal products
p.002017: products or work under contract with those companies.
p.002017: Section II.
p.002017: Registers
p.002017: Art. 18. (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 19. (1) The Executive Agency for Medicines shall keep and keep registers of:
p.002017: 1. (amended, SG No. 102/2012, effective 21.12.2012) Manufacturers and importers
p.002017: of medicinal products on the territory of the Republic of Bulgaria and the qualified persons under
p.002017: Art. 148, item 2 and under Art. 161, para. 2, Vol. 1;
p.002017: 2. (amend. - SG 102/02, in force from 21.12.2012) the manufacturers, importers and
p.002017: wholesalers of active substances;
p.002017: 3. the authorized and registered medicinal products on the territory of
p.002017: Republic of Bulgaria;
p.002017: 4. wholesalers of medicinal products on the territory of the Republic of Bulgaria;
p.002017: 4a. (new, SG No. 102/2012, effective 21.12.2012) intermediaries in the field of
p.002017: medicinal products;
p.002017: 5. (amend. - SG 60/11, in force from 05.08.2011) the issued permits for
p.002017: retailing of medicinal products;
p.002017: 6. approved clinical trials;
p.002017: 7. the licenses issued for parallel import;
p.002017: 8. (New, SG No. 18/2014) the notifications on export of medicinal products in the order
p.002017: to Chapter Nine "b".
p.002017: (2) The data from the registers under para. 1, items 1-5 and 7 shall be published within 14 days of issue
p.002017: of the relevant permission on the BDA website on the Internet.
p.002017: (3) The Drug Enforcement Agency maintains electronic exchange systems for
p.002017: data with the regulatory authorities of other Member States, the European Commission and the European Commission
p.002017: drug agency.
p.002017: Art. 19a. (New, SG No. 60/2011, effective 05.08.2011) (1) The respective SICs shall also keep
p.002017: maintain public registers for the drugstore registration certificates they have issued.
p.002017: (2) Within 7 days from the issuance of a certificate for registration of a drugstore
p.002017: the respective RII sends to the Ministry of Health information on the issued act.
p.002017: (3) The Ministry of Health shall maintain and maintain on its website
p.002017: public national register of drugstore registration certificates issued.
p.002017: Section III.
p.002017: Financing
p.002017: Art. 20. (1) The activities of the BDA shall be financed by budgetary funds and revenues from
p.002017: own business.
p.002017: (2) (amend. - SG 15/2013, in force from 01.01.2014) The budgetary funds shall be
p.002017: provide a subsidy from the state budget through the budget of the Ministry of Finance
p.002017: healthcare.
p.002017: Art. 21. (1) The Executive Agency for Medicines shall be the revenue administrator of
p.002017: own activity, which are formed by:
p.002017: 1. chemical-pharmaceutical expertise;
p.002017: 2. laboratory analyzes and tests;
p.002017: 3. evaluation of documentation and issuance of permits, certificates, certificates and
p.002017: other documents specified in this law;
p.002017: 4. evaluation of the renewal, modification and deletion of the marketing authorization, and
p.002017: certificate of registration of a medicinal product;
p.002017: 5. maintenance of the marketing authorizations or the registration certificates of
p.002017: medicine;
p.002017: 6. fines and pecuniary sanctions imposed by criminal decrees issued for
p.002017: violations under this law;
p.002017: 7. consulting, publishing and research activities in the field of
p.002017: the medical sector;
...
p.002017: conducted by the manufacturer of the medicinal product confirm that the active substance is manufactured in
p.002017: compliance with the principles and guidelines for Good
p.002017: manufacturing practice; the declaration shall indicate the date on which the audit was carried out;
p.002017: 9. an assessment of the potential risk of the medicinal product to the environment for everyone
p.002017: the individual case and the measures envisaged to limit it;
p.002017: 10. results from:
p.002017: (a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.002017: (b) preclinical (toxicological and pharmacological) studies;
p.002017: (c) clinical trials;
p.002017: 11. a statement that in clinical trials conducted outside the territory of
p.002017: Member States have complied with the ethical principles of Good Clinical Practice;
p.002017: 12. (amended, SG No. 102/2012, effective 21.12.2012) summary of the system for
p.002017: pharmacovigilance monitoring, which includes the following elements:
p.002017: a) the name of the qualified person under Art. 191, curriculum vitae - education acquired
p.002017: professional experience in the field of pharmacovigilance monitoring and qualification for
p.002017: fulfillment of his duties in accordance with Chapter Eight;
p.002017: (b) any Member State in which the qualified person fulfills the obligations
p.002017: his;
p.002017: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002017: (d) the address at which the primary document of the traceability system is stored
p.002017: drug safety;
p.002017: 12a. (new - SG 102/2012, in force since 21.12.2012) statement by the applicant that
p.002017: has the necessary means to fulfill the obligations of Chapter Eight;
p.002017: 13. (Amended, SG No. 102/2012, effective 21.12.2012) risk management plan with
p.002017: a description of the risk management system that the applicant will put in place for that person
p.002017: medicinal product, together with a summary of the plan;
p.002017: 14. a brief description of the product according to Art. 34;
p.002017: 15. layout of the primary and secondary packaging of the product and a leaflet in
p.002017: compliance with the requirements of Chapter Six;
p.002017: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country where
p.002017: production shall be carried out accompanied by a certificate of good manufacturing practice or
p.002017: certificate certifying that the manufacture of the medicinal product and of the active substances included in
p.002017: its composition was done in accordance with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 17. a copy of the document identifying the medicinal product for treatment,
p.002017: prevention or diagnosis of rare diseases, accompanied by a copy of the opinion of
p.002017: The European Medicines Agency;
p.002017: 18. copies of any marketing authorization issued in another Member State or in
p.002017: a third country for the medicinal product for which a marketing authorization is sought;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) copy of the summary of the safety data, including
...
p.002017: a medicinal product containing active substances of well - established use that has not been used in
p.002017: the proposed combination for therapeutic purposes. In this
p.002017: no documentation is submitted in respect of each individual active substance.
p.002017: (3) When an active substance within the meaning of para. 1 has a proven new therapeutic indication on the base
p.002017: significant preclinical or clinical data related to the new indication, once for a period of
p.002017: one year the next applicant cannot rely on
p.002017: data on the new indication of the active substance.
p.002017: Art. 31. In the case where a medicinal product contains active substances used in the authorized composition
p.002017: for use medicinal products but not used in the proposed combination for therapeutic purposes, the person
p.002017: under Art. 26, para. 1 presents the results of preclinical and clinical trials related to
p.002017: this combination. In this case, the applicant does not provide documentation on the safety and efficacy of each
p.002017: separately
p.002017: active substance.
p.002017: Art. 32. The holder of an authorization to use a medicinal product may authorize the use of the pharmaceutical,
p.002017: the preclinical and clinical documentation contained in the dossier of the medicinal product when evaluating
p.002017: subsequent drug applications
p.002017: products of the same qualitative and quantitative composition as regards the active substances and with
p.002017: same dosage form.
p.002017: Art. 33. Conducting the necessary studies and tests to prepare authorization documentation
p.002017: for use and subsequent practical requirements for the authorization of medicinal products under
p.002017: Art. 28 and 29 is not a patent infringement
p.002017: or the supplementary protection certificate for a medicinal product.
p.002017: Art. 34. (1) The summary of product characteristics shall contain the following information:
p.002017: 1. name of the medicinal product, quantity of active substance for dosage
p.002017: unit, dosage form;
p.002017: 2. quantitative and qualitative composition in respect of the active substances and those of
p.002017: excipients for which information is essential for the proper application of
p.002017: product; the common name or chemical description is used;
p.002017: 3. dosage form;
p.002017: 4. clinical data:
p.002017: (a) therapeutic indications;
p.002017: (b) dosage and route of administration for adults and children;
p.002017: c) contraindications;
p.002017: (d) special warnings and precautions for use; for immunological
p.002017: medicinal products - precautions for persons handling and administering them
p.002017: patients, as well as the precautions to be taken by the patient;
p.002017: (e) interactions with other medicinal products or other forms of interaction;
p.002017: (f) use in pregnancy or lactation;
p.002017: (g) effects on the ability to drive and use machines;
p.002017: h) side effects;
...
p.002017: use;
p.002017: 10. date on which the content of the summary of the Summary of Product Characteristics was made
p.002017: product;
p.002017: 11. for radiopharmaceuticals - comprehensive information on internal radiation
p.002017: dosimetry;
p.002017: 12. for radiopharmaceuticals - detailed instructions for extemporaneous preparation and quality control and, where applicable
p.002017: applicable, the maximum storage time during which the relevant intermediate such as eluate or ready
p.002017: for pharmacist use corresponds to
p.002017: its specification.
p.002017: (2) In the summary of the medicinal products under Art. 28 - 33 parts of the short may not be included
p.002017: a characteristic of the reference medicinal product relating to the indications and dosage forms that have been
p.002017: under patent protection at a time when
p.002017: the generic product was on the market.
p.002017: (3) Requirements for the form and content of the summary of product characteristics
p.002017: shall be determined in the ordinance under Art. 42.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) The summary of the characteristics of medicinal products,
p.002017: included in the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains
p.002017: information with the following text: "This medicinal product is subject to additional monitoring". In front of the text
p.002017: signs in black color according to Art. 23 (5) of Regulation (EC) No 726/2004 of the European Parliament and
p.002017: The Council,
p.002017: accompanied by an explanatory note.
p.002017: (5) (New, SG No. 102/2012, effective 21.12.2012) The summary of product characteristics
p.002017: contains standard text that encourages medical professionals to report any suspected adverse drug reactions
p.002017: reaction according to the models of art. 185, para.
p.002017: 2, Vol. 4.
p.002017: Section III.
p.002017: Specific requirements for homeopathic medicinal products
p.002017: Art. 35. (1) A certificate for registration of a homeopathic medicinal product shall be issued
p.002017: by a simplified procedure if it fulfills the following conditions:
p.002017: 1. is administered orally or externally;
p.002017: 2. they are not indicated on its packaging or in other information related to it
p.002017: specific therapeutic indications;
p.002017: 3. it is diluted sufficiently to guarantee the safety of the product and contains no more than one
p.002017: ten thousandth of the mother's tincture or more than one hundredth of the smallest dose used in
p.002017: allopathy, of the active substances whose presence in
p.002017: allopathic medicinal product leads to mandatory medical prescription.
p.002017: (2) For the issuance of a certificate for registration of a homeopathic medicinal product the person under Art. 26, para.
p.002017: 1 shall submit to the BDA an application in a form in which a series of medicinal products may be indicated,
p.002017: obtained from the same homeopathic source or from the same
p.002017: same sources.
p.002017: (3) To demonstrate the pharmaceutical quality and homogeneity of batches of medicinal products
p.002017: product to the application under para. 2, the following documentation shall be attached:
p.002017: 1. (amend. - SG 71/08, in force from 12.08.2008) scientific name or
p.002017: pharmacopoeial name of the homeopathic source or sources together with the various
p.002017: routes of administration, dosage forms and degree of dilution;
p.002017: 2. a file describing the method of obtaining and controlling the homeopathic
p.002017: source or sources proving homeopathic use based on appropriate
p.002017: bibliography;
...
p.002017: manufacturer to carry out certain stages of production or control
p.002017: of the medicinal product.
p.002017: (2) When the BDA carries out an on-site inspection of a production site, the term under Art. 44
p.002017: stops running until a report of the results of the audit is drawn up.
p.002017: (3) In the cases of para. 1, items 2 and 3 the manufacturers shall pay a fee in the amount specified in
p.002017: the tariff under Art. 21, para. 2.
p.002017: Art. 47. (1) To the Executive Director of the BDA as consultative bodies shall be established
p.002017: the following specialized committees:
p.002017: 1. Committee for Medicinal Products;
p.002017: 2. Committee on Immunological Medicinal Products;
p.002017: 3. Committee for Homeopathic Medicinal Products;
p.002017: 4. Committee for Herbal Medicinal Products;
p.002017: 5. Radiopharmaceuticals Commission;
p.002017: 6. (new - SG 71/08, in force from 12.08.2008) Committee for Medicinal Products
p.002017: with application in pediatrics;
p.002017: 7. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force
p.002017: from 21.12.2012) Committee for Medicinal Products for Advanced Therapies;
p.002017: 8. (New, SG No. 102/2012, in force since 21.12.2012)
p.002017: pharmacovigilance monitoring.
p.002017: (2) If necessary, the BDA Executive Director may create others
p.002017: specialized committees outside the ones specified in para. 1.
p.002017: (3) Specialized commissions shall include specialists having scientific
p.002017: achievements and practical experience in the relevant fields of application of medicinal products.
p.002017: (4) External experts with a special status may be involved in the permanent composition of the commissions
p.002017: scientific knowledge and practical experience in the field of the specific drug group.
p.002017: (5) The Executive Director of the BDA shall determine by an order the composition of the commissions for a term
p.002017: three years, the amount of their remuneration and approve the terms and conditions of the
p.002017: their work.
p.002017: (6) By 30 January each year, the Executive Director of the BDA shall approve the lists of
p.002017: the experts outside the composition of the commissions under para. 1 after approval by the Minister of
p.002017: healthcare.
p.002017: (7) The BDA Executive Director may release a member of the BDA early
p.002017: specialized committee at his request for failure to fulfill his obligations for more than three
p.002017: months or in bad faith in the performance of its functions.
p.002017: (8) The composition of the commissions and the list of experts under para. 6 are announced on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 48. (1) The members of the specialized commissions under Art. 47, para. 1 and the experts under Art.
p.002017: 47, para. 4 sign a declaration, obliging them not to:
p.002017: 1. disclose data and circumstances that have become known to them on or on occasion
p.002017: carrying out their activity;
p.002017: 2. participate in activities related to the production or wholesale and retail trade with
p.002017: medical products.
p.002017: (2) In case the persons under para. 1 have participated in one of the preparation stages of
p.002017: the documentation necessary to authorize the use of the medicinal product cannot be provided
p.002017: participate in the meetings of the respective specialized commission under art. 47.
p.002017: (3) The persons under para. 1 shall not vote in decisions on matters on which they or
p.002017: their family members have commercial, financial or other interests.
...
p.002017: of the BDA issues the authorization for renewal of the marketing authorization / certificate for
p.002017: registration of the medicinal product or motivated refusal.
p.002017: Art. 59b. (New, SG No. 71/2008, effective 12.08.2008) (1) The Executive Director of the BDA
p.002017: refuses to renew the Marketing Authorization / Marketing Authorization
p.002017: product when, after evaluation of the dossier under Art. 59a, para. 1 se
p.002017: found that:
p.002017: 1. the medicinal product is harmful when used correctly, or
p.002017: 2. lack of therapeutic efficacy, or
p.002017: 3. the benefit / risk balance is unfavorable when used correctly, or
p.002017: 4. the quantitative and qualitative composition of the medicinal product does not correspond to
p.002017: descriptions in the file, or
p.002017: 5. the data in the file under art. 59a, para. 1 are incorrect, or
p.002017: 6. the control of the medicinal product and / or of the ingredients and the intermediate stages of
p.002017: the manufacturing process has not been performed or no other requirement is fulfilled, where it is
p.002017: the production authorization has been issued, or
p.002017: 7. some of the data in the file do not meet the requirements of Art. 59a, para. 1 and 2.
p.002017: (2) Refusal of the Executive Director of the BDA to renew the authorization for
p.002017: use / registration certificate of a medicinal product may be appealed in the order of
p.002017: Code of Administrative Procedure.
p.002017: (3) The refusal of the BDA Executive Director and the reasons shall be published on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 59c. (New, SG No. 60/2011, effective 05.08.2011, amended - SG No. 102/2012, effective 01.04.2013
p.002017: d.) The Drugs Executive Agency notifies the National Drug Price and Reimbursement Council
p.002017: products for the revoked and revoked marketing authorizations, as well as for the refusals to renew
p.002017: authorizations granted for
p.002017: medicinal products within 7 days of the issuance of the relevant act.
p.002017: Section VI.
p.002017: Changes to the marketing authorization issued
p.002017: Art. 60. (1) (amend. - SG 12/11, in force from 08.02.2011)
p.002017: a marketing authorization is obliged to notify the BDA of any change to
p.002017: the conditions under which the authorization was granted.
p.002017: (2) (Amended, SG No. 12/2011, effective 08.02.2011) Changes may be of the type
p.002017: IA, Type IB, Type II, Extension of Marketing Authorization and Emergency Restrictions
p.002017: safety measures.
p.002017: (3) (amend. - SG 12/11, in force from 08.02.2011) The conditions and criteria for
p.002017: classification of the changes shall be determined by the ordinance under Art. 42.
p.002017: (4) (amend. - SG 12/11, in force from 08.02.2011) Change that does not occur
p.002017: extension and whose classification remains uncertain after the conditions have been applied
p.002017: and the criteria of the ordinance under Art. 42, is considered to be a type IB change by default.
p.002017: (5) (New, SG No. 12/2011, effective 08.02.2011) As an exception to para. 4
p.002017: a change that is not an extension of scope and whose classification remains uncertain
p.002017: after applying the conditions and criteria of the ordinance under Art. 42, is considered to be a type II change
p.002017: the following cases:
p.002017: 1. at the request of the holder of the marketing authorization indicated in the application for
p.002017: change;
p.002017: 2. when the BDA after evaluating the validity of the notification under Art. 63 considered that
p.002017: change can have a significant impact on quality, safety or
...
p.002017: product and leaflet for the patient;
p.002017: 6. (New, SG No. 18/2014) inform the BDA of any action taken by it concerning temporary suspension
p.002017: placing on the market of a particular medicinal product, withdrawal from the market of a specific medicinal product, request for
p.002017: termination of the marketing authorization or the stated intention not to renew the marketing authorization,
p.002017: and indicate the reasons why this action was taken; in these cases the holder
p.002017: of the marketing authorization declares whether the actions taken by him are due to any of the
p.002017: the grounds under Art. 276 or under Art. 277;
p.002017: 7. (New, SG No. 18/2014) inform the BDA if the actions under item 6 have been undertaken in
p.002017: third country and are due to any of the grounds under art. 276 or under Art. 277;
p.002017: 8. (new, SG No. 18/2014) inform the European Medicines Agency when
p.002017: the actions under items 6 and 7 have been undertaken on the basis of Art. 276 and 277;
p.002017: 9. (new, SG No. 18/2014) provide sufficient quantities of the medicinal product
p.002017: product for satisfying the health needs of the population of the Republic of Bulgaria.
p.002017: (2) The holder of the marketing authorization / registration certificate is obliged
p.002017: upon request from the BDA to submit:
p.002017: 1. data in support of the positive benefit / risk ratio for the medicinal product;
p.002017: 2. (amend. - SG 18/04) data on the volume of sales of the medicinal product and
p.002017: any other information available to the marketing authorization holder,
p.002017: on the volume of prescriptions for the product;
p.002017: 3. a copy of the basic documentation of the drug monitoring system
p.002017: safety.
p.002017: (3) The Marketing Authorization Holder shall provide the BDA with the documentation on
p.002017: para. 2, item 3 within 7 days after receiving the request.
p.002017: Art. 69. (1) The holder of the authorization for use of the vaccine or immunological
p.002017: medicinal product intended for immunization prior to the release of each batch of product
p.002017: on the market is obliged to present in the BDA:
p.002017: 1. a sample of the final product and / or a sample of the bulk product / non-spilled product;
p.002017: 2. production and quality control protocols;
p.002017: 3. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (2) The holder of the authorization for the use of new immunological medicinal products or immunological medicinal products
p.002017: medicinal products manufactured with new or modified technologies or with technologies new to the individual manufacturer,
p.002017: fulfills the obligations under para. 1 for
p.002017: the specific period specified in the Marketing Authorization.
p.002017: (3) Within 60 days from the date of submission of the complete set of BDA documents
p.002017: evaluates production protocols and quality control of live vaccines,
p.002017: immunological and new immunological medicinal products and testing of the provided samples in an accredited one
p.002017: laboratory to determine whether the medicinal products under para. 1 and 2 are
p.002017: manufactured in accordance with approved specifications.
p.002017: (4) Upon a positive result of the test, the BDA shall issue a certificate of release
p.002017: of the lot.
p.002017: (5) The conditions, procedure, and requirements for the documentation for the issuance of
p.002017: batch release certificate for the products under para. 1 and 2 shall be determined in an ordinance of
p.002017: the Minister of Health.
...
p.002017: people unable to give informed consent, in the cases under Art. 100 and 101;
p.002017: 8. the anticipated compensation or compensation in the event of injury or death, which
p.002017: may be the result of a clinical trial;
p.002017: 9. the insurance covering the liability of the researcher and the assignor;
p.002017: 10. where necessary, the terms and conditions for the remuneration or compensation of
p.002017: the researchers and the participants in the clinical trial and the elements of the contract between
p.002017: the client and the medical establishment;
p.002017: 11. the conditions and procedure for recruiting participants.
p.002017: (2) The Ethics Committee shall:
p.002017: 1. gives a favorable opinion;
p.002017: 2. motivated refuses, or
p.002017: 3. requires a change in some of the documentation as a condition for receiving a positive one
p.002017: position.
p.002017: Art. 112. (1) Within 60 days from the submission of an application, the relevant ethics committee shall
p.002017: delivers an opinion to the applicant and the BDA.
p.002017: (2) Where the clinical trial includes a gene therapy medicinal product or
p.002017: somatic cell therapy or a medicinal product containing genetically modified
p.002017: organisms, the term under para. 1 is extended to 30 days.
p.002017: (3) The deadline for issuing an opinion is 180 days, when for clinical examination
p.002017: a trial involving a gene therapy or somatic cell therapy drug
p.002017: or a medicinal product containing genetically modified organisms is required to be consulted
p.002017: expert commission specially created by order of the BDA Director.
p.002017: Art. 113. (1) When evaluating the documentation, the Ethics Committee may require
p.002017: one additional written documentation from the applicant. The time limits under Art. 112 stop yes
p.002017: run until the required documentation is submitted.
p.002017: (2) The procedure for examining the study shall be terminated if, within 60 days from
p.002017: receiving the request for additional information, the contracting authority did not submit the request by
p.002017: commission documentation.
p.002017: Art. 114. (1) When the test will be conducted in more than one center in the territory
p.002017: of the Republic of Bulgaria, an application shall be submitted to the Ethics Committee for Multicenter Tests
p.002017: under Art. 103, para. 1.
p.002017: (2) When the test will be conducted in only one center in the territory of the Republic
p.002017: Bulgaria, an application may be submitted to the relevant Ethics Committee under Art. 103, para. 1 or 2 on
p.002017: choice of the contracting authority.
p.002017: (3) The opinion of the Ethics Committee under Art. 103, para. 1 is valid for all centers of
p.002017: the territory of the Republic of Bulgaria.
p.002017: (4) (New - SG 12/2011, in force from 08.02.2011) For submission of applications for
...
p.002017: the clinical trial, at the latest 15 days after receipt of information on their occurrence.
p.002017: Art. 139. (1) The assignor may fulfill its obligations under Art. 138, para. 1 and 3, such
p.002017: submit reports to the European Adverse Reaction Database.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) When the clinical trial is conducted outside
p.002017: Member States, the contracting entity shall submit reports of suspected unexpected serious adverse reactions
p.002017: reactions in the European Adverse Reactions Database.
p.002017: (3) (Amended, SG No. 102/2012, effective 21.12.2012) The format and content of
p.002017: reports of adverse reactions are specified in the ordinance under Art. 82, para. 3.
p.002017: (4) The contracting authority shall inform the researchers conducting the clinical trial with
p.002017: medicinal product, for any suspected unexpected serious adverse reaction,
p.002017: related to the investigational medicinal product, regardless of its origin.
p.002017: Art. 140. (1) The contracting authority shall provide the BDA and the respective commission once a year
p.002017: ethics list of all suspected serious side effects that are
p.002017: occurred during the previous period, and a safety report of the test participants.
p.002017: (2) (Amended, SG No. 102/2012, effective 21.12.2012) The form and content of
p.002017: the report shall be specified in the ordinance under Art. 82, para. 3.
p.002017: Art. 141. (1) The Executive Agency for Medicines shall document each provided under
p.002017: the order of art. 138, para. 1 and 3 information on suspected unexpected serious adverse reactions
p.002017: drug reactions of tested medicinal products.
p.002017: (2) The executive medicine agency shall immediately enter the information under para. 1 c
p.002017: European database of adverse reactions.
p.002017: Section VIII.
p.002017: Notification of completion of clinical trial
p.002017: Art. 142. (1) The assignor shall notify in writing the BDA and the relevant ethics committee about
p.002017: the completion of the test on the territory of the Republic of Bulgaria.
p.002017: (2) The notification must be submitted within 90 days of the completion of the survey in a format,
p.002017: defined in the ordinance under art. 82, para. 3.
p.002017: (3) Unless otherwise stated in the protocol approved by the relevant Ethics Committee,
p.002017: completion of the test is considered the last visit of a participant.
p.002017: (4) When the test is terminated prematurely, the contracting authority shall notify the BDA and
p.002017: the relevant ethics committee, within 15 days of the decision, stating the reasons
p.002017: for that.
p.002017: Art. 143. The contracting authority shall submit to the BDA and to the relevant ethics committee
p.002017: final clinical trial report.
p.002017: Art. 144. (1) The Executive Agency for Medicinal Products shall enter data in the European Clinical Trials Database
p.002017: for each clinical trial in the territory of the Republic of Bulgaria - application submitted, decision of
p.002017: ethics committee, permission to conduct,
...
p.002017: the reasons for this.
p.002017: (3) The Executive Director of the BDA within 30 days of receipt of the documentation
p.002017: under para. 2 approves the amended protocol or issues a reasoned refusal and notifies the holder of
p.002017: the marketing authorization.
p.002017: (4) The Commission under Art. 103, para. 1, respectively the commissions under art. 103, para. 2, within 30 days of
p.002017: the date of receipt of the documentation under para. 2 sends to the holder of the authorization for
p.002017: use a positive or negative opinion.
p.002017: (5) The BDA Executive Director shall refuse the changes under para. 1 with one or more of
p.002017: the reasons referred to in Art. 145f, para. 2, Vol. 2.
p.002017: (6) The holder of the marketing authorization may apply the changes under para. 1 next
p.002017: obtaining approval from the BDA and a positive opinion from the committee under Art. 103, para. 1,
p.002017: respectively the commissions under art. 103, para. 2.
p.002017: (7) To evaluate the documentation under para. 1 The BDA collects a fee in the amount specified in
p.002017: the tariff under Art. 21, para. 2.
p.002017: Art. 145d. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002017: use shall submit a final report of the BDA study within 12 months of completion of the collection
p.002017: data. A summary of the results is attached to the report
p.002017: from the study.
p.002017: (2) The marketing authorization holder may submit a reasoned request to
p.002017: BDA for postponement of the term under para. 1 at least three months before the submission date of
p.002017: the final report referred to in the minutes.
p.002017: (3) The Drug Enforcement Agency shall approve or make a reasoned refusal
p.002017: the request under para. 2 and notify the holder of the marketing authorization.
p.002017: (4) When the holder of the marketing authorization based on the report under para. 1
p.002017: considered that a change to the marketing authorization was necessary, he submitted to the BDA an application for
p.002017: change in the order of Chapter Three, Section VI.
p.002017: (5) The BDA Executive Director shall by order suspend or terminate the marketing authorization,
p.002017: when the BDA based on the report under para. 1 and after consultation with the marketing authorization holder
p.002017: consider stopping or stopping
p.002017: of the Marketing Authorization.
p.002017: Art. 145f. (New, SG No. 102/2012, effective 21.12.2012) (1) When the study is conducted as on
p.002017: the territory of the Republic of Bulgaria and of the territory of other Member States for medicinal products,
p.002017: authorized under Regulation (EC) No 726/2004 of the European Parliament and of the Council or in accordance with Chapter
p.002017: third, section VII in fulfillment of the obligations under art. 55a or under Art. 56a, the authorization holder
p.002017: for use filed by
p.002017: the committee under Art. 56a, para. 1, item 1 of the draft protocol.
p.002017: (2) Within 60 days from the date of receipt of the documentation under para. 1 the committee under art.
p.002017: 56a, para. 1, item 1 prepares an opinion and sends to the holder of the marketing authorization:
p.002017: 1. notification of approval, or
p.002017: 2. a reasoned refusal when:
p.002017: (a) found that the study promoted the use of the medicinal product
p.002017: product, and / or
p.002017: (b) consider that the design of the study will not achieve the objectives of the report,
p.002017: and / or
...
p.002017: termination of the marketing authorization, including a timetable for the implementation of the opinion.
p.002017: The opinion shall be published on the European Internet Portal for Medicinal Products under Art. 68, para. 1, Vol. 4
p.002017: and sent to
p.002017: the holder of the marketing authorization.
p.002017: (10) Where in the opinion under para. 9 is a position for regulatory action
p.002017: action on marketing authorizations, the European Commission decides on
p.002017: modification, suspension or termination of marketing authorizations granted under the Regulation
p.002017: (EC) No 726/2004 of the European Parliament and of the Council.
p.002017: Art. 145k. (New, SG No. 102/2012, effective 21.12.2012) (1) Non-interventional
p.002017: surveys on the territory of the Republic of Bulgaria shall be conducted in accordance with Art. 145c - 145d.
p.002017: (2) When conducting non-interventional studies under para. 1 indicates the source
p.002017: of financing.
p.002017: Chapter Five.
p.002017: MANUFACTURE AND IMPORTATION OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES
p.002017: (TITLE AM. - SG, iss. 102 OF 2012, IN EFFECT OF 02/01/2013)
p.002017: Section I.
p.002017: Production
p.002017: Art. 146. (1) (amend. - SG 102/2012, in force from 02.01.2013) The production of all types
p.002017: medicinal products within the meaning of this Act and of medicinal products intended for clinical use
p.002017: testing, may be carried out on the territory of the Republic of Bulgaria only by natural or legal persons,
p.002017: registered as traders in the territory of a Member State who have been granted a manufacturing authorization,
p.002017: issued by the Director of
p.002017: Drug Enforcement Agency.
p.002017: (2) A production permit shall also be required in the cases where the products under para. 1 are
p.002017: intended for export only.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008)
p.002017: requires also for persons performing simultaneously or individually one of the following activities:
p.002017: full or partial production, various processes of packaging, packaging, repackaging, labeling, quality
p.002017: control and release of batches of medicinal products and
p.002017: medicinal products intended for clinical trial.
p.002017: (4) (Repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: (5) No production authorization is required where the cutting processes,
p.002017: mixing or packaging is carried out according to the main or pharmacopoeial formulation in a pharmacy.
p.002017: Art. 147. (amend. - SG 102/2012, in force from 02.01.2013) The Executive Agency for Medicines shall introduce
p.002017: information on marketing authorizations for medicinal products and certificates of good manufacturing
p.002017: practice in the European Union database.
p.002017: Art. 148. For obtaining a production permit the person under Art. 146 should
p.002017: has:
p.002017: 1. with appropriately qualified personnel, depending on the specifics of
p.002017: manufactured types of medicinal products and dosage forms;
p.002017: 2. at any one time with at least one qualified person who is eligible
p.002017: Art. 159;
p.002017: 3. premises for production, control and storage of medicinal products,
p.002017: provided with the necessary technical equipment and control laboratories.
p.002017: Art. 149. Managers of production and quality control of medicinal products
p.002017: products in manufacturing enterprises are persons:
p.002017: 1. who hold a Master's degree in a specialty
...
p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
p.002017: production of radiopharmaceuticals or medicinal products subject to ionization
p.002017: radiation during their production;
p.002017: 8. permission to use the premises for production, control and storage,
p.002017: issued by the order of the Spatial Planning Act, or other substitute document;
p.002017: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 10. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) In the manufacture of narcotic substances and dosage forms containing
p.002017: such substances are also complied with the requirements of the Drug Control Act and
p.002017: precursors.
p.002017: (4) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 2, Vol. 1,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
p.002017: perform by contract in another object on the territory of the Republic of Bulgaria or outside it, the persons under art. 146
p.002017: are required to indicate the location of this
p.002017: an object and a copy of the contract setting out the responsibilities of each party in respect of
p.002017: compliance with the requirements of Good Manufacturing Practice of Medicinal Products
p.002017: products and obligations of the qualified person under Art. 148, Vol. 2.
p.002017: Art. 152. (amend. - SG 102/2012, in force from 02.01.2013) (1) The principles and requirements for
p.002017: Good manufacturing practice for all types of medicinal products, clinical medicinal products
p.002017: test and of the active substances are determined by the ordinance of
p.002017: the Minister of Health and with acts and guidelines adopted by the European Commission.
p.002017: (2) The principles and requirements for a formal risk assessment to establish the
p.002017: Good manufacturing practice for excipients shall be determined by the ordinance under para. 1 and p
p.002017: guidelines adopted by the European Commission.
p.002017: Art. 153. (1) Upon receipt of an application under Art. 150 BDA evaluates the submitted documentation and
p.002017: perform on-site inspection of the production, control and storage sites, including in the cases under Art.
...
p.002017: substances and medicinal products intended for clinical use
p.002017: tests, under the conditions and in the order specified in the ordinance under art. 152.
p.002017: (5) (Renumbered from Paragraph (3), SG No. 102/2012, in force from 02.01.2013) In the case of a medicinal product
p.002017: product for clinical trial, the holder of the manufacturing authorization shall ensure that
p.002017: all production operations shall be carried out in accordance with
p.002017: the information provided by the contracting authority to the BDA in accordance with the ordinance under Art. 82, para. 3.
p.002017: (6) (Renumbered from Paragraph (4), SG No. 102/2012, effective 02.01.2013)
p.002017: each transaction is kept for 5 years and contains the date, name of the medicinal product
p.002017: product, quantity delivered, name and address of consignee, and batch number.
p.002017: (7) (Renumbered from Paragraph (5), SG No. 102/2012, effective 02.01.2013)
p.002017: a production authorization provides and maintains a system for blocking and withdrawing from the market
p.002017: medicinal products that have shown non-compliance with quality requirements.
p.002017: (8) (Renumbered from Paragraph (6), SG No. 102/2012, effective 02.01.2013)
p.002017: a manufacturing authorization is required to block and withdraw the medicinal products shown
p.002017: non-compliance with the requirements for quality, efficiency and safety, in accordance with the ordinance of
p.002017: Art. 274, para. 1.
p.002017: (9) (Renumbered from Paragraph (7), SG No. 102/2012, effective 02/01/2013)
p.002017: a manufacturing authorization is required to update production methods in accordance
p.002017: with the development of new technologies and the development of test drug products.
p.002017: (10) (New - SG, iss. 12 in 2011, in force since 08.02.2011, previous para 8, amended - SG, iss. 102 in 2012, in force since
p.002017: 02.01.2013) Based on the manufacturing authorization issued under
p.002017: the order of this section, its holder may import the auxiliaries necessary for
p.002017: the manufacture of the medicinal products referred to in the marketing authorization
p.002017: production.
p.002017: Art. 160a. (New, SG No. 60/2011, effective 05.08.2011) (1) The Executive Director of the BDA
p.002017: by an order revokes the issued production permit when the conditions under art. 148 and they are not
p.002017: the requirements of Good Manufacturing Practice have been met,
p.002017: determined in accordance with Art. 152.
p.002017: (2) The BDA Executive Director shall by an order terminate the permit for
p.002017: production:
p.002017: 1. at the written request of its holder;
p.002017: 2. upon termination of the activities for which it was issued;
p.002017: 3. upon deletion of the registration of the trader;
p.002017: 4. at the death of the individual - sole trader.
p.002017: (3) The order under para. 1 may be appealed by the order of the Administrative Procedure
p.002017: Code, the appeal does not stop enforcement.
p.002017: Section II.
p.002017: Import of medicinal products (Title amend. - SG 102/02, in force from 02.01.2013)
p.002017: Art. 161. (1) (amend. - SG 102/02, in force from 02.01.2013) Imports into the territory of the Republic of Bulgaria from
p.002017: third country of all types of medicinal products and medicinal products intended for clinical use
p.002017: testing may only be carried out by natural or legal persons registered as traders under the legislation
p.002017: of a Member State that are
p.002017: have received an import permit issued by the BDA Executive Director.
p.002017: (2) In order to obtain an import permit, the person under para. 1 must have:
...
p.002017: of § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002017: caused by a defect in the goods,
p.002017: provided for therein.
p.002017: Chapter Six.
p.002017: PACKAGING AND PACKAGE LEAFLET
p.002017: Art. 168. (1) The packaging of a medicinal product shall consist of primary and / or secondary
p.002017: packing and leaflet for the patient.
p.002017: (2) (amend. - SG 61/11, in force from 10.11.2011)
p.002017: medicinal products containing substances specified in the list under Art. 3, para. 2, item 2 of the Law on
p.002017: control of drugs and precursors is diagonally marked with two red bars and the secondary
p.002017: packaging of medicinal products containing substances from the list under Art. 3, para. 2, item 3 of the Control Act
p.002017: narcotic drugs and precursors - with two blue bars. The packaging must contain an indication that
p.002017: the medicinal product is only available at
p.002017: special medical prescription.
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products included in
p.002017: the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains information
p.002017: with the following text: "This medicinal product is subject to additional monitoring". A text in front of the text is placed
p.002017: black in accordance with Article 23 (5) of Regulation (EC) No 726/2004 of the European Parliament and of the Council, accompanied by
p.002017: from the explanatory note.
p.002017: (4) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products shall include
p.002017: a standard text asking patients to report to medical professionals or directly to
p.002017: BDA any suspected adverse drug reaction
p.002017: reaction according to the models of art. 185, para. 2, Vol. 4.
p.002017: (5) Where the medicinal product is authorized for use in the territory of the Republic
p.002017: Bulgaria, on its secondary packaging, shall be marked with a separate collection and
p.002017: recycling in accordance with the Waste Management Act and its implementing acts.
p.002017: (6) Where a medicinal product is authorized, its name shall be
p.002017: the outer carton, the dosage form and the content of the active substance in the dose
p.002017: the unit is also written in Braille.
p.002017: (7) The requirements of para. 6 shall not apply to vaccines and medicinal products in hospital
p.002017: packaging.
p.002017: (8) (New, SG No. 102/2012, effective 21.12.2012) On the outer packaging, and
p.002017: if not, on the immediate packaging of the medicinal products except
p.002017: radiopharmaceuticals, applied:
p.002017: 1. an individual identifier for the safety indicators it gives
p.002017: opportunity for wholesalers and retailers to:
p.002017: (a) verify the authenticity of the medicinal product;
p.002017: (b) identify the individual packaging;
p.002017: 2. a means by which to check the packaging of the medicinal product
p.002017: whether it was forged.
p.002017: Art. 168a. (New, SG No. 102/2012, effective 21.12.2012) (1) On the packaging of a medicinal product that
p.002017: shall be granted on medical prescription, safety indicators according to art. 168, para. 8, except
p.002017: of cases where the medicinal product is
p.002017: included in the list determined by the European Commission by a delegated act under art. 168b.
p.002017: (2) No indications for the packaging of a medicinal product dispensed without a medical prescription shall be given.
p.002017: safety under Art. 168, para. 8, except where the medicinal product is included in the list,
p.002017: designated by the European Commission by means of a delegated act
p.002017: under Art. 168b, having been assessed as being at risk of forgery.
p.002017: (3) The Medicines Executive Agency shall notify the European Commission of:
p.002017: 1. for medicinal products which are available without a prescription for which it is
p.002017: found that there was a risk of counterfeiting;
p.002017: 2. for medicinal products for which it has been established that there is no risk of
p.002017: falsification, taking into account the following criteria:
p.002017: (a) the price and sales volume of the medicinal product;
p.002017: (b) the number and incidence of cases of counterfeit medicinal products registered in
p.002017: within the European Union and in third countries, and the change in the number and frequency of such cases in
p.002017: historical plan;
p.002017: (c) specific characteristics of the medicinal products concerned;
p.002017: (d) the severity of the disease to be treated;
p.002017: (e) other potential risks to public health.
p.002017: Art. 168b. (New, SG No. 102/2012, effective 21.12.2012) (1) The Rules on
p.002017: the safety indicators under Art. 168, para. 8 are defined by the European Commission with
p.002017: the delegated acts referred to in Article 54a (2) of Directive 2001/83 / EC.
p.002017: (2) Safety indicators shall not be eliminated or partially or completely closed,
p.002017: unless the following conditions are met:
p.002017: 1. the holder of the manufacturing authorization before partially or fully
p.002017: removes or closes safety features, checks to see if the appropriate drug
p.002017: the product is authentic and has not been tampered with;
p.002017: 2. the holder of a production permit in compliance with the requirements of Art. 168, para.
p.002017: 8 may replace safety indicators with equivalents with respect to
p.002017: the ability to guarantee the authenticity, identification and assurance of
p.002017: evidence of tampering with the medicinal product.
p.002017: (3) Safety indicators shall be considered equivalent if:
p.002017: 1. meet the requirements laid down in the delegated acts referred to in Article 54a (2)
p.002017: of Directive 2001/83 / EC, and
p.002017: 2. are equally effective in allowing authentication; and
p.002017: the identification of medicinal products and the provision of evidence of forgery
p.002017: them.
p.002017: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of
p.002017: the medicinal product and in accordance with good manufacturing practice for medicinal products
p.002017: products.
p.002017: (5) The Medicines Executive Agency shall oversee the replacement of
p.002017: safety indicators.
p.002017: Art. 169. (1) The information on the packaging and the package leaflet of the medicinal product must be complete
p.002017: compliance with the particulars in the summary of product characteristics approved by the BDA when granting the marketing authorization
p.002017: use and meet the requirements set out in
p.002017: the ordinance under Art. 170.
p.002017: (2) The information on the packaging and the package leaflet may be in several languages, but
p.002017: one of them must be Bulgarian. The content of the information is different
p.002017: languages must be identical.
p.002017: (3) The name of the medicinal product shall be written in Bulgarian
...
p.002017: the product is identified by the BDA in the Marketing Authorization / Registration Certificate or
p.002017: the authorization for parallel importation of the medicinal product into the territory of
p.002017: Republic of Bulgaria.
p.002017: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in
p.002017: the application for the marketing authorization / registration certificate for modification of
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
p.002017: 2. are often and very widely applied incorrectly and as a result can
p.002017: pose a danger to human health;
p.002017: 3. contain substances whose activity and / or undesirable effects require it
p.002017: subsequent follow-up study;
p.002017: 4. usually prescribed by a doctor for parenteral administration.
p.002017: Art. 174. Medicinal products shall be subject to special medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. contain narcotic substances within the meaning of the Drug Control Act
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
...
p.002017: the documentation for making a change in the classification shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish it on the page
p.002017: your online list of prescription medicines
p.002017: the territory of the Republic of Bulgaria.
p.002017: (2) The list under para. 1 is updated annually.
p.002017: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002017: or the certificate of registration, the BDA shall review and, where necessary, amend the classification according to
p.002017: the requirements of Art. 173 and the criteria specified
p.002017: in the ordinance under art. 178.
p.002017: Art. 181. Where a change in the classification of a medicinal product on the basis of
p.002017: significant pre-clinical or clinical trials, no subsequent applicant or marketing authorization holder
p.002017: may be invoked within one year from the date of the variation authorization issued by a regulatory authority of a country
p.002017: State upon filing
p.002017: an application to change the classification of the same substance.
p.002017: Art. 182. The European Medicines Agency shall be notified annually by the Executive Agency for Medicinal Products
p.002017: the Commission and the regulatory authorities of the other Member States for changes to the
p.002017: Art. 179.
p.002017: Chapter Eight.
p.002017: PHARMACEUTICAL SAFETY TRACKING
p.002017: Section I.
p.002017: General Provisions (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 183. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the drug agency organizes and maintains a drug tracking system
p.002017: safety to fulfill the obligations under this Chapter.
p.002017: (2) The system of para. 1 is used to gather information on the risks of medicinal products
p.002017: for patients' health and public health. The information covers adverse drug reports
p.002017: reactions when using the medicinal product in accordance with the approved summary of product characteristics, and
p.002017: misuse and use information that is inconsistent with the approved summary
p.002017: product characteristics, including information on side effects observed with
p.002017: execution of
p.002017: professional duties.
p.002017: (3) The Executive Agency for Medicines shall validate, process and classify the information under para.
p.002017: 2, conducts a scientific analysis of the data collected with a view to assessing the potential for reduction and
p.002017: risk prevention and take the necessary action
p.002017: with regard to the authorization of the medicinal product.
p.002017: (4) The Executive Agency for Medicines shall carry out audits of the system under para. 1 and on
p.002017: sends a report every two years to the European Commission on the results thereof.
p.002017: (5) The Medicines Executive Agency shall implement an adequate and effective quality system in order
p.002017: ensure compliance of the system under para. 1 with the requirements of this law. The minimum system requirements
p.002017: quality is determined by the Implementing Regulation (EU)
p.002017: № 520/2012.
p.002017: Art. 184. (Amended, SG No. 102/2012, effective 21.12.2012) (1) Medical
p.002017: Specialists are obliged to immediately inform the marketing authorization holder or the BDA of each
p.002017: suspected serious adverse reaction and provide at
p.002017: requesting additional information from case tracking.
p.002017: (2) Patients may report undesirable effects at any time
p.002017: medical specialists or the BDA.
p.002017: (3) In the cases of para. 1 and 2, where the communication concerns a biological medicinal product prescribed,
p.002017: distributed or sold on the territory of the Republic of Bulgaria, it must be clearly identified by
p.002017: the communicator with his trade name and account number or
p.002017: this information should be made available in follow-up.
p.002017: Art. 185. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the medicines agency maintains a national internet portal for related medicinal products
p.002017: with the European Internet portal for medicinal products under Art. 68, para. 1, Vol. 4.
p.002017: (2) The Executive Agency for Medicines shall make available through the portal under para. 1 at least
p.002017: following information:
p.002017: 1. the public evaluation reports under art. 53, para. 2 and their summaries;
p.002017: 2. the summary of product characteristics and leaflets;
p.002017: 3. summary of the risk management plans for the medicinal products authorized for
p.002017: use on the territory of the Republic of Bulgaria;
p.002017: 4. specimens of standardized reporting forms for suspected adverse reactions
p.002017: medical reactions by medical professionals and patients prepared in accordance with
p.002017: the requirements of Article 25 of Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 5. an updated list of medicinal products referred to in Article 23 of Regulation (EC) No
p.002017: 726/2004 of the European Parliament and of the Council;
p.002017: 6. communications providing information to the general public about concerns
p.002017: on the safety of the use of a medicinal product;
p.002017: 7. instructions for all ways and forms for reporting suspected unwanted
p.002017: drug reactions by medical professionals and patients.
p.002017: Art. 186. (amend. - SG 102/02, in force from 21.12.2012) The Executive Agency
p.002017: on medicinal products performs the following activities for medicinal products placed on the market in
p.002017: Republic of Bulgaria:
p.002017: 1. monitoring the outcome of the risk reduction measures for a medicinal product,
p.002017: contained in the risk management plan;
p.002017: 2. monitoring of the result of the fulfillment of conditions specified in Art. 55a, 56 or 56a;
p.002017: 3. evaluation of the update of the risk management system;
p.002017: 4. monitoring of the EudraVigilance database set up in accordance with Article 24
p.002017: of Regulation (EC) No 726/2004 of the European Parliament and of the Council on new risks or on
p.002017: change in already established and change in benefit / risk ratio.
p.002017: Art. 187. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: The European Medicines Agency and the Marketing Authorization Holder have been informed by the European Medicines Agency
p.002017: identifying signals for new risks or for changing identified risks, or when changing
p.002017: the benefit / risk ratio of the medicinal product.
p.002017: (2) The Committee under Art. 56a, para. 1, item 1 analyzes and prioritizes validated alerts for new risks or changes in
p.002017: already established for changing the benefit / risk ratio.
p.002017: (3) Where the Committee under Art. 56a, para. 1, item 1 recommends follow-up,
...
p.002017: The European Medicines Agency, the regulatory authorities of the other Member States, shall be informed by the European Medicines Agency
p.002017: The European Commission at least 24 hours prior to the public disclosure of information regarding concerns
p.002017: with the monitoring of the safety of a medicinal product, unless the protection of
p.002017: public health requires
p.002017: immediate disclosure of information.
p.002017: (2) The Medicines Executive Agency shall publish information relating to the active substances contained in
p.002017: medicinal products authorized in other countries
p.002017: Member States, using a harmonized draft communication and timetable for publication,
p.002017: proposed by the European Medicines Agency.
p.002017: (3) In the cases of para. 1 and 2 information containing personal data or representing
p.002017: trade secrets shall be deleted unless such disclosure is necessary for safeguarding
p.002017: of public health.
p.002017: Art. 189. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the medicines agency may delegate some of the rights and obligations under this chapter to
p.002017: regulatory authority of another Member State by concluding an agreement.
p.002017: (2) In the cases of para. 1 The BDA informs the European Commission, the European Medicines and Regulatory Agency
p.002017: authorities of the other Member States for the delegation of powers and publish a communication to the
p.002017: Internet portal under Art. 185, para. 1 or on the Internet
p.002017: your page.
p.002017: Art. 190. (amend. - SG 102/02, in force from 21.12.2012) (1) The holder of
p.002017: a marketing authorization is required to have a drug tracking system
p.002017: safety to fulfill its obligations under this Chapter.
p.002017: (2) The holder of a marketing authorization through the system of para. 1 makes a scientific assessment of the information collected
p.002017: on the safety of medicinal products, consider the possibility of minimizing or
p.002017: risk prevention and take the necessary
p.002017: measures.
p.002017: (3) The Marketing Authorization Holder shall implement an adequate and effective quality system to ensure
p.002017: compliance of the system under para. 1 with the requirements of this law. The minimum requirements for the
p.002017: quality is defined in the Implementing Regulation (EU)
p.002017: № 520/2012.
p.002017: (4) The marketing authorization holder shall regularly audit the system under para.
p.002017: 1. Information on the main findings of the audit shall be noted in the system's main documentation and shall serve
p.002017: to draw up a plan for the implementation of appropriate corrective actions. This one
p.002017: information may be deleted after complete corrective action.
p.002017: Art. 191. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the marketing authorization designates a qualified person with the appropriate qualification responsible for
p.002017: pharmacovigilance monitoring.
p.002017: (2) The person under para. 1 is established in the territory of a Member State and is permanent and
p.002017: continuously at the disposal of the holder of the marketing authorization.
p.002017: (3) To support the activity of the qualified person, the holder of the permit
p.002017: designates for use a person established in the territory of the Republic of Bulgaria. The appointment of
p.002017: such person does not release the qualified person under para. 1 of his responsibilities under this chapter.
...
p.002017: 3. monitors the outcome of the measures contained in the plan for
p.002017: risk management, or
p.002017: 4. monitor the result of the fulfillment of the conditions under Art. 55a, 56 or
p.002017: 56a;
p.002017: 5. update the risk management system;
p.002017: 6. monitors the data from the system under Art. 190, para. 1 to identify
p.002017: new risks or change in identified risks, and determine whether they have occurred
p.002017: changes in the benefit / risk balance of the observed medicinal product.
p.002017: (2) The content and procedure for maintaining the basic documentation of the
p.002017: pharmacovigilance monitoring is governed by Implementing Regulation (EU) No 520/2012.
p.002017: Art. 193. (Amended, SG No. 102/2012, effective 21.12.2012) The holder of a permit for
p.002017: use informs the BDA and the European Medicines Agency in the event that new signals are identified
p.002017: risks or to change the identified risks, or
p.002017: change in the benefit / risk ratio of a medicinal product.
p.002017: Art. 194. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of a permit for
p.002017: use concurrently or before providing the public with new information on related concerns
p.002017: by monitoring the safety of a medicinal product authorized in the territory of the Republic
p.002017: Bulgaria, informs BDA, European
p.002017: the Medicines Agency and the European Commission.
p.002017: (2) The information under para. 1 must be objective and not misleading.
p.002017: (3) Before disseminating information related to drug monitoring
p.002017: safety, the Marketing Authorization Holder agrees with the BDA in advance with
p.002017: except for the cases under para. 1.
p.002017: (4) For carrying out the evaluation of the information under para. 3 is paid a fee of
p.002017: determined in the tariff under Art. 21, para. 2.
p.002017: Art. 194a. (New, SG No. 102/2012, effective 21.12.2012) (1) The principles and
p.002017: the requirements of Good Practice for Monitoring Pharmacovigilance are set out in
p.002017: guidance issued by the European Medicines Agency.
p.002017: (2) In carrying out pharmacovigilance monitoring activities
p.002017: the holder of the marketing authorization complies with the good practice under para. 1.
p.002017: Section II.
p.002017: Collection and reporting of information on suspected adverse reactions
p.002017: (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 194b. (New, SG No. 102/2012, effective 21.12.2012) The holder of the authorization for
p.002017: use in fulfillment of their obligations under Art. 190 is required to document all reports of suspected spam
p.002017: drug reactions observed on the territory of the European Union or in third countries, reported spontaneously by
p.002017: medical professionals or from patients or emerging from post-marketing research.
p.002017: Art. 194c. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the permit
p.002017: submit for use electronically in the database "EudraVigilance" under Art. 24 of Regulation (EC) No
p.002017: 726/2004 of the European Parliament and of the Council of reports of serious suspected adverse reactions,
p.002017: occurred on the territory of the European Union and in
p.002017: third countries, within 15 days of the date of receipt of the communication.
p.002017: (2) The Marketing Authorization Holder submits to the EudraVigilance database electronically
p.002017: all suspected adverse reactions other than those mentioned in para. 1 occurred on the territory of
p.002017: European Union, within 90 days from the date of
p.002017: receiving the message.
p.002017: (3) The Marketing Authorization Holder monitors publications in specialized medical literature and
p.002017: report to the EudraVigilance database any suspected adverse drug drug listed in it
p.002017: reaction with the exception of suspected adverse reactions from medicinal products containing active
p.002017: substances listed in the article list
p.002017: 27 of Regulation (EC) No 726/2004 of the European Parliament and of the Council and described in
p.002017: literature sources monitored by the European Medicines Agency.
p.002017: (4) The marketing authorization holder establishes procedures for the collection of accurate and reliable data,
p.002017: allowing the scientific evaluation of reports of suspected adverse reactions. The owner
p.002017: of the Marketing Authorization collects a follow-up
p.002017: information regarding these messages and provides updated data in "EudraVigilance".
p.002017: (5) The form and content of the reports under para. 1 - 3 are determined by Regulation
p.002017: Implementation (EU) No 520/2012.
p.002017: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: register the medicines in the system of art. 183 all reports of suspected adverse drug reactions
p.002017: reactions occurring on the territory of the Republic of Bulgaria by
p.002017: medical professionals and patients, and requires, if necessary, additional
p.002017: case tracking information.
p.002017: (2) When reports of suspected adverse reactions occurring on
p.002017: the territory of the Republic of Bulgaria, have been submitted by the holder of the marketing authorization,
p.002017: it provides additional follow-up information to the BDA upon request.
p.002017: Art. 194d. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: medicines submit reports to the EudraVigilance database for all serious suspects
p.002017: adverse reactions occurring on the territory of
p.002017: Republic of Bulgaria, within 15 days from the date of their receipt.
p.002017: (2) The Drug Enforcement Agency submits electronically to the EudraVigilance database
p.002017: reports of all suspected adverse reactions other than those specified in para. 1 occurred on
p.002017: the territory of the Republic of Bulgaria, within 90 days from the date
p.002017: of receiving the message.
p.002017: (3) The Drug Enforcement Agency submits electronically to the EudraVigilance database
p.002017: reports of suspected adverse reactions occurring on the territory of the Republic of Bulgaria,
p.002017: due to improper use of the medicinal product. The Medicines Executive Agency shall inform thereof
p.002017: Ministry of Health
p.002017: and professional organizations of medical specialists.
p.002017: (4) Any body or institution to which information about a suspect has been received
p.002017: reported an adverse reaction occurring on the territory of the Republic of Bulgaria
p.002017: BDA for that.
p.002017: (5) The content and format of the communications and reports under para. 1 - 3 are determined by
p.002017: Implementing Regulation (EU) No 520/2012.
p.002017: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: the medication receives information from the marketing authorization holder about serious suspects
p.002017: adverse reactions occurring on the territory
p.002017: of the European Union or in a third country through the EudraVigilance database.
p.002017: (2) The requirements for monitoring information in the EudraVigilance database are
p.002017: set out in Implementing Regulation (EU) No 520/2012.
p.002017: Art. 194g. (New - SG 102/2012, in force since 21.12.2012) In the process of exchange of information of the BDA,
p.002017: the Marketing Authorization Holders and the European Medicines Agency are cooperating with the European Medicines Agency
p.002017: detect duplicate reports of suspected spam
p.002017: drug reactions.
p.002017: Section III.
p.002017: Periodic safety update reports (New, SG No. 102/2012, effective from
p.002017: 12/21/2012)
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the Marketing Authorization is obliged to make the European Agency for Europe available electronically
p.002017: medicines periodic safety update reports containing:
p.002017: 1. summaries of data on the benefit / risk balance of the medicinal product,
p.002017: including the results of all studies, with a view to their potential impact on
p.002017: the marketing authorization;
p.002017: 2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
p.002017: available data, including clinical trial data for unauthorized indications and target groups,
p.002017: which are not included in the summary of
p.002017: product;
p.002017: 3. all data on the volume of sales of the medicinal product and any other information with which
p.002017: the holder of the marketing authorization is in possession of the volume of prescriptions, including approximate ones
p.002017: number of persons who used the medicinal product
p.002017: or exposed to it for another reason.
p.002017: (2) The content and format of the electronic periodic updated reports on
p.002017: safety is determined by Implementing Regulation (EU) No 520/2012.
p.002017: (3) The information under para. 1 shall be collected and stored in a register established in the order of a member
p.002017: 25a of Regulation (EC) No 726/2004 of the European Parliament and of the Council, and is accessible to the BDA.
p.002017: Art. 194i. (New, SG No. 102/2012, effective 21.12.2012) The holders of
...
p.002017: medicinal products for human use within 30 days of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the retention, amendment, suspension or termination of validity
p.002017: of the relevant marketing authorizations, including a timetable for the implementation of
p.002017: the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. Decides to change, suspend or terminate the marketing authorizations,
p.002017: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 2. adopt a decision recommending change, suspension or termination of authorizations
p.002017: for use issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 2, Vol. 2.
p.002017: Section IV.
p.002017: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002017: 12/21/2012)
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure of
p.002017: the European Union level can be initiated by the European Commission, by the European Commission
p.002017: drug agency or from a Member State.
p.002017: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under
p.002017: the procedure for this section by notifying the regulatory authorities of the other Member States, the European Agency for Europe
p.002017: medicines and the European Commission, when for drug-related reasons
p.002017: safety, consider that a medicinal product placed on the Bulgarian market requires undertaking
p.002017: to any of the
p.002017: the following measures:
p.002017: 1. suspension or termination of the marketing authorization;
p.002017: 2. prohibition of distribution of a medicinal product;
p.002017: 3. issuing a refusal to renew the marketing authorization.
p.002017: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para.
p.002017: 2, when notified by the marketing authorization holder that for reasons related to
p.002017: drug safety monitoring, discontinued
p.002017: the distribution of the medicinal product has either taken or intends to take action on
p.002017: it will be removed from the market or it will not take any action to renew it
p.002017: the marketing authorization issued.
p.002017: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure
p.002017: under para. 2 and in cases where it considers that for reasons related to drug monitoring
p.002017: safety, a new contraindication or reduction should be added to a medicinal product
p.002017: the recommended dose or indication
p.002017: be limited.
p.002017: (5) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products shall provide the European Medicines Agency
p.002017: medicines and regulatory authorities of other Member States all the scientific information by which
p.002017: have, as well as the data assessment performed, and
p.002017: the reasons for initiating the procedure under this section.
p.002017: (6) (Amended, SG No. 18/2014) In the cases of para. 2 - 4 European Medicines Agency
p.002017: notifies the BDA of the initiation of the procedure when the safety concerns relate to others
p.002017: medicinal products belonging to or containing the same therapeutic group
p.002017: active substance with the product specified in the information under para. 5, or where this medicinal product is authorized
p.002017: for use in another or
p.002017: in other Member States.
p.002017: (7) (amend. - SG 18/04) In the cases of para. 4 when you do not have to
p.002017: take urgent measures, the BDA applies the procedure under Art. 77 or 79b.
p.002017: (8) (New, SG No. 18/2014) The Executive Agency for Medicines shall inform
p.002017: the holder of the marketing authorization in order to initiate the procedure under this section.
p.002017: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases under Art. 194y, para. 2 when
p.002017: considered it necessary to take urgent measures to protect public health, BDA
p.002017: may suspend the marketing authorization and prohibit the use of the medicinal product
p.002017: the territory of the Republic of Bulgaria until the adoption of the
...
p.002017: from the date of its receipt, issue an opinion on the retention, modification, suspension, termination
p.002017: of the relevant authorizations or refusals to renew them, including a timetable for
p.002017: implementation of the opinion.
p.002017: (2) Where the opinion recommends that the measures under Art. 194ts, para. 3, Vol. 5,
p.002017: the Executive Director of the BDA shall, by order, suspend or revoke the authorization for
p.002017: use, or refuses to renew it.
p.002017: (3) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (4) Where in the opinion under para. 1 it is recommended to take measures under art. 194ts, para.
p.002017: 3, items 2 - 4, the holder of the marketing authorization takes the necessary actions and
p.002017: inform the BDA and the regulatory authorities of the other Member States.
p.002017: (5) Where, within the coordination group under Art. 77, para. 2 could not be reached,
p.002017: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002017: decision with recommendation for change, suspension or termination
p.002017: of the marketing authorization issued by the relevant regulatory authorities of the Member States.
p.002017: (6) The Drug Enforcement Agency shall implement the recommendations recommended in the decision under para. 5
p.002017: interim and / or definitive measures.
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Where within the scope of the procedure under Art. 194y
p.002017: a medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002017: Parliament and the Council, the Committee for Medicinal Products for Human Use, based on the recommendation under Art. 194ts, para.
p.002017: 3, within 30 days from the date of its receipt, issue an opinion on the retention, change,
p.002017: suspension, termination of the relevant marketing authorizations or refusal of
p.002017: their renewal, including a timetable for the implementation of the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. adopt a decision to change, suspend or terminate the validity of the permits
p.002017: for use, issued under Regulation (EC) No 726/2004 of the European Parliament and of the
p.002017: The Council;
p.002017: 2. adopt a decision recommending the change, suspension or termination of validity of
p.002017: marketing authorizations issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Drug Enforcement Agency shall implement the recommendations recommended in the decision of the European Medicines Agency
p.002017: The European Commission under para. 2, item 2 provisional and / or final measures.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) The recommendation under Art. 194c,
p.002017: para. 1, the opinion under art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and
p.002017: Art. 194h, para. 2 shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: Chapter Nine.
p.002017: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN
p.002017: THE MEDICINAL PRODUCTS AREA (HEADING, amended, SG No. 71/2008,
p.002017: POWER FROM 12.08.2008, ISM. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
p.002017: (Title "Section I. Wholesale trade of medicinal products" - SG, issue 71 of 2008, in
p.002017: with effect from 12.08.2008)
p.002017: Art. 195. (1) Wholesale trade in medicinal products may be carried out physically and
p.002017: legal persons authorized to do so by a regulatory body of
p.002017: the Member State concerned.
p.002017: (2) When the person under para. 1 has warehouses on the territory of the Republic
p.002017: Bulgaria, it may carry out wholesale of medicinal products after receiving
p.002017: permission from the BDA Executive Director.
p.002017: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may
p.002017: only wholesale medicinal products for which a marketing authorization has been granted
p.002017: production.
p.002017: (2) An importer of medicinal products within the meaning of this Act may perform
p.002017: wholesale only of medicinal products for which import authorization has been granted.
...
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
p.002017: containing such substances, the requirements of the Control Act also apply
p.002017: drugs and precursors.
p.002017: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Agency
p.002017: for nuclear regulation.
p.002017: (5) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the person under para. 1, Vol. 3,
p.002017: when he is a Bulgarian citizen.
p.002017: Art. 200. The Drug Enforcement Agency evaluates the documentation and performs it
p.002017: on - the - spot verification of the sites indicated in the application for their compliance with
p.002017: requirements for Good Distribution Practice.
p.002017: Art. 201. (1) The Executive Agency for Medicines shall notify the applicant in writing,
p.002017: when it finds deficiencies in the documentation submitted.
p.002017: (2) In the cases of para. 1 the term under Art. 202, para. 1 stops running.
p.002017: Art. 202. (1) Within 90 days from the date of submission of the application under Art. 199, para. 1
p.002017: the Executive Director of the BDA issues the permit for wholesale trade or makes it motivated
p.002017: refusal.
p.002017: (2) The refusal under para. 1 shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: Art. 203. Within 15 days from the date of submission of the documentation under Art. 199, para. 2
p.002017: the BDA Executive Director issues a Wholesale Trade Registration Certificate to
p.002017: the territory of the Republic of Bulgaria of the person under Art. 195, para. 1.
p.002017: Art. 204. (1) The permit for wholesale of medicinal products shall be indefinite.
p.002017: (2) The authorization under Art. 202 or the certificate under Art. 203 is terminated if
p.002017: the holder requested this in writing from the BDA Executive Director.
p.002017: (3) The person under art. 195 is obliged to notify the BDA in writing within 7 days after the termination of
p.002017: its activity in the wholesale of medicinal products. In these cases, the BDA Executive Director
p.002017: terminates the issued marketing authorizations / certificates
p.002017: of medicines.
p.002017: Art. 205. (1) The Executive Agency for Medicines shall keep a register of the issued ones
p.002017: permits for wholesale trade in medicinal products under Art. 202, para. 1, which contains:
...
p.002017: 7. a proposal for a leaflet for the patient for the parallel medicinal product, accompanied by a declaration,
p.002017: that the contents of the package leaflet are identical to the contents of the product leaflet authorized for use in
p.002017: The Republic of Bulgaria, with the exception of the following
p.002017: data:
p.002017: (a) the name and management address of the parallel importer;
p.002017: (b) the name of the manufacturer, where different for the two products;
p.002017: (c) a period of stability when different for the two products;
p.002017: (d) excipients, where different in the two products;
p.002017: 8. in the case of repackaging:
p.002017: a) (amend. - SG 71/08, in force from 12.08.2008) a sample of the medicinal product
p.002017: as it will be marketed in Bulgaria;
p.002017: (b) a copy of the contract between the parallel importer and the importer
p.002017: partial production activity - packaging, labeling;
p.002017: (c) a certificate of Good Manufacturing Practice when repackaging processes take place
p.002017: carry out outside the territory of the Republic of Bulgaria;
p.002017: d) when performed by the person under Art. 213 - a copy of the manufacturing authorization,
p.002017: issued by the regulatory authority of the Member State where the repackaging takes place;
p.002017: 9. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) Where between the medicinal product for
p.002017: There are differences in parallel imports and the product authorized for use on the territory of the Republic of Bulgaria
p.002017: (in the composition of excipients and others), the person under para. 1 presents evidence that they did not
p.002017: reflect the therapeutic properties of the drug
p.002017: product for parallel imports.
p.002017: (4) In the cases of para. 3 the person under para. 1 indicates on the packaging and the package leaflet
p.002017: the patient of the parallel medicinal product differences.
p.002017: (5) Where the person under Art. 213 carries out repackaging and / or labeling of the medicinal product
p.002017: a product in Bulgarian on the territory of the Republic of Bulgaria, it must have
p.002017: manufacturing authorization issued by the BDA Executive Director.
p.002017: (6) The parallel imported product is used subject to the conditions of the authorization granted for
p.002017: use of the medicinal product on the territory of the Republic of Bulgaria.
p.002017: Art. 216. (1) The permit for parallel import into the territory of the Republic
p.002017: Bulgaria shall be issued within 45 days from the date of submission of the documentation to the BDA.
p.002017: (2) When the BDA requests additional documentation from the applicant, the term under para. 1 stops
p.002017: run until the requested information is received.
p.002017: (3) When requested by the BDA of the regulatory authority of the Member State from which it is carried out
p.002017: parallel import, information related to the granting of the import authorization
p.002017: medicinal product, the term under para. 1 is extended by 45 days.
p.002017: (4) If, within the term of para. 3 The BDA did not receive the requested documentation, the issuing procedure
p.002017: of a parallel import permit on the territory of the Republic of Bulgaria shall be terminated.
p.002017: (5) Licenses issued for parallel imports into the territory of
p.002017: The Republic of Bulgaria is published on the BDA website on the Internet.
p.002017: (6) The authorization for parallel importation shall be for a period of 5 years. New permission
...
p.002017: 5. the country where the export is planned to take place.
p.002017: Art. 217c. (New, SG No. 18/2014, declared unconstitutional by RKS No. 1 of 2015 - SG, No. 12/2015)
p.002017: (1) Upon receipt of a notification under Art. 217b BDA requires information on the medicinal product intended for export
p.002017: for a period of 6 months from the date of filing
p.002017: notification:
p.002017: 1. for the consumption of the respective medicinal product by the National Health Insurance Fund and / or by
p.002017: The Ministry of Health;
p.002017: 2. for the deliveries of the respective medicinal product in the Republic of Bulgaria by the holder of
p.002017: the marketing authorization.
p.002017: (2) The persons under para. 1 provide the information requested by the BDA within 15 days of receipt of
p.002017: the request.
p.002017: (3) The Executive Agency for Medicines shall perform an analysis of the received under para. 2 information about
p.002017: the respective medicinal product by comparing the data on the quantities used under para. 1, item 1 and
p.002017: the quantities delivered under para. 1, item 2 with the available data received in accordance with Art. 217b, item 4 for number of packages,
p.002017: intended for
p.002017: wear.
p.002017: (4) Where within 30 days from the date of receipt of the notification under Art. 217b, the executive
p.002017: the BDA director did not object to the export in writing, it is considered that there is a tacit consent for
p.002017: export.
p.002017: (5) The Executive Director of the BDA may, within the term of para. 4 to refuse by reasoned order the execution
p.002017: to export when, when carrying out the analysis under para. 3 found that:
p.002017: 1. the ones available at the time of notification under Art. 217b quantities of the respective drug
p.002017: product in the Republic of Bulgaria are not sufficient to meet the health needs of the population;
p.002017: 2. there may be a temporary shortage of the necessary for export as a result of the export
p.002017: meeting the health needs of the population with the quantities of the medicinal product concerned;
p.002017: 3. the lack of sufficient quantities of the respective medicinal product to satisfy the health requirements
p.002017: the needs of the population can seriously endanger the life and health of the population.
p.002017: (6) The refusal under para. 5 shall be subject to appeal by the order of the Administrative Procedure Code.
p.002017: (7) Data on export of medicinal products from the territory of the Republic of Bulgaria are provided
p.002017: posted on the BDA's website.
p.002017: Art. 217g. (New, SG No. 18/2014) Export of medicinal products shall be effected on time
p.002017: within three months from the expiry of the term under Art. 217c, para. 4.
p.002017: Chapter Ten.
p.002017: RETAIL TRADE OF MEDICINAL PRODUCTS
p.002017: Art. 218. Retail trade in medicinal products is carried out only in pharmacies and
p.002017: drugstores under the procedure of this law, except for the cases under art. 232, para. 2.
p.002017: Art. 219. (1) (amend. - SG 71/08, in force from 12.08.2008, add. - SG, iss. 23 in 2009, in force from
p.002017: March 30, 2009, Suppl. - SG, issue. 41 of 2009, in force since 02.06.2009, as amended. - SG, issue. 60 of 2011, in force since
p.002017: 08/05/2011) The pharmacy is a health establishment, where the following activities are performed: storage, preparation,
p.002017: packing, controlling, consulting, medical and non-prescribing
p.002017: for use in the Republic of Bulgaria medicinal products, medical devices, diet foods for
p.002017: special medical purposes and infant formulas and follow-on formulas and nutritional supplements, cosmetic and
p.002017: hygiene products.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The device, the order and
p.002017: the organization of the work of pharmacies, the nomenclature of medicinal products, are determined
p.002017: in an ordinance of the Minister of Health.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008, repealed - SG, iss. 23 in 2009, in force
p.002017: from 30.03.2009)
p.002017: Art. 220. (1) The activities under art. 219, para. 1 are performed by the Master of Pharmacy.
p.002017: (2) (suppl. - SG 71/08, in force from 12.08.2008) The master pharmacist shall be obliged
p.002017: to fulfill a prescription issued, including for dosage forms prepared under
p.002017: highway and pharmacopoeial formulation, according to the procedure specified in the ordinance under Art. 221, para. 1.
p.002017: (3) (amend. - SG 102/2012, in force from 02.01.2013) The assistant-pharmacist may perform all
p.002017: activities under art. 219, para. 1 under the control of a pharmacist, with the exception of: granting
p.002017: prescription drug, control and administration
p.002017: advice on medicinal products.
p.002017: Art. 221. (1) (Former text of Art. 221 - SG 71/08, in force from 12.08.2008)
p.002017: Health determines in an ordinance the medical professionals who can issue prescriptions, the order for prescribing
p.002017: medicinal products, the time limit for implementation, and the cases and the order in which the master pharmacist may
p.002017: to refuse to perform medically
p.002017: prescription.
p.002017: (2) (New, SG No. 71/2008, effective 12.08.2008, amended, SG No. 9/2011)
p.002017: Bulgarian citizens and foreigners who are allowed to reside in the country when traveling outside the Republic
p.002017: Bulgaria may carry or export medicinal products,
p.002017: intended for their treatment, under the conditions and in the order specified in the ordinance under para. 1.
p.002017: (3) (New, SG No. 71/2008, effective 12.08.2008, amended, SG No. 9/2011)
p.002017: Foreigners who have been issued a short-stay visa on the territory of the Republic of Bulgaria may
p.002017: possess medicinal products intended solely for their treatment, c
p.002017: quantities determined in the ordinance under para. 1.
p.002017: (4) (New, SG No. 1/2014, effective 03.01.2014) Requirements for medical
p.002017: prescriptions that are issued at the request of a patient who intends to use them in another
p.002017: Member State, as well as the recognition and enforcement of those issued in anotherXcountry
p.002017: State, shall be carried out under the conditions and in the order determined by the ordinance under para. 1.
p.002017: (5) (New, SG No. 1/2014, effective 03.01.2014) Reimbursement of expenses for medicinal products under
p.002017: medical prescriptions fulfilled in another Member State shall be carried out under the conditions and in accordance with the procedure laid down in
p.002017: the ordinance under Art. 80s, para. 4 of the Health Act
...
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
p.002017: registration of a drugstore or for making a change under Art. 242 the respective RIC collects fees
p.002017: in the amount determined by the tariff under Art. 21, para. 2.
p.002017: (6) (New - SG 103 2017, in force from 01.01.2018)
p.002017: food safety ex officio establishes the circumstances of a person 's criminal record
p.002017: para. 2, item 2, when he is a Bulgarian citizen.
p.002017: Art. 240. (amend. - SG 60/11, in force from 05.08.2011) (1) Within 14 days from
p.002017: performing the inspection under Art. 239, para. 3 or by eliminating the incompleteness of art. 239, para. 4
...
p.002017: for its publication.
p.002017: (2) (New, SG No. 102/2012, effective 21.12.2012)
p.002017: refuses to issue a certificate of registration of the person under Art. 238, para. 2 when:
p.002017: 1. none of the documents under Art. 239, para. 2;
p.002017: 2. within the term of art. 239, para. 4 the applicant did not remove the incompleteness found.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) When, within the term of para. 1
p.002017: the director of RZI did not issue a certificate for registration of a drugstore or did not
p.002017: motivated refusal, it is considered that there is tacit consent.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 3 the applicant can start
p.002017: performing the requested activities in compliance with Art. 29 of the Administrative Restriction Act
p.002017: regulation and administrative control over the economic activity.
p.002017: (5) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012)
p.002017: of RZI under para. 1 shall be subject to appeal by the order of the Administrative Procedure Code.
p.002017: Art. 240a. (New, SG No. 102/2012, effective 21.12.2012) (1) The Director of
p.002017: the respective RZI shall terminate the registration of a drugstore by order:
p.002017: 1. at the request of the person who has received a certificate for registration of a drugstore;
p.002017: 2. by termination of the activity of the person under art. 238, para. 2, of which it notifies
p.002017: the relevant REI.
p.002017: (2) Within 14 days of termination of the activity under para. 1, item 2 the person under art. 238, para. 2
p.002017: notifies the relevant RIC in writing.
p.002017: Art. 241. (1) (amend. - SG 60/11, in force from 05.08.2011)
p.002017: keep a register of issued drug registration certificates, which contains:
p.002017: 1. number and date of the certificate issued;
p.002017: 2. seat and address of the person who has received a drugstore registration certificate;
p.002017: 3. name, personal data and address of the head of the drugstore;
p.002017: 4. address of the drugstore;
p.002017: 5. date of termination of the registration and the reason for it;
p.002017: 6. notes on the entered circumstances.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) Data from the register shall be
p.002017: publish on the website of the respective RII on the Internet.
p.002017: Art. 241a. (New, SG No. 60/2011, effective 05.08.2011) The National Register of
p.002017: the issued certificates for registration of a drugstore under Art. 19a, para. 3 contains:
p.002017: 1. the name of the respective RHI which issued the registration certificate;
p.002017: 2. number and date of the issued certificate;
p.002017: 3. seat and address of the person who has received a drugstore registration certificate;
p.002017: 4. name of the head of the drugstore;
p.002017: 5. address of the drugstore;
p.002017: 6. date of termination of the registration and the reason for it.
p.002017: Art. 242. When the address of the drugstore or manager is changed, the person receiving it
p.002017: certificate of its opening, submits an application in accordance with Art. 239, para. 2 and related to
p.002017: change documents.
p.002017: Art. 243. The terms and conditions for the organization of work in the drugstore shall be laid down in an ordinance
p.002017: of the Minister of Health.
p.002017: Chapter eleven.
p.002017: ADVERTISING OF MEDICINAL PRODUCTS
p.002017: Art. 244. (1) Advertising of medicinal products is any form of information,
p.002017: presenting, promoting or offering to promote prescription, sale, or
p.002017: the use of the medicinal product and includes:
...
p.002017: side effects warnings as part of general safety measures
p.002017: of the medicinal product, commercial catalogs and price lists, provided that they do not include data
p.002017: promotional in relation to the medicinal product;
p.002017: 4. statements relating to human health or diseases when directly or
p.002017: do not indirectly refer to the treatment, prevention or diagnosis of medicinal products;
p.002017: 5. vaccination campaigns conducted by the Ministry of Health
p.002017: population when related materials do not contain data for a specific medicinal product.
p.002017: Art. 245. (1) The holder of the marketing authorization shall be obliged to create a scientific one
p.002017: a unit for the dissemination of information on the medicinal products for which he has received
p.002017: authorization for use under this law.
p.002017: (2) The marketing authorization holder shall be obliged to:
p.002017: 1. ensure that the advertising of the medicinal product is presented to the public or to
p.002017: medical professionals in a form that complies with the requirements of this Chapter; and
p.002017: compliance with the issued authorization for advertising by the BDA;
p.002017: 2. have data and materials from all advertising campaigns undertaken within the framework
p.002017: of his business, including information about the ad groups he is targeting,
p.002017: how it was implemented, and the date the campaign started.
p.002017: 3. ensure the training of medical sales representatives;
p.002017: 4. Execute precisely and in due time the instructions of the control officials
p.002017: of the ad.
p.002017: (3) The medical sales representatives shall report to the scientific units under para. 1 any information about
p.002017: the use of the medicinal products they advertise, especially with regard to adverse drug information
p.002017: drug reactions reported to them by medical
p.002017: specialists.
p.002017: Art. 245a. (New, SG No. 71/2008, effective 12.08.2008)
p.002017: medicinal products for which a marketing authorization has been granted under this Act.
p.002017: Art. 246. (1) The content of the advertisement must correspond to the data of the approved one
p.002017: when authorizing the use of the summary of product characteristics and present
p.002017: only the indications indicated in the marketing authorization.
p.002017: (2) The advertising of a medicinal product should only point to its correct one
p.002017: use by presenting objectively the therapeutic indications of the medicinal product without
p.002017: exaggerates the possibilities of treatment, prevention or diagnosis with the medicinal product.
p.002017: (3) Advertising must not contain misleading information.
p.002017: (4) (New, SG No. 71/2008, effective 12.08.2008) Advertising may not contain
p.002017: an offer and / or promise of a gift and / or other material or non-material benefit.
p.002017: (5) (New, SG No. 71/2008, effective 12.08.2008) Medical specialist or
p.002017: a person posing as a healthcare professional cannot perform directly or indirectly
p.002017: advertising of medicinal products in print and / or electronic media and on the Internet.
p.002017: Art. 247. Only medicinal products may be advertised to the public
p.002017: leave without a doctor's prescription.
p.002017: Art. 248. (Supplemented, SG No. 71/2008, effective 12.08.2008) Outside the cases under Art. 247 adverts are allowed
p.002017: vaccination campaigns conducted by marketing authorization holders, subject to the requirements of
p.002017: Art. 251 and under the conditions and in the order specified in the ordinance
p.002017: under Art. 249.
p.002017: Art. 248a. (New, SG No. 71/2008, effective 12.08.2008)
p.002017: internet of prescription medicines, except
...
p.002017: 2. medicinal products paid from the budget of the medical establishments under art. 5 of
p.002017: The Law on Health Care Facilities and the Budget of Health Care Facilities with State and / or Municipal
p.002017: participation under Art. 9 and 10 of the Medical Establishments Act;
p.002017: 3. medicinal products intended for the treatment of AIDS, infectious diseases, of
p.002017: diseases outside the scope of the Health Insurance Act, paid in accordance with Art. 82, para. 1, item 8 of
p.002017: The Health Act, as well as vaccines for compulsory immunizations and immunizations, vaccines for special indications and
p.002017: in exceptional circumstances, specific
p.002017: sera, immunoglobulins;
p.002017: 4. the marginal price of the medicinal products under Art. 261a, para. 4 by elements.
p.002017: (7) The Ministry of Health and the NHIF may submit proposals to the council
p.002017: under Art. 258, para. 1 for the review of included medicinal products in the Positive Medicinal Product
p.002017: a list under the conditions and in the order specified in the ordinance under Art. 261a, para. 5.
p.002017: (8) The National Health Insurance Fund shall pay for the medicinal products under para. 6, vol.
p.002017: 1 under the terms and procedure of the ordinance under Art. 45, para. 9 of the Health Insurance Act.
p.002017: (9) (New, SG No. 18/2014, Supplemented, SG No. 48/2015) Conditions, rules and criteria
p.002017: to include, modify and / or exclude medicinal products from the Positive Medicinal List and for
p.002017: maintaining the reimbursement status of medicinal products
p.002017: determine in the ordinance under art. 261a, para. 5.
p.002017: (10) (New, SG No. 48/2015) The medicinal products under Art. 45, para. 10, 13 and 19 of the Health Act
p.002017: insurance that has not been negotiated is not included in the Positive Drug List. The contracts for
p.002017: granting discounts go to council on
p.002017: the order specified in the ordinance under Art. 261a, para. 5.
p.002017: (11) (New, SG No. 48/2015) The medicinal products for which in the procedure under Art. 259, para. 1, item 7 is not
p.002017: prove positive when included, are excluded from
p.002017: Positive drug list.
p.002017: Art. 262a. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012,
p.002017: (in force since 21.12.2012)
p.002017: Art. 263. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 15 in 2013, is in force since 01.01.2014
p.002017: d.) With state budget funds outside the scope of compulsory health insurance may be
p.002017: pay for prescription medicines not included in the list under Art. 262,
p.002017: para. 1 required for the prevention or treatment of epidemic outbreaks, epidemics, pandemics, and
p.002017: in the presence of suspected or confirmed distribution of chemical or biological agents; or
p.002017: nuclear radiation.
p.002017: Art. 264. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012
p.002017: d.) (1) (Supplemented, SG No. 18/2014) Upon termination of the sales under Art. 54, para. 3 of a medicinal product that
p.002017: is included in the Positive Medicinal List, and when there is no international non-patent name within the relevant
p.002017: authorized for use by this law another medicinal product, the holder of the marketing authorization
p.002017: notifies the Ministry of Health and the National Board of Prices and Reimbursement in writing
p.002017: of medicinal products.
p.002017: (2) (Supplemented, SG No. 18/2014) The holder of the marketing authorization in writing
p.002017: notifies the Ministry of Health and the National Board of Prices and Reimbursement
p.002017: of medicinal products and in the event of discontinuation of sales of a medicinal product,
p.002017: the price of which is to establish a benchmark within the relevant international
p.002017: non-patent name and dosage form.
p.002017: (3) Where the product under para. 1 and 2 is intended to treat diseases that are
p.002017: shall be paid by the holder of the marketing authorization under the Health Insurance Act
p.002017: shall also notify the NHIF in writing within the time limits under para. 4.
p.002017: (4) The marketing authorization holder shall be obliged to make the notification under
p.002017: para. 1 not later than 18 months before the date of cessation of sales, but in the cases of
p.002017: para. 2 - not later than three months before the date of cessation of sales.
p.002017: (5) (Supplemented, SG No. 18/2014) Until the termination of the sales under para. 1 and 2 the holder of
p.002017: the marketing authorization is required to provide sufficient quantities of the medicinal product concerned for
p.002017: meeting health needs, unless
p.002017: when the suspension is due to any of the grounds under Art. 276 or under Art. 277.
p.002017: (6) After the expiry of the terms under para. 4 the Marketing Authorization Holder
p.002017: submit an application for the exclusion of the medicinal product from the
p.002017: Positive drug list.
p.002017: (7) Where, following the cessation of sales of the medicinal product, the holder of the
p.002017: the marketing authorization did not fulfill its obligation under para. 6, the council under art. 258, para. 1
p.002017: officially excludes him from the Positive Drug List.
p.002017: Art. 265. (1) The Council of Ministers shall establish a Transparency Committee.
p.002017: (2) (Supplemented, SG No. 60/2011, effective 05.08.2011) The composition of the Transparency Committee
p.002017: shall be determined by the Council of Ministers on the proposal of the Minister of Health. In her
p.002017: representatives of the Ministry of Health and the Ministry of Health are obligatory included
p.002017: labor and social policy, the BDA, the NHIF, the Bulgarian Medical Union, the Bulgarian Dental
p.002017: Union of the Bulgarian Pharmaceutical
p.002017: union and patient organizations and the pharmaceutical industry.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in
p.002017: (Effective 21.12.2012) A person who is a member of the Transparency Committee may not be a member of
p.002017: National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (4) The Council of Ministers shall lay down the rules and procedures for the work of the Commission
p.002017: for transparency.
p.002017: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012
p.002017: The Transparency Committee is an appealable body
p.002017: the decisions of the National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority
p.002017: ѝ.
p.002017: (3) The decisions under par. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a respective disease is without
...
p.002017: their remuneration shall be determined in an ordinance of the Minister of Health.
p.002017: (2) When challenging the results of laboratory tests, they shall be made
p.002017: retesting. They shall be made upon written request from the interested party,
p.002017: made within 7 days from the date of receipt of the result of the original test.
p.002017: (3) The repeated tests under para. 2 shall be carried out by experts designated by
p.002017: the BDA's Executive Director, who did not participate in the initial test, c
p.002017: the presence of an authorized representative of the interested party.
p.002017: Art. 274. (1) The conditions and the order for blocking and withdrawal of medicinal products,
p.002017: have shown non - compliance with the requirements for quality, safety and efficacy, shall be defined in
p.002017: ordinance of the Minister of Health.
p.002017: (2) The conditions and procedure for the destruction, processing or use for others
p.002017: the goals of the medicinal products are set out in an ordinance of the Minister of Health.
p.002017: Art. Article 275. (1) In exercising control, the BDA shall take all necessary measures to ensure proper validation of
p.002017: the processes of production and purification of medicinal products derived from human blood or human plasma,
p.002017: consistency in batch quality and ensuring, as far as technology allows, the absence of
p.002017: specific viral
p.002017: contamination.
p.002017: (2) Manufacturers shall notify the BDA of the method used to reduce or
p.002017: removal of pathogenic viruses that can be transmitted through medicinal products,
p.002017: obtained from human blood or human plasma.
p.002017: (3) The Drug Enforcement Agency shall test or send for testing to another
p.002017: official laboratory for control of medicinal products in the Republic of Bulgaria or in another
p.002017: Member State samples of the bulk / non - spilled product and / or test product or
p.002017: in the course of evaluating an application for marketing authorization under Art. 46, para. 1, item 2 or after issue
p.002017: of the marketing authorization.
p.002017: Art. 276. The Executive Director of the BDA shall, by order, suspend, revoke,
p.002017: suspend or change the marketing authorization / registration,
p.002017: when it is established that:
p.002017: 1. there is an unacceptable side effect when used properly, or
p.002017: 2. lack of therapeutic efficacy (therapeutic efficacy is lacking when
p.002017: found that the declared therapeutic results could not be obtained at the time of authorization
p.002017: for use), or
p.002017: 3. the benefit / risk balance is unfavorable when used correctly, or
p.002017: 4. the quantitative and qualitative composition of the medicinal product does not correspond to
p.002017: declarations at the time of marketing authorization, or
p.002017: 5. the data from the file under art. 27 - 32 are incorrect, or
p.002017: 6. (amend. - SG 71/08, in force from 12.08.2008) the data from the file under art. 27 - 32
p.002017: have not been supplemented or modified in accordance with the requirements of Chapter Three, Section VI, or
p.002017: 6a. (new - SG 102/2012, in force since 21.12.2012) the conditions under
p.002017: Art. 55a, 56 or 56a, or
p.002017: 6b. (new - SG 102/2012, in force since 21.12.2012) the production of the medicinal
p.002017: the product has not been produced in accordance with the described method of production under Art. 27, para. 1, Vol. 7,
p.002017: or
p.002017: 7. (amend. - SG 102/02, in force from 21.12.2012) no controls have been carried out
p.002017: tests or they are not carried out in accordance with the methods specified in Art. 27, para. 1, item 8, or
p.002017: 8. the particulars on the packaging and / or in the package leaflet are not in accordance with those approved by
p.002017: the granting of the marketing authorization;
p.002017: 9. (new - SG 71/08, in force from 12.08.2008) the holder of a permit for
p.002017: use has failed to fulfill the obligations of Article 45 (1) of Regulation (EC) No 1901/2006.
p.002017: Art. 277. (1) The Executive Director of the BDA, notwithstanding the measures under Art. 276,
p.002017: prohibits the supply of the medicinal product by order and orders its blocking
p.002017: its withdrawal from the market when:
p.002017: 1. (amend. - SG 102/02, in force from 21.12.2012) there is inadmissible undesirable
p.002017: drug reaction, or
p.002017: 2. lack of therapeutic efficacy, or
p.002017: 3. (amended, SG No. 102/2012, effective 21.12.2012) the benefit / risk ratio shall be
p.002017: unfavorable, or
p.002017: 4. the quantitative and qualitative composition of the medicinal product does not correspond to
p.002017: declarations at the time of marketing authorization, or
p.002017: 5. the control of the medicinal product and / or the constituents and the intermediate stages of
p.002017: the manufacturing process has not been completed or the requirements for which it was issued are not fulfilled
p.002017: the manufacturing authorization.
p.002017: (2) The BDA Executive Director may impose a prohibition under para. 1 and only under
p.002017: treatment of specific batches of the medicinal product.
p.002017: Art. 278. (1) The Executive Director of the BDA shall, by order, suspend or revoke it
p.002017: the authorization to use a group or all medicinal products for which it is relevant
p.002017: their place of production does not meet the requirements under which the authorization was granted
p.002017: for production.
p.002017: (2) In addition to the measures under Art. 276 may by order
p.002017: suspend the importation of a group or all medicinal products from third countries, or
p.002017: withdraw the authorization to import a group or all medicinal products when not
p.002017: comply with the requirements of Chapter Five.
p.002017: (3) In addition to the measures under Art. 276 may by order
p.002017: suspend or revoke the authorization to produce a group or all
p.002017: medicinal products which do not comply with the requirements of Chapter Five.
p.002017: Art. 279. (1) The orders under art. 276, 277 or 278 shall be served on the holder of
p.002017: the marketing authorization of the manufacturer or importer.
...
p.002017: penalties.
p.002017: Art. 297. In the cases of Art. 281, 282, 283, 284, 285 and 287, the penal authority shall also order
p.002017: withdrawal of medicinal products subject to the offense in favor of the State,
p.002017: under the conditions and in the order specified in an ordinance of the Minister of Health.
p.002017: Additional provisions
p.002017: § 1. For the purposes of this Act:
p.002017: 1. (amend. - SG 102/02, in force from 02.01.2013) "Active substance" shall be any substance or
p.002017: a mixture of substances intended for use in the manufacture of a medicinal product which when used
p.002017: in its manufacture they become the active ingredient of this product, intended for the exercise of
p.002017: pharmacological, immunological or metabolic action for the purpose of restoring, correcting or altering
p.002017: physiological functions
p.002017: or to make a medical diagnosis.
p.002017: 2. "Bioequivalence" is present when the medicinal products are pharmaceutical
p.002017: equivalent or pharmaceutical alternatives, and if their bioavailability after administration in
p.002017: the same molar dose is similar to such an extent that its effects in terms of efficacy and
p.002017: safety is substantially similar.
p.002017: 3. "Bioavailability" is the rate and extent at which the active substance or the therapeutically active part of it is absorbed
p.002017: of the dosage form and becomes available at the site of action. When the drug substance is intended to
p.002017: exercise a systemic therapeutic effect, bioavailability means the speed and degree at which a drug substance or
p.002017: therapeutically
p.002017: its active part is released from the dosage form and goes into general circulation.
p.002017: 4. "Researcher's Brochure" means the aggregate of clinical and non-clinical data for
p.002017: the investigational medicinal product (s) that are relevant for the test of the product or product
p.002017: products on people.
p.002017: 5. "Valid documentation" shall mean documentation which in content and completeness corresponds to
p.002017: the requirements laid down in a particular procedure under this Act.
p.002017: 6. "Substance with well established use in medical practice" is a substance for
p.002017: the following criteria may apply:
p.002017: (a) the period of proof of well-established use in medical practice is not less than 10 years from
p.002017: the date of the first systematic and documented use of the substance as a medicinal product in
p.002017: The European Union or the European Economic Community
p.002017: space;
p.002017: (b) quantitative aspects of the use of the substance, taking into account the degree of medical use
p.002017: practice, the degree of geographical use and the degree of tracking through the safety system,
p.002017: including pre-market research and scientific research published thereafter
p.002017: epidemiological literature
...
p.002017: publications) and unity in the scientific community in scientific evaluations.
p.002017: 7. "Secondary packaging" is a packaging which does not come in direct contact with
p.002017: the medicinal product.
p.002017: 8. "Contracting Authority" means a natural or legal person, institution or organization which
p.002017: is responsible for initiating, managing and / or financing the clinical trial.
p.002017: 9. "Generic medicinal product" is a medicinal product which has the same qualitative and
p.002017: quantitative composition with respect to the active substances and the same dosage form as the reference
p.002017: medicinal product, and its bioequivalence with the reference medicinal product has been demonstrated to be appropriate
p.002017: bioavailability tests. The various immediate-release oral dosage forms are considered to be one
p.002017: and the same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of
p.002017: active substance are considered to be the same active substance, unless they differ significantly in their nature
p.002017: safety and / or efficiency.
p.002017: 10. "Principal Investigator" is the doctor or dentist appointed by the contracting authority, who direct
p.002017: the overall conduct of the clinical trial in accordance with the approved protocol and the Good Guideline
p.002017: clinical practice and responsible for the work of
p.002017: the researchers.
p.002017: 11. "Defined daily dose" is an average daily maintenance dose of a drug
p.002017: product for use in adults according to the primary indication of the medicinal product.
p.002017: 12. "Good clinical practice" is the set of internationally recognized ethical and
p.002017: scientific quality requirements to be met when planning, conducting, reporting and
p.002017: reporting of clinical trials.
p.002017: 13. "Good laboratory practice" is a system of internationally recognized rules
p.002017: in terms of planning conditions, processes of organizing, executing, tracking and
p.002017: documentation of laboratory tests.
p.002017: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers all
p.002017: production sides - personnel, premises, facilities, materials, documentation, quality control, and aims
p.002017: to ensure safety, efficiency and
p.002017: according to the specification.
p.002017: 15. (suppl. - SG 71/08, in force from 12.08.2008) "Member State" is a state,
p.002017: Member State of the European Union or a State Party to the Agreement on the European Union
p.002017: economic space.
p.002017: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002017: 17. "Immunological medicinal product" is a medicinal product containing vaccines, toxins, serums or allergens. IN
p.002017: the range of vaccines, toxins and serums include agents used to create active immunity or to
p.002017: establish a state of immunity or induce passive immunity. Allergens are medicinal products that are
p.002017: intended to identify or stimulate a specific targeted change in the immunological response
p.002017: to an allergic agent.
p.002017: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002017: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative, and
p.002017: when their bioavailability after application in the same
p.002017: the molar dose is similar to a degree which is a condition of equivalent efficacy and safety.
p.002017: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and extent of
p.002017: in which the active substance or the therapeutically significant portion of the test drug reaches
p.002017: from the dosage form to the systemic
p.002017: blood circulation.
p.002017: 20. "Tested medicinal product" means the dosage form of the active substance or placebo to be tested
p.002017: or used as a comparison in a clinical trial, including authorized products
p.002017: for use, but are used for unauthorized use or for the purpose of obtaining additional information on
p.002017: the authorized form, or they are
p.002017: completed (in medicinal or packaged form) in a way other than the approved form.
p.002017: 21. "Researcher" means the doctor or dentist designated by the sponsor and the principal investigator,
p.002017: who practically conducts the clinical trial under the direction of the principal investigator according to
p.002017: the approved protocol and the Good Clinical Practice Guide at the Research Center for
p.002017: the clinical trial. If the clinical trial is conducted by a team, the investigator is the supervisor responsible for
p.002017: team and is called the Principal Investigator.
p.002017: 22. "Informed consent" is a statement of will that must be written, dated and signed in order to participate in
p.002017: a clinical trial taken completely free after being duly informed of its nature,
p.002017: significance, consequences and risks and properly documented by any person who is able to consent
p.002017: or when the person is not
p.002017: able to give his consent - from his legal representative.
...
p.002017: for use as a medicinal product in the European Union;
p.002017: (b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that is
p.002017: has been authorized for use as a medicinal product in the European Union but differs in
p.002017: the safety and efficacy of a previously authorized substance;
p.002017: (c) a biological substance which has been authorized for use as a medicinal product in
p.002017: European Union, but with a different molecular structure, with different origins in terms of
p.002017: the source material or is obtained through a different manufacturing process;
p.002017: (d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which have not been
p.002017: authorized as a medicinal product in the European Union, or the mechanism for pairing molecules
p.002017: and radionuclides was not allowed in
p.002017: The European Union.
p.002017: 40. "Adverse event" means any adverse change in health status,
p.002017: observed when administering a medicinal product to a patient or clinical participant
p.002017: a test that is not necessarily causally related to this treatment.
p.002017: 41. (amend. - SG 102/2012, in force since 21.12.2012) "Adverse drug reaction" is any undesirable and
p.002017: unexpected response to a medicinal product. In the case of a clinical trial - any undesirable or unforeseen
p.002017: response to the investigational medicinal product independently
p.002017: of the administered dose. The types of side effects are:
p.002017: (a) "unexpected" - an adverse reaction not listed in the summary of product characteristics;
p.002017: the product or whose character, weight or output does not meet the product characteristics mentioned in the summary; in
p.002017: case of clinical trial is an adverse reaction whose nature, severity or outcome do not match
p.002017: of test information
p.002017: medicinal product specified in the investigator's brochure;
p.002017: (b) "suspected" - an adverse reaction for which the notifier or the holder
p.002017: of the Marketing Authorization implies that there is a possible causal link with
p.002017: the received medicinal product;
p.002017: (c) "serious" - any adverse effect on a health condition which has caused the death,
p.002017: imminent danger to life, hospitalization or prolongation of hospitalization, significant or
p.002017: permanent disability, disability and congenital
p.002017: anomalies;
p.002017: (d) combinations of reactions under letters "a", "b" and "c".
p.002017: 42. "Common name" means the international non-patent name of a medicinal or excipient
p.002017: (INN) recommended by WHO; if not, the name in the European Pharmacopoeia is used, if there
p.002017: missing - another pharmacopoeial name; when not
p.002017: pharmacopoeial name, the usual accepted name is used.
p.002017: 42a. (new - SG 102/2012, in force since 21.12.2012) "Main documentation of the system for
p.002017: Drug Safety Tracking "is a detailed description of the drug tracking system
p.002017: the safety used by the holder of the
p.002017: use in relation to one or more authorized medicinal products.
p.002017: 42b. (new - SG 48/2015) "Assessment of health technologies" is:
p.002017: (a) a form of research policy exploring the short-term
p.002017: and the long-term results associated with the implementation of health technologies and aims to
p.002017: provided information on alternative health strategies;
p.002017: (b) a multidisciplinary activity that systematically assesses technical characteristics,
p.002017: safety, clinical efficacy and effectiveness, cost, value effectiveness, organizational, social,
p.002017: the legal and ethical implications of the administration of medicinal products in health care and focus
p.002017: on clinical and economic value, the analysis being comparable to existing or
p.002017: best to
p.002017: currently an alternative.
p.002017: 43. "Batch" means the specified quantity of the medicine manufactured in accordance with
p.002017: a reproducible technological scheme has been established to provide the required batch
p.002017: homogeneity with respect to the required control parameters.
p.002017: 43a. (new, SG No. 102/2012, effective 21.12.2012) "Risk Management Plan"
p.002017: is a detailed description of the risk management system.
p.002017: 44. "Maintenance of the authorization for a medicinal product" includes all
p.002017: necessary activities to maintain the current registration status of the medicinal product
p.002017: product, including drug safety monitoring.
p.002017: 44a. (new - SG 48/2015) "Maintenance of reimbursement status" is an assessment of
p.002017: medicinal product on the basis of evidence of efficacy, therapeutic efficacy,
p.002017: safety and analysis of pharmacoeconomic indicators.
p.002017: 45. "Benefit" is the positive result / therapeutic efficacy of the medicinal product
p.002017: for an individual patient, a group of patients, or for the community. Quantification of expected
p.002017: the benefit involves an approximate calculation of the probability of this positive result.
p.002017: 46. (amend. - SG 102/02, in force from 02.01.2013) "Excipient" shall be any
p.002017: an ingredient of a medicinal product other than the active substance and the packaging material.
p.002017: 47. "Post-marketing study" means any study conducted using the
p.002017: the medicinal product within the approved summary of product characteristics during the period
p.002017: after authorization for use.
p.002017: 47a. (new - SG 102/2012, in force from 02.01.2013) "Mediation in the field of medicinal products" are
p.002017: all activities except for the conclusion of a contract for the purchase or sale of medicinal products
p.002017: of wholesale, which do not involve physical holding and which are independently negotiated
p.002017: and on behalf of another
p.002017: legal or natural person.
p.002017: 48. (amend. - SG 102/2012, in force since 21.12.2012) "Post-marketing safety study" is any
p.002017: a study relating to an authorized medicinal product to identify itself,
p.002017: characterize or determine the degree of safety risk, confirm the profile of
p.002017: the safety of the medicinal product
...
p.002017: 59. "Herbal medicinal product" is a medicinal product containing as medicinal substances
p.002017: one or more herbal substances or one or more herbal preparations or one or more
p.002017: plant matter in combination with one or more
p.002017: herbal preparations.
p.002017: 60. "Vegetable substances" are mainly plants or parts of plants, algae, fungi, lichens, which are whole,
p.002017: broken or chopped, and used in the raw state, usually in the dried state, but sometimes also fresh.
p.002017: Some exudates that have not undergone specific treatment also apply to plant substances.
p.002017: The plant matter must have a specific botanical scientific name for the plant, from
p.002017: who
p.002017: originate according to the binomial system (genus, species, variety and author).
p.002017: 61. "Vegetable preparation" means the product obtained after extraction, distillation, squeezing, fractionation,
p.002017: purification, concentration or fermentation of the plant substance. The herbal preparation may be
p.002017: also ground or powdered vegetable
p.002017: substances, tinctures, extracts, essential oils, processed vegetable fluids / juices.
p.002017: 62. "Rare diseases" are diseases that are characterized by a frequency of
p.002017: prevalence no higher than 5 in 10,000 people.
p.002017: 63. "Reference medicinal product" is a medicinal product authorized in accordance with Art. 23 c
p.002017: compliance with the requirements of Art. 27.
p.002017: 64. "Defined daily dose reference value" for an international non-patent name with the relevant
p.002017: Anatomy Therapeutic Drug Classification Formula is the Lowest Value for a Defined Daily
p.002017: dose determined on the basis of defined daily dose values for the different medicinal products for
p.002017: the relevant international non - patent name with the relevant dosage form
p.002017: anatomic therapy
p.002017: classification of medicines.
p.002017: 65. "Therapeutic course reference value" is the lowest therapeutic value
p.002017: a course determined on the basis of the values of a therapeutic course of medicines internationally
p.002017: non-patent name with appropriate dosage form.
p.002017: 66. "Risk in use of a medicinal product" is:
p.002017: (a) the risk to the health of the patient or the risk to the health of the population associated with
p.002017: the quality, safety or efficacy of the medicinal product;
p.002017: (b) the risk of adverse effects on the environment.
p.002017: 67. "Serious adverse event" is any adverse change in health status that is
p.002017: causing fatal outcome, imminent danger to life, hospitalization or prolongation of
p.002017: hospitalization period, significant or lasting
p.002017: disability, disability and congenital anomalies.
p.002017: 68. "Batch Release Certificate" is a document issued by
p.002017: the qualified person of the manufacturer or importer for each individual lot and includes
p.002017: requirements in accordance with the specification as well as all test results for
p.002017: batch release.
p.002017: 69. "Certificate of additional protection" is a document that provides additional
p.002017: patent protection of the medicinal product for a maximum of 5 years after the expiry date of
p.002017: the basic patent.
p.002017: 69a. (new, SG No. 102/2012, effective 21.12.2012) "Risk Management System" is
p.002017: a system of pharmacovigilance measures and activities designed to
p.002017: identifying, characterizing, preventing or minimizing drug-related risks
p.002017: product, including an evaluation of the effectiveness of these
p.002017: activities and measures.
p.002017: 69b. (new - SG 102/2012, in force since 21.12.2012) "Tracking system of
p.002017: 'safety' is a system used by the marketing authorization holder and
p.002017: BDA for the accomplishment of the tasks and responsibilities of Chapter Eight intended for implementation
p.002017: monitoring the safety of authorized medicinal products and detection
p.002017: of any change in the benefit / risk ratio.
p.002017: 70. "Emergency restrictive safety measures" are temporary changes to product information with respect to
p.002017: one or more parts of the summary of product characteristics, indications, method of administration, contraindications
p.002017: and warnings that result from a new one
p.002017: information related to the safe use of the medicinal product.
p.002017: 71. "Spontaneous message" is a voluntarily sent message about suspected unwanted
p.002017: reaction when using the medicinal product to the marketing authorization holder, up to
p.002017: authorities for the supervision of medicinal products or other organizations not originating in
p.002017: a survey or other organized information gathering system.
p.002017: 72. "Shelf life of a medicinal product" is the time interval at which, if stored at
p.002017: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002017: based on stability studies of several batches of
p.002017: the finished form.
p.002017: 73. (amend. - SG 71/08, in force from 12.08.2008) "Relevant medicinal product of
p.002017: herbal medicinal product "is a product that contains the same active substances, regardless of composition
p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
...
p.002017: psychological effects.
p.002017: 86. (new - SG 41/09, in force from 02.06.2009) "Infants" shall be children under 12
p.002017: months.
p.002017: 87. (new - SG 41/09, in force from 02.06.2009) "Foods for infants" are foods,
p.002017: intended for specific nutritional use by infants during their first months alone
p.002017: are sufficient to satisfy the nutritional needs of these infants up to
p.002017: the moment of introduction of suitable supplementary food.
p.002017: 88. (new - SG 41/09, in force from 02.06.2009) "Transitional foods" are foods,
p.002017: intended for the specific nutritional use of infants when administered appropriate
p.002017: supplemental food and which constitute the main liquid food of progressively increasing
p.002017: are the variety of foods in these infants.
p.002017: 89. (new - SG 12/11, in force from 08.02.2011) "Type IA change" is a change with
p.002017: minimal or no impact on quality, safety or efficacy
p.002017: of the respective medicinal product.
p.002017: 90. (new - SG 12/11, in force from 08.02.2011) "Type IB change" is a change,
p.002017: which is neither a Type IA nor a Type II change nor an extension of the authorization of
p.002017: use.
p.002017: 91. (new - SG 12/11, in force from 08.02.2011) "Type II change" is a change that does not
p.002017: is an extension of the marketing authorization and which can have a significant impact
p.002017: on the quality, safety or efficacy of the person concerned
p.002017: medicine.
p.002017: 92. (new - SG 102/2012, in force from 21.12.2012) "Delegated act" is an act under
p.002017: the meaning of Art. 290 of the Treaty on the Functioning of the European Union.
p.002017: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
p.002017: § 3. The Council of Ministers shall determine the terms and conditions for the acquisition, storage and storage
p.002017: updating of medicinal products stored by the State Agency of the State Reserve and
p.002017: wartime stocks ".
p.002017: § 4. (Supplemented, SG No. 18/2014) This Act introduces the provisions of Directive 2001/83 / EC
p.002017: The European Parliament and the Council establishing a Community code for medicinal products for human use
p.002017: use as last amended by Directive 2004/27 / EC of the European Parliament and of the Council and Directive
p.002017: 2012/26 / EU of the European Parliament and of the Council of 25 October 2012 amending Directive
p.002017: 2001/83 / EC as regards
p.002017: pharmacovigilance (OJ L 299/1 of 27 October 2012).
p.002017: § 5. Data protection deadlines for the reference medicinal products shall be applied in accordance with the provisions
p.002017: of Art. 89 of Regulation (EC) No 726/2004 of the European Parliament and the
p.002017: Council and Art. 2 of Directive 2004/27 / EC of the European Parliament and of the Council.
p.002017: § 5a. (New, SG No. 60/2011, effective 30.09.2011) (1) (Amended, SG No. 102/2012, effective from
p.002017: 21.12.2012, amend. - SG, issue. 85 of 2017) Ministry of Health, National Council on
p.002017: prices and reimbursement of medicines, the Executive Agency for Medicines and Regional
p.002017: health inspections provide the opportunity to provide information and to accept applications and documents
p.002017: this law electronically under the terms and procedure of the Electronic Document and Electronic Certification Act
p.002017: services and the eGovernment Act.
p.002017: (2) Provision of information and acceptance of applications and documents under
...
p.002017: medicinal products submitted prior to the entry into force of this Act shall be considered and terminated
p.002017: under the conditions and in the manner provided therein.
p.002017: § 12. (1) Manufacturers of medicinal products authorized to manufacture under the procedure of
p.002017: repeal of the Medicines and Pharmacies Act in the human medicine, bring the manufacturing
p.002017: its activities in accordance with the requirements of this Act with respect to a qualified person
p.002017: under Art. 148, item 2 within three months from the entry into force of this Act.
p.002017: (2) Manufacturers welded to the entry into force of this Act shall carry out
p.002017: their activity on the basis of the Medicines and Pharmacies Act issued by them under the repealed Act
p.002017: in human medicine permissions.
p.002017: § 13. (1) The persons who have received a permit for wholesale of medicines under the procedure of
p.002017: the repealed Law on Medicines and Pharmacies in Human Medicine bring its business to
p.002017: compliance with the requirements of this law within 12 months of its entry into force.
p.002017: (2) Until the granting of a wholesale marketing authorization for medicinal products under the procedure of
p.002017: this law, but no later than the expiration of the term under para. 1, the persons under para. 1 carry out the activity
p.002017: based on what was issued under the repealed Humane Medicines and Pharmacies Act
p.002017: medicine medicine wholesale authorization.
p.002017: (3) By issuing a wholesale marketing authorization for medicinal products under the procedure of
p.002017: this law, respectively, with the expiration of the term under para. 1, issued pursuant to the repealed Law on
p.002017: medicines and drugstores in the human medicine wholesale marketing authorization drug
p.002017: terminated.
p.002017: § 14. (1) The persons who have received a permit for wholesale of medicines under the repealed Law on
p.002017: medicines and pharmacies in the human medicine can import medicinal products into the territory of
p.002017: Republic of Bulgaria from third countries on the basis of this authorization pending the receipt of an import permit in accordance with the
p.002017: this law, but not later than 12
p.002017: months after its entry into force.
p.002017: (2) Within one month from the entry into force of this Act the persons under para. 1 filed with the BDA
p.002017: notification of the person who will perform the functions of a qualified person within the meaning of Art.
p.002017: 161, para. 2, Vol. 1.
p.002017: § 15. The term of validity of the wholesale marketing authorizations for medical devices,
p.002017: issued under the repealed Law on Medicines and Pharmacies in Human Medicine,
p.002017: extended ex officio until 31 December 2007.
p.002017: § 16. (Repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: § 17. (1) The drugstores welded until the entry into force of this Act shall carry out the activity
p.002017: on the basis of their certificates issued under the repealed Medicines Act and
p.002017: pharmacies in human medicine.
p.002017: (2) Applications for Issuance of Certificates for Registration of Drugstores Submitted to
p.002017: the entry into force of this Act shall be considered and concluded under the conditions and in the manner provided
p.002017: in him.
p.002017: § 18. (1) (Am. - SG, iss. 71 in 2008, effective from 14.04.2008, amended - SG, iss. 10 in 2009, in
p.002017: effective from 29.01.2009) The positive medical list under this law shall be made in the order,
p.002017: provided for therein and shall enter into force on 31 March 2009.
p.002017: (2) (amend. - SG 71/08, in force from 14.04.2008) Until the entry into force of the list under para. 1 active
p.002017: Positive Medication List is the Positive Medicinal List adopted with the Ordinance for determining positive
p.002017: medical list in the Republic of Bulgaria (promulgated, SG, issue.
p.002017: 113 of 2003; amend. 18 of 2004, issue. 4 of 2005 and issue. 8, 107 and 112 of 2007).
p.002017: (3) (New, SG No. 71/2008, effective 14.04.2008; amend. - SG 23/09, in force from 30.03.2009)
p.002017: two months after the entry into force of the list under para. 1, medical care providers prescribe and the NHIF pays
p.002017: medicinal products according to the NHIF medicinal list, adopted by Decision No. РД-УС-04-127 of December 27
p.002017: 2007 to determine the conditions to be fulfilled by medical care providers, the procedure for conclusion
p.002017: of the contracts with them and other conditions under art. 55, para. 2, items 2, 4, 6 and 7 of the Health Act
p.002017: insurance.
p.002017: § 19. (1) Within three months from the entry into force of this Act:
p.002017: 1. The Council of Ministers shall amend and supplement the Rules of Procedure of the Executive
p.002017: a drug agency in accordance with this law;
p.002017: 2. the Minister of Health issues the ordinance under Art. 82, para. 3.
p.002017: (2) Within 6 months from the entry into force of this Act, the Council of Ministers shall adopt and
p.002017: the Minister of Health issues other normative acts for the implementation of the law.
p.002017: § 20. After the expiry of the first two years of the term of office of the members of the commissions under Art. 103, 107, 259 and 261 by lot
p.002017: determine the half of the members whose term of office is terminated.
p.002017: § 21. (amend. - SG 71/08, in force from 14.04.2008) Within two years from entering into
p.002017: by virtue of this law, the BDA shall take the necessary steps to accredit its laboratory for the control of
p.002017: medicinal products and active substances of the European
p.002017: Directorate for Quality of Medicines and Health.
p.002017: § 22. (In force since 14.04.2008) In the Health Insurance Act (promulgated, SG, issue 70 of
p.002017: 1998; amend. 93 and 153 of 1998; 62, 65, 67, 69, 110 and 113 of 1999, issue. 1, 31 and 64 of 2000
p.002017: , issue. 41 of 2001, issue. 1, 54, 74, 107, 112, 119 and 120 of 2002; 8, 50, 107 and 114 of 2003
p.002017: 28, 38, 49, 70, 85 and 111 of 2004; 39, 45, 76, 99, 102, 103 and 105 of 2005; 17, 18, 30, 33, 34,
p.002017: 59, 95 and 105 of 2006; 11 of 2007, issue. 26 of 2007 - Judgment No. 3 of the Constitutional Court
p.002017: from 2007) the following amendments are made:
p.002017: 1. In Art. 45:
p.002017: (a) paragraphs 4, 5, 6 and 7 are repealed;
p.002017: (b) paragraph 8 is amended as follows:
p.002017: "(8) The conditions and procedure for payment of medicinal products included in the Positive Medicinal List under Article 262
p.002017: of the Medicinal Products in Human Medicine, Medical Devices and Dietetic Products Act
p.002017: special medical purposes are governed by an ordinance of
...
p.002000: healthcare is provided to the Executive Agency for Medicinal Products by a foster care provider
p.002000: protocol of the archive of the completed proceedings.
p.002000: (3) Within two months of the entry into force of this Act, the Ministry of Transport
p.002000: healthcare is provided to the Executive Agency for Medicinal Products by a foster care provider
p.002000: Minutes kept by the Ministry of Health of the register of licenses issued
p.002000: retail of medicines in a pharmacy.
p.002000: (4) After issuing a permit in accordance with the procedure of para. 1 Ministry of Health
p.002000: shall, within three days, ex officio send a copy of it to the BDA
p.002000: entry in the register of issued marketing authorizations for medicinal products.
p.002000: (5) Upon completion of the proceedings under para. 1 Ministry of Health
p.002000: provides the Executive Agency for Medicinal Products with a transceiver protocol
p.002000: archive.
p.002000: § 68. (1) Applications for the issue or change of certificates of registration of
p.002000: drugstores submitted prior to the entry into force of this Act shall be considered under the terms and procedure,
p.002000: provided for therein.
p.002000: (2) Within one month of the entry into force of this Act, the Executive Agency for Medicines shall provide the
p.002000: the relevant Regional Health Inspectorate with the acceptance protocol of the applications and documents submitted for
p.002000: the procedures for the issue of certificates
p.002000: for registration of drugstores, as well as the archive of completed proceedings.
p.002000: (3) Within one month of the entry into force of this Act, the Executive Agency under the
p.002000: medicines provided to the Ministry of Health with a foster care
p.002000: the record kept by the BDA of the issued drug registration certificates.
p.002000: (4) Within one month of the submission of the register under para. 3 Ministry of Agriculture
p.002000: the health register shall be drawn up and published on its web site by the national register of the issues issued up to
p.002000: the entry into force of this law certificates for registration of drugstores.
p.002000: § 69. (1) Within three months from the entry into force of this Act the procedures for
p.002000: the validation or registration of prices of medicinal products shall be effected at
p.002000: so far, by the Committee on Medicinal Products Prices.
p.002000: (2) After the expiration of the term under para. 1 The Committee on Medicinal Products Prices shall submit to the Commission the
p.002000: prices and reimbursement by transceiving protocol applications and documents submitted for the procedures under
p.002000: para. 1, as well as the archive of the completed
p.002000: procedures for approving or registering drug prices.
p.002000: (3) After the expiration of the term under para. 1 The Committee on Medicinal Products Prices shall provide the Committee on Prices and
p.002000: reimbursement with the handover protocol, kept by the commission registers of the issued decisions for
p.002000: validation or registration of prices of
p.002000: medicinal products.
p.002000: § 70. (1) Within three months from the entry into force of this Act the procedures under
p.002000: inclusion, exclusion and / or modification of Positive Medicinal Products
p.002000: the list is made so far by the Positive Drug List Committee.
p.002000: (2) After the expiration of the term under para. 1 The Committee on the Positive Medicinal List shall submit it to the Commission
p.002000: on prices and reimbursement with the transceiver protocol, the applications and documents submitted for
p.002000: the procedures under para. 1, as well as an archive of completed procedures for turning on, off and / or changes to
p.002000: medicinal products from the Positive
p.002000: medication list.
p.002000: § 71. State fees paid under the procedures under § 69, para. 1 and § 70, para. 1, are spent
p.002000: to secure the relevant administrative proceedings as well as to the activity of
p.002000: Transparency Committee.
p.002000: § 72. (1) The prices determined in accordance with Art. 258, para. 1, of medicinal products which
p.002000: as of the entry into force of this Act, they are included in the Positive Medicinal List and are also considered
p.002000: their marginal prices for their retail sale in accordance with Art. 258, para. 3.
p.002000: (2) Within three months of the entry into force of this Act, the Commission for the prices of
p.002000: medicinal products are officially deleted from the register of marginal prices
p.002000: marginal prices of the medicinal products under para. 1.
p.002000: (3) Until 31 December 2012, marketing authorization holders may not change the price of
p.002000: medicinal product with the exception of its reduction for products which were in force at the time of entry into force of this Act
p.002000: a certain price but not included in the Positive
p.002000: medication list.
p.002000: § 73. (1) With the entry into force of this Act, the established marginal prices of the medicinal products granted under
p.002000: prescription, and the registered prices of non-prescription medicinal products,
p.002000: shall be considered their registered prices under Art. 258,
p.002000: para. 2.
...
p.002000: intends to introduce for the respective medicinal product.
p.002000: (3) In the cases of para. 2 The BDA shall notify the authorization holder in writing of
p.002000: use, stating the reasons for the obligation and the time limit for the submission of the
p.002000: the detailed description of the risk management system.
p.002000: (4) Within 30 days from receipt of the notification under para. 3 the holder of
p.002000: the marketing authorization may require the BDA to provide an opportunity to submit a
p.002000: information on the imposed obligation under para. 2.
p.002000: (5) Upon receipt of the request under para. 4 The BDA sets a deadline for submission of the
p.002000: information from the Marketing Authorization Holder.
p.002000: (6) On the basis of the information provided, the BDA may confirm the imposed
p.002000: obligation under para. 2 or cancel it.
p.002000: (7) The Executive Agency for Medicinal Products shall notify the holder of the decision taken
p.002000: under para. 6.
p.002000: (8) When the BDA confirms the obligation, the Executive Director issues it ex officio
p.002000: modification of the marketing authorization by including in it the obligation imposed
p.002000: under para. 2.
p.002000: § 123. Holders of marketing authorizations for medicinal products issued
p.002000: before July 21, 2012, fulfill the obligation under Art. 192, para. 1, item 1 with effect from 21 July 2015.
p.002000: or from the date of renewal of the marketing authorization for the medicinal product concerned in
p.002000: whichever comes first.
p.002000: § 124
p.002000: finish up to date.
p.002000: § 125. (1) Until the conditions and the term under Art. 2, point 3 of Directive 2010/84 / EU
p.002000: holders of marketing authorizations send messages for serious undesirable
p.002000: drug reactions occurring on the territory of the Republic of Bulgaria, to the BDA and to
p.002000: The European Medicines Agency within 15 days of receipt.
p.002000: (2) The Drug Enforcement Agency shall verify the fulfillment of the obligation under
p.002000: para. 1.
p.002000: (3) Where the communication relates to a serious adverse reaction that has occurred
p.002000: in the territory of a third country, holders of marketing authorizations within the period of para. 1
p.002000: notify the European Medicines Agency.
p.002000: § 126. (1) Holders of marketing authorizations shall submit periodically to the BDA
p.002000: updated safety reports in accordance with the time intervals under Art. 194k, para. 3 for
p.002000: medicinal products authorized before 21 July 2012 and for
p.002000: which the frequency and filing dates of periodic safety update reports do not
p.002000: are listed as conditions in the Marketing Authorization.
p.002000: (2) The provision of para. 1 shall apply until a different frequency or other dates are specified
p.002000: submission of reports in the Marketing Authorization or until date and frequency
p.002000: according to Art. 194l - 194n.
p.002000: § 127. (1) Holders of marketing authorizations shall submit periodically updated reports on
p.002000: safety under Art. 194h, para. 1 in the register under Art. 194h, para. 3 after the expiration of 12 months from the date,
p.002000: notified by the European Medicines Agency
p.002000: its functioning.
p.002000: (2) Until the term of para. 1 the marketing authorization holders submit
p.002000: the periodic safety update reports of the BDA and the regulatory authorities of
p.002000: other Member States in which the medicinal product concerned is authorized.
p.002000: § 128. Holders of authorization / certificate for retail sale of medicinal products in a pharmacy or drug store
p.002000: Art. 234, para. 5 place on the website the logo under Art. 234, para. 6 within one year from the date of
p.002000: publication of the act under art. 85c, paragraph 3 of
p.002000: Directive 2001/83 / EC.
p.002000: § 129. The Executive Agency for Medicines shall perform the first audit of the system under Art.
p.002000: 183, para. 1 and shall send the European Commission a report on its results by 21 at the latest
p.002000: September 2013
p.002000: § 130. (1) By March 20, 2013, the proceedings initiated and closed by the Commission under
p.002000: prices and reimbursement are completed by it in the previous order.
p.002000: (2) After 1 April 2013, the proceedings pending before the Commission on prices and
p.002000: reimbursement is completed by the National Board of Prices and Reimbursement of Medicinal Products
p.002000: products under the terms and procedures of this Act.
p.002000: (3) By 31 March 2013, the Price and Reimbursement Commission shall submit to the National Price Council
p.002000: and reimbursement of medicines with a protocol of acceptance of applications and documents submitted for
p.002000: the procedures under para. 1, as well as the archive of
p.002000: completed procedures.
p.002000: (4) By 31 March 2013, the Pricing and Reimbursement Committee has provided the
p.002000: National Council on Prices and Reimbursement of Medicinal Products with Reception and Transfer
p.002000: minutes kept by the commission registers.
p.002000: § 131. (1) By March 20, 2013, fees for submitting price confirmation / price caps,
p.002000: registering prices for medicinal products to include, exclude or change medicinal products in
p.002000: The positive drug list is collected by
p.002000: The Ministry of Health in the amounts specified in the tariff under Art. 21, para. 2.
p.002000: (2) The funds collected by March 20, 2013 under para. 1 shall be expended for the activity
p.002000: the Pricing and Reimbursement Committee and the Transparency Committee.
p.002000: § 132. Within three months of the entry into force of this Act, the Council of Ministers under
p.002000: proposal of the Minister of Health:
p.002000: 1. appoints the chairman and the members of the National Council for prices and reimbursement of
p.002000: medicinal products;
p.002000: 2. adopts the Rules of Procedure of the National Council for Prices and Reimbursement of
p.002000: medicinal products.
p.002000: § 133. (1) Within two months of the entry into force of this Act the Council of Ministers
p.002000: change the tariff under Art. 21, para. 2.
p.002000: (2) By 1 April 2013 the Council of Ministers shall adopt the ordinance under Art. 261a, para. 5.
p.002000: § 134. The obligations under art. 159, para. 4, Art. 168, para. 8, Art. 168a and 168b begin
p.002000: fulfill three years after the date of publication of the delegated acts under art. 54a
p.002000: of Directive 2001/83 / EC in the Official Journal of the European Union.
p.002000: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002000: § 138. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: except for:
p.002000: 1. paragraph 9, item 1, letter "a", § 29 - 36, § 38 - 43, § 44 regarding Art. 167a, 167b, 167b, 167g,
p.002000: 167e, Art. 167f, para. 1 and para. 2, item 1 and art. 167h, § 65-76, § 98, paragraphs 1 and 2, § 101, paragraph 1, letters "a" and "b", § 102, 103,106
p.002000: - 108, 111, 116, § 117, item 1, letters "a", "f", "g" and "l", effective January 2, 2013
p.002000: d .;
p.002013: 2013
p.002013: 2. paragraphs 20 and 117, item 2, which shall enter into force on 1 April 2013;
p.002013: 3. paragraph 44 concerning Art. 167f, para. 2, item 2 and para. 3 and Art. 167g, effective July 2
p.002013: Transitional and Final Provisions
p.002013: TO THE PUBLIC FINANCE LAW
p.002013: (Promulgated - SG, issue 15 of 2013, in force since 01.01.2014)
p.002013: § 123. The law shall enter into force on January 1, 2014, with the exception of § 115, which shall enter into force
p.002013: of January 1, 2013, and § 18, § 114, § 120, § 121 and § 122, effective February 1, 2013.
p.002013: Transitional and Final Provisions
p.002013: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002013: (Official Gazette, SG No. 1/2004, IN EFFECT OF 03/01/2014)
p.002013: § 18. Within one month after the entry into force of this Act, the Minister of
p.002013: the health care shall align with it the ordinance of art. 221, para. 1 of the Law on
p.002013: medicinal products in human medicine.
p.002013: § 19. The law shall enter into force on the day of its promulgation in the State Gazette.
p.002013: Transitional and Final Provisions
p.002013: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002013: INSURANCE
p.002013: (Official Gazette, SG 48/15)
p.002013: § 46. (1) Within three months from the entry into force of this Act, medical scientific companies shall submit to
p.002013: National Council on Drug Price and Reimbursement
p.002013: products manuals and algorithms of art. 259, para. 1, item 4 of the Law on Medicinal Products
p.002013: in human medicine.
p.002013: (2) When, within the term of para. 1, the medical scientific companies do not submit the manuals and algorithms under Art. 259, para. 1,
p.002013: Item 4 of the Law on Medicinal Products in Human Medicine, National Council on Prices and Reimbursement
p.002013: medicinal products are organized by national consultants or other healthcare professionals,
p.002013: who have experience
p.002013: in the relevant area.
p.002013: (3) The National Council for the prices and reimbursement of medicinal products shall approve
p.002013: the manuals and algorithms of art. 259, para. 1, item 4 of the Law on Medicinal Products in
p.002013: human medicine within three months from the expiry of the term under para. 1.
p.002013: § 47. (1) Within three months from the entry into force of this Act, the Minister of
p.002013: the health care shall issue the ordinance under art. 262, para. 4 of the Medicinal Products Act in
p.002013: human medicine.
p.002013: (2) Within 6 months from the entry into force of this Act in the Positive Medicinal List
p.002013: may include medicinal products with new international non-patent names without
p.002013: to have an assessment of health technologies.
p.002013: Transitional and Final Provisions
p.002013: TO THE LAW TO SUPPLEMENT THE LIMITATION OF LAW
p.002013: ADMINISTRATIVE REGULATION AND ADMINISTRATIVE CONTROL
p.002013: ECONOMIC ACTIVITY
p.002013: (Official Gazette, No. 103 OF 2017, IN EFFECT OF 01/01/2018)
p.002013: § 68. This Act shall enter into force on 1 January 2018.
p.002013: Relevant European legislation
p.002013: DIRECTIVE 2012/26 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: October 2012 amending Directive 2001/83 / EC as regards
p.002013: pharmacovigilance
...
Searching for indicator substance:
(return to top)
p.002017: GENERAL
p.002017: Section I.
p.002017: general provisions
p.002017: Art. 1. This Act regulates the terms and conditions for:
p.002017: 1. authorizing the use or registration of industrially produced or
p.002017: manufactured by a method involving an industrial process, medicinal products intended for
p.002017: human medicine;
p.002017: 2. (amend. - SG 102/2012, in force from 21.12.2012) authorization of the production and
p.002017: imports of medicinal products;
p.002017: 2a. (new - SG 102/2012, in force since 21.12.2012) production, import and
p.002017: wholesale of active substances;
p.002017: 3. authorization and conduct of clinical trials;
p.002017: 4. wholesale and retail trade in medicinal products;
p.002017: 5. parallel import of medicinal products;
p.002017: 5a. (new - SG 102/2012, in force since 21.12.2012) mediation in the field of
p.002017: medicinal products;
p.002017: 5b. (new, SG No. 18/2014) export of medicinal products under the procedure of Chapter Nine
p.002017: "b";
p.002017: 6. advertising of medicinal products;
p.002017: 7. monitoring the safety of medicinal products placed on the market;
p.002017: 8. the classification of the manner of prescribing and dispensing of medicinal products;
p.002017: 9. control of production and import, wholesale and retail trade, conducting of
p.002017: clinical trials, advertising, and the safety monitoring system for the released
p.002017: medicinal products on the market;
p.002017: 10. the pricing of medicinal products;
p.002017: 11. drawing up a positive medical list.
p.002017: Art. 2. This law is intended to create the conditions that ensure the marketing of
p.002017: medicinal products that meet the requirements for quality, safety and efficacy.
p.002017: Art. 3. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal product in
p.002017: human medicine is:
p.002017: 1. any substance or combination of substances presented as possessing properties
p.002017: for the treatment or prevention of human diseases, or
p.002017: 2. any substance or combination of substances that may be used or
p.002017: applied to humans for the purpose of:
p.002017: (a) restoration, correction or alteration of physiological functions through
p.002017: pharmacological, immunological or metabolic action, or
p.002017: b) making a medical diagnosis.
p.002017: (2) A substance is any substance the origin of which may be:
p.002017: 1. human (human blood, human blood products and others);
p.002017: 2. animal (microorganisms, animal organs, extracts, secretions, toxins,
p.002017: blood products and others);
p.002017: 3. plant (microorganisms, plants, plant parts, plant extracts,
p.002017: secrets and others);
p.002017: 4. chemical (elements, natural chemical materials, synthetic or semi-synthetic)
p.002017: substances and others).
p.002017: Art. 4. When a product simultaneously meets the characteristics of a medicinal product
p.002017: a product and a product governed by another law, the requirements of that law shall apply.
p.002017: Art. 5. Medicinal products shall be classified according to
p.002017: anatomical-therapeutic-chemical classification in accordance with the requirements of the World
p.002017: Health Organization (WHO).
p.002017: Art. 6. This law shall not apply to:
p.002017: 1. hermetically sealed radionuclides;
p.002017: 2. blood, plasma or blood cells of human origin, except for plasma which is
p.002017: obtained by a method involving an industrial process.
p.002017: Art. 7. (1) Manufacturing, import, wholesale and retail trade, advertising shall be allowed
p.002017: and treatment, prevention and diagnosis with only the medicines they have received
p.002017: authorization for use in the order of:
p.002017: 1. this law, or
p.002017: 2. Regulation (EC) No 726/2004 of the European Parliament and of the Council.
p.002017: (2) It is prohibited to import, trade, treat, prevent and diagnose with
p.002017: expired medicinal products.
p.002017: (3) Holding a permit or certificate of use, production and
p.002017: clinical trials of medicinal products issued under this Act shall not be justified
p.002017: discharge under applicable law.
p.002017: Art. 8. No marketing authorization is required under this Act for:
...
p.002017: is obliged to ensure compliance with the label, patient leaflet, classification,
p.002017: advertising and monitoring the safety of the marketed medicinal product under para. 1 with the requirements of this one
p.002017: law. Information on the packaging and the package leaflet
p.002017: the medicinal product under para. 1 does not have to be in Bulgarian.
p.002017: (4) The Executive Director of the BDA shall inform the European Commission of the issues
p.002017: permissions under para. 1, the name and address of the authorization holder, as well as the date of
p.002017: termination of their validity.
p.002017: Art. 12. (1) The official pharmacopoeia in the Republic of Bulgaria is the European Pharmacopoeia.
p.002017: (2) The official pharmacopoeia may be supplemented by the requirements of the Bulgarian Pharmacopoeia
p.002017: pharmacopoeia.
p.002017: (3) The Minister of Health shall determine with an order the dates of entry into force of
p.002017: the current edition of the Official Pharmacopoeia and its Supplements.
p.002017: (4) The order under para. 3 shall be promulgated in the State Gazette and published on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 13. (1) Monographs of the European Pharmacopoeia are obligatory for all substances, preparations and
p.002017: dosage forms contained therein. In cases where there are no monographs in the European Pharmacopoeia, the
p.002017: apply the requirements of the current editions of the pharmacopoeia of the Member States, the USA and Japan, if they are in
p.002017: in accordance with the general rules of
p.002017: The European Pharmacopoeia.
p.002017: (2) Where the specification contained in a monograph of the European Pharmacopoeia or in another national
p.002017: pharmacopoeia is insufficient to ensure the quality of the substance or dosage form, the BDA may
p.002017: request that the specification be supplemented by
p.002017: the applicant / holder of the marketing authorization.
p.002017: Chapter Two.
p.002017: MANAGEMENT AND FINANCING BODIES
p.002017: Section I.
p.002017: Authorities
p.002017: Art. 14. (1) Medicinal policy is part of the state health policy in the Republic
p.002017: Bulgaria and is implemented by the Minister of Health. (2) The Minister of Health shall:
p.002017: 1. is a national coordinator for the problems of medicinal products;
p.002017: 2. participates in international bodies and organizations performing activities in the field of
p.002017: medicinal products;
p.002017: 3. (repealed, SG No. 60/2011, effective 05.08.2011, new - SG No. 102/2012, in force
p.002017: of 21.12.2012) organizes the provision of public information to patients' organizations and to
p.002017: consumer organizations on actions taken against
p.002017: counterfeiting of medicinal products;
p.002017: 4. performs other activities specified by law.
p.002017: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 15. (1) A Pharmacopoeial Committee shall be established to the Minister of Health as
p.002017: an advisory body on the current pharmacopoeia.
p.002017: (2) The Minister of Health at the proposal of the Executive Director of
p.002017: The BDA determines by order the composition of the Pharmacopoeial Committee and the expert groups attached to it
p.002017: and approve the rules of procedure.
p.002017: (3) The activities of the Pharmacopoeia Committee shall be financed from the budget of the Ministry
p.002017: of health.
p.002017: Art. 16. (1) A Higher Board of Pharmacy shall be established with the Minister of Health, which shall include five
p.002017: representatives appointed by the Minister of Health, five representatives of the Bulgarian
...
p.002017: legislation.
p.002017: Section II.
p.002017: Requirements to the marketing authorization documentation
p.002017: Art. 27. (1) (amend. - SG 71/08, in force from 12.08.2008) To issue a permit for
p.002017: use of a medicinal product by the person under Art. 26, para. 1 submits an application to the BDA following a model, accompanied by a file
p.002017: in the format "Electronic Common Technical Document", which
p.002017: contains:
p.002017: 1. name and address of management / permanent address of the applicant and the representative under art. 26,
p.002017: para. 2; where the applicant is a person other than the manufacturer or manufacturers, the address of
p.002017: production sites;
p.002017: 2. name of the medicinal product;
p.002017: 3. data on the qualitative and quantitative composition of the medicinal product, such as
p.002017: points to the international non-patent name recommended by the WHO, if any,
p.002017: or the corresponding chemical name;
p.002017: 4. therapeutic indications, contraindications and side effects;
p.002017: 5. (amend. - SG 71/08, in force from 12.08.2008) dosage, dosage form,
p.002017: route of administration and route of administration and proposed shelf life;
p.002017: 6. precautionary measures and safety precautions during storage of the product, at
p.002017: its administration to patients and the disposal of product waste accompanied by
p.002017: guidance on the potential risks of the medicinal product to the environment;
p.002017: 7. description of the production method;
p.002017: 8. description of the control methods used by the manufacturer;
p.002017: 8a. (new - SG 102/2012, in force from 02.01.2013) declaration that the results of the audit under art. 160, para. 2,
p.002017: conducted by the manufacturer of the medicinal product confirm that the active substance is manufactured in
p.002017: compliance with the principles and guidelines for Good
p.002017: manufacturing practice; the declaration shall indicate the date on which the audit was carried out;
p.002017: 9. an assessment of the potential risk of the medicinal product to the environment for everyone
p.002017: the individual case and the measures envisaged to limit it;
p.002017: 10. results from:
p.002017: (a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.002017: (b) preclinical (toxicological and pharmacological) studies;
p.002017: (c) clinical trials;
p.002017: 11. a statement that in clinical trials conducted outside the territory of
p.002017: Member States have complied with the ethical principles of Good Clinical Practice;
p.002017: 12. (amended, SG No. 102/2012, effective 21.12.2012) summary of the system for
p.002017: pharmacovigilance monitoring, which includes the following elements:
p.002017: a) the name of the qualified person under Art. 191, curriculum vitae - education acquired
p.002017: professional experience in the field of pharmacovigilance monitoring and qualification for
p.002017: fulfillment of his duties in accordance with Chapter Eight;
p.002017: (b) any Member State in which the qualified person fulfills the obligations
p.002017: his;
p.002017: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002017: (d) the address at which the primary document of the traceability system is stored
p.002017: drug safety;
p.002017: 12a. (new - SG 102/2012, in force since 21.12.2012) statement by the applicant that
p.002017: has the necessary means to fulfill the obligations of Chapter Eight;
...
p.002017: use within the territory of the Republic
p.002017: Bulgaria.
p.002017: (4) In the cases of para. 3 the person under art. 26, para. 1 shall indicate in the application under Art. 27, para. 1
p.002017: the Member State in which the reference product is authorized or has been authorized.
p.002017: (5) In the cases of para. 3 The BDA requires the regulatory authority of the Member State,
p.002017: referred to in the application under Art. 27, para. 1, confirmation of the information under para. 4, the quantitative and
p.002017: the qualitative composition of the reference product and, if necessary, additional documentation.
p.002017: (6) The Executive Agency for Medicinal Products makes available on request to a regulatory authority of a Member State, c
p.002017: which has been submitted for a generic reference product that has been authorized or has been authorized
p.002017: for use on the territory of the Republic
p.002017: Bulgaria, the necessary information under para. 5 within one month from the date of request.
p.002017: (7) The ten-year period under par. 2 may be extended by up to one year at the request of the holder of
p.002017: the marketing authorization for the reference medicinal product if, within the first 8 years of dispensing
p.002017: the marketing authorization was granted to the holder of the reference medicinal product for the same product
p.002017: a new therapeutic indication whose significant clinical advantages over existing treatment options are scientific
p.002017: justified.
p.002017: (8) (New - SG 12/11, in force from 08.02.2011) When originally issued for a medicinal product
p.002017: marketing authorization in accordance with Art. 23, for any change in the amount of active substance, c
p.002017: the dosage form, in the amount in the package, in the route of administration of the medicinal product, and for all
p.002017: other changes or extensions of the marketing authorization shall also be granted in accordance with
p.002017: the requirements of this Act or the original marketing authorization shall be supplemented. All these permissions are considered as
p.002017: belonging to a global marketing authorization for the medicinal product for
p.002017: the purposes of applying this Article.
p.002017: Art. 29. (1) The person under art. 26, para. 1 presents in the BDA the results of the necessary
p.002017: preclinical and / or clinical trials where the medicinal product referred to in
p.002017: application:
p.002017: 1. cannot be defined as generic, or
p.002017: 2. bioavailability tests do not prove bioequivalence, or
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) there is a change in the active substance or substances in
p.002017: the amount of active substance or substances per dosage unit, the therapeutic indication, of
p.002017: the dosage form, the route of administration against
p.002017: the reference medicinal product.
p.002017: 4. (repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: (2) Where the biological medicinal product referred to in the application is similar to a reference biological
p.002017: is not eligible to be classified as a generic medicinal product because of
p.002017: different production method or different starting materials compared to reference or other
p.002017: reasons, the applicant submits to the BDA the results of the required preclinical and / or clinical trials,
p.002017: related to these conditions.
p.002017: (3) In the cases of para. 1 and 2 the documentation specified in the ordinance under Art.
p.002017: 42.
p.002017: Art. 30. (1) The person under art. 26, para. 1 insofar as it does not violate industrial and commercial rights
p.002017: property, does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b" or "c", if he can prove, under the conditions,
p.002017: defined in the ordinance under art. 42 that the active substance included in the proposed authorization for
p.002017: use of a medicinal product is well established in medical practice, has recognized efficacy and
p.002017: acceptable level of safety. In these cases, the test results and tests may be replaced
p.002017: with the relevant ones
p.002017: scientific publications.
p.002017: (2) The person under para. 1 presents the results of the necessary preclinical and clinical trials in the case of
p.002017: a medicinal product containing active substances of well - established use that has not been used in
p.002017: the proposed combination for therapeutic purposes. In this
p.002017: no documentation is submitted in respect of each individual active substance.
p.002017: (3) When an active substance within the meaning of para. 1 has a proven new therapeutic indication on the base
p.002017: significant preclinical or clinical data related to the new indication, once for a period of
p.002017: one year the next applicant cannot rely on
p.002017: data on the new indication of the active substance.
p.002017: Art. 31. In the case where a medicinal product contains active substances used in the authorized composition
p.002017: for use medicinal products but not used in the proposed combination for therapeutic purposes, the person
p.002017: under Art. 26, para. 1 presents the results of preclinical and clinical trials related to
p.002017: this combination. In this case, the applicant does not provide documentation on the safety and efficacy of each
p.002017: separately
p.002017: active substance.
p.002017: Art. 32. The holder of an authorization to use a medicinal product may authorize the use of the pharmaceutical,
p.002017: the preclinical and clinical documentation contained in the dossier of the medicinal product when evaluating
p.002017: subsequent drug applications
p.002017: products of the same qualitative and quantitative composition as regards the active substances and with
p.002017: same dosage form.
p.002017: Art. 33. Conducting the necessary studies and tests to prepare authorization documentation
p.002017: for use and subsequent practical requirements for the authorization of medicinal products under
p.002017: Art. 28 and 29 is not a patent infringement
p.002017: or the supplementary protection certificate for a medicinal product.
p.002017: Art. 34. (1) The summary of product characteristics shall contain the following information:
p.002017: 1. name of the medicinal product, quantity of active substance for dosage
p.002017: unit, dosage form;
p.002017: 2. quantitative and qualitative composition in respect of the active substances and those of
p.002017: excipients for which information is essential for the proper application of
p.002017: product; the common name or chemical description is used;
p.002017: 3. dosage form;
p.002017: 4. clinical data:
p.002017: (a) therapeutic indications;
p.002017: (b) dosage and route of administration for adults and children;
p.002017: c) contraindications;
p.002017: (d) special warnings and precautions for use; for immunological
p.002017: medicinal products - precautions for persons handling and administering them
p.002017: patients, as well as the precautions to be taken by the patient;
p.002017: (e) interactions with other medicinal products or other forms of interaction;
p.002017: (f) use in pregnancy or lactation;
p.002017: (g) effects on the ability to drive and use machines;
p.002017: h) side effects;
p.002017: i) overdose (symptoms, antidotes, emergency measures);
p.002017: 5. pharmacological data:
p.002017: a) pharmacodynamic properties;
p.002017: b) pharmacokinetic properties;
p.002017: (c) preclinical safety data;
p.002017: 6. pharmaceutical data:
p.002017: (a) a list of excipients;
p.002017: (b) major incompatibilities;
p.002017: c) shelf life; shelf life after reconstitution of the medicinal product (at
p.002017: need) or after opening the immediate packaging for the first time;
p.002017: (d) special storage instructions;
p.002017: (e) the nature and composition of the packages;
p.002017: (f) specific instructions for disposal of the remainder of the medicinal product or of
p.002017: waste materials therefrom;
p.002017: 7. the holder of the marketing authorization;
p.002017: 8. registration number;
...
p.002017: the requirements for Good Manufacturing Practice;
p.002017: 5. copies of the authorizations or marketing authorizations received for the same products in
p.002017: other Member States;
p.002017: 6. layout of the primary and / or secondary packaging of the product;
p.002017: 7. product stability data.
p.002017: (4) The data requirements under para. 3 shall be determined in the ordinance under Art. 42.
p.002017: Art. 36. (1) For homeopathic medicinal products other than those specified in Art. 35, para.
p.002017: 1, the provisions of Art. 27 - 32.
p.002017: (2) For homeopathic medicinal products under para. 1 the person under art. 26, para. 1 does not present results from preclinical and
p.002017: clinical trials where it can prove with bibliographic evidence from the scientific literature that
p.002017: homeopathic use of the medicinal product or
p.002017: the homeopathic sources that make up it are safe.
p.002017: (3) In the cases of para. 2 of the bibliographic data must be established:
p.002017: 1. the homeopathic nature of the raw materials used and their traditional uses
p.002017: at the stated statement;
p.002017: 2. the safety of the homeopathic medicinal product with respect to the degree of
p.002017: dilution of each of the ingredients.
p.002017: Section IV.
p.002017: Specific requirements for traditional herbal medicinal products
p.002017: Art. 37. (1) Certificate of registration of a traditional herbal medicinal product
p.002017: is issued under a simplified procedure if it meets the following conditions:
p.002017: 1. there are therapeutic indications inherent in the use of traditional herbs
p.002017: medicinal products, and by composition and purpose, is intended for use without
p.002017: prescribing and monitoring;
p.002017: 2. is administered only in a fixed amount of the medicinal substance in a dose
p.002017: unit and at a specific dosage;
p.002017: 3. administered orally, by inhalation (inhalation) or intended for external use
p.002017: use;
p.002017: 4. the period of traditional use according to art. 38, para. 1, item 5 has expired;
p.002017: 5. the data on the traditional use of the medicinal product prove that it is not harmful
p.002017: under certain conditions of use and the pharmacological effect or efficacy of
p.002017: the medicinal product has been established through years of use and experience.
p.002017: (2) The Executive Agency for Medicines may apply the procedure under para. 1 versus vegetable
p.002017: medicinal product containing vitamins or minerals, the safety of which has been documented
p.002017: and whose action against herbal remedies
p.002017: substances in the product with respect to its specific indications is ancillary.
p.002017: Art. 38. (1) To issue a certificate of registration of a traditional plant
p.002017: medicinal product the person under Art. 26, para. 1 shall submit an application to the BDA, accompanied by the following
p.002017: documentation:
p.002017: 1. the data referred to in Art. 27, para. 1, items 1 - 9 and item 10, letter "a";
p.002017: 2. (amend. - SG 71/08, in force from 12.08.2008) a brief description of
p.002017: the product, except for the data under art. 34, para. 1, Vol. 5;
p.002017: 3. in the case of a herbal medicinal product within the meaning of Art. 37, para. 2 or the combined vegetable
p.002017: medicinal product - the information under art. 37, para. 1, item 5 for the combination; when the individual active substances of
p.002017: the combined product is not known enough
p.002017: provide data on the traditional use of each;
p.002017: 4. a copy of the marketing authorization or the plant registration certificate
p.002017: a medicinal product issued by a Member State or a third country and / or a copy of the refusal,
...
p.002017: the medicinal product.
p.002017: (4) The submitted data under para. 1, item 5 shall also be valid in cases where during the 30-year period
p.002017: use in medical practice:
p.002017: 1. the relevant medicinal product of the product applied for
p.002017: registration, has been on the market without authorization or registration for use, or
p.002017: 2. when the number of ingredients in the medicinal product for which an application has been submitted
p.002017: registration, their amount in dosage unit is reduced or decreased.
p.002017: Art. 39. (1) Where the herbal medicinal product has been on the Community market for less than 15 years, but
p.002017: meets the conditions of Art. 37, para. 1, the BDA shall submit for the opinion the documentation under Art. 38, para. 1 on
p.002017: The Committee for Herbal Medicinal Products at
p.002017: European Medicines Agency.
p.002017: (2) The Executive Agency for Medicines shall take a final decision after
p.002017: the publication of a monograph by the committee under para. 1 for product compliance with the criteria
p.002017: for registration for traditional use.
p.002017: (3) In the cases of para. 1 the term under Art. 44 stops running.
p.002017: Art. 40. The Medicines Executive Agency may require the applicant to
p.002017: herbal medicinal product to submit documentation under Art. 27 - 32 or under Art. 35.
p.002017: Art. 41. (1) (amend. - SG 71/08, in force from 12.08.2008) The Executive Agency for Medicines shall publish
p.002017: on your site's list of herbal substances,
p.002017: preparations or combinations thereof used in traditional herbal medicinal products prepared
p.002017: by the Committee for Herbal Medicinal Products at the European Medicines Agency. The list contains for everyone
p.002017: herbal substance therapeutic indications, active ingredient content per unit dose and dosage,
p.002017: route of administration and other information necessary for the safe use of the herbal substance as traditional
p.002017: medicine.
p.002017: (2) When they propose a registration product for traditional use in the application
p.002017: contains a herbal substance, preparation or a combination thereof, listed in para. 1,
p.002017: the applicant does not submit the data referred to in Art. 38, para. 1, Vols 4 - 6.
p.002017: (3) When the herbal substance, the preparation or the combination thereof are excluded from the list under para. 1, the holder
p.002017: of the registration certificate of the herbal medicinal product must submit to the BDA the full
p.002017: documentation under art. 38 within three months of
p.002017: the change.
p.002017: (4) In case the holder of the plant registration certificate
p.002017: medicinal product does not fulfill the obligation under para. 3, the BDA terminates the certificate for
p.002017: product registration.
p.002017: Section V.
p.002017: Procedure for marketing authorization and registration
p.002017: of homeopathic and traditional herbal products
p.002017: Art. 42. The requirements for the data and documents from the file under Art. 27 - 32, Art. 35, para. 3,
p.002017: Art. 36, para. 2 and Art. 38 shall be determined in an ordinance of the Minister of Health.
p.002017: Art. 43. (1) Within 30 days from the date of submission of the documentation under Art. 27 - 32, Art. 35, para. 3 or under Art. 38
p.002017: The BDA shall verify the completeness of the parts of the dossier accompanying the application and their compliance with the requirements for
p.002017: the granting of the marketing authorization or
p.002017: the certificate of registration under this Act.
p.002017: (2) When it does not identify incompleteness or inconsistencies in the submitted documentation, the BDA
p.002017: notifies the applicant in writing, within the term of para. 1 that the documentation is valid. The notification is
p.002017: indicate the date from which the term under Art. 44.
p.002017: (3) When establishing incompleteness and / or inconsistencies in the documentation under para. 1, the BDA shall notify in writing
p.002017: provide the applicant with additional information and / or provide an oral or written explanation of the findings
p.002017: incompleteness and inconsistency within 14 days of
p.002017: the date of the notification.
...
p.002017: (5) When the requirements of para. 3 have been fulfilled within the set deadline, the BDA informs
p.002017: in writing to the applicant that the documentation is valid, indicating in the notification the date from which
p.002017: the term under Art. 44.
p.002017: Art. 44. The procedure for granting the marketing authorization or the registration of
p.002017: medicinal product starts from the date specified in the notification under Art. 43, para. 2, respectively under Art.
p.002017: 43, para. 5, and ends within 210 days.
p.002017: Art. 45. (1) When an application for authorization for use or registration of a medicinal product is submitted to the BDA
p.002017: a product for which, in accordance with the data under Art. 27, para. 1, item 18, there is information that there is in a Member State
p.002017: granted marketing authorization for the same medicinal product
p.002017: BDA shall notify the applicant in writing of the application of the procedure under Art. 74.
p.002017: (2) When an application for a marketing authorization or registration of a medicinal product for which
p.002017: compliance with the data under Art. 27, para. 1, item 19 there is information that in a Member State the dossier of the same medicinal product
p.002017: product is under evaluation, BDA does not review the documentation under Art. 27 - 32 or Art. 35, para. 3, or
p.002017: under Art. 38 and notify in writing
p.002017: the applicant for the application of the procedure under Art. 75.
p.002017: (3) For the implementation of the provisions of para. 1 and 2 the medicinal product is defined as one and
p.002017: the same authorized in another Member State or as a product under evaluation
p.002017: the dossier in another Member State where the two medicinal products:
p.002017: 1. have the same qualitative and quantitative composition as regards the active substance
p.002017: substance / substances and are available in the same dosage form, with differences in
p.002017: excipients if this does not affect safety and efficacy, and when
p.002017: 2. belong to one company, or apply for medicinal products by persons belonging to
p.002017: the same company or associations of companies, or when applying for medicinal products
p.002017: persons who have concluded a license or another
p.002017: contract or joint action related to the marketing of the respective
p.002017: medicinal product in different Member States.
p.002017: Art. 46. (1) When evaluating the BDA documentation:
p.002017: 1. may test the finished product, the intermediate, or the starting materials for
p.002017: the medicinal product, and send them to the laboratory for testing in the official control system
p.002017: medicinal laboratories in a Member State to determine whether the control methods of analysis used by
p.002017: the manufacturer and described in the dossier,
p.002017: meet the requirements;
p.002017: 2. confirm, after on-the-spot verification or on the basis of documents, that the manufacturers of medicinal products from
p.002017: third countries shall carry out the production in accordance with the data described in Art. 27, para. 1, item 7, and / or perform
p.002017: control in accordance with the methods described in Art.
p.002017: 27, para. 1, Vol. 8;
p.002017: 3. checks the production establishment specified in the application when
p.002017: the manufacturer / manufacturers of the medicinal products from third countries have, by way of exception, assigned to another
p.002017: manufacturer to carry out certain stages of production or control
p.002017: of the medicinal product.
p.002017: (2) When the BDA carries out an on-site inspection of a production site, the term under Art. 44
p.002017: stops running until a report of the results of the audit is drawn up.
...
p.002017: Art. 50. (1) When the BDA finds inconsistencies in the dossier with the requirements for granting a marketing authorization or
p.002017: certificate of registration under this law, notifies the applicant in writing to provide additional information,
p.002017: related to the documentation under Art. 27 - 32 or
p.002017: under Art. 35, para. 3, or under Art. 38 and / or provide an oral or written explanation of
p.002017: incompleteness and non-compliance found within 180 days from the date of notification.
p.002017: (2) In the cases of para. 1 the term under Art. 44 ceases to run from the date of notification to
p.002017: providing the requested information.
p.002017: (3) The Executive Director of the BDA shall terminate the procedure for issuing the BDA
p.002017: of a marketing authorization or a marketing authorization for a medicinal product where:
p.002017: 1. the applicant has not provided the information under para. 1 within the specified period;
p.002017: 2. the persons under art. 26, para. 1 request termination in writing.
p.002017: Art. 51. Within 10 days from the preparation of the evaluation report under Art. 49, para. 1
p.002017: the BDA Executive Director issues a Marketing Authorization / Registration Certificate
p.002017: of the medicinal product or a reasoned refusal.
p.002017: Art. 52. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 5 days from the date of
p.002017: issuance of the marketing authorization / registration certificate in the register of art. 19, para.
p.002017: 1, item 3, the following data on the permit / certificate shall be entered:
p.002017: 1. registration number;
p.002017: 2. number and date of the marketing authorization / registration certificate of
p.002017: the medicinal product;
p.002017: 3. name of the medicinal product;
p.002017: 4. the international non-patent name of each active substance;
p.002017: 5. the name and address of the holder of the marketing authorization / certificate of use
p.002017: registration;
p.002017: 5a. (new - SG 102/2012, in force since 21.12.2012) the conditions under art. 55a, 56 and 56a,
p.002017: entered in the Marketing Authorization / Registration Certificate;
p.002017: 6. date of change of the Marketing Authorization / Certificate
p.002017: registration;
p.002017: 7. date of termination of the marketing authorization / registration certificate;
p.002017: 8. other data.
p.002017: (2) The marketing authorization / marketing authorization for the medicinal product
p.002017: shall be served on the person under Art. 26, para. 1 and shall enter into force on the date of its entry in the register under Art.
p.002017: 19, para. 1, Vol. 3.
p.002017: Art. 53. (amend. - SG 102/02, in force from 21.12.2012) (1) The Executive Agency for Medicines shall publish
p.002017: on your website within 14 days of the granting of the marketing authorization / marketing authorization
p.002017: registration of the data under art. 52, para. 1, approved
p.002017: summary of product characteristics and package leaflet.
p.002017: (2) The Executive Agency for Medicinal Products shall publish on its website
p.002017: the assessment report under art. 49, para. 1 with the reasons for the decision, deleting the data,
p.002017: representing a trade secret.
p.002017: (3) The report under para. 2 shall be accompanied by a summary of a language comprehensible to the public.
p.002017: The summary contains a section relating to the conditions of use of the medicinal product.
p.002017: Art. 54. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of the permit for
p.002017: use / the registration certificate of the medicinal product shall notify the BDA in writing of the date of
p.002017: the actual marketing of the medicinal product in
...
p.002017: change can have a significant impact on quality, safety or
p.002017: the efficacy of the medicinal product.
p.002017: Art. 61. (amend. - SG 12/11, in force from 08.02.2011) (1) For each change of type
p.002017: IA, Type IB, Type II or Extension of Holder of Marketing Authorization
p.002017: the medicinal product submits to the BDA a separate notification, respectively an application.
p.002017: (2) When a change leads to a change in the summary data of
p.002017: the product, on the packaging and / or in the package leaflet, these changes are accepted as part of the application
p.002017: change and no separate application is made for them.
p.002017: (3) The Marketing Authorization Holder may group the changes when:
p.002017: 1. notify simultaneously the same type IA changes in the conditions of one or
p.002017: more marketing authorizations;
p.002017: 2. declares several changes to the terms of the marketing authorizations at the same time,
p.002017: belonging to the global marketing authorization under Art. 28, para. 8 of the medicinal product,
p.002017: provided that the relevant changes occur in one of the following cases:
p.002017: (a) one of the changes in the group is the extension of the marketing authorization;
p.002017: (b) one of the changes in the group is a type II change and all other changes in the group are
p.002017: changes resulting from the Type II change;
p.002017: c) one of the changes in the group is a type IB change and all other changes in the group are
p.002017: changes resulting from the type IB change;
p.002017: (d) all changes in the group are only administrative changes in
p.002017: the summary of product characteristics, patient package leaflet or packaging;
p.002017: (e) All changes in the group are changes in the active documentation of the asset
p.002017: substance, vaccine antigen background, or background documentation for
p.002017: plasma;
p.002017: (f) any changes to the group are in relation to a project designed to refine
p.002017: the manufacturing process and the quality of the medicinal product concerned or its
p.002017: active substance (s);
p.002017: (g) all changes in the group are changes that affect the quality of the pandemic
p.002017: influenza vaccine;
p.002017: h) all changes in the group are changes in the pharmacovigilance system by chapter
p.002017: the eighth;
p.002017: (i) any changes to the group are the result of a specific emergency safety measure; and
p.002017: were filed in accordance with Art. 66;
p.002017: k) all changes in the group are related to the inclusion of information about a given
p.002017: pharmacotherapeutic class;
p.002017: (l) any changes in the group are the result of the evaluation of the periodic report for the
p.002017: safety;
p.002017: (m) any changes to the group result from a post-authorization study
p.002017: for use under the supervision of the marketing authorization holder;
p.002017: (n) any changes to the group are the result of the fulfillment of a condition of authorization for
p.002017: use of art. 56;
p.002017: 3. the requested changes in the conditions of the same marketing authorization do not fall under
p.002017: the cases under item 2, provided that the BDA agreed to apply the same to these changes
p.002017: procedure.
p.002017: (4) When grouping changes under para. 3, items 2 and 3, the holder of the authorization for
p.002017: use submitted to the BDA:
p.002017: 1. single notification when at least one of the changes is type IB and all others are type
p.002017: IA or type IB;
p.002017: 2. a single application where the major change is type II and none of the other changes
p.002017: is not an extension of the marketing authorization;
p.002017: 3. a single application where the major change is the extension of
p.002017: the marketing authorization.
...
p.002017: BDA:
p.002017: 1. approve the change or give a reasoned refusal and notify the holder of the change
p.002017: the marketing authorization;
p.002017: 2. notify the holder of the marketing authorization whether the approved change leads to
p.002017: change of data in the issued marketing authorization; when a change is required
p.002017: marketing authorization, Art. 64a.
p.002017: (7) The Marketing Authorization Holder may apply the approved change
p.002017: type II only after the issuance of a permit for change under Art. 64a.
p.002017: Art. 64a. (New, SG No. 12/2011, effective 08.02.2011) The Executive Director of
p.002017: The BDA shall issue an authorization for change of the marketing authorization within the following period:
p.002017: 1. thirty days from the issuance of the notification under Art. 62, para. 4, Vol. 2, Art. 63, para. 2, Vol. 2,
p.002017: respectively Art. 63, para. 6, item 2 or art. 64, para. 6, item 2, when the corresponding change leads to an extension
p.002017: 6 months within the period referred to in Article 13 (1) and (2) of Council Regulation (EEC) No 1768/92
p.002017: of 18 June 1992 establishing a supplementary certificate for the protection of medicinal products
p.002017: products in accordance with Art. 36 of Regulation (EC) No 1901/2006;
p.002017: 2. sixty days from the issuance of the notification under Art. 62, para. 4, item 2 - in case of type IA changes,
p.002017: which do not require immediate notification;
p.002017: 3. sixty days from the issuance of the notification under Art. 64, para. 6, item 2 - for type II changes;
p.002017: 4. one hundred and eighty days - in all other cases.
p.002017: Art. 64b. (New - SG 12/2011, in force from 08.02.2011) (1) In case of changes related to changes in the active
p.002017: substance for the purpose of the annual update of influenza vaccines, the holder of the marketing authorization
p.002017: submit to the BDA an application, accompanied by documentation determined by the ordinance under Art. 42. Within 7 days the BDA
p.002017: checks the completeness of
p.002017: the documentation submitted.
p.002017: (2) When the application meets the requirements of para. 1, the BDA shall notify the holder
p.002017: of the marketing authorization that the application is valid, stating the date from which the period of validity
p.002017: para. 3 starts to flow.
p.002017: (3) Within 45 days of receipt of a valid application, the BDA shall evaluate the documentation
p.002017: and prepares an evaluation report.
p.002017: (4) The Executive Agency for Medicinal Products may require the authorization holder to
p.002017: use to provide clinical and stability data for the medicinal product.
p.002017: The Marketing Authorization Holder submits to the BDA the required
p.002017: data within 12 days from the expiry of the term under para. 3.
p.002017: (5) The Executive Agency for Medicines shall evaluate the documentation and take the final decision
p.002017: decision within 10 days from receipt of the data under para. 4 by issuing a change permit
p.002017: or refusal.
p.002017: Art. 65. (1) When the holder of the marketing authorization establishes a health risk
p.002017: when using the medicinal product, it shall take urgent restrictive measures and
p.002017: immediately notify the BDA in writing.
p.002017: (2) The Executive Agency for Medicines shall decide on the measures within 24 hours from
p.002017: the notification.
p.002017: (3) When the BDA does not make its decision within the term under para. 2, the measures are considered to be approved.
p.002017: (4) When the BDA determines that there is a risk to human health from the use of
p.002017: the medicinal product orders the marketing authorization holder to take
p.002017: restrictive measures immediately.
p.002017: (5) In the cases of para. 1 and 4 of the Marketing Authorization Holder
p.002017: the product agrees with the BDA on the manner and deadlines for implementation of the measures taken.
p.002017: (6) The marketing authorization holder shall submit to
p.002017: the Executive Director of the BDA application for change in accordance with Art. 64 not later than 15 days
p.002017: after the date of action.
p.002017: Art. 66. (1) (amend. - SG 12/11, in force from 08.02.2011)
p.002017: marketing authorization for the medicinal product applies for the extension of
p.002017: the marketing authorization issued for:
p.002017: 1. change of active substance (s):
p.002017: (a) replacement of a chemically active substance with a different complex / derivative including
p.002017: salt / ester, with the same therapeutic moiety as the characteristics of
p.002017: efficacy / safety do not differ significantly;
p.002017: b) replacement with different isomer, different mixture of isomers, replacement of mixture with isolated
p.002017: isomer (for example of a single enantiomer racemate), wherein the characteristics of
p.002017: efficiency / safety do not differ significantly;
p.002017: (c) replacement of a biologically active substance with one having a slightly different molecular structure,
p.002017: in which the performance / safety characteristics do not differ significantly, except for
p.002017: changes in the active substance of seasonal,
p.002017: a pre-pandemic or pandemic influenza vaccine for human use;
p.002017: (d) modification of the vector used to produce the antigen or starting material,
p.002017: including a new core cell bank from another source, where the features of
p.002017: efficiency / safety do not differ significantly;
p.002017: (e) a new ligand or binding mechanism for a radiopharmaceutical in which
p.002017: the performance / safety characteristics do not differ significantly;
p.002017: (f) a change in the extraction solvent or in the ratio of vegetable
p.002017: substance / herbal preparation in which the efficacy / safety characteristics are not
p.002017: differ significantly;
p.002017: 2. change in the amount of active substance, dosage form and route of
p.002017: introduction:
p.002017: (a) change in bioavailability;
p.002017: (b) a change in pharmacokinetics, such as a change in the rate of release;
p.002017: (c) modification or addition of a new amount of the active substance / activity;
p.002017: (d) modifying or adding a new dosage form;
p.002017: e) change or addition of a new route of administration - in parenteral administration
p.002017: a distinction needs to be made between intraarterial, intravenous, intramuscular,
p.002017: subcutaneous and other routes of administration.
p.002017: (2) The application under para. 1 shall be submitted together with the documentation under Art. 27, para. 1, Vol. 10,
p.002017: related to the changes under par. 1.
p.002017: (3) The requirements to the documentation under para. 2 shall be determined in the ordinance under art. 42.
p.002017: (4) The name of the medicinal product in the marketing authorization granted
p.002017: the scope of the original marketing authorization is not changed.
p.002017: (5) Authorization to extend the scope of an authorization already granted for
p.002017: use of a medicinal product shall be carried out under the conditions and in accordance with Art. 49 - 51.
p.002017: Art. 67. (1) The holder of the marketing authorization for the medicinal product shall file
p.002017: application for a new marketing authorization for:
p.002017: 1. the addition or removal of one or more active substances, including
p.002017: antigenic components for vaccines;
p.002017: 2. a change in the quality of the active substance indicated in the dossier which is being modified
p.002017: substantially the safety and efficacy characteristics of the medicinal product, and
p.002017: the changed substance is defined as new;
p.002017: 3. adding a new or changing existing indication for treatment,
p.002017: prevention or diagnosis in another therapeutic area.
p.002017: (2) (New, SG No. 71/2008, effective 12.08.2008) The holder of the marketing authorization for
p.002017: the medicinal product applies for a new marketing authorization when the application is made
p.002017: the renewal of the marketing authorization was not filed within the time limit
p.002017: under Art. 59a, para. 1.
p.002017: (3) (Renumbered from Paragraph (2), SG No. 71/2008, effective 12.08.2008)
p.002017: is accompanied by documentation specified in the ordinance under Art. 42.
p.002017: (4) (Renumbered from Paragraph (3), Supplemented, SG No. 71/2008, effective 12.08.2008).
p.002017: 1 and 2 the procedure of art. 49 - 51.
p.002017: Art. 68. (amend. - SG 102/02, in force from 21.12.2012) (1) The holder of
p.002017: the Marketing Authorization / Marketing Authorization is required to:
p.002017: 1. take into account the achievements of scientific and technical progress and introduce all necessary
p.002017: changes in the documentation under Art. 27, para. 1, items 7 and 8 for the purpose of manufacturing the medicinal product
p.002017: and controls according to conventional scientific methods; changes are made in the order of chapters
p.002017: third and fifth;
p.002017: 2. immediately submit to the BDA any new information that may necessitate a change to
p.002017: the data and documents under art. 27 - 32 and in the summary of product characteristics;
p.002017: 3. immediately inform the BDA of any prohibition or restriction imposed by regulatory authorities of other countries in the
p.002017: which medicinal product has been placed on the market, the reasons for which such measures have been imposed, and
p.002017: any other new information you may have
...
p.002017: the chairman of the Central Ethics Committee may invite the contracting authority or
p.002017: the principal investigator.
p.002017: (7) The Council of Ministers, upon a proposal by the Minister of Health, shall designate with
p.002017: Rules of Procedure of the Central Ethics Committee.
p.002017: Art. 108. (1) A member of the Central Ethics Committee may not be appointed to the same
p.002017: committee for more than two consecutive terms. The term of office is 4 years.
p.002017: (2) Every two years, one-half of the composition of the Central Ethics Committee shall be
p.002017: is updating.
p.002017: Section IV.
p.002017: Permission to conduct a clinical trial
p.002017: Art. 109. A clinical trial may begin when the following conditions are fulfilled:
p.002017: 1. the relevant ethics committee has given a favorable opinion, and
p.002017: 2. the Executive Director of the BDA has issued a written permit for its conduct,
p.002017: when any of the tested medicinal products is:
p.002017: (a) a gene therapy medicinal product;
p.002017: (b) somatic cell therapy medicinal product;
p.002017: (c) a medicinal product containing genetically modified organisms;
p.002017: (d) a high-tech medicinal product as defined in the Annex to the Regulation
p.002017: (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: (e) a medicinal product containing a biologically active substance (s)
p.002017: human or of animal origin or containing biological or human components
p.002017: animal origin, or in the manufacture of which such components are used, or
p.002017: 3. within the period specified by the law, the assignor has not been notified in writing by the BDA that
p.002017: the test cannot be conducted - for medicinal products other than those under item 2.
p.002017: Art. 110. (1) In order to obtain an opinion, the principal or coordinating researcher and
p.002017: the assignor shall submit to the respective ethics committee under art. 103
p.002017: 1. administrative documentation;
p.002017: 2. information about a participant;
p.002017: 3. documentation of the test report;
p.002017: 4. documentation of the tested medicinal product / products;
p.002017: 5. documentation of technical requirements and personnel;
p.002017: 6. data on the financing and the administrative organization of the test.
p.002017: (2) The content, form and requirements for the documentation under para. 1 are defined in
p.002017: the ordinance under Art. 82, para. 3.
p.002017: Art. 111. (1) The Ethics Committee shall prepare an opinion, having regard to the following:
p.002017: 1. the importance of the clinical trial;
p.002017: 2. the positive assessment of the ratio of expected benefits and risks according to Art.
p.002017: 90, item 1 and the motivation of the conclusions;
p.002017: 3. the clinical trial protocol;
p.002017: 4. the suitability of the principal investigator and the research team for the conduct
p.002017: the clinical trial;
p.002017: 5. the researcher's brochure;
p.002017: 6. availability of the necessary equipment and its corresponding quality;
...
p.002017: the register under Art. 167d the applicant submits to the BDA an application in the form approved by the executive
p.002017: Director of the BDA, which contains:
p.002017: 1. name, seat and address of management of the person under art. 167a;
p.002017: 2. a list of the active substances to be imported, manufactured or marketed;
p.002017: 3. the activities that the person under art. 167a will perform;
p.002017: 4. the address of the premises and the data on the technical equipment for the implementation of
p.002017: the activities of the persons under Art. 167a.
p.002017: (2) To the application under para. 1 shall apply:
p.002017: 1. data on the unique identification code of the trader and for the companies registered
p.002017: in a Member State - a document for current registration under national law issued
p.002017: by a competent authority of the country concerned;
p.002017: 2. document for paid fee under Art. 21, para. 2.
p.002017: (3) Within 60 days of receipt of the application and documentation under para. 1 and 2 of the BDA
p.002017: basis of risk assessment:
p.002017: 1. enter the person under Art. 167a in the register under Art. 167d, of which he informs him or
p.002017: 2. notify of the date of inspection for conformity assessment of
p.002017: the conditions for carrying out the activities under Art. 167a with the requirements of Good Manufacturing
p.002017: practice of art. 152, para. 1 and the Good Distribution Practices of Active Substances under Art. 198.
p.002017: (4) Where, as a result of the inspection under para. 3, item 2 BDA has established compliance with
p.002017: the requirements of Good Manufacturing Practice under Art. 152, para. 1 and Good Distributor
p.002017: active substance practices under Art. 198, it shall enter the applicant in the register under Art. 167g for which it
p.002017: informs.
p.002017: (5) The expenses for carrying out the inspection under para. 3, item 2 shall be at the expense of the applicant.
p.002017: (6) For carrying out the inspection under para. 3, item 2 the applicant shall pay a fee of
p.002017: determined in the tariff under Art. 21, para. 2.
p.002017: (7) In the cases of para. 3, item 1 and para. 4 the applicant may commence the activity
p.002017: after entry in the register under Art. 167g.
p.002017: Art. 167c. (New, SG No. 102/2012, effective 02/01/2013) When, within the term of art. 167b,
p.002017: para. 3 The BDA did not inform that an inspection would be carried out, the applicant could start
p.002017: carrying out the activity.
p.002017: Art. 167g. (New, SG No. 102/2012, effective 02.01.2013) (1) The Executive
p.002017: the medicines agency keeps a public register of importers, manufacturers and traders
p.002017: wholesale of active substances, containing:
p.002017: 1. name, seat and address of management of the person under art. 167a;
p.002017: 2. a list of the active substances that are imported, manufactured or marketed;
p.002017: 3. the activities that the person under art. 167a will perform;
p.002017: 4. address of the premises where the activities are carried out;
p.002017: 5. notes on the entered circumstances.
p.002017: (2) The Executive Agency for Medicines shall enter into the database under Art. 147
p.002017: information on registered importers, manufacturers and wholesalers of active
p.002017: substances.
p.002017: Art. 167d. (New - SG 102/02, in force from 02.01.2013) (1) The person under art. 167a
p.002017: submit to the BDA annually by 31 January a notification of changes in the information,
p.002017: entered in the register under Art. 167g.
p.002017: (2) When changes occur that may affect the quality of or
...
p.002017: Good manufacturing practice and Good distribution practices for active substances.
p.002017: (2) Importers may import active substances only if the following conditions are met:
p.002017: 1. the active substances were manufactured in accordance with Good standards
p.002017: manufacturing practices that are at least equivalent to those established by the European
p.002017: union, and
p.002017: 2. (In force from 02.07.2013) The active substances shall be accompanied in writing
p.002017: confirmation by the competent authority of the exporting country that:
p.002017: (a) Good manufacturing practice standards applicable to the site for
p.002017: production of the exported active substances are at least equivalent to those established by
p.002017: The European Union;
p.002017: (b) the production site concerned is subject to regular control and is effectively implemented by the Good
p.002017: manufacturing practice, including repeated and unannounced inspections, to ensure the protection of
p.002017: public health at least equivalent to that of
p.002017: The European Union, and
p.002017: (c) in the event of non-compliance, the exporting country will
p.002017: inform the BDA immediately.
p.002017: (3) (In force from 02.07.2013) The requirement of para. 2, item 2 shall not apply if the state
p.002017: exporter is included in the list under Art. 111b of Directive 2001/83 / EC.
p.002017: Art. 167g. (New, SG No. 102/2012, effective 02.07.2013) (1) Exceptionally, when necessary to
p.002017: ensure the availability of medicinal products, the importer may import the active substance without the written request
p.002017: confirmation of art. 167f, para. 2, item 2 for a period not longer than the validity of the certificate of Good
p.002017: manufacturing practice where the manufacturing site of the active substance in the exporting country was
p.002017: inspected by a regulatory authority of a Member State and found to comply with the principles and guidelines
p.002017: for good
p.002017: manufacturing practice.
p.002017: (2) In the cases of para. 1 The BDA shall notify the European Commission.
p.002017: Art. 167h. (New, SG No. 102/2012, effective 02.01.2013) Holders of authorizations for
p.002017: proceedings, including those performing the activities of art. 168b, para. 2, are considered producers in the sense
p.002017: of § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002017: caused by a defect in the goods,
p.002017: provided for therein.
p.002017: Chapter Six.
p.002017: PACKAGING AND PACKAGE LEAFLET
p.002017: Art. 168. (1) The packaging of a medicinal product shall consist of primary and / or secondary
p.002017: packing and leaflet for the patient.
p.002017: (2) (amend. - SG 61/11, in force from 10.11.2011)
p.002017: medicinal products containing substances specified in the list under Art. 3, para. 2, item 2 of the Law on
p.002017: control of drugs and precursors is diagonally marked with two red bars and the secondary
p.002017: packaging of medicinal products containing substances from the list under Art. 3, para. 2, item 3 of the Control Act
p.002017: narcotic drugs and precursors - with two blue bars. The packaging must contain an indication that
p.002017: the medicinal product is only available at
p.002017: special medical prescription.
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products included in
p.002017: the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains information
p.002017: with the following text: "This medicinal product is subject to additional monitoring". A text in front of the text is placed
p.002017: black in accordance with Article 23 (5) of Regulation (EC) No 726/2004 of the European Parliament and of the Council, accompanied by
p.002017: from the explanatory note.
p.002017: (4) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products shall include
p.002017: a standard text asking patients to report to medical professionals or directly to
p.002017: BDA any suspected adverse drug reaction
p.002017: reaction according to the models of art. 185, para. 2, Vol. 4.
p.002017: (5) Where the medicinal product is authorized for use in the territory of the Republic
p.002017: Bulgaria, on its secondary packaging, shall be marked with a separate collection and
p.002017: recycling in accordance with the Waste Management Act and its implementing acts.
p.002017: (6) Where a medicinal product is authorized, its name shall be
p.002017: the outer carton, the dosage form and the content of the active substance in the dose
p.002017: the unit is also written in Braille.
p.002017: (7) The requirements of para. 6 shall not apply to vaccines and medicinal products in hospital
p.002017: packaging.
p.002017: (8) (New, SG No. 102/2012, effective 21.12.2012) On the outer packaging, and
p.002017: if not, on the immediate packaging of the medicinal products except
p.002017: radiopharmaceuticals, applied:
p.002017: 1. an individual identifier for the safety indicators it gives
p.002017: opportunity for wholesalers and retailers to:
p.002017: (a) verify the authenticity of the medicinal product;
p.002017: (b) identify the individual packaging;
p.002017: 2. a means by which to check the packaging of the medicinal product
p.002017: whether it was forged.
p.002017: Art. 168a. (New, SG No. 102/2012, effective 21.12.2012) (1) On the packaging of a medicinal product that
p.002017: shall be granted on medical prescription, safety indicators according to art. 168, para. 8, except
p.002017: of cases where the medicinal product is
p.002017: included in the list determined by the European Commission by a delegated act under art. 168b.
p.002017: (2) No indications for the packaging of a medicinal product dispensed without a medical prescription shall be given.
p.002017: safety under Art. 168, para. 8, except where the medicinal product is included in the list,
p.002017: designated by the European Commission by means of a delegated act
p.002017: under Art. 168b, having been assessed as being at risk of forgery.
p.002017: (3) The Medicines Executive Agency shall notify the European Commission of:
p.002017: 1. for medicinal products which are available without a prescription for which it is
p.002017: found that there was a risk of counterfeiting;
...
p.002017: 2. the holder of a production permit in compliance with the requirements of Art. 168, para.
p.002017: 8 may replace safety indicators with equivalents with respect to
p.002017: the ability to guarantee the authenticity, identification and assurance of
p.002017: evidence of tampering with the medicinal product.
p.002017: (3) Safety indicators shall be considered equivalent if:
p.002017: 1. meet the requirements laid down in the delegated acts referred to in Article 54a (2)
p.002017: of Directive 2001/83 / EC, and
p.002017: 2. are equally effective in allowing authentication; and
p.002017: the identification of medicinal products and the provision of evidence of forgery
p.002017: them.
p.002017: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of
p.002017: the medicinal product and in accordance with good manufacturing practice for medicinal products
p.002017: products.
p.002017: (5) The Medicines Executive Agency shall oversee the replacement of
p.002017: safety indicators.
p.002017: Art. 169. (1) The information on the packaging and the package leaflet of the medicinal product must be complete
p.002017: compliance with the particulars in the summary of product characteristics approved by the BDA when granting the marketing authorization
p.002017: use and meet the requirements set out in
p.002017: the ordinance under Art. 170.
p.002017: (2) The information on the packaging and the package leaflet may be in several languages, but
p.002017: one of them must be Bulgarian. The content of the information is different
p.002017: languages must be identical.
p.002017: (3) The name of the medicinal product shall be written in Bulgarian
p.002017: language, and the international non-patent name of the medicinal substance is given according to
p.002017: WHO anatomical-therapeutic-chemical classification. The name and address of
p.002017: the holder of the marketing authorization may be written in Latin.
p.002017: (4) The information on the packaging and the package leaflet must be understandable to the patient
p.002017: language, be legible and indelible.
p.002017: (5) (New, SG No. 18/2014) The leaflet must be designed in such a way that it is
p.002017: clear and comprehensible, allowing the patient to take appropriate action at
p.002017: need, with the help of medical professionals.
p.002017: Art. 170. (1) (Former text of Article 170 - SG, issue 102 of 2012, in force since 01.03.2013)
p.002017: The requirements for the packaging and package leaflet of the medicinal products shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: (2) (New - SG, iss. 102 in 2012, in force since 21.12.2012, suppl. - SG, iss. 18 in 2014)
p.002017: a product authorized for use under this Act is not intended for direct delivery to the patient or
p.002017: not available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data specified in
p.002017: the ordinance under para. 1, not applied
p.002017: on the packaging or the package leaflet.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2
p.002017: The information on the packaging and the package leaflet may not be provided in English
p.002017: language.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) Delivery terms and procedure
p.002017: of the medicinal products under para. 2 shall be determined by the ordinance under art. 198.
p.002017: Chapter seven.
p.002017: CLASSIFICATION OF MEDICINAL PRODUCTS
...
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
p.002017: the medicinal product is classified as a prescription only product.
p.002017: Art. 177. Medicinal products that do not meet the requirements of Art. 173, 174 and
p.002017: 175 and the criteria set out in the ordinance under Art. 178, are granted without medical prescription.
p.002017: Art. 178. The criteria for classification of medicinal products and the requirements for
p.002017: the documentation for making a change in the classification shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish it on the page
p.002017: your online list of prescription medicines
p.002017: the territory of the Republic of Bulgaria.
p.002017: (2) The list under para. 1 is updated annually.
p.002017: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002017: or the certificate of registration, the BDA shall review and, where necessary, amend the classification according to
p.002017: the requirements of Art. 173 and the criteria specified
p.002017: in the ordinance under art. 178.
p.002017: Art. 181. Where a change in the classification of a medicinal product on the basis of
p.002017: significant pre-clinical or clinical trials, no subsequent applicant or marketing authorization holder
p.002017: may be invoked within one year from the date of the variation authorization issued by a regulatory authority of a country
p.002017: State upon filing
p.002017: an application to change the classification of the same substance.
p.002017: Art. 182. The European Medicines Agency shall be notified annually by the Executive Agency for Medicinal Products
p.002017: the Commission and the regulatory authorities of the other Member States for changes to the
p.002017: Art. 179.
p.002017: Chapter Eight.
p.002017: PHARMACEUTICAL SAFETY TRACKING
p.002017: Section I.
p.002017: General Provisions (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 183. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the drug agency organizes and maintains a drug tracking system
p.002017: safety to fulfill the obligations under this Chapter.
p.002017: (2) The system of para. 1 is used to gather information on the risks of medicinal products
p.002017: for patients' health and public health. The information covers adverse drug reports
p.002017: reactions when using the medicinal product in accordance with the approved summary of product characteristics, and
p.002017: misuse and use information that is inconsistent with the approved summary
p.002017: product characteristics, including information on side effects observed with
p.002017: execution of
p.002017: professional duties.
p.002017: (3) The Executive Agency for Medicines shall validate, process and classify the information under para.
p.002017: 2, conducts a scientific analysis of the data collected with a view to assessing the potential for reduction and
p.002017: risk prevention and take the necessary action
p.002017: with regard to the authorization of the medicinal product.
...
p.002017: the marketing authorization;
p.002017: 2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
p.002017: available data, including clinical trial data for unauthorized indications and target groups,
p.002017: which are not included in the summary of
p.002017: product;
p.002017: 3. all data on the volume of sales of the medicinal product and any other information with which
p.002017: the holder of the marketing authorization is in possession of the volume of prescriptions, including approximate ones
p.002017: number of persons who used the medicinal product
p.002017: or exposed to it for another reason.
p.002017: (2) The content and format of the electronic periodic updated reports on
p.002017: safety is determined by Implementing Regulation (EU) No 520/2012.
p.002017: (3) The information under para. 1 shall be collected and stored in a register established in the order of a member
p.002017: 25a of Regulation (EC) No 726/2004 of the European Parliament and of the Council, and is accessible to the BDA.
p.002017: Art. 194i. (New, SG No. 102/2012, effective 21.12.2012) The holders of
p.002017: marketing authorizations / certificates for registration of medicinal products under Art. 28, 30, 35
p.002017: and 37 submit periodic safety update reports only when:
p.002017: 1. submission of a report is a condition under Art. 55a or 56, entered in the authorization for
p.002017: use / registration certificate, or
p.002017: 2. The Executive Agency for Medicinal Products or a regulatory authority of another Member State shall so request
p.002017: on the basis of safety considerations for the medicinal product or
p.002017: due to the absence of periodic safety update reports for the active substance contained in
p.002017: the medicinal product authorized
p.002017: use / registration certificate.
p.002017: Art. 194k. (New, SG No. 102/2012, effective 21.12.2012) (1) In the authorization for
p.002017: use / registration certificate is determined by the frequency of submission of periodic
p.002017: updated safety reports.
p.002017: (2) The filing dates of the reports depending on the frequency under para. 1 are calculated by
p.002017: the date of issue of the marketing authorization / registration certificate.
p.002017: (3) Periodic safety update reports shall be submitted through the following
p.002017: time intervals, except where reporting frequency is a condition of
p.002017: issuing the marketing authorization / registration certificate or is
p.002017: determined in accordance with Art. 194l, 194m and 194h:
p.002017: 1. every 6 months from the date of issue of the marketing authorization / certificate
p.002017: for the registration of a medicinal product by the date of its placing on the market;
p.002017: 2. every 6 months during the first two years from the date of placing on the market of
p.002017: the medicinal product;
p.002017: 3. once a year for the next two years;
p.002017: 4. once every three years after the fourth year from the date of placing on the market of
p.002017: the medicinal product.
p.002017: (4) Outside the cases under para. 3, periodic safety update reports are issued
p.002017: shall submit immediately upon request to the BDA or to a regulatory authority of a Member State.
p.002017: (5) Paragraphs 3 and 4 shall also apply to medicinal products authorized for use only
p.002017: the territory of the Republic of Bulgaria, which are not covered by Art. 194l.
p.002017: Art. 194l. (New, SG No. 102/2012, effective 21.12.2012) Where medicinal products which
p.002017: contain the same active substance or a combination of the same active substances, have been obtained separately
p.002017: marketing authorizations / registration certificate, frequency and filing dates for periodic updates
p.002017: safety reports may be modified and harmonized in order to carry out a uniform assessment of those reports.
p.002017: Art. 194m. (New, SG No. 102/2012, effective 21.12.2012) (1) The filing dates of
p.002017: the periodic safety update reports for the medicinal products under Art. 194l
p.002017: calculated according to the European Union reference date.
p.002017: (2) The European Union reference date under para. 1 is:
p.002017: 1. the date of the first authorization for use in the European Union of the medicinal product
p.002017: a product containing the relevant active substance or the corresponding combination of active substances
p.002017: substances, or
p.002017: 2. the earliest known date of authorization of the medicinal product,
p.002017: containing the relevant active substance or the corresponding combination of active substances, if
p.002017: the date referred to in item 1 cannot be determined.
p.002017: Art. 194n. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the permit
p.002017: for the use of medicinal products under Art. 194l may submit a reasoned request to the Committee
p.002017: medicinal products for human use, respectively to the coordination group under Art. 77, para. 2 for
p.002017: fixing a European Union reference date or changing the filing frequency of periodic updates
p.002017: safety reports
p.002017: on one of the following grounds:
p.002017: 1. reasons for public health;
p.002017: 2. to avoid duplicate assessment;
p.002017: 3. to achieve international harmonization.
p.002017: (2) the Committee for Medicinal Products for Human Use, respectively
p.002017: the coordination group of art. 77, para. 2 after consultation with the committee under Art. 56a, para. 1, v. 1
p.002017: approves the request or makes a reasoned refusal.
p.002017: (3) The filing frequency and the European Union reference date shall be fixed after
p.002017: consultation with the committee under Art. 56a, para. 1, item 1 of:
p.002017: 1. The Committee for Medicinal Products for Human Use - where at least one of the Marketing Authorizations
p.002017: for medicinal products containing the active substance concerned is provided in accordance with the centralized one
p.002017: procedure provided for in Chapter II of Title II of the
p.002017: Regulation (EC) No 726/2004 of the European Parliament and of the Council, or
p.002017: 2. the coordination group of art. 77, para. 2 - for cases other than those specified in item 1.
p.002017: (4) The European Union reference dates for medicinal products under
p.002017: Art. 194l and the harmonized frequency for submitting their periodic up-to-date reports
p.002017: safety shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: (5) The holder of the marketing authorization after the publication of the data under para. 4 presents to the BDA an application for
p.002017: modification of the marketing authorization for the medicinal product concerned. Any change in filing dates and on
p.002017: the frequency of submission of periodic safety update reports specified in the
p.002017: use, effective 6
p.002017: months after their date of publication.
p.002017: Art. 194o. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: Medicines evaluates periodic safety update reports for medicinal products for
p.002017: to determine if there are new risks, or a change in
p.002017: identified risks, or change in benefit / risk ratio.
p.002017: (2) The Medicines Executive Agency shall carry out a uniform assessment of the periodic up-to-date reports on
p.002017: safety for medicinal products for which the Republic of Bulgaria has fulfilled the functions of a reference country
p.002017: within the meaning of Art. 76, and is determined by
p.002017: the coordination group of art. 77, para. 2.
...
p.002017: 2. prohibition of distribution of a medicinal product;
p.002017: 3. issuing a refusal to renew the marketing authorization.
p.002017: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para.
p.002017: 2, when notified by the marketing authorization holder that for reasons related to
p.002017: drug safety monitoring, discontinued
p.002017: the distribution of the medicinal product has either taken or intends to take action on
p.002017: it will be removed from the market or it will not take any action to renew it
p.002017: the marketing authorization issued.
p.002017: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure
p.002017: under para. 2 and in cases where it considers that for reasons related to drug monitoring
p.002017: safety, a new contraindication or reduction should be added to a medicinal product
p.002017: the recommended dose or indication
p.002017: be limited.
p.002017: (5) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products shall provide the European Medicines Agency
p.002017: medicines and regulatory authorities of other Member States all the scientific information by which
p.002017: have, as well as the data assessment performed, and
p.002017: the reasons for initiating the procedure under this section.
p.002017: (6) (Amended, SG No. 18/2014) In the cases of para. 2 - 4 European Medicines Agency
p.002017: notifies the BDA of the initiation of the procedure when the safety concerns relate to others
p.002017: medicinal products belonging to or containing the same therapeutic group
p.002017: active substance with the product specified in the information under para. 5, or where this medicinal product is authorized
p.002017: for use in another or
p.002017: in other Member States.
p.002017: (7) (amend. - SG 18/04) In the cases of para. 4 when you do not have to
p.002017: take urgent measures, the BDA applies the procedure under Art. 77 or 79b.
p.002017: (8) (New, SG No. 18/2014) The Executive Agency for Medicines shall inform
p.002017: the holder of the marketing authorization in order to initiate the procedure under this section.
p.002017: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases under Art. 194y, para. 2 when
p.002017: considered it necessary to take urgent measures to protect public health, BDA
p.002017: may suspend the marketing authorization and prohibit the use of the medicinal product
p.002017: the territory of the Republic of Bulgaria until the adoption of the
p.002017: final decision under art. 194h or 194h.
p.002017: (2) The Medicines Executive Agency shall notify the European Medicines Agency, the European Medicines Agency
p.002017: the Commission and the regulatory authorities of the other Member States for the measures taken under para. 1 within one working day
p.002017: day from their implementation and state the reasons for
p.002017: this.
p.002017: (3) Where the Medicines Executive Agency participates in the procedure under this section, at the request of the European Medicines Agency
p.002017: the BDA Commission takes the recommended provisional measures with regard to the Marketing Authorization for
p.002017: medicinal product or where the medicinal product is authorized under Regulation (EC) No
p.002017: 726/2004 of the European Union
p.002017: Parliament and Council - with regard to the product itself, pending the completion of the procedure.
...
p.002017: 6. immediately inform the BDA and the Marketing Authorization Holder, where applicable
p.002017: has established or suspects that the medicinal product subject to mediation is
p.002017: counterfeit;
p.002017: 7. check that the trader holds a wholesale trade permit with
p.002017: medical products;
p.002017: 8. verify that the manufacturer or importer holds an authorization for
p.002017: production / import;
p.002017: 9. to keep the data under item 3 for a period of at least 5 years and to provide them at
p.002017: request from the inspection bodies.
p.002017: (2) Requirements for mediation activities in the field of medicines
p.002017: products are determined by the ordinance under art. 198 and in European Commission guidance.
p.002017: Chapter Nine "a".
p.002017: PARALLEL IMPORTS OF MEDICINAL PRODUCTS (PREVIOUS SECTION II - SG, ISP.
p.002017: 71 FROM 2008, IN EFFECT OF 12/08/2008)
p.002017: Art. 213. (amend. - SG 71/08, in force from 12.08.2008) Parallel import of medicinal products
p.002017: products on the territory of the Republic of Bulgaria may be performed by a natural or legal person registered under
p.002017: Commercial law, under the law of a Member State, after obtaining a parallel import permit issued by
p.002017: the BDA Executive Director.
p.002017: Art. 214. (1) A medicinal product authorized for use in another Member State may
p.002017: shall be imported in parallel in the territory of the Republic of Bulgaria when it is identical or similar to
p.002017: medicinal product authorized for use in the Republic of Bulgaria under this Law.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 12/2011, in force from 08.02.2011)
p.002017: the meaning of para. 1 identical or similar medicinal product is the one available
p.002017: uniform qualitative and quantitative composition with respect to the active substance (s),
p.002017: comes in the same dosage form, comes in the same primary
p.002017: packaging with a similar graphic design to the package.
p.002017: Art. 215. (1) (amend. - SG 71/08, in force from 12.08.2008) For obtaining a permit for parallel
p.002017: import of a medicinal product into the territory of the Republic of Bulgaria by the person under Art. 213 applied to
p.002017: the Executive Director of the BDA, in which he indicates
p.002017: the Member State from which the medicinal product will be imported in parallel.
p.002017: (2) The following data and documents shall be attached to the application:
p.002017: 1. name, dosage form, amount of active substance in dosage form
p.002017: unit of marketing authorization for a medicinal product in the Republic of Bulgaria;
p.002017: 2. name, dosage form, amount of active substance in dosage form
p.002017: unit of medicinal product intended for parallel import;
p.002017: 3. (suppl. - SG 12/11, in force from 08.02.2011) name of the holder of
p.002017: the marketing authorization of the manufacturer, if any, other than the holder of
p.002017: the marketing authorization for the medicinal product intended for parallel import;
p.002017: 4. the number of the marketing authorization for the medicinal product in the Republic of Bulgaria and
p.002017: the authorization number of the medicinal product in the Member State of origin
p.002017: performs parallel imports;
p.002017: 5. statement on establishing the circumstances under art. 217, v. 1;
p.002017: 6. a copy of the leaflet for the patient and a sample of the medicinal product as it is
p.002017: sell in the Member State from which the parallel importation takes place, a translation of the contents of
p.002017: the leaflet in Bulgarian, accompanied by a declaration that the translation is in conformity with the original
p.002017: the leaflet;
p.002017: 7. a proposal for a leaflet for the patient for the parallel medicinal product, accompanied by a declaration,
p.002017: that the contents of the package leaflet are identical to the contents of the product leaflet authorized for use in
p.002017: The Republic of Bulgaria, with the exception of the following
p.002017: data:
p.002017: (a) the name and management address of the parallel importer;
p.002017: (b) the name of the manufacturer, where different for the two products;
p.002017: (c) a period of stability when different for the two products;
p.002017: (d) excipients, where different in the two products;
p.002017: 8. in the case of repackaging:
p.002017: a) (amend. - SG 71/08, in force from 12.08.2008) a sample of the medicinal product
p.002017: as it will be marketed in Bulgaria;
p.002017: (b) a copy of the contract between the parallel importer and the importer
...
p.002017: medicine;
p.002017: b) (amend. - SG 71/08, in force from 12.08.2008) a statement that the content of
p.002017: the leaflet under letter "a" is identical to the contents of the product leaflet authorized for
p.002017: use in the Republic of Bulgaria, except for the data under Art. 215, para. 2, item 7, letters "a" - "d";
p.002017: 4. document and report to the Marketing Authorization Holder and the BDA
p.002017: all reports of suspected adverse reactions to the medicinal product introduced
p.002017: product.
p.002017: Chapter Nine "b".
p.002017: EXPORT OF MEDICINAL PRODUCTS (NEW, SG No. 18/2014)
p.002017: Art. 217a. (New, SG No. 18/2014) (1) Export of medicinal products from the territory of the Republic of Bulgaria may
p.002017: to carry out a natural or legal person who holds a marketing authorization for a medicinal product
p.002017: products or marketing authorization holder
p.002017: production.
p.002017: (2) The holder of a manufacturing authorization may export only to
p.002017: its medicinal products.
p.002017: (3) For the purposes of this Chapter, exports are also intra - Community supplies within the framework of
p.002017: The European Union.
p.002017: (4) Export of medicinal products included in the Positive Medicinal List under Art.
p.002017: 262, para. 1, from the territory of the Republic of Bulgaria shall be made after notification to
p.002017: BDA on a case - by - case basis where the export is carried out by the holder of a
p.002017: wholesale of medicines.
p.002017: Art. 217b. (New, SG No. 18/2014) The notification under Art. 217a, para. 4 is filed by
p.002017: the Executive Director of the BDA and contains the following data:
p.002017: 1. name and address of management of the person under art. 217a, para. 1;
p.002017: 2. name, dosage form and quantity of active substance in dosage form
p.002017: unit of medicinal product intended for export;
p.002017: 3. number of the authorization for wholesale of medicinal products;
p.002017: 4. number of packages of the medicinal product intended for export;
p.002017: 5. the country where the export is planned to take place.
p.002017: Art. 217c. (New, SG No. 18/2014, declared unconstitutional by RKS No. 1 of 2015 - SG, No. 12/2015)
p.002017: (1) Upon receipt of a notification under Art. 217b BDA requires information on the medicinal product intended for export
p.002017: for a period of 6 months from the date of filing
p.002017: notification:
p.002017: 1. for the consumption of the respective medicinal product by the National Health Insurance Fund and / or by
p.002017: The Ministry of Health;
p.002017: 2. for the deliveries of the respective medicinal product in the Republic of Bulgaria by the holder of
p.002017: the marketing authorization.
p.002017: (2) The persons under para. 1 provide the information requested by the BDA within 15 days of receipt of
p.002017: the request.
p.002017: (3) The Executive Agency for Medicines shall perform an analysis of the received under para. 2 information about
p.002017: the respective medicinal product by comparing the data on the quantities used under para. 1, item 1 and
p.002017: the quantities delivered under para. 1, item 2 with the available data received in accordance with Art. 217b, item 4 for number of packages,
p.002017: intended for
p.002017: wear.
p.002017: (4) Where within 30 days from the date of receipt of the notification under Art. 217b, the executive
p.002017: the BDA director did not object to the export in writing, it is considered that there is a tacit consent for
p.002017: export.
p.002017: (5) The Executive Director of the BDA may, within the term of para. 4 to refuse by reasoned order the execution
...
p.002017: the budget of the medical establishments under art. 5 of the Medical Institutions Act and the budget of the medical establishments with
p.002017: state and / or
p.002017: municipal participation under Art. 9 and 10 of the Medical Institutions Act.
p.002017: (2) The positive medicinal list includes medicinal products classified under
p.002017: pharmacological groups according to the code of anatomical-therapeutic-chemical classification, with the relevant international ones
p.002017: non-patent names, their respective names, with the corresponding defined daily dose / therapeutic
p.002017: rate, price under art. 261a, para. 1, the marginal price of medicinal products when sold to
p.002017: retail, reference daily dose / therapeutic reference value, packaging value,
p.002017: calculated on the basis of a reference value / therapeutic course for a defined daily dose and payment level,
p.002017: needed for their treatment, as well as diseases under the International Disease Code (ICD).
p.002017: (3) For medicinal products for which there is no defined daily dose,
p.002017: the reference value is determined on the basis of therapeutic rate, concentration or volume.
p.002017: (4) (Supplemented, SG No. 48/2015) The medicinal products in the Positive Medicinal List shall be selected
p.002017: according to evidence of efficacy, therapeutic efficacy, safety and analysis of
p.002017: pharmacoeconomic indicators such as for medicines with a new international non-patent name are
p.002017: also performs health technology assessments. The assessment of health technologies is carried out under conditions and in order
p.002017: defined by an ordinance of
p.002017: the Minister of Health.
p.002017: (5) When one or more medicinal products of the same international non-patent name, the dosage form
p.002017: and concentration of the active substance, except for the medicinal products under Art. 29, already are
p.002017: included in the relevant part of the Positive
p.002017: medical list, no assessment under para. 4.
p.002017: (6) The positive medical list includes:
p.002017: 1. medicinal products intended for the treatment of diseases payable at
p.002017: the procedure of the Health Insurance Act;
p.002017: 2. medicinal products paid from the budget of the medical establishments under art. 5 of
p.002017: The Law on Health Care Facilities and the Budget of Health Care Facilities with State and / or Municipal
p.002017: participation under Art. 9 and 10 of the Medical Establishments Act;
p.002017: 3. medicinal products intended for the treatment of AIDS, infectious diseases, of
p.002017: diseases outside the scope of the Health Insurance Act, paid in accordance with Art. 82, para. 1, item 8 of
p.002017: The Health Act, as well as vaccines for compulsory immunizations and immunizations, vaccines for special indications and
p.002017: in exceptional circumstances, specific
p.002017: sera, immunoglobulins;
p.002017: 4. the marginal price of the medicinal products under Art. 261a, para. 4 by elements.
p.002017: (7) The Ministry of Health and the NHIF may submit proposals to the council
p.002017: under Art. 258, para. 1 for the review of included medicinal products in the Positive Medicinal Product
p.002017: a list under the conditions and in the order specified in the ordinance under Art. 261a, para. 5.
p.002017: (8) The National Health Insurance Fund shall pay for the medicinal products under para. 6, vol.
p.002017: 1 under the terms and procedure of the ordinance under Art. 45, para. 9 of the Health Insurance Act.
p.002017: (9) (New, SG No. 18/2014, Supplemented, SG No. 48/2015) Conditions, rules and criteria
p.002017: to include, modify and / or exclude medicinal products from the Positive Medicinal List and for
...
p.002017: (4) The Council of Ministers shall lay down the rules and procedures for the work of the Commission
p.002017: for transparency.
p.002017: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012
p.002017: The Transparency Committee is an appealable body
p.002017: the decisions of the National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority
p.002017: ѝ.
p.002017: (3) The decisions under par. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a respective disease is without
p.002017: alternative in the country, for a particular patient may be administered a medicinal product that is authorized for
p.002017: use in a Member State of the European Union,
p.002017: it is authorized for use according to the procedure of this law, but it is not distributed on the Bulgarian market.
p.002017: (2) Annually upon proposal by the medical establishments for hospital care and after the opinion of the respective
p.002017: the national consultant on the disease profile, the Minister of Health approves the list of
p.002017: the medicinal products under para. 1 which contains
p.002017: following information:
p.002017: 1. anatomical-therapeutic-chemical classification code;
p.002017: 2. an international non-patent name to which the product belongs;
p.002017: 3. disease according to the international disease code;
p.002017: 4. the dosage form and the amount of active substance;
p.002017: 5. additional information.
p.002017: (3) The list under para. 2 is published on the Ministry of Justice's website
p.002017: healthcare on the internet.
p.002017: (4) The conditions and procedure for inclusion, modification or exclusion of medicinal products in
p.002017: the list under para. 2 shall be determined by the ordinance under art. 9, para. 1.
p.002017: (5) The medicinal product under para. 1 is delivered by special order curative
p.002017: hospital care facility under the terms and procedures established by the ordinance under Art. 9, para. 1.
p.002017: (6) The head of the medical establishment under para. 5 is responsible for the implementation of
p.002017: the treatment under para. 1.
p.002017: Chapter thirteen.
p.002017: STATE CONTROLS ON MEDICINAL PRODUCTS
p.002017: Art. 267. (1) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, effective from
p.002017: 12/21/2012) The Ministry of Health supervises the state control over medicinal products.
p.002017: The direct management is carried out by the Chief State Health Inspector, by the President of
p.002017: the Council under Art. 258, para. 1, by the Executive Director of the BDA and by the Directors of the State Health Insurance Fund, which are state-owned
p.002017: control inspectors
p.002017: medicinal products.
p.002017: (2) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 in 2012, in
p.002017: (21 December 2012) The authorities responsible for the state control of medicinal products are the Council of the
p.002017: Art. 258, para. 1, BDA and RZI.
p.002017: (3) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 in 2012, in
p.002017: effective 21.12.2012) The direct control is exercised by officials - inspectors
...
p.002017: (5) The orders under para. 1 - 4 are subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 294. Who violates the provisions of this law or its implementing regulations,
p.002017: outside the cases under Art. 281 - 293, shall be punished by a fine from 1000 to 3000 levs, and in case of a repeated fine
p.002017: committing the same offense - with a fine of 3000 to 5000 BGN.
p.002017: Art. 295. (1) (amend. - SG 98/10, in force from 01.01.2011) The violations on this
p.002017: Act shall be established by acts drawn up by state inspectors of the BDA, respectively by the Health Insurance Fund.
p.002017: (2) The violations under Art. 289 shall be established by officials designated by
p.002017: the Minister of Health.
p.002017: (3) (amend. - SG 98/10, in force from 01.01.2011) The penal decrees shall be issued by the Minister
p.002017: of Health, by the Chief State Health Inspector, by the Executive Director of the BDA and by
p.002017: the directors of the SIC, depending on the subordination of
p.002017: the official who found the infringement.
p.002017: Art. 296. Drafting of acts, issuing, appealing and executing
p.002017: the penal decrees shall be executed in accordance with the procedure of the Administrative Offenses Act and
p.002017: penalties.
p.002017: Art. 297. In the cases of Art. 281, 282, 283, 284, 285 and 287, the penal authority shall also order
p.002017: withdrawal of medicinal products subject to the offense in favor of the State,
p.002017: under the conditions and in the order specified in an ordinance of the Minister of Health.
p.002017: Additional provisions
p.002017: § 1. For the purposes of this Act:
p.002017: 1. (amend. - SG 102/02, in force from 02.01.2013) "Active substance" shall be any substance or
p.002017: a mixture of substances intended for use in the manufacture of a medicinal product which when used
p.002017: in its manufacture they become the active ingredient of this product, intended for the exercise of
p.002017: pharmacological, immunological or metabolic action for the purpose of restoring, correcting or altering
p.002017: physiological functions
p.002017: or to make a medical diagnosis.
p.002017: 2. "Bioequivalence" is present when the medicinal products are pharmaceutical
p.002017: equivalent or pharmaceutical alternatives, and if their bioavailability after administration in
p.002017: the same molar dose is similar to such an extent that its effects in terms of efficacy and
p.002017: safety is substantially similar.
p.002017: 3. "Bioavailability" is the rate and extent at which the active substance or the therapeutically active part of it is absorbed
p.002017: of the dosage form and becomes available at the site of action. When the drug substance is intended to
p.002017: exercise a systemic therapeutic effect, bioavailability means the speed and degree at which a drug substance or
p.002017: therapeutically
p.002017: its active part is released from the dosage form and goes into general circulation.
p.002017: 4. "Researcher's Brochure" means the aggregate of clinical and non-clinical data for
p.002017: the investigational medicinal product (s) that are relevant for the test of the product or product
p.002017: products on people.
p.002017: 5. "Valid documentation" shall mean documentation which in content and completeness corresponds to
p.002017: the requirements laid down in a particular procedure under this Act.
p.002017: 6. "Substance with well established use in medical practice" is a substance for
p.002017: the following criteria may apply:
p.002017: (a) the period of proof of well-established use in medical practice is not less than 10 years from
p.002017: the date of the first systematic and documented use of the substance as a medicinal product in
p.002017: The European Union or the European Economic Community
p.002017: space;
p.002017: (b) quantitative aspects of the use of the substance, taking into account the degree of medical use
p.002017: practice, the degree of geographical use and the degree of tracking through the safety system,
p.002017: including pre-market research and scientific research published thereafter
p.002017: epidemiological literature
p.002017: studies and, in particular, comparative epidemiological studies;
p.002017: (c) a high level of scientific interest in the use of the substance (number of scientific
p.002017: publications) and unity in the scientific community in scientific evaluations.
p.002017: 7. "Secondary packaging" is a packaging which does not come in direct contact with
p.002017: the medicinal product.
p.002017: 8. "Contracting Authority" means a natural or legal person, institution or organization which
p.002017: is responsible for initiating, managing and / or financing the clinical trial.
p.002017: 9. "Generic medicinal product" is a medicinal product which has the same qualitative and
p.002017: quantitative composition with respect to the active substances and the same dosage form as the reference
p.002017: medicinal product, and its bioequivalence with the reference medicinal product has been demonstrated to be appropriate
p.002017: bioavailability tests. The various immediate-release oral dosage forms are considered to be one
p.002017: and the same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of
p.002017: active substance are considered to be the same active substance, unless they differ significantly in their nature
p.002017: safety and / or efficiency.
p.002017: 10. "Principal Investigator" is the doctor or dentist appointed by the contracting authority, who direct
p.002017: the overall conduct of the clinical trial in accordance with the approved protocol and the Good Guideline
p.002017: clinical practice and responsible for the work of
p.002017: the researchers.
p.002017: 11. "Defined daily dose" is an average daily maintenance dose of a drug
p.002017: product for use in adults according to the primary indication of the medicinal product.
p.002017: 12. "Good clinical practice" is the set of internationally recognized ethical and
p.002017: scientific quality requirements to be met when planning, conducting, reporting and
p.002017: reporting of clinical trials.
p.002017: 13. "Good laboratory practice" is a system of internationally recognized rules
p.002017: in terms of planning conditions, processes of organizing, executing, tracking and
p.002017: documentation of laboratory tests.
p.002017: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers all
p.002017: production sides - personnel, premises, facilities, materials, documentation, quality control, and aims
p.002017: to ensure safety, efficiency and
p.002017: according to the specification.
p.002017: 15. (suppl. - SG 71/08, in force from 12.08.2008) "Member State" is a state,
p.002017: Member State of the European Union or a State Party to the Agreement on the European Union
p.002017: economic space.
p.002017: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002017: 17. "Immunological medicinal product" is a medicinal product containing vaccines, toxins, serums or allergens. IN
p.002017: the range of vaccines, toxins and serums include agents used to create active immunity or to
p.002017: establish a state of immunity or induce passive immunity. Allergens are medicinal products that are
p.002017: intended to identify or stimulate a specific targeted change in the immunological response
p.002017: to an allergic agent.
p.002017: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002017: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative, and
p.002017: when their bioavailability after application in the same
p.002017: the molar dose is similar to a degree which is a condition of equivalent efficacy and safety.
p.002017: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and extent of
p.002017: in which the active substance or the therapeutically significant portion of the test drug reaches
p.002017: from the dosage form to the systemic
p.002017: blood circulation.
p.002017: 20. "Tested medicinal product" means the dosage form of the active substance or placebo to be tested
p.002017: or used as a comparison in a clinical trial, including authorized products
p.002017: for use, but are used for unauthorized use or for the purpose of obtaining additional information on
p.002017: the authorized form, or they are
p.002017: completed (in medicinal or packaged form) in a way other than the approved form.
p.002017: 21. "Researcher" means the doctor or dentist designated by the sponsor and the principal investigator,
p.002017: who practically conducts the clinical trial under the direction of the principal investigator according to
p.002017: the approved protocol and the Good Clinical Practice Guide at the Research Center for
p.002017: the clinical trial. If the clinical trial is conducted by a team, the investigator is the supervisor responsible for
p.002017: team and is called the Principal Investigator.
p.002017: 22. "Informed consent" is a statement of will that must be written, dated and signed in order to participate in
p.002017: a clinical trial taken completely free after being duly informed of its nature,
p.002017: significance, consequences and risks and properly documented by any person who is able to consent
p.002017: or when the person is not
p.002017: able to give his consent - from his legal representative.
p.002017: 23. "Whale" means any substance which is usually dissolved, suspended, before use,
p.002017: dilute or combine with radionuclides, resulting in the finished radioactive
p.002017: medicine.
p.002017: 24. "Clinical trial of a medicinal product" means any human study intended to
p.002017: the clinical, pharmacological and / or other pharmacodynamic effects of one or
p.002017: more tested medicinal products, and / or identify adverse reactions to one or more tested
p.002017: medicinal products, and / or to study the absorption, distribution, metabolism and excretion of one
p.002017: or more
p.002017: tested medicinal products to determine their safety and / or efficacy.
p.002017: 25. "Clinical advantage" is a significant therapeutic or diagnostic benefit of
p.002017: one medicinal product compared to a medicinal product which has already been authorized
p.002017: use.
p.002017: 26. "Coordinating researcher" means a researcher appointed to coordinate
p.002017: researchers from different centers participating in the multi-center test.
p.002017: 27. "Patient leaflet" is a leaflet containing information about the user that
p.002017: accompanies the medicinal product.
p.002017: 27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002017: "Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No 1394/2007.
p.002017: Of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and for
p.002017: amendment of the Directive
p.002017: 2001/83 / EC and Regulation (EC) No 726/2004.
p.002017: 28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product made from human
p.002017: blood components and by a method involving an industrial process. These include albumin, immunoglobulins,
p.002017: coagulation factors and antiproteases, solutions of
p.002017: plasma proteins, other plasma fractions or combinations thereof.
p.002017: 29. "Medicinal product intended for the treatment, prevention and diagnosis of rare
p.002017: diseases "is a product that:
p.002017: (a) is intended for the diagnosis, prophylaxis or treatment of life-threatening diseases
p.002017: diseases or progressive chronic diseases affecting no more than 5 in 10
p.002017: 000 people on the territory of the country, or
p.002017: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002017: health-damaging chronic conditions (diseases with a high incidence of incapacity for work and
p.002017: disability) and evidence was provided that the sale of the product did not provide a satisfactory one
p.002017: returns to justify the investment needed for R&D without
p.002017: incentives for
p.002017: the creator of the product, and
p.002017: (c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of
p.002017: the condition, or if there is one, the proposed medicinal product
p.002017: far more benefits than that and benefits for those affected by this condition.
p.002017: 30. A "dosage form" is an acceptable accepting structure containing the active substance (s) which
p.002017: may or may not include excipients obtained by the application of certain technological
p.002017: operations providing the desired healing effect and
p.002017: storage stability over the shelf life.
p.002017: 31. (amend. - SG 71/08, in force from 12.08.2008) "Person established in the territory of a Member State"
p.002017: is a legal entity registered under the civil or commercial law of a Member State or
p.002017: created by a legal act having its registered office and registered office in a Member State or in a State -
p.002017: Party to the Agreement on
p.002017: The European Economic Area.
p.002017: 32. "Highway formulation" is a prescription for a medicinal product made in a pharmacy under
p.002017: prescription from a healthcare professional or an approved prescription for a particular patient.
p.002017: 33. "International non-patent name" is the recommended name of
p.002017: the active substance approved and published by the WHO.
p.002017: 34. "Medical specialists" are doctors, doctors of dental medicine,
p.002017: master pharmacists, nurses, midwives, medical assistants, paramedics, and
p.002017: assistant pharmacist.
p.002017: 35. "Medical sales representative" is a person who has undergone special training and
p.002017: having the scientific knowledge to provide accurate and complete information on
p.002017: the medicinal product it advertises.
p.002017: 35a. (new - SG 1/2014, in force from 03.01.2014) "Medical prescription" is a prescription of
p.002017: medicinal product or medical device issued by a person practicing regulated medical
p.002017: profession within the meaning of § 1, item 1 of the additional provisions of the Law on the recognition of
p.002017: professional qualifications and what is legal
p.002017: the right to do so in the Member State where the medical prescription is issued.
p.002017: 36. "Multicenter Clinical Trial" is a clinical trial conducted under
p.002017: one protocol but in more than one center and more than one researcher. The research
p.002017: centers may be located in the territory of one Member State in more than one
p.002017: Member State and / or Member States and third countries.
p.002017: 37. "Name of a medicinal product" is the name given to the product which may
p.002017: be:
p.002017: a) freely chosen name (trade name);
p.002017: b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the commercial
p.002017: the make or the name of the marketing authorization holder;
p.002017: c) (amend. - SG 12/11, in force from 08.02.2011) scientific name together with the trade name
p.002017: the make or the name of the marketing authorization holder.
p.002017: 38. "Scientific literature" is a publication / publications of the results of scientific research in
p.002017: specialized international scientific publications.
p.002017: 39. "New active substance" is:
p.002017: (a) a chemical, biological or radiopharmaceutical that has not been authorized
p.002017: for use as a medicinal product in the European Union;
p.002017: (b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that is
p.002017: has been authorized for use as a medicinal product in the European Union but differs in
p.002017: the safety and efficacy of a previously authorized substance;
p.002017: (c) a biological substance which has been authorized for use as a medicinal product in
p.002017: European Union, but with a different molecular structure, with different origins in terms of
p.002017: the source material or is obtained through a different manufacturing process;
p.002017: (d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which have not been
p.002017: authorized as a medicinal product in the European Union, or the mechanism for pairing molecules
p.002017: and radionuclides was not allowed in
p.002017: The European Union.
p.002017: 40. "Adverse event" means any adverse change in health status,
p.002017: observed when administering a medicinal product to a patient or clinical participant
p.002017: a test that is not necessarily causally related to this treatment.
p.002017: 41. (amend. - SG 102/2012, in force since 21.12.2012) "Adverse drug reaction" is any undesirable and
p.002017: unexpected response to a medicinal product. In the case of a clinical trial - any undesirable or unforeseen
p.002017: response to the investigational medicinal product independently
p.002017: of the administered dose. The types of side effects are:
p.002017: (a) "unexpected" - an adverse reaction not listed in the summary of product characteristics;
p.002017: the product or whose character, weight or output does not meet the product characteristics mentioned in the summary; in
p.002017: case of clinical trial is an adverse reaction whose nature, severity or outcome do not match
p.002017: of test information
p.002017: medicinal product specified in the investigator's brochure;
p.002017: (b) "suspected" - an adverse reaction for which the notifier or the holder
p.002017: of the Marketing Authorization implies that there is a possible causal link with
p.002017: the received medicinal product;
p.002017: (c) "serious" - any adverse effect on a health condition which has caused the death,
...
p.002017: the legal and ethical implications of the administration of medicinal products in health care and focus
p.002017: on clinical and economic value, the analysis being comparable to existing or
p.002017: best to
p.002017: currently an alternative.
p.002017: 43. "Batch" means the specified quantity of the medicine manufactured in accordance with
p.002017: a reproducible technological scheme has been established to provide the required batch
p.002017: homogeneity with respect to the required control parameters.
p.002017: 43a. (new, SG No. 102/2012, effective 21.12.2012) "Risk Management Plan"
p.002017: is a detailed description of the risk management system.
p.002017: 44. "Maintenance of the authorization for a medicinal product" includes all
p.002017: necessary activities to maintain the current registration status of the medicinal product
p.002017: product, including drug safety monitoring.
p.002017: 44a. (new - SG 48/2015) "Maintenance of reimbursement status" is an assessment of
p.002017: medicinal product on the basis of evidence of efficacy, therapeutic efficacy,
p.002017: safety and analysis of pharmacoeconomic indicators.
p.002017: 45. "Benefit" is the positive result / therapeutic efficacy of the medicinal product
p.002017: for an individual patient, a group of patients, or for the community. Quantification of expected
p.002017: the benefit involves an approximate calculation of the probability of this positive result.
p.002017: 46. (amend. - SG 102/02, in force from 02.01.2013) "Excipient" shall be any
p.002017: an ingredient of a medicinal product other than the active substance and the packaging material.
p.002017: 47. "Post-marketing study" means any study conducted using the
p.002017: the medicinal product within the approved summary of product characteristics during the period
p.002017: after authorization for use.
p.002017: 47a. (new - SG 102/2012, in force from 02.01.2013) "Mediation in the field of medicinal products" are
p.002017: all activities except for the conclusion of a contract for the purchase or sale of medicinal products
p.002017: of wholesale, which do not involve physical holding and which are independently negotiated
p.002017: and on behalf of another
p.002017: legal or natural person.
p.002017: 48. (amend. - SG 102/2012, in force since 21.12.2012) "Post-marketing safety study" is any
p.002017: a study relating to an authorized medicinal product to identify itself,
p.002017: characterize or determine the degree of safety risk, confirm the profile of
p.002017: the safety of the medicinal product
p.002017: or to evaluate the effectiveness of risk management measures.
p.002017: 49. "Potential serious risk to public health" exists when there is a high degree of probability
p.002017: use of the medicinal product to cause irreversible, irreversible and irreversible negative effects
p.002017: consequences. The evaluation process identifies the risk of harm to the health of the population and
p.002017: its actual exposure to the wide use of the product. The serious health risk in the context of
p.002017: use of
p.002017: a particular medicinal product may be evaluated under the following conditions:
...
p.002017: the marketing authorization to represent it before
p.002017: regulatory authorities on the territory of the Republic of Bulgaria.
p.002017: 51. An "acceptable level of safety" is present when the submitted data is accepted
p.002017: at statistically significant safety according to clinical trials conducted at
p.002017: compliance with Good Clinical Practice.
p.002017: 52. "Manufacture of a medicinal product" are all operations related to the procurement of materials, theirs
p.002017: processing in the production process, including packaging and labeling, quality control,
p.002017: batch release, storage, shipping and
p.002017: the control associated with these operations.
p.002017: 53. "Clinical Trial Protocol" is a document that describes the purpose (s), project (s),
p.002017: methodology, statistical processing and organization of the test. The protocol includes
p.002017: and any subsequent amendments thereto.
p.002017: 54. "Placing on the market" is the distribution of a medicinal product in a commercial one
p.002017: network on the territory of the Republic of Bulgaria beyond the direct control of the owner of the
p.002017: the marketing authorization.
p.002017: 55. "Primary packaging" means packaging that comes into direct contact with
p.002017: the medicinal product.
p.002017: 56. "Radiopharmaceutical" is a medicinal product which, when ready for use,
p.002017: contains one or more radionuclides (radioactive isotopes) for medical purposes.
p.002017: 57. "Radionuclide generator" means any system that includes a fixed mater
p.002017: a radionuclide from which a daughter radionuclide is produced which is recovered by elution or
p.002017: by other methods and is used in radiopharmaceuticals.
p.002017: 58. "radionuclide precursor" means any other radionuclide produced for radioactive purposes
p.002017: marking of another substance just before its introduction into the patient's body.
p.002017: 59. "Herbal medicinal product" is a medicinal product containing as medicinal substances
p.002017: one or more herbal substances or one or more herbal preparations or one or more
p.002017: plant matter in combination with one or more
p.002017: herbal preparations.
p.002017: 60. "Vegetable substances" are mainly plants or parts of plants, algae, fungi, lichens, which are whole,
p.002017: broken or chopped, and used in the raw state, usually in the dried state, but sometimes also fresh.
p.002017: Some exudates that have not undergone specific treatment also apply to plant substances.
p.002017: The plant matter must have a specific botanical scientific name for the plant, from
p.002017: who
p.002017: originate according to the binomial system (genus, species, variety and author).
p.002017: 61. "Vegetable preparation" means the product obtained after extraction, distillation, squeezing, fractionation,
p.002017: purification, concentration or fermentation of the plant substance. The herbal preparation may be
p.002017: also ground or powdered vegetable
p.002017: substances, tinctures, extracts, essential oils, processed vegetable fluids / juices.
p.002017: 62. "Rare diseases" are diseases that are characterized by a frequency of
p.002017: prevalence no higher than 5 in 10,000 people.
p.002017: 63. "Reference medicinal product" is a medicinal product authorized in accordance with Art. 23 c
p.002017: compliance with the requirements of Art. 27.
p.002017: 64. "Defined daily dose reference value" for an international non-patent name with the relevant
p.002017: Anatomy Therapeutic Drug Classification Formula is the Lowest Value for a Defined Daily
p.002017: dose determined on the basis of defined daily dose values for the different medicinal products for
p.002017: the relevant international non - patent name with the relevant dosage form
p.002017: anatomic therapy
p.002017: classification of medicines.
p.002017: 65. "Therapeutic course reference value" is the lowest therapeutic value
p.002017: a course determined on the basis of the values of a therapeutic course of medicines internationally
p.002017: non-patent name with appropriate dosage form.
p.002017: 66. "Risk in use of a medicinal product" is:
p.002017: (a) the risk to the health of the patient or the risk to the health of the population associated with
p.002017: the quality, safety or efficacy of the medicinal product;
p.002017: (b) the risk of adverse effects on the environment.
p.002017: 67. "Serious adverse event" is any adverse change in health status that is
...
p.002017: activities and measures.
p.002017: 69b. (new - SG 102/2012, in force since 21.12.2012) "Tracking system of
p.002017: 'safety' is a system used by the marketing authorization holder and
p.002017: BDA for the accomplishment of the tasks and responsibilities of Chapter Eight intended for implementation
p.002017: monitoring the safety of authorized medicinal products and detection
p.002017: of any change in the benefit / risk ratio.
p.002017: 70. "Emergency restrictive safety measures" are temporary changes to product information with respect to
p.002017: one or more parts of the summary of product characteristics, indications, method of administration, contraindications
p.002017: and warnings that result from a new one
p.002017: information related to the safe use of the medicinal product.
p.002017: 71. "Spontaneous message" is a voluntarily sent message about suspected unwanted
p.002017: reaction when using the medicinal product to the marketing authorization holder, up to
p.002017: authorities for the supervision of medicinal products or other organizations not originating in
p.002017: a survey or other organized information gathering system.
p.002017: 72. "Shelf life of a medicinal product" is the time interval at which, if stored at
p.002017: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002017: based on stability studies of several batches of
p.002017: the finished form.
p.002017: 73. (amend. - SG 71/08, in force from 12.08.2008) "Relevant medicinal product of
p.002017: herbal medicinal product "is a product that contains the same active substances, regardless of composition
p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
...
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
p.002017: quality deviations, as well as a medicinal product that has been placed on the market in breach of
p.002017: intellectual property rights.
p.002017: 82. "Homeopathic medicinal product" is a medicinal product made from substances,
p.002017: called a homeopathic source, according to European production procedures
p.002017: pharmacopoeia, and in the absence thereof, according to the national pharmacopoeia of a Member State.
p.002017: 83. "Price calculated on the basis of a benchmark" is the price formed for each
p.002017: medicinal product included in the Positive Medicinal List, calculated on the basis of that established
p.002017: reference value for a defined daily dose or therapeutic course.
p.002017: 84. "Center" is a structure of the medical establishment in which it is conducted clinically
p.002017: testing.
p.002017: 85. "Misuse of medicinal products" is permanent or occasional intentional misuse
p.002017: excessive use of medicinal products accompanied by harmful physical or
p.002017: psychological effects.
p.002017: 86. (new - SG 41/09, in force from 02.06.2009) "Infants" shall be children under 12
p.002017: months.
p.002017: 87. (new - SG 41/09, in force from 02.06.2009) "Foods for infants" are foods,
p.002017: intended for specific nutritional use by infants during their first months alone
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.002017: products under development and research.
p.002017: (2) Data requirements for clinical packaging of medicinal products
p.002017: testing shall be determined in the ordinance under art. 170.
p.002017: which is:
p.002017: Art. 96. (1) Clinical testing of medicinal products shall be allowed only on a person,
p.002017: 1. informed in advance conversation with a doctor - member of the research team, about
p.002017: the objectives, risks and inconveniences of the test and the conditions under which it will be conducted;
p.002017: 2. informed of his right at any time to withdraw from the test without
p.002017: its negative consequences;
p.002017: 3. has given his / her written informed consent to participate after being acquainted with
p.002017: the nature, significance, consequences and potential risks of the clinical trial.
p.002017: (2) When the person is unable to write, informed consent to participate in the clinical trial shall be given
p.002017: orally in the presence of at least one independent witness who certifies in writing that the person
p.002017: has personally informed consent to participate in
p.002017: the clinical trial.
p.002017: (3) Informed consent under para. 1, item 3 and para. 2 can only give a capable person who understands
p.002017: the nature, significance, scope and potential risks of the clinical trial. Informed consent to participate in
p.002017: a clinical trial may be withdrawn at any time
p.002017: time.
p.002017: (4) Informed consent under para. 1, item 3 for a disabled adult is given by his / her legal person
p.002017: representative. The consent of the legal representative must represent the intended will of
p.002017: participant and can be withdrawn at any time without negatives
p.002017: consequences for the participant.
p.002017: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent gives
p.002017: the person appointed by the court.
p.002017: (6) The incapable adult is provided with information about the test,
p.002017: the potential risks and rewards of understanding it.
p.002017: (7) The explicit desire of an incapable adult to refuse to participate or to participate
p.002017: withdraw at any time from the clinical trial must be considered by
p.002017: the researcher and, if necessary, the principal investigator.
p.002017: Art. 97. (1) A clinical trial on a minor shall be conducted upon receipt of
p.002017: written informed consent of both parents or guardians of the person at
p.002017: compliance with Art. 96, para. 1 and 3.
p.002017: (2) The consent of the parents and guardians must represent the presumed
p.002017: the will of the minor and may be withdrawn at any time without negative consequences
p.002017: for a minor.
...
Searching for indicator disability:
(return to top)
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: defined in advance and are constantly monitored by
p.002017: test time;
p.002017: 9. the study is planned and is conducted in accordance with the guidelines of
p.002017: The European Medicines Agency;
p.002017: 10. no financial or other incentives are given except compensation.
p.002017: Art. 101. (1) Clinical trials on the persons under art. 96, para. 4 and 5, which are not in
p.002017: able to give informed consent shall be conducted in accordance with the requirements of art. 90.
p.002017: (2) In addition to the requirements of para. 1 inclusion in clinical trials of adults
p.002017: persons who are unable to give informed consent are permitted, provided that:
p.002017: 1. the relevant ethics committee with the participation of specialists with competence in the respective disease, or
p.002017: in the patient group approved the protocol after discussing clinical, moral and psychosocial aspects,
p.002017: relating to the disease in question and to
p.002017: the patient group;
p.002017: 2. it can be expected that the intake of the medicinal product being tested will
p.002017: lead to benefits that outweigh the risks or the risks are completely eliminated;
p.002017: 3. the purpose of the test is to verify data obtained from clinical trials on
p.002017: persons who are able to give informed consent or to data obtained through others
p.002017: research methods;
p.002017: 4. the test is directly related to life-threatening or leading to disability
p.002017: a disease in which the relevant adult is unable to give
p.002017: an informed consent;
p.002017: 5. clinical trials are designed so that pain, discomfort, fear and other foreseeable risks
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: predefined and constantly monitored
p.002017: during the test;
p.002017: 6. no financial or other incentives are given except compensation.
p.002017: Art. 102. No clinical trial of a medicinal product on
p.002017: pregnant women and nursing mothers unless the medicinal product is required for treatment
p.002017: they may or may not be tested on another group of patients.
p.002017: Section III.
p.002017: Ethics Committees
p.002017: Art. 103. (1) (amend. - SG 60/11, in force from 05.08.2011) To the Minister of
p.002017: a multi - center ethics committee is set up by the Health Committee, whose composition is determined by
p.002017: Minister's order and includes regular and reserve members. Reserve members
p.002017: participate in committee meetings and have the right to vote in the absence of full members.
p.002017: (2) To the medical establishments where clinical trials are carried out shall be established
p.002017: ethics committees composed of the head of the hospital.
p.002017: (3) The Executive Agency for Medicines shall maintain and keep a register of the Committees on
p.002017: ethics.
...
p.002017: 4. general information on the risks associated with the medicinal products delivered to
p.002017: Internet users in violation of the ordinance under Art. 234, para. 5.
p.002017: (2) The website of the BDA under para. 1 is linked to
p.002017: European Medicines Agency.
p.002017: Art. 234b. (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines shall participate in the
p.002017: information campaigns conducted by the European Commission and the European Medicines Agency
p.002017: the risk of counterfeit medicines
p.002017: products.
p.002017: Art. 235. (1) The permit for carrying out retail trade in medicinal products
p.002017: under Art. 229, para. 2 shall be terminated by termination of the activity of the persons under art. 222 and 225.
p.002017: (2) (Amended, SG No. 60/2011, effective 05.08.2011) The Executive Director of
p.002017: The BDA suspends the authorization to trade in medicinal products:
p.002017: 1. at the request of the person who has received a permit for retail trade;
p.002017: 2. when it is established that the pharmacy manager does not meet the requirements,
p.002017: referred to in Art. 224 and 225.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 14 days from termination
p.002017: of the activity under para. 1 persons under art. 222 and 225 shall notify the BDA in writing.
p.002017: Art. 236. (1) The pharmacy may not be closed for more than 30 days within one
p.002017: calendar year due to the absence of its manager.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 12/2011, effective 08.02.2011,
p.002017: ed. - SG, issue. 60 of 2011, effective 05.08.2011) When the pharmacy manager is unable to
p.002017: performs his / her duties due to the use of temporary disability leave due to illness, pregnancy and
p.002017: birth or adoption and parental leave in accordance with the Labor Code, pharmacy
p.002017: may work for no more than two years under the direction of another
p.002017: Master Pharmacist, respectively Assistant Pharmacist, in the cases under Art. 225, which meets the requirements of Art. 224
p.002017: In these
p.002017: cases, a permit is issued by the BDA Executive Director.
p.002017: (3) The permit under para. 2 shall be issued within 30 days.
p.002017: Art. 237. Upon termination of the activity of the person, authorized to open
p.002017: pharmacy, medicinal products may be sold to persons who have been authorized
p.002017: wholesale of medicines.
p.002017: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002017: prescription, can be sold in a drugstore. Drugstores can also sell products and
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
...
p.002017: use.
p.002017: 26. "Coordinating researcher" means a researcher appointed to coordinate
p.002017: researchers from different centers participating in the multi-center test.
p.002017: 27. "Patient leaflet" is a leaflet containing information about the user that
p.002017: accompanies the medicinal product.
p.002017: 27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002017: "Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No 1394/2007.
p.002017: Of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and for
p.002017: amendment of the Directive
p.002017: 2001/83 / EC and Regulation (EC) No 726/2004.
p.002017: 28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product made from human
p.002017: blood components and by a method involving an industrial process. These include albumin, immunoglobulins,
p.002017: coagulation factors and antiproteases, solutions of
p.002017: plasma proteins, other plasma fractions or combinations thereof.
p.002017: 29. "Medicinal product intended for the treatment, prevention and diagnosis of rare
p.002017: diseases "is a product that:
p.002017: (a) is intended for the diagnosis, prophylaxis or treatment of life-threatening diseases
p.002017: diseases or progressive chronic diseases affecting no more than 5 in 10
p.002017: 000 people on the territory of the country, or
p.002017: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002017: health-damaging chronic conditions (diseases with a high incidence of incapacity for work and
p.002017: disability) and evidence was provided that the sale of the product did not provide a satisfactory one
p.002017: returns to justify the investment needed for R&D without
p.002017: incentives for
p.002017: the creator of the product, and
p.002017: (c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of
p.002017: the condition, or if there is one, the proposed medicinal product
p.002017: far more benefits than that and benefits for those affected by this condition.
p.002017: 30. A "dosage form" is an acceptable accepting structure containing the active substance (s) which
p.002017: may or may not include excipients obtained by the application of certain technological
p.002017: operations providing the desired healing effect and
p.002017: storage stability over the shelf life.
p.002017: 31. (amend. - SG 71/08, in force from 12.08.2008) "Person established in the territory of a Member State"
p.002017: is a legal entity registered under the civil or commercial law of a Member State or
p.002017: created by a legal act having its registered office and registered office in a Member State or in a State -
p.002017: Party to the Agreement on
p.002017: The European Economic Area.
p.002017: 32. "Highway formulation" is a prescription for a medicinal product made in a pharmacy under
p.002017: prescription from a healthcare professional or an approved prescription for a particular patient.
p.002017: 33. "International non-patent name" is the recommended name of
p.002017: the active substance approved and published by the WHO.
p.002017: 34. "Medical specialists" are doctors, doctors of dental medicine,
p.002017: master pharmacists, nurses, midwives, medical assistants, paramedics, and
p.002017: assistant pharmacist.
...
p.002017: authorized as a medicinal product in the European Union, or the mechanism for pairing molecules
p.002017: and radionuclides was not allowed in
p.002017: The European Union.
p.002017: 40. "Adverse event" means any adverse change in health status,
p.002017: observed when administering a medicinal product to a patient or clinical participant
p.002017: a test that is not necessarily causally related to this treatment.
p.002017: 41. (amend. - SG 102/2012, in force since 21.12.2012) "Adverse drug reaction" is any undesirable and
p.002017: unexpected response to a medicinal product. In the case of a clinical trial - any undesirable or unforeseen
p.002017: response to the investigational medicinal product independently
p.002017: of the administered dose. The types of side effects are:
p.002017: (a) "unexpected" - an adverse reaction not listed in the summary of product characteristics;
p.002017: the product or whose character, weight or output does not meet the product characteristics mentioned in the summary; in
p.002017: case of clinical trial is an adverse reaction whose nature, severity or outcome do not match
p.002017: of test information
p.002017: medicinal product specified in the investigator's brochure;
p.002017: (b) "suspected" - an adverse reaction for which the notifier or the holder
p.002017: of the Marketing Authorization implies that there is a possible causal link with
p.002017: the received medicinal product;
p.002017: (c) "serious" - any adverse effect on a health condition which has caused the death,
p.002017: imminent danger to life, hospitalization or prolongation of hospitalization, significant or
p.002017: permanent disability, disability and congenital
p.002017: anomalies;
p.002017: (d) combinations of reactions under letters "a", "b" and "c".
p.002017: 42. "Common name" means the international non-patent name of a medicinal or excipient
p.002017: (INN) recommended by WHO; if not, the name in the European Pharmacopoeia is used, if there
p.002017: missing - another pharmacopoeial name; when not
p.002017: pharmacopoeial name, the usual accepted name is used.
p.002017: 42a. (new - SG 102/2012, in force since 21.12.2012) "Main documentation of the system for
p.002017: Drug Safety Tracking "is a detailed description of the drug tracking system
p.002017: the safety used by the holder of the
p.002017: use in relation to one or more authorized medicinal products.
p.002017: 42b. (new - SG 48/2015) "Assessment of health technologies" is:
p.002017: (a) a form of research policy exploring the short-term
p.002017: and the long-term results associated with the implementation of health technologies and aims to
p.002017: provided information on alternative health strategies;
p.002017: (b) a multidisciplinary activity that systematically assesses technical characteristics,
p.002017: safety, clinical efficacy and effectiveness, cost, value effectiveness, organizational, social,
p.002017: the legal and ethical implications of the administration of medicinal products in health care and focus
p.002017: on clinical and economic value, the analysis being comparable to existing or
p.002017: best to
p.002017: currently an alternative.
p.002017: 43. "Batch" means the specified quantity of the medicine manufactured in accordance with
p.002017: a reproducible technological scheme has been established to provide the required batch
p.002017: homogeneity with respect to the required control parameters.
...
p.002017: 62. "Rare diseases" are diseases that are characterized by a frequency of
p.002017: prevalence no higher than 5 in 10,000 people.
p.002017: 63. "Reference medicinal product" is a medicinal product authorized in accordance with Art. 23 c
p.002017: compliance with the requirements of Art. 27.
p.002017: 64. "Defined daily dose reference value" for an international non-patent name with the relevant
p.002017: Anatomy Therapeutic Drug Classification Formula is the Lowest Value for a Defined Daily
p.002017: dose determined on the basis of defined daily dose values for the different medicinal products for
p.002017: the relevant international non - patent name with the relevant dosage form
p.002017: anatomic therapy
p.002017: classification of medicines.
p.002017: 65. "Therapeutic course reference value" is the lowest therapeutic value
p.002017: a course determined on the basis of the values of a therapeutic course of medicines internationally
p.002017: non-patent name with appropriate dosage form.
p.002017: 66. "Risk in use of a medicinal product" is:
p.002017: (a) the risk to the health of the patient or the risk to the health of the population associated with
p.002017: the quality, safety or efficacy of the medicinal product;
p.002017: (b) the risk of adverse effects on the environment.
p.002017: 67. "Serious adverse event" is any adverse change in health status that is
p.002017: causing fatal outcome, imminent danger to life, hospitalization or prolongation of
p.002017: hospitalization period, significant or lasting
p.002017: disability, disability and congenital anomalies.
p.002017: 68. "Batch Release Certificate" is a document issued by
p.002017: the qualified person of the manufacturer or importer for each individual lot and includes
p.002017: requirements in accordance with the specification as well as all test results for
p.002017: batch release.
p.002017: 69. "Certificate of additional protection" is a document that provides additional
p.002017: patent protection of the medicinal product for a maximum of 5 years after the expiry date of
p.002017: the basic patent.
p.002017: 69a. (new, SG No. 102/2012, effective 21.12.2012) "Risk Management System" is
p.002017: a system of pharmacovigilance measures and activities designed to
p.002017: identifying, characterizing, preventing or minimizing drug-related risks
p.002017: product, including an evaluation of the effectiveness of these
p.002017: activities and measures.
p.002017: 69b. (new - SG 102/2012, in force since 21.12.2012) "Tracking system of
p.002017: 'safety' is a system used by the marketing authorization holder and
p.002017: BDA for the accomplishment of the tasks and responsibilities of Chapter Eight intended for implementation
p.002017: monitoring the safety of authorized medicinal products and detection
p.002017: of any change in the benefit / risk ratio.
p.002017: 70. "Emergency restrictive safety measures" are temporary changes to product information with respect to
p.002017: one or more parts of the summary of product characteristics, indications, method of administration, contraindications
p.002017: and warnings that result from a new one
...
p.002017: or as cooperatives under the Cooperatives Act, bring their names in line with
p.002017: § 2 of this Act and record the change in the commercial register, the BULSTAT register and in the respective
p.002017: Regional Health Center by 31 December 2007 "
p.002017: 2. Para. 2, 3 and 4:
p.002017: "(2) Individual dental care practices not registered as
p.002017: traders under the Commerce Act, align their names in accordance with § 2 of that law and
p.002017: register the change in the BULSTAT register and in the respective regional health center in
p.002017: term under para. 1.
p.002017: (3) The entry of the change of the name for the practices and centers under para. 1 c
p.002017: the commercial register and the BULSTAT register shall be carried out as follows:
p.002017: 1. by July 1, 2007 - in accordance with the provisions of the Commercial Act, the Cooperatives Act and the Law on Public Utilities
p.002017: register BULSTAT;
p.002017: 2. from July 1, 2007 - under the procedure of the Commercial Register Act.
p.002017: (4) State fees for recording the changes under para. 1 and 2 are not due. "
p.002017: § 25. In the Law on Patents and Registration of Utility Models (promulgated, SG No. 27/2005)
p.002017: 1993; 83, 1996, issue. 11 of 1998, issue. 81 of 1999, issue. 45 and 66 of 2002; 17, 30 and 64
p.002017: from 2006) in Art. 20 item 7 shall be repealed.
p.002017: § 26. In the Law on the Professional Organization of Master Pharmacists (promulgated SG 75/75)
p.002017: 2006; amend. 105 of 2006) in Art. 5 item 9 is amended as follows:
p.002017: "9. give opinions on opening pharmacies in accordance with Article 228, Paragraph 1, Item 9 of the Law on Pharmacy
p.002017: medicinal products in human medicine. "
p.002017: § 27. In § 1, item 7 of the additional provision of the Disability Integration Act (promulgated,
p.002017: SG, issue 81 of 2004; amend. 28, 88, 94, 103 and 105 of 2005; 18, 30, 33, 37, 63, 95, 97 and 108 of 2006
p.002017: (d) the second sentence is amended as follows: "Medical devices are not
p.002017: auxiliaries, accessories and equipment ".
p.002017: § 28. In the Law on Excise Duties and Tax Warehouses (promulgated, SG No. 91/2005; amend.
p.002017: from 2005, issue. 30, 34, 63, 81, 105 and 108 of 2006) in Art. 22, para. 3, item 2 the words "the Law on Medicines
p.002017: and drugstores in human medicine "are replaced by" the Human Medicines Act
p.002017: medicine ".
p.002017: § 29. In the Law on Genetically Modified Organisms (promulgated, SG No. 27/2005; amend. SG 88/99, No. 30)
p.002017: from 2006) in Art. 2, para. 2, item 3 the words "the Law on Medicines and Pharmacies in the Human Medicine" shall be replaced
p.002017: with the Humane Medicinal Products Act
p.002017: medicine ".
p.002017: § 30. In the Consumer Protection Act (promulgated, SG No. 99/2005; amend., Nos. 30, 51, 53, 59, 105 and 108)
p.002017: 2006) in Art. 186, para. 2, item 4 the words "The Law on Medicines and Pharmacies in Human Medicine" shall be
p.002017: replaced by "Medicinal Products in Human Medicine" Act.
p.002017: § 31. In the Health Act (promulgated, SG No. 70/2004; amend., Nos. 46, 76, 85, 88, 94 and 103 of
p.002017: 2005, issue. 18, 30, 34, 59, 71, 75, 81, 95 and 102 of 2006), the following amendments are made:
p.002017: 1. In Art. 4 the words "the Law on Medicines and Pharmacies in Human Medicine" are replaced
p.002017: with the "Law on Medicinal Products in Human Medicine".
p.002017: 2. In Art. 21, para. 3 the words "The Law on Medicines and Pharmacies in Human Medicine" are
p.002017: replaced by "Medicinal Products in Human Medicine" Act.
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.002017: its negative consequences;
p.002017: 3. has given his / her written informed consent to participate after being acquainted with
p.002017: the nature, significance, consequences and potential risks of the clinical trial.
p.002017: (2) When the person is unable to write, informed consent to participate in the clinical trial shall be given
p.002017: orally in the presence of at least one independent witness who certifies in writing that the person
p.002017: has personally informed consent to participate in
p.002017: the clinical trial.
p.002017: (3) Informed consent under para. 1, item 3 and para. 2 can only give a capable person who understands
p.002017: the nature, significance, scope and potential risks of the clinical trial. Informed consent to participate in
p.002017: a clinical trial may be withdrawn at any time
p.002017: time.
p.002017: (4) Informed consent under para. 1, item 3 for a disabled adult is given by his / her legal person
p.002017: representative. The consent of the legal representative must represent the intended will of
p.002017: participant and can be withdrawn at any time without negatives
p.002017: consequences for the participant.
p.002017: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent gives
p.002017: the person appointed by the court.
p.002017: (6) The incapable adult is provided with information about the test,
p.002017: the potential risks and rewards of understanding it.
p.002017: (7) The explicit desire of an incapable adult to refuse to participate or to participate
p.002017: withdraw at any time from the clinical trial must be considered by
p.002017: the researcher and, if necessary, the principal investigator.
p.002017: Art. 97. (1) A clinical trial on a minor shall be conducted upon receipt of
p.002017: written informed consent of both parents or guardians of the person at
p.002017: compliance with Art. 96, para. 1 and 3.
p.002017: (2) The consent of the parents and guardians must represent the presumed
p.002017: the will of the minor and may be withdrawn at any time without negative consequences
p.002017: for a minor.
p.002017: (3) The express wish of the minor to refuse to participate or to withdraw under
p.002017: any time in the clinical trial should be taken into account by the investigator, and at
p.002017: need - from the principal investigator.
p.002017: (4) A clinical trial on a minor shall be conducted upon receipt of written informed consent from
p.002017: the person from both parents or the guardian in compliance with Art. 96, para. 1 and 3. When one parent is unknown,
p.002017: died or was deprived of parental rights or not granted such rights in cases of divorce,
p.002017: written informed
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.002017: (5) The Executive Director of the BDA shall determine by an order the composition of the commissions for a term
p.002017: three years, the amount of their remuneration and approve the terms and conditions of the
p.002017: their work.
p.002017: (6) By 30 January each year, the Executive Director of the BDA shall approve the lists of
p.002017: the experts outside the composition of the commissions under para. 1 after approval by the Minister of
p.002017: healthcare.
p.002017: (7) The BDA Executive Director may release a member of the BDA early
p.002017: specialized committee at his request for failure to fulfill his obligations for more than three
p.002017: months or in bad faith in the performance of its functions.
p.002017: (8) The composition of the commissions and the list of experts under para. 6 are announced on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 48. (1) The members of the specialized commissions under Art. 47, para. 1 and the experts under Art.
p.002017: 47, para. 4 sign a declaration, obliging them not to:
p.002017: 1. disclose data and circumstances that have become known to them on or on occasion
p.002017: carrying out their activity;
p.002017: 2. participate in activities related to the production or wholesale and retail trade with
p.002017: medical products.
p.002017: (2) In case the persons under para. 1 have participated in one of the preparation stages of
p.002017: the documentation necessary to authorize the use of the medicinal product cannot be provided
p.002017: participate in the meetings of the respective specialized commission under art. 47.
p.002017: (3) The persons under para. 1 shall not vote in decisions on matters on which they or
p.002017: their family members have commercial, financial or other interests.
p.002017: Art. 49. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 200 days from the date of receipt of
p.002017: valid documentation of the BDA together with the relevant commission under Art. 47, para. 1 evaluates quality, safety and
p.002017: the efficacy of the medicinal product and produces an evaluation report commenting on the results of the pharmaceutical and
p.002017: the preclinical tests, the clinical trials, the risk management system and the
p.002017: monitoring the safety of the medicinal product concerned. The evaluation report prepared shall be submitted to
p.002017: the BDA Executive Director.
p.002017: (2) (New, SG No. 102/2012, effective 21.12.2012) The report under para. 1 se
p.002017: updated in the presence of new information relevant to the assessment of quality, safety and health
p.002017: the efficacy of the medicinal product.
p.002017: (3) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012) Where the medicinal product contains genetically
p.002017: modified organisms, the BDA provides the Ministry of Environment and Water with the necessary
p.002017: dossier documentation for the medicinal product and
p.002017: requests an opinion within 60 days on the potential environmental risk.
p.002017: The sixty-day period is within the term of para. 1.
p.002017: (4) (Renumbered from Paragraph 3, SG No. 102/2012, effective 21.12.2012) In the cases of
p.002017: radiopharmaceuticals BDA provides the required documentation from the dossier of the medicinal product and requires it
p.002017: opinion within 60 days by the Nuclear Regulatory Agency with respect to
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.002017: Internet users in violation of the ordinance under Art. 234, para. 5.
p.002017: (2) The website of the BDA under para. 1 is linked to
p.002017: European Medicines Agency.
p.002017: Art. 234b. (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines shall participate in the
p.002017: information campaigns conducted by the European Commission and the European Medicines Agency
p.002017: the risk of counterfeit medicines
p.002017: products.
p.002017: Art. 235. (1) The permit for carrying out retail trade in medicinal products
p.002017: under Art. 229, para. 2 shall be terminated by termination of the activity of the persons under art. 222 and 225.
p.002017: (2) (Amended, SG No. 60/2011, effective 05.08.2011) The Executive Director of
p.002017: The BDA suspends the authorization to trade in medicinal products:
p.002017: 1. at the request of the person who has received a permit for retail trade;
p.002017: 2. when it is established that the pharmacy manager does not meet the requirements,
p.002017: referred to in Art. 224 and 225.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 14 days from termination
p.002017: of the activity under para. 1 persons under art. 222 and 225 shall notify the BDA in writing.
p.002017: Art. 236. (1) The pharmacy may not be closed for more than 30 days within one
p.002017: calendar year due to the absence of its manager.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 12/2011, effective 08.02.2011,
p.002017: ed. - SG, issue. 60 of 2011, effective 05.08.2011) When the pharmacy manager is unable to
p.002017: performs his / her duties due to the use of temporary disability leave due to illness, pregnancy and
p.002017: birth or adoption and parental leave in accordance with the Labor Code, pharmacy
p.002017: may work for no more than two years under the direction of another
p.002017: Master Pharmacist, respectively Assistant Pharmacist, in the cases under Art. 225, which meets the requirements of Art. 224
p.002017: In these
p.002017: cases, a permit is issued by the BDA Executive Director.
p.002017: (3) The permit under para. 2 shall be issued within 30 days.
p.002017: Art. 237. Upon termination of the activity of the person, authorized to open
p.002017: pharmacy, medicinal products may be sold to persons who have been authorized
p.002017: wholesale of medicines.
p.002017: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002017: prescription, can be sold in a drugstore. Drugstores can also sell products and
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
...
Searching for indicator physically:
(return to top)
p.002017: (4) (New - SG 71/08, in force from 12.08.2008) On the territory of the Republic of Bulgaria may be
p.002017: only medicinal products marketed by the Marketing Authorization Holder / Marketing Authorization Holder
p.002017: registration is established in the territory of a country
p.002017: state.
p.002017: Art. 24. (1) (amend. - SG 71/08, in force from 12.08.2008) Permission for use is not required for
p.002017: radiopharmaceuticals prepared immediately before use by authorized radionuclides
p.002017: generators, radionuclide precursors or kits in
p.002017: in accordance with the manufacturer's instructions.
p.002017: (2) The products of para. 1 shall be prepared by qualified persons in laboratories or
p.002017: institutes that have been authorized to carry out such activity under the terms of the
p.002017: safe use of nuclear energy.
p.002017: (3) The preparation, use and application of the products under para. 1 is performed
p.002017: according to the medical standard in nuclear medicine.
p.002017: Art. 25. (1) The criteria for determining a medicinal product intended for treatment,
p.002017: the prevention or diagnosis of rare diseases are covered by Regulation (EC) No 141/2000
p.002017: The European Parliament and the Council.
p.002017: (2) The conditions and procedure for granting a marketing authorization for medicinal products
p.002017: under para. 1 are laid down in Regulation (EC) No 726/2004 of the European Parliament and of the Council.
p.002017: Art. 26. (1) (amend. - SG 71/08, in force from 12.08.2008) Permission for use
p.002017: of a medicinal product, a certificate for registration of a homeopathic medicinal product under Art.
p.002017: 35 or certificate for registration of a traditional herbal medicinal product under Art. 37 on
p.002017: the territory of the Republic of Bulgaria is issued by the Executive Director of the BDA physically
p.002017: or a legal person established in the territory of a Member State.
p.002017: (2) When the person under para. 1 is not established in the territory of the Republic of Bulgaria, it
p.002017: appoints its representative.
p.002017: (3) The holder of the marketing authorization shall be responsible for the medicinal products placed on the market.
p.002017: The determination of a person under para. 2 shall not exempt the holder of the marketing authorization from
p.002017: responsibility in accordance with the effective ones in the Republic of Bulgaria
p.002017: legislation.
p.002017: Section II.
p.002017: Requirements to the marketing authorization documentation
p.002017: Art. 27. (1) (amend. - SG 71/08, in force from 12.08.2008) To issue a permit for
p.002017: use of a medicinal product by the person under Art. 26, para. 1 submits an application to the BDA following a model, accompanied by a file
p.002017: in the format "Electronic Common Technical Document", which
p.002017: contains:
p.002017: 1. name and address of management / permanent address of the applicant and the representative under art. 26,
p.002017: para. 2; where the applicant is a person other than the manufacturer or manufacturers, the address of
p.002017: production sites;
p.002017: 2. name of the medicinal product;
p.002017: 3. data on the qualitative and quantitative composition of the medicinal product, such as
p.002017: points to the international non-patent name recommended by the WHO, if any,
p.002017: or the corresponding chemical name;
p.002017: 4. therapeutic indications, contraindications and side effects;
p.002017: 5. (amend. - SG 71/08, in force from 12.08.2008) dosage, dosage form,
p.002017: route of administration and route of administration and proposed shelf life;
p.002017: 6. precautionary measures and safety precautions during storage of the product, at
...
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. adopt a decision to change, suspend or terminate the validity of the permits
p.002017: for use, issued under Regulation (EC) No 726/2004 of the European Parliament and of the
p.002017: The Council;
p.002017: 2. adopt a decision recommending the change, suspension or termination of validity of
p.002017: marketing authorizations issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Drug Enforcement Agency shall implement the recommendations recommended in the decision of the European Medicines Agency
p.002017: The European Commission under para. 2, item 2 provisional and / or final measures.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) The recommendation under Art. 194c,
p.002017: para. 1, the opinion under art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and
p.002017: Art. 194h, para. 2 shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: Chapter Nine.
p.002017: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN
p.002017: THE MEDICINAL PRODUCTS AREA (HEADING, amended, SG No. 71/2008,
p.002017: POWER FROM 12.08.2008, ISM. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
p.002017: (Title "Section I. Wholesale trade of medicinal products" - SG, issue 71 of 2008, in
p.002017: with effect from 12.08.2008)
p.002017: Art. 195. (1) Wholesale trade in medicinal products may be carried out physically and
p.002017: legal persons authorized to do so by a regulatory body of
p.002017: the Member State concerned.
p.002017: (2) When the person under para. 1 has warehouses on the territory of the Republic
p.002017: Bulgaria, it may carry out wholesale of medicinal products after receiving
p.002017: permission from the BDA Executive Director.
p.002017: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may
p.002017: only wholesale medicinal products for which a marketing authorization has been granted
p.002017: production.
p.002017: (2) An importer of medicinal products within the meaning of this Act may perform
p.002017: wholesale only of medicinal products for which import authorization has been granted.
p.002017: Art. 197. The persons under art. 195 must have:
p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
...
p.002017: for all persons who have supplied the samples, the type, quantity and time of delivery and
p.002017: make this information available to inspection bodies on request.
p.002017: Art. 211. (1) Wholesalers must have a blocking and withdrawal system
p.002017: of medicinal products which have shown non-compliance with the requirements for quality, safety and health
p.002017: efficiency.
p.002017: (2) The holder of a wholesale trade permit shall be obliged to block and withdraw
p.002017: medicinal products which have shown non - compliance with the requirements for quality, safety and health
p.002017: efficiency according to the procedure specified in the ordinance under Art. 274, para. 1.
p.002017: Art. 212. (1) The Executive Director of the BDA shall notify the European Commission, the regulatory authorities of
p.002017: other Member States and the European Medicines Agency for wholesale marketing authorizations for
p.002017: suspended or revoked permissions for
p.002017: the reasons for this.
p.002017: (2) (amend. - SG 102/2012, in force from 02.01.2013) Where the executive director of the BDA
p.002017: establish that the person under Art. 195, para. 1 does not fulfill the obligations under Art. 207, para. 1, Vol. 2 - 14, he informs
p.002017: the regulatory authority of the Member State which granted the authorization
p.002017: wholesale, and the European Commission.
p.002017: (3) Where the regulatory body under para. 2 temporarily suspend or revoke permission for
p.002017: wholesale trade of the person under art. 195, para. 1, it shall notify the BDA Executive Director and
p.002017: The European Commission.
p.002017: Art. 212a. (New, SG No. 102/2012, effective 02/01/2013) (1) (Amended, SG No. 18/2012)
p.002017: 2014) Mediation in the field of medicinal products can physically and
p.002017: legal entities registered as commercial intermediaries within the meaning of the Commercial Law of
p.002017: The Republic of Bulgaria, which are registered for carrying out this activity by the BDA.
p.002017: (2) The persons under para. 1, who wish to register as intermediaries, shall file with the BDA
p.002017: notification according to a model approved by the BDA Executive Director, containing:
p.002017: 1. name, seat and address of management;
p.002017: 2. contact details.
p.002017: (3) To the notification under para. 2 shall apply:
p.002017: 1. data on the unique identification code;
p.002017: 2. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (4) The Executive Agency for Medicines shall enter in the public register the persons,
p.002017: mediators in the field of medicinal products.
p.002017: (5) The persons under para. 1 may mediate in the field of medicines
p.002017: products after submission of the notification under para. 2 in the BDA.
p.002017: (6) The persons under para. 1 shall notify the BDA within 7 days from the occurrence of a change in any of the
p.002017: the circumstances under para. 2.
p.002017: Art. 212b. (New - SG 102/02, in force from 02.01.2013) (1) The persons under art. 212a, para.
p.002017: 1 shall:
p.002017: 1. carry out their activity only with authorized medicinal products;
p.002017: 2. Have an emergency plan that contains effective measures for withdrawal of a medicinal product
p.002017: from the market at the disposal of the BDA or at the initiative of the manufacturer or the holder of the marketing authorization
p.002017: use of the respective medicinal product;
p.002017: 3. to store data including the following information for each transaction made
p.002017: through mediation medicinal products:
p.002017: (a) the date of the transaction;
...
Health / patients in emergency situations
Searching for indicator emergencies:
(return to top)
p.002017: (3) When, within the term of para. 2 The BDA found inconsistencies in the submitted documentation with
p.002017: the requirements of the law and the ordinance under Art. 42, it notifies the authorization holder of
p.002017: use.
p.002017: (4) Within 30 days from receipt of the notification under para. 3 the holder of
p.002017: the marketing authorization may amend or supplement the documentation.
p.002017: (5) When, within the term of para. 4 the Marketing Authorization Holder did not submit
p.002017: changed or supplemented documentation, BDA terminates the procedure and notifies it
p.002017: the holder of the marketing authorization.
p.002017: (6) Within 30 days from receipt of the changed documentation under para. 4 BDA
p.002017: notify the holder of the marketing authorization:
p.002017: 1. whether he approves the change or not; where the change is not approved, they shall be indicated
p.002017: the reasons for this, and
p.002017: 2. whether the change leads to a change in the data in the issued marketing authorization;
p.002017: when a change in the issued marketing authorization is required, Art. 64a.
p.002017: (7) The Marketing Authorization Holder applies the type IB variation approved after
p.002017: receiving notification under para. 2, item 1, respectively under para. 6, item 1 for approval of the change.
p.002017: Art. 64. (amend. - SG 12/11, in force from 08.02.2011) (1) Where the application for
p.002017: Type II change meets the requirements of Art. 61, the BDA shall notify the authorization holder
p.002017: for use, that the application is valid, indicating the date from which the period under par. 2 starts to
p.002017: flowing.
p.002017: (2) Within 60 days of receipt of a valid application, the BDA shall prepare an evaluation report
p.002017: about change.
p.002017: (3) The term under para. 2 can be:
p.002017: 1. reduced in emergencies related to the safe use of
p.002017: the medicinal product, or
p.002017: 2. extended up to 90 days in the event of a change which is modified or added therapeutically
p.002017: testimony.
p.002017: (4) When the BDA finds inconsistencies in the submitted documentation with the requirements of
p.002017: the law and the ordinance under art. 42, it notifies the marketing authorization holder and determines
p.002017: deadline for submission of additional information and documentation.
p.002017: (5) In the cases of para. 4 the term under para. 2 stops running until the additional is presented
p.002017: information and documentation.
p.002017: (6) Within 15 days of the preparation of the evaluation report, the Executive Director of
p.002017: BDA:
p.002017: 1. approve the change or give a reasoned refusal and notify the holder of the change
p.002017: the marketing authorization;
p.002017: 2. notify the holder of the marketing authorization whether the approved change leads to
p.002017: change of data in the issued marketing authorization; when a change is required
p.002017: marketing authorization, Art. 64a.
p.002017: (7) The Marketing Authorization Holder may apply the approved change
p.002017: type II only after the issuance of a permit for change under Art. 64a.
p.002017: Art. 64a. (New, SG No. 12/2011, effective 08.02.2011) The Executive Director of
p.002017: The BDA shall issue an authorization for change of the marketing authorization within the following period:
p.002017: 1. thirty days from the issuance of the notification under Art. 62, para. 4, Vol. 2, Art. 63, para. 2, Vol. 2,
p.002017: respectively Art. 63, para. 6, item 2 or art. 64, para. 6, item 2, when the corresponding change leads to an extension
p.002017: 6 months within the period referred to in Article 13 (1) and (2) of Council Regulation (EEC) No 1768/92
...
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
p.002017: quality deviations, as well as a medicinal product that has been placed on the market in breach of
p.002017: intellectual property rights.
p.002017: 82. "Homeopathic medicinal product" is a medicinal product made from substances,
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.002017: 18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain
p.002017: national internet portal for medicinal products;
p.002017: 19. performs other activities specified by law.
p.002017: (6) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: medicines coordinates its activities with regional health inspections (RICs) in the area of
p.002017: control of medicinal products.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under
p.002017: this law related to preventing the entry and distribution of counterfeit
p.002017: medicinal products, is carried out in cooperation between the BDA and the customs authorities.
p.002017: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health
p.002017: inspections issue certificates for registration of drugstores.
p.002017: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002017: retail of medicinal products, which includes three representatives of the Bulgarian
p.002017: pharmaceutical union, one representative of the faculties of pharmacy of the medical colleges and
p.002017: four BDA representatives. The composition of the Board is determined by an order of the Executive Director of the BDA,
p.002017: agreed with the Minister of
p.002017: healthcare.
p.002017: (2) The council under para. 1 is an advisory unit which:
p.002017: 1. prepares opinions on the applications and documents submitted to the BDA under Art. 228, para. 1 and 5,
p.002017: which he presents to the Executive Director of the BDA;
p.002017: 2. make motivated proposals to the Minister of Health through
p.002017: the BDA's Executive Director for improving public access to medicines
p.002017: products.
p.002017: (3) The organization and activity of the expert council under para. 1 shall be governed by regulations,
p.002017: issued by the BDA Executive Director on a proposal from the Board.
p.002017: (4) The members of the expert council under para. 1 shall not receive remuneration for participation in
p.002017: council meetings.
p.002017: (5) The expert council under para. 1 shall be reported annually to the Minister of
p.002017: healthcare.
p.002017: Art. 17c. (New, SG No. 18/2014) They may not be members of the Expert Council of
p.002017: Art. 17b, para. 1 people who are:
p.002017: 1. owners, members of management and control bodies of commercial companies or
p.002017: sole proprietors manufacturing, importing, wholesale or retail trade with
p.002017: medical products;
p.002017: 2. partners or shareholders holding more than 5 percent of the capital in commercial
p.002017: companies active in the manufacture, import, wholesale or retail of medicinal products
p.002017: products or work under contract with those companies.
p.002017: Section II.
p.002017: Registers
p.002017: Art. 18. (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 19. (1) The Executive Agency for Medicines shall keep and keep registers of:
p.002017: 1. (amended, SG No. 102/2012, effective 21.12.2012) Manufacturers and importers
p.002017: of medicinal products on the territory of the Republic of Bulgaria and the qualified persons under
p.002017: Art. 148, item 2 and under Art. 161, para. 2, Vol. 1;
p.002017: 2. (amend. - SG 102/02, in force from 21.12.2012) the manufacturers, importers and
p.002017: wholesalers of active substances;
p.002017: 3. the authorized and registered medicinal products on the territory of
p.002017: Republic of Bulgaria;
p.002017: 4. wholesalers of medicinal products on the territory of the Republic of Bulgaria;
...
p.002017: notification of reasons for disapproval of the clinical trial.
p.002017: (6) If the assignor does not submit an application under para. 2 within the time limit specified, the procedure shall be
p.002017: terminated and no clinical trial was conducted.
p.002017: Art. 119. (1) Within 60 days from the date of submission of the application for clinical trial with
p.002017: the medicinal products under Art. 109, item 2, the Executive Director of the BDA shall: 1. issue a permit for carrying out the BDA
p.002017: the clinical trial, or
p.002017: 2. Reasonably refuses to issue a permit.
p.002017: (2) The refusal under para. 1, item 2 shall be subject to appeal in the order of
p.002017: Code of Administrative Procedure.
p.002017: Art. 120. (1) In the cases of medicinal products under Art. 109, item 2, letters "a" - "c" the term under
p.002017: Art. 119, para. 1 for the authorization of the BDA to conduct a clinical trial may
p.002017: extended by 30 days.
p.002017: (2) In case the BDA consults the expert commission under Art. 112, para. 3 which
p.002017: assess the safety of the medicinal products under para. 1, the extension under para. 1 term can be
p.002017: extended by another 90 days.
p.002017: Art. 121. The Executive Director of the BDA refused to issue an authorization for the holding of a BDA
p.002017: clinical trial of gene therapy medicinal products where there is a risk of modification
p.002017: of the genome of the reproductive cells of the participant in
p.002017: the test.
p.002017: Art. 122. (1) In multicenter testing in the Republic of Bulgaria and in a third country, the BDA
p.002017: requires the contracting authority to provide a declaration that it will grant access to the representatives of
p.002017: BDA for inspection in order to establish compliance with the requirements and principles of the Good
p.002017: clinical practice and Good Manufacturing Practice.
p.002017: (2) When the contracting authority fails to submit the declaration under para. 1, the BDA does not consider
p.002017: the application submitted.
p.002017: Art. 123. The sponsor declares that it has been submitted to the BDA and to the Ethics Committee
p.002017: the documentation contains the same information.
p.002017: Art. 124. (1) The procedures in the Ethics Committee and in the BDA may be conducted
p.002017: simultaneously or sequentially at the option of the contracting authority.
p.002017: (2) The term under Art. 118, para. 1 for the examination of the documentation does not stop running at
p.002017: the lack of a decision by the Ethics Committee.
p.002017: Art. 125. The clinical trial shall be conducted in accordance with the protocol it has received
p.002017: positive opinion from the relevant ethics committee under art. 103, and under the conditions set out in
p.002017: the documentation submitted.
p.002017: Section V.
p.002017: Changes
p.002017: Art. 126. (1) The contracting authority may at any time make changes other than
p.002017: the substantial changes under Art. 127, para. 2, in the clinical trial protocol.
...
p.002017: the ordinance under Art. 152.
p.002017: Art. 160. (1) The holder of a manufacturing authorization shall:
p.002017: 1. ensure that production operations are carried out in accordance with the requirements
p.002017: of Good Manufacturing Practice and in accordance with the information approved by the BDA under Art.
p.002017: 27, para. 1, items 7 and 8, and in the case of medicinal products for clinical trial, in accordance with
p.002017: the information under Art. 110, para. 1, item 4, provided to the Agency by the contracting authority;
p.002017: 2. (amend. - SG 102/2012, in force from 02.01.2013) use only active substances,
p.002017: which are manufactured in accordance with the requirements of Good Manufacturing Practice for
p.002017: active substances;
p.002017: 2a. (new - SG 102/2012, in force from 02.01.2013) make sure that the excipients,
p.002017: used in medicinal products are manufactured in accordance with good manufacturing practice
p.002017: for excipients determined on the basis of a formal
p.002017: risk assessment in accordance with applicable guidelines adopted by the European Commission;
p.002017: 3. provide permanently qualified production and control personnel in accordance with
p.002017: the requirements of the ordinance under Art. 152;
p.002017: 4. (amend. - SG 12/11, in force from 08.02.2011) has only medicinal products
p.002017: products authorized to be used, subject to the requirements of this Act;
p.002017: 5. (repealed, SG No. 12/2011, effective 08.02.2011)
p.002017: 6. notify immediately the control bodies in case of change of the qualified person
p.002017: under Art. 148, Vol. 2;
p.002017: 7. ensure at all times access of the control bodies to the premises and
p.002017: documentation;
p.002017: 8. provide to the qualified person under Art. 148, item 2 the necessary conditions for
p.002017: performance of his duties;
p.002017: 9. (new - SG 102/2012, in force from 02.01.2013) inform immediately the BDA and the holder of the permit for
p.002017: use if he / she receives information that the medicinal products fall within the scope of his authorization
p.002017: production, are falsified or there are doubts about falsification, regardless of whether these medicinal products
p.002017: products have been distributed within the legal supply chain or illegally,
p.002017: including through illicit sale through the information society services;
p.002017: 10. (new - SG 102/2012, in force from 02.01.2013) check whether
p.002017: the manufacturers, importers or traders from which it receives the active substances are
p.002017: registered by the competent authority of the Member State in which they are established;
p.002017: 11. (New, SG No. 102/2012, effective 02.01.2013) verify the authenticity and
p.002017: the quality of the active substances and of the excipients.
p.002017: (2) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing permit shall exercise
p.002017: audits at the sites for the production and marketing of active substances for compliance with Good Manufacturing
p.002017: practice and Good distribution practice. The holder of the manufacturing authorization may
p.002017: contract with a third party yes
p.002017: performed the audit on his behalf and on his behalf.
p.002017: (3) (New, SG No. 102/2012, effective 02.01.2013) The holder of the permit
p.002017: document the undertakings under para. 1, items 2 and 2a measures.
...
p.002017: (2) The Executive Agency for Medicines shall keep a register of the certificates issued
p.002017: under Art. 203 for wholesale of medicinal products, which contains:
p.002017: 1. number and date of the certificate;
p.002017: 2. the number of the marketing authorization for the medicinal products and the body which has it
p.002017: has issued;
p.002017: 3. name, seat and address of management of the person receiving the certificate;
p.002017: 4. details of the person under art. 199, para. 2, Vol. 2;
p.002017: 5. date of deletion of the certificate from the register and the reason for it;
p.002017: 6. notes on the entered circumstances.
p.002017: (3) Data from the registers shall be published on the BDA website on the Internet.
p.002017: (4) (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines
p.002017: enter into the database under Art. 147 information on marketing authorizations issued
p.002017: of medicines.
p.002017: (5) (New, SG No. 102/2012, effective 02.01.2013) Upon request by the European Commission or by a State
p.002017: Member of the BDA shall provide information on the issued authorization for
p.002017: wholesale of medicines.
p.002017: Art. 206. (1) In case of change of the circumstances, related to the issued permit for wholesale trade,
p.002017: the holder submits an application to the BDA pursuant to Art. 199, to which
p.002017: apply the change-related documentation.
p.002017: (2) The permit for change shall be issued under the conditions and by the order of art. 200 - 202. When changing
p.002017: the storage premises shall be subject to the term of art. 202, and in other cases
p.002017: the deadline is 14 days.
p.002017: Art. 207. (1) The holder of a wholesale trade permit who carries out the activity
p.002017: on the territory of the Republic of Bulgaria, is obliged to:
p.002017: 1. shall provide access at all times to the control bodies of the premises for
p.002017: storage of medicinal products;
p.002017: 2. trade only in medicinal products authorized under this Law;
p.002017: 3. trade in medicinal products whose packaging and leaflets are in accordance with the authorization granted
p.002017: use, under the terms and procedure of this Act and their term of validity
p.002017: fitness has not expired;
p.002017: 4. supplies medicinal products only to manufacturers, importers or wholesalers of medicinal products,
p.002017: have been authorized to carry out this activity under the terms of
p.002017: this law;
p.002017: 4a. (new - SG 102/2012, in force from 02.01.2013) check whether the received medicinal products
p.002017: the products of the persons under item 4 are not falsified by checking the indicators for
p.002017: safety on the outer packaging;
p.002017: 5. supply medicinal products to other marketing authorization holders of
p.002017: wholesale, pharmacies and drugstores opened under this law;
p.002017: 5a. (new - SG 71/08, in force from 12.08.2008) supplies medicinal products
p.002017: medical establishments for own needs;
p.002017: 6. supply doctors and dentists with medicinal products when there is no place in the settlement
p.002017: pharmacy, under the conditions and in the order laid down in an ordinance of the Minister of Health
p.002017: healthcare;
p.002017: 6a. (new - SG 102/2012, in force from 02.01.2013) shall enter in the documents for
p.002017: delivery of batch number of delivered medicinal products;
p.002017: 6b. (new - SG 102/2012, in force from 02.01.2013) there is an emergency action plan
p.002017: situations containing effective measures to withdraw a medicinal product from the market by order of
p.002017: BDA or at the initiative of the manufacturer or the holder of
...
p.002017: Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good Distributor
p.002017: practices, where applicable, issued by the BDA to the manufacturer, importer or wholesaler
p.002017: Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice in
p.002017: up to 90 days from
p.002017: carrying out the inspection.
p.002017: (2) When, as a result of an inspection under Art. 269, para. 3 found that the manufacturer,
p.002017: the importer or wholesaler of the medicinal products or the active substances does not comply
p.002017: the requirements of the law and / or the principles and guidelines of Good Manufacturing Practice and / or of
p.002017: Good distribution practices, the BDA issues an opinion on
p.002017: discrepancy.
p.002017: (3) The Executive Agency for Medicines shall enter into the database under Art. 147 issued
p.002017: certificates under para. 1 and information under para. 2.
p.002017: Art. 269c. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002017: Art. 270, para. 1, item 5 it is established that the holder of the marketing authorization does not comply with the requirements of
p.002017: Chapter Eight, the BDA prescribes the removal of
p.002017: inconsistencies.
p.002017: (2) In the cases of para. 1 The BDA shall notify the Member States, the European Agency for the Protection of Energy
p.002017: medicines and the European Commission.
p.002017: right:
p.002017: Art. 270. (1) Within the limits of their competence, the officials under Art. 267, para. 3 have
p.002017: 1. (amend. - SG 102/2012, in force from 02.01.2013) access to all documents,
p.002017: related to the subject matter of the inspection, as well as to documents related directly or indirectly to a violation of
p.002017: this law or the legislation of the Member States implementing it
p.002017: the requirements of Directive 2001/83 / EC, regardless of the format of the document;
p.002017: 2. order each person to provide information about the violations under item 1, which are his
p.002017: famous;
p.002017: 2a. (new - SG 102/2012, in force from 02.01.2013) to inspect
p.002017: the manufacturing and trading sites of the manufacturers of medicinal products, active or auxiliary
p.002017: substances, as well as the laboratories used by the authorization holders
p.002017: production or import;
p.002017: 3. to inspect at any time the sites to be inspected and to require that
p.002017: verify and make copies of all documents relating to the overall business of
p.002017: the controlled site;
p.002017: 4. take samples of medicinal products, active substances and excipients for
p.002017: laboratory testing;
p.002017: 5. (amend. - SG 102/02, in force from 21.12.2012) to inspect the premises, archives, documents and
p.002017: the main documentation of the Marketing Authorization Holder of the Marketing Authorization Holder
p.002017: use or persons to whom he has assigned
p.002017: carrying out the activities of Chapter Eight;
p.002017: 6. (new - SG 102/2012, in force since 21.12.2012) to carry out a check on
p.002017: observance of the approved prices, the marginal prices or the registered prices at the sale of
p.002017: medical products;
p.002017: 7. (Renumbered from Item 6, SG No. 102/2012, effective 21.12.2012) to draw up acts for
p.002017: establishment of administrative violations.
p.002017: (2) (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002017: (3) (amend. - SG 98/10, in force from 01.01.2011) The Executive Director of
...
p.002000: 1. The Minister of Health shall amend and supplement the ordinances under Art. 82, para. 3, Art. 219,
p.002000: para. 2 and Art. 243 in accordance with this law.
p.002000: 2. The Council of Ministers shall adopt the ordinance under Art. 258, para. 5 and amend the tariff under Art. 21,
p.002000: para. 2 and the Regulations of the Ministry of Health in accordance with this
p.002000: law.
p.002000: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002000: § 84. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: with the exception of § 65, which comes into force on 30 September 2011.
p.002000: Transitional and Final Provisions
p.002000: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002000: DRUGS AND PRECURSORS
p.002000: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002000: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002000: Transitional and Final Provisions
p.002000: TO THE LAW AMENDING AND SUPPLEMENTING THE STATE LAW
p.002000: EMPLOYEE
p.002000: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002000: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in
p.002000: "State Gazette":
p.002000: 1. The Council of Ministers shall bring the Classifier of posts in administration to
p.002000: compliance with this law;
p.002000: 2. the competent authorities shall bring the planning acts of the respective
p.002000: administration in accordance with this law.
p.002000: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002000: the independent financial audit, the Electronic Communications Act, the Financial Supervision Commission Act, the Access Act and
p.002000: disclosure of documents and declaring of belonging of Bulgarian citizens to the State Security and
p.002000: Intelligence Services of the Bulgarian People's Army, Law on Forfeiture in favor of the State of Property Acquired
p.002000: of criminal activity, the Conflict of Interest Prevention and Identification Act, the Code of Conduct
p.002000: social security, the Health Insurance Act, the Farmers Support Act, and
p.002000: The Roads Act is governed by the terms and procedures of § 36 of the transitional and final provisions of the Act
p.002000: amending and supplementing the
p.002000: the civil servant (State Gazette, issue 24 of 2006).
p.002000: (2) The act of appointment of the civil servant shall:
p.002000: 1. assigns the definitions in the Classifier of posts in the administration
p.002000: minimum rank for the position held, unless the employee holds a higher rank;
p.002000: 2. determines the individual basic monthly salary.
p.002000: (3) The additional necessary funds for social security contributions of the persons under para. 2 se
p.002000: provide, within the cost of wages, salaries and social security contributions,
p.002000: the budgets of the authorizing officers concerned.
p.002000: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account
p.002000: of the State Fund for Agriculture, resulting from this law.
p.002000: (5) The governing bodies of the National Social Security Institute and the National Social Security Institute
p.002000: Health Insurance Fund to make the necessary changes to the respective budgets,
p.002000: arising from this law.
p.002000: (6) Unused employment leave shall be maintained and shall not be maintained
p.002000: offset by cash benefits.
...
Social / Age
Searching for indicator age:
(return to top)
p.002017: one or more parts of the summary of product characteristics, indications, method of administration, contraindications
p.002017: and warnings that result from a new one
p.002017: information related to the safe use of the medicinal product.
p.002017: 71. "Spontaneous message" is a voluntarily sent message about suspected unwanted
p.002017: reaction when using the medicinal product to the marketing authorization holder, up to
p.002017: authorities for the supervision of medicinal products or other organizations not originating in
p.002017: a survey or other organized information gathering system.
p.002017: 72. "Shelf life of a medicinal product" is the time interval at which, if stored at
p.002017: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002017: based on stability studies of several batches of
p.002017: the finished form.
p.002017: 73. (amend. - SG 71/08, in force from 12.08.2008) "Relevant medicinal product of
p.002017: herbal medicinal product "is a product that contains the same active substances, regardless of composition
p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
...
Social / Child
Searching for indicator children:
(return to top)
p.002017: this combination. In this case, the applicant does not provide documentation on the safety and efficacy of each
p.002017: separately
p.002017: active substance.
p.002017: Art. 32. The holder of an authorization to use a medicinal product may authorize the use of the pharmaceutical,
p.002017: the preclinical and clinical documentation contained in the dossier of the medicinal product when evaluating
p.002017: subsequent drug applications
p.002017: products of the same qualitative and quantitative composition as regards the active substances and with
p.002017: same dosage form.
p.002017: Art. 33. Conducting the necessary studies and tests to prepare authorization documentation
p.002017: for use and subsequent practical requirements for the authorization of medicinal products under
p.002017: Art. 28 and 29 is not a patent infringement
p.002017: or the supplementary protection certificate for a medicinal product.
p.002017: Art. 34. (1) The summary of product characteristics shall contain the following information:
p.002017: 1. name of the medicinal product, quantity of active substance for dosage
p.002017: unit, dosage form;
p.002017: 2. quantitative and qualitative composition in respect of the active substances and those of
p.002017: excipients for which information is essential for the proper application of
p.002017: product; the common name or chemical description is used;
p.002017: 3. dosage form;
p.002017: 4. clinical data:
p.002017: (a) therapeutic indications;
p.002017: (b) dosage and route of administration for adults and children;
p.002017: c) contraindications;
p.002017: (d) special warnings and precautions for use; for immunological
p.002017: medicinal products - precautions for persons handling and administering them
p.002017: patients, as well as the precautions to be taken by the patient;
p.002017: (e) interactions with other medicinal products or other forms of interaction;
p.002017: (f) use in pregnancy or lactation;
p.002017: (g) effects on the ability to drive and use machines;
p.002017: h) side effects;
p.002017: i) overdose (symptoms, antidotes, emergency measures);
p.002017: 5. pharmacological data:
p.002017: a) pharmacodynamic properties;
p.002017: b) pharmacokinetic properties;
p.002017: (c) preclinical safety data;
p.002017: 6. pharmaceutical data:
p.002017: (a) a list of excipients;
p.002017: (b) major incompatibilities;
p.002017: c) shelf life; shelf life after reconstitution of the medicinal product (at
p.002017: need) or after opening the immediate packaging for the first time;
p.002017: (d) special storage instructions;
p.002017: (e) the nature and composition of the packages;
p.002017: (f) specific instructions for disposal of the remainder of the medicinal product or of
p.002017: waste materials therefrom;
p.002017: 7. the holder of the marketing authorization;
p.002017: 8. registration number;
p.002017: 9. date of first authorization or renewal of the authorization
p.002017: use;
p.002017: 10. date on which the content of the summary of the Summary of Product Characteristics was made
p.002017: product;
p.002017: 11. for radiopharmaceuticals - comprehensive information on internal radiation
p.002017: dosimetry;
p.002017: 12. for radiopharmaceuticals - detailed instructions for extemporaneous preparation and quality control and, where applicable
...
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
p.002017: quality deviations, as well as a medicinal product that has been placed on the market in breach of
p.002017: intellectual property rights.
p.002017: 82. "Homeopathic medicinal product" is a medicinal product made from substances,
p.002017: called a homeopathic source, according to European production procedures
p.002017: pharmacopoeia, and in the absence thereof, according to the national pharmacopoeia of a Member State.
p.002017: 83. "Price calculated on the basis of a benchmark" is the price formed for each
p.002017: medicinal product included in the Positive Medicinal List, calculated on the basis of that established
p.002017: reference value for a defined daily dose or therapeutic course.
p.002017: 84. "Center" is a structure of the medical establishment in which it is conducted clinically
p.002017: testing.
p.002017: 85. "Misuse of medicinal products" is permanent or occasional intentional misuse
p.002017: excessive use of medicinal products accompanied by harmful physical or
p.002017: psychological effects.
p.002017: 86. (new - SG 41/09, in force from 02.06.2009) "Infants" shall be children under 12
p.002017: months.
p.002017: 87. (new - SG 41/09, in force from 02.06.2009) "Foods for infants" are foods,
p.002017: intended for specific nutritional use by infants during their first months alone
p.002017: are sufficient to satisfy the nutritional needs of these infants up to
p.002017: the moment of introduction of suitable supplementary food.
p.002017: 88. (new - SG 41/09, in force from 02.06.2009) "Transitional foods" are foods,
p.002017: intended for the specific nutritional use of infants when administered appropriate
p.002017: supplemental food and which constitute the main liquid food of progressively increasing
p.002017: are the variety of foods in these infants.
p.002017: 89. (new - SG 12/11, in force from 08.02.2011) "Type IA change" is a change with
p.002017: minimal or no impact on quality, safety or efficacy
p.002017: of the respective medicinal product.
p.002017: 90. (new - SG 12/11, in force from 08.02.2011) "Type IB change" is a change,
p.002017: which is neither a Type IA nor a Type II change nor an extension of the authorization of
p.002017: use.
p.002017: 91. (new - SG 12/11, in force from 08.02.2011) "Type II change" is a change that does not
p.002017: is an extension of the marketing authorization and which can have a significant impact
p.002017: on the quality, safety or efficacy of the person concerned
p.002017: medicine.
p.002017: 92. (new - SG 102/2012, in force from 21.12.2012) "Delegated act" is an act under
p.002017: the meaning of Art. 290 of the Treaty on the Functioning of the European Union.
p.002017: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
p.002017: § 3. The Council of Ministers shall determine the terms and conditions for the acquisition, storage and storage
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
...
Searching for indicator restricted:
(return to top)
p.002017: a product authorized for use under this Act is not intended for direct delivery to the patient or
p.002017: not available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data specified in
p.002017: the ordinance under para. 1, not applied
p.002017: on the packaging or the package leaflet.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2
p.002017: The information on the packaging and the package leaflet may not be provided in English
p.002017: language.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) Delivery terms and procedure
p.002017: of the medicinal products under para. 2 shall be determined by the ordinance under art. 198.
p.002017: Chapter seven.
p.002017: CLASSIFICATION OF MEDICINAL PRODUCTS
p.002017: Art. 171. (1) Depending on the manner of dispensing the medicinal products shall be
p.002017: classified as:
p.002017: 1. prescription medicinal products;
p.002017: 2. medicinal products dispensed without a prescription.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008)
p.002017: the product is identified by the BDA in the Marketing Authorization / Registration Certificate or
p.002017: the authorization for parallel importation of the medicinal product into the territory of
p.002017: Republic of Bulgaria.
p.002017: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in
p.002017: the application for the marketing authorization / registration certificate for modification of
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
p.002017: 2. are often and very widely applied incorrectly and as a result can
p.002017: pose a danger to human health;
p.002017: 3. contain substances whose activity and / or undesirable effects require it
p.002017: subsequent follow-up study;
p.002017: 4. usually prescribed by a doctor for parenteral administration.
p.002017: Art. 174. Medicinal products shall be subject to special medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. contain narcotic substances within the meaning of the Drug Control Act
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
p.002017: the medicinal product is classified as a prescription only product.
p.002017: Art. 177. Medicinal products that do not meet the requirements of Art. 173, 174 and
p.002017: 175 and the criteria set out in the ordinance under Art. 178, are granted without medical prescription.
p.002017: Art. 178. The criteria for classification of medicinal products and the requirements for
p.002017: the documentation for making a change in the classification shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish it on the page
...
Social / Infant
Searching for indicator infant:
(return to top)
p.002017: product in the Republic of Bulgaria are not sufficient to meet the health needs of the population;
p.002017: 2. there may be a temporary shortage of the necessary for export as a result of the export
p.002017: meeting the health needs of the population with the quantities of the medicinal product concerned;
p.002017: 3. the lack of sufficient quantities of the respective medicinal product to satisfy the health requirements
p.002017: the needs of the population can seriously endanger the life and health of the population.
p.002017: (6) The refusal under para. 5 shall be subject to appeal by the order of the Administrative Procedure Code.
p.002017: (7) Data on export of medicinal products from the territory of the Republic of Bulgaria are provided
p.002017: posted on the BDA's website.
p.002017: Art. 217g. (New, SG No. 18/2014) Export of medicinal products shall be effected on time
p.002017: within three months from the expiry of the term under Art. 217c, para. 4.
p.002017: Chapter Ten.
p.002017: RETAIL TRADE OF MEDICINAL PRODUCTS
p.002017: Art. 218. Retail trade in medicinal products is carried out only in pharmacies and
p.002017: drugstores under the procedure of this law, except for the cases under art. 232, para. 2.
p.002017: Art. 219. (1) (amend. - SG 71/08, in force from 12.08.2008, add. - SG, iss. 23 in 2009, in force from
p.002017: March 30, 2009, Suppl. - SG, issue. 41 of 2009, in force since 02.06.2009, as amended. - SG, issue. 60 of 2011, in force since
p.002017: 08/05/2011) The pharmacy is a health establishment, where the following activities are performed: storage, preparation,
p.002017: packing, controlling, consulting, medical and non-prescribing
p.002017: for use in the Republic of Bulgaria medicinal products, medical devices, diet foods for
p.002017: special medical purposes and infant formulas and follow-on formulas and nutritional supplements, cosmetic and
p.002017: hygiene products.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The device, the order and
p.002017: the organization of the work of pharmacies, the nomenclature of medicinal products, are determined
p.002017: in an ordinance of the Minister of Health.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008, repealed - SG, iss. 23 in 2009, in force
p.002017: from 30.03.2009)
p.002017: Art. 220. (1) The activities under art. 219, para. 1 are performed by the Master of Pharmacy.
p.002017: (2) (suppl. - SG 71/08, in force from 12.08.2008) The master pharmacist shall be obliged
p.002017: to fulfill a prescription issued, including for dosage forms prepared under
p.002017: highway and pharmacopoeial formulation, according to the procedure specified in the ordinance under Art. 221, para. 1.
p.002017: (3) (amend. - SG 102/2012, in force from 02.01.2013) The assistant-pharmacist may perform all
p.002017: activities under art. 219, para. 1 under the control of a pharmacist, with the exception of: granting
p.002017: prescription drug, control and administration
p.002017: advice on medicinal products.
p.002017: Art. 221. (1) (Former text of Art. 221 - SG 71/08, in force from 12.08.2008)
p.002017: Health determines in an ordinance the medical professionals who can issue prescriptions, the order for prescribing
p.002017: medicinal products, the time limit for implementation, and the cases and the order in which the master pharmacist may
p.002017: to refuse to perform medically
p.002017: prescription.
p.002017: (2) (New, SG No. 71/2008, effective 12.08.2008, amended, SG No. 9/2011)
p.002017: Bulgarian citizens and foreigners who are allowed to reside in the country when traveling outside the Republic
p.002017: Bulgaria may carry or export medicinal products,
...
p.002017: (3) The person under para. 1, authorized to trade in medicinal products, no
p.002017: can be the owner or participate in trading companies with the subject of production, import
p.002017: or wholesale of medicinal products,
p.002017: including in companies of related parties within the meaning of the Commercial Law.
p.002017: cases;
p.002017: Art. 224. The pharmacy manager must:
p.002017: 1. is a master pharmacist, respectively an assistant pharmacist, in accordance with the law
p.002017: 2. is not deprived of the right to practice the profession;
p.002017: 3. has not been convicted of any offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 4. has at least one year of experience as a master pharmacist.
p.002017: Art. 225. (amend. - SG 71/08, in force from 26.07.2008) (1) In a settlement on whose territory there is no
p.002017: opened a pharmacy, the right to carry out retail trade in medicinal products has a person under Art. 222, para. 1 which
p.002017: has concluded an employment contract or contract for managing a pharmacy with an assistant pharmacist or a master pharmacist with
p.002017: less than one year's work
p.002017: internship.
p.002017: (2) The assistant pharmacist or the master pharmacist under para. 1 is the head of
p.002017: pharmacy and necessarily work in it.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Assistant Pharmacist - Head of
p.002017: the pharmacy under para. 1, may perform the following activities: preservation and release without prescription of
p.002017: medicinal products, medical devices, dietary foods authorized for use in the Republic of Bulgaria
p.002017: for special medical purposes and infant formulas and follow-on formulas, and nutritional supplements, cosmetic and
p.002017: sanitary and hygienic
p.002017: funds.
p.002017: Art. 226. (1) On the territory of medical establishments for outpatient care may be
p.002017: open pharmacies to sell medicinal products to citizens.
p.002017: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, curative
p.002017: establishments for hospital care and medical establishments under art. 10 of the Law on medical establishments does not
p.002017: pharmacies can be opened to sell medicinal products to citizens.
p.002017: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009)
p.002017: The requirements for the location and the premises of the pharmacy are laid down in the ordinance of
p.002017: Art. 219, para. 2.
p.002017: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in
p.002017: (requirements from 05.08.2011) Requirements to the device and premises of pharmacies under Art. 228, para.
p.002017: 5 shall be determined in the ordinance under para. 1.
p.002017: Art. 228. (amend. - SG 71/08, in force from 26.07.2008) (1) (amend. - SG 60/11, in force from 26.07.2008)
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002017: director of the BDA on the basis of a model application to
p.002017: applicable:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a country Party
...
p.002017: retail with medicinal products at a pharmacy or make a motivated refusal to grant an authorization.
p.002017: The permit or refusal shall be
p.002017: served on the applicant.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation under Art.
p.002017: 228, para. 6 The BDA shall check the submitted documents and notify the applicant in writing of the established ones
p.002017: inconsistencies or incompleteness. In these cases
p.002017: the term under para. 2 shall cease to run from the day of notification until the deficiencies have been rectified.
p.002017: (4) (New - SG 71/08, in force from 12.08.2008) In case within 60 days from the date of notification
p.002017: under para. 3, the applicant has not remedied any inconsistencies or incompleteness found in the proceedings for the issuance of
p.002017: retail authorization for medicinal products
p.002017: products or for a change to an authorization is terminated.
p.002017: (5) (Renumbered from Paragraph (4), SG No. 71/2008, effective 12.08.2008, amended, SG No. 60/2008)
p.002017: 2011, effective 05.08.2011) The refusal of the BDA Executive Director to issue a
p.002017: permission shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002017: Art. 229a. (New, SG No. 23/2009, effective 30.03.2009) (1) (amend. - SG 41/09, in force from 30.03.2009)
p.002017: 02.06.2009, amend. - SG, issue. 98 of 2010, effective January 1, 2011, as amended. - SG, issue. 60 of 2011, in force since
p.002017: 08/05/2011) The Executive Agency for Medicinal Products officially sends to the Regional Health Insurance Institute at the location of the respective
p.002017: pharmacy with issued permit under art. 229, para. 2, which includes the retail trade of food
p.002017: supplements, dietary foods for special medical purposes, infant formulas and follow-on foods, copy of
p.002017: the permission for
p.002017: entry in the register of art. 14, para. 1 of the Food Act.
p.002017: (2) (amend. - SG 41/09, in force from 02.06.2009)
p.002017: retail trade of food supplements, dietetic foods for special medical purposes
p.002017: whole, infant formulas and follow-on foods are subject to control under the Food Act.
p.002017: Art. 230. (1) (amend. - SG 60/11, in force from 05.08.2011) The Executive Agency
p.002017: on medicines keep a register of issued licenses for retail trade of medicines
p.002017: products of art. 229, para. 2, which contains:
p.002017: 1. number and date of authorization;
p.002017: 2. (suppl. - SG 71/08, in force from 12.08.2008) name, type of the trader,
p.002017: the seat and management address of the authorized person;
p.002017: 3. (amend. - SG 12/11, in force from 08.02.2011) name, unique civil number of
p.002017: the pharmacy manager;
p.002017: 4. pharmacy address;
p.002017: 5. the activities to be performed in the pharmacy;
p.002017: 6. the date of termination of the permit and deletion from the register and the reason for
p.002017: this;
p.002017: 7. remarks on entered circumstances.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) Data from the register shall be
p.002017: published on the website of the Executive Agency for Medicines on the Internet.
p.002017: the face,
p.002017: Art. 231. (1) Upon change of the entries in the register under Art. 230, para. 1, items 2 - 5 circumstances received permission for
p.002017: retail trade of medicinal products,
p.002017: submit an application in accordance with Art. 228, para. 1, to which it also applies the change
p.002017: documents.
p.002017: (2) (New - SG 60/11, in force from 05.08.2011) In case of change
p.002017: both the name and type of merchant, pharmacy address and pharmacy manager
p.002017: a new application shall be submitted in accordance with Art. 228, para. 1 and the license fee shall be paid
p.002017: for retail sale of medicinal products in a pharmacy specified in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) A person who has received a permit for
...
p.002017: with the exception of the provision of § 64, item 2, which enters into force on April 14, 2008, and
p.002017: the provisions of § 9, item 4, § 41, 42 and 43, which shall enter into force on 26 July 2008.
p.002017: Final provisions
p.002017: TO THE LAW FOR AMENDMENT OF THE MEDICINAL PRODUCTS ACT
p.002017: HUMAN MEDICINE
p.002017: (Official Gazette of the Republic of Bulgaria, Issue 10 of 2009, Effective 29.01.2009)
p.002017: § 2. The law shall enter into force on January 29, 2009.
p.002017: Transitional and Final Provisions
p.002017: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002017: PRODUCTS IN HUMAN MEDICINE
p.002017: (Official Gazette of the Republic of Bulgaria, Issue 23 of 2009, Effective 30.03.2009)
p.002017: § 4. The persons who have received a permit under Art. 229, para. 2,
p.002017: including trading in nutritional supplements may also trade on
p.002017: retail sale of dietetic foods for special medical purposes.
p.002017: § 5. Within two months of the entry into force of this Act, the Ministry of
p.002017: Health officially sends to the respective RIPCPH at the location of pharmacies for
p.002017: entry in the register of art. 14, para. 1 of the Food Act a copy of the authorizations under Art. 229, para. 2,
p.002017: issued pending the entry into force of this Act.
p.002017: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002017: § 7. The law shall enter into force on March 30, 2009.
p.002017: Transitional and Final Provisions
p.002017: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002017: (Promulgated - SG, issue 41 of 2009, effective 02.06.2009)
p.002017: § 92. (1) The persons who have received a permit under Art. 229, para. 2
p.002017: of the Law on Medicinal Products in Human Medicine, which includes trading
p.002017: with nutritional supplements, they can also retail infant and transitional foods
p.002017: food.
p.002017: (2) Within two months of the entry into force of this Act, the Ministry of Health
p.002017: officially sends to the respective RIPCPH at the location of pharmacies operating and retail
p.002017: with infant formulas and follow-on foods under para. 1, for entry in the register under Art. 14, para. 1 of the Law on
p.002017: keep a copy of the permits under Art. 229, para. 2 of the Law on Medicinal Products in Human Medicine,
p.002017: issued pending entry into force of
p.002017: this law. "
p.002017: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002017: § 96. The law shall enter into force on the day of its promulgation in the State Gazette, p
p.002017: except for:
p.002017: 1. paragraphs 3, 5, 6 and 9, which shall take effect from 1 January 2009;
p.002017: 2. Paragraphs 26, 36, 38, 39, 40, 41, 42, 43, 44, 65, 66, 69, 70, 73, 77, 78, 79, 80, 81, 82, 83,
p.002017: 88, 89 and 90, which shall take effect from 1 July 2009;
p.002017: 3. paragraph 21, which shall take effect from 1 June 2010.
p.002017: Final provisions
p.002017: TO THE LAW FOR SUPPLEMENTATION OF THE MEDICINAL PRODUCTS ACT
p.002017: HUMAN MEDICINE
p.002017: (Official Gazette of the Republic of Bulgaria, issue 88 of 2009, effective 06.11.2009)
p.002017: § 2. The law shall enter into force on the day of its promulgation in the State Gazette.
p.002017: Transitional and Final Provisions
p.002017: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002017: PRODUCTS IN HUMAN MEDICINE
p.002017: (Official Gazette, issue 102 of 2009, effective 22.12.2009)
p.002017: § 4. (1) Master-pharmacists and
p.002017: Assistant pharmacists who have obtained permission to open a pharmacy in the settlements under Art. 228, para. 4 on
p.002017: the order of the repealed Law on Medicines and Pharmacies in Human Medicine (promulgated, SG No. 36/1995; Decision No.
p.002017: 10 of the Constitutional Court of 1996 - issue no. 61 of 1996; amend. 38 of 1998, issue. 30 of 1999, issue. 10 of 2000
p.002017: d .; Decision No. 3 of the Constitutional Court of 2000 - issue no. 37 of 2000; amend. 59 of 2000; Decision # 7 of
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.002017: 1, item 3, the following data on the permit / certificate shall be entered:
p.002017: 1. registration number;
p.002017: 2. number and date of the marketing authorization / registration certificate of
p.002017: the medicinal product;
p.002017: 3. name of the medicinal product;
p.002017: 4. the international non-patent name of each active substance;
p.002017: 5. the name and address of the holder of the marketing authorization / certificate of use
p.002017: registration;
p.002017: 5a. (new - SG 102/2012, in force since 21.12.2012) the conditions under art. 55a, 56 and 56a,
p.002017: entered in the Marketing Authorization / Registration Certificate;
p.002017: 6. date of change of the Marketing Authorization / Certificate
p.002017: registration;
p.002017: 7. date of termination of the marketing authorization / registration certificate;
p.002017: 8. other data.
p.002017: (2) The marketing authorization / marketing authorization for the medicinal product
p.002017: shall be served on the person under Art. 26, para. 1 and shall enter into force on the date of its entry in the register under Art.
p.002017: 19, para. 1, Vol. 3.
p.002017: Art. 53. (amend. - SG 102/02, in force from 21.12.2012) (1) The Executive Agency for Medicines shall publish
p.002017: on your website within 14 days of the granting of the marketing authorization / marketing authorization
p.002017: registration of the data under art. 52, para. 1, approved
p.002017: summary of product characteristics and package leaflet.
p.002017: (2) The Executive Agency for Medicinal Products shall publish on its website
p.002017: the assessment report under art. 49, para. 1 with the reasons for the decision, deleting the data,
p.002017: representing a trade secret.
p.002017: (3) The report under para. 2 shall be accompanied by a summary of a language comprehensible to the public.
p.002017: The summary contains a section relating to the conditions of use of the medicinal product.
p.002017: Art. 54. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of the permit for
p.002017: use / the registration certificate of the medicinal product shall notify the BDA in writing of the date of
p.002017: the actual marketing of the medicinal product in
p.002017: Republic of Bulgaria.
p.002017: (2) (Amended, SG No. 18/2014) The holder of the authorization for
p.002017: use / the registration certificate of a medicinal product shall notify the BDA at least two in writing
p.002017: months before the sale of a medicinal product ceases, regardless
p.002017: whether temporary or permanent.
p.002017: (3) (Amended, SG No. 18/2014) The holder of the authorization for
p.002017: the use / registration certificate of the medicinal product indicates the reasons for the suspension
p.002017: sales in accordance with Art. 68, para. 1, item 6 and declare whether undertaken
p.002017: from it actions under para. 2 shall be due to any of the grounds under Art. 276 or under Art. 277.
p.002017: (4) (Amended, SG No. 18/2014) Upon termination of the sales of the medicinal product
p.002017: product as a result of unforeseen circumstances the holder of the marketing authorization
p.002017: use / the registration certificate for a medicinal product shall notify the BDA in writing
p.002017: within 7 days of the establishment of the circumstances.
p.002017: d) At
p.002017: Art. 54a. (New, SG No. 60/2011, effective 05.08.2011) (1) (amend. - SG 18/04) receiving a signal
p.002017: in the Executive Agency for Cessation Drugs
p.002017: sales of a medicinal product, except in cases under Art. 54, para. 2 and 4, the agency
p.002017: carries out verification within 30 days of receiving the alert.
...
p.002017: the product is authentic and has not been tampered with;
p.002017: 2. the holder of a production permit in compliance with the requirements of Art. 168, para.
p.002017: 8 may replace safety indicators with equivalents with respect to
p.002017: the ability to guarantee the authenticity, identification and assurance of
p.002017: evidence of tampering with the medicinal product.
p.002017: (3) Safety indicators shall be considered equivalent if:
p.002017: 1. meet the requirements laid down in the delegated acts referred to in Article 54a (2)
p.002017: of Directive 2001/83 / EC, and
p.002017: 2. are equally effective in allowing authentication; and
p.002017: the identification of medicinal products and the provision of evidence of forgery
p.002017: them.
p.002017: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of
p.002017: the medicinal product and in accordance with good manufacturing practice for medicinal products
p.002017: products.
p.002017: (5) The Medicines Executive Agency shall oversee the replacement of
p.002017: safety indicators.
p.002017: Art. 169. (1) The information on the packaging and the package leaflet of the medicinal product must be complete
p.002017: compliance with the particulars in the summary of product characteristics approved by the BDA when granting the marketing authorization
p.002017: use and meet the requirements set out in
p.002017: the ordinance under Art. 170.
p.002017: (2) The information on the packaging and the package leaflet may be in several languages, but
p.002017: one of them must be Bulgarian. The content of the information is different
p.002017: languages must be identical.
p.002017: (3) The name of the medicinal product shall be written in Bulgarian
p.002017: language, and the international non-patent name of the medicinal substance is given according to
p.002017: WHO anatomical-therapeutic-chemical classification. The name and address of
p.002017: the holder of the marketing authorization may be written in Latin.
p.002017: (4) The information on the packaging and the package leaflet must be understandable to the patient
p.002017: language, be legible and indelible.
p.002017: (5) (New, SG No. 18/2014) The leaflet must be designed in such a way that it is
p.002017: clear and comprehensible, allowing the patient to take appropriate action at
p.002017: need, with the help of medical professionals.
p.002017: Art. 170. (1) (Former text of Article 170 - SG, issue 102 of 2012, in force since 01.03.2013)
p.002017: The requirements for the packaging and package leaflet of the medicinal products shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: (2) (New - SG, iss. 102 in 2012, in force since 21.12.2012, suppl. - SG, iss. 18 in 2014)
p.002017: a product authorized for use under this Act is not intended for direct delivery to the patient or
p.002017: not available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data specified in
p.002017: the ordinance under para. 1, not applied
p.002017: on the packaging or the package leaflet.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2
p.002017: The information on the packaging and the package leaflet may not be provided in English
p.002017: language.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) Delivery terms and procedure
p.002017: of the medicinal products under para. 2 shall be determined by the ordinance under art. 198.
p.002017: Chapter seven.
p.002017: CLASSIFICATION OF MEDICINAL PRODUCTS
p.002017: Art. 171. (1) Depending on the manner of dispensing the medicinal products shall be
p.002017: classified as:
p.002017: 1. prescription medicinal products;
p.002017: 2. medicinal products dispensed without a prescription.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008)
p.002017: the product is identified by the BDA in the Marketing Authorization / Registration Certificate or
p.002017: the authorization for parallel importation of the medicinal product into the territory of
p.002017: Republic of Bulgaria.
p.002017: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in
p.002017: the application for the marketing authorization / registration certificate for modification of
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.002017: (e) All changes in the group are changes in the active documentation of the asset
p.002017: substance, vaccine antigen background, or background documentation for
p.002017: plasma;
p.002017: (f) any changes to the group are in relation to a project designed to refine
p.002017: the manufacturing process and the quality of the medicinal product concerned or its
p.002017: active substance (s);
p.002017: (g) all changes in the group are changes that affect the quality of the pandemic
p.002017: influenza vaccine;
p.002017: h) all changes in the group are changes in the pharmacovigilance system by chapter
p.002017: the eighth;
p.002017: (i) any changes to the group are the result of a specific emergency safety measure; and
p.002017: were filed in accordance with Art. 66;
p.002017: k) all changes in the group are related to the inclusion of information about a given
p.002017: pharmacotherapeutic class;
p.002017: (l) any changes in the group are the result of the evaluation of the periodic report for the
p.002017: safety;
p.002017: (m) any changes to the group result from a post-authorization study
p.002017: for use under the supervision of the marketing authorization holder;
p.002017: (n) any changes to the group are the result of the fulfillment of a condition of authorization for
p.002017: use of art. 56;
p.002017: 3. the requested changes in the conditions of the same marketing authorization do not fall under
p.002017: the cases under item 2, provided that the BDA agreed to apply the same to these changes
p.002017: procedure.
p.002017: (4) When grouping changes under para. 3, items 2 and 3, the holder of the authorization for
p.002017: use submitted to the BDA:
p.002017: 1. single notification when at least one of the changes is type IB and all others are type
p.002017: IA or type IB;
p.002017: 2. a single application where the major change is type II and none of the other changes
p.002017: is not an extension of the marketing authorization;
p.002017: 3. a single application where the major change is the extension of
p.002017: the marketing authorization.
p.002017: (5) Along with the application, respectively, the notification under para. 1 or 4, the holder of
p.002017: the marketing authorization shall submit:
p.002017: 1. documentation related to the changes, determined by the ordinance under Art. 42;
p.002017: 2. a document for a paid fee in the amount determined by the tariff under Art. 21, para. 2.
p.002017: (6) The Executive Director of the BDA shall approve the models of the application, respectively
p.002017: notification under para. 1 and 4, which are published on the BDA website.
p.002017: Art. 62. (amend. - SG 12/11, in force from 08.02.2011) (1) The holder of
p.002017: the Marketing Authorization can notify Type IA changes within 12 months of
p.002017: their implementation except changes that require immediate notification.
p.002017: (2) Type IA changes requiring immediate notification shall be determined by the ordinance
p.002017: under Art. 42.
p.002017: (3) In the cases of para. 2, the Marketing Authorization Holder notifies
p.002017: change of type IA immediately after its application.
p.002017: (4) Within 30 days from receipt of the notification under para. 1, respectively under para. 3, BDA
p.002017: notify the holder of the marketing authorization:
p.002017: 1. whether the change (s) are accepted / accepted or not; when the change / changes do not
p.002017: accepted / accepted, state the reasons for this, and
p.002017: 2. whether the change / changes lead to a change of the data in the issued
p.002017: marketing authorization; when a change to the marketing authorization is required,
p.002017: shall apply Art. 64a.
p.002017: (5) The Marketing Authorization Holder shall immediately suspend the application of
p.002017: the relevant change (s) type IA upon receipt of the notification under para. 4, Vol. 1
p.002017: for rejection.
...
p.002017: when using the medicinal product, it shall take urgent restrictive measures and
p.002017: immediately notify the BDA in writing.
p.002017: (2) The Executive Agency for Medicines shall decide on the measures within 24 hours from
p.002017: the notification.
p.002017: (3) When the BDA does not make its decision within the term under para. 2, the measures are considered to be approved.
p.002017: (4) When the BDA determines that there is a risk to human health from the use of
p.002017: the medicinal product orders the marketing authorization holder to take
p.002017: restrictive measures immediately.
p.002017: (5) In the cases of para. 1 and 4 of the Marketing Authorization Holder
p.002017: the product agrees with the BDA on the manner and deadlines for implementation of the measures taken.
p.002017: (6) The marketing authorization holder shall submit to
p.002017: the Executive Director of the BDA application for change in accordance with Art. 64 not later than 15 days
p.002017: after the date of action.
p.002017: Art. 66. (1) (amend. - SG 12/11, in force from 08.02.2011)
p.002017: marketing authorization for the medicinal product applies for the extension of
p.002017: the marketing authorization issued for:
p.002017: 1. change of active substance (s):
p.002017: (a) replacement of a chemically active substance with a different complex / derivative including
p.002017: salt / ester, with the same therapeutic moiety as the characteristics of
p.002017: efficacy / safety do not differ significantly;
p.002017: b) replacement with different isomer, different mixture of isomers, replacement of mixture with isolated
p.002017: isomer (for example of a single enantiomer racemate), wherein the characteristics of
p.002017: efficiency / safety do not differ significantly;
p.002017: (c) replacement of a biologically active substance with one having a slightly different molecular structure,
p.002017: in which the performance / safety characteristics do not differ significantly, except for
p.002017: changes in the active substance of seasonal,
p.002017: a pre-pandemic or pandemic influenza vaccine for human use;
p.002017: (d) modification of the vector used to produce the antigen or starting material,
p.002017: including a new core cell bank from another source, where the features of
p.002017: efficiency / safety do not differ significantly;
p.002017: (e) a new ligand or binding mechanism for a radiopharmaceutical in which
p.002017: the performance / safety characteristics do not differ significantly;
p.002017: (f) a change in the extraction solvent or in the ratio of vegetable
p.002017: substance / herbal preparation in which the efficacy / safety characteristics are not
p.002017: differ significantly;
p.002017: 2. change in the amount of active substance, dosage form and route of
p.002017: introduction:
p.002017: (a) change in bioavailability;
p.002017: (b) a change in pharmacokinetics, such as a change in the rate of release;
p.002017: (c) modification or addition of a new amount of the active substance / activity;
p.002017: (d) modifying or adding a new dosage form;
p.002017: e) change or addition of a new route of administration - in parenteral administration
p.002017: a distinction needs to be made between intraarterial, intravenous, intramuscular,
...
p.002017: the ordinance under para. 1, not applied
p.002017: on the packaging or the package leaflet.
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2
p.002017: The information on the packaging and the package leaflet may not be provided in English
p.002017: language.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) Delivery terms and procedure
p.002017: of the medicinal products under para. 2 shall be determined by the ordinance under art. 198.
p.002017: Chapter seven.
p.002017: CLASSIFICATION OF MEDICINAL PRODUCTS
p.002017: Art. 171. (1) Depending on the manner of dispensing the medicinal products shall be
p.002017: classified as:
p.002017: 1. prescription medicinal products;
p.002017: 2. medicinal products dispensed without a prescription.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008)
p.002017: the product is identified by the BDA in the Marketing Authorization / Registration Certificate or
p.002017: the authorization for parallel importation of the medicinal product into the territory of
p.002017: Republic of Bulgaria.
p.002017: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in
p.002017: the application for the marketing authorization / registration certificate for modification of
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
p.002017: 2. are often and very widely applied incorrectly and as a result can
p.002017: pose a danger to human health;
p.002017: 3. contain substances whose activity and / or undesirable effects require it
p.002017: subsequent follow-up study;
p.002017: 4. usually prescribed by a doctor for parenteral administration.
p.002017: Art. 174. Medicinal products shall be subject to special medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. contain narcotic substances within the meaning of the Drug Control Act
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
p.002017: the medicinal product is classified as a prescription only product.
p.002017: Art. 177. Medicinal products that do not meet the requirements of Art. 173, 174 and
p.002017: 175 and the criteria set out in the ordinance under Art. 178, are granted without medical prescription.
p.002017: Art. 178. The criteria for classification of medicinal products and the requirements for
p.002017: the documentation for making a change in the classification shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish it on the page
p.002017: your online list of prescription medicines
p.002017: the territory of the Republic of Bulgaria.
p.002017: (2) The list under para. 1 is updated annually.
p.002017: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002017: or the certificate of registration, the BDA shall review and, where necessary, amend the classification according to
p.002017: the requirements of Art. 173 and the criteria specified
p.002017: in the ordinance under art. 178.
p.002017: Art. 181. Where a change in the classification of a medicinal product on the basis of
p.002017: significant pre-clinical or clinical trials, no subsequent applicant or marketing authorization holder
...
p.002017: procedure provided for in Chapter II of Title II of the
p.002017: Regulation (EC) No 726/2004 of the European Parliament and of the Council, or
p.002017: 2. the coordination group of art. 77, para. 2 - for cases other than those specified in item 1.
p.002017: (4) The European Union reference dates for medicinal products under
p.002017: Art. 194l and the harmonized frequency for submitting their periodic up-to-date reports
p.002017: safety shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: (5) The holder of the marketing authorization after the publication of the data under para. 4 presents to the BDA an application for
p.002017: modification of the marketing authorization for the medicinal product concerned. Any change in filing dates and on
p.002017: the frequency of submission of periodic safety update reports specified in the
p.002017: use, effective 6
p.002017: months after their date of publication.
p.002017: Art. 194o. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: Medicines evaluates periodic safety update reports for medicinal products for
p.002017: to determine if there are new risks, or a change in
p.002017: identified risks, or change in benefit / risk ratio.
p.002017: (2) The Medicines Executive Agency shall carry out a uniform assessment of the periodic up-to-date reports on
p.002017: safety for medicinal products for which the Republic of Bulgaria has fulfilled the functions of a reference country
p.002017: within the meaning of Art. 76, and is determined by
p.002017: the coordination group of art. 77, para. 2.
p.002017: (3) A rapporteur from the Republic of Bulgaria shall participate in the single evaluation of the periodic reports
p.002017: updated safety reports for medicinal products where at least one of the products
p.002017: has been authorized under Regulation (EC) No 726/2004 of the European Parliament and of the European Parliament
p.002017: The Council, and is designated as such by the committee under Art. 56a, para. 1, v. 1.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases under Art. 194o, para. 2 and 3 BDA,
p.002017: respectively, the rapporteur from the Republic of Bulgaria within 60 days from the date of receipt of the periodic
p.002017: an updated safety report shall prepare an evaluation report and send it electronically to the European
p.002017: the Medicines Agency and the regulatory authorities of the Member States. The Marketing Authorization Holder receives
p.002017: the evaluation report from
p.002017: European Medicines Agency.
p.002017: (2) Within 30 days of receipt of the report under para. 1 holder of the authorization for
p.002017: Member States' regulatory authorities or authorities may submit their comments
p.002017: to the European Medicines Agency and to the BDA.
p.002017: (3) Within 15 days from the date of receipt of the comments under para. 2 BDA updates
p.002017: the evaluation report, taking into account all the objections presented, and forwarding it to the committee
p.002017: under Art. 56a, para. 1, item 1 for approval and recommendation.
p.002017: (4) The European Medicines Agency has included the evaluation report adopted and
p.002017: the recommendation of the Committee under Art. 56a, para. 1, item 1 in the register under Art. 194h, para. 3 and sends it to
p.002017: the holder of the marketing authorization.
p.002017: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) Where the Republic of Bulgaria is not
p.002017: rapporteur in the procedure under Art. 194o, para. 2, the BDA may submit comments within the term under Art. 194p, para. 2 to
p.002017: The European Medicines Agency and the regulatory authority of the European Medicines Agency
p.002017: the Member State that produced the assessment report.
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and when none of the authorizations for
p.002017: the use of these products has not been issued under Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: the coordination group of art. 77, para. 2 within 30 days from the date of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the preservation, modification, suspension or termination of
p.002017: relevant marketing authorizations, including a timetable for the implementation of the opinion.
p.002017: (2) Where the represented Member States in the coordination group under Art. 77, para. 2
p.002017: they agree on the actions to be taken, the BDA implements
p.002017: the decision taken.
p.002017: (3) Where the opinion under para. 1 is to suspend or terminate the authorization for
p.002017: The BDA Executive Director issues an order.
p.002017: (4) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (5) When agreement cannot be reached within the coordination group under Art. 77, para. 2, the position of
p.002017: the majority of the Member States are referred to the European Commission, which decides on the change,
p.002017: suspension or termination of permissions for
p.002017: use issued by the relevant regulatory authorities of the Member States.
p.002017: (6) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 5.
p.002017: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and where at least one of the authorizations for
p.002017: the use has been issued in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: medicinal products for human use within 30 days of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the retention, amendment, suspension or termination of validity
p.002017: of the relevant marketing authorizations, including a timetable for the implementation of
p.002017: the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. Decides to change, suspend or terminate the marketing authorizations,
p.002017: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 2. adopt a decision recommending change, suspension or termination of authorizations
p.002017: for use issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 2, Vol. 2.
p.002017: Section IV.
p.002017: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002017: 12/21/2012)
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure of
...
p.002017: wholesalers, pharmacies and drugstores,
p.002017: located in the territory of the respective area.
p.002017: (3) The investment projects for the construction of new and / or shall be coordinated with the BDA
p.002017: redevelopment of existing facilities related to the manufacture of medicinal products
p.002017: in accordance with the rules of Good Manufacturing Practice for Medicinal Products.
p.002017: Art. 268a. (New - SG 60/11, in force from 05.08.2011) (1) Donations of medicinal products by holders of
p.002017: Authorization for use, manufacturers, wholesalers and retailers and the Bulgarian Red Cross can be made
p.002017: only after approval by the donor with the BDA by submitting an application in the form approved by the Minister of
p.002017: healthcare on
p.002017: proposal of the BDA Executive Director.
p.002017: (2) Donations shall be made in accordance with the rules of Good Donation Practice of
p.002017: World Health Organization.
p.002017: (3) Where within 10 days from the receipt of the application under para. 1 BDA does not
p.002017: replied in writing to the donor, it is considered that there is tacit agreement to perform
p.002017: the donation.
p.002017: (4) The medical establishments and the Bulgarian Red Cross shall notify the BDA of the received
p.002017: donations of medicinal products within 7 days of receipt.
p.002017: (5) At the end of each quarter, the BDA shall send information to the Ministry of Finance
p.002017: healthcare for the donations made under para. 4.
p.002017: (6) To make a donation of a medicinal product at the request of a medical establishment,
p.002017: intended for the treatment of a particular patient in a life-threatening condition, the donor
p.002017: notify the BDA within 7 days of its completion.
p.002017: (7) The donations under para. 6 may not exceed the amount required for a single use
p.002017: course of treatment.
p.002017: Art. 269. (1) The control under art. 267 is performed through inspections and laboratory tests.
p.002017: (2) The inspections and laboratory tests under para. 1 shall be carried out:
p.002017: 1. in connection with the granting of authorizations for use, production, import and certificates
p.002017: by the order of this law;
p.002017: 2. in connection with the supervision of the market of medicinal products;
p.002017: 3. at the request of the European Commission, of the European Agency of the European Communities
p.002017: medicines or by the competent authority of another Member State;
p.002017: 4. upon application by a manufacturer, importer or holder of an authorization for
p.002017: use out of the cases under item 1.
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012)
p.002017: medicines carries out inspections:
p.002017: 1. to manufacturers of medicinal products located in the territory of the Republic
p.002017: Bulgaria, per Member State or in third countries;
p.002017: 2. to importers and wholesalers of medicinal products;
p.002017: 3. at the premises of the manufacturers, importers and wholesalers of the active
p.002017: substances located on the territory of the Republic of Bulgaria;
p.002017: 4. at the premises of manufacturers or wholesalers of active substances,
p.002017: located in third countries as well as manufacturers or importers of excipients;
p.002017: 5. at the premises of the holders of marketing authorization
p.002017: products and intermediaries in the field of medicinal products, registered in accordance with Art.
p.002017: 212a;
p.002017: 6. as part of the certification procedure relating to the monographs of
p.002017: The European Pharmacopoeia;
p.002017: 7. to manufacturers of starting materials at the written request of the manufacturer.
...
Social / Mothers
Searching for indicator mothers:
(return to top)
p.002017: persons who are unable to give informed consent are permitted, provided that:
p.002017: 1. the relevant ethics committee with the participation of specialists with competence in the respective disease, or
p.002017: in the patient group approved the protocol after discussing clinical, moral and psychosocial aspects,
p.002017: relating to the disease in question and to
p.002017: the patient group;
p.002017: 2. it can be expected that the intake of the medicinal product being tested will
p.002017: lead to benefits that outweigh the risks or the risks are completely eliminated;
p.002017: 3. the purpose of the test is to verify data obtained from clinical trials on
p.002017: persons who are able to give informed consent or to data obtained through others
p.002017: research methods;
p.002017: 4. the test is directly related to life-threatening or leading to disability
p.002017: a disease in which the relevant adult is unable to give
p.002017: an informed consent;
p.002017: 5. clinical trials are designed so that pain, discomfort, fear and other foreseeable risks
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: predefined and constantly monitored
p.002017: during the test;
p.002017: 6. no financial or other incentives are given except compensation.
p.002017: Art. 102. No clinical trial of a medicinal product on
p.002017: pregnant women and nursing mothers unless the medicinal product is required for treatment
p.002017: they may or may not be tested on another group of patients.
p.002017: Section III.
p.002017: Ethics Committees
p.002017: Art. 103. (1) (amend. - SG 60/11, in force from 05.08.2011) To the Minister of
p.002017: a multi - center ethics committee is set up by the Health Committee, whose composition is determined by
p.002017: Minister's order and includes regular and reserve members. Reserve members
p.002017: participate in committee meetings and have the right to vote in the absence of full members.
p.002017: (2) To the medical establishments where clinical trials are carried out shall be established
p.002017: ethics committees composed of the head of the hospital.
p.002017: (3) The Executive Agency for Medicines shall maintain and keep a register of the Committees on
p.002017: ethics.
p.002017: (4) The register of medical establishments to which ethics committees are established shall be
p.002017: published on the BDA website on the Internet.
p.002017: Art. 104. (1) The commissions under art. 103, para. 1 and 2 consist of 7 to 12 members who have
p.002017: qualification and experience to consider and evaluate the scientific, medical and ethical aspects of
p.002017: the proposed clinical trial.
p.002017: (2) The commissions under para. 1 shall include at least two non-medical members
p.002017: education - representatives of both sexes who are financially and administratively independent
p.002017: from the hospital where the clinical trial is being conducted.
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.002017: the medical sales representatives of art. 244, para. 1, item 3 of the population.
p.002017: Art. 256. Samples of medicinal products shall be made available to medical specialists
p.002017: under the conditions and by the order specified in the ordinance under art. 249.
p.002017: Art. 257. (1) The medical commercial representatives of art. 244, para. 1, item 3 must have received training,
p.002017: organized by the marketing authorization holder who assigned them to have scientific knowledge and
p.002017: be able to deliver as accurate and complete as possible
p.002017: information on the medicinal product they are presenting.
p.002017: (2) During each visit, the medical sales representatives must
p.002017: have the summary of product characteristics and the pricing data for the medicinal product and
p.002017: the terms of payment and make them available upon request.
p.002017: (3) When presenting medicinal products to medical specialists
p.002017: medical sales representatives cannot offer gifts and other property
p.002017: non-material benefit.
p.002017: Chapter twelve.
p.002017: ADJUSTMENT OF THE PRICES OF THE MEDICINAL PRODUCTS (HEADING - SG, No.
p.002017: 102 FROM 2012)
p.002017: Section I.
p.002017: National Council for Prices and Reimbursement of Medicinal Products (New, SG No. 102/2006)
p.002017: from 2012, in force since 21.12.2012)
p.002017: Art. 258. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012
p.002017: d.) (1) (Amended, SG No. 43/2016) A National Council on Prices and
p.002017: reimbursement of medicinal products, hereinafter referred to as "tips". The Council is a legal entity of
p.002017: budget support - minor
p.002017: budget authorizing officer. It has the status of a state commission based in Sofia.
p.002017: (2) The activity of the council shall be financed from the state budget through the budget of
p.002017: Ministry of Health.
p.002017: (3) The Council is a collegial body and consists of a chairman and six members, three of whom are doctors or
p.002017: Master's in Pharmacy, two lawyers and two economists, all with at least 5 years of experience.
p.002017: The Chairman and the members of the Council are elected and dismissed by a decision of the Council of Ministers
p.002017: at the proposal of the Minister of
p.002017: healthcare. The chairman directs and represents the board.
p.002017: (4) The members of the council may not occupy a position or carry out activity under Art. 19,
p.002017: para. 6 of the Administration Act.
p.002017: (5) The activities of the Council shall be assisted by an administration whose structure and organization
p.002017: work is determined by the rules of procedure adopted by the Council of Ministers.
p.002017: Art. 259. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012,
p.002017: in force since 21.12.2012) (1) The Council shall:
p.002017: 1. approve, refuse to approve, amend or delete the price of medicinal products under
p.002017: Art. 261a, para. 1;
p.002017: 2. approve, refuse to approve, amend or delete the marginal price of medicinal products
p.002017: products of art. 261a, para. 2;
p.002017: 3. register, refuse to register, amend or delete the prices of the medicinal products
p.002017: products granted without a doctor's prescription under Art. 261a, para. 3;
p.002017: 4. (amend. - SG 48/2015) approve, repeal or amend pharmacotherapeutic guidelines, including
p.002017: criteria for evaluating the outcome of therapy, as well as recommendations for algorithms for treatment with
p.002017: medicinal products offered by relevant national consultants, medical research companies and
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.002017: Regulation (EC) No 1901/2006.
p.002017: (2) (Supplemented, SG No. 18/2014) The documents under para. 1, items 18 and 18a with respect to
p.002017: Member States, respectively under point 19, shall be submitted only in the procedures under Section VII.
p.002017: (3) For radionuclide generators to the data of para. 1 are presented additionally
p.002017: the following documents:
p.002017: 1. a description of the system together with a detailed description of its components that it can
p.002017: affect the composition or quality of daughter radionuclides;
p.002017: 2. the qualitative and quantitative characteristics of the eluate or sublimate.
p.002017: (4) Documents and data from pharmaceutical, preclinical and clinical
p.002017: the tests shall be accompanied by summary reports prepared by experts with the necessary technical and
p.002017: qualification. An autobiographical report is attached to the reports
p.002017: to the experts who produced the report.
p.002017: (5) The dossier of the medicinal product shall be submitted in Bulgarian and / or English.
p.002017: (6) (New, SG No. 102/2012, effective 21.12.2012) The risk management system of para. 1, v. 13
p.002017: should be proportionate to the identified and potential risks of the medicinal product and of
p.002017: the need to collect safety data from
p.002017: post-marketing studies.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The holder of the permit
p.002017: for use updates the data from the file under para. 1. It shall apply to any change in the dossier
p.002017: the order of Chapter Three, Section VI, where applicable.
p.002017: Art. 28. (1) (amend. - SG 71/08, in force from 12.08.2008) The person under art. 26, para. 1 insofar as it does not violate
p.002017: industrial and commercial property rights, does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b" and "c",
p.002017: if it can prove that the medicinal product referred to in the application is generic to the reference medicinal product,
p.002017: which is allowed or is
p.002017: was authorized for use in a Member State not less than 8 years ago.
p.002017: (2) The holder of the authorization for use of the generic product under para. 1 cannot
p.002017: to place it on the market before the expiry of 10 years from the date of first authorization
p.002017: of the reference medicinal product.
p.002017: (3) The person under art. 26, para. 1, subject to the conditions of para. 1 and 2 may apply to the BDA for permission to
p.002017: use of a generic reference product and where the reference product was not authorized
p.002017: use within the territory of the Republic
p.002017: Bulgaria.
p.002017: (4) In the cases of para. 3 the person under art. 26, para. 1 shall indicate in the application under Art. 27, para. 1
p.002017: the Member State in which the reference product is authorized or has been authorized.
p.002017: (5) In the cases of para. 3 The BDA requires the regulatory authority of the Member State,
p.002017: referred to in the application under Art. 27, para. 1, confirmation of the information under para. 4, the quantitative and
p.002017: the qualitative composition of the reference product and, if necessary, additional documentation.
p.002017: (6) The Executive Agency for Medicinal Products makes available on request to a regulatory authority of a Member State, c
p.002017: which has been submitted for a generic reference product that has been authorized or has been authorized
p.002017: for use on the territory of the Republic
...
p.002017: the requirements of this Act or the original marketing authorization shall be supplemented. All these permissions are considered as
p.002017: belonging to a global marketing authorization for the medicinal product for
p.002017: the purposes of applying this Article.
p.002017: Art. 29. (1) The person under art. 26, para. 1 presents in the BDA the results of the necessary
p.002017: preclinical and / or clinical trials where the medicinal product referred to in
p.002017: application:
p.002017: 1. cannot be defined as generic, or
p.002017: 2. bioavailability tests do not prove bioequivalence, or
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) there is a change in the active substance or substances in
p.002017: the amount of active substance or substances per dosage unit, the therapeutic indication, of
p.002017: the dosage form, the route of administration against
p.002017: the reference medicinal product.
p.002017: 4. (repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: (2) Where the biological medicinal product referred to in the application is similar to a reference biological
p.002017: is not eligible to be classified as a generic medicinal product because of
p.002017: different production method or different starting materials compared to reference or other
p.002017: reasons, the applicant submits to the BDA the results of the required preclinical and / or clinical trials,
p.002017: related to these conditions.
p.002017: (3) In the cases of para. 1 and 2 the documentation specified in the ordinance under Art.
p.002017: 42.
p.002017: Art. 30. (1) The person under art. 26, para. 1 insofar as it does not violate industrial and commercial rights
p.002017: property, does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b" or "c", if he can prove, under the conditions,
p.002017: defined in the ordinance under art. 42 that the active substance included in the proposed authorization for
p.002017: use of a medicinal product is well established in medical practice, has recognized efficacy and
p.002017: acceptable level of safety. In these cases, the test results and tests may be replaced
p.002017: with the relevant ones
p.002017: scientific publications.
p.002017: (2) The person under para. 1 presents the results of the necessary preclinical and clinical trials in the case of
p.002017: a medicinal product containing active substances of well - established use that has not been used in
p.002017: the proposed combination for therapeutic purposes. In this
p.002017: no documentation is submitted in respect of each individual active substance.
p.002017: (3) When an active substance within the meaning of para. 1 has a proven new therapeutic indication on the base
p.002017: significant preclinical or clinical data related to the new indication, once for a period of
p.002017: one year the next applicant cannot rely on
p.002017: data on the new indication of the active substance.
p.002017: Art. 31. In the case where a medicinal product contains active substances used in the authorized composition
p.002017: for use medicinal products but not used in the proposed combination for therapeutic purposes, the person
p.002017: under Art. 26, para. 1 presents the results of preclinical and clinical trials related to
p.002017: this combination. In this case, the applicant does not provide documentation on the safety and efficacy of each
...
p.002017: establishments under para. 4, which do not have an open pharmacy, can be obtained from a pharmacy at a medical establishment,
p.002017: has received a retail authorization for medicinal products
p.002017: products under the conditions and in the order determined by the ordinance under art. 219, para. 2.
p.002017: (6) (Repealed, previous para. 4 - SG, iss. 71 in 2008, effective from 26.07.2008, previous para.
p.002017: 2011, in force since 05/08/2011) Pharmacies of outpatient medical establishments at
p.002017: The Ministry of Defense and the Ministry of the Interior may be led by a pharmacist assistant
p.002017: proposal from the relevant agency
p.002017: and after permission was issued by the Executive Director of the BDA.
p.002017: Art. 223. (1) A master pharmacist or an assistant pharmacist may be a manager
p.002017: only one pharmacy and must work in it.
p.002017: (2) (amend. - SG 12/11, in force from 08.02.2011) The Master of Pharmacy or
p.002017: pharmacist assistant pharmacist cannot be hired on contract with
p.002017: a sole proprietor or a trading company having a manufacturing activity,
p.002017: import, wholesale or retail of medicinal products.
p.002017: (3) The person under para. 1, authorized to trade in medicinal products, no
p.002017: can be the owner or participate in trading companies with the subject of production, import
p.002017: or wholesale of medicinal products,
p.002017: including in companies of related parties within the meaning of the Commercial Law.
p.002017: cases;
p.002017: Art. 224. The pharmacy manager must:
p.002017: 1. is a master pharmacist, respectively an assistant pharmacist, in accordance with the law
p.002017: 2. is not deprived of the right to practice the profession;
p.002017: 3. has not been convicted of any offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 4. has at least one year of experience as a master pharmacist.
p.002017: Art. 225. (amend. - SG 71/08, in force from 26.07.2008) (1) In a settlement on whose territory there is no
p.002017: opened a pharmacy, the right to carry out retail trade in medicinal products has a person under Art. 222, para. 1 which
p.002017: has concluded an employment contract or contract for managing a pharmacy with an assistant pharmacist or a master pharmacist with
p.002017: less than one year's work
p.002017: internship.
p.002017: (2) The assistant pharmacist or the master pharmacist under para. 1 is the head of
p.002017: pharmacy and necessarily work in it.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Assistant Pharmacist - Head of
p.002017: the pharmacy under para. 1, may perform the following activities: preservation and release without prescription of
p.002017: medicinal products, medical devices, dietary foods authorized for use in the Republic of Bulgaria
p.002017: for special medical purposes and infant formulas and follow-on formulas, and nutritional supplements, cosmetic and
p.002017: sanitary and hygienic
p.002017: funds.
p.002017: Art. 226. (1) On the territory of medical establishments for outpatient care may be
p.002017: open pharmacies to sell medicinal products to citizens.
p.002017: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, curative
p.002017: establishments for hospital care and medical establishments under art. 10 of the Law on medical establishments does not
p.002017: pharmacies can be opened to sell medicinal products to citizens.
p.002017: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009)
...
p.002017: performs his / her duties due to the use of temporary disability leave due to illness, pregnancy and
p.002017: birth or adoption and parental leave in accordance with the Labor Code, pharmacy
p.002017: may work for no more than two years under the direction of another
p.002017: Master Pharmacist, respectively Assistant Pharmacist, in the cases under Art. 225, which meets the requirements of Art. 224
p.002017: In these
p.002017: cases, a permit is issued by the BDA Executive Director.
p.002017: (3) The permit under para. 2 shall be issued within 30 days.
p.002017: Art. 237. Upon termination of the activity of the person, authorized to open
p.002017: pharmacy, medicinal products may be sold to persons who have been authorized
p.002017: wholesale of medicines.
p.002017: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002017: prescription, can be sold in a drugstore. Drugstores can also sell products and
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
...
p.002017: the order of art. 251.
p.002017: Art. 254a. (New, SG No. 60/2011, effective 05.08.2011) (1) Advertising,
p.002017: intended for medical specialists shall not be authorized in accordance with Art. 250 - 252.
p.002017: (2) The advertisement under para. 1 shall be distributed upon notification to the BDA at
p.002017: which applies to the design of the advertisement and subject to the requirements of this chapter and the regulation
p.002017: under Art. 249.
p.002017: Art. 255. (1) It is prohibited to distribute samples of medicinal products,
p.002017: containing narcotic substances within the meaning of the Narcotics Control Act
p.002017: and precursors.
p.002017: (2) It is prohibited to directly provide samples of medicinal products from
p.002017: the medical sales representatives of art. 244, para. 1, item 3 of the population.
p.002017: Art. 256. Samples of medicinal products shall be made available to medical specialists
p.002017: under the conditions and by the order specified in the ordinance under art. 249.
p.002017: Art. 257. (1) The medical commercial representatives of art. 244, para. 1, item 3 must have received training,
p.002017: organized by the marketing authorization holder who assigned them to have scientific knowledge and
p.002017: be able to deliver as accurate and complete as possible
p.002017: information on the medicinal product they are presenting.
p.002017: (2) During each visit, the medical sales representatives must
p.002017: have the summary of product characteristics and the pricing data for the medicinal product and
p.002017: the terms of payment and make them available upon request.
p.002017: (3) When presenting medicinal products to medical specialists
p.002017: medical sales representatives cannot offer gifts and other property
p.002017: non-material benefit.
p.002017: Chapter twelve.
p.002017: ADJUSTMENT OF THE PRICES OF THE MEDICINAL PRODUCTS (HEADING - SG, No.
p.002017: 102 FROM 2012)
p.002017: Section I.
p.002017: National Council for Prices and Reimbursement of Medicinal Products (New, SG No. 102/2006)
p.002017: from 2012, in force since 21.12.2012)
p.002017: Art. 258. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012
p.002017: d.) (1) (Amended, SG No. 43/2016) A National Council on Prices and
p.002017: reimbursement of medicinal products, hereinafter referred to as "tips". The Council is a legal entity of
p.002017: budget support - minor
p.002017: budget authorizing officer. It has the status of a state commission based in Sofia.
p.002017: (2) The activity of the council shall be financed from the state budget through the budget of
p.002017: Ministry of Health.
p.002017: (3) The Council is a collegial body and consists of a chairman and six members, three of whom are doctors or
p.002017: Master's in Pharmacy, two lawyers and two economists, all with at least 5 years of experience.
p.002017: The Chairman and the members of the Council are elected and dismissed by a decision of the Council of Ministers
p.002017: at the proposal of the Minister of
p.002017: healthcare. The chairman directs and represents the board.
p.002017: (4) The members of the council may not occupy a position or carry out activity under Art. 19,
p.002017: para. 6 of the Administration Act.
p.002017: (5) The activities of the Council shall be assisted by an administration whose structure and organization
p.002017: work is determined by the rules of procedure adopted by the Council of Ministers.
...
p.002017: expired, is liable to a fine of BGN 10,000 to BGN 20,000.
p.002017: (2) Who breaks the primary / secondary packaging or sells / provides medicinal products
p.002017: products with broken primary / secondary packaging are punished with a fine of 750 to 1500 levs, and for
p.002017: repeated violation - with a fine from 1500 to 3000 BGN.
p.002017: Art. 284. (1) Who manufactures, imports or wholesale medicinal products or
p.002017: sells medicinal products without permission, is fined BGN 50,000.
p.002017: (2) (suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 02.01.2013)
p.002017: Who manufactures, imports or wholesale medicinal products or sells medicinal products in violation of
p.002017: the authorization is granted or the sale, storage or supply of medicinal products which are of unknown origin,
p.002017: shall be punished by a fine of 25
p.002017: 000 to 50 000 BGN
p.002017: (3) (suppl. - SG 71/08, in force from 12.08.2008) In the cases of para. 1 and 2 organs
p.002017: of state control stop the operation of the site by order.
p.002017: (4) The order under para. 3 shall be subject to appeal by the order of the Administrative Procedure
p.002017: Code, and the appeal does not suspend its enforcement.
p.002017: Art. 284a. (New, SG No. 102/2012, effective 02.01.2013) Who produces, imports, exports, stores,
p.002017: sells or provides counterfeit medicinal products, and mediates the purchase and sale of
p.002017: falsified medicinal products, shall be punished by
p.002017: fine from BGN 25,000 to BGN 50,000
p.002017: Art. 284b. (New, SG No. 102/2012, effective 02/01/2013) Holder of a production permit, which
p.002017: does not fulfill its obligations under Art. 160, shall be punished by a pecuniary sanction from 5000 to 10 000 levs;
p.002017: re-committing the same violation - with property
p.002017: fine from BGN 10,000 to BGN 20,000
p.002017: Art. 284c. (New, SG No. 102/2012, effective 02.01.2013) Holder of a wholesale trade permit
p.002017: medicinal products, which does not fulfill its obligations under Art. 207, shall be punished by a pecuniary sanction from 2000 to
p.002017: 5000 BGN, and if you do the same again
p.002017: violation - with a property sanction from 5000 to 10 000 BGN.
p.002017: Art. 285. (1) Who trades in medicinal products without a certificate of release of
p.002017: batch, shall be punished by a fine of BGN 5,000 to BGN 10,000, and upon re-doing the same
p.002017: violation - with a fine of 10,000 to 20,000 BGN.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) A wholesaler who supplies medicinal drugstores
p.002017: prescription products are punished with a property sanction of 2500 to 5000 levs, and
p.002017: in the case of repeated infringement - with a fine from 5000 to 10,000
p.002017: BGN
p.002017: (3) Qualified person, authorized to sell lots of medicines
p.002017: products without a batch release certificate are fined 2500
p.002017: up to 5000 BGN
p.002017: Art. 285a. (New - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012
p.002017: (d) The Marketing Authorization Holder who has not notified the Minister of Health of
p.002017: suspension of sales under Art. 264, shall be punished by a pecuniary sanction of 25,000 to 50,000
p.002017: BGN
p.002017: Art. 285b. (New, SG No. 102/2012, effective 21.12.2012) Who produces, imports,
p.002017: exports, sells or stores active substances in violation of the requirements of this Act,
p.002017: fines from 10,000 to 20,000 BGN.
p.002017: Art. 285c. (New, SG No. 18/2014) Holder of a marketing authorization for a medicinal product which does not
p.002017: notified the BDA of export of medicinal products under Art. 217a, para. 4, shall be punished by a fine, respectively
p.002017: a pecuniary sanction in the amount of BGN 50,000 to BGN 100,000, and in the case of repeated infringement - in the amount of 100
p.002017: 000 to 200 000 BGN
p.002017: Art. 286. (1) For clinical trials performed in violation of this law, if the done does not constitute
p.002017: a fine of BGN 5,000 to 10,000 is imposed on the perpetrators who committed or committed the violation,
p.002017: and upon re-admission or making
p.002017: the same offense - a fine of 10,000 to 20,000 BGN.
p.002017: (2) To medical specialists who have admitted or committed violations under para. 1, can
p.002017: a sentence of "deprivation of the right to exercise their profession" was imposed from 6 months to two
p.002017: years.
p.002017: (3) The measure under para. 2 shall be imposed by the Minister of Health on the proposal of
...
p.002017: issued by the Executive Director of an Executive Agency
p.002017: "Medical Audit".
p.002017: Art. 290. (1) (amend. - SG 71/08, in force from 12.08.2008) Who advertises
p.002017: medicinal products which are not authorized for use under this Act shall be punished by
p.002017: fine from BGN 10,000 to BGN 20,000
p.002017: (2) (New, SG No. 71/2008, effective 12.08.2008) Who advertises a product, such as
p.002017: attributes and / or directs it to properties related to the prevention, diagnosis or treatment of
p.002017: human diseases, punishable by a fine of 10,000 to 20,000 BGN.
p.002017: (3) (prev. Para 2 - SG 71/08, in force from 12.08.2008) Who advertises
p.002017: medicinal products in violation of this law, shall be fined BGN 10,000 to BGN 20,000.
p.002017: (4) (Renumbered from Paragraph (3), amend. - SG 71/08, in force from 12.08.2008)
p.002017: para. 1 - 3 are also imposed on the persons who have allowed the broadcasting, publication and distribution of
p.002017: advertising.
p.002017: Art. 290a. (New - SG 71/08, in force from 12.08.2008) Medical specialist
p.002017: or a person posing as a healthcare professional performing direct or indirect advertising
p.002017: medicinal products in the print and / or electronic media, as well as on the Internet, are punished
p.002017: with a fine from 1000 to 5000 levs, and in the case of repeated violation - from 3000 to 10,000 levs.
p.002017: Art. 290b. (New, SG No. 60/2011, effective 05.08.2011) Who makes a donation to
p.002017: medicinal products in violation of Art. 268a, para. 1 shall be punished by a fine of from 1000 to 3000 levs
p.002017: repeated infringement - with a fine from 3000 to 5000 BGN.
p.002017: Art. 290c. (New - SG 102/2012, in force since 21.12.2012) The holder of a marketing authorization which
p.002017: conducts non-interventional studies in violation of this law, is punished by a property sanction of 5000
p.002017: up to BGN 10,000, and if you do the same again
p.002017: violation - with a property sanction from BGN 10,000 to BGN 20,000
p.002017: Art. 290g. (New, SG No. 102/2012, effective 21.12.2012) Holder of a marketing authorization which does not
p.002017: fulfills the conditions of art. 55a, 56a and 56b shall be punishable by a pecuniary sanction of from BGN 5,000 to BGN 10,000, and for
p.002017: re-committing the same violation - with property
p.002017: fine from BGN 10,000 to BGN 20,000
p.002017: Art. 290d. (New, SG No. 102/2012, effective 21.12.2012) Permission holder
p.002017: for use which does not fulfill the obligations under Art. 190 - 192, 194b, 194c, 194h and 194i, shall be punished
p.002017: with a pecuniary sanction from BGN 5,000 to 10,000, and in the case of repeated infringement -
p.002017: with a property sanction of BGN 10,000 to BGN 20,000
p.002017: Art. 290s. (New, SG No. 102/2012, effective 21.12.2012) Holder of a marketing authorization which does not
p.002017: fulfills the obligations under Art. 193 and 194, shall be punished by a pecuniary sanction from 2000 to 5000 levs, and in case of a repeated sanction
p.002017: committing the same offense - with property
p.002017: fine from $ 5,000 to $ 10,000
p.002017: Art. 291. (1) (Supplemented, SG No. 60/2011, effective 05.08.2011, suppl. - SG 60/02, in force from 05.08.2011
p.002017: 07.08.2012, amended - SG, issue. 102 of 2012, effective 21.12.2012) Where the violations under Art. 281 -
p.002017: 284a, 285, 285b, art. 286, para. 1, Art. 287 and 287b, Art. 289, para. 1, Art. 289a, Art. 290, Art. 290b, Art. 292 and Art. 294 are
p.002017: committed by legal persons or sole proprietors, property penalties of not less than
p.002017: the triple amount of the minimum amounts of the respective fines and not more than triple the amount of the fines
p.002017: provided for
p.002017: the maximum amounts of the fines concerned.
p.002017: (2) (Supplemented, SG No. 60/2012, effective 07.08.2012) For violations of art. 289, para. 1
p.002017: the pecuniary sanction shall be nine times the amount of the excess amount if it exceeds the maximum
p.002017: the amount of the sanction under para. 1.
p.002017: (3) The imposition of a pecuniary sanction shall not preclude the imposition of a fine on the guilty persons
p.002017: officials.
p.002017: (4) The imposition of pecuniary sanctions shall not preclude the imposition of the measures provided for
p.002017: on the competence of medical professionals and qualified persons.
p.002017: Art. 292. (1) Who does not comply with the order, prescription or instruction of the bodies of
p.002017: state control under this law, except in cases under Art. 270, para. 1, item 2 and para. 3, shall be punished by a fine
p.002017: from 1500 to 3000 BGN
p.002017: (2) For failure to comply with an order under Art. 270, para. 1, item 2 and para. 3 guilty persons
p.002017: fined from 500 to 1000 levs
p.002017: Art. 293. (1) (amend. - SG 102/2012, in force from 02.01.2013) In case of non-compliance with the conditions,
p.002017: under which the manufacturing / import licenses, parallel importations, trade licenses have been issued
p.002017: wholesale and retail trade of medicinal products in a pharmacy, as well as in the cases under Art. 281, para. 1 - 3 and Art. 283, para. 1
p.002017: the Executive Director of the BDA issues an order for
p.002017: their seizure.
p.002017: (2) (amend. - SG 102/2012, in force from 02.01.2013) In case of non-compliance with the conditions,
p.002017: in which a certificate for registration of a drugstore was issued, as well as in the cases under Art. 287,
...
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
p.002017: quality deviations, as well as a medicinal product that has been placed on the market in breach of
p.002017: intellectual property rights.
p.002017: 82. "Homeopathic medicinal product" is a medicinal product made from substances,
p.002017: called a homeopathic source, according to European production procedures
p.002017: pharmacopoeia, and in the absence thereof, according to the national pharmacopoeia of a Member State.
p.002017: 83. "Price calculated on the basis of a benchmark" is the price formed for each
p.002017: medicinal product included in the Positive Medicinal List, calculated on the basis of that established
p.002017: reference value for a defined daily dose or therapeutic course.
p.002017: 84. "Center" is a structure of the medical establishment in which it is conducted clinically
p.002017: testing.
p.002017: 85. "Misuse of medicinal products" is permanent or occasional intentional misuse
p.002017: excessive use of medicinal products accompanied by harmful physical or
p.002017: psychological effects.
p.002017: 86. (new - SG 41/09, in force from 02.06.2009) "Infants" shall be children under 12
p.002017: months.
p.002017: 87. (new - SG 41/09, in force from 02.06.2009) "Foods for infants" are foods,
p.002017: intended for specific nutritional use by infants during their first months alone
p.002017: are sufficient to satisfy the nutritional needs of these infants up to
p.002017: the moment of introduction of suitable supplementary food.
p.002017: 88. (new - SG 41/09, in force from 02.06.2009) "Transitional foods" are foods,
p.002017: intended for the specific nutritional use of infants when administered appropriate
p.002017: supplemental food and which constitute the main liquid food of progressively increasing
p.002017: are the variety of foods in these infants.
p.002017: 89. (new - SG 12/11, in force from 08.02.2011) "Type IA change" is a change with
p.002017: minimal or no impact on quality, safety or efficacy
p.002017: of the respective medicinal product.
...
p.002000: law.
p.002000: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002000: § 84. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: with the exception of § 65, which comes into force on 30 September 2011.
p.002000: Transitional and Final Provisions
p.002000: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002000: DRUGS AND PRECURSORS
p.002000: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002000: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002000: Transitional and Final Provisions
p.002000: TO THE LAW AMENDING AND SUPPLEMENTING THE STATE LAW
p.002000: EMPLOYEE
p.002000: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002000: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in
p.002000: "State Gazette":
p.002000: 1. The Council of Ministers shall bring the Classifier of posts in administration to
p.002000: compliance with this law;
p.002000: 2. the competent authorities shall bring the planning acts of the respective
p.002000: administration in accordance with this law.
p.002000: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002000: the independent financial audit, the Electronic Communications Act, the Financial Supervision Commission Act, the Access Act and
p.002000: disclosure of documents and declaring of belonging of Bulgarian citizens to the State Security and
p.002000: Intelligence Services of the Bulgarian People's Army, Law on Forfeiture in favor of the State of Property Acquired
p.002000: of criminal activity, the Conflict of Interest Prevention and Identification Act, the Code of Conduct
p.002000: social security, the Health Insurance Act, the Farmers Support Act, and
p.002000: The Roads Act is governed by the terms and procedures of § 36 of the transitional and final provisions of the Act
p.002000: amending and supplementing the
p.002000: the civil servant (State Gazette, issue 24 of 2006).
p.002000: (2) The act of appointment of the civil servant shall:
p.002000: 1. assigns the definitions in the Classifier of posts in the administration
p.002000: minimum rank for the position held, unless the employee holds a higher rank;
p.002000: 2. determines the individual basic monthly salary.
p.002000: (3) The additional necessary funds for social security contributions of the persons under para. 2 se
p.002000: provide, within the cost of wages, salaries and social security contributions,
p.002000: the budgets of the authorizing officers concerned.
p.002000: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account
p.002000: of the State Fund for Agriculture, resulting from this law.
p.002000: (5) The governing bodies of the National Social Security Institute and the National Social Security Institute
p.002000: Health Insurance Fund to make the necessary changes to the respective budgets,
p.002000: arising from this law.
p.002000: (6) Unused employment leave shall be maintained and shall not be maintained
p.002000: offset by cash benefits.
p.002000: § 86. (1) Within one month from the entry into force of this Act the individual basic monthly salary of the employee
p.002000: is determined so that the same, less the tax due and the mandatory social security contributions at the expense of
p.002000: the insured person, if they were owed, no lower than the gross monthly salary received so far,
...
Social / Religion
Searching for indicator faith:
(return to top)
p.002017: 3. Committee for Homeopathic Medicinal Products;
p.002017: 4. Committee for Herbal Medicinal Products;
p.002017: 5. Radiopharmaceuticals Commission;
p.002017: 6. (new - SG 71/08, in force from 12.08.2008) Committee for Medicinal Products
p.002017: with application in pediatrics;
p.002017: 7. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force
p.002017: from 21.12.2012) Committee for Medicinal Products for Advanced Therapies;
p.002017: 8. (New, SG No. 102/2012, in force since 21.12.2012)
p.002017: pharmacovigilance monitoring.
p.002017: (2) If necessary, the BDA Executive Director may create others
p.002017: specialized committees outside the ones specified in para. 1.
p.002017: (3) Specialized commissions shall include specialists having scientific
p.002017: achievements and practical experience in the relevant fields of application of medicinal products.
p.002017: (4) External experts with a special status may be involved in the permanent composition of the commissions
p.002017: scientific knowledge and practical experience in the field of the specific drug group.
p.002017: (5) The Executive Director of the BDA shall determine by an order the composition of the commissions for a term
p.002017: three years, the amount of their remuneration and approve the terms and conditions of the
p.002017: their work.
p.002017: (6) By 30 January each year, the Executive Director of the BDA shall approve the lists of
p.002017: the experts outside the composition of the commissions under para. 1 after approval by the Minister of
p.002017: healthcare.
p.002017: (7) The BDA Executive Director may release a member of the BDA early
p.002017: specialized committee at his request for failure to fulfill his obligations for more than three
p.002017: months or in bad faith in the performance of its functions.
p.002017: (8) The composition of the commissions and the list of experts under para. 6 are announced on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 48. (1) The members of the specialized commissions under Art. 47, para. 1 and the experts under Art.
p.002017: 47, para. 4 sign a declaration, obliging them not to:
p.002017: 1. disclose data and circumstances that have become known to them on or on occasion
p.002017: carrying out their activity;
p.002017: 2. participate in activities related to the production or wholesale and retail trade with
p.002017: medical products.
p.002017: (2) In case the persons under para. 1 have participated in one of the preparation stages of
p.002017: the documentation necessary to authorize the use of the medicinal product cannot be provided
p.002017: participate in the meetings of the respective specialized commission under art. 47.
p.002017: (3) The persons under para. 1 shall not vote in decisions on matters on which they or
p.002017: their family members have commercial, financial or other interests.
p.002017: Art. 49. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 200 days from the date of receipt of
p.002017: valid documentation of the BDA together with the relevant commission under Art. 47, para. 1 evaluates quality, safety and
p.002017: the efficacy of the medicinal product and produces an evaluation report commenting on the results of the pharmaceutical and
p.002017: the preclinical tests, the clinical trials, the risk management system and the
p.002017: monitoring the safety of the medicinal product concerned. The evaluation report prepared shall be submitted to
p.002017: the BDA Executive Director.
p.002017: (2) (New, SG No. 102/2012, effective 21.12.2012) The report under para. 1 se
...
Social / Soldier
Searching for indicator army:
(return to top)
p.002000: para. 2 and the Regulations of the Ministry of Health in accordance with this
p.002000: law.
p.002000: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002000: § 84. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: with the exception of § 65, which comes into force on 30 September 2011.
p.002000: Transitional and Final Provisions
p.002000: TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
p.002000: DRUGS AND PRECURSORS
p.002000: (Official Gazette, SG No. 61/2011, effective 10.11.2011)
p.002000: § 54. This law shall enter into force three months after its promulgation in the State Gazette.
p.002000: Transitional and Final Provisions
p.002000: TO THE LAW AMENDING AND SUPPLEMENTING THE STATE LAW
p.002000: EMPLOYEE
p.002000: (Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
p.002000: § 84. (In force from May 18, 2012) Within one month of the promulgation of this law in
p.002000: "State Gazette":
p.002000: 1. The Council of Ministers shall bring the Classifier of posts in administration to
p.002000: compliance with this law;
p.002000: 2. the competent authorities shall bring the planning acts of the respective
p.002000: administration in accordance with this law.
p.002000: § 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
p.002000: the independent financial audit, the Electronic Communications Act, the Financial Supervision Commission Act, the Access Act and
p.002000: disclosure of documents and declaring of belonging of Bulgarian citizens to the State Security and
p.002000: Intelligence Services of the Bulgarian People's Army, Law on Forfeiture in favor of the State of Property Acquired
p.002000: of criminal activity, the Conflict of Interest Prevention and Identification Act, the Code of Conduct
p.002000: social security, the Health Insurance Act, the Farmers Support Act, and
p.002000: The Roads Act is governed by the terms and procedures of § 36 of the transitional and final provisions of the Act
p.002000: amending and supplementing the
p.002000: the civil servant (State Gazette, issue 24 of 2006).
p.002000: (2) The act of appointment of the civil servant shall:
p.002000: 1. assigns the definitions in the Classifier of posts in the administration
p.002000: minimum rank for the position held, unless the employee holds a higher rank;
p.002000: 2. determines the individual basic monthly salary.
p.002000: (3) The additional necessary funds for social security contributions of the persons under para. 2 se
p.002000: provide, within the cost of wages, salaries and social security contributions,
p.002000: the budgets of the authorizing officers concerned.
p.002000: (4) The Council of Ministers shall make the necessary changes to the extra-budgetary account
p.002000: of the State Fund for Agriculture, resulting from this law.
p.002000: (5) The governing bodies of the National Social Security Institute and the National Social Security Institute
p.002000: Health Insurance Fund to make the necessary changes to the respective budgets,
p.002000: arising from this law.
p.002000: (6) Unused employment leave shall be maintained and shall not be maintained
p.002000: offset by cash benefits.
p.002000: § 86. (1) Within one month from the entry into force of this Act the individual basic monthly salary of the employee
p.002000: is determined so that the same, less the tax due and the mandatory social security contributions at the expense of
...
Searching for indicator military:
(return to top)
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.002017: request that the specification be supplemented by
p.002017: the applicant / holder of the marketing authorization.
p.002017: Chapter Two.
p.002017: MANAGEMENT AND FINANCING BODIES
p.002017: Section I.
p.002017: Authorities
p.002017: Art. 14. (1) Medicinal policy is part of the state health policy in the Republic
p.002017: Bulgaria and is implemented by the Minister of Health. (2) The Minister of Health shall:
p.002017: 1. is a national coordinator for the problems of medicinal products;
p.002017: 2. participates in international bodies and organizations performing activities in the field of
p.002017: medicinal products;
p.002017: 3. (repealed, SG No. 60/2011, effective 05.08.2011, new - SG No. 102/2012, in force
p.002017: of 21.12.2012) organizes the provision of public information to patients' organizations and to
p.002017: consumer organizations on actions taken against
p.002017: counterfeiting of medicinal products;
p.002017: 4. performs other activities specified by law.
p.002017: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 15. (1) A Pharmacopoeial Committee shall be established to the Minister of Health as
p.002017: an advisory body on the current pharmacopoeia.
p.002017: (2) The Minister of Health at the proposal of the Executive Director of
p.002017: The BDA determines by order the composition of the Pharmacopoeial Committee and the expert groups attached to it
p.002017: and approve the rules of procedure.
p.002017: (3) The activities of the Pharmacopoeia Committee shall be financed from the budget of the Ministry
p.002017: of health.
p.002017: Art. 16. (1) A Higher Board of Pharmacy shall be established with the Minister of Health, which shall include five
p.002017: representatives appointed by the Minister of Health, five representatives of the Bulgarian
p.002017: pharmaceutical union, two representatives of the National Health Insurance Fund (NHIF) and one each
p.002017: representative of the faculties of pharmacy at medical colleges. It is the Minister of Health
p.002017: chairman of the board without
p.002017: right to vote.
p.002017: (2) The High Pharmacy Council is an advisory body that deliberates and gives opinions
p.002017: by:
p.002017: 1. the main directions and priorities in the field of pharmacy;
p.002017: 2. ethical problems of pharmacy;
p.002017: 3. draft legislative acts related to pharmacy;
p.002017: 4. scientific priorities in the field of pharmacy;
p.002017: 5. programs for organizing public educational campaigns in the field of
p.002017: medicinal products.
p.002017: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: (4) The organization and activities of the Supreme Pharmacy Council shall be governed by regulations,
p.002017: issued by the Minister of Health at the proposal of the High Council on Pharmacy.
p.002017: Art. 17. (1) The Executive Agency for Medicines shall be a specialized body to the Minister
p.002017: of health to oversee the quality, safety and efficacy of medicines.
p.002017: (2) (amend. - SG 15/2013, in force from 01.01.2014)
p.002017: Medicines is a budget-funded legal entity with its seat in Sofia to the Minister
p.002017: of health.
p.002017: (3) The Executive Agency for Medicines shall be managed and represented by an Executive Agency
p.002017: director, who is appointed in accordance with the Law on Administration.
p.002017: (4) The structure, functions and organization of work of the BDA shall be defined in
p.002017: Rules of Procedure adopted by the Council of Ministers.
p.002017: (5) The Medicines Executive Agency shall:
p.002017: 1. issues authorizations for the manufacture of medicinal products;
...
p.002017: the development of the Bulgarian Pharmacopoeia;
p.002017: 18. participate in activities in the field of medicinal products related to the work of the European Agency
p.002017: on Medicines, European Directorate for Quality of Medicines and Health, international
p.002017: bodies and organizations as well as with the implementation of
p.002017: international treaties to which the Republic of Bulgaria is a party;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) participates in the international
p.002017: harmonization and standardization of technical measures related to traceability
p.002017: drug safety, coordinated by the European Medicines Agency;
p.002017: 18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain
p.002017: national internet portal for medicinal products;
p.002017: 19. performs other activities specified by law.
p.002017: (6) (amend. - SG 98/10, in force from 01.01.2011)
p.002017: medicines coordinates its activities with regional health inspections (RICs) in the area of
p.002017: control of medicinal products.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under
p.002017: this law related to preventing the entry and distribution of counterfeit
p.002017: medicinal products, is carried out in cooperation between the BDA and the customs authorities.
p.002017: Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health
p.002017: inspections issue certificates for registration of drugstores.
p.002017: Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
p.002017: retail of medicinal products, which includes three representatives of the Bulgarian
p.002017: pharmaceutical union, one representative of the faculties of pharmacy of the medical colleges and
p.002017: four BDA representatives. The composition of the Board is determined by an order of the Executive Director of the BDA,
p.002017: agreed with the Minister of
p.002017: healthcare.
p.002017: (2) The council under para. 1 is an advisory unit which:
p.002017: 1. prepares opinions on the applications and documents submitted to the BDA under Art. 228, para. 1 and 5,
p.002017: which he presents to the Executive Director of the BDA;
p.002017: 2. make motivated proposals to the Minister of Health through
p.002017: the BDA's Executive Director for improving public access to medicines
p.002017: products.
p.002017: (3) The organization and activity of the expert council under para. 1 shall be governed by regulations,
p.002017: issued by the BDA Executive Director on a proposal from the Board.
p.002017: (4) The members of the expert council under para. 1 shall not receive remuneration for participation in
p.002017: council meetings.
p.002017: (5) The expert council under para. 1 shall be reported annually to the Minister of
p.002017: healthcare.
p.002017: Art. 17c. (New, SG No. 18/2014) They may not be members of the Expert Council of
p.002017: Art. 17b, para. 1 people who are:
p.002017: 1. owners, members of management and control bodies of commercial companies or
p.002017: sole proprietors manufacturing, importing, wholesale or retail trade with
p.002017: medical products;
p.002017: 2. partners or shareholders holding more than 5 percent of the capital in commercial
p.002017: companies active in the manufacture, import, wholesale or retail of medicinal products
p.002017: products or work under contract with those companies.
p.002017: Section II.
p.002017: Registers
p.002017: Art. 18. (Repealed, SG No. 60/2011, effective 05.08.2011)
...
p.002017: The European Commission.
p.002017: Art. 79. (1) Where the regulatory authorities of one or more Member States have adopted different decisions
p.002017: with regard to the authorization to use the same medicinal product or its temporary use
p.002017: suspension or withdrawal, the BDA referred the matter to the Committee for Medicinal Products for Human Use at
p.002017: European Medicines Agency for arbitration. The applicant or
p.002017: the Marketing Authorization Holder may refer the matter to the Committee for Medicinal Products for
p.002017: human use to the European Medicines Agency for arbitration
p.002017: a procedure at its discretion.
p.002017: (2) (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012) In the cases of para. 1 BDA or
p.002017: the applicant / marketing authorization holder shall submit to the
p.002017: The European Medicines Agency has all the information available on this subject.
p.002017: (4) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: (5) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 79a. (New, SG No. 60/2011, effective 05.08.2011) (1) Subject to
p.002017: the decision of the European Commission after the conclusion of the BDA arbitration procedure within 30 days
p.002017: days after receipt of notification:
p.002017: 1. issues, suspends or suspends a marketing authorization, or
p.002017: 2. Requests that changes be made to the permit issued to achieve
p.002017: in accordance with the European Commission decision.
p.002017: (2) The Medicines Executive Agency shall notify the European Commission and
p.002017: The European Medicines Agency for the act issued under para. 1.
p.002017: Art. 79b. (New, SG No. 102/2012, effective 21.12.2012) (1) In cases where the interests of
p.002017: The European Union and before deciding on the authorization of a medicinal product
p.002017: product, its suspension, termination or change, BDA, applicant or holder of
p.002017: marketing authorization may apply
p.002017: the question to the committee under art. 79, para. 1 for the application of the arbitration procedure.
p.002017: (2) In the cases of para. 1 where referral is the result of an evaluation of tracking data
p.002017: the safety of an authorized medicinal product, the matter is referred to the
p.002017: Art. 56a, para. 1, item 1 and the procedure of art. 194h or
p.002017: 194y.
p.002017: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall apply
p.002017: the procedure for Chapter Eight, Section IV, where one of the measures is necessary,
p.002017: referred to in Art. 194y, para. 2 and 3.
p.002017: (4) (New, SG No. 18/2014) Notwithstanding para. 1 - 3, when emergency action is needed to protect
p.002017: public health at some stage of the arbitration procedure, the BDA may suspend the authorization of
p.002017: use and prohibit the use of the respective medicinal product in the territory of the Republic of Bulgaria until
p.002017: acceptance of the final
p.002017: answer.
p.002017: (5) (New, SG No. 18/2014) In the cases of para. 4 The BDA informs the European
p.002017: the Commission, the European Medicines Agency and the other Member States for their reasons
p.002017: decision no later than the next business day.
p.002017: Art. 80. (amend. - SG 12/11, in force from 08.02.2011) The conditions and the procedure for carrying out
p.002017: changes to the authorizations granted under this section shall be governed by Regulation (EC) No 1234/2008 of the European Communities
...
p.002017: for use filed by
p.002017: the committee under Art. 56a, para. 1, item 1 of the draft protocol.
p.002017: (2) Within 60 days from the date of receipt of the documentation under para. 1 the committee under art.
p.002017: 56a, para. 1, item 1 prepares an opinion and sends to the holder of the marketing authorization:
p.002017: 1. notification of approval, or
p.002017: 2. a reasoned refusal when:
p.002017: (a) found that the study promoted the use of the medicinal product
p.002017: product, and / or
p.002017: (b) consider that the design of the study will not achieve the objectives of the report,
p.002017: and / or
p.002017: (c) the study is of a clinical trial nature.
p.002017: (3) In the cases of para. 2, item 1 the marketing authorization holder shall submit
p.002017: the notification of the BDA and the commissions under Art. 103, para. 1 or 2, where applicable.
p.002017: (4) The Commission under Art. 103, para. 1, respectively the commissions under art. 103, para. 2, within 15 days of
p.002017: the date of receipt of the notification under para. 3 shall send the holder of the authorization for
p.002017: use a positive or negative opinion.
p.002017: (5) The conduct of the study may commence upon receipt of a positive one
p.002017: opinion of the commission under art. 103, para. 1, respectively by a commission under Art. 103, para. 2.
p.002017: (6) The content and format of the protocol under para. 1 shall be determined by Regulation
p.002017: Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of the
p.002017: the pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Union
p.002017: Parliament and of the Council and in Directive 2001/83 / EC of the European Parliament and of the Council (OJ, L 159/5 of
p.002017: 20 June 2012), hereinafter referred to as "the
p.002017: Implementation (EU) No 520/2012 ".
p.002017: Art. 145g. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the authorization for use in the cases under Art. 145f, para. 1 implements planned significant changes to
p.002017: the minutes of the study after their prior approval by the committee under Art. 56a, para. 1, v. 1.
p.002017: (2) The holder of the marketing authorization shall submit to the committee referred to in Art. 56a, para. 1, vol.
p.002017: 1 the documentation related to the changes and the reasons for this.
p.002017: (3) Where the committee under Art. 56a, para. 1, item 1 approved the changes to the protocol, the holder
p.002017: of the marketing authorization shall notify the BDA and the Commission under Art. 103, para. 1, respectively commissions
p.002017: under Art. 103, para. 2.
p.002017: (4) The holder of the marketing authorization may apply the changes under para. 1 next
p.002017: receiving a positive opinion from the commission under art. 103, para. 1, respectively the commissions under
p.002017: Art. 103, para. 2.
p.002017: Art. 145h. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002017: submit electronically to the committee under Art. 56a, para. 1, item 1 final report, accompanied by
p.002017: summarizing the results of the study within 12 months
p.002017: upon completion of data collection.
p.002017: (2) The marketing authorization holder may submit a reasoned request to
p.002017: the committee under Art. 56a, para. 1, item 1 for postponement of the term under para. 1 at least three months before the date of
...
p.002017: Chapter Five.
p.002017: MANUFACTURE AND IMPORTATION OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES
p.002017: (TITLE AM. - SG, iss. 102 OF 2012, IN EFFECT OF 02/01/2013)
p.002017: Section I.
p.002017: Production
p.002017: Art. 146. (1) (amend. - SG 102/2012, in force from 02.01.2013) The production of all types
p.002017: medicinal products within the meaning of this Act and of medicinal products intended for clinical use
p.002017: testing, may be carried out on the territory of the Republic of Bulgaria only by natural or legal persons,
p.002017: registered as traders in the territory of a Member State who have been granted a manufacturing authorization,
p.002017: issued by the Director of
p.002017: Drug Enforcement Agency.
p.002017: (2) A production permit shall also be required in the cases where the products under para. 1 are
p.002017: intended for export only.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008)
p.002017: requires also for persons performing simultaneously or individually one of the following activities:
p.002017: full or partial production, various processes of packaging, packaging, repackaging, labeling, quality
p.002017: control and release of batches of medicinal products and
p.002017: medicinal products intended for clinical trial.
p.002017: (4) (Repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: (5) No production authorization is required where the cutting processes,
p.002017: mixing or packaging is carried out according to the main or pharmacopoeial formulation in a pharmacy.
p.002017: Art. 147. (amend. - SG 102/2012, in force from 02.01.2013) The Executive Agency for Medicines shall introduce
p.002017: information on marketing authorizations for medicinal products and certificates of good manufacturing
p.002017: practice in the European Union database.
p.002017: Art. 148. For obtaining a production permit the person under Art. 146 should
p.002017: has:
p.002017: 1. with appropriately qualified personnel, depending on the specifics of
p.002017: manufactured types of medicinal products and dosage forms;
p.002017: 2. at any one time with at least one qualified person who is eligible
p.002017: Art. 159;
p.002017: 3. premises for production, control and storage of medicinal products,
p.002017: provided with the necessary technical equipment and control laboratories.
p.002017: Art. 149. Managers of production and quality control of medicinal products
p.002017: products in manufacturing enterprises are persons:
p.002017: 1. who hold a Master's degree in a specialty
p.002017: "pharmacy", "chemistry" or "biology" and at least two years' practical experience in
p.002017: pharmaceutical production;
p.002017: 2. which meet the requirements of item 1 and have an additional recognized specialty in
p.002017: radiobiology or radiochemistry - for radiopharmaceuticals or for medicinal products,
p.002017: exposed to ionizing radiation;
p.002017: 3. with recognized specialty in clinical hematology, medical microbiology, virology or
p.002017: immunology - for the production of immunological medicinal products - vaccines, toxins, sera, for
p.002017: biotech products and for medicinal products derived from
p.002017: human plasma or human blood.
p.002017: Art. 150. (1) The person under art. 146 submits to the BDA an application in the form approved by
p.002017: the director of the agency.
p.002017: (2) Together with the application under para. 1 the applicant shall also submit:
p.002017: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002017: specialty, work record, criminal record or similar document, if not
p.002017: Bulgarian citizen, and employment contract for the persons under Art.
p.002017: 148, item 2 and art. 149;
p.002017: 2. copies of contracts for the assignment of production and / or control of the applications for
p.002017: production of products - in the cases of art. 151;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union,
p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
p.002017: production of radiopharmaceuticals or medicinal products subject to ionization
p.002017: radiation during their production;
p.002017: 8. permission to use the premises for production, control and storage,
p.002017: issued by the order of the Spatial Planning Act, or other substitute document;
p.002017: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 10. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) In the manufacture of narcotic substances and dosage forms containing
p.002017: such substances are also complied with the requirements of the Drug Control Act and
p.002017: precursors.
...
p.002017: Code, the appeal does not stop enforcement.
p.002017: Section II.
p.002017: Import of medicinal products (Title amend. - SG 102/02, in force from 02.01.2013)
p.002017: Art. 161. (1) (amend. - SG 102/02, in force from 02.01.2013) Imports into the territory of the Republic of Bulgaria from
p.002017: third country of all types of medicinal products and medicinal products intended for clinical use
p.002017: testing may only be carried out by natural or legal persons registered as traders under the legislation
p.002017: of a Member State that are
p.002017: have received an import permit issued by the BDA Executive Director.
p.002017: (2) In order to obtain an import permit, the person under para. 1 must have:
p.002017: 1. (amend. - SG 102/2012, in force from 02.01.2013) at any time with at least one
p.002017: a qualified person who meets the requirements of Art. 159, para. 2 and 10;
p.002017: 2. (amend. - SG 102/2012, in force from 02.01.2013) with a laboratory for quality control in
p.002017: compliance with the requirements of the ordinance under Art. 152 and storage facilities for medicinal products, and
p.002017: clinical trial medicinal products provided with
p.002017: the necessary technical equipment, in accordance with the requirements of the ordinance under Art. 198.
p.002017: Art. 162. (1) In order to obtain an import permit, the person under Art. 161, para. 1 submits to the BDA
p.002017: an application in accordance with a model approved by the Executive Director of the Agency.
p.002017: (2) To the application under para. 1 shall apply:
p.002017: 1. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: Economic Space - Document for current registration under national law, issued by
p.002017: competent
p.002017: authority of the country concerned;
p.002017: 2. (amend. - SG 102/02, in force from 02.01.2013) list of the medicinal products
p.002017: products and forms to be imported;
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) a copy of the production permit,
p.002017: issued by the regulatory authority of the exporting country and a certificate attesting the conformity of
p.002017: conditions for production, control and storage with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 4. documents certifying the circumstances under Art. 159, para. 1 and 2 for
p.002017: the qualified person;
p.002017: 5. data on the address of a laboratory on the territory of the Republic of Bulgaria for performing full quantitative and
p.002017: qualitative analysis of at least the active substances and of all other tests and verifications for the demonstration of
p.002017: the quality of each imported batch of medicinal product in accordance with the requirements of the marketing authorization
p.002017: use in accordance with this law and the address of
p.002017: storage facilities;
p.002017: 6. a contract which defines the responsibilities of each party in respect of compliance with
p.002017: the principles of Good Manufacturing Practice by the contractor and the manner in which the qualified person under Art.
p.002017: 161, para. 2, item 1 shall perform its duties in the cases,
p.002017: when the person under Art. 161, para. 1 does not have its own laboratory;
p.002017: 7. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
...
p.002017: the medicines agency keeps a public register of importers, manufacturers and traders
p.002017: wholesale of active substances, containing:
p.002017: 1. name, seat and address of management of the person under art. 167a;
p.002017: 2. a list of the active substances that are imported, manufactured or marketed;
p.002017: 3. the activities that the person under art. 167a will perform;
p.002017: 4. address of the premises where the activities are carried out;
p.002017: 5. notes on the entered circumstances.
p.002017: (2) The Executive Agency for Medicines shall enter into the database under Art. 147
p.002017: information on registered importers, manufacturers and wholesalers of active
p.002017: substances.
p.002017: Art. 167d. (New - SG 102/02, in force from 02.01.2013) (1) The person under art. 167a
p.002017: submit to the BDA annually by 31 January a notification of changes in the information,
p.002017: entered in the register under Art. 167g.
p.002017: (2) When changes occur that may affect the quality of or
p.002017: the safety of the active substances that are produced, imported or distributed by the individual
p.002017: under Art. 167a shall notify the BDA immediately.
p.002017: Art. 167f. (1) (New, SG No. 102/2012, effective 02.01.2013) The production, the import and
p.002017: wholesale of active substances on the territory of the Republic of Bulgaria, including active substances
p.002017: substances intended for export shall be carried out in accordance with
p.002017: Good manufacturing practice and Good distribution practices for active substances.
p.002017: (2) Importers may import active substances only if the following conditions are met:
p.002017: 1. the active substances were manufactured in accordance with Good standards
p.002017: manufacturing practices that are at least equivalent to those established by the European
p.002017: union, and
p.002017: 2. (In force from 02.07.2013) The active substances shall be accompanied in writing
p.002017: confirmation by the competent authority of the exporting country that:
p.002017: (a) Good manufacturing practice standards applicable to the site for
p.002017: production of the exported active substances are at least equivalent to those established by
p.002017: The European Union;
p.002017: (b) the production site concerned is subject to regular control and is effectively implemented by the Good
p.002017: manufacturing practice, including repeated and unannounced inspections, to ensure the protection of
p.002017: public health at least equivalent to that of
p.002017: The European Union, and
p.002017: (c) in the event of non-compliance, the exporting country will
p.002017: inform the BDA immediately.
p.002017: (3) (In force from 02.07.2013) The requirement of para. 2, item 2 shall not apply if the state
p.002017: exporter is included in the list under Art. 111b of Directive 2001/83 / EC.
p.002017: Art. 167g. (New, SG No. 102/2012, effective 02.07.2013) (1) Exceptionally, when necessary to
p.002017: ensure the availability of medicinal products, the importer may import the active substance without the written request
p.002017: confirmation of art. 167f, para. 2, item 2 for a period not longer than the validity of the certificate of Good
p.002017: manufacturing practice where the manufacturing site of the active substance in the exporting country was
p.002017: inspected by a regulatory authority of a Member State and found to comply with the principles and guidelines
p.002017: for good
p.002017: manufacturing practice.
p.002017: (2) In the cases of para. 1 The BDA shall notify the European Commission.
p.002017: Art. 167h. (New, SG No. 102/2012, effective 02.01.2013) Holders of authorizations for
p.002017: proceedings, including those performing the activities of art. 168b, para. 2, are considered producers in the sense
p.002017: of § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002017: caused by a defect in the goods,
p.002017: provided for therein.
p.002017: Chapter Six.
p.002017: PACKAGING AND PACKAGE LEAFLET
p.002017: Art. 168. (1) The packaging of a medicinal product shall consist of primary and / or secondary
p.002017: packing and leaflet for the patient.
...
p.002017: 1. an individual identifier for the safety indicators it gives
p.002017: opportunity for wholesalers and retailers to:
p.002017: (a) verify the authenticity of the medicinal product;
p.002017: (b) identify the individual packaging;
p.002017: 2. a means by which to check the packaging of the medicinal product
p.002017: whether it was forged.
p.002017: Art. 168a. (New, SG No. 102/2012, effective 21.12.2012) (1) On the packaging of a medicinal product that
p.002017: shall be granted on medical prescription, safety indicators according to art. 168, para. 8, except
p.002017: of cases where the medicinal product is
p.002017: included in the list determined by the European Commission by a delegated act under art. 168b.
p.002017: (2) No indications for the packaging of a medicinal product dispensed without a medical prescription shall be given.
p.002017: safety under Art. 168, para. 8, except where the medicinal product is included in the list,
p.002017: designated by the European Commission by means of a delegated act
p.002017: under Art. 168b, having been assessed as being at risk of forgery.
p.002017: (3) The Medicines Executive Agency shall notify the European Commission of:
p.002017: 1. for medicinal products which are available without a prescription for which it is
p.002017: found that there was a risk of counterfeiting;
p.002017: 2. for medicinal products for which it has been established that there is no risk of
p.002017: falsification, taking into account the following criteria:
p.002017: (a) the price and sales volume of the medicinal product;
p.002017: (b) the number and incidence of cases of counterfeit medicinal products registered in
p.002017: within the European Union and in third countries, and the change in the number and frequency of such cases in
p.002017: historical plan;
p.002017: (c) specific characteristics of the medicinal products concerned;
p.002017: (d) the severity of the disease to be treated;
p.002017: (e) other potential risks to public health.
p.002017: Art. 168b. (New, SG No. 102/2012, effective 21.12.2012) (1) The Rules on
p.002017: the safety indicators under Art. 168, para. 8 are defined by the European Commission with
p.002017: the delegated acts referred to in Article 54a (2) of Directive 2001/83 / EC.
p.002017: (2) Safety indicators shall not be eliminated or partially or completely closed,
p.002017: unless the following conditions are met:
p.002017: 1. the holder of the manufacturing authorization before partially or fully
p.002017: removes or closes safety features, checks to see if the appropriate drug
p.002017: the product is authentic and has not been tampered with;
p.002017: 2. the holder of a production permit in compliance with the requirements of Art. 168, para.
p.002017: 8 may replace safety indicators with equivalents with respect to
p.002017: the ability to guarantee the authenticity, identification and assurance of
p.002017: evidence of tampering with the medicinal product.
p.002017: (3) Safety indicators shall be considered equivalent if:
p.002017: 1. meet the requirements laid down in the delegated acts referred to in Article 54a (2)
p.002017: of Directive 2001/83 / EC, and
p.002017: 2. are equally effective in allowing authentication; and
p.002017: the identification of medicinal products and the provision of evidence of forgery
p.002017: them.
p.002017: (4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of
p.002017: the medicinal product and in accordance with good manufacturing practice for medicinal products
...
p.002017: Art. 194. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of a permit for
p.002017: use concurrently or before providing the public with new information on related concerns
p.002017: by monitoring the safety of a medicinal product authorized in the territory of the Republic
p.002017: Bulgaria, informs BDA, European
p.002017: the Medicines Agency and the European Commission.
p.002017: (2) The information under para. 1 must be objective and not misleading.
p.002017: (3) Before disseminating information related to drug monitoring
p.002017: safety, the Marketing Authorization Holder agrees with the BDA in advance with
p.002017: except for the cases under para. 1.
p.002017: (4) For carrying out the evaluation of the information under para. 3 is paid a fee of
p.002017: determined in the tariff under Art. 21, para. 2.
p.002017: Art. 194a. (New, SG No. 102/2012, effective 21.12.2012) (1) The principles and
p.002017: the requirements of Good Practice for Monitoring Pharmacovigilance are set out in
p.002017: guidance issued by the European Medicines Agency.
p.002017: (2) In carrying out pharmacovigilance monitoring activities
p.002017: the holder of the marketing authorization complies with the good practice under para. 1.
p.002017: Section II.
p.002017: Collection and reporting of information on suspected adverse reactions
p.002017: (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 194b. (New, SG No. 102/2012, effective 21.12.2012) The holder of the authorization for
p.002017: use in fulfillment of their obligations under Art. 190 is required to document all reports of suspected spam
p.002017: drug reactions observed on the territory of the European Union or in third countries, reported spontaneously by
p.002017: medical professionals or from patients or emerging from post-marketing research.
p.002017: Art. 194c. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the permit
p.002017: submit for use electronically in the database "EudraVigilance" under Art. 24 of Regulation (EC) No
p.002017: 726/2004 of the European Parliament and of the Council of reports of serious suspected adverse reactions,
p.002017: occurred on the territory of the European Union and in
p.002017: third countries, within 15 days of the date of receipt of the communication.
p.002017: (2) The Marketing Authorization Holder submits to the EudraVigilance database electronically
p.002017: all suspected adverse reactions other than those mentioned in para. 1 occurred on the territory of
p.002017: European Union, within 90 days from the date of
p.002017: receiving the message.
p.002017: (3) The Marketing Authorization Holder monitors publications in specialized medical literature and
p.002017: report to the EudraVigilance database any suspected adverse drug drug listed in it
p.002017: reaction with the exception of suspected adverse reactions from medicinal products containing active
p.002017: substances listed in the article list
p.002017: 27 of Regulation (EC) No 726/2004 of the European Parliament and of the Council and described in
p.002017: literature sources monitored by the European Medicines Agency.
p.002017: (4) The marketing authorization holder establishes procedures for the collection of accurate and reliable data,
p.002017: allowing the scientific evaluation of reports of suspected adverse reactions. The owner
p.002017: of the Marketing Authorization collects a follow-up
p.002017: information regarding these messages and provides updated data in "EudraVigilance".
p.002017: (5) The form and content of the reports under para. 1 - 3 are determined by Regulation
p.002017: Implementation (EU) No 520/2012.
p.002017: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: register the medicines in the system of art. 183 all reports of suspected adverse drug reactions
p.002017: reactions occurring on the territory of the Republic of Bulgaria by
p.002017: medical professionals and patients, and requires, if necessary, additional
p.002017: case tracking information.
p.002017: (2) When reports of suspected adverse reactions occurring on
p.002017: the territory of the Republic of Bulgaria, have been submitted by the holder of the marketing authorization,
p.002017: it provides additional follow-up information to the BDA upon request.
p.002017: Art. 194d. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: medicines submit reports to the EudraVigilance database for all serious suspects
p.002017: adverse reactions occurring on the territory of
p.002017: Republic of Bulgaria, within 15 days from the date of their receipt.
p.002017: (2) The Drug Enforcement Agency submits electronically to the EudraVigilance database
p.002017: reports of all suspected adverse reactions other than those specified in para. 1 occurred on
p.002017: the territory of the Republic of Bulgaria, within 90 days from the date
p.002017: of receiving the message.
p.002017: (3) The Drug Enforcement Agency submits electronically to the EudraVigilance database
p.002017: reports of suspected adverse reactions occurring on the territory of the Republic of Bulgaria,
p.002017: due to improper use of the medicinal product. The Medicines Executive Agency shall inform thereof
p.002017: Ministry of Health
p.002017: and professional organizations of medical specialists.
p.002017: (4) Any body or institution to which information about a suspect has been received
p.002017: reported an adverse reaction occurring on the territory of the Republic of Bulgaria
p.002017: BDA for that.
p.002017: (5) The content and format of the communications and reports under para. 1 - 3 are determined by
p.002017: Implementing Regulation (EU) No 520/2012.
p.002017: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: the medication receives information from the marketing authorization holder about serious suspects
p.002017: adverse reactions occurring on the territory
p.002017: of the European Union or in a third country through the EudraVigilance database.
p.002017: (2) The requirements for monitoring information in the EudraVigilance database are
p.002017: set out in Implementing Regulation (EU) No 520/2012.
p.002017: Art. 194g. (New - SG 102/2012, in force since 21.12.2012) In the process of exchange of information of the BDA,
p.002017: the Marketing Authorization Holders and the European Medicines Agency are cooperating with the European Medicines Agency
p.002017: detect duplicate reports of suspected spam
p.002017: drug reactions.
p.002017: Section III.
p.002017: Periodic safety update reports (New, SG No. 102/2012, effective from
p.002017: 12/21/2012)
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the Marketing Authorization is obliged to make the European Agency for Europe available electronically
p.002017: medicines periodic safety update reports containing:
p.002017: 1. summaries of data on the benefit / risk balance of the medicinal product,
p.002017: including the results of all studies, with a view to their potential impact on
p.002017: the marketing authorization;
p.002017: 2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
p.002017: available data, including clinical trial data for unauthorized indications and target groups,
p.002017: which are not included in the summary of
p.002017: product;
p.002017: 3. all data on the volume of sales of the medicinal product and any other information with which
p.002017: the holder of the marketing authorization is in possession of the volume of prescriptions, including approximate ones
p.002017: number of persons who used the medicinal product
...
p.002017: issuing the marketing authorization / registration certificate or is
p.002017: determined in accordance with Art. 194l, 194m and 194h:
p.002017: 1. every 6 months from the date of issue of the marketing authorization / certificate
p.002017: for the registration of a medicinal product by the date of its placing on the market;
p.002017: 2. every 6 months during the first two years from the date of placing on the market of
p.002017: the medicinal product;
p.002017: 3. once a year for the next two years;
p.002017: 4. once every three years after the fourth year from the date of placing on the market of
p.002017: the medicinal product.
p.002017: (4) Outside the cases under para. 3, periodic safety update reports are issued
p.002017: shall submit immediately upon request to the BDA or to a regulatory authority of a Member State.
p.002017: (5) Paragraphs 3 and 4 shall also apply to medicinal products authorized for use only
p.002017: the territory of the Republic of Bulgaria, which are not covered by Art. 194l.
p.002017: Art. 194l. (New, SG No. 102/2012, effective 21.12.2012) Where medicinal products which
p.002017: contain the same active substance or a combination of the same active substances, have been obtained separately
p.002017: marketing authorizations / registration certificate, frequency and filing dates for periodic updates
p.002017: safety reports may be modified and harmonized in order to carry out a uniform assessment of those reports.
p.002017: Art. 194m. (New, SG No. 102/2012, effective 21.12.2012) (1) The filing dates of
p.002017: the periodic safety update reports for the medicinal products under Art. 194l
p.002017: calculated according to the European Union reference date.
p.002017: (2) The European Union reference date under para. 1 is:
p.002017: 1. the date of the first authorization for use in the European Union of the medicinal product
p.002017: a product containing the relevant active substance or the corresponding combination of active substances
p.002017: substances, or
p.002017: 2. the earliest known date of authorization of the medicinal product,
p.002017: containing the relevant active substance or the corresponding combination of active substances, if
p.002017: the date referred to in item 1 cannot be determined.
p.002017: Art. 194n. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the permit
p.002017: for the use of medicinal products under Art. 194l may submit a reasoned request to the Committee
p.002017: medicinal products for human use, respectively to the coordination group under Art. 77, para. 2 for
p.002017: fixing a European Union reference date or changing the filing frequency of periodic updates
p.002017: safety reports
p.002017: on one of the following grounds:
p.002017: 1. reasons for public health;
p.002017: 2. to avoid duplicate assessment;
p.002017: 3. to achieve international harmonization.
p.002017: (2) the Committee for Medicinal Products for Human Use, respectively
p.002017: the coordination group of art. 77, para. 2 after consultation with the committee under Art. 56a, para. 1, v. 1
p.002017: approves the request or makes a reasoned refusal.
p.002017: (3) The filing frequency and the European Union reference date shall be fixed after
p.002017: consultation with the committee under Art. 56a, para. 1, item 1 of:
p.002017: 1. The Committee for Medicinal Products for Human Use - where at least one of the Marketing Authorizations
p.002017: for medicinal products containing the active substance concerned is provided in accordance with the centralized one
p.002017: procedure provided for in Chapter II of Title II of the
p.002017: Regulation (EC) No 726/2004 of the European Parliament and of the Council, or
p.002017: 2. the coordination group of art. 77, para. 2 - for cases other than those specified in item 1.
p.002017: (4) The European Union reference dates for medicinal products under
p.002017: Art. 194l and the harmonized frequency for submitting their periodic up-to-date reports
p.002017: safety shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: (5) The holder of the marketing authorization after the publication of the data under para. 4 presents to the BDA an application for
p.002017: modification of the marketing authorization for the medicinal product concerned. Any change in filing dates and on
p.002017: the frequency of submission of periodic safety update reports specified in the
p.002017: use, effective 6
p.002017: months after their date of publication.
p.002017: Art. 194o. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: Medicines evaluates periodic safety update reports for medicinal products for
p.002017: to determine if there are new risks, or a change in
p.002017: identified risks, or change in benefit / risk ratio.
p.002017: (2) The Medicines Executive Agency shall carry out a uniform assessment of the periodic up-to-date reports on
p.002017: safety for medicinal products for which the Republic of Bulgaria has fulfilled the functions of a reference country
p.002017: within the meaning of Art. 76, and is determined by
p.002017: the coordination group of art. 77, para. 2.
p.002017: (3) A rapporteur from the Republic of Bulgaria shall participate in the single evaluation of the periodic reports
p.002017: updated safety reports for medicinal products where at least one of the products
p.002017: has been authorized under Regulation (EC) No 726/2004 of the European Parliament and of the European Parliament
p.002017: The Council, and is designated as such by the committee under Art. 56a, para. 1, v. 1.
...
p.002017: measures from the decision under para. 5.
p.002017: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and where at least one of the authorizations for
p.002017: the use has been issued in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: medicinal products for human use within 30 days of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the retention, amendment, suspension or termination of validity
p.002017: of the relevant marketing authorizations, including a timetable for the implementation of
p.002017: the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. Decides to change, suspend or terminate the marketing authorizations,
p.002017: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 2. adopt a decision recommending change, suspension or termination of authorizations
p.002017: for use issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 2, Vol. 2.
p.002017: Section IV.
p.002017: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002017: 12/21/2012)
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure of
p.002017: the European Union level can be initiated by the European Commission, by the European Commission
p.002017: drug agency or from a Member State.
p.002017: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under
p.002017: the procedure for this section by notifying the regulatory authorities of the other Member States, the European Agency for Europe
p.002017: medicines and the European Commission, when for drug-related reasons
p.002017: safety, consider that a medicinal product placed on the Bulgarian market requires undertaking
p.002017: to any of the
p.002017: the following measures:
p.002017: 1. suspension or termination of the marketing authorization;
p.002017: 2. prohibition of distribution of a medicinal product;
p.002017: 3. issuing a refusal to renew the marketing authorization.
p.002017: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para.
p.002017: 2, when notified by the marketing authorization holder that for reasons related to
p.002017: drug safety monitoring, discontinued
p.002017: the distribution of the medicinal product has either taken or intends to take action on
p.002017: it will be removed from the market or it will not take any action to renew it
p.002017: the marketing authorization issued.
p.002017: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure
p.002017: under para. 2 and in cases where it considers that for reasons related to drug monitoring
p.002017: safety, a new contraindication or reduction should be added to a medicinal product
p.002017: the recommended dose or indication
p.002017: be limited.
...
p.002017: active substance with the product specified in the information under para. 5, or where this medicinal product is authorized
p.002017: for use in another or
p.002017: in other Member States.
p.002017: (7) (amend. - SG 18/04) In the cases of para. 4 when you do not have to
p.002017: take urgent measures, the BDA applies the procedure under Art. 77 or 79b.
p.002017: (8) (New, SG No. 18/2014) The Executive Agency for Medicines shall inform
p.002017: the holder of the marketing authorization in order to initiate the procedure under this section.
p.002017: Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases under Art. 194y, para. 2 when
p.002017: considered it necessary to take urgent measures to protect public health, BDA
p.002017: may suspend the marketing authorization and prohibit the use of the medicinal product
p.002017: the territory of the Republic of Bulgaria until the adoption of the
p.002017: final decision under art. 194h or 194h.
p.002017: (2) The Medicines Executive Agency shall notify the European Medicines Agency, the European Medicines Agency
p.002017: the Commission and the regulatory authorities of the other Member States for the measures taken under para. 1 within one working day
p.002017: day from their implementation and state the reasons for
p.002017: this.
p.002017: (3) Where the Medicines Executive Agency participates in the procedure under this section, at the request of the European Medicines Agency
p.002017: the BDA Commission takes the recommended provisional measures with regard to the Marketing Authorization for
p.002017: medicinal product or where the medicinal product is authorized under Regulation (EC) No
p.002017: 726/2004 of the European Union
p.002017: Parliament and Council - with regard to the product itself, pending the completion of the procedure.
p.002017: Art. 194x. (New - SG 102/2012, in force since 21.12.2012) The Executive Agency for Medicines shall publish
p.002017: announcement of the national internet portal under art. 185, para. 1 on how stakeholders can
p.002017: provide information to the European Internet portal under Art. 68, para. 1, item 4 for the medicinal product subject to
p.002017: the procedure under Art. 194y, and for
p.002017: the opportunity to participate in a public hearing, if announced.
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) The Committee under Art. 56a, para. 1, item 1 by the time of
p.002017: 60 days from the date of the announcement of the European Internet procedure
p.002017: portal makes a reasoned recommendation.
p.002017: (2) The holder of the marketing authorization may, within the term of para. 1 to provide
p.002017: written comments.
p.002017: (3) The recommendation under para. 1 shall be published on the European Internet portal under Art. 68, para. 1, vol.
p.002017: 4 and contains one or more of the following conclusions:
p.002017: 1. no further investigation or action is required on
p.002017: Community level;
p.002017: 2. the holder of the marketing authorization must carry out additional work
p.002017: study and analysis of data;
p.002017: 3. the marketing authorization holder must carry out post-marketing
p.002017: a safety study with a subsequent evaluation of its results;
p.002017: 4. the Member State or the holder of the marketing authorization to apply measures to
p.002017: risk reduction;
p.002017: 5. the marketing authorization must be suspended, suspended or issued
p.002017: refusal to renew it;
p.002017: 6. the marketing authorization must be modified.
p.002017: (4) The specific measures under para. 3, item 4, as well as the conditions and restrictions that should
p.002017: be included in the marketing authorization, the recommendation states.
p.002017: (5) In the cases of para. 3, item 6, when the changes are related to the amendment or addition of information in the brief
p.002017: a specification, on the packaging or package leaflet of the medicinal product, shall be included in the recommendation
p.002017: the wording of the amended or added
p.002017: information and the place where it should be displayed.
p.002017: Art. 194h. (New, SG No. 102/2012, effective 21.12.2012) (1) Where within the scope of the procedure under Art. 194y
p.002017: no medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002017: Parliament and the Council, the coordination group under Art. 77, para. 2 on the basis of the recommendation under Art. 194s within 30 days
p.002017: from the date of its receipt, issue an opinion on the retention, modification, suspension, termination
p.002017: of the relevant authorizations or refusals to renew them, including a timetable for
p.002017: implementation of the opinion.
p.002017: (2) Where the opinion recommends that the measures under Art. 194ts, para. 3, Vol. 5,
p.002017: the Executive Director of the BDA shall, by order, suspend or revoke the authorization for
p.002017: use, or refuses to renew it.
p.002017: (3) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (4) Where in the opinion under para. 1 it is recommended to take measures under art. 194ts, para.
p.002017: 3, items 2 - 4, the holder of the marketing authorization takes the necessary actions and
p.002017: inform the BDA and the regulatory authorities of the other Member States.
p.002017: (5) Where, within the coordination group under Art. 77, para. 2 could not be reached,
p.002017: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002017: decision with recommendation for change, suspension or termination
p.002017: of the marketing authorization issued by the relevant regulatory authorities of the Member States.
p.002017: (6) The Drug Enforcement Agency shall implement the recommendations recommended in the decision under para. 5
p.002017: interim and / or definitive measures.
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Where within the scope of the procedure under Art. 194y
p.002017: a medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002017: Parliament and the Council, the Committee for Medicinal Products for Human Use, based on the recommendation under Art. 194ts, para.
p.002017: 3, within 30 days from the date of its receipt, issue an opinion on the retention, change,
p.002017: suspension, termination of the relevant marketing authorizations or refusal of
p.002017: their renewal, including a timetable for the implementation of the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. adopt a decision to change, suspend or terminate the validity of the permits
p.002017: for use, issued under Regulation (EC) No 726/2004 of the European Parliament and of the
p.002017: The Council;
p.002017: 2. adopt a decision recommending the change, suspension or termination of validity of
p.002017: marketing authorizations issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Drug Enforcement Agency shall implement the recommendations recommended in the decision of the European Medicines Agency
p.002017: The European Commission under para. 2, item 2 provisional and / or final measures.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) The recommendation under Art. 194c,
p.002017: para. 1, the opinion under art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and
p.002017: Art. 194h, para. 2 shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: Chapter Nine.
p.002017: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN
...
p.002017: permission from the BDA Executive Director.
p.002017: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may
p.002017: only wholesale medicinal products for which a marketing authorization has been granted
p.002017: production.
p.002017: (2) An importer of medicinal products within the meaning of this Act may perform
p.002017: wholesale only of medicinal products for which import authorization has been granted.
p.002017: Art. 197. The persons under art. 195 must have:
p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
p.002017: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible master pharmacist under Art. 197, v. 2 and
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
p.002017: containing such substances, the requirements of the Control Act also apply
p.002017: drugs and precursors.
...
p.002017: the market on the territory of the Republic of Bulgaria for its intention to carry out parallel imports and
p.002017: upon request, provide him with a sample of the medicinal product in parallel;
p.002017: 2. keep for 5 years the following documentation: name and address of the person to whom he / she is
p.002017: delivered in parallel the imported medicinal product, date of delivery, delivered quantity
p.002017: and batch number;
p.002017: 3. submit to the BDA:
p.002017: (a) an updated patient leaflet for the parallel imported product in accordance with
p.002017: changes have occurred in the granted marketing authorization in the Republic of Bulgaria
p.002017: medicine;
p.002017: b) (amend. - SG 71/08, in force from 12.08.2008) a statement that the content of
p.002017: the leaflet under letter "a" is identical to the contents of the product leaflet authorized for
p.002017: use in the Republic of Bulgaria, except for the data under Art. 215, para. 2, item 7, letters "a" - "d";
p.002017: 4. document and report to the Marketing Authorization Holder and the BDA
p.002017: all reports of suspected adverse reactions to the medicinal product introduced
p.002017: product.
p.002017: Chapter Nine "b".
p.002017: EXPORT OF MEDICINAL PRODUCTS (NEW, SG No. 18/2014)
p.002017: Art. 217a. (New, SG No. 18/2014) (1) Export of medicinal products from the territory of the Republic of Bulgaria may
p.002017: to carry out a natural or legal person who holds a marketing authorization for a medicinal product
p.002017: products or marketing authorization holder
p.002017: production.
p.002017: (2) The holder of a manufacturing authorization may export only to
p.002017: its medicinal products.
p.002017: (3) For the purposes of this Chapter, exports are also intra - Community supplies within the framework of
p.002017: The European Union.
p.002017: (4) Export of medicinal products included in the Positive Medicinal List under Art.
p.002017: 262, para. 1, from the territory of the Republic of Bulgaria shall be made after notification to
p.002017: BDA on a case - by - case basis where the export is carried out by the holder of a
p.002017: wholesale of medicines.
p.002017: Art. 217b. (New, SG No. 18/2014) The notification under Art. 217a, para. 4 is filed by
p.002017: the Executive Director of the BDA and contains the following data:
p.002017: 1. name and address of management of the person under art. 217a, para. 1;
p.002017: 2. name, dosage form and quantity of active substance in dosage form
p.002017: unit of medicinal product intended for export;
p.002017: 3. number of the authorization for wholesale of medicinal products;
p.002017: 4. number of packages of the medicinal product intended for export;
p.002017: 5. the country where the export is planned to take place.
p.002017: Art. 217c. (New, SG No. 18/2014, declared unconstitutional by RKS No. 1 of 2015 - SG, No. 12/2015)
p.002017: (1) Upon receipt of a notification under Art. 217b BDA requires information on the medicinal product intended for export
p.002017: for a period of 6 months from the date of filing
p.002017: notification:
p.002017: 1. for the consumption of the respective medicinal product by the National Health Insurance Fund and / or by
p.002017: The Ministry of Health;
p.002017: 2. for the deliveries of the respective medicinal product in the Republic of Bulgaria by the holder of
p.002017: the marketing authorization.
p.002017: (2) The persons under para. 1 provide the information requested by the BDA within 15 days of receipt of
p.002017: the request.
p.002017: (3) The Executive Agency for Medicines shall perform an analysis of the received under para. 2 information about
...
p.002017: for special medical purposes and infant formulas and follow-on formulas, and nutritional supplements, cosmetic and
p.002017: sanitary and hygienic
p.002017: funds.
p.002017: Art. 226. (1) On the territory of medical establishments for outpatient care may be
p.002017: open pharmacies to sell medicinal products to citizens.
p.002017: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, curative
p.002017: establishments for hospital care and medical establishments under art. 10 of the Law on medical establishments does not
p.002017: pharmacies can be opened to sell medicinal products to citizens.
p.002017: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009)
p.002017: The requirements for the location and the premises of the pharmacy are laid down in the ordinance of
p.002017: Art. 219, para. 2.
p.002017: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in
p.002017: (requirements from 05.08.2011) Requirements to the device and premises of pharmacies under Art. 228, para.
p.002017: 5 shall be determined in the ordinance under para. 1.
p.002017: Art. 228. (amend. - SG 71/08, in force from 26.07.2008) (1) (amend. - SG 60/11, in force from 26.07.2008)
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002017: director of the BDA on the basis of a model application to
p.002017: applicable:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a country Party
p.002017: Agreement on the European Economic Area - Document for the up - to - date registration of the European Economic Area
p.002017: national legislation issued by the competent authority of the relevant
p.002017: the state of the persons under art. 222, para. 1;
p.002017: 2. employment contract or contract for management of the pharmacy, concluded with the master pharmacist
p.002017: or with a pharmacist assistant;
p.002017: 3. a copy of the act for the creation of the persons under Art. 222, para. 4;
p.002017: 4. documents certifying that the requirements of Art. 224 Hours;
p.002017: 5. (suppl. - SG 103/07, in force from 01.01.2018) criminal record of
p.002017: Master of Pharmacy, respectively of the Assistant Pharmacist appointed as Head of Pharmacy,
p.002017: if they are not Bulgarian citizens;
p.002017: 6. medical certificate of the Master of Pharmacy, respectively
p.002017: assistant pharmacist appointed as pharmacy manager;
p.002017: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002017: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued
p.002017: from the relevant RI;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002017: medicinal products are checked to see if the diploma of the master pharmacist / assistant pharmacist is presented
p.002017: issued by the relevant competent authority
p.002017: institution.
p.002017: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies under Art.
...
p.002017: and the requirements of the Drugs and Precursors Control Act.
p.002017: (5) (New - SG, iss. 102 in 2009, in force since 22.12.2009, previous para 4 - SG, iss. 60 in 2011, in force since
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy opened in a population
p.002017: a place with a population of less than 10,000 inhabitants is issued on the basis of
p.002017: application form to which shall be attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) the documents under para. 1, items 1 - 7a and
p.002017: a document issued by the mayor of the respective municipality certifying the number of residents of
p.002017: the respective settlement;
p.002017: 2. (amend. - SG 102/02, in force from 02.01.2013) document for paid fee in
p.002017: 50 per cent of the fee determined in the tariff under Art. 21, para. 2 for the authorization of
p.002017: retail trade of medicinal products under Art. 222, para. 1.
p.002017: (6) (Renumbered from Paragraph (4), Suppl. - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 98)
p.002017: from 2010, in force from 01.01.2011, previous para. 5, amend. - SG, issue. 60 of 2011, effective 05.08.2011
p.002017: d.) The application and documents under para. 1 and 5 shall be submitted to the BDA.
p.002017: (7) (Renumbered from Paragraph (5), amend. - SG 102/09, in force from 22.12.2009, amended - SG, issue 98
p.002017: from 2010, in force from 01.01.2011, previous para. 6, amend. - SG, issue. 60 of 2011, effective 05.08.2011
p.002017: (d) Regional health inspections shall issue a hygienic conclusion within 14 days of the date
p.002017: of applying for it.
p.002017: (8) (New, SG No. 48/2015) On the day of receipt of the application under para. 1 and 5, the BDA shall send a request on its own motion
p.002017: to the Board of Directors of the Bulgarian Pharmaceutical Union for issuance of a certificate for registration in the national
p.002017: electronic register of the members of the Bulgarian Pharmaceutical Union - for the master pharmacist, head of
p.002017: pharmacy, as well as providing information on penalties imposed under the Commercial Law
p.002017: the organization of master pharmacists and the Health Act.
p.002017: (9) (New, SG No. 48/2015) The Managing Board shall submit the documents under para. 8th c
p.002017: 5 working days after receiving the request.
p.002017: (10) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 1, Vol. 5,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 229. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, repealed - SG No. 60/2011)
p.002017: (in force from 05.08.2011)
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 102/2009, effective 22.12.2009,
p.002017: ed. - SG, issue. 60 of 2011, in force since 05.08.2011, suppl. - SG, issue. 18 of 2014) Within one month from
p.002017: receipt of the documentation under Art. 228, para. 6 the Executive Director of the BDA after the opinion of
p.002017: The Expert Council for Retail Trade in Medicinal Products issues a marketing authorization
p.002017: retail with medicinal products at a pharmacy or make a motivated refusal to grant an authorization.
p.002017: The permit or refusal shall be
p.002017: served on the applicant.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation under Art.
p.002017: 228, para. 6 The BDA shall check the submitted documents and notify the applicant in writing of the established ones
p.002017: inconsistencies or incompleteness. In these cases
p.002017: the term under para. 2 shall cease to run from the day of notification until the deficiencies have been rectified.
...
p.002017: pharmacy specified in the tariff under Art. 21, para. 2.
p.002017: (5) (Renumbered from Paragraph (2), SG No. 60/2011, effective 05.08.2011)
p.002017: the permit permitting the change under para. 1, the provisions of Art. 229
p.002017: Art. 232. (1) Doctors and doctors in dental medicine may store medicines
p.002017: products on a list determined by the Minister of Health.
p.002017: (2) Where there is no pharmacy in the settlement, the persons under para. 1 can store and yes
p.002017: sell medicinal products only if they have been authorized to do so in the order specified in
p.002017: ordinance of the Minister of Health.
p.002017: Art. 233. The head of the pharmacy shall be responsible for the activities referred to in Art. 219,
p.002017: para. 1.
p.002017: Art. 234. (1) It is prohibited to sell medicinal products through automatic machines, except for
p.002017: the medicinal products specified in the list specified in the ordinance under Art. 219, para. 2.
p.002017: (2) The automatic machines under para. 1 may be owned only by the persons under Art. 222 and Art. 238,
p.002017: para. 2.
p.002017: (3) The sale of medicinal products shall be prohibited.
p.002017: (4) It is prohibited to sell on the Internet medicines medicinal products
p.002017: prescription.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) Medicinal products without
p.002017: prescription may only be sold online from a pharmacy or drugstore that they have obtained
p.002017: authorization under the terms and conditions of this Act and the ordinance under Art. 219, para. 2, respectively
p.002017: Art. 243.
p.002017: (6) (New, SG No. 102/2012, effective 02.01.2013) The pharmacies and drugstores of para. 5
p.002017: publish on the website through which they trade medicinal products without
p.002017: prescription, a general logo recognizable throughout the European Union.
p.002017: (7) (New, SG No. 102/2012, effective 02.01.2013) Requirements to the common logo
p.002017: under para. 6 shall be determined by a delegated act under Art. 85c (3) of Directive 2001/83 / EC.
p.002017: Art. 234a. (New, SG No. 102/2012, effective 02.01.2013) (1) The Executive
p.002017: Medicines Agency publishes and maintains on its website:
p.002017: 1. information on national legislation applicable to the marketing of medicinal products for
p.002017: Internet sales, including information that there may be differences between
p.002017: Member States with regard to the classification of
p.002017: the medicinal products and the conditions for their delivery;
p.002017: 2. information on the purpose of the common logo;
p.002017: 3. a list of persons offering medicinal products for sale on the Internet, and
p.002017: the addresses of their websites;
p.002017: 4. general information on the risks associated with the medicinal products delivered to
p.002017: Internet users in violation of the ordinance under Art. 234, para. 5.
p.002017: (2) The website of the BDA under para. 1 is linked to
p.002017: European Medicines Agency.
p.002017: Art. 234b. (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines shall participate in the
p.002017: information campaigns conducted by the European Commission and the European Medicines Agency
p.002017: the risk of counterfeit medicines
p.002017: products.
p.002017: Art. 235. (1) The permit for carrying out retail trade in medicinal products
p.002017: under Art. 229, para. 2 shall be terminated by termination of the activity of the persons under art. 222 and 225.
p.002017: (2) (Amended, SG No. 60/2011, effective 05.08.2011) The Executive Director of
p.002017: The BDA suspends the authorization to trade in medicinal products:
...
p.002017: pharmacy, medicinal products may be sold to persons who have been authorized
p.002017: wholesale of medicines.
p.002017: Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
p.002017: prescription, can be sold in a drugstore. Drugstores can also sell products and
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
p.002017: registration of a drugstore or for making a change under Art. 242 the respective RIC collects fees
...
p.002017: internet of prescription medicines, except
p.002017: vaccination advertising campaigns carried out in accordance with Art. 248 and approved by the competent
p.002017: organs.
p.002017: Art. 249. The requirements for the advertising of medicinal products shall be laid down in an ordinance
p.002017: of the Minister of Health.
p.002017: Art. 250. An application for a marketing authorization for a medicinal product shall be submitted by
p.002017: the holder of the marketing authorization or the authorized product
p.002017: face.
p.002017: Art. 251. (1) The person under art. 250 submits an application to the BDA on
p.002017: a model approved by the Executive Director of the Agency, accompanied by:
p.002017: 1. advertising project;
p.002017: 2. a notarized power of attorney from the holder of the marketing authorization,
p.002017: when the application is submitted by another person;
p.002017: 3. the literary sources of the quotations, tables or other materials used,
p.002017: when there are any;
p.002017: 4. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (2) The advertising projects under para. 1, item 1 must be clear, with intelligible text, in cases where
p.002017: and, where available, to evaluate all its elements - text and
p.002017: illustrations.
p.002017: (3) An Expert Council on Advertising shall be established at the BDA. It includes doctors and practitioners with practical experience in
p.002017: the field of advertising. The Executive Director of the BDA shall determine by an order the composition of the Board to which it is appointed
p.002017: include one representative of the Professional Ethics Committee of the Bulgarian Medical Association, the Bulgarian Medical Association
p.002017: dental
p.002017: Union and the Bulgarian Pharmaceutical Union, the amount of the remuneration of its members and approves regulations
p.002017: about the terms and conditions for his work. The board can be
p.002017: representatives of patient organizations are also included.
p.002017: (4) The council under para. 3 prepares expertise for the advertising project and prepares an opinion by
p.002017: the BDA Executive Director.
p.002017: (5) In case of finding inconsistencies of the advertising with the requirements of this law within 7 days from
p.002017: the date of submission of the application under para. 1 The BDA gives written instructions for their removal in one month
p.002017: term from the date of notification. The time limit for pronouncement is suspended
p.002017: run for the period from the day of notification to the elimination of inconsistencies.
p.002017: (6) In case the applicant does not comply with the instructions within one month from the date of
p.002017: the notification under para. 5, the authorization procedure is terminated.
p.002017: Art. 252. (1) Within one month from submission of the documentation under Art. 251, para. 1 on the basis of the opinion under Art.
p.002017: 251, para. 4, the BDA Executive Director authorizes the advertisement by order or makes a reasoned refusal for which
p.002017: notify the authorization holder of
p.002017: use.
p.002017: (2) (New, SG No. 60/2011, effective 05.08.2011) When, within the term of para. 1
p.002017: the BDA's executive director did not authorize the advertisement or motivated it
p.002017: refusal, it is considered that there is tacit agreement with the project of advertising under Art. 251, para. 1, item 1 and she
p.002017: can be distributed.
p.002017: (3) (Renumbered from Paragraph (2), SG No. 60/2011, effective 05.08.2011)
...
p.002017: shall also notify the NHIF in writing within the time limits under para. 4.
p.002017: (4) The marketing authorization holder shall be obliged to make the notification under
p.002017: para. 1 not later than 18 months before the date of cessation of sales, but in the cases of
p.002017: para. 2 - not later than three months before the date of cessation of sales.
p.002017: (5) (Supplemented, SG No. 18/2014) Until the termination of the sales under para. 1 and 2 the holder of
p.002017: the marketing authorization is required to provide sufficient quantities of the medicinal product concerned for
p.002017: meeting health needs, unless
p.002017: when the suspension is due to any of the grounds under Art. 276 or under Art. 277.
p.002017: (6) After the expiry of the terms under para. 4 the Marketing Authorization Holder
p.002017: submit an application for the exclusion of the medicinal product from the
p.002017: Positive drug list.
p.002017: (7) Where, following the cessation of sales of the medicinal product, the holder of the
p.002017: the marketing authorization did not fulfill its obligation under para. 6, the council under art. 258, para. 1
p.002017: officially excludes him from the Positive Drug List.
p.002017: Art. 265. (1) The Council of Ministers shall establish a Transparency Committee.
p.002017: (2) (Supplemented, SG No. 60/2011, effective 05.08.2011) The composition of the Transparency Committee
p.002017: shall be determined by the Council of Ministers on the proposal of the Minister of Health. In her
p.002017: representatives of the Ministry of Health and the Ministry of Health are obligatory included
p.002017: labor and social policy, the BDA, the NHIF, the Bulgarian Medical Union, the Bulgarian Dental
p.002017: Union of the Bulgarian Pharmaceutical
p.002017: union and patient organizations and the pharmaceutical industry.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in
p.002017: (Effective 21.12.2012) A person who is a member of the Transparency Committee may not be a member of
p.002017: National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (4) The Council of Ministers shall lay down the rules and procedures for the work of the Commission
p.002017: for transparency.
p.002017: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012
p.002017: The Transparency Committee is an appealable body
p.002017: the decisions of the National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority
p.002017: ѝ.
p.002017: (3) The decisions under par. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a respective disease is without
p.002017: alternative in the country, for a particular patient may be administered a medicinal product that is authorized for
p.002017: use in a Member State of the European Union,
p.002017: it is authorized for use according to the procedure of this law, but it is not distributed on the Bulgarian market.
p.002017: (2) Annually upon proposal by the medical establishments for hospital care and after the opinion of the respective
p.002017: the national consultant on the disease profile, the Minister of Health approves the list of
p.002017: the medicinal products under para. 1 which contains
p.002017: following information:
p.002017: 1. anatomical-therapeutic-chemical classification code;
p.002017: 2. an international non-patent name to which the product belongs;
p.002017: 3. disease according to the international disease code;
p.002017: 4. the dosage form and the amount of active substance;
p.002017: 5. additional information.
p.002017: (3) The list under para. 2 is published on the Ministry of Justice's website
p.002017: healthcare on the internet.
p.002017: (4) The conditions and procedure for inclusion, modification or exclusion of medicinal products in
p.002017: the list under para. 2 shall be determined by the ordinance under art. 9, para. 1.
p.002017: (5) The medicinal product under para. 1 is delivered by special order curative
p.002017: hospital care facility under the terms and procedures established by the ordinance under Art. 9, para. 1.
p.002017: (6) The head of the medical establishment under para. 5 is responsible for the implementation of
p.002017: the treatment under para. 1.
p.002017: Chapter thirteen.
p.002017: STATE CONTROLS ON MEDICINAL PRODUCTS
p.002017: Art. 267. (1) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, effective from
p.002017: 12/21/2012) The Ministry of Health supervises the state control over medicinal products.
...
p.002017: use out of the cases under item 1.
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012)
p.002017: medicines carries out inspections:
p.002017: 1. to manufacturers of medicinal products located in the territory of the Republic
p.002017: Bulgaria, per Member State or in third countries;
p.002017: 2. to importers and wholesalers of medicinal products;
p.002017: 3. at the premises of the manufacturers, importers and wholesalers of the active
p.002017: substances located on the territory of the Republic of Bulgaria;
p.002017: 4. at the premises of manufacturers or wholesalers of active substances,
p.002017: located in third countries as well as manufacturers or importers of excipients;
p.002017: 5. at the premises of the holders of marketing authorization
p.002017: products and intermediaries in the field of medicinal products, registered in accordance with Art.
p.002017: 212a;
p.002017: 6. as part of the certification procedure relating to the monographs of
p.002017: The European Pharmacopoeia;
p.002017: 7. to manufacturers of starting materials at the written request of the manufacturer.
p.002017: (4) The Medicines Executive Agency shall carry out inspections of manufacturers of
p.002017: medicinal products established in a third country in connection with an application for
p.002017: obtaining a marketing authorization or import.
p.002017: (5) (Amended, SG No. 102/2012, effective 21.12.2012) The inspections under para. 3 and 4 are
p.002017: carried out in accordance with guidelines adopted by the European Commission.
p.002017: (6) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines
p.002017: participate, at the request of the European Commission, the European Medicines Agency or a Member State, in
p.002017: carrying out inspections under para. 3 in the European Union or in the third
p.002017: countries.
p.002017: (7) (Amended, SG No. 102/2012, effective 21.12.2012)
p.002017: medicines cooperates and exchanges information with the European Medicines Agency at
p.002017: planning and carrying out the inspections under para. 3.
p.002017: (8) (New, SG No. 102/2012, in force since 21.12.2012)
p.002017: medicines cooperates with the European Medicines Agency in coordinating
p.002017: inspections in third countries.
p.002017: Art. 269a. (New, SG No. 102/2012, effective 21.12.2012) (1) The officials of
p.002017: Art. 267, para. 3 prepare a report for each inspection carried out under Art. 269, para. 3 and 4 for compliance with
p.002017: principles and guidelines for Good Manufacturing Practice or Good Distribution
p.002017: practices, or to comply with the requirements of Chapter Eight, and the requirements of this Act.
p.002017: (2) The report under para. 1 shall be provided to the verified person who may submit
p.002017: notes on it.
p.002017: (3) Upon receiving a reasoned request, the BDA shall electronically send the reports on
p.002017: para. 1 of the competent authority of another Member State or of the European Agency for the European Union
p.002017: medicines.
p.002017: Art. 269b. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002017: Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good Distributor
p.002017: practices, where applicable, issued by the BDA to the manufacturer, importer or wholesaler
p.002017: Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice in
p.002017: up to 90 days from
p.002017: carrying out the inspection.
p.002017: (2) When, as a result of an inspection under Art. 269, para. 3 found that the manufacturer,
p.002017: the importer or wholesaler of the medicinal products or the active substances does not comply
p.002017: the requirements of the law and / or the principles and guidelines of Good Manufacturing Practice and / or of
p.002017: Good distribution practices, the BDA issues an opinion on
p.002017: discrepancy.
p.002017: (3) The Executive Agency for Medicines shall enter into the database under Art. 147 issued
p.002017: certificates under para. 1 and information under para. 2.
p.002017: Art. 269c. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002017: Art. 270, para. 1, item 5 it is established that the holder of the marketing authorization does not comply with the requirements of
p.002017: Chapter Eight, the BDA prescribes the removal of
p.002017: inconsistencies.
p.002017: (2) In the cases of para. 1 The BDA shall notify the Member States, the European Agency for the Protection of Energy
p.002017: medicines and the European Commission.
p.002017: right:
p.002017: Art. 270. (1) Within the limits of their competence, the officials under Art. 267, para. 3 have
...
p.002017: violation of this law, as well as medicinal products that are available in packs of leaflets which
p.002017: do not meet the requirements of this law; order withdrawals from pharmacies and, if necessary
p.002017: drugstores, from wholesale warehouses, from manufacturers and medical establishments, and notify
p.002017: this Ministry of
p.002017: healthcare;
p.002017: 5. suspend clinical trials for established disorders until they are corrected or
p.002017: orders their termination;
p.002017: 5a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: effective 02.01.2013) orders the blocking, downloading and destruction of counterfeit goods
p.002017: medicinal and non-originating medicinal products;
p.002017: 5b. (new - SG 60/11, in force from 05.08.2011) carries out inspections of
p.002017: the donations made under Art. 268a, para. 1;
p.002017: 6. issue orders, instructions and instructions within its competence,
p.002017: which are binding on all persons;
p.002017: 7. (new - SG 60/11, in force from 05.08.2011) place medicinal products under suspension
p.002017: products and active substances in case of doubt as to their quality deviation by affixing
p.002017: certificates at production sites.
p.002017: (2) The compulsory administrative measures under para. 1 or under Art. 270, para. 3 are imposed by
p.002017: order of the BDA Director.
p.002017: (3) The orders under para. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 272a. (New, SG No. 102/2012, effective 02.01.2013) (1) By delegated acts under Art. 52b, paragraph
p.002017: 2 of Directive 2001/83 / EC lays down the necessary measures to prevent the placing on the market of
p.002017: medicinal products introduced into the European Union but not intended to be placed on the market in the European Union,
p.002017: for which there is enough
p.002017: grounds for suspecting that they have been falsified.
p.002017: (2) The Executive Agency for Medicinal Products shall take the necessary measures in accordance with the delegated ones
p.002017: acts under para. 1 to prevent the release of medicinal products introduced into the European Union
p.002017: union but not intended to be marketed
p.002017: of the European Union for which there are sufficient grounds for suspecting that they have been falsified.
p.002017: (3) The customs authorities shall notify the BDA of the introduction into the territory of the Republic
p.002017: Bulgaria of medicinal products under para. 1 with a view to taking measures under para. 2.
p.002017: Art. 273. (1) The conditions and the procedure for sampling, testing and
p.002017: their remuneration shall be determined in an ordinance of the Minister of Health.
p.002017: (2) When challenging the results of laboratory tests, they shall be made
p.002017: retesting. They shall be made upon written request from the interested party,
p.002017: made within 7 days from the date of receipt of the result of the original test.
p.002017: (3) The repeated tests under para. 2 shall be carried out by experts designated by
p.002017: the BDA's Executive Director, who did not participate in the initial test, c
p.002017: the presence of an authorized representative of the interested party.
p.002017: Art. 274. (1) The conditions and the order for blocking and withdrawal of medicinal products,
p.002017: have shown non - compliance with the requirements for quality, safety and efficacy, shall be defined in
p.002017: ordinance of the Minister of Health.
p.002017: (2) The conditions and procedure for the destruction, processing or use for others
p.002017: the goals of the medicinal products are set out in an ordinance of the Minister of Health.
p.002017: Art. Article 275. (1) In exercising control, the BDA shall take all necessary measures to ensure proper validation of
p.002017: the processes of production and purification of medicinal products derived from human blood or human plasma,
p.002017: consistency in batch quality and ensuring, as far as technology allows, the absence of
p.002017: specific viral
...
p.002017: the same molar dose is similar to such an extent that its effects in terms of efficacy and
p.002017: safety is substantially similar.
p.002017: 3. "Bioavailability" is the rate and extent at which the active substance or the therapeutically active part of it is absorbed
p.002017: of the dosage form and becomes available at the site of action. When the drug substance is intended to
p.002017: exercise a systemic therapeutic effect, bioavailability means the speed and degree at which a drug substance or
p.002017: therapeutically
p.002017: its active part is released from the dosage form and goes into general circulation.
p.002017: 4. "Researcher's Brochure" means the aggregate of clinical and non-clinical data for
p.002017: the investigational medicinal product (s) that are relevant for the test of the product or product
p.002017: products on people.
p.002017: 5. "Valid documentation" shall mean documentation which in content and completeness corresponds to
p.002017: the requirements laid down in a particular procedure under this Act.
p.002017: 6. "Substance with well established use in medical practice" is a substance for
p.002017: the following criteria may apply:
p.002017: (a) the period of proof of well-established use in medical practice is not less than 10 years from
p.002017: the date of the first systematic and documented use of the substance as a medicinal product in
p.002017: The European Union or the European Economic Community
p.002017: space;
p.002017: (b) quantitative aspects of the use of the substance, taking into account the degree of medical use
p.002017: practice, the degree of geographical use and the degree of tracking through the safety system,
p.002017: including pre-market research and scientific research published thereafter
p.002017: epidemiological literature
p.002017: studies and, in particular, comparative epidemiological studies;
p.002017: (c) a high level of scientific interest in the use of the substance (number of scientific
p.002017: publications) and unity in the scientific community in scientific evaluations.
p.002017: 7. "Secondary packaging" is a packaging which does not come in direct contact with
p.002017: the medicinal product.
p.002017: 8. "Contracting Authority" means a natural or legal person, institution or organization which
p.002017: is responsible for initiating, managing and / or financing the clinical trial.
p.002017: 9. "Generic medicinal product" is a medicinal product which has the same qualitative and
p.002017: quantitative composition with respect to the active substances and the same dosage form as the reference
p.002017: medicinal product, and its bioequivalence with the reference medicinal product has been demonstrated to be appropriate
p.002017: bioavailability tests. The various immediate-release oral dosage forms are considered to be one
p.002017: and the same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of
p.002017: active substance are considered to be the same active substance, unless they differ significantly in their nature
p.002017: safety and / or efficiency.
p.002017: 10. "Principal Investigator" is the doctor or dentist appointed by the contracting authority, who direct
p.002017: the overall conduct of the clinical trial in accordance with the approved protocol and the Good Guideline
p.002017: clinical practice and responsible for the work of
p.002017: the researchers.
p.002017: 11. "Defined daily dose" is an average daily maintenance dose of a drug
p.002017: product for use in adults according to the primary indication of the medicinal product.
p.002017: 12. "Good clinical practice" is the set of internationally recognized ethical and
p.002017: scientific quality requirements to be met when planning, conducting, reporting and
p.002017: reporting of clinical trials.
p.002017: 13. "Good laboratory practice" is a system of internationally recognized rules
p.002017: in terms of planning conditions, processes of organizing, executing, tracking and
p.002017: documentation of laboratory tests.
p.002017: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers all
p.002017: production sides - personnel, premises, facilities, materials, documentation, quality control, and aims
p.002017: to ensure safety, efficiency and
p.002017: according to the specification.
p.002017: 15. (suppl. - SG 71/08, in force from 12.08.2008) "Member State" is a state,
p.002017: Member State of the European Union or a State Party to the Agreement on the European Union
p.002017: economic space.
p.002017: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002017: 17. "Immunological medicinal product" is a medicinal product containing vaccines, toxins, serums or allergens. IN
p.002017: the range of vaccines, toxins and serums include agents used to create active immunity or to
p.002017: establish a state of immunity or induce passive immunity. Allergens are medicinal products that are
p.002017: intended to identify or stimulate a specific targeted change in the immunological response
p.002017: to an allergic agent.
p.002017: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002017: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative, and
p.002017: when their bioavailability after application in the same
p.002017: the molar dose is similar to a degree which is a condition of equivalent efficacy and safety.
p.002017: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and extent of
p.002017: in which the active substance or the therapeutically significant portion of the test drug reaches
p.002017: from the dosage form to the systemic
p.002017: blood circulation.
p.002017: 20. "Tested medicinal product" means the dosage form of the active substance or placebo to be tested
p.002017: or used as a comparison in a clinical trial, including authorized products
p.002017: for use, but are used for unauthorized use or for the purpose of obtaining additional information on
p.002017: the authorized form, or they are
p.002017: completed (in medicinal or packaged form) in a way other than the approved form.
...
p.002017: having the scientific knowledge to provide accurate and complete information on
p.002017: the medicinal product it advertises.
p.002017: 35a. (new - SG 1/2014, in force from 03.01.2014) "Medical prescription" is a prescription of
p.002017: medicinal product or medical device issued by a person practicing regulated medical
p.002017: profession within the meaning of § 1, item 1 of the additional provisions of the Law on the recognition of
p.002017: professional qualifications and what is legal
p.002017: the right to do so in the Member State where the medical prescription is issued.
p.002017: 36. "Multicenter Clinical Trial" is a clinical trial conducted under
p.002017: one protocol but in more than one center and more than one researcher. The research
p.002017: centers may be located in the territory of one Member State in more than one
p.002017: Member State and / or Member States and third countries.
p.002017: 37. "Name of a medicinal product" is the name given to the product which may
p.002017: be:
p.002017: a) freely chosen name (trade name);
p.002017: b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the commercial
p.002017: the make or the name of the marketing authorization holder;
p.002017: c) (amend. - SG 12/11, in force from 08.02.2011) scientific name together with the trade name
p.002017: the make or the name of the marketing authorization holder.
p.002017: 38. "Scientific literature" is a publication / publications of the results of scientific research in
p.002017: specialized international scientific publications.
p.002017: 39. "New active substance" is:
p.002017: (a) a chemical, biological or radiopharmaceutical that has not been authorized
p.002017: for use as a medicinal product in the European Union;
p.002017: (b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that is
p.002017: has been authorized for use as a medicinal product in the European Union but differs in
p.002017: the safety and efficacy of a previously authorized substance;
p.002017: (c) a biological substance which has been authorized for use as a medicinal product in
p.002017: European Union, but with a different molecular structure, with different origins in terms of
p.002017: the source material or is obtained through a different manufacturing process;
p.002017: (d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which have not been
p.002017: authorized as a medicinal product in the European Union, or the mechanism for pairing molecules
p.002017: and radionuclides was not allowed in
p.002017: The European Union.
p.002017: 40. "Adverse event" means any adverse change in health status,
p.002017: observed when administering a medicinal product to a patient or clinical participant
p.002017: a test that is not necessarily causally related to this treatment.
p.002017: 41. (amend. - SG 102/2012, in force since 21.12.2012) "Adverse drug reaction" is any undesirable and
p.002017: unexpected response to a medicinal product. In the case of a clinical trial - any undesirable or unforeseen
p.002017: response to the investigational medicinal product independently
p.002017: of the administered dose. The types of side effects are:
p.002017: (a) "unexpected" - an adverse reaction not listed in the summary of product characteristics;
p.002017: the product or whose character, weight or output does not meet the product characteristics mentioned in the summary; in
p.002017: case of clinical trial is an adverse reaction whose nature, severity or outcome do not match
p.002017: of test information
p.002017: medicinal product specified in the investigator's brochure;
p.002017: (b) "suspected" - an adverse reaction for which the notifier or the holder
p.002017: of the Marketing Authorization implies that there is a possible causal link with
p.002017: the received medicinal product;
p.002017: (c) "serious" - any adverse effect on a health condition which has caused the death,
p.002017: imminent danger to life, hospitalization or prolongation of hospitalization, significant or
p.002017: permanent disability, disability and congenital
p.002017: anomalies;
p.002017: (d) combinations of reactions under letters "a", "b" and "c".
p.002017: 42. "Common name" means the international non-patent name of a medicinal or excipient
...
p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
...
p.002017: excessive use of medicinal products accompanied by harmful physical or
p.002017: psychological effects.
p.002017: 86. (new - SG 41/09, in force from 02.06.2009) "Infants" shall be children under 12
p.002017: months.
p.002017: 87. (new - SG 41/09, in force from 02.06.2009) "Foods for infants" are foods,
p.002017: intended for specific nutritional use by infants during their first months alone
p.002017: are sufficient to satisfy the nutritional needs of these infants up to
p.002017: the moment of introduction of suitable supplementary food.
p.002017: 88. (new - SG 41/09, in force from 02.06.2009) "Transitional foods" are foods,
p.002017: intended for the specific nutritional use of infants when administered appropriate
p.002017: supplemental food and which constitute the main liquid food of progressively increasing
p.002017: are the variety of foods in these infants.
p.002017: 89. (new - SG 12/11, in force from 08.02.2011) "Type IA change" is a change with
p.002017: minimal or no impact on quality, safety or efficacy
p.002017: of the respective medicinal product.
p.002017: 90. (new - SG 12/11, in force from 08.02.2011) "Type IB change" is a change,
p.002017: which is neither a Type IA nor a Type II change nor an extension of the authorization of
p.002017: use.
p.002017: 91. (new - SG 12/11, in force from 08.02.2011) "Type II change" is a change that does not
p.002017: is an extension of the marketing authorization and which can have a significant impact
p.002017: on the quality, safety or efficacy of the person concerned
p.002017: medicine.
p.002017: 92. (new - SG 102/2012, in force from 21.12.2012) "Delegated act" is an act under
p.002017: the meaning of Art. 290 of the Treaty on the Functioning of the European Union.
p.002017: § 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
p.002017: § 3. The Council of Ministers shall determine the terms and conditions for the acquisition, storage and storage
p.002017: updating of medicinal products stored by the State Agency of the State Reserve and
p.002017: wartime stocks ".
p.002017: § 4. (Supplemented, SG No. 18/2014) This Act introduces the provisions of Directive 2001/83 / EC
p.002017: The European Parliament and the Council establishing a Community code for medicinal products for human use
p.002017: use as last amended by Directive 2004/27 / EC of the European Parliament and of the Council and Directive
p.002017: 2012/26 / EU of the European Parliament and of the Council of 25 October 2012 amending Directive
p.002017: 2001/83 / EC as regards
p.002017: pharmacovigilance (OJ L 299/1 of 27 October 2012).
p.002017: § 5. Data protection deadlines for the reference medicinal products shall be applied in accordance with the provisions
p.002017: of Art. 89 of Regulation (EC) No 726/2004 of the European Parliament and the
p.002017: Council and Art. 2 of Directive 2004/27 / EC of the European Parliament and of the Council.
p.002017: § 5a. (New, SG No. 60/2011, effective 30.09.2011) (1) (Amended, SG No. 102/2012, effective from
p.002017: 21.12.2012, amend. - SG, issue. 85 of 2017) Ministry of Health, National Council on
p.002017: prices and reimbursement of medicines, the Executive Agency for Medicines and Regional
p.002017: health inspections provide the opportunity to provide information and to accept applications and documents
p.002017: this law electronically under the terms and procedure of the Electronic Document and Electronic Certification Act
p.002017: services and the eGovernment Act.
...
p.002017: conditions, as well as the relevant software products.
p.002017: Transitional and Final Provisions
p.002017: § 6. The Law on Medicines and Pharmacies in Human Medicine (promulgated, SG No. 36/1995;
p.002017: pcs. 61 of 1996 - Decision No. 10 of the Constitutional Court of 1996; amend. 38 of 1998, issue. 30
p.002017: from 1999, issue. 10 of 2000, issue. 37 of 2000 - Decision No. 3 of the Constitutional Court of 2000;
p.002017: amend. 59 of 2000, issue. 78 of 2000 - Decision No. 7 of the Constitutional Court of 2000; edit,
p.002017: pcs. 41 of 2001, issue. 107 and 120 of 2002; ref., issue 2 of 2003; amend. 56, 71 and 112 of 2003,
p.002017: pcs. 70 and 111 of 2004, nos. 37, 76, 85, 87, 99 and 105 of 2005; 30, 31, 34, 75 and 105 of 2006)
p.002017: cancel, except for the provision of Art. 10, para. 2, which shall apply for a period of up to one year from
p.002017: the day this law enters into force.
p.002017: § 7. (1) The marketing authorizations for medicinal products issued prior to their entry into force
p.002017: of this law under national procedure, which are also allowed in the Member States under
p.002017: the centralized procedure shall be terminated with effect from 1 January 2007.
p.002017: (2) Marketing authorizations for medicinal products issued before the entry into force of
p.002017: this law under the national procedure shall be brought into conformity with its requirements by the date
p.002017: of their renewal.
p.002017: (3) Marketing authorizations for medicinal products covered by Regulation (EC) No 726/2004
p.002017: of the European Parliament and of the Council and are authorized for use under the repealed Medicines Act and
p.002017: drugstores in human medicine as substantially similar products but are not authorized for use in
p.002017: European Union in a centralized way
p.002017: procedure is terminated.
p.002017: (4) Medicinal products authorized in the European Union for centralized use
p.002017: a procedure whose national marketing authorization is terminated in accordance with para. 1, can be sold on
p.002017: the territory of the Republic of Bulgaria in packs and leaflets in accordance with the terminated national authorization for
p.002017: use for a period not exceeding one
p.002017: year from the date of termination.
p.002017: § 8. (1) The approved marginal prices and the registered prices in the order of the repealed Law on Medicines and Pharmacies in
p.002017: human medicine for medicinal products authorized in the European Union for centralized use
p.002017: a procedure whose national authorization is
p.002017: use is terminated in accordance with § 7, para. 1 shall remain in force for one year from the date of
p.002017: its termination.
p.002017: (2) The approved marginal prices and the registered prices in the order of the repealed Law on
p.002017: medicines and pharmacies in human medicine for medicinal products, other than those under para. 1,
p.002017: shall remain in force until 31 December 2007.
p.002017: § 9. (1) The applications for authorization for use, renewal, change of issued
p.002017: permits submitted prior to the entry into force of this Act shall be considered and terminated at
p.002017: the terms and conditions provided therein.
p.002017: (2) Submitted applications and documentation for authorization of medicinal products
p.002017: products that fall within the scope of the procedure under Art. 74, respectively under Art. 75, are brought into
p.002017: compliance with the requirements of this law within three months of its entry into force.
p.002017: (3) When, within the term of para. 2 the application and documentation under para. 2 are not listed in
p.002017: in accordance with the requirements of this law, the procedure for reviewing them is terminated.
p.002017: § 10. (1) The clinical trials authorized until the entry into force of this Act shall be
p.002017: finish up to date.
p.002017: (2) Applications for conducting a clinical trial in the territory of the Republic
p.002017: Bulgaria shall be submitted, examined and terminated under the conditions and by the procedure of this Act, after
p.002017: the entry into force of the ordinance under Art. 82, para. 3.
p.002017: (3) Applications for changes to permitted clinical trials submitted prior to entry into the
p.002017: force of this law shall be considered and concluded under the conditions and in the order provided in it.
...
p.002017: its requirements within one year of its entry into force.
p.002017: (4) The persons under para. 3 submit to the Ministry of Health an application for
p.002017: re-registration, to which shall apply:
p.002017: 1. application for authorization of retail trade of medicinal products from
p.002017: the persons under art. 222, para. 1, according to the model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration of the person under art. 222, para. 1;
p.002017: 3. a copy of the issued in accordance with the repealed Law on Medicines and Pharmacies in
p.002017: human medicine permit to open a pharmacy;
p.002017: 4. a certified copy of the employment contract or contract for management assignment
p.002017: the pharmacy manager - in cases where such is required;
p.002017: 5. declaration by the persons under art. 222, para. 1 that the conditions under which it was issued are preserved
p.002017: the permit for retail sale of medicinal products of the persons under para. 2;
p.002017: 6. document for a one-time fee of BGN 100
p.002017: § 67. Persons who have submitted prior to the entry into force of this Law applications for re-registration under
p.002017: the order of repeal of § 16 of the transitional and final provisions which will carry on their business
p.002017: according to the requirements of this law, submit to the Ministry of
p.002017: within three months of its entry into force, the following documents:
p.002017: 1. an application in accordance with a model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration or certified copy of a similar document under national law
p.002017: of a Member State of the European Union, or under the law of another State Party
p.002017: of the Agreement on the European Economic Area, Art. 222, para. 1;
p.002017: 3. employment contract or contract for the management of the pharmacy concluded with the master pharmacist
p.002017: or pharmacist assistant.
p.002017: § 68. (1) Master-pharmacist or assistant-pharmacist who has been authorized for
p.002017: opening a pharmacy under the repealed § 16 of the transitional and final provisions,
p.002017: may transfer his issued permit to a person under Art. 222, para. 1.
p.002017: (2) For carrying out the transfer the persons under para. 1 filed with the Ministry of
p.002017: healthcare application to which attach:
p.002017: 1. application for authorization of retail trade of medicinal products from
p.002017: the persons under art. 222, para. 1, according to the model approved by the Minister of Health;
p.002017: 2. an up-to-date certificate for entry in the commercial register, respectively a document for
p.002017: current registration of the person under art. 222, para. 1;
p.002017: 3. a copy of the issued in accordance with the repealed Law on Medicines and Pharmacies in
p.002017: human medicine permit to open a pharmacy or permit to re - register under
p.002017: the procedure for repealing § 16 of the transitional and final provisions;
p.002017: 4. a certified copy of the employment contract or management contract of the head of
p.002017: pharmacy;
p.002017: 5. declaration by the persons under art. 222, para. 1 that the conditions under which it was issued are preserved
p.002017: the permit for retail sale of medicinal products of the persons under para. 1.
p.002017: (3) The transfer under para. 1 may be completed within one year of its entry into force
p.002017: of this law.
p.002017: § 69. The drugstores welded upon the entry into force of this Act shall continue to be
...
p.002000: the procedures under para. 1, as well as the archive of
p.002000: completed procedures.
p.002000: (4) By 31 March 2013, the Pricing and Reimbursement Committee has provided the
p.002000: National Council on Prices and Reimbursement of Medicinal Products with Reception and Transfer
p.002000: minutes kept by the commission registers.
p.002000: § 131. (1) By March 20, 2013, fees for submitting price confirmation / price caps,
p.002000: registering prices for medicinal products to include, exclude or change medicinal products in
p.002000: The positive drug list is collected by
p.002000: The Ministry of Health in the amounts specified in the tariff under Art. 21, para. 2.
p.002000: (2) The funds collected by March 20, 2013 under para. 1 shall be expended for the activity
p.002000: the Pricing and Reimbursement Committee and the Transparency Committee.
p.002000: § 132. Within three months of the entry into force of this Act, the Council of Ministers under
p.002000: proposal of the Minister of Health:
p.002000: 1. appoints the chairman and the members of the National Council for prices and reimbursement of
p.002000: medicinal products;
p.002000: 2. adopts the Rules of Procedure of the National Council for Prices and Reimbursement of
p.002000: medicinal products.
p.002000: § 133. (1) Within two months of the entry into force of this Act the Council of Ministers
p.002000: change the tariff under Art. 21, para. 2.
p.002000: (2) By 1 April 2013 the Council of Ministers shall adopt the ordinance under Art. 261a, para. 5.
p.002000: § 134. The obligations under art. 159, para. 4, Art. 168, para. 8, Art. 168a and 168b begin
p.002000: fulfill three years after the date of publication of the delegated acts under art. 54a
p.002000: of Directive 2001/83 / EC in the Official Journal of the European Union.
p.002000: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002000: § 138. The law shall enter into force on the day of its promulgation in the State Gazette p
p.002000: except for:
p.002000: 1. paragraph 9, item 1, letter "a", § 29 - 36, § 38 - 43, § 44 regarding Art. 167a, 167b, 167b, 167g,
p.002000: 167e, Art. 167f, para. 1 and para. 2, item 1 and art. 167h, § 65-76, § 98, paragraphs 1 and 2, § 101, paragraph 1, letters "a" and "b", § 102, 103,106
p.002000: - 108, 111, 116, § 117, item 1, letters "a", "f", "g" and "l", effective January 2, 2013
p.002000: d .;
p.002013: 2013
p.002013: 2. paragraphs 20 and 117, item 2, which shall enter into force on 1 April 2013;
p.002013: 3. paragraph 44 concerning Art. 167f, para. 2, item 2 and para. 3 and Art. 167g, effective July 2
p.002013: Transitional and Final Provisions
p.002013: TO THE PUBLIC FINANCE LAW
p.002013: (Promulgated - SG, issue 15 of 2013, in force since 01.01.2014)
p.002013: § 123. The law shall enter into force on January 1, 2014, with the exception of § 115, which shall enter into force
p.002013: of January 1, 2013, and § 18, § 114, § 120, § 121 and § 122, effective February 1, 2013.
p.002013: Transitional and Final Provisions
p.002013: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002013: (Official Gazette, SG No. 1/2004, IN EFFECT OF 03/01/2014)
p.002013: § 18. Within one month after the entry into force of this Act, the Minister of
p.002013: the health care shall align with it the ordinance of art. 221, para. 1 of the Law on
p.002013: medicinal products in human medicine.
p.002013: § 19. The law shall enter into force on the day of its promulgation in the State Gazette.
p.002013: Transitional and Final Provisions
p.002013: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002013: INSURANCE
p.002013: (Official Gazette, SG 48/15)
...
Social / Unemployment
Searching for indicator unemployed:
(return to top)
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
p.002017: the country in which it was placed on the market or the holder of its marketing authorization, or
p.002017: (c) the timeline, including records and documents related to the chain used
p.002017: on delivery.
p.002017: It is not considered to be a falsified medicinal product with inadvertent admission
p.002017: quality deviations, as well as a medicinal product that has been placed on the market in breach of
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.002017: (3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in
p.002017: the application for the marketing authorization / registration certificate for modification of
p.002017: the marketing authorization or its renewal.
p.002017: Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
p.002017: 1. medicinal products with restricted medical prescription intended for use
p.002017: only in some specialized areas;
p.002017: 2. medicinal products - subject to special medical prescription;
p.002017: 3. medicinal products for multiple or single dispensing at the same time
p.002017: doctor's prescription.
p.002017: Art. 173. Prescription medicines shall be granted medicinal products which meet
p.002017: the following requirements:
p.002017: 1. may pose a direct or indirect danger to human health, even in the case of
p.002017: proper use if administered without medical supervision;
p.002017: 2. are often and very widely applied incorrectly and as a result can
p.002017: pose a danger to human health;
p.002017: 3. contain substances whose activity and / or undesirable effects require it
p.002017: subsequent follow-up study;
p.002017: 4. usually prescribed by a doctor for parenteral administration.
p.002017: Art. 174. Medicinal products shall be subject to special medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. contain narcotic substances within the meaning of the Drug Control Act
p.002017: substances and precursors in quantities acceptable;
p.002017: 2. when used improperly, can create a significant risk of abuse, yes
p.002017: lead to drug addiction or to be used for illegal purposes;
p.002017: 3. contain new medicinal substances whose characteristics are not sufficient
p.002017: known for this reason may be referred to the group for preventive purposes
p.002017: medicinal products under item 2.
p.002017: Art. 175. Medicinal products are subject to limited medical prescription when
p.002017: satisfy any of the following conditions:
p.002017: 1. restricted to hospital use only because of limited experience with
p.002017: use or in the interest of public health;
p.002017: 2. are intended for the treatment of disease states which may be
p.002017: diagnosed only in healthcare settings, despite their implementation and follow-up
p.002017: during the course of treatment they can be carried out in other health establishments;
p.002017: 3. are intended for the treatment of outpatients, but their use may
p.002017: caused serious side effects requiring a specialist and
p.002017: monitoring during treatment.
p.002017: Art. 176. (1) The Executive Agency for Medicines may not approve the requests made by
p.002017: of the applicant under Art. 26, para. 1 medication delivery regimen based on an assessment of:
p.002017: 1. the maximum single dose, the maximum daily dose, the amount active
p.002017: substance in a unit dose, dosage form, specific type of primary packaging
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
...
Social / Women
Searching for indicator women:
(return to top)
p.002017: (2) In addition to the requirements of para. 1 inclusion in clinical trials of adults
p.002017: persons who are unable to give informed consent are permitted, provided that:
p.002017: 1. the relevant ethics committee with the participation of specialists with competence in the respective disease, or
p.002017: in the patient group approved the protocol after discussing clinical, moral and psychosocial aspects,
p.002017: relating to the disease in question and to
p.002017: the patient group;
p.002017: 2. it can be expected that the intake of the medicinal product being tested will
p.002017: lead to benefits that outweigh the risks or the risks are completely eliminated;
p.002017: 3. the purpose of the test is to verify data obtained from clinical trials on
p.002017: persons who are able to give informed consent or to data obtained through others
p.002017: research methods;
p.002017: 4. the test is directly related to life-threatening or leading to disability
p.002017: a disease in which the relevant adult is unable to give
p.002017: an informed consent;
p.002017: 5. clinical trials are designed so that pain, discomfort, fear and other foreseeable risks
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: predefined and constantly monitored
p.002017: during the test;
p.002017: 6. no financial or other incentives are given except compensation.
p.002017: Art. 102. No clinical trial of a medicinal product on
p.002017: pregnant women and nursing mothers unless the medicinal product is required for treatment
p.002017: they may or may not be tested on another group of patients.
p.002017: Section III.
p.002017: Ethics Committees
p.002017: Art. 103. (1) (amend. - SG 60/11, in force from 05.08.2011) To the Minister of
p.002017: a multi - center ethics committee is set up by the Health Committee, whose composition is determined by
p.002017: Minister's order and includes regular and reserve members. Reserve members
p.002017: participate in committee meetings and have the right to vote in the absence of full members.
p.002017: (2) To the medical establishments where clinical trials are carried out shall be established
p.002017: ethics committees composed of the head of the hospital.
p.002017: (3) The Executive Agency for Medicines shall maintain and keep a register of the Committees on
p.002017: ethics.
p.002017: (4) The register of medical establishments to which ethics committees are established shall be
p.002017: published on the BDA website on the Internet.
p.002017: Art. 104. (1) The commissions under art. 103, para. 1 and 2 consist of 7 to 12 members who have
p.002017: qualification and experience to consider and evaluate the scientific, medical and ethical aspects of
p.002017: the proposed clinical trial.
p.002017: (2) The commissions under para. 1 shall include at least two non-medical members
p.002017: education - representatives of both sexes who are financially and administratively independent
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.002017: has personally informed consent to participate in
p.002017: the clinical trial.
p.002017: (3) Informed consent under para. 1, item 3 and para. 2 can only give a capable person who understands
p.002017: the nature, significance, scope and potential risks of the clinical trial. Informed consent to participate in
p.002017: a clinical trial may be withdrawn at any time
p.002017: time.
p.002017: (4) Informed consent under para. 1, item 3 for a disabled adult is given by his / her legal person
p.002017: representative. The consent of the legal representative must represent the intended will of
p.002017: participant and can be withdrawn at any time without negatives
p.002017: consequences for the participant.
p.002017: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent gives
p.002017: the person appointed by the court.
p.002017: (6) The incapable adult is provided with information about the test,
p.002017: the potential risks and rewards of understanding it.
p.002017: (7) The explicit desire of an incapable adult to refuse to participate or to participate
p.002017: withdraw at any time from the clinical trial must be considered by
p.002017: the researcher and, if necessary, the principal investigator.
p.002017: Art. 97. (1) A clinical trial on a minor shall be conducted upon receipt of
p.002017: written informed consent of both parents or guardians of the person at
p.002017: compliance with Art. 96, para. 1 and 3.
p.002017: (2) The consent of the parents and guardians must represent the presumed
p.002017: the will of the minor and may be withdrawn at any time without negative consequences
p.002017: for a minor.
p.002017: (3) The express wish of the minor to refuse to participate or to withdraw under
p.002017: any time in the clinical trial should be taken into account by the investigator, and at
p.002017: need - from the principal investigator.
p.002017: (4) A clinical trial on a minor shall be conducted upon receipt of written informed consent from
p.002017: the person from both parents or the guardian in compliance with Art. 96, para. 1 and 3. When one parent is unknown,
p.002017: died or was deprived of parental rights or not granted such rights in cases of divorce,
p.002017: written informed
p.002017: consent is given by the minor and by the parent exercising parental rights.
p.002017: (5) The consent of the minor, the parents or the guardian may be
p.002017: withdrawn at any time without negative consequences for the minor.
p.002017: (6) The express wish of the minor to withdraw at any time from
p.002017: the clinical trial must be considered by the investigator and, if necessary, by the
p.002017: the principal investigator.
p.002017: (7) The information of the test is provided to the minor or minor,
p.002017: about the potential risks and benefits of a physician who has experience with it in an understandable way
p.002017: minors.
p.002017: Art. 98. Informed consent to participate in a clinical trial is not required if
p.002017: imposes an immediate decision to save the person's life, and if at that moment that consent
p.002017: could not be received. The decision is made by at least two doctors who do not participate in
p.002017: the research team.
p.002017: Art. 99. (1) During the test the participant receives an additional upon request
p.002017: information from an independent entity.
p.002017: (2) The written information provided to the participants in the clinical trial of
p.002017: medicinal product, contains contact details of the independent person for additional
p.002017: information.
p.002017: Section II.
p.002017: A clinical trial with vulnerable patient groups
p.002017: Art. 100. A clinical trial of minors may be
p.002017: undertake, provided that:
p.002017: 1. the protocol is approved by the relevant ethics committee after discussion of the clinical,
p.002017: moral and psychosocial aspects of childhood, in which they participated no less than
p.002017: two pediatricians;
p.002017: 2. there is an expected direct benefit of the clinical trial for the group of patients who will
p.002017: be included;
p.002017: 3. the test is directly related to the clinical condition of the minor
p.002017: or the minor;
p.002017: 4. the investigational medicinal product is intended for diagnosis, treatment or
p.002017: prevention of diseases specific to minors;
p.002017: 5. the test is intended to be conducted on minors or minors;
p.002017: 6. the purpose of the test is to verify data obtained from clinical trials on
p.002017: persons who are able to give informed consent or data obtained through others
p.002017: research methods;
p.002017: 7. the results of clinical trials on adults and their results
p.002017: interpretations cannot be considered valid for both minors and minors;
p.002017: 8. the test is designed so that pain, discomfort, fear and other foreseeable risks
p.002017: they are minimized in relation to the disease and the risk threshold and degree of physical pain are
p.002017: defined in advance and are constantly monitored by
p.002017: test time;
p.002017: 9. the study is planned and is conducted in accordance with the guidelines of
p.002017: The European Medicines Agency;
p.002017: 10. no financial or other incentives are given except compensation.
p.002017: Art. 101. (1) Clinical trials on the persons under art. 96, para. 4 and 5, which are not in
p.002017: able to give informed consent shall be conducted in accordance with the requirements of art. 90.
p.002017: (2) In addition to the requirements of para. 1 inclusion in clinical trials of adults
p.002017: persons who are unable to give informed consent are permitted, provided that:
p.002017: 1. the relevant ethics committee with the participation of specialists with competence in the respective disease, or
...
p.002017: (2) It is prohibited to directly provide samples of medicinal products from
p.002017: the medical sales representatives of art. 244, para. 1, item 3 of the population.
p.002017: Art. 256. Samples of medicinal products shall be made available to medical specialists
p.002017: under the conditions and by the order specified in the ordinance under art. 249.
p.002017: Art. 257. (1) The medical commercial representatives of art. 244, para. 1, item 3 must have received training,
p.002017: organized by the marketing authorization holder who assigned them to have scientific knowledge and
p.002017: be able to deliver as accurate and complete as possible
p.002017: information on the medicinal product they are presenting.
p.002017: (2) During each visit, the medical sales representatives must
p.002017: have the summary of product characteristics and the pricing data for the medicinal product and
p.002017: the terms of payment and make them available upon request.
p.002017: (3) When presenting medicinal products to medical specialists
p.002017: medical sales representatives cannot offer gifts and other property
p.002017: non-material benefit.
p.002017: Chapter twelve.
p.002017: ADJUSTMENT OF THE PRICES OF THE MEDICINAL PRODUCTS (HEADING - SG, No.
p.002017: 102 FROM 2012)
p.002017: Section I.
p.002017: National Council for Prices and Reimbursement of Medicinal Products (New, SG No. 102/2006)
p.002017: from 2012, in force since 21.12.2012)
p.002017: Art. 258. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012
p.002017: d.) (1) (Amended, SG No. 43/2016) A National Council on Prices and
p.002017: reimbursement of medicinal products, hereinafter referred to as "tips". The Council is a legal entity of
p.002017: budget support - minor
p.002017: budget authorizing officer. It has the status of a state commission based in Sofia.
p.002017: (2) The activity of the council shall be financed from the state budget through the budget of
p.002017: Ministry of Health.
p.002017: (3) The Council is a collegial body and consists of a chairman and six members, three of whom are doctors or
p.002017: Master's in Pharmacy, two lawyers and two economists, all with at least 5 years of experience.
p.002017: The Chairman and the members of the Council are elected and dismissed by a decision of the Council of Ministers
p.002017: at the proposal of the Minister of
p.002017: healthcare. The chairman directs and represents the board.
p.002017: (4) The members of the council may not occupy a position or carry out activity under Art. 19,
p.002017: para. 6 of the Administration Act.
p.002017: (5) The activities of the Council shall be assisted by an administration whose structure and organization
p.002017: work is determined by the rules of procedure adopted by the Council of Ministers.
p.002017: Art. 259. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012,
p.002017: in force since 21.12.2012) (1) The Council shall:
p.002017: 1. approve, refuse to approve, amend or delete the price of medicinal products under
p.002017: Art. 261a, para. 1;
p.002017: 2. approve, refuse to approve, amend or delete the marginal price of medicinal products
p.002017: products of art. 261a, para. 2;
p.002017: 3. register, refuse to register, amend or delete the prices of the medicinal products
p.002017: products granted without a doctor's prescription under Art. 261a, para. 3;
p.002017: 4. (amend. - SG 48/2015) approve, repeal or amend pharmacotherapeutic guidelines, including
p.002017: criteria for evaluating the outcome of therapy, as well as recommendations for algorithms for treatment with
...
Social / education
Searching for indicator education:
(return to top)
p.002017: route of administration and route of administration and proposed shelf life;
p.002017: 6. precautionary measures and safety precautions during storage of the product, at
p.002017: its administration to patients and the disposal of product waste accompanied by
p.002017: guidance on the potential risks of the medicinal product to the environment;
p.002017: 7. description of the production method;
p.002017: 8. description of the control methods used by the manufacturer;
p.002017: 8a. (new - SG 102/2012, in force from 02.01.2013) declaration that the results of the audit under art. 160, para. 2,
p.002017: conducted by the manufacturer of the medicinal product confirm that the active substance is manufactured in
p.002017: compliance with the principles and guidelines for Good
p.002017: manufacturing practice; the declaration shall indicate the date on which the audit was carried out;
p.002017: 9. an assessment of the potential risk of the medicinal product to the environment for everyone
p.002017: the individual case and the measures envisaged to limit it;
p.002017: 10. results from:
p.002017: (a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.002017: (b) preclinical (toxicological and pharmacological) studies;
p.002017: (c) clinical trials;
p.002017: 11. a statement that in clinical trials conducted outside the territory of
p.002017: Member States have complied with the ethical principles of Good Clinical Practice;
p.002017: 12. (amended, SG No. 102/2012, effective 21.12.2012) summary of the system for
p.002017: pharmacovigilance monitoring, which includes the following elements:
p.002017: a) the name of the qualified person under Art. 191, curriculum vitae - education acquired
p.002017: professional experience in the field of pharmacovigilance monitoring and qualification for
p.002017: fulfillment of his duties in accordance with Chapter Eight;
p.002017: (b) any Member State in which the qualified person fulfills the obligations
p.002017: his;
p.002017: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002017: (d) the address at which the primary document of the traceability system is stored
p.002017: drug safety;
p.002017: 12a. (new - SG 102/2012, in force since 21.12.2012) statement by the applicant that
p.002017: has the necessary means to fulfill the obligations of Chapter Eight;
p.002017: 13. (Amended, SG No. 102/2012, effective 21.12.2012) risk management plan with
p.002017: a description of the risk management system that the applicant will put in place for that person
p.002017: medicinal product, together with a summary of the plan;
p.002017: 14. a brief description of the product according to Art. 34;
p.002017: 15. layout of the primary and secondary packaging of the product and a leaflet in
p.002017: compliance with the requirements of Chapter Six;
p.002017: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country where
p.002017: production shall be carried out accompanied by a certificate of good manufacturing practice or
p.002017: certificate certifying that the manufacture of the medicinal product and of the active substances included in
p.002017: its composition was done in accordance with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 17. a copy of the document identifying the medicinal product for treatment,
...
p.002017: Art. 102. No clinical trial of a medicinal product on
p.002017: pregnant women and nursing mothers unless the medicinal product is required for treatment
p.002017: they may or may not be tested on another group of patients.
p.002017: Section III.
p.002017: Ethics Committees
p.002017: Art. 103. (1) (amend. - SG 60/11, in force from 05.08.2011) To the Minister of
p.002017: a multi - center ethics committee is set up by the Health Committee, whose composition is determined by
p.002017: Minister's order and includes regular and reserve members. Reserve members
p.002017: participate in committee meetings and have the right to vote in the absence of full members.
p.002017: (2) To the medical establishments where clinical trials are carried out shall be established
p.002017: ethics committees composed of the head of the hospital.
p.002017: (3) The Executive Agency for Medicines shall maintain and keep a register of the Committees on
p.002017: ethics.
p.002017: (4) The register of medical establishments to which ethics committees are established shall be
p.002017: published on the BDA website on the Internet.
p.002017: Art. 104. (1) The commissions under art. 103, para. 1 and 2 consist of 7 to 12 members who have
p.002017: qualification and experience to consider and evaluate the scientific, medical and ethical aspects of
p.002017: the proposed clinical trial.
p.002017: (2) The commissions under para. 1 shall include at least two non-medical members
p.002017: education - representatives of both sexes who are financially and administratively independent
p.002017: from the hospital where the clinical trial is being conducted.
p.002017: (3) For the needs of their work, the commissions under para. 1 can attract outsiders
p.002017: specialists.
p.002017: (4) In the case of clinical trials on minors to assist the
p.002017: The respective Ethics Committee at the medical establishment must attract its activity
p.002017: external specialists.
p.002017: Art. 105. (1) The mandate of the members of the ethics committees under Art. 103, para. 1 and 2 is c
p.002017: duration 4 years.
p.002017: (2) Every two years, one-half of the composition of the Ethics Committees shall be updated.
p.002017: (3) A member of the Ethics Committee may not be appointed to the same committee for more
p.002017: from two consecutive terms.
p.002017: Art. 106. (1) The Ethics Commissions under Art. 103, para. 1 and 2 within one month of creation
p.002017: prepare written standard operating procedures in accordance with the Good Rules
p.002017: clinical practice to determine the terms and conditions for their work.
p.002017: (2) The standard operating procedures of ethics committees shall be approved by
p.002017: the BDA Executive Director.
p.002017: (3) The meetings of the Ethics Committees shall be closed. If necessary, the President of
...
p.002017: practice in the European Union database.
p.002017: Art. 148. For obtaining a production permit the person under Art. 146 should
p.002017: has:
p.002017: 1. with appropriately qualified personnel, depending on the specifics of
p.002017: manufactured types of medicinal products and dosage forms;
p.002017: 2. at any one time with at least one qualified person who is eligible
p.002017: Art. 159;
p.002017: 3. premises for production, control and storage of medicinal products,
p.002017: provided with the necessary technical equipment and control laboratories.
p.002017: Art. 149. Managers of production and quality control of medicinal products
p.002017: products in manufacturing enterprises are persons:
p.002017: 1. who hold a Master's degree in a specialty
p.002017: "pharmacy", "chemistry" or "biology" and at least two years' practical experience in
p.002017: pharmaceutical production;
p.002017: 2. which meet the requirements of item 1 and have an additional recognized specialty in
p.002017: radiobiology or radiochemistry - for radiopharmaceuticals or for medicinal products,
p.002017: exposed to ionizing radiation;
p.002017: 3. with recognized specialty in clinical hematology, medical microbiology, virology or
p.002017: immunology - for the production of immunological medicinal products - vaccines, toxins, sera, for
p.002017: biotech products and for medicinal products derived from
p.002017: human plasma or human blood.
p.002017: Art. 150. (1) The person under art. 146 submits to the BDA an application in the form approved by
p.002017: the director of the agency.
p.002017: (2) Together with the application under para. 1 the applicant shall also submit:
p.002017: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002017: specialty, work record, criminal record or similar document, if not
p.002017: Bulgarian citizen, and employment contract for the persons under Art.
p.002017: 148, item 2 and art. 149;
p.002017: 2. copies of contracts for the assignment of production and / or control of the applications for
p.002017: production of products - in the cases of art. 151;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union,
p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
...
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
p.002017: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible master pharmacist under Art. 197, v. 2 and
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
p.002017: containing such substances, the requirements of the Control Act also apply
p.002017: drugs and precursors.
p.002017: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Agency
p.002017: for nuclear regulation.
p.002017: (5) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the person under para. 1, Vol. 3,
p.002017: when he is a Bulgarian citizen.
...
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
p.002017: registration of a drugstore or for making a change under Art. 242 the respective RIC collects fees
p.002017: in the amount determined by the tariff under Art. 21, para. 2.
p.002017: (6) (New - SG 103 2017, in force from 01.01.2018)
p.002017: food safety ex officio establishes the circumstances of a person 's criminal record
p.002017: para. 2, item 2, when he is a Bulgarian citizen.
...
Searching for indicator educational:
(return to top)
p.002017: of 21.12.2012) organizes the provision of public information to patients' organizations and to
p.002017: consumer organizations on actions taken against
p.002017: counterfeiting of medicinal products;
p.002017: 4. performs other activities specified by law.
p.002017: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 15. (1) A Pharmacopoeial Committee shall be established to the Minister of Health as
p.002017: an advisory body on the current pharmacopoeia.
p.002017: (2) The Minister of Health at the proposal of the Executive Director of
p.002017: The BDA determines by order the composition of the Pharmacopoeial Committee and the expert groups attached to it
p.002017: and approve the rules of procedure.
p.002017: (3) The activities of the Pharmacopoeia Committee shall be financed from the budget of the Ministry
p.002017: of health.
p.002017: Art. 16. (1) A Higher Board of Pharmacy shall be established with the Minister of Health, which shall include five
p.002017: representatives appointed by the Minister of Health, five representatives of the Bulgarian
p.002017: pharmaceutical union, two representatives of the National Health Insurance Fund (NHIF) and one each
p.002017: representative of the faculties of pharmacy at medical colleges. It is the Minister of Health
p.002017: chairman of the board without
p.002017: right to vote.
p.002017: (2) The High Pharmacy Council is an advisory body that deliberates and gives opinions
p.002017: by:
p.002017: 1. the main directions and priorities in the field of pharmacy;
p.002017: 2. ethical problems of pharmacy;
p.002017: 3. draft legislative acts related to pharmacy;
p.002017: 4. scientific priorities in the field of pharmacy;
p.002017: 5. programs for organizing public educational campaigns in the field of
p.002017: medicinal products.
p.002017: (3) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: (4) The organization and activities of the Supreme Pharmacy Council shall be governed by regulations,
p.002017: issued by the Minister of Health at the proposal of the High Council on Pharmacy.
p.002017: Art. 17. (1) The Executive Agency for Medicines shall be a specialized body to the Minister
p.002017: of health to oversee the quality, safety and efficacy of medicines.
p.002017: (2) (amend. - SG 15/2013, in force from 01.01.2014)
p.002017: Medicines is a budget-funded legal entity with its seat in Sofia to the Minister
p.002017: of health.
p.002017: (3) The Executive Agency for Medicines shall be managed and represented by an Executive Agency
p.002017: director, who is appointed in accordance with the Law on Administration.
p.002017: (4) The structure, functions and organization of work of the BDA shall be defined in
p.002017: Rules of Procedure adopted by the Council of Ministers.
p.002017: (5) The Medicines Executive Agency shall:
p.002017: 1. issues authorizations for the manufacture of medicinal products;
p.002017: 2. issues authorizations for use and certificates for registration of medicinal products
p.002017: products;
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) issue permits and
p.002017: wholesale trade certificates for medicinal products;
p.002017: 4. issue permits for parallel import of medicinal products;
p.002017: 5. (amend. - SG 60/11, in force from 05.08.2011) issue, refuse or terminate
p.002017: retail marketing authorizations for medicinal products;
p.002017: 5a. (new - SG 102/2012, in force from 21.12.2012) shall enter the manufacturers,
p.002017: importers and wholesalers of active substances;
p.002017: 5b. (new, SG No. 102/2012, effective 21.12.2012) keep a register of persons,
p.002017: mediators in the field of medicinal products;
...
Social / employees
Searching for indicator employees:
(return to top)
p.002017: 4. thirty days when the application for registration, modification or deletion of
p.002017: price under art. 261a, para. 3;
p.002017: 5. thirty days for approval / registration of the price of medicinal products for which
p.002017: a parallel import permit has been obtained;
p.002017: 6. (new, SG No. 48/2015) ninety days when an application for inclusion is submitted
p.002017: in the Positive Medicinal Product List for a new international non-patent
p.002017: name;
p.002017: 7. (new, SG No. 48/2015) sixty days, when an application for
p.002017: maintaining the reimbursement status of the included medicinal product in the Positive Medicinal Product
p.002017: list.
p.002017: (2) For the medicinal products under Art. 262, para. 5 the council shall act within thirty
p.002017: days when an application for price approval under Art. 261a, para. 1 and turn on
p.002017: product in the Positive Medication List.
p.002017: (3) The time limits under para. 1 and 2 shall commence on the date of submission of the application in the order of
p.002017: the ordinance under Art. 261a, para. 5.
p.002017: Art. 259c. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012,
p.002017: (in force since 21.12.2012)
p.002017: Art. 259g. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012,
p.002017: (in force since 21.12.2012)
p.002017: Art. 260. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012,
p.002017: public authorities, officials and applicants under this Chapter are
p.002017: shall be obliged to assist the council and its staff in the execution of the delegated tasks
p.002017: their duties.
p.002017: Art. 261. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 05.08.2011)
p.002017: 12/21/2012) (1) The members of the council and its employees shall be obliged not to disclose circumstances and
p.002017: facts made known to them in the course of or in connection with the performance of their official duties under this Act, except under
p.002017: a written request from a public authority when
p.002017: this is provided by law.
p.002017: (2) In connection with their obligations under para. 1 persons sign a model declaration,
p.002017: approved by the Chairman of the Board.
p.002017: Section II.
p.002017: Regulation and registration of the prices of medicinal products. Algorithms for treatment with
p.002017: medicinal products (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 261a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102/2012)
p.002017: 21.12.2012) (1) The Council regulates the prices of medicinal products included in the Positive Medicinal Product
p.002017: list under Art. 262, para. 1 and paid with public funds, in accordance
p.002017: with the lowest reference prices from Member States.
p.002017: (2) The Council shall regulate the marginal prices of medicinal products to be granted under
p.002017: medical prescription, other than those under para. 1 according to the lowest reference prices of
p.002017: Member States.
p.002017: (3) The Council registers maximum retail selling prices for medicinal products
p.002017: non-prescription products.
p.002017: (4) The price determined in accordance with the procedure of para. 1, is also the marginal cost of medicinal products at
p.002017: retail.
p.002017: (5) The Council of Ministers, upon a proposal by the Minister of Health, shall determine by an ordinance the conditions and rules for
p.002017: regulation of the prices of the medicinal products under para. 1, to regulate the marginal prices of medical allowances
...
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
p.002017: related to the participation or refusal of participation of the person in the clinical trial. Examples of a group in
p.002017: the hierarchical structure are: medical, pharmacy, dentistry or nursing students, laboratory
p.002017: personnel, employees in the pharmaceutical industry, serving in the military or persons deprived of their liberty. Others
p.002017: vulnerable groups are patients with incurable diseases, people in nursing homes, unemployed or begging, patients in
p.002017: emergencies, street children, vagrants, minors, minors and
p.002017: persons who are unable to consent.
p.002017: 80. "Pharmacopoeia" is a collection of approved specifications and relevant production requirements,
p.002017: testing, storage and labeling of active substances, excipients, dosage forms, materials
p.002017: for the packaging and components of the medicinal product.
p.002017: 81. "Pharmacopoeial formulation" is a prescription for a medicinal product made in a pharmacy
p.002017: according to a prescription from an active pharmacopoeia and intended for delivery to patients there
p.002017: pharmacy.
p.002017: 81a. (new - SG, iss. 71 in 2008, in force since 12.08.2008, amended - SG, iss. 102 in 2012, in
p.002017: (2 January 2013) "Counterfeit medicinal product" means any medicinal product at
p.002017: who are misrepresented:
p.002017: (a) its identity, including data on its primary or secondary
p.002017: the packaging, its name or contents in respect of any of its constituents,
p.002017: including excipients and the amount of active substance per unit dose;
p.002017: (b) its source, including its manufacturer, the country in which it was manufactured,
...
Social / gender
Searching for indicator gender:
(return to top)
p.002017: and warnings that result from a new one
p.002017: information related to the safe use of the medicinal product.
p.002017: 71. "Spontaneous message" is a voluntarily sent message about suspected unwanted
p.002017: reaction when using the medicinal product to the marketing authorization holder, up to
p.002017: authorities for the supervision of medicinal products or other organizations not originating in
p.002017: a survey or other organized information gathering system.
p.002017: 72. "Shelf life of a medicinal product" is the time interval at which, if stored at
p.002017: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002017: based on stability studies of several batches of
p.002017: the finished form.
p.002017: 73. (amend. - SG 71/08, in force from 12.08.2008) "Relevant medicinal product of
p.002017: herbal medicinal product "is a product that contains the same active substances, regardless of composition
p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
p.002017: the communicator (initials or address or profession / specialty), the patient (initials or age, or date
p.002017: birth or gender), side effect / event and suspected drug.
p.002017: 75. "Substantial change in clinical trial protocol" means any change to
p.002017: the protocol and / or in the information in the supporting documentation that affects:
p.002017: (a) the safety or physical and mental integrity of the participants;
p.002017: (b) the scientific value of the study;
p.002017: (c) the conduct or organization of the study;
p.002017: (d) the quality or safety of any of the tested medicinal products.
p.002017: 75a. (new - SG 102/2012, in force since 21.12.2012) "Substantial changes in the protocol of
p.002017: non - interventional post - marketing research "are changes that affect safety, physical or
p.002017: the mental integrity of patients or of
p.002017: the results of the study and their interpretation.
p.002017: 76. (amend. - SG 71/08, in force from 12.08.2008) "Third country" is a state which
p.002017: it is not a Member State of the European Union or is not a State Party to the
p.002017: The European Economic Area.
p.002017: 77. "Wholesale" means all activities of acquisition, storage, supply,
p.002017: importation or exportation of medicinal products, except where provided
p.002017: medicinal products directly to the population.
p.002017: 78. "Participant" means the person participating in a clinical trial, whether receiving
p.002017: the investigational medicinal product or medicinal product used for comparison.
p.002017: 79. "Vulnerable patient groups" are persons whose desire to participate in a clinical trial may be influenced by
p.002017: anticipation of benefits or possibly punished by senior officials in the hierarchy,
...
Social / orphan
Searching for indicator orphan:
(return to top)
p.002013: COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 of 19 June 2012
p.002013: the year of the pharmacovigilance activities provided for in the Regulation
p.002013: (EC) No 726/2004 of the European Parliament and of the Council and in a Directive
p.002013: 2001/83 / EC of the European Parliament and of the Council
p.002013: COMMISSION REGULATION (EC) No 1234/2008 of 24 November
p.002013: consideration of changes to the terms of marketing authorizations for medicinal products for
p.002013: human use and veterinary medicinal products
p.002013: REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: 13 November 2007 on advanced therapy medicinal products and amending
p.002013: Directive 2001/83 / EC and Regulation (EC) No 726/2004
p.002013: REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: 12 December 2006 on medicinal products for pediatric use and amending
p.002013: Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC and
p.002013: Regulation (EC) No 726/2004
p.002013: REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: 31 March 2004 establishing Community procedures for the authorization and control of medicinal products for
p.002013: human and veterinary use and on the creation of a European one
p.002013: Medicines Agency (Consolidated Version)
p.002013: COMMISSION REGULATION (EC) No 1084/2003 of 3 June 2003 examining changes to the conditions
p.002013: of the marketing authorizations for medicinal products for human use and veterinary medicinal products granted
p.002013: by a competent authority of
p.002013: Member State (repealed)
p.002013: REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (EC) No 141/2000
p.002013: December 16, 1999 for orphan drugs
p.002013: COUNCIL REGULATION (Council of the European Community) No 2309/93 of 22 July 1993 establishing
p.002013: the Community procedure for granting authorizations (licenses) and the supervision of medicinal products
p.002013: funds used in human and veterinary medicine
p.002013: medicine, and a European Medicines Assessment Agency is set up (repealed)
p.002013: COUNCIL REGULATION (EEC) No 1768/92 of 18 June 1992
...
Social / parents
Searching for indicator parent:
(return to top)
p.002017: withdraw at any time from the clinical trial must be considered by
p.002017: the researcher and, if necessary, the principal investigator.
p.002017: Art. 97. (1) A clinical trial on a minor shall be conducted upon receipt of
p.002017: written informed consent of both parents or guardians of the person at
p.002017: compliance with Art. 96, para. 1 and 3.
p.002017: (2) The consent of the parents and guardians must represent the presumed
p.002017: the will of the minor and may be withdrawn at any time without negative consequences
p.002017: for a minor.
p.002017: (3) The express wish of the minor to refuse to participate or to withdraw under
p.002017: any time in the clinical trial should be taken into account by the investigator, and at
p.002017: need - from the principal investigator.
p.002017: (4) A clinical trial on a minor shall be conducted upon receipt of written informed consent from
p.002017: the person from both parents or the guardian in compliance with Art. 96, para. 1 and 3. When one parent is unknown,
p.002017: died or was deprived of parental rights or not granted such rights in cases of divorce,
p.002017: written informed
p.002017: consent is given by the minor and by the parent exercising parental rights.
p.002017: (5) The consent of the minor, the parents or the guardian may be
p.002017: withdrawn at any time without negative consequences for the minor.
p.002017: (6) The express wish of the minor to withdraw at any time from
p.002017: the clinical trial must be considered by the investigator and, if necessary, by the
p.002017: the principal investigator.
p.002017: (7) The information of the test is provided to the minor or minor,
p.002017: about the potential risks and benefits of a physician who has experience with it in an understandable way
p.002017: minors.
p.002017: Art. 98. Informed consent to participate in a clinical trial is not required if
p.002017: imposes an immediate decision to save the person's life, and if at that moment that consent
p.002017: could not be received. The decision is made by at least two doctors who do not participate in
p.002017: the research team.
p.002017: Art. 99. (1) During the test the participant receives an additional upon request
p.002017: information from an independent entity.
p.002017: (2) The written information provided to the participants in the clinical trial of
p.002017: medicinal product, contains contact details of the independent person for additional
p.002017: information.
p.002017: Section II.
...
Searching for indicator parents:
(return to top)
p.002017: the clinical trial.
p.002017: (3) Informed consent under para. 1, item 3 and para. 2 can only give a capable person who understands
p.002017: the nature, significance, scope and potential risks of the clinical trial. Informed consent to participate in
p.002017: a clinical trial may be withdrawn at any time
p.002017: time.
p.002017: (4) Informed consent under para. 1, item 3 for a disabled adult is given by his / her legal person
p.002017: representative. The consent of the legal representative must represent the intended will of
p.002017: participant and can be withdrawn at any time without negatives
p.002017: consequences for the participant.
p.002017: (5) In the cases under Art. 162, para. 3 of the Health Act informed consent gives
p.002017: the person appointed by the court.
p.002017: (6) The incapable adult is provided with information about the test,
p.002017: the potential risks and rewards of understanding it.
p.002017: (7) The explicit desire of an incapable adult to refuse to participate or to participate
p.002017: withdraw at any time from the clinical trial must be considered by
p.002017: the researcher and, if necessary, the principal investigator.
p.002017: Art. 97. (1) A clinical trial on a minor shall be conducted upon receipt of
p.002017: written informed consent of both parents or guardians of the person at
p.002017: compliance with Art. 96, para. 1 and 3.
p.002017: (2) The consent of the parents and guardians must represent the presumed
p.002017: the will of the minor and may be withdrawn at any time without negative consequences
p.002017: for a minor.
p.002017: (3) The express wish of the minor to refuse to participate or to withdraw under
p.002017: any time in the clinical trial should be taken into account by the investigator, and at
p.002017: need - from the principal investigator.
p.002017: (4) A clinical trial on a minor shall be conducted upon receipt of written informed consent from
p.002017: the person from both parents or the guardian in compliance with Art. 96, para. 1 and 3. When one parent is unknown,
p.002017: died or was deprived of parental rights or not granted such rights in cases of divorce,
p.002017: written informed
p.002017: consent is given by the minor and by the parent exercising parental rights.
p.002017: (5) The consent of the minor, the parents or the guardian may be
p.002017: withdrawn at any time without negative consequences for the minor.
p.002017: (6) The express wish of the minor to withdraw at any time from
p.002017: the clinical trial must be considered by the investigator and, if necessary, by the
p.002017: the principal investigator.
p.002017: (7) The information of the test is provided to the minor or minor,
p.002017: about the potential risks and benefits of a physician who has experience with it in an understandable way
p.002017: minors.
p.002017: Art. 98. Informed consent to participate in a clinical trial is not required if
p.002017: imposes an immediate decision to save the person's life, and if at that moment that consent
p.002017: could not be received. The decision is made by at least two doctors who do not participate in
p.002017: the research team.
p.002017: Art. 99. (1) During the test the participant receives an additional upon request
p.002017: information from an independent entity.
p.002017: (2) The written information provided to the participants in the clinical trial of
p.002017: medicinal product, contains contact details of the independent person for additional
p.002017: information.
p.002017: Section II.
p.002017: A clinical trial with vulnerable patient groups
p.002017: Art. 100. A clinical trial of minors may be
p.002017: undertake, provided that:
p.002017: 1. the protocol is approved by the relevant ethics committee after discussion of the clinical,
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.002017: (b) any Member State in which the qualified person fulfills the obligations
p.002017: his;
p.002017: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002017: (d) the address at which the primary document of the traceability system is stored
p.002017: drug safety;
p.002017: 12a. (new - SG 102/2012, in force since 21.12.2012) statement by the applicant that
p.002017: has the necessary means to fulfill the obligations of Chapter Eight;
p.002017: 13. (Amended, SG No. 102/2012, effective 21.12.2012) risk management plan with
p.002017: a description of the risk management system that the applicant will put in place for that person
p.002017: medicinal product, together with a summary of the plan;
p.002017: 14. a brief description of the product according to Art. 34;
p.002017: 15. layout of the primary and secondary packaging of the product and a leaflet in
p.002017: compliance with the requirements of Chapter Six;
p.002017: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country where
p.002017: production shall be carried out accompanied by a certificate of good manufacturing practice or
p.002017: certificate certifying that the manufacture of the medicinal product and of the active substances included in
p.002017: its composition was done in accordance with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 17. a copy of the document identifying the medicinal product for treatment,
p.002017: prevention or diagnosis of rare diseases, accompanied by a copy of the opinion of
p.002017: The European Medicines Agency;
p.002017: 18. copies of any marketing authorization issued in another Member State or in
p.002017: a third country for the medicinal product for which a marketing authorization is sought;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) copy of the summary of the safety data, including
p.002017: data contained in periodic safety update reports and, where available, communications
p.002017: for suspected side effects
p.002017: reactions;
p.002017: 19. a list of the Member States in which an application for authorization is submitted
p.002017: for the use of a medicinal product;
p.002017: 20. (amend. - SG 71/08, in force from 12.08.2008) copy of the summary of product characteristics, proposed
p.002017: by the person under Art. 26, para. 1, or a copy of the summary of product characteristics approved by the regulatory authority
p.002017: authority of a Member State (s) already issued
p.002017: marketing authorization;
p.002017: 21. a copy of the refusal of the marketing authorization in a Member State or in a third
p.002017: country accompanied by motives; suspension or termination information
p.002017: the validity of the marketing authorization;
p.002017: 22. a copy of the proposed package leaflet for the patient, accompanied by a summary of the evaluation results
p.002017: at the level of readability of the contents of the package leaflet from the patient's target group or copy
p.002017: from a leaflet approved by the regulatory body of
p.002017: a Member State which has already granted a marketing authorization;
p.002017: 23. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2;
p.002017: 24. (new - SG 71/08, in force from 26.07.2008) the documents under art. 7 of
p.002017: Regulation (EC) No 1901/2006.
...
p.002017: the product, except for the data under art. 34, para. 1, Vol. 5;
p.002017: 3. in the case of a herbal medicinal product within the meaning of Art. 37, para. 2 or the combined vegetable
p.002017: medicinal product - the information under art. 37, para. 1, item 5 for the combination; when the individual active substances of
p.002017: the combined product is not known enough
p.002017: provide data on the traditional use of each;
p.002017: 4. a copy of the marketing authorization or the plant registration certificate
p.002017: a medicinal product issued by a Member State or a third country and / or a copy of the refusal,
p.002017: accompanied by the reasons for the decision;
p.002017: 5. (amend. - SG 71/08, in force from 12.08.2008) bibliographic data or
p.002017: expert opinions proving that the herbal medicinal product for which it was submitted
p.002017: the application for registration or the product corresponding thereto has at least 30 years of use
p.002017: in world medical practice, of which at least 15 years of use in the territory of a country
p.002017: Member by the date of submission of the application for registration;
p.002017: 6. bibliographic data on the safety of the product, accompanied by an expert
p.002017: a report;
p.002017: 7. a copy of the manufacturing authorization, accompanied by a certificate of Good
p.002017: manufacturing practice or with a certificate proving that the product is manufactured under conditions,
p.002017: equivalent to the requirements of Good Manufacturing Practice.
p.002017: (2) The Executive Agency for Medicinal Products may request from the applicant an additional one
p.002017: information for the safety assessment of the medicinal product under para. 1.
p.002017: (3) The Executive Agency for Medicinal Products may request an opinion from the Committee for Herbal Medicinal Products
p.002017: to the European Medicines Agency on the accuracy of the data under para. 1, item 5, as his
p.002017: provided the necessary parts of the dossier to
p.002017: the medicinal product.
p.002017: (4) The submitted data under para. 1, item 5 shall also be valid in cases where during the 30-year period
p.002017: use in medical practice:
p.002017: 1. the relevant medicinal product of the product applied for
p.002017: registration, has been on the market without authorization or registration for use, or
p.002017: 2. when the number of ingredients in the medicinal product for which an application has been submitted
p.002017: registration, their amount in dosage unit is reduced or decreased.
p.002017: Art. 39. (1) Where the herbal medicinal product has been on the Community market for less than 15 years, but
p.002017: meets the conditions of Art. 37, para. 1, the BDA shall submit for the opinion the documentation under Art. 38, para. 1 on
p.002017: The Committee for Herbal Medicinal Products at
p.002017: European Medicines Agency.
p.002017: (2) The Executive Agency for Medicines shall take a final decision after
p.002017: the publication of a monograph by the committee under para. 1 for product compliance with the criteria
p.002017: for registration for traditional use.
p.002017: (3) In the cases of para. 1 the term under Art. 44 stops running.
p.002017: Art. 40. The Medicines Executive Agency may require the applicant to
p.002017: herbal medicinal product to submit documentation under Art. 27 - 32 or under Art. 35.
p.002017: Art. 41. (1) (amend. - SG 71/08, in force from 12.08.2008) The Executive Agency for Medicines shall publish
p.002017: on your site's list of herbal substances,
p.002017: preparations or combinations thereof used in traditional herbal medicinal products prepared
p.002017: by the Committee for Herbal Medicinal Products at the European Medicines Agency. The list contains for everyone
p.002017: herbal substance therapeutic indications, active ingredient content per unit dose and dosage,
p.002017: route of administration and other information necessary for the safe use of the herbal substance as traditional
p.002017: medicine.
p.002017: (2) When they propose a registration product for traditional use in the application
p.002017: contains a herbal substance, preparation or a combination thereof, listed in para. 1,
p.002017: the applicant does not submit the data referred to in Art. 38, para. 1, Vols 4 - 6.
p.002017: (3) When the herbal substance, the preparation or the combination thereof are excluded from the list under para. 1, the holder
...
p.002017: medical products.
p.002017: (2) In case the persons under para. 1 have participated in one of the preparation stages of
p.002017: the documentation necessary to authorize the use of the medicinal product cannot be provided
p.002017: participate in the meetings of the respective specialized commission under art. 47.
p.002017: (3) The persons under para. 1 shall not vote in decisions on matters on which they or
p.002017: their family members have commercial, financial or other interests.
p.002017: Art. 49. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 200 days from the date of receipt of
p.002017: valid documentation of the BDA together with the relevant commission under Art. 47, para. 1 evaluates quality, safety and
p.002017: the efficacy of the medicinal product and produces an evaluation report commenting on the results of the pharmaceutical and
p.002017: the preclinical tests, the clinical trials, the risk management system and the
p.002017: monitoring the safety of the medicinal product concerned. The evaluation report prepared shall be submitted to
p.002017: the BDA Executive Director.
p.002017: (2) (New, SG No. 102/2012, effective 21.12.2012) The report under para. 1 se
p.002017: updated in the presence of new information relevant to the assessment of quality, safety and health
p.002017: the efficacy of the medicinal product.
p.002017: (3) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012) Where the medicinal product contains genetically
p.002017: modified organisms, the BDA provides the Ministry of Environment and Water with the necessary
p.002017: dossier documentation for the medicinal product and
p.002017: requests an opinion within 60 days on the potential environmental risk.
p.002017: The sixty-day period is within the term of para. 1.
p.002017: (4) (Renumbered from Paragraph 3, SG No. 102/2012, effective 21.12.2012) In the cases of
p.002017: radiopharmaceuticals BDA provides the required documentation from the dossier of the medicinal product and requires it
p.002017: opinion within 60 days by the Nuclear Regulatory Agency with respect to
p.002017: the quality and safety of the product. The sixty-day period is within the term of para. 1.
p.002017: (5) (Renumbered from Paragraph (4), amend. - SG 102/02, in force from 21.12.2012) Where
p.002017: The Ministry of the Environment and Waters and the Nuclear Regulatory Agency do not express their opinion in the
p.002017: the established under para. 3 and 4 terms, their opinion is considered positive.
p.002017: Art. 50. (1) When the BDA finds inconsistencies in the dossier with the requirements for granting a marketing authorization or
p.002017: certificate of registration under this law, notifies the applicant in writing to provide additional information,
p.002017: related to the documentation under Art. 27 - 32 or
p.002017: under Art. 35, para. 3, or under Art. 38 and / or provide an oral or written explanation of
p.002017: incompleteness and non-compliance found within 180 days from the date of notification.
p.002017: (2) In the cases of para. 1 the term under Art. 44 ceases to run from the date of notification to
p.002017: providing the requested information.
p.002017: (3) The Executive Director of the BDA shall terminate the procedure for issuing the BDA
p.002017: of a marketing authorization or a marketing authorization for a medicinal product where:
p.002017: 1. the applicant has not provided the information under para. 1 within the specified period;
p.002017: 2. the persons under art. 26, para. 1 request termination in writing.
p.002017: Art. 51. Within 10 days from the preparation of the evaluation report under Art. 49, para. 1
p.002017: the BDA Executive Director issues a Marketing Authorization / Registration Certificate
p.002017: of the medicinal product or a reasoned refusal.
p.002017: Art. 52. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 5 days from the date of
p.002017: issuance of the marketing authorization / registration certificate in the register of art. 19, para.
p.002017: 1, item 3, the following data on the permit / certificate shall be entered:
p.002017: 1. registration number;
p.002017: 2. number and date of the marketing authorization / registration certificate of
p.002017: the medicinal product;
p.002017: 3. name of the medicinal product;
...
p.002017: the field of clinical trials, when referred to by the ethics committees under art. 103, para. 1 and 2,
p.002017: by the BDA or by the contracting authority.
p.002017: (5) The Central Ethics Committee shall exercise methodological guidance towards
p.002017: ethics committees under art. 103, para. 1 and 2.
p.002017: (6) The meetings of the Central Ethics Committee shall be closed. If necessary
p.002017: the chairman of the Central Ethics Committee may invite the contracting authority or
p.002017: the principal investigator.
p.002017: (7) The Council of Ministers, upon a proposal by the Minister of Health, shall designate with
p.002017: Rules of Procedure of the Central Ethics Committee.
p.002017: Art. 108. (1) A member of the Central Ethics Committee may not be appointed to the same
p.002017: committee for more than two consecutive terms. The term of office is 4 years.
p.002017: (2) Every two years, one-half of the composition of the Central Ethics Committee shall be
p.002017: is updating.
p.002017: Section IV.
p.002017: Permission to conduct a clinical trial
p.002017: Art. 109. A clinical trial may begin when the following conditions are fulfilled:
p.002017: 1. the relevant ethics committee has given a favorable opinion, and
p.002017: 2. the Executive Director of the BDA has issued a written permit for its conduct,
p.002017: when any of the tested medicinal products is:
p.002017: (a) a gene therapy medicinal product;
p.002017: (b) somatic cell therapy medicinal product;
p.002017: (c) a medicinal product containing genetically modified organisms;
p.002017: (d) a high-tech medicinal product as defined in the Annex to the Regulation
p.002017: (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: (e) a medicinal product containing a biologically active substance (s)
p.002017: human or of animal origin or containing biological or human components
p.002017: animal origin, or in the manufacture of which such components are used, or
p.002017: 3. within the period specified by the law, the assignor has not been notified in writing by the BDA that
p.002017: the test cannot be conducted - for medicinal products other than those under item 2.
p.002017: Art. 110. (1) In order to obtain an opinion, the principal or coordinating researcher and
p.002017: the assignor shall submit to the respective ethics committee under art. 103
p.002017: 1. administrative documentation;
p.002017: 2. information about a participant;
p.002017: 3. documentation of the test report;
p.002017: 4. documentation of the tested medicinal product / products;
p.002017: 5. documentation of technical requirements and personnel;
p.002017: 6. data on the financing and the administrative organization of the test.
p.002017: (2) The content, form and requirements for the documentation under para. 1 are defined in
p.002017: the ordinance under Art. 82, para. 3.
p.002017: Art. 111. (1) The Ethics Committee shall prepare an opinion, having regard to the following:
p.002017: 1. the importance of the clinical trial;
p.002017: 2. the positive assessment of the ratio of expected benefits and risks according to Art.
p.002017: 90, item 1 and the motivation of the conclusions;
p.002017: 3. the clinical trial protocol;
p.002017: 4. the suitability of the principal investigator and the research team for the conduct
p.002017: the clinical trial;
p.002017: 5. the researcher's brochure;
p.002017: 6. availability of the necessary equipment and its corresponding quality;
p.002017: 7. the correspondence and completeness of the written information to be provided, and
p.002017: the procedure for obtaining informed consent and the validity of the test
p.002017: people unable to give informed consent, in the cases under Art. 100 and 101;
p.002017: 8. the anticipated compensation or compensation in the event of injury or death, which
p.002017: may be the result of a clinical trial;
p.002017: 9. the insurance covering the liability of the researcher and the assignor;
p.002017: 10. where necessary, the terms and conditions for the remuneration or compensation of
p.002017: the researchers and the participants in the clinical trial and the elements of the contract between
p.002017: the client and the medical establishment;
p.002017: 11. the conditions and procedure for recruiting participants.
p.002017: (2) The Ethics Committee shall:
p.002017: 1. gives a favorable opinion;
p.002017: 2. motivated refuses, or
p.002017: 3. requires a change in some of the documentation as a condition for receiving a positive one
p.002017: position.
p.002017: Art. 112. (1) Within 60 days from the submission of an application, the relevant ethics committee shall
p.002017: delivers an opinion to the applicant and the BDA.
p.002017: (2) Where the clinical trial includes a gene therapy medicinal product or
p.002017: somatic cell therapy or a medicinal product containing genetically modified
p.002017: organisms, the term under para. 1 is extended to 30 days.
p.002017: (3) The deadline for issuing an opinion is 180 days, when for clinical examination
p.002017: a trial involving a gene therapy or somatic cell therapy drug
p.002017: or a medicinal product containing genetically modified organisms is required to be consulted
p.002017: expert commission specially created by order of the BDA Director.
p.002017: Art. 113. (1) When evaluating the documentation, the Ethics Committee may require
p.002017: one additional written documentation from the applicant. The time limits under Art. 112 stop yes
p.002017: run until the required documentation is submitted.
p.002017: (2) The procedure for examining the study shall be terminated if, within 60 days from
p.002017: receiving the request for additional information, the contracting authority did not submit the request by
p.002017: commission documentation.
p.002017: Art. 114. (1) When the test will be conducted in more than one center in the territory
p.002017: of the Republic of Bulgaria, an application shall be submitted to the Ethics Committee for Multicenter Tests
p.002017: under Art. 103, para. 1.
p.002017: (2) When the test will be conducted in only one center in the territory of the Republic
p.002017: Bulgaria, an application may be submitted to the relevant Ethics Committee under Art. 103, para. 1 or 2 on
p.002017: choice of the contracting authority.
p.002017: (3) The opinion of the Ethics Committee under Art. 103, para. 1 is valid for all centers of
p.002017: the territory of the Republic of Bulgaria.
p.002017: (4) (New - SG 12/2011, in force from 08.02.2011) For submission of applications for
p.002017: the Ministry of Health collects an opinion from the Ethics Committee
p.002017: a fee in the amount determined by the tariff under Art. 21, para. 2.
p.002017: Art. 115. (1) Where the opinion of the respective Ethics Committee under Art. 103 e
p.002017: negative, the contracting authority may appeal within 90 days from the date of notification
p.002017: its decision before the Central Ethics Committee.
p.002017: (2) When the negative opinion of the respective Ethics Committee under Art. 103 was prepared without taking
p.002017: the opinion of the expert commission under art. 112, para. 3, the contracting authority may within 14 days from the date of notification
p.002017: to request in writing that the committee review it
p.002017: your opinion.
p.002017: (3) The expert commission under Art. 112, para. 3 within 60 days from the date of receipt of the written application by
p.002017: the contracting authority decides on the negative opinion of the relevant ethics committee and can challenge it
p.002017: or endorse, in writing, informing her.
p.002017: The Ethics Committee takes a final opinion, which it sends to the contracting authority.
p.002017: (4) Where the expert commission under Art. 112, para. 3 supported the negative opinion,
p.002017: the contracting authority may, within 14 days from the date of notification, appeal against the decision to
p.002017: Central Ethics Committee.
p.002017: (5) The opinion of the Central Ethics Committee is final and binding
p.002017: the relevant ethics committee.
p.002017: Art. 116. (1) The contracting authority shall submit to the BDA an application in accordance with a specimen for carrying out of
p.002017: clinical trial.
p.002017: (2) Where the applicant for the clinical trial is not the sponsor, the application shall be
p.002017: is accompanied by documentation certifying that the person is authorized by
p.002017: the contracting authority.
p.002017: (3) Where the assignor is not registered as a natural or legal person of
p.002017: the territory of the Republic of Bulgaria, the application shall be accompanied by a document containing the data
p.002017: of his authorized representative for the territory of the Republic of Bulgaria.
p.002017: (4) The following shall be attached to the application:
p.002017: 1. administrative documents;
p.002017: 2. information about a participant;
p.002017: 3. documentation of the test report;
p.002017: 4. documentation of the tested medicinal product / products;
p.002017: 5. documentation of technical requirements and personnel;
p.002017: 6. documentation of financing and administrative organization of the test.
p.002017: (5) The content, form and requirements for the documentation under para. 4 are defined in
p.002017: the ordinance under Art. 82, para. 3.
p.002017: Art. 117. (1) When evaluating the documentation under Art. 116 The BDA may, in writing, only once
p.002017: requested additional documentation from the applicant.
p.002017: (2) The time limits under Art. 118, 119 and 120 shall cease to run until the request has been submitted
p.002017: documentation.
...
p.002017: clinical trial of gene therapy medicinal products where there is a risk of modification
p.002017: of the genome of the reproductive cells of the participant in
p.002017: the test.
p.002017: Art. 122. (1) In multicenter testing in the Republic of Bulgaria and in a third country, the BDA
p.002017: requires the contracting authority to provide a declaration that it will grant access to the representatives of
p.002017: BDA for inspection in order to establish compliance with the requirements and principles of the Good
p.002017: clinical practice and Good Manufacturing Practice.
p.002017: (2) When the contracting authority fails to submit the declaration under para. 1, the BDA does not consider
p.002017: the application submitted.
p.002017: Art. 123. The sponsor declares that it has been submitted to the BDA and to the Ethics Committee
p.002017: the documentation contains the same information.
p.002017: Art. 124. (1) The procedures in the Ethics Committee and in the BDA may be conducted
p.002017: simultaneously or sequentially at the option of the contracting authority.
p.002017: (2) The term under Art. 118, para. 1 for the examination of the documentation does not stop running at
p.002017: the lack of a decision by the Ethics Committee.
p.002017: Art. 125. The clinical trial shall be conducted in accordance with the protocol it has received
p.002017: positive opinion from the relevant ethics committee under art. 103, and under the conditions set out in
p.002017: the documentation submitted.
p.002017: Section V.
p.002017: Changes
p.002017: Art. 126. (1) The contracting authority may at any time make changes other than
p.002017: the substantial changes under Art. 127, para. 2, in the clinical trial protocol.
p.002017: (2) In the cases of para. 1 the contracting authority shall keep the documentation related to the changes, and
p.002017: it shall be made available to the BDA and the Ethics Committee upon request.
p.002017: Art. 127. (1) A change in the conduct of a clinical trial may be requested by
p.002017: BDA, when necessary to ensure the safety of participants, scientific
p.002017: the value of testing and / or adherence to the Good Clinical Practice rules.
p.002017: (2) A significant change in the conduct of the study is any change in the protocol
p.002017: and / or in the information and documentation under Art. 110 and 116, which affects:
p.002017: 1. the safety or physical and mental integrity of the participants;
p.002017: 2. the scientific value of the study;
p.002017: 3. conducting or organizing the survey;
p.002017: 4. the quality or safety of any of the tested medicinal products.
p.002017: Art. 128. (1) The contracting authority may apply planned substantial changes to the protocol
p.002017: of the test and in the documentation under Art. 110 and 116 when:
p.002017: 1. the relevant Ethics Committee has given a positive opinion in writing;
p.002017: 2. the BDA Executive Director has issued a written authorization for this - for clinical purposes
p.002017: tests with medicinal products under art. 109, item 2, or
p.002017: 3. within the period specified by the law, the assignor has not been notified by the BDA of not accepting
p.002017: the proposed changes in the clinical trial of medicinal products under Art. 109, Vol. 3.
p.002017: (2) The provision of para. 1 shall not apply to changes to the approved protocol which are
p.002017: require to protect participants from imminent danger when new information emerges,
p.002017: related to the conduct of the test or to the design of the tests
p.002017: medicine.
p.002017: (3) In the cases of para. 2 the contracting authority shall immediately inform the commission under para. 1, item 1 and
p.002017: BDA for new information available, measures taken and changes to the protocol implemented.
p.002017: Art. 129. (1) When planning significant changes in the clinical trial and in
p.002017: the documentation under Art. 110 and 116 the applicant submits a written application in a model to the BDA and to
p.002017: the relevant ethics committee.
p.002017: (2) The application shall be accompanied by the documentation necessary to justify the
p.002017: changes and certifying that after applying the change, the ratio estimate
p.002017: between the benefit and the risk under Art. 90, item 1 shall be retained.
p.002017: (3) The requirements for the application and documentation for change shall be specified in the ordinance
p.002017: under Art. 82, para. 3.
p.002017: Art. 130. (1) Within 35 days of receipt of an application for change, the Ethics Committee
p.002017: shall notify the contracting authority of its decision by issuing:
p.002017: 1. a positive opinion on the changes requested, or
p.002017: 2. a motivated refusal for changes in the clinical trial.
p.002017: (2) Within 35 days from the date of receipt of an application with a positive opinion
p.002017: of the BDA Ethics Committee:
p.002017: 1. approve the changes in the clinical trial of medicinal products under Art. 109, item 2, or
p.002017: 2. does not approve the changes, explicitly motivating.
p.002017: (3) If, within 35 days of submission of clinical change documentation
p.002017: tests with medicinal products under art. 109, item 3 the applicant did not receive a notification of refusal,
p.002017: proposed changes can be made.
p.002017: Art. 131. (1) In the cases of art. 130, para. 2, item 2 the contracting authority may submit an amendment
p.002017: in the proposed motives, at the latest 14 days before the date of application
p.002017: changes.
p.002017: (2) Within 14 days from the date of receipt of the changed documentation under para. 1 BDA
p.002017: issues a change in the authorization for a clinical trial of medicinal products under Art. 109, Vol. 2
p.002017: or refuses.
p.002017: (3) The refusal under para. 2 shall not be subject to appeal.
p.002017: Section VI.
p.002017: Suspension of clinical trial
p.002017: Art. 132. (1) The contracting authority or the researcher may take urgent measures to
p.002017: protect participants in the clinical trial from sudden risks to theirs
p.002017: safety and health.
p.002017: (2) In the cases of para. 1, the contracting authority shall immediately inform the BDA and the relevant commission
p.002017: ethics of the actions taken and the reasons that caused them.
p.002017: Art. 133. (1) When the test is carried out under conditions other than those determined at the time of granting the permit, or
p.002017: information is available to disprove the scientific validity of
p.002017: testing, or whether there is a risk to the safety of participants, the BDA may suspend
p.002017: conducting the test or terminating it.
p.002017: (2) Termination may be required for a particular center or for all centers at
p.002017: multicenter clinical trial on the territory of the Republic of Bulgaria.
p.002017: (3) In the event of termination of the clinical trial at all Centers of
p.002017: the territory of the Republic of Bulgaria BDA, before taking action under para. 1, informs
p.002017: in writing by the contracting authority and the principal or coordinating researcher.
p.002017: (4) Within 7 days of receipt of the notification, the assignor and / or the principal
p.002017: researchers may express an opinion on the measures taken by the BDA.
p.002017: (5) The provision of para. 3 shall not apply where there is an imminent risk of
p.002017: the health and safety of the test participants.
p.002017: Art. 134. In the cases under Art. 133, para. 1 The BDA shall immediately notify the relevant Commission on
p.002017: ethics, the regulatory authorities of all Member States, the European Medicines Agency and
p.002017: The European Commission on the measures taken and the reasons for this.
p.002017: Section VII.
p.002017: Safety monitoring
p.002017: Art. 135. (1) The principal investigator shall immediately inform the contracting authority orally or
p.002017: in writing for any serious adverse event occurring during the clinical trial at
p.002017: participant in the center for which he is responsible.
p.002017: (2) Following the notification under para. 1 shall submit a detailed written report.
p.002017: (3) Upon notification under para. 1 and in the report under para. 2 the test participant shall
p.002017: identifies with a unique code number specified in the test report.
p.002017: (4) The provisions of para. 1 and 2 shall not apply if in the clinical trial protocol
p.002017: or the researcher's brochure explicitly states that it does not require an emergency message for
p.002017: a specific serious adverse event.
p.002017: (5) The investigator shall report to the sponsor all adverse events or
p.002017: laboratory abnormalities identified in the protocol as critical to
p.002017: safety, in time and format in accordance with protocol requirements.
p.002017: Art. 136. When the outcome of a clinical adverse event
...
p.002017: the benefit / risk ratio for the medicinal product.
p.002017: (2) The marketing authorization holder shall notify the BDA of any new one
p.002017: information that could affect the benefit / risk balance of the medicinal product.
p.002017: (3) The obligation under para. 2 shall not exempt the holder of the marketing authorization from
p.002017: the requirement of Art. 194h for providing the information under para. 2 and through the periodic ones
p.002017: updated safety reports.
p.002017: Art. 145c. (New, SG No. 102/2012, effective 21.12.2012) (1) When the study is conducted only on
p.002017: the territory of the Republic of Bulgaria in fulfillment of an obligation under Art. 56a, the holder of the authorization for
p.002017: use drafts of the study protocol in the BDA. The draft minutes, together with
p.002017: written consent under Art. 145a, para. 2, it does
p.002017: submit to the committees under art. 103, para. 1 or 2, where applicable.
p.002017: (2) The Executive Director of the BDA within 60 days from the date of receipt of the BDA
p.002017: the documentation under para. 1 shall send the marketing authorization holder a notification of
p.002017: approve the study or make a reasoned refusal.
p.002017: (3) The Executive Director of the BDA shall refuse to conduct the study with one or
p.002017: more than the reasons under Art. 145f, para. 2, Vol. 2.
p.002017: (4) The Commission under Art. 103, para. 1, respectively the commissions under art. 103, para. 2, within 60 days of
p.002017: the date of receipt of the documentation under para. 1 shall send the holder of the authorization for
p.002017: use a positive or negative opinion.
p.002017: (5) The study may be initiated after obtaining the approval of
p.002017: BDA and positive opinion from the commission under art. 103, para. 1, respectively by the commissions under art.
p.002017: 103, para. 2.
p.002017: (6) To evaluate the documentation under para. 1 The BDA collects a fee in the amount specified in
p.002017: the tariff under Art. 21, para. 2.
p.002017: Art. 145g. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002017: use apply significant changes to the protocol in the cases under art. 145c, para. 1 after their preliminary
p.002017: approval by the BDA and the Commission under Art. 103, para. 1,
p.002017: respectively the commissions under art. 103, para. 2.
p.002017: (2) The holder of the marketing authorization shall submit to the BDA and to the commission under Art.
p.002017: 103, para. 1, respectively in the commissions under art. 103, para. 2, documentation related to the changes, and
p.002017: the reasons for this.
p.002017: (3) The Executive Director of the BDA within 30 days of receipt of the documentation
p.002017: under para. 2 approves the amended protocol or issues a reasoned refusal and notifies the holder of
p.002017: the marketing authorization.
p.002017: (4) The Commission under Art. 103, para. 1, respectively the commissions under art. 103, para. 2, within 30 days of
p.002017: the date of receipt of the documentation under para. 2 sends to the holder of the authorization for
p.002017: use a positive or negative opinion.
p.002017: (5) The BDA Executive Director shall refuse the changes under para. 1 with one or more of
p.002017: the reasons referred to in Art. 145f, para. 2, Vol. 2.
p.002017: (6) The holder of the marketing authorization may apply the changes under para. 1 next
p.002017: obtaining approval from the BDA and a positive opinion from the committee under Art. 103, para. 1,
p.002017: respectively the commissions under art. 103, para. 2.
p.002017: (7) To evaluate the documentation under para. 1 The BDA collects a fee in the amount specified in
p.002017: the tariff under Art. 21, para. 2.
p.002017: Art. 145d. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002017: use shall submit a final report of the BDA study within 12 months of completion of the collection
p.002017: data. A summary of the results is attached to the report
p.002017: from the study.
p.002017: (2) The marketing authorization holder may submit a reasoned request to
p.002017: BDA for postponement of the term under para. 1 at least three months before the submission date of
p.002017: the final report referred to in the minutes.
p.002017: (3) The Drug Enforcement Agency shall approve or make a reasoned refusal
p.002017: the request under para. 2 and notify the holder of the marketing authorization.
p.002017: (4) When the holder of the marketing authorization based on the report under para. 1
p.002017: considered that a change to the marketing authorization was necessary, he submitted to the BDA an application for
p.002017: change in the order of Chapter Three, Section VI.
p.002017: (5) The BDA Executive Director shall by order suspend or terminate the marketing authorization,
p.002017: when the BDA based on the report under para. 1 and after consultation with the marketing authorization holder
p.002017: consider stopping or stopping
p.002017: of the Marketing Authorization.
p.002017: Art. 145f. (New, SG No. 102/2012, effective 21.12.2012) (1) When the study is conducted as on
p.002017: the territory of the Republic of Bulgaria and of the territory of other Member States for medicinal products,
p.002017: authorized under Regulation (EC) No 726/2004 of the European Parliament and of the Council or in accordance with Chapter
p.002017: third, section VII in fulfillment of the obligations under art. 55a or under Art. 56a, the authorization holder
p.002017: for use filed by
p.002017: the committee under Art. 56a, para. 1, item 1 of the draft protocol.
p.002017: (2) Within 60 days from the date of receipt of the documentation under para. 1 the committee under art.
p.002017: 56a, para. 1, item 1 prepares an opinion and sends to the holder of the marketing authorization:
p.002017: 1. notification of approval, or
p.002017: 2. a reasoned refusal when:
p.002017: (a) found that the study promoted the use of the medicinal product
p.002017: product, and / or
p.002017: (b) consider that the design of the study will not achieve the objectives of the report,
p.002017: and / or
p.002017: (c) the study is of a clinical trial nature.
p.002017: (3) In the cases of para. 2, item 1 the marketing authorization holder shall submit
p.002017: the notification of the BDA and the commissions under Art. 103, para. 1 or 2, where applicable.
p.002017: (4) The Commission under Art. 103, para. 1, respectively the commissions under art. 103, para. 2, within 15 days of
p.002017: the date of receipt of the notification under para. 3 shall send the holder of the authorization for
p.002017: use a positive or negative opinion.
p.002017: (5) The conduct of the study may commence upon receipt of a positive one
p.002017: opinion of the commission under art. 103, para. 1, respectively by a commission under Art. 103, para. 2.
p.002017: (6) The content and format of the protocol under para. 1 shall be determined by Regulation
p.002017: Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the implementation of the
p.002017: the pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Union
p.002017: Parliament and of the Council and in Directive 2001/83 / EC of the European Parliament and of the Council (OJ, L 159/5 of
p.002017: 20 June 2012), hereinafter referred to as "the
p.002017: Implementation (EU) No 520/2012 ".
p.002017: Art. 145g. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the authorization for use in the cases under Art. 145f, para. 1 implements planned significant changes to
p.002017: the minutes of the study after their prior approval by the committee under Art. 56a, para. 1, v. 1.
p.002017: (2) The holder of the marketing authorization shall submit to the committee referred to in Art. 56a, para. 1, vol.
p.002017: 1 the documentation related to the changes and the reasons for this.
p.002017: (3) Where the committee under Art. 56a, para. 1, item 1 approved the changes to the protocol, the holder
p.002017: of the marketing authorization shall notify the BDA and the Commission under Art. 103, para. 1, respectively commissions
p.002017: under Art. 103, para. 2.
p.002017: (4) The holder of the marketing authorization may apply the changes under para. 1 next
p.002017: receiving a positive opinion from the commission under art. 103, para. 1, respectively the commissions under
p.002017: Art. 103, para. 2.
p.002017: Art. 145h. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
p.002017: submit electronically to the committee under Art. 56a, para. 1, item 1 final report, accompanied by
p.002017: summarizing the results of the study within 12 months
p.002017: upon completion of data collection.
p.002017: (2) The marketing authorization holder may submit a reasoned request to
p.002017: the committee under Art. 56a, para. 1, item 1 for postponement of the term under para. 1 at least three months before the date of
p.002017: submission of the final report referred to in the minutes.
p.002017: (3) The Committee under Art. 56a, para. 1, item 1 approves or makes a reasoned refusal of the request under
p.002017: para. 2 and notify the holder of the marketing authorization.
p.002017: (4) The content and format of the report under para. 1 shall be determined by the Implementing Regulation
p.002017: (EU) No 520/2012.
p.002017: Art. 145i. (New, SG No. 102/2012, effective 21.12.2012) (1) The Committee under Art. 56a, para. 1, item 1 on the basis
p.002017: of the report under Art. 145h, para. 1 and after consulting the marketing authorization holder issues
p.002017: a reasoned recommendation for a marketing authorization
p.002017: the medicinal product and sends it to:
p.002017: 1. The Committee for Medicinal Products for Human Use under Art. 5 of Regulation (EC)
p.002017: No 726/2004 of the European Parliament and of the Council, or
p.002017: 2. the coordination group of art. 77, para. 2.
p.002017: (2) In the cases of para. 1, item 2, when the committee under art. 56a, para. 1, item 1 recommended a change,
p.002017: suspension or termination of the marketing authorization, coordination group represented
p.002017: from the Member States in which the study was conducted, issue an opinion on the necessary actions which
p.002017: should be taken with regard to authorization
p.002017: for use, including a timetable for its implementation.
p.002017: (3) When the Member States represented in the coordination group agree on
p.002017: the opinion under para. 2, it shall be published on the European Internet portal for medicinal products under Art. 68,
p.002017: para. 1, item 4 and shall be sent to the holder of the authorization for
p.002017: use.
p.002017: (4) The BDA Executive Director in accordance with the opinion under para. 2 stops
p.002017: the operation or termination of the marketing authorization.
p.002017: (5) Where in the opinion under para. 2 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization within the specified implementation schedule submits to the BDA an application for a change to
p.002017: the order of Chapter Three, Section VI, including
p.002017: updated summary of product characteristics and package leaflet.
p.002017: (6) Where agreement cannot be reached within the coordination group,
p.002017: the position of the majority of the Member States is submitted to the European Commission, which
p.002017: adopts the decision to change, suspend or terminate the marketing authorization issued by
p.002017: the relevant regulatory authorities of the Member States.
p.002017: (7) The decision under para. 6 is published on the European Medicines Portal
p.002017: products of art. 68, para. 1, item 4 and shall be sent to the holder of the marketing authorization.
p.002017: (8) The Medicines Executive Agency shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 6 and inform the European Medicines Agency and the European Medicines Agency
p.002017: commission.
p.002017: (9) In the cases of para. 1, item 1 The Committee for Medicinal Products for Human Use, in accordance with the recommendation
p.002017: of the Committee under Art. 56a, para. 1, item 1 issues an opinion on the retention, amendment, suspension or
p.002017: termination of the marketing authorization, including a timetable for the implementation of the opinion.
p.002017: The opinion shall be published on the European Internet Portal for Medicinal Products under Art. 68, para. 1, Vol. 4
p.002017: and sent to
p.002017: the holder of the marketing authorization.
p.002017: (10) Where in the opinion under para. 9 is a position for regulatory action
p.002017: action on marketing authorizations, the European Commission decides on
p.002017: modification, suspension or termination of marketing authorizations granted under the Regulation
p.002017: (EC) No 726/2004 of the European Parliament and of the Council.
p.002017: Art. 145k. (New, SG No. 102/2012, effective 21.12.2012) (1) Non-interventional
p.002017: surveys on the territory of the Republic of Bulgaria shall be conducted in accordance with Art. 145c - 145d.
p.002017: (2) When conducting non-interventional studies under para. 1 indicates the source
p.002017: of financing.
p.002017: Chapter Five.
p.002017: MANUFACTURE AND IMPORTATION OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES
p.002017: (TITLE AM. - SG, iss. 102 OF 2012, IN EFFECT OF 02/01/2013)
p.002017: Section I.
p.002017: Production
p.002017: Art. 146. (1) (amend. - SG 102/2012, in force from 02.01.2013) The production of all types
p.002017: medicinal products within the meaning of this Act and of medicinal products intended for clinical use
p.002017: testing, may be carried out on the territory of the Republic of Bulgaria only by natural or legal persons,
p.002017: registered as traders in the territory of a Member State who have been granted a manufacturing authorization,
p.002017: issued by the Director of
p.002017: Drug Enforcement Agency.
p.002017: (2) A production permit shall also be required in the cases where the products under para. 1 are
p.002017: intended for export only.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008)
p.002017: requires also for persons performing simultaneously or individually one of the following activities:
p.002017: full or partial production, various processes of packaging, packaging, repackaging, labeling, quality
p.002017: control and release of batches of medicinal products and
...
p.002017: on medicinal products performs the following activities for medicinal products placed on the market in
p.002017: Republic of Bulgaria:
p.002017: 1. monitoring the outcome of the risk reduction measures for a medicinal product,
p.002017: contained in the risk management plan;
p.002017: 2. monitoring of the result of the fulfillment of conditions specified in Art. 55a, 56 or 56a;
p.002017: 3. evaluation of the update of the risk management system;
p.002017: 4. monitoring of the EudraVigilance database set up in accordance with Article 24
p.002017: of Regulation (EC) No 726/2004 of the European Parliament and of the Council on new risks or on
p.002017: change in already established and change in benefit / risk ratio.
p.002017: Art. 187. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: The European Medicines Agency and the Marketing Authorization Holder have been informed by the European Medicines Agency
p.002017: identifying signals for new risks or for changing identified risks, or when changing
p.002017: the benefit / risk ratio of the medicinal product.
p.002017: (2) The Committee under Art. 56a, para. 1, item 1 analyzes and prioritizes validated alerts for new risks or changes in
p.002017: already established for changing the benefit / risk ratio.
p.002017: (3) Where the Committee under Art. 56a, para. 1, item 1 recommends follow-up,
p.002017: the coordination group of art. 77, para. 2 or the Committee for Medicinal Products for
p.002017: drafts an opinion on regulatory actions regarding the authorization of
p.002017: use within a schedule drawn up in accordance with the severity and degree of danger.
p.002017: (4) The Medicines Executive Agency implements the recommendations in the opinion of
p.002017: the coordination group of art. 77, para. 2 or in the decision of the European Commission provisional
p.002017: and / or final measures.
p.002017: Art. 188. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: The European Medicines Agency, the regulatory authorities of the other Member States, shall be informed by the European Medicines Agency
p.002017: The European Commission at least 24 hours prior to the public disclosure of information regarding concerns
p.002017: with the monitoring of the safety of a medicinal product, unless the protection of
p.002017: public health requires
p.002017: immediate disclosure of information.
p.002017: (2) The Medicines Executive Agency shall publish information relating to the active substances contained in
p.002017: medicinal products authorized in other countries
p.002017: Member States, using a harmonized draft communication and timetable for publication,
p.002017: proposed by the European Medicines Agency.
p.002017: (3) In the cases of para. 1 and 2 information containing personal data or representing
p.002017: trade secrets shall be deleted unless such disclosure is necessary for safeguarding
p.002017: of public health.
p.002017: Art. 189. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the medicines agency may delegate some of the rights and obligations under this chapter to
p.002017: regulatory authority of another Member State by concluding an agreement.
p.002017: (2) In the cases of para. 1 The BDA informs the European Commission, the European Medicines and Regulatory Agency
p.002017: authorities of the other Member States for the delegation of powers and publish a communication to the
p.002017: Internet portal under Art. 185, para. 1 or on the Internet
p.002017: your page.
...
p.002017: (2) Within 30 days of receipt of the report under para. 1 holder of the authorization for
p.002017: Member States' regulatory authorities or authorities may submit their comments
p.002017: to the European Medicines Agency and to the BDA.
p.002017: (3) Within 15 days from the date of receipt of the comments under para. 2 BDA updates
p.002017: the evaluation report, taking into account all the objections presented, and forwarding it to the committee
p.002017: under Art. 56a, para. 1, item 1 for approval and recommendation.
p.002017: (4) The European Medicines Agency has included the evaluation report adopted and
p.002017: the recommendation of the Committee under Art. 56a, para. 1, item 1 in the register under Art. 194h, para. 3 and sends it to
p.002017: the holder of the marketing authorization.
p.002017: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) Where the Republic of Bulgaria is not
p.002017: rapporteur in the procedure under Art. 194o, para. 2, the BDA may submit comments within the term under Art. 194p, para. 2 to
p.002017: The European Medicines Agency and the regulatory authority of the European Medicines Agency
p.002017: the Member State that produced the assessment report.
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and when none of the authorizations for
p.002017: the use of these products has not been issued under Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: the coordination group of art. 77, para. 2 within 30 days from the date of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the preservation, modification, suspension or termination of
p.002017: relevant marketing authorizations, including a timetable for the implementation of the opinion.
p.002017: (2) Where the represented Member States in the coordination group under Art. 77, para. 2
p.002017: they agree on the actions to be taken, the BDA implements
p.002017: the decision taken.
p.002017: (3) Where the opinion under para. 1 is to suspend or terminate the authorization for
p.002017: The BDA Executive Director issues an order.
p.002017: (4) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (5) When agreement cannot be reached within the coordination group under Art. 77, para. 2, the position of
p.002017: the majority of the Member States are referred to the European Commission, which decides on the change,
p.002017: suspension or termination of permissions for
p.002017: use issued by the relevant regulatory authorities of the Member States.
p.002017: (6) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 5.
p.002017: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and where at least one of the authorizations for
p.002017: the use has been issued in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: medicinal products for human use within 30 days of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the retention, amendment, suspension or termination of validity
p.002017: of the relevant marketing authorizations, including a timetable for the implementation of
p.002017: the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. Decides to change, suspend or terminate the marketing authorizations,
p.002017: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 2. adopt a decision recommending change, suspension or termination of authorizations
p.002017: for use issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 2, Vol. 2.
p.002017: Section IV.
p.002017: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002017: 12/21/2012)
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure of
p.002017: the European Union level can be initiated by the European Commission, by the European Commission
p.002017: drug agency or from a Member State.
p.002017: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under
p.002017: the procedure for this section by notifying the regulatory authorities of the other Member States, the European Agency for Europe
p.002017: medicines and the European Commission, when for drug-related reasons
p.002017: safety, consider that a medicinal product placed on the Bulgarian market requires undertaking
p.002017: to any of the
p.002017: the following measures:
p.002017: 1. suspension or termination of the marketing authorization;
...
p.002017: 4 and contains one or more of the following conclusions:
p.002017: 1. no further investigation or action is required on
p.002017: Community level;
p.002017: 2. the holder of the marketing authorization must carry out additional work
p.002017: study and analysis of data;
p.002017: 3. the marketing authorization holder must carry out post-marketing
p.002017: a safety study with a subsequent evaluation of its results;
p.002017: 4. the Member State or the holder of the marketing authorization to apply measures to
p.002017: risk reduction;
p.002017: 5. the marketing authorization must be suspended, suspended or issued
p.002017: refusal to renew it;
p.002017: 6. the marketing authorization must be modified.
p.002017: (4) The specific measures under para. 3, item 4, as well as the conditions and restrictions that should
p.002017: be included in the marketing authorization, the recommendation states.
p.002017: (5) In the cases of para. 3, item 6, when the changes are related to the amendment or addition of information in the brief
p.002017: a specification, on the packaging or package leaflet of the medicinal product, shall be included in the recommendation
p.002017: the wording of the amended or added
p.002017: information and the place where it should be displayed.
p.002017: Art. 194h. (New, SG No. 102/2012, effective 21.12.2012) (1) Where within the scope of the procedure under Art. 194y
p.002017: no medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002017: Parliament and the Council, the coordination group under Art. 77, para. 2 on the basis of the recommendation under Art. 194s within 30 days
p.002017: from the date of its receipt, issue an opinion on the retention, modification, suspension, termination
p.002017: of the relevant authorizations or refusals to renew them, including a timetable for
p.002017: implementation of the opinion.
p.002017: (2) Where the opinion recommends that the measures under Art. 194ts, para. 3, Vol. 5,
p.002017: the Executive Director of the BDA shall, by order, suspend or revoke the authorization for
p.002017: use, or refuses to renew it.
p.002017: (3) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (4) Where in the opinion under para. 1 it is recommended to take measures under art. 194ts, para.
p.002017: 3, items 2 - 4, the holder of the marketing authorization takes the necessary actions and
p.002017: inform the BDA and the regulatory authorities of the other Member States.
p.002017: (5) Where, within the coordination group under Art. 77, para. 2 could not be reached,
p.002017: the position of the majority of the Member States is submitted to the European Commission, which accepts
p.002017: decision with recommendation for change, suspension or termination
p.002017: of the marketing authorization issued by the relevant regulatory authorities of the Member States.
p.002017: (6) The Drug Enforcement Agency shall implement the recommendations recommended in the decision under para. 5
p.002017: interim and / or definitive measures.
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Where within the scope of the procedure under Art. 194y
p.002017: a medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
p.002017: Parliament and the Council, the Committee for Medicinal Products for Human Use, based on the recommendation under Art. 194ts, para.
p.002017: 3, within 30 days from the date of its receipt, issue an opinion on the retention, change,
p.002017: suspension, termination of the relevant marketing authorizations or refusal of
p.002017: their renewal, including a timetable for the implementation of the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. adopt a decision to change, suspend or terminate the validity of the permits
p.002017: for use, issued under Regulation (EC) No 726/2004 of the European Parliament and of the
p.002017: The Council;
p.002017: 2. adopt a decision recommending the change, suspension or termination of validity of
p.002017: marketing authorizations issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Drug Enforcement Agency shall implement the recommendations recommended in the decision of the European Medicines Agency
p.002017: The European Commission under para. 2, item 2 provisional and / or final measures.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) The recommendation under Art. 194c,
p.002017: para. 1, the opinion under art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and
p.002017: Art. 194h, para. 2 shall be published on the European Internet portal under Art. 68, para. 1, Vol. 4.
p.002017: Chapter Nine.
p.002017: WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN
p.002017: THE MEDICINAL PRODUCTS AREA (HEADING, amended, SG No. 71/2008,
p.002017: POWER FROM 12.08.2008, ISM. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
p.002017: (Title "Section I. Wholesale trade of medicinal products" - SG, issue 71 of 2008, in
p.002017: with effect from 12.08.2008)
p.002017: Art. 195. (1) Wholesale trade in medicinal products may be carried out physically and
p.002017: legal persons authorized to do so by a regulatory body of
p.002017: the Member State concerned.
p.002017: (2) When the person under para. 1 has warehouses on the territory of the Republic
p.002017: Bulgaria, it may carry out wholesale of medicinal products after receiving
p.002017: permission from the BDA Executive Director.
p.002017: Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may
p.002017: only wholesale medicinal products for which a marketing authorization has been granted
p.002017: production.
p.002017: (2) An importer of medicinal products within the meaning of this Act may perform
p.002017: wholesale only of medicinal products for which import authorization has been granted.
p.002017: Art. 197. The persons under art. 195 must have:
p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
...
p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible master pharmacist under Art. 197, v. 2 and
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
p.002017: containing such substances, the requirements of the Control Act also apply
p.002017: drugs and precursors.
p.002017: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Agency
p.002017: for nuclear regulation.
p.002017: (5) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the person under para. 1, Vol. 3,
p.002017: when he is a Bulgarian citizen.
p.002017: Art. 200. The Drug Enforcement Agency evaluates the documentation and performs it
p.002017: on - the - spot verification of the sites indicated in the application for their compliance with
p.002017: requirements for Good Distribution Practice.
p.002017: Art. 201. (1) The Executive Agency for Medicines shall notify the applicant in writing,
p.002017: when it finds deficiencies in the documentation submitted.
p.002017: (2) In the cases of para. 1 the term under Art. 202, para. 1 stops running.
p.002017: Art. 202. (1) Within 90 days from the date of submission of the application under Art. 199, para. 1
p.002017: the Executive Director of the BDA issues the permit for wholesale trade or makes it motivated
p.002017: refusal.
p.002017: (2) The refusal under para. 1 shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: Art. 203. Within 15 days from the date of submission of the documentation under Art. 199, para. 2
p.002017: the BDA Executive Director issues a Wholesale Trade Registration Certificate to
p.002017: the territory of the Republic of Bulgaria of the person under Art. 195, para. 1.
p.002017: Art. 204. (1) The permit for wholesale of medicinal products shall be indefinite.
p.002017: (2) The authorization under Art. 202 or the certificate under Art. 203 is terminated if
p.002017: the holder requested this in writing from the BDA Executive Director.
...
p.002017: from 2010, in force from 01.01.2011, previous para. 6, amend. - SG, issue. 60 of 2011, effective 05.08.2011
p.002017: (d) Regional health inspections shall issue a hygienic conclusion within 14 days of the date
p.002017: of applying for it.
p.002017: (8) (New, SG No. 48/2015) On the day of receipt of the application under para. 1 and 5, the BDA shall send a request on its own motion
p.002017: to the Board of Directors of the Bulgarian Pharmaceutical Union for issuance of a certificate for registration in the national
p.002017: electronic register of the members of the Bulgarian Pharmaceutical Union - for the master pharmacist, head of
p.002017: pharmacy, as well as providing information on penalties imposed under the Commercial Law
p.002017: the organization of master pharmacists and the Health Act.
p.002017: (9) (New, SG No. 48/2015) The Managing Board shall submit the documents under para. 8th c
p.002017: 5 working days after receiving the request.
p.002017: (10) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 1, Vol. 5,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 229. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, repealed - SG No. 60/2011)
p.002017: (in force from 05.08.2011)
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 102/2009, effective 22.12.2009,
p.002017: ed. - SG, issue. 60 of 2011, in force since 05.08.2011, suppl. - SG, issue. 18 of 2014) Within one month from
p.002017: receipt of the documentation under Art. 228, para. 6 the Executive Director of the BDA after the opinion of
p.002017: The Expert Council for Retail Trade in Medicinal Products issues a marketing authorization
p.002017: retail with medicinal products at a pharmacy or make a motivated refusal to grant an authorization.
p.002017: The permit or refusal shall be
p.002017: served on the applicant.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation under Art.
p.002017: 228, para. 6 The BDA shall check the submitted documents and notify the applicant in writing of the established ones
p.002017: inconsistencies or incompleteness. In these cases
p.002017: the term under para. 2 shall cease to run from the day of notification until the deficiencies have been rectified.
p.002017: (4) (New - SG 71/08, in force from 12.08.2008) In case within 60 days from the date of notification
p.002017: under para. 3, the applicant has not remedied any inconsistencies or incompleteness found in the proceedings for the issuance of
p.002017: retail authorization for medicinal products
p.002017: products or for a change to an authorization is terminated.
p.002017: (5) (Renumbered from Paragraph (4), SG No. 71/2008, effective 12.08.2008, amended, SG No. 60/2008)
p.002017: 2011, effective 05.08.2011) The refusal of the BDA Executive Director to issue a
p.002017: permission shall be subject to appeal in accordance with the Administrative Procedure Code.
p.002017: Art. 229a. (New, SG No. 23/2009, effective 30.03.2009) (1) (amend. - SG 41/09, in force from 30.03.2009)
p.002017: 02.06.2009, amend. - SG, issue. 98 of 2010, effective January 1, 2011, as amended. - SG, issue. 60 of 2011, in force since
p.002017: 08/05/2011) The Executive Agency for Medicinal Products officially sends to the Regional Health Insurance Institute at the location of the respective
p.002017: pharmacy with issued permit under art. 229, para. 2, which includes the retail trade of food
...
p.002017: the holder of the marketing authorization or the authorized product
p.002017: face.
p.002017: Art. 251. (1) The person under art. 250 submits an application to the BDA on
p.002017: a model approved by the Executive Director of the Agency, accompanied by:
p.002017: 1. advertising project;
p.002017: 2. a notarized power of attorney from the holder of the marketing authorization,
p.002017: when the application is submitted by another person;
p.002017: 3. the literary sources of the quotations, tables or other materials used,
p.002017: when there are any;
p.002017: 4. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (2) The advertising projects under para. 1, item 1 must be clear, with intelligible text, in cases where
p.002017: and, where available, to evaluate all its elements - text and
p.002017: illustrations.
p.002017: (3) An Expert Council on Advertising shall be established at the BDA. It includes doctors and practitioners with practical experience in
p.002017: the field of advertising. The Executive Director of the BDA shall determine by an order the composition of the Board to which it is appointed
p.002017: include one representative of the Professional Ethics Committee of the Bulgarian Medical Association, the Bulgarian Medical Association
p.002017: dental
p.002017: Union and the Bulgarian Pharmaceutical Union, the amount of the remuneration of its members and approves regulations
p.002017: about the terms and conditions for his work. The board can be
p.002017: representatives of patient organizations are also included.
p.002017: (4) The council under para. 3 prepares expertise for the advertising project and prepares an opinion by
p.002017: the BDA Executive Director.
p.002017: (5) In case of finding inconsistencies of the advertising with the requirements of this law within 7 days from
p.002017: the date of submission of the application under para. 1 The BDA gives written instructions for their removal in one month
p.002017: term from the date of notification. The time limit for pronouncement is suspended
p.002017: run for the period from the day of notification to the elimination of inconsistencies.
p.002017: (6) In case the applicant does not comply with the instructions within one month from the date of
p.002017: the notification under para. 5, the authorization procedure is terminated.
p.002017: Art. 252. (1) Within one month from submission of the documentation under Art. 251, para. 1 on the basis of the opinion under Art.
p.002017: 251, para. 4, the BDA Executive Director authorizes the advertisement by order or makes a reasoned refusal for which
p.002017: notify the authorization holder of
p.002017: use.
p.002017: (2) (New, SG No. 60/2011, effective 05.08.2011) When, within the term of para. 1
p.002017: the BDA's executive director did not authorize the advertisement or motivated it
p.002017: refusal, it is considered that there is tacit agreement with the project of advertising under Art. 251, para. 1, item 1 and she
p.002017: can be distributed.
p.002017: (3) (Renumbered from Paragraph (2), SG No. 60/2011, effective 05.08.2011)
p.002017: the Executive Director shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: Art. 253. (1) The issued permission of the advertisement under Art. 252, para. 1 refers to a specific
p.002017: medicinal product within the period of validity of its marketing authorization.
p.002017: (2) When changes have been made to the marketing authorization for a medicinal product,
p.002017: that result in changes to the allowed ad for this product, the holder of the
p.002017: use submitted to the BDA application for change.
p.002017: Art. 254. In case of change of the permitted advertising the person under Art. 250 is applying for
p.002017: the order of art. 251.
p.002017: Art. 254a. (New, SG No. 60/2011, effective 05.08.2011) (1) Advertising,
p.002017: intended for medical specialists shall not be authorized in accordance with Art. 250 - 252.
p.002017: (2) The advertisement under para. 1 shall be distributed upon notification to the BDA at
p.002017: which applies to the design of the advertisement and subject to the requirements of this chapter and the regulation
p.002017: under Art. 249.
p.002017: Art. 255. (1) It is prohibited to distribute samples of medicinal products,
...
p.002017: Union of the Bulgarian Pharmaceutical
p.002017: union and patient organizations and the pharmaceutical industry.
p.002017: (3) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in
p.002017: (Effective 21.12.2012) A person who is a member of the Transparency Committee may not be a member of
p.002017: National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (4) The Council of Ministers shall lay down the rules and procedures for the work of the Commission
p.002017: for transparency.
p.002017: Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012
p.002017: The Transparency Committee is an appealable body
p.002017: the decisions of the National Council on Prices and Reimbursement of Medicinal Products.
p.002017: (2) Decisions of the Transparency Committee shall be taken by a two-thirds majority
p.002017: ѝ.
p.002017: (3) The decisions under par. 2 shall be subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a respective disease is without
p.002017: alternative in the country, for a particular patient may be administered a medicinal product that is authorized for
p.002017: use in a Member State of the European Union,
p.002017: it is authorized for use according to the procedure of this law, but it is not distributed on the Bulgarian market.
p.002017: (2) Annually upon proposal by the medical establishments for hospital care and after the opinion of the respective
p.002017: the national consultant on the disease profile, the Minister of Health approves the list of
p.002017: the medicinal products under para. 1 which contains
p.002017: following information:
p.002017: 1. anatomical-therapeutic-chemical classification code;
p.002017: 2. an international non-patent name to which the product belongs;
p.002017: 3. disease according to the international disease code;
p.002017: 4. the dosage form and the amount of active substance;
p.002017: 5. additional information.
p.002017: (3) The list under para. 2 is published on the Ministry of Justice's website
p.002017: healthcare on the internet.
p.002017: (4) The conditions and procedure for inclusion, modification or exclusion of medicinal products in
p.002017: the list under para. 2 shall be determined by the ordinance under art. 9, para. 1.
p.002017: (5) The medicinal product under para. 1 is delivered by special order curative
p.002017: hospital care facility under the terms and procedures established by the ordinance under Art. 9, para. 1.
p.002017: (6) The head of the medical establishment under para. 5 is responsible for the implementation of
p.002017: the treatment under para. 1.
p.002017: Chapter thirteen.
p.002017: STATE CONTROLS ON MEDICINAL PRODUCTS
p.002017: Art. 267. (1) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, effective from
p.002017: 12/21/2012) The Ministry of Health supervises the state control over medicinal products.
p.002017: The direct management is carried out by the Chief State Health Inspector, by the President of
p.002017: the Council under Art. 258, para. 1, by the Executive Director of the BDA and by the Directors of the State Health Insurance Fund, which are state-owned
p.002017: control inspectors
p.002017: medicinal products.
...
p.002017: inspections in third countries.
p.002017: Art. 269a. (New, SG No. 102/2012, effective 21.12.2012) (1) The officials of
p.002017: Art. 267, para. 3 prepare a report for each inspection carried out under Art. 269, para. 3 and 4 for compliance with
p.002017: principles and guidelines for Good Manufacturing Practice or Good Distribution
p.002017: practices, or to comply with the requirements of Chapter Eight, and the requirements of this Act.
p.002017: (2) The report under para. 1 shall be provided to the verified person who may submit
p.002017: notes on it.
p.002017: (3) Upon receiving a reasoned request, the BDA shall electronically send the reports on
p.002017: para. 1 of the competent authority of another Member State or of the European Agency for the European Union
p.002017: medicines.
p.002017: Art. 269b. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002017: Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good Distributor
p.002017: practices, where applicable, issued by the BDA to the manufacturer, importer or wholesaler
p.002017: Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice in
p.002017: up to 90 days from
p.002017: carrying out the inspection.
p.002017: (2) When, as a result of an inspection under Art. 269, para. 3 found that the manufacturer,
p.002017: the importer or wholesaler of the medicinal products or the active substances does not comply
p.002017: the requirements of the law and / or the principles and guidelines of Good Manufacturing Practice and / or of
p.002017: Good distribution practices, the BDA issues an opinion on
p.002017: discrepancy.
p.002017: (3) The Executive Agency for Medicines shall enter into the database under Art. 147 issued
p.002017: certificates under para. 1 and information under para. 2.
p.002017: Art. 269c. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002017: Art. 270, para. 1, item 5 it is established that the holder of the marketing authorization does not comply with the requirements of
p.002017: Chapter Eight, the BDA prescribes the removal of
p.002017: inconsistencies.
p.002017: (2) In the cases of para. 1 The BDA shall notify the Member States, the European Agency for the Protection of Energy
p.002017: medicines and the European Commission.
p.002017: right:
p.002017: Art. 270. (1) Within the limits of their competence, the officials under Art. 267, para. 3 have
p.002017: 1. (amend. - SG 102/2012, in force from 02.01.2013) access to all documents,
p.002017: related to the subject matter of the inspection, as well as to documents related directly or indirectly to a violation of
p.002017: this law or the legislation of the Member States implementing it
p.002017: the requirements of Directive 2001/83 / EC, regardless of the format of the document;
p.002017: 2. order each person to provide information about the violations under item 1, which are his
p.002017: famous;
p.002017: 2a. (new - SG 102/2012, in force from 02.01.2013) to inspect
p.002017: the manufacturing and trading sites of the manufacturers of medicinal products, active or auxiliary
p.002017: substances, as well as the laboratories used by the authorization holders
p.002017: production or import;
p.002017: 3. to inspect at any time the sites to be inspected and to require that
p.002017: verify and make copies of all documents relating to the overall business of
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.002017: Who sells or stores in a drugstore prescription medicines or
p.002017: products and goods relevant for human health beyond those specified in the ordinance under Art. 243, se
p.002017: punish with the fine under para. 1, and the repeated violation of the same violation shall be revoked
p.002017: certificate of registration of
p.002017: drugstore.
p.002017: (4) In the cases of para. 1 and 2 the bodies of state control over medicinal products
p.002017: stop the operation of the site by order.
p.002017: (5) The order under para. 4 shall be subject to appeal by the order of the Administrative Procedure
p.002017: Code, and the appeal does not suspend its enforcement.
p.002017: (6) (Repealed, SG No. 71/2008, effective 12.08.2008)
p.002017: Art. 287a. (New, SG No. 71/2008, effective 12.08.2008) (1) Medical specialist,
p.002017: who works for retailers of medicinal products without having
p.002017: permission / certificate for this is fined from 2500 to 5000 BGN.
p.002017: (2) The punishment under para. 1 shall also be imposed on a person under para. 1 that works in a pharmacy or drugstore
p.002017: after termination of the permit / certificate.
p.002017: (3) In case of more than two violations under para. 1 and 2 the Minister of
p.002017: healthcare may deprive the concerned healthcare professional of the right to exercise
p.002017: his profession for up to two years.
p.002017: Art. 287b. (New, SG No. 102/2012, effective 02/01/2013) Who conducts trading
p.002017: with medicinal products on the Internet in violation of the requirements of this law and the regulation
p.002017: under Art. 234, para. 5, shall be liable to a fine of from BGN 5,000 to BGN 10,000.
p.002017: Art. 288. (1) The retailer of medicinal products who has authorized the activities,
p.002017: referred to in Art. 219, to be carried out by an incapacitated person, shall be punished by a pecuniary sanction
p.002017: from 5000 to 10 000 levs, and in case of repeated infringement the issued marketing authorization of
p.002017: retail.
p.002017: (2) In the cases of para. 1 the state control bodies shall stop by an order
p.002017: the operation of the site.
p.002017: Art. 289. (1) (Former text of Art. 289 - SG 60/2012, in force since 07.08.2012)
p.002017: Who sells medicinal products at prices other than those established under this Act shall be
p.002017: shall be liable to a fine of from BGN 5,000 to BGN 10,000 and, in the case of a repeated offense, to a fine
p.002017: from 6000 to 12 000 BGN
p.002017: (2) (New - SG, iss. 60 in 2012, in force since 07.08.2012, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
p.002017: Holder of a marketing authorization that fails to fulfill an obligation specified in the ordinance under Art. 261a, para. 5,
p.002017: shall be punished by a pecuniary sanction from 5000 to 10 000 levs, and by repeated infringement - by pecuniary sanction
p.002017: a penalty of 10,000 to 20
p.002017: BGN 000
p.002017: (3) (New, SG No. 102/2012, effective 21.12.2012) The violations under para. 1 and 2 shall be established by acts,
p.002017: composed of officials designated by the chairman of the council under Art. 258, para. 1, and the penal provisions shall be
p.002017: issued by the chairman of the council under Art. 258, para.
p.002017: 1 or by a member of the Council authorized by him.
p.002017: Art. 289a. (New, SG No. 60/2011, effective 05.08.2011) (1) (amend. - SG 102/02)
p.002017: 2012, effective 21.12.2012) Who works in violation of approved pharmacotherapeutic
p.002017: guide or evaluate the efficacy of therapy in deviation from the criteria of
p.002017: Art. 259, para. 1, item 4, shall be punished by a fine of from 1000 to 2000 levs, and in case of repeated commission of the same
...
Searching for indicator incapacity:
(return to top)
p.002017: one medicinal product compared to a medicinal product which has already been authorized
p.002017: use.
p.002017: 26. "Coordinating researcher" means a researcher appointed to coordinate
p.002017: researchers from different centers participating in the multi-center test.
p.002017: 27. "Patient leaflet" is a leaflet containing information about the user that
p.002017: accompanies the medicinal product.
p.002017: 27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
p.002017: "Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No 1394/2007.
p.002017: Of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and for
p.002017: amendment of the Directive
p.002017: 2001/83 / EC and Regulation (EC) No 726/2004.
p.002017: 28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product made from human
p.002017: blood components and by a method involving an industrial process. These include albumin, immunoglobulins,
p.002017: coagulation factors and antiproteases, solutions of
p.002017: plasma proteins, other plasma fractions or combinations thereof.
p.002017: 29. "Medicinal product intended for the treatment, prevention and diagnosis of rare
p.002017: diseases "is a product that:
p.002017: (a) is intended for the diagnosis, prophylaxis or treatment of life-threatening diseases
p.002017: diseases or progressive chronic diseases affecting no more than 5 in 10
p.002017: 000 people on the territory of the country, or
p.002017: (b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
p.002017: health-damaging chronic conditions (diseases with a high incidence of incapacity for work and
p.002017: disability) and evidence was provided that the sale of the product did not provide a satisfactory one
p.002017: returns to justify the investment needed for R&D without
p.002017: incentives for
p.002017: the creator of the product, and
p.002017: (c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of
p.002017: the condition, or if there is one, the proposed medicinal product
p.002017: far more benefits than that and benefits for those affected by this condition.
p.002017: 30. A "dosage form" is an acceptable accepting structure containing the active substance (s) which
p.002017: may or may not include excipients obtained by the application of certain technological
p.002017: operations providing the desired healing effect and
p.002017: storage stability over the shelf life.
p.002017: 31. (amend. - SG 71/08, in force from 12.08.2008) "Person established in the territory of a Member State"
p.002017: is a legal entity registered under the civil or commercial law of a Member State or
p.002017: created by a legal act having its registered office and registered office in a Member State or in a State -
p.002017: Party to the Agreement on
p.002017: The European Economic Area.
p.002017: 32. "Highway formulation" is a prescription for a medicinal product made in a pharmacy under
p.002017: prescription from a healthcare professional or an approved prescription for a particular patient.
p.002017: 33. "International non-patent name" is the recommended name of
p.002017: the active substance approved and published by the WHO.
p.002017: 34. "Medical specialists" are doctors, doctors of dental medicine,
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.002017: products of the same qualitative and quantitative composition as regards the active substances and with
p.002017: same dosage form.
p.002017: Art. 33. Conducting the necessary studies and tests to prepare authorization documentation
p.002017: for use and subsequent practical requirements for the authorization of medicinal products under
p.002017: Art. 28 and 29 is not a patent infringement
p.002017: or the supplementary protection certificate for a medicinal product.
p.002017: Art. 34. (1) The summary of product characteristics shall contain the following information:
p.002017: 1. name of the medicinal product, quantity of active substance for dosage
p.002017: unit, dosage form;
p.002017: 2. quantitative and qualitative composition in respect of the active substances and those of
p.002017: excipients for which information is essential for the proper application of
p.002017: product; the common name or chemical description is used;
p.002017: 3. dosage form;
p.002017: 4. clinical data:
p.002017: (a) therapeutic indications;
p.002017: (b) dosage and route of administration for adults and children;
p.002017: c) contraindications;
p.002017: (d) special warnings and precautions for use; for immunological
p.002017: medicinal products - precautions for persons handling and administering them
p.002017: patients, as well as the precautions to be taken by the patient;
p.002017: (e) interactions with other medicinal products or other forms of interaction;
p.002017: (f) use in pregnancy or lactation;
p.002017: (g) effects on the ability to drive and use machines;
p.002017: h) side effects;
p.002017: i) overdose (symptoms, antidotes, emergency measures);
p.002017: 5. pharmacological data:
p.002017: a) pharmacodynamic properties;
p.002017: b) pharmacokinetic properties;
p.002017: (c) preclinical safety data;
p.002017: 6. pharmaceutical data:
p.002017: (a) a list of excipients;
p.002017: (b) major incompatibilities;
p.002017: c) shelf life; shelf life after reconstitution of the medicinal product (at
p.002017: need) or after opening the immediate packaging for the first time;
p.002017: (d) special storage instructions;
p.002017: (e) the nature and composition of the packages;
p.002017: (f) specific instructions for disposal of the remainder of the medicinal product or of
p.002017: waste materials therefrom;
p.002017: 7. the holder of the marketing authorization;
p.002017: 8. registration number;
p.002017: 9. date of first authorization or renewal of the authorization
p.002017: use;
p.002017: 10. date on which the content of the summary of the Summary of Product Characteristics was made
p.002017: product;
p.002017: 11. for radiopharmaceuticals - comprehensive information on internal radiation
p.002017: dosimetry;
p.002017: 12. for radiopharmaceuticals - detailed instructions for extemporaneous preparation and quality control and, where applicable
p.002017: applicable, the maximum storage time during which the relevant intermediate such as eluate or ready
p.002017: for pharmacist use corresponds to
p.002017: its specification.
p.002017: (2) In the summary of the medicinal products under Art. 28 - 33 parts of the short may not be included
p.002017: a characteristic of the reference medicinal product relating to the indications and dosage forms that have been
p.002017: under patent protection at a time when
p.002017: the generic product was on the market.
p.002017: (3) Requirements for the form and content of the summary of product characteristics
...
p.002017: descriptions in the file, or
p.002017: 5. the data in the file under art. 59a, para. 1 are incorrect, or
p.002017: 6. the control of the medicinal product and / or of the ingredients and the intermediate stages of
p.002017: the manufacturing process has not been performed or no other requirement is fulfilled, where it is
p.002017: the production authorization has been issued, or
p.002017: 7. some of the data in the file do not meet the requirements of Art. 59a, para. 1 and 2.
p.002017: (2) Refusal of the Executive Director of the BDA to renew the authorization for
p.002017: use / registration certificate of a medicinal product may be appealed in the order of
p.002017: Code of Administrative Procedure.
p.002017: (3) The refusal of the BDA Executive Director and the reasons shall be published on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 59c. (New, SG No. 60/2011, effective 05.08.2011, amended - SG No. 102/2012, effective 01.04.2013
p.002017: d.) The Drugs Executive Agency notifies the National Drug Price and Reimbursement Council
p.002017: products for the revoked and revoked marketing authorizations, as well as for the refusals to renew
p.002017: authorizations granted for
p.002017: medicinal products within 7 days of the issuance of the relevant act.
p.002017: Section VI.
p.002017: Changes to the marketing authorization issued
p.002017: Art. 60. (1) (amend. - SG 12/11, in force from 08.02.2011)
p.002017: a marketing authorization is obliged to notify the BDA of any change to
p.002017: the conditions under which the authorization was granted.
p.002017: (2) (Amended, SG No. 12/2011, effective 08.02.2011) Changes may be of the type
p.002017: IA, Type IB, Type II, Extension of Marketing Authorization and Emergency Restrictions
p.002017: safety measures.
p.002017: (3) (amend. - SG 12/11, in force from 08.02.2011) The conditions and criteria for
p.002017: classification of the changes shall be determined by the ordinance under Art. 42.
p.002017: (4) (amend. - SG 12/11, in force from 08.02.2011) Change that does not occur
p.002017: extension and whose classification remains uncertain after the conditions have been applied
p.002017: and the criteria of the ordinance under Art. 42, is considered to be a type IB change by default.
p.002017: (5) (New, SG No. 12/2011, effective 08.02.2011) As an exception to para. 4
p.002017: a change that is not an extension of scope and whose classification remains uncertain
p.002017: after applying the conditions and criteria of the ordinance under Art. 42, is considered to be a type II change
p.002017: the following cases:
p.002017: 1. at the request of the holder of the marketing authorization indicated in the application for
p.002017: change;
p.002017: 2. when the BDA after evaluating the validity of the notification under Art. 63 considered that
p.002017: change can have a significant impact on quality, safety or
p.002017: the efficacy of the medicinal product.
p.002017: Art. 61. (amend. - SG 12/11, in force from 08.02.2011) (1) For each change of type
p.002017: IA, Type IB, Type II or Extension of Holder of Marketing Authorization
p.002017: the medicinal product submits to the BDA a separate notification, respectively an application.
p.002017: (2) When a change leads to a change in the summary data of
p.002017: the product, on the packaging and / or in the package leaflet, these changes are accepted as part of the application
p.002017: change and no separate application is made for them.
p.002017: (3) The Marketing Authorization Holder may group the changes when:
p.002017: 1. notify simultaneously the same type IA changes in the conditions of one or
p.002017: more marketing authorizations;
p.002017: 2. declares several changes to the terms of the marketing authorizations at the same time,
p.002017: belonging to the global marketing authorization under Art. 28, para. 8 of the medicinal product,
p.002017: provided that the relevant changes occur in one of the following cases:
p.002017: (a) one of the changes in the group is the extension of the marketing authorization;
p.002017: (b) one of the changes in the group is a type II change and all other changes in the group are
p.002017: changes resulting from the Type II change;
p.002017: c) one of the changes in the group is a type IB change and all other changes in the group are
p.002017: changes resulting from the type IB change;
p.002017: (d) all changes in the group are only administrative changes in
p.002017: the summary of product characteristics, patient package leaflet or packaging;
p.002017: (e) All changes in the group are changes in the active documentation of the asset
p.002017: substance, vaccine antigen background, or background documentation for
p.002017: plasma;
p.002017: (f) any changes to the group are in relation to a project designed to refine
p.002017: the manufacturing process and the quality of the medicinal product concerned or its
p.002017: active substance (s);
p.002017: (g) all changes in the group are changes that affect the quality of the pandemic
p.002017: influenza vaccine;
p.002017: h) all changes in the group are changes in the pharmacovigilance system by chapter
p.002017: the eighth;
p.002017: (i) any changes to the group are the result of a specific emergency safety measure; and
p.002017: were filed in accordance with Art. 66;
p.002017: k) all changes in the group are related to the inclusion of information about a given
p.002017: pharmacotherapeutic class;
p.002017: (l) any changes in the group are the result of the evaluation of the periodic report for the
p.002017: safety;
p.002017: (m) any changes to the group result from a post-authorization study
p.002017: for use under the supervision of the marketing authorization holder;
p.002017: (n) any changes to the group are the result of the fulfillment of a condition of authorization for
p.002017: use of art. 56;
p.002017: 3. the requested changes in the conditions of the same marketing authorization do not fall under
p.002017: the cases under item 2, provided that the BDA agreed to apply the same to these changes
p.002017: procedure.
p.002017: (4) When grouping changes under para. 3, items 2 and 3, the holder of the authorization for
p.002017: use submitted to the BDA:
p.002017: 1. single notification when at least one of the changes is type IB and all others are type
p.002017: IA or type IB;
p.002017: 2. a single application where the major change is type II and none of the other changes
p.002017: is not an extension of the marketing authorization;
p.002017: 3. a single application where the major change is the extension of
p.002017: the marketing authorization.
p.002017: (5) Along with the application, respectively, the notification under para. 1 or 4, the holder of
p.002017: the marketing authorization shall submit:
p.002017: 1. documentation related to the changes, determined by the ordinance under Art. 42;
p.002017: 2. a document for a paid fee in the amount determined by the tariff under Art. 21, para. 2.
...
p.002017: (4) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: (5) (Repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: Art. 79a. (New, SG No. 60/2011, effective 05.08.2011) (1) Subject to
p.002017: the decision of the European Commission after the conclusion of the BDA arbitration procedure within 30 days
p.002017: days after receipt of notification:
p.002017: 1. issues, suspends or suspends a marketing authorization, or
p.002017: 2. Requests that changes be made to the permit issued to achieve
p.002017: in accordance with the European Commission decision.
p.002017: (2) The Medicines Executive Agency shall notify the European Commission and
p.002017: The European Medicines Agency for the act issued under para. 1.
p.002017: Art. 79b. (New, SG No. 102/2012, effective 21.12.2012) (1) In cases where the interests of
p.002017: The European Union and before deciding on the authorization of a medicinal product
p.002017: product, its suspension, termination or change, BDA, applicant or holder of
p.002017: marketing authorization may apply
p.002017: the question to the committee under art. 79, para. 1 for the application of the arbitration procedure.
p.002017: (2) In the cases of para. 1 where referral is the result of an evaluation of tracking data
p.002017: the safety of an authorized medicinal product, the matter is referred to the
p.002017: Art. 56a, para. 1, item 1 and the procedure of art. 194h or
p.002017: 194y.
p.002017: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall apply
p.002017: the procedure for Chapter Eight, Section IV, where one of the measures is necessary,
p.002017: referred to in Art. 194y, para. 2 and 3.
p.002017: (4) (New, SG No. 18/2014) Notwithstanding para. 1 - 3, when emergency action is needed to protect
p.002017: public health at some stage of the arbitration procedure, the BDA may suspend the authorization of
p.002017: use and prohibit the use of the respective medicinal product in the territory of the Republic of Bulgaria until
p.002017: acceptance of the final
p.002017: answer.
p.002017: (5) (New, SG No. 18/2014) In the cases of para. 4 The BDA informs the European
p.002017: the Commission, the European Medicines Agency and the other Member States for their reasons
p.002017: decision no later than the next business day.
p.002017: Art. 80. (amend. - SG 12/11, in force from 08.02.2011) The conditions and the procedure for carrying out
p.002017: changes to the authorizations granted under this section shall be governed by Regulation (EC) No 1234/2008 of the European Communities
p.002017: November 2008 on the examination of changes in the conditions of marketing authorizations for medicinal products
p.002017: products for human use and
p.002017: veterinary medicinal products (OJ L 334/7 of 12 December 2008).
p.002017: to be:
p.002017: Chapter Four.
p.002017: CLINICAL TESTS
p.002017: Section I.
p.002017: general provisions
p.002017: Art. 81. Clinical testing of medicinal products on humans may be carried out,
p.002017: 1. detect or confirm clinical, pharmacological or pharmacodynamic properties
p.002017: effects of one or more tested medicinal products;
p.002017: 2. identify adverse reactions to one or more tested medicinal products;
p.002017: 3. examines the absorption, distribution, metabolism and excretion of one or
p.002017: more tested medicinal products and / or to ascertain their safety and / or
p.002017: efficiency.
p.002017: Art. 82. (1) Clinical trial on humans shall be conducted in compliance with the basic ones
...
p.002017: the territory of the Republic of Bulgaria BDA, before taking action under para. 1, informs
p.002017: in writing by the contracting authority and the principal or coordinating researcher.
p.002017: (4) Within 7 days of receipt of the notification, the assignor and / or the principal
p.002017: researchers may express an opinion on the measures taken by the BDA.
p.002017: (5) The provision of para. 3 shall not apply where there is an imminent risk of
p.002017: the health and safety of the test participants.
p.002017: Art. 134. In the cases under Art. 133, para. 1 The BDA shall immediately notify the relevant Commission on
p.002017: ethics, the regulatory authorities of all Member States, the European Medicines Agency and
p.002017: The European Commission on the measures taken and the reasons for this.
p.002017: Section VII.
p.002017: Safety monitoring
p.002017: Art. 135. (1) The principal investigator shall immediately inform the contracting authority orally or
p.002017: in writing for any serious adverse event occurring during the clinical trial at
p.002017: participant in the center for which he is responsible.
p.002017: (2) Following the notification under para. 1 shall submit a detailed written report.
p.002017: (3) Upon notification under para. 1 and in the report under para. 2 the test participant shall
p.002017: identifies with a unique code number specified in the test report.
p.002017: (4) The provisions of para. 1 and 2 shall not apply if in the clinical trial protocol
p.002017: or the researcher's brochure explicitly states that it does not require an emergency message for
p.002017: a specific serious adverse event.
p.002017: (5) The investigator shall report to the sponsor all adverse events or
p.002017: laboratory abnormalities identified in the protocol as critical to
p.002017: safety, in time and format in accordance with protocol requirements.
p.002017: Art. 136. When the outcome of a clinical adverse event
p.002017: trial is death, the researcher is obliged to provide the commissioner and the commissions on
p.002017: ethics any additional information requested.
p.002017: Art. 137. The Contracting Authority shall keep detailed records of all serious adverse events provided
p.002017: provided by the researchers, and made available to them by the BDA or the regulatory authorities of the Member States upon request, c
p.002017: which is being tested at multicenter
p.002017: testing.
p.002017: Art. 138. (1) The contracting authority shall notify the BDA, the regulatory authorities of all the Member States in which it is held.
p.002017: the multicenter trial, and the relevant ethics committee for each clinical course
p.002017: test suspected unexpected serious
p.002017: adverse reaction leading to death or life-threatening, at the latest 7 days
p.002017: from receiving information about it.
p.002017: (2) The contracting authority shall provide the bodies of para. 1 additional information on the case in
p.002017: 8 days from the date on which the notification is sent.
p.002017: (3) The contracting authority shall notify the bodies of para. 1 for all other than those mentioned in
...
p.002017: (6) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 5.
p.002017: Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and where at least one of the authorizations for
p.002017: the use has been issued in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: medicinal products for human use within 30 days of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the retention, amendment, suspension or termination of validity
p.002017: of the relevant marketing authorizations, including a timetable for the implementation of
p.002017: the opinion.
p.002017: (2) Where in the opinion under para. 1 is a position for regulatory action
p.002017: action on marketing authorizations, European Commission:
p.002017: 1. Decides to change, suspend or terminate the marketing authorizations,
p.002017: issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: 2. adopt a decision recommending change, suspension or termination of authorizations
p.002017: for use issued by the relevant regulatory authorities of the Member States.
p.002017: (3) The Executive Agency for Medicines shall apply provisional and / or definitive ones
p.002017: measures from the decision under para. 2, Vol. 2.
p.002017: Section IV.
p.002017: Emergency procedure at European Union level (New, SG No. 102/2012, in force from
p.002017: 12/21/2012)
p.002017: Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure of
p.002017: the European Union level can be initiated by the European Commission, by the European Commission
p.002017: drug agency or from a Member State.
p.002017: (2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under
p.002017: the procedure for this section by notifying the regulatory authorities of the other Member States, the European Agency for Europe
p.002017: medicines and the European Commission, when for drug-related reasons
p.002017: safety, consider that a medicinal product placed on the Bulgarian market requires undertaking
p.002017: to any of the
p.002017: the following measures:
p.002017: 1. suspension or termination of the marketing authorization;
p.002017: 2. prohibition of distribution of a medicinal product;
p.002017: 3. issuing a refusal to renew the marketing authorization.
p.002017: (3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para.
p.002017: 2, when notified by the marketing authorization holder that for reasons related to
p.002017: drug safety monitoring, discontinued
p.002017: the distribution of the medicinal product has either taken or intends to take action on
p.002017: it will be removed from the market or it will not take any action to renew it
p.002017: the marketing authorization issued.
p.002017: (4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure
p.002017: under para. 2 and in cases where it considers that for reasons related to drug monitoring
p.002017: safety, a new contraindication or reduction should be added to a medicinal product
...
p.002017: Art. 207. (1) The holder of a wholesale trade permit who carries out the activity
p.002017: on the territory of the Republic of Bulgaria, is obliged to:
p.002017: 1. shall provide access at all times to the control bodies of the premises for
p.002017: storage of medicinal products;
p.002017: 2. trade only in medicinal products authorized under this Law;
p.002017: 3. trade in medicinal products whose packaging and leaflets are in accordance with the authorization granted
p.002017: use, under the terms and procedure of this Act and their term of validity
p.002017: fitness has not expired;
p.002017: 4. supplies medicinal products only to manufacturers, importers or wholesalers of medicinal products,
p.002017: have been authorized to carry out this activity under the terms of
p.002017: this law;
p.002017: 4a. (new - SG 102/2012, in force from 02.01.2013) check whether the received medicinal products
p.002017: the products of the persons under item 4 are not falsified by checking the indicators for
p.002017: safety on the outer packaging;
p.002017: 5. supply medicinal products to other marketing authorization holders of
p.002017: wholesale, pharmacies and drugstores opened under this law;
p.002017: 5a. (new - SG 71/08, in force from 12.08.2008) supplies medicinal products
p.002017: medical establishments for own needs;
p.002017: 6. supply doctors and dentists with medicinal products when there is no place in the settlement
p.002017: pharmacy, under the conditions and in the order laid down in an ordinance of the Minister of Health
p.002017: healthcare;
p.002017: 6a. (new - SG 102/2012, in force from 02.01.2013) shall enter in the documents for
p.002017: delivery of batch number of delivered medicinal products;
p.002017: 6b. (new - SG 102/2012, in force from 02.01.2013) there is an emergency action plan
p.002017: situations containing effective measures to withdraw a medicinal product from the market by order of
p.002017: BDA or at the initiative of the manufacturer or the holder of
p.002017: the authorization to use the medicinal product concerned;
p.002017: 6c. (new, SG No. 18/2014) ensure the supply of sufficient quantities of medicinal products
p.002017: to meet the health needs of the population of the Republic
p.002017: Bulgaria;
p.002017: 7. (amend. - SG 102/2012, in force from 02.01.2013) store data for each transaction with
p.002017: medicinal products obtained, delivered or intermediated in the form of invoices for
p.002017: sale or in electronic form or in any other form as
p.002017: should:
p.002017: (a) date of receipt and delivery;
p.002017: (b) the name of the medicinal product;
p.002017: (c) the quantity received, delivered or sold through mediation;
p.002017: (d) the name and address of the person from whom the medicinal product was obtained or delivered;
p.002017: (e) the batch number and the batch exemption certificate number issued by
p.002017: the qualified person under Art. 148, item 2, respectively by the qualified person under art. 161, para. 2, Vol. 1,
p.002017: and the batch release certificate number issued by the BDA - in the cases under Art. 69 and 70;
p.002017: 8. keep records of the purchases and / or sales of all medicinal products
p.002017: products;
p.002017: 9. complies with the requirements of the Good Distribution Practice as defined in the Ordinance on
p.002017: Art. 198;
p.002017: 10. (new, SG No. 102/2012, effective 02.01.2013) maintain a quality system,
p.002017: defining the responsibilities, processes and measures for managing the risk associated with the activity
p.002017: his;
p.002017: 11. (New, SG No. 102/2012, effective 02.01.2013) shall immediately inform the BDA and
...
p.002017: 13. (new - SG 102/2012, in force from 02.01.2013) check whether the manufacturer
p.002017: or the importer from whom he received the medicinal product has a marketing authorization
p.002017: production / import;
p.002017: 14. (new - SG 102/2012, in force from 02.01.2013) check whether the mediator,
p.002017: by whom he received the medicinal product meets the requirements of this Chapter.
p.002017: (2) The documentation under para. 1, items 7 and 8 shall be kept for at least 5 years and shall be kept
p.002017: shall make available to the inspection bodies upon request.
p.002017: Art. 208. (suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 02.01.2013
p.002017: d.) The provisions of Art. 207, para. 1, items 2 - 14 and para. 2 and Art. 209a shall also apply to the wholesalers of art. 203,
p.002017: as well as for importers and manufacturers trading with
p.002017: their medicinal products.
p.002017: Art. 209. For the wholesale of medicinal products containing narcotic substances
p.002017: or derived from blood, immunological products and radiopharmaceuticals are also administered
p.002017: the special requirements of other laws.
p.002017: Art. 209a. (New - SG 71/08, in force from 12.08.2008) (1) Wholesale traders with
p.002017: medicinal products may supply medicinal products:
p.002017: 1. other wholesalers of medicinal products;
p.002017: 2. pharmacies and drugstores;
p.002017: 3. The Ministry of Defense and the Ministry of the Interior for their own
p.002017: needs, with the exception of their departmental health establishments, as well as the State Agency
p.002017: "State reserve and wartime stocks";
p.002017: 4. The Ministry of Health with:
p.002017: (a) vaccines, toxins and serums necessary for the implementation of the Immunization
p.002017: calendar of the Republic of Bulgaria, as well as in emergency epidemic situations;
p.002017: (b) medicinal products intended to treat remunerated diseases
p.002017: under the Health Act, as well as to ensure the implementation of national programs in the
p.002017: healthcare.
p.002017: 5. (new - SG 60/2012, effective from 07.08.2012) medical establishments for
p.002017: outpatient care contracted with the National Health Insurance Fund with medicinal products,
p.002017: necessary for the implementation of the health activities under art. 82, para. 2, item 3 of
p.002017: Health Law.
p.002017: (2) Doctors and dentists in places where there is no pharmacy,
p.002017: may be supplied with medicinal products by the wholesalers in accordance with the ordinance under Art.
p.002017: 207, para. 1, v. 6.
p.002017: Art. 209b. (New, SG No. 102/2012, effective 02.01.2013) (1) In the case of wholesale trade with
p.002017: medicinal products in third countries do not apply the requirements of Art. 207, para. 1, items 2, 5 and 6,
p.002017: as well as the requirements of Chapter Nine "a".
p.002017: (2) Where a medicinal product is obtained directly from a third country but not imported on
p.002017: the territory of the Republic of Bulgaria, the requirements of Art. 207, para. 1, items 4 and 4a.
p.002017: (3) (New, SG No. 18/2014) In the cases of para. 1 the wholesalers certify with the relevant documents,
p.002017: that the medicinal products were obtained from persons authorized or entitled to deliver
p.002017: medicinal products, as applicable
p.002017: third country national legislation.
p.002017: (4) (New, SG No. 18/2014) Where the wholesaler supplies medicinal products to persons in the
p.002017: third countries, it certifies with the relevant documents that the supplies are only for persons who have them
p.002017: authorization or right to receive medicinal products intended for wholesale or delivery
p.002017: of the population, as applicable
...
p.002017: (3) Where the regulatory body under para. 2 temporarily suspend or revoke permission for
p.002017: wholesale trade of the person under art. 195, para. 1, it shall notify the BDA Executive Director and
p.002017: The European Commission.
p.002017: Art. 212a. (New, SG No. 102/2012, effective 02/01/2013) (1) (Amended, SG No. 18/2012)
p.002017: 2014) Mediation in the field of medicinal products can physically and
p.002017: legal entities registered as commercial intermediaries within the meaning of the Commercial Law of
p.002017: The Republic of Bulgaria, which are registered for carrying out this activity by the BDA.
p.002017: (2) The persons under para. 1, who wish to register as intermediaries, shall file with the BDA
p.002017: notification according to a model approved by the BDA Executive Director, containing:
p.002017: 1. name, seat and address of management;
p.002017: 2. contact details.
p.002017: (3) To the notification under para. 2 shall apply:
p.002017: 1. data on the unique identification code;
p.002017: 2. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (4) The Executive Agency for Medicines shall enter in the public register the persons,
p.002017: mediators in the field of medicinal products.
p.002017: (5) The persons under para. 1 may mediate in the field of medicines
p.002017: products after submission of the notification under para. 2 in the BDA.
p.002017: (6) The persons under para. 1 shall notify the BDA within 7 days from the occurrence of a change in any of the
p.002017: the circumstances under para. 2.
p.002017: Art. 212b. (New - SG 102/02, in force from 02.01.2013) (1) The persons under art. 212a, para.
p.002017: 1 shall:
p.002017: 1. carry out their activity only with authorized medicinal products;
p.002017: 2. Have an emergency plan that contains effective measures for withdrawal of a medicinal product
p.002017: from the market at the disposal of the BDA or at the initiative of the manufacturer or the holder of the marketing authorization
p.002017: use of the respective medicinal product;
p.002017: 3. to store data including the following information for each transaction made
p.002017: through mediation medicinal products:
p.002017: (a) the date of the transaction;
p.002017: (b) the name of the medicinal product;
p.002017: (c) the quantity realized through mediation;
p.002017: (d) the name and address of the persons who received and delivered the medicinal product;
p.002017: (e) account number;
p.002017: 4. to comply with the requirements of the Good Distribution Practice, adopted by the Ordinance under
p.002017: Art. 198;
p.002017: 5. maintain a quality system that defines responsibilities, processes and measures
p.002017: to manage the risk associated with its business;
p.002017: 6. immediately inform the BDA and the Marketing Authorization Holder, where applicable
p.002017: has established or suspects that the medicinal product subject to mediation is
p.002017: counterfeit;
p.002017: 7. check that the trader holds a wholesale trade permit with
p.002017: medical products;
p.002017: 8. verify that the manufacturer or importer holds an authorization for
p.002017: production / import;
p.002017: 9. to keep the data under item 3 for a period of at least 5 years and to provide them at
p.002017: request from the inspection bodies.
p.002017: (2) Requirements for mediation activities in the field of medicines
p.002017: products are determined by the ordinance under art. 198 and in European Commission guidance.
p.002017: Chapter Nine "a".
p.002017: PARALLEL IMPORTS OF MEDICINAL PRODUCTS (PREVIOUS SECTION II - SG, ISP.
p.002017: 71 FROM 2008, IN EFFECT OF 12/08/2008)
...
p.002017: causing fatal outcome, imminent danger to life, hospitalization or prolongation of
p.002017: hospitalization period, significant or lasting
p.002017: disability, disability and congenital anomalies.
p.002017: 68. "Batch Release Certificate" is a document issued by
p.002017: the qualified person of the manufacturer or importer for each individual lot and includes
p.002017: requirements in accordance with the specification as well as all test results for
p.002017: batch release.
p.002017: 69. "Certificate of additional protection" is a document that provides additional
p.002017: patent protection of the medicinal product for a maximum of 5 years after the expiry date of
p.002017: the basic patent.
p.002017: 69a. (new, SG No. 102/2012, effective 21.12.2012) "Risk Management System" is
p.002017: a system of pharmacovigilance measures and activities designed to
p.002017: identifying, characterizing, preventing or minimizing drug-related risks
p.002017: product, including an evaluation of the effectiveness of these
p.002017: activities and measures.
p.002017: 69b. (new - SG 102/2012, in force since 21.12.2012) "Tracking system of
p.002017: 'safety' is a system used by the marketing authorization holder and
p.002017: BDA for the accomplishment of the tasks and responsibilities of Chapter Eight intended for implementation
p.002017: monitoring the safety of authorized medicinal products and detection
p.002017: of any change in the benefit / risk ratio.
p.002017: 70. "Emergency restrictive safety measures" are temporary changes to product information with respect to
p.002017: one or more parts of the summary of product characteristics, indications, method of administration, contraindications
p.002017: and warnings that result from a new one
p.002017: information related to the safe use of the medicinal product.
p.002017: 71. "Spontaneous message" is a voluntarily sent message about suspected unwanted
p.002017: reaction when using the medicinal product to the marketing authorization holder, up to
p.002017: authorities for the supervision of medicinal products or other organizations not originating in
p.002017: a survey or other organized information gathering system.
p.002017: 72. "Shelf life of a medicinal product" is the time interval at which, if stored at
p.002017: the prescribed conditions, the medicinal product meets the requirements of the specification developed on
p.002017: based on stability studies of several batches of
p.002017: the finished form.
p.002017: 73. (amend. - SG 71/08, in force from 12.08.2008) "Relevant medicinal product of
p.002017: herbal medicinal product "is a product that contains the same active substances, regardless of composition
p.002017: of excipients intended for the same purpose with an equivalent amount of the medicinal substance / substances,
p.002017: and at the same dosage, and with
p.002017: the same or similar route of introduction as the product applied for.
p.002017: 74. "Adverse reaction message" is the documented information on one or more suspected adverse reactions
p.002017: reactions associated with the use of one or more medicinal products by one patient. For the sake of respect
p.002017: the validity of the adverse reaction message requires a minimum of identification data
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.002017: in agreement with the Executive Director of the Executive Agency for Medicinal Products (BDA), may authorize
p.002017: treatment for a fixed term with a medicinal product not authorized under Chapter Three when in the country
p.002017: has an epidemic caused by pathogens or toxins, or is suspected or confirmed
p.002017: proliferation of chemical agents or nuclear radiation and is not appropriately authorized for
p.002017: use of medicinal product.
p.002017: (2) In the cases of para. 1 marketing authorization holders, manufacturers and
p.002017: medical professionals are not liable for civil or administrative penalties for
p.002017: the consequences of using an unauthorized indication of a medicinal product or medicinal product
p.002017: a product not authorized in accordance with Chapter Three.
p.002017: (3) The provision of para. 2 does not exclude liability for defective goods under the Act
p.002017: consumer protection.
p.002017: Art. 11. (1) The Minister of Health may, for reasons connected with the protection of the health of the population,
p.002017: ordering the BDA Executive Director to authorize a medicinal product for use,
p.002017: which has not been authorized for use on the territory of the Republic of Bulgaria and for which no application has been submitted
p.002017: but it is
p.002017: authorized in another Member State.
p.002017: (2) In the cases of para. 1, the Executive Director of the BDA or his authorized representative
p.002017: face:
p.002017: 1. inform the holder of the marketing authorization for the medicinal product
p.002017: initiation of a product authorization procedure;
p.002017: 2. enter as the holder in the issued permit the person under item 1;
p.002017: 3. Requires the regulatory authority of the Member State which granted the marketing authorization,
p.002017: a copy of the evaluation report and a copy of the marketing authorization.
p.002017: (3) (Supplemented, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines
p.002017: is obliged to ensure compliance with the label, patient leaflet, classification,
p.002017: advertising and monitoring the safety of the marketed medicinal product under para. 1 with the requirements of this one
p.002017: law. Information on the packaging and the package leaflet
p.002017: the medicinal product under para. 1 does not have to be in Bulgarian.
p.002017: (4) The Executive Director of the BDA shall inform the European Commission of the issues
p.002017: permissions under para. 1, the name and address of the authorization holder, as well as the date of
p.002017: termination of their validity.
p.002017: Art. 12. (1) The official pharmacopoeia in the Republic of Bulgaria is the European Pharmacopoeia.
p.002017: (2) The official pharmacopoeia may be supplemented by the requirements of the Bulgarian Pharmacopoeia
p.002017: pharmacopoeia.
p.002017: (3) The Minister of Health shall determine with an order the dates of entry into force of
p.002017: the current edition of the Official Pharmacopoeia and its Supplements.
p.002017: (4) The order under para. 3 shall be promulgated in the State Gazette and published on the page
p.002017: of the BDA on the Internet.
p.002017: Art. 13. (1) Monographs of the European Pharmacopoeia are obligatory for all substances, preparations and
p.002017: dosage forms contained therein. In cases where there are no monographs in the European Pharmacopoeia, the
p.002017: apply the requirements of the current editions of the pharmacopoeia of the Member States, the USA and Japan, if they are in
p.002017: in accordance with the general rules of
p.002017: The European Pharmacopoeia.
...
p.002017: 11. a statement that in clinical trials conducted outside the territory of
p.002017: Member States have complied with the ethical principles of Good Clinical Practice;
p.002017: 12. (amended, SG No. 102/2012, effective 21.12.2012) summary of the system for
p.002017: pharmacovigilance monitoring, which includes the following elements:
p.002017: a) the name of the qualified person under Art. 191, curriculum vitae - education acquired
p.002017: professional experience in the field of pharmacovigilance monitoring and qualification for
p.002017: fulfillment of his duties in accordance with Chapter Eight;
p.002017: (b) any Member State in which the qualified person fulfills the obligations
p.002017: his;
p.002017: c) address, telephone, fax, e-mail address of the person under letter "a";
p.002017: (d) the address at which the primary document of the traceability system is stored
p.002017: drug safety;
p.002017: 12a. (new - SG 102/2012, in force since 21.12.2012) statement by the applicant that
p.002017: has the necessary means to fulfill the obligations of Chapter Eight;
p.002017: 13. (Amended, SG No. 102/2012, effective 21.12.2012) risk management plan with
p.002017: a description of the risk management system that the applicant will put in place for that person
p.002017: medicinal product, together with a summary of the plan;
p.002017: 14. a brief description of the product according to Art. 34;
p.002017: 15. layout of the primary and secondary packaging of the product and a leaflet in
p.002017: compliance with the requirements of Chapter Six;
p.002017: 16. a copy of the manufacturing authorization issued by the regulatory authority of the country where
p.002017: production shall be carried out accompanied by a certificate of good manufacturing practice or
p.002017: certificate certifying that the manufacture of the medicinal product and of the active substances included in
p.002017: its composition was done in accordance with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 17. a copy of the document identifying the medicinal product for treatment,
p.002017: prevention or diagnosis of rare diseases, accompanied by a copy of the opinion of
p.002017: The European Medicines Agency;
p.002017: 18. copies of any marketing authorization issued in another Member State or in
p.002017: a third country for the medicinal product for which a marketing authorization is sought;
p.002017: 18a. (new - SG 102/2012, in force since 21.12.2012) copy of the summary of the safety data, including
p.002017: data contained in periodic safety update reports and, where available, communications
p.002017: for suspected side effects
p.002017: reactions;
p.002017: 19. a list of the Member States in which an application for authorization is submitted
p.002017: for the use of a medicinal product;
p.002017: 20. (amend. - SG 71/08, in force from 12.08.2008) copy of the summary of product characteristics, proposed
p.002017: by the person under Art. 26, para. 1, or a copy of the summary of product characteristics approved by the regulatory authority
p.002017: authority of a Member State (s) already issued
p.002017: marketing authorization;
p.002017: 21. a copy of the refusal of the marketing authorization in a Member State or in a third
p.002017: country accompanied by motives; suspension or termination information
p.002017: the validity of the marketing authorization;
p.002017: 22. a copy of the proposed package leaflet for the patient, accompanied by a summary of the evaluation results
p.002017: at the level of readability of the contents of the package leaflet from the patient's target group or copy
p.002017: from a leaflet approved by the regulatory body of
p.002017: a Member State which has already granted a marketing authorization;
p.002017: 23. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2;
p.002017: 24. (new - SG 71/08, in force from 26.07.2008) the documents under art. 7 of
p.002017: Regulation (EC) No 1901/2006.
p.002017: (2) (Supplemented, SG No. 18/2014) The documents under para. 1, items 18 and 18a with respect to
p.002017: Member States, respectively under point 19, shall be submitted only in the procedures under Section VII.
p.002017: (3) For radionuclide generators to the data of para. 1 are presented additionally
p.002017: the following documents:
p.002017: 1. a description of the system together with a detailed description of its components that it can
p.002017: affect the composition or quality of daughter radionuclides;
p.002017: 2. the qualitative and quantitative characteristics of the eluate or sublimate.
p.002017: (4) Documents and data from pharmaceutical, preclinical and clinical
p.002017: the tests shall be accompanied by summary reports prepared by experts with the necessary technical and
p.002017: qualification. An autobiographical report is attached to the reports
p.002017: to the experts who produced the report.
...
p.002017: should be proportionate to the identified and potential risks of the medicinal product and of
p.002017: the need to collect safety data from
p.002017: post-marketing studies.
p.002017: (7) (New, SG No. 102/2012, effective 21.12.2012) The holder of the permit
p.002017: for use updates the data from the file under para. 1. It shall apply to any change in the dossier
p.002017: the order of Chapter Three, Section VI, where applicable.
p.002017: Art. 28. (1) (amend. - SG 71/08, in force from 12.08.2008) The person under art. 26, para. 1 insofar as it does not violate
p.002017: industrial and commercial property rights, does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b" and "c",
p.002017: if it can prove that the medicinal product referred to in the application is generic to the reference medicinal product,
p.002017: which is allowed or is
p.002017: was authorized for use in a Member State not less than 8 years ago.
p.002017: (2) The holder of the authorization for use of the generic product under para. 1 cannot
p.002017: to place it on the market before the expiry of 10 years from the date of first authorization
p.002017: of the reference medicinal product.
p.002017: (3) The person under art. 26, para. 1, subject to the conditions of para. 1 and 2 may apply to the BDA for permission to
p.002017: use of a generic reference product and where the reference product was not authorized
p.002017: use within the territory of the Republic
p.002017: Bulgaria.
p.002017: (4) In the cases of para. 3 the person under art. 26, para. 1 shall indicate in the application under Art. 27, para. 1
p.002017: the Member State in which the reference product is authorized or has been authorized.
p.002017: (5) In the cases of para. 3 The BDA requires the regulatory authority of the Member State,
p.002017: referred to in the application under Art. 27, para. 1, confirmation of the information under para. 4, the quantitative and
p.002017: the qualitative composition of the reference product and, if necessary, additional documentation.
p.002017: (6) The Executive Agency for Medicinal Products makes available on request to a regulatory authority of a Member State, c
p.002017: which has been submitted for a generic reference product that has been authorized or has been authorized
p.002017: for use on the territory of the Republic
p.002017: Bulgaria, the necessary information under para. 5 within one month from the date of request.
p.002017: (7) The ten-year period under par. 2 may be extended by up to one year at the request of the holder of
p.002017: the marketing authorization for the reference medicinal product if, within the first 8 years of dispensing
p.002017: the marketing authorization was granted to the holder of the reference medicinal product for the same product
p.002017: a new therapeutic indication whose significant clinical advantages over existing treatment options are scientific
p.002017: justified.
p.002017: (8) (New - SG 12/11, in force from 08.02.2011) When originally issued for a medicinal product
p.002017: marketing authorization in accordance with Art. 23, for any change in the amount of active substance, c
p.002017: the dosage form, in the amount in the package, in the route of administration of the medicinal product, and for all
p.002017: other changes or extensions of the marketing authorization shall also be granted in accordance with
p.002017: the requirements of this Act or the original marketing authorization shall be supplemented. All these permissions are considered as
p.002017: belonging to a global marketing authorization for the medicinal product for
p.002017: the purposes of applying this Article.
p.002017: Art. 29. (1) The person under art. 26, para. 1 presents in the BDA the results of the necessary
p.002017: preclinical and / or clinical trials where the medicinal product referred to in
p.002017: application:
p.002017: 1. cannot be defined as generic, or
p.002017: 2. bioavailability tests do not prove bioequivalence, or
...
p.002017: 1. a sample of the final product and / or a sample of the bulk product / non-spilled product;
p.002017: 2. production and quality control protocols;
p.002017: 3. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (2) The holder of the authorization for the use of new immunological medicinal products or immunological medicinal products
p.002017: medicinal products manufactured with new or modified technologies or with technologies new to the individual manufacturer,
p.002017: fulfills the obligations under para. 1 for
p.002017: the specific period specified in the Marketing Authorization.
p.002017: (3) Within 60 days from the date of submission of the complete set of BDA documents
p.002017: evaluates production protocols and quality control of live vaccines,
p.002017: immunological and new immunological medicinal products and testing of the provided samples in an accredited one
p.002017: laboratory to determine whether the medicinal products under para. 1 and 2 are
p.002017: manufactured in accordance with approved specifications.
p.002017: (4) Upon a positive result of the test, the BDA shall issue a certificate of release
p.002017: of the lot.
p.002017: (5) The conditions, procedure, and requirements for the documentation for the issuance of
p.002017: batch release certificate for the products under para. 1 and 2 shall be determined in an ordinance of
p.002017: the Minister of Health.
p.002017: (6) When the assessment and testing under para. 3 for the respective batch of medicinal products are made official
p.002017: laboratory for the control of medicinal products in another Member State, the holder of the marketing authorization
p.002017: use shall submit to the BDA the certificate of release of the batch of medicinal products issued by
p.002017: the regulatory authority of the State
p.002017: state.
p.002017: (7) In the cases of para. 6 The BDA does not carry out the activities under para. 3 and 4.
p.002017: Art. 70. (1) The holder of a marketing authorization for a medicinal product obtained from
p.002017: human blood or human plasma before any batch of product is placed on the market
p.002017: obliged to submit to the BDA:
p.002017: 1. a sample of the final product and / or a sample of the bulk product / non-spilled product;
p.002017: 2. production and quality control protocols;
p.002017: 3. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (2) Within 60 days from the date of submission of the complete set of documents, the BDA shall carry out an evaluation of
p.002017: the protocols for the manufacture and quality control of the medicinal product obtained from human blood or human
p.002017: plasma, and testing of samples provided at an accredited laboratory to determine whether the medicinal product is
p.002017: para. 1 was produced in
p.002017: conformance to approved specifications.
p.002017: (3) Upon a positive result of the test, the BDA shall issue a certificate of release
p.002017: of the lot.
p.002017: (4) The conditions, the order, and the requirements for the documentation for the issue of
p.002017: batch release certificate for the products under para. 1 shall be determined in the ordinance under Art. 69, para. 5.
p.002017: (5) When the assessment and testing under para. 2 for the respective batch of medicinal product are made official
p.002017: laboratory for the control of medicinal products in another Member State, the holder of the marketing authorization
p.002017: use presents in the BDA the certificate of release of the batch medicinal product issued by
p.002017: the regulatory authority of the State
p.002017: state.
p.002017: (6) In the cases of para. 5 BDA does not carry out the activities under para. 2 and 3.
p.002017: Art. 71. (1) The marketing authorization holder shall be obliged to maintain a system for
p.002017: blocking and withdrawal of non-compliant medicinal products from the market
p.002017: quality, safety and efficiency.
p.002017: (2) The marketing authorization holder shall be obliged to block and withdraw
p.002017: medicinal products which have shown non - compliance with the requirements for quality, efficacy and
p.002017: safety, in accordance with the ordinance of art. 274, para. 1.
p.002017: Art. 72. (Repealed, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 73. (1) The holder of the marketing authorization may transfer the rights over
p.002017: the authorization to use the medicinal product of another legal entity or of
p.002017: associations which are not legal persons established within the territory of the Member States.
p.002017: (2) The marketing authorization holder shall submit to the BDA an application to which
p.002017: apply the documentation specified in the ordinance under Art. 42, indicating a proposal for a date of
p.002017: the transfer.
p.002017: (3) In case of finding incompleteness in documentation under para. 2 The BDA shall notify the authorization holder in writing
p.002017: for use, provide the necessary additional information within 30 days. The term under para. 5 stops running
p.002017: from the date of notification until the date on which the
p.002017: the information requested.
p.002017: (4) If, within the term of para. 3 the Marketing Authorization Holder did not complete
p.002017: the documentation, the procedure for transferring the marketing authorization
p.002017: product is discontinued.
p.002017: (5) Within 30 days from the date of submission of the application under para. 2 the Executive Director
p.002017: of the BDA issues a change approval approving the transfer. In the permission for
p.002017: the date of transfer of the marketing authorization shall also be indicated.
p.002017: (6) The new marketing authorization holder fully assumes his rights
p.002017: the obligations of the previous holder of the marketing authorization.
p.002017: (7) When transferring the marketing authorization for a medicinal product under the procedure of para. 1 - 6 its duration is not changed.
p.002017: Section VII.
p.002017: Mutual recognition procedure and decentralized procedure
p.002017: Art. 74. (1) When the person under Art. 26, para. 1 has been authorized in another Member State for the same
p.002017: medicinal product within the meaning of Art. 45, para. 3 for which it has applied for a marketing authorization
p.002017: to the BDA, it shall submit a request to the regulatory authority of a Member State designated by it in the application, called
p.002017: hereinafter referred to as the "reference country", yes
p.002017: prepare an evaluation report or update an existing one.
p.002017: (2) With the application the person under para. 1 submits to the BDA a dossier identical to
p.002017: the submission in the reference country and in the other Member States referred to in the application,
p.002017: hereinafter referred to as the countries concerned.
p.002017: (3) The Executive Agency for Medicinal Products and the applicant shall receive, ex officio, from the regulatory body of
p.002017: the reference country under para. 1 the evaluation report together with the approved summary of product characteristics and c
p.002017: approved packaging layout and package leaflet
p.002017: patient.
p.002017: (4) The Executive Agency for Medicines shall consider the documents under para. 3 and in writing
p.002017: inform the reference State of the decision taken within 90 days of the date of receipt
p.002017: them.
p.002017: (5) Within 30 days of receipt of notification of completion of the procedure by the reference country
p.002017: the BDA Executive Director issues a marketing authorization for the medicinal product on the territory
p.002017: of the Republic of Bulgaria with the approved brief
p.002017: product characteristics, package layout and package leaflet for the patient.
p.002017: Art. 75. (1) When the person under Art. 26, para. 1 submits an application simultaneously to the BDA and other Member States
p.002017: of a marketing authorization for a medicinal product for which a marketing authorization has not been granted
p.002017: the territory of a Member State, it shall indicate in the application the regulatory authority of the Member State called
p.002017: hereinafter referred to as the "reference country" to draft the evaluation report, draft summary of characteristics
p.002017: of the product and project of
p.002017: layout of the package and package leaflet for the patient.
p.002017: (2) With the application the person under para. 1 submits to the BDA a file identical to the one submitted to
p.002017: all other Member States referred to in the application, hereinafter referred to as "concerned
p.002017: countries ".
p.002017: (3) The Executive Agency for Medicinal Products and the applicant shall receive an official application from
p.002017: the regulatory authority of the reference country draft evaluation report, draft summary
p.002017: Product characteristics and design of the package and the package leaflet for the patient.
p.002017: (4) The Executive Agency for Medicines shall consider the documents under para. 3 and in writing
p.002017: inform the reference State of the decision taken within 90 days of the date of receipt
p.002017: them.
p.002017: (5) Within 30 days of receipt of notification of completion of the procedure by the reference country
p.002017: the BDA Executive Director issues a marketing authorization for the medicinal product on the territory
p.002017: of the Republic of Bulgaria with the approved brief
p.002017: product characteristics, package layout and package leaflet for the patient.
p.002017: Art. 76. (1) When the Republic of Bulgaria is a reference country under Art. 74, BDA:
p.002017: 1. within 90 days from the date of submission of valid documentation, send to the regulatory authorities
p.002017: the authorities of the countries concerned and the applicant, the assessment report, together with the approved summary description
p.002017: of the product and with the approved mock - up of the packaging and
p.002017: the patient leaflet;
p.002017: 2. closes the procedure and notifies the applicant and the countries concerned, if any
p.002017: the countries concerned have approved it.
p.002017: (2) Within 30 days of the closing of the procedure under para. 1, item 2, the BDA Executive Director issues a permit for
p.002017: use of the medicinal product on the territory of the Republic of Bulgaria with the approved summary of the characteristics of
p.002017: product, package layout and package leaflet
p.002017: for the patient.
p.002017: (3) Where the Republic of Bulgaria is a reference country under Art. 75, BDA:
p.002017: 1. within 120 days from the date of submission of valid documentation, send to the regulatory authorities
...
p.002017: effects of one or more tested medicinal products;
p.002017: 2. identify adverse reactions to one or more tested medicinal products;
p.002017: 3. examines the absorption, distribution, metabolism and excretion of one or
p.002017: more tested medicinal products and / or to ascertain their safety and / or
p.002017: efficiency.
p.002017: Art. 82. (1) Clinical trial on humans shall be conducted in compliance with the basic ones
p.002017: principles for the protection of human rights and human dignity in all
p.002017: a biomedical study according to the Declaration of Helsinki.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) All clinical trials of medicinal products
p.002017: on humans, including bioavailability and bioequivalence tests are planned,
p.002017: conduct and report in accordance with the Good Rules
p.002017: clinical practice, the requirements of this Act and of Regulation (EC) No 1901/2006.
p.002017: (3) The rules for Good Clinical Practice shall be laid down in an ordinance of the Minister of Health
p.002017: healthcare.
p.002017: Art. 83. (1) The rights, safety and health of the participants in the clinical trial shall be
p.002017: place the interests of science and society at stake.
p.002017: (2) Available preclinical and / or clinical data for the investigational medicinal product
p.002017: should be sufficient to justify the conduct of a clinical trial.
p.002017: Art. 84. (1) The clinical trial must be scientifically substantiated and clear and detailed
p.002017: described in the test report.
p.002017: (2) When developing the documentation and conducting a clinical trial of a medicinal product
p.002017: the contracting authority and the researcher take into account all available guidance published by the European Commission and
p.002017: European Medicines and Scientific Agency
p.002017: committees to it.
p.002017: Art. 85. (1) Clinical testing of medicinal products on humans shall be conducted at
p.002017: adherence to the necessary quality assurance procedures for each aspect of
p.002017: the clinical trial.
p.002017: (2) All information from a clinical trial shall be recorded, processed and stored by
p.002017: a way of ensuring that it is accurately reported, interpreted and validated, while protecting
p.002017: the personal data of the participants.
p.002017: Art. 86. (1) All persons conducting a clinical trial must have the appropriate one
p.002017: professional qualification, training and experience to fulfill the test-related requirements
p.002017: tasks in accordance with the Good Clinical Practice rules.
p.002017: (2) A clinical trial of a medicinal product shall be carried out under the supervision of a physician or dentist with
p.002017: recognized medical specialty in the relevant field who is familiar with the preclinical and / or available
p.002017: clinical data on the product and its risks;
p.002017: the study procedures.
p.002017: (3) During a clinical trial for the medical care provided to the participant
p.002017: in the test, and in making medical decisions, it is the responsibility of the appropriate physician
p.002017: qualification or doctor in dental medicine.
p.002017: Art. 87. (1) (amend. - SG 59/10, in force from 31.07.2010, amended - SG, issue 60 from 2011)
p.002017: 08/05/2011) Clinical trial can be performed in hospitals, centers for
p.002017: mental health, skin and venereal disease centers, complex oncology centers,
p.002017: diagnostic and consulting centers, medical
p.002017: Centers, Dental Centers and Dental Authorized Centers
...
p.002017: test for an unauthorized indication, for a dosage form other than the authorized one, in
p.002017: an unprecedented group of patients or to obtain additional information.
p.002017: (2) Authorized for use in the Republic of Bulgaria within the meaning of para. 1, item 2 are medicinal
p.002017: products which have been authorized under this Act or under Regulation (EC)
p.002017: No 726/2004 of the European Parliament and of the Council.
p.002017: Art. 89. (1) A clinical trial on humans shall be conducted with medicinal products which
p.002017: produced, maintained and stored in accordance with the rules of good manufacturing practice
p.002017: of medicinal products under development and research.
p.002017: (2) The rules of Good manufacturing practice for medicinal products in the process of
p.002017: development and research are determined in the ordinance under art. 152.
p.002017: (3) For a clinical trial, a medicinal product may be offered
p.002017: pharmacological-toxicological studies in accordance with the requirements of the Good
p.002017: laboratory practice.
p.002017: Art. 90. A clinical trial may be initiated and conducted when:
p.002017: 1. the expected therapeutic benefits for the trial participants, for the current and
p.002017: future patients and health benefits justify the foreseeable risks;
p.002017: 2. the physical and mental integrity of the participant in
p.002017: examination, the right to privacy and the right to the protection of individuals
p.002017: his data in accordance with the Personal Data Protection Act;
p.002017: 3. insurance or indemnity is provided to cover the liability of
p.002017: the researcher or the assignor.
p.002017: Art. 91. The contracting authority and the principal investigator are covered by insurance
p.002017: their responsibility for those caused during or on the occasion of the clinical trial
p.002017: non-material and material damage to participants.
p.002017: Art. 92. (1) The contracting authority shall be liable in case of health or death injuries caused on or on occasion
p.002017: conducting the clinical trial when the trial has been performed in accordance with the requirements and procedures of
p.002017: approved by the Ethics Committee
p.002017: protocol.
p.002017: (2) The Principal Investigator shall be liable in the event of health or injury
p.002017: deaths caused by, or on the occasion of, a clinical trial when not
p.002017: the requirements and procedures of the protocol approved by the Ethics Committee have been complied with.
p.002017: Art. 93. (1) The sponsor of a clinical trial shall be a person established in the territory of
p.002017: member country.
p.002017: (2) The contracting authority and the researcher may be one and the same person.
p.002017: Art. 94. The sponsor shall provide the tested medicinal product / products free of charge
p.002017: and any device necessary for its implementation.
p.002017: Art. 95. (1) The assignor shall prepare a labeling of the tested medicinal product in
p.002017: compliance with the requirements of Good Manufacturing Practices for Medicinal Products
p.002017: products under development and research.
p.002017: (2) Data requirements for clinical packaging of medicinal products
p.002017: testing shall be determined in the ordinance under art. 170.
p.002017: which is:
p.002017: Art. 96. (1) Clinical testing of medicinal products shall be allowed only on a person,
p.002017: 1. informed in advance conversation with a doctor - member of the research team, about
p.002017: the objectives, risks and inconveniences of the test and the conditions under which it will be conducted;
p.002017: 2. informed of his right at any time to withdraw from the test without
p.002017: its negative consequences;
p.002017: 3. has given his / her written informed consent to participate after being acquainted with
p.002017: the nature, significance, consequences and potential risks of the clinical trial.
p.002017: (2) When the person is unable to write, informed consent to participate in the clinical trial shall be given
p.002017: orally in the presence of at least one independent witness who certifies in writing that the person
p.002017: has personally informed consent to participate in
p.002017: the clinical trial.
p.002017: (3) Informed consent under para. 1, item 3 and para. 2 can only give a capable person who understands
...
p.002017: from the hospital where the clinical trial is being conducted.
p.002017: (3) For the needs of their work, the commissions under para. 1 can attract outsiders
p.002017: specialists.
p.002017: (4) In the case of clinical trials on minors to assist the
p.002017: The respective Ethics Committee at the medical establishment must attract its activity
p.002017: external specialists.
p.002017: Art. 105. (1) The mandate of the members of the ethics committees under Art. 103, para. 1 and 2 is c
p.002017: duration 4 years.
p.002017: (2) Every two years, one-half of the composition of the Ethics Committees shall be updated.
p.002017: (3) A member of the Ethics Committee may not be appointed to the same committee for more
p.002017: from two consecutive terms.
p.002017: Art. 106. (1) The Ethics Commissions under Art. 103, para. 1 and 2 within one month of creation
p.002017: prepare written standard operating procedures in accordance with the Good Rules
p.002017: clinical practice to determine the terms and conditions for their work.
p.002017: (2) The standard operating procedures of ethics committees shall be approved by
p.002017: the BDA Executive Director.
p.002017: (3) The meetings of the Ethics Committees shall be closed. If necessary, the President of
p.002017: the Ethics Committee may invite the Contracting Authority or the Principal Investigator to participate.
p.002017: (4) Only members of ethics committees who do not participate in a specific trial and are
p.002017: administratively and financially independent of the contracting authority and the principal investigator may
p.002017: vote and participate in the discussion.
p.002017: (5) To certify the circumstances under para. 4 members of the Ethics Committee
p.002017: sign a declaration of conflict of interest.
p.002017: Art. 107. (1) A Central Ethics Committee shall be established at the Council of Ministers.
p.002017: (2) The Central Ethics Committee shall be composed of 9 members - representatives of both sexes,
p.002017: and includes necessarily physicians, dentists, psychologists, theologians and lawyers.
p.002017: (3) The composition of the commission shall be determined by a decision of the Council of Ministers on
p.002017: proposal of the Minister of Health for 4 years.
p.002017: (4) The Central Ethics Committee shall deliver opinions on deontological and ethical issues in
p.002017: the field of clinical trials, when referred to by the ethics committees under art. 103, para. 1 and 2,
p.002017: by the BDA or by the contracting authority.
p.002017: (5) The Central Ethics Committee shall exercise methodological guidance towards
p.002017: ethics committees under art. 103, para. 1 and 2.
p.002017: (6) The meetings of the Central Ethics Committee shall be closed. If necessary
p.002017: the chairman of the Central Ethics Committee may invite the contracting authority or
p.002017: the principal investigator.
p.002017: (7) The Council of Ministers, upon a proposal by the Minister of Health, shall designate with
p.002017: Rules of Procedure of the Central Ethics Committee.
p.002017: Art. 108. (1) A member of the Central Ethics Committee may not be appointed to the same
p.002017: committee for more than two consecutive terms. The term of office is 4 years.
p.002017: (2) Every two years, one-half of the composition of the Central Ethics Committee shall be
p.002017: is updating.
p.002017: Section IV.
p.002017: Permission to conduct a clinical trial
p.002017: Art. 109. A clinical trial may begin when the following conditions are fulfilled:
p.002017: 1. the relevant ethics committee has given a favorable opinion, and
p.002017: 2. the Executive Director of the BDA has issued a written permit for its conduct,
p.002017: when any of the tested medicinal products is:
p.002017: (a) a gene therapy medicinal product;
p.002017: (b) somatic cell therapy medicinal product;
p.002017: (c) a medicinal product containing genetically modified organisms;
p.002017: (d) a high-tech medicinal product as defined in the Annex to the Regulation
p.002017: (EC) No 726/2004 of the European Parliament and of the Council;
p.002017: (e) a medicinal product containing a biologically active substance (s)
p.002017: human or of animal origin or containing biological or human components
p.002017: animal origin, or in the manufacture of which such components are used, or
p.002017: 3. within the period specified by the law, the assignor has not been notified in writing by the BDA that
...
p.002017: (2) The Ethics Committee shall:
p.002017: 1. gives a favorable opinion;
p.002017: 2. motivated refuses, or
p.002017: 3. requires a change in some of the documentation as a condition for receiving a positive one
p.002017: position.
p.002017: Art. 112. (1) Within 60 days from the submission of an application, the relevant ethics committee shall
p.002017: delivers an opinion to the applicant and the BDA.
p.002017: (2) Where the clinical trial includes a gene therapy medicinal product or
p.002017: somatic cell therapy or a medicinal product containing genetically modified
p.002017: organisms, the term under para. 1 is extended to 30 days.
p.002017: (3) The deadline for issuing an opinion is 180 days, when for clinical examination
p.002017: a trial involving a gene therapy or somatic cell therapy drug
p.002017: or a medicinal product containing genetically modified organisms is required to be consulted
p.002017: expert commission specially created by order of the BDA Director.
p.002017: Art. 113. (1) When evaluating the documentation, the Ethics Committee may require
p.002017: one additional written documentation from the applicant. The time limits under Art. 112 stop yes
p.002017: run until the required documentation is submitted.
p.002017: (2) The procedure for examining the study shall be terminated if, within 60 days from
p.002017: receiving the request for additional information, the contracting authority did not submit the request by
p.002017: commission documentation.
p.002017: Art. 114. (1) When the test will be conducted in more than one center in the territory
p.002017: of the Republic of Bulgaria, an application shall be submitted to the Ethics Committee for Multicenter Tests
p.002017: under Art. 103, para. 1.
p.002017: (2) When the test will be conducted in only one center in the territory of the Republic
p.002017: Bulgaria, an application may be submitted to the relevant Ethics Committee under Art. 103, para. 1 or 2 on
p.002017: choice of the contracting authority.
p.002017: (3) The opinion of the Ethics Committee under Art. 103, para. 1 is valid for all centers of
p.002017: the territory of the Republic of Bulgaria.
p.002017: (4) (New - SG 12/2011, in force from 08.02.2011) For submission of applications for
p.002017: the Ministry of Health collects an opinion from the Ethics Committee
p.002017: a fee in the amount determined by the tariff under Art. 21, para. 2.
p.002017: Art. 115. (1) Where the opinion of the respective Ethics Committee under Art. 103 e
p.002017: negative, the contracting authority may appeal within 90 days from the date of notification
p.002017: its decision before the Central Ethics Committee.
p.002017: (2) When the negative opinion of the respective Ethics Committee under Art. 103 was prepared without taking
p.002017: the opinion of the expert commission under art. 112, para. 3, the contracting authority may within 14 days from the date of notification
p.002017: to request in writing that the committee review it
p.002017: your opinion.
p.002017: (3) The expert commission under Art. 112, para. 3 within 60 days from the date of receipt of the written application by
p.002017: the contracting authority decides on the negative opinion of the relevant ethics committee and can challenge it
p.002017: or endorse, in writing, informing her.
p.002017: The Ethics Committee takes a final opinion, which it sends to the contracting authority.
p.002017: (4) Where the expert commission under Art. 112, para. 3 supported the negative opinion,
p.002017: the contracting authority may, within 14 days from the date of notification, appeal against the decision to
p.002017: Central Ethics Committee.
p.002017: (5) The opinion of the Central Ethics Committee is final and binding
p.002017: the relevant ethics committee.
p.002017: Art. 116. (1) The contracting authority shall submit to the BDA an application in accordance with a specimen for carrying out of
p.002017: clinical trial.
p.002017: (2) Where the applicant for the clinical trial is not the sponsor, the application shall be
p.002017: is accompanied by documentation certifying that the person is authorized by
p.002017: the contracting authority.
p.002017: (3) Where the assignor is not registered as a natural or legal person of
p.002017: the territory of the Republic of Bulgaria, the application shall be accompanied by a document containing the data
p.002017: of his authorized representative for the territory of the Republic of Bulgaria.
p.002017: (4) The following shall be attached to the application:
p.002017: 1. administrative documents;
p.002017: 2. information about a participant;
p.002017: 3. documentation of the test report;
p.002017: 4. documentation of the tested medicinal product / products;
p.002017: 5. documentation of technical requirements and personnel;
p.002017: 6. documentation of financing and administrative organization of the test.
p.002017: (5) The content, form and requirements for the documentation under para. 4 are defined in
p.002017: the ordinance under Art. 82, para. 3.
p.002017: Art. 117. (1) When evaluating the documentation under Art. 116 The BDA may, in writing, only once
p.002017: requested additional documentation from the applicant.
p.002017: (2) The time limits under Art. 118, 119 and 120 shall cease to run until the request has been submitted
p.002017: documentation.
p.002017: Art. 118. (1) Within 60 days from the date of submission of an application for a clinical trial
p.002017: of medicinal products under Art. 109, item 3, the BDA shall notify the applicant in writing that the test:
p.002017: 1. it may be conducted on the territory of the Republic of Bulgaria, or
p.002017: 2. it cannot be conducted, stating the reasons for it.
p.002017: (2) In the cases of para. 1, item 2 the contracting authority may submit to the BDA within 30 days
p.002017: an application modified in accordance with the reasons given or to provide the necessary
p.002017: information in accordance with the requirements of the BDA.
p.002017: (3) Within 30 days from the date of submission of the amended application or
p.002017: the additional information under para. 2 The BDA shall notify the contracting authority in writing that:
p.002017: 1. the test may be conducted on the territory of the Republic of Bulgaria, or
p.002017: 2. refuses to conduct the clinical trial, stating the reasons for doing so.
p.002017: (4) The refusal under para. 3, item 2 shall be subject to appeal in the order of
p.002017: Code of Administrative Procedure.
p.002017: (5) The clinical trial may commence if, within the period of para. 1 BDA has not issued
p.002017: notification of reasons for disapproval of the clinical trial.
p.002017: (6) If the assignor does not submit an application under para. 2 within the time limit specified, the procedure shall be
p.002017: terminated and no clinical trial was conducted.
p.002017: Art. 119. (1) Within 60 days from the date of submission of the application for clinical trial with
p.002017: the medicinal products under Art. 109, item 2, the Executive Director of the BDA shall: 1. issue a permit for carrying out the BDA
p.002017: the clinical trial, or
p.002017: 2. Reasonably refuses to issue a permit.
p.002017: (2) The refusal under para. 1, item 2 shall be subject to appeal in the order of
p.002017: Code of Administrative Procedure.
p.002017: Art. 120. (1) In the cases of medicinal products under Art. 109, item 2, letters "a" - "c" the term under
p.002017: Art. 119, para. 1 for the authorization of the BDA to conduct a clinical trial may
p.002017: extended by 30 days.
p.002017: (2) In case the BDA consults the expert commission under Art. 112, para. 3 which
p.002017: assess the safety of the medicinal products under para. 1, the extension under para. 1 term can be
p.002017: extended by another 90 days.
p.002017: Art. 121. The Executive Director of the BDA refused to issue an authorization for the holding of a BDA
p.002017: clinical trial of gene therapy medicinal products where there is a risk of modification
p.002017: of the genome of the reproductive cells of the participant in
p.002017: the test.
p.002017: Art. 122. (1) In multicenter testing in the Republic of Bulgaria and in a third country, the BDA
p.002017: requires the contracting authority to provide a declaration that it will grant access to the representatives of
p.002017: BDA for inspection in order to establish compliance with the requirements and principles of the Good
p.002017: clinical practice and Good Manufacturing Practice.
p.002017: (2) When the contracting authority fails to submit the declaration under para. 1, the BDA does not consider
p.002017: the application submitted.
p.002017: Art. 123. The sponsor declares that it has been submitted to the BDA and to the Ethics Committee
p.002017: the documentation contains the same information.
p.002017: Art. 124. (1) The procedures in the Ethics Committee and in the BDA may be conducted
p.002017: simultaneously or sequentially at the option of the contracting authority.
p.002017: (2) The term under Art. 118, para. 1 for the examination of the documentation does not stop running at
p.002017: the lack of a decision by the Ethics Committee.
p.002017: Art. 125. The clinical trial shall be conducted in accordance with the protocol it has received
p.002017: positive opinion from the relevant ethics committee under art. 103, and under the conditions set out in
p.002017: the documentation submitted.
p.002017: Section V.
p.002017: Changes
p.002017: Art. 126. (1) The contracting authority may at any time make changes other than
p.002017: the substantial changes under Art. 127, para. 2, in the clinical trial protocol.
p.002017: (2) In the cases of para. 1 the contracting authority shall keep the documentation related to the changes, and
p.002017: it shall be made available to the BDA and the Ethics Committee upon request.
p.002017: Art. 127. (1) A change in the conduct of a clinical trial may be requested by
p.002017: BDA, when necessary to ensure the safety of participants, scientific
p.002017: the value of testing and / or adherence to the Good Clinical Practice rules.
p.002017: (2) A significant change in the conduct of the study is any change in the protocol
p.002017: and / or in the information and documentation under Art. 110 and 116, which affects:
p.002017: 1. the safety or physical and mental integrity of the participants;
p.002017: 2. the scientific value of the study;
p.002017: 3. conducting or organizing the survey;
p.002017: 4. the quality or safety of any of the tested medicinal products.
p.002017: Art. 128. (1) The contracting authority may apply planned substantial changes to the protocol
p.002017: of the test and in the documentation under Art. 110 and 116 when:
p.002017: 1. the relevant Ethics Committee has given a positive opinion in writing;
p.002017: 2. the BDA Executive Director has issued a written authorization for this - for clinical purposes
p.002017: tests with medicinal products under art. 109, item 2, or
p.002017: 3. within the period specified by the law, the assignor has not been notified by the BDA of not accepting
p.002017: the proposed changes in the clinical trial of medicinal products under Art. 109, Vol. 3.
p.002017: (2) The provision of para. 1 shall not apply to changes to the approved protocol which are
p.002017: require to protect participants from imminent danger when new information emerges,
p.002017: related to the conduct of the test or to the design of the tests
p.002017: medicine.
p.002017: (3) In the cases of para. 2 the contracting authority shall immediately inform the commission under para. 1, item 1 and
p.002017: BDA for new information available, measures taken and changes to the protocol implemented.
p.002017: Art. 129. (1) When planning significant changes in the clinical trial and in
p.002017: the documentation under Art. 110 and 116 the applicant submits a written application in a model to the BDA and to
p.002017: the relevant ethics committee.
p.002017: (2) The application shall be accompanied by the documentation necessary to justify the
p.002017: changes and certifying that after applying the change, the ratio estimate
p.002017: between the benefit and the risk under Art. 90, item 1 shall be retained.
p.002017: (3) The requirements for the application and documentation for change shall be specified in the ordinance
p.002017: under Art. 82, para. 3.
p.002017: Art. 130. (1) Within 35 days of receipt of an application for change, the Ethics Committee
p.002017: shall notify the contracting authority of its decision by issuing:
p.002017: 1. a positive opinion on the changes requested, or
p.002017: 2. a motivated refusal for changes in the clinical trial.
p.002017: (2) Within 35 days from the date of receipt of an application with a positive opinion
p.002017: of the BDA Ethics Committee:
p.002017: 1. approve the changes in the clinical trial of medicinal products under Art. 109, item 2, or
p.002017: 2. does not approve the changes, explicitly motivating.
p.002017: (3) If, within 35 days of submission of clinical change documentation
p.002017: tests with medicinal products under art. 109, item 3 the applicant did not receive a notification of refusal,
p.002017: proposed changes can be made.
p.002017: Art. 131. (1) In the cases of art. 130, para. 2, item 2 the contracting authority may submit an amendment
p.002017: in the proposed motives, at the latest 14 days before the date of application
p.002017: changes.
p.002017: (2) Within 14 days from the date of receipt of the changed documentation under para. 1 BDA
p.002017: issues a change in the authorization for a clinical trial of medicinal products under Art. 109, Vol. 2
p.002017: or refuses.
p.002017: (3) The refusal under para. 2 shall not be subject to appeal.
p.002017: Section VI.
p.002017: Suspension of clinical trial
p.002017: Art. 132. (1) The contracting authority or the researcher may take urgent measures to
p.002017: protect participants in the clinical trial from sudden risks to theirs
p.002017: safety and health.
p.002017: (2) In the cases of para. 1, the contracting authority shall immediately inform the BDA and the relevant commission
p.002017: ethics of the actions taken and the reasons that caused them.
p.002017: Art. 133. (1) When the test is carried out under conditions other than those determined at the time of granting the permit, or
p.002017: information is available to disprove the scientific validity of
p.002017: testing, or whether there is a risk to the safety of participants, the BDA may suspend
p.002017: conducting the test or terminating it.
p.002017: (2) Termination may be required for a particular center or for all centers at
p.002017: multicenter clinical trial on the territory of the Republic of Bulgaria.
p.002017: (3) In the event of termination of the clinical trial at all Centers of
p.002017: the territory of the Republic of Bulgaria BDA, before taking action under para. 1, informs
p.002017: in writing by the contracting authority and the principal or coordinating researcher.
p.002017: (4) Within 7 days of receipt of the notification, the assignor and / or the principal
p.002017: researchers may express an opinion on the measures taken by the BDA.
p.002017: (5) The provision of para. 3 shall not apply where there is an imminent risk of
p.002017: the health and safety of the test participants.
p.002017: Art. 134. In the cases under Art. 133, para. 1 The BDA shall immediately notify the relevant Commission on
p.002017: ethics, the regulatory authorities of all Member States, the European Medicines Agency and
p.002017: The European Commission on the measures taken and the reasons for this.
p.002017: Section VII.
p.002017: Safety monitoring
p.002017: Art. 135. (1) The principal investigator shall immediately inform the contracting authority orally or
p.002017: in writing for any serious adverse event occurring during the clinical trial at
p.002017: participant in the center for which he is responsible.
p.002017: (2) Following the notification under para. 1 shall submit a detailed written report.
p.002017: (3) Upon notification under para. 1 and in the report under para. 2 the test participant shall
p.002017: identifies with a unique code number specified in the test report.
p.002017: (4) The provisions of para. 1 and 2 shall not apply if in the clinical trial protocol
p.002017: or the researcher's brochure explicitly states that it does not require an emergency message for
p.002017: a specific serious adverse event.
p.002017: (5) The investigator shall report to the sponsor all adverse events or
p.002017: laboratory abnormalities identified in the protocol as critical to
p.002017: safety, in time and format in accordance with protocol requirements.
p.002017: Art. 136. When the outcome of a clinical adverse event
p.002017: trial is death, the researcher is obliged to provide the commissioner and the commissions on
p.002017: ethics any additional information requested.
p.002017: Art. 137. The Contracting Authority shall keep detailed records of all serious adverse events provided
p.002017: provided by the researchers, and made available to them by the BDA or the regulatory authorities of the Member States upon request, c
p.002017: which is being tested at multicenter
p.002017: testing.
p.002017: Art. 138. (1) The contracting authority shall notify the BDA, the regulatory authorities of all the Member States in which it is held.
p.002017: the multicenter trial, and the relevant ethics committee for each clinical course
p.002017: test suspected unexpected serious
p.002017: adverse reaction leading to death or life-threatening, at the latest 7 days
p.002017: from receiving information about it.
p.002017: (2) The contracting authority shall provide the bodies of para. 1 additional information on the case in
p.002017: 8 days from the date on which the notification is sent.
p.002017: (3) The contracting authority shall notify the bodies of para. 1 for all other than those mentioned in
p.002017: para. 1, suspected unexpected serious adverse reactions occurring in the course of
p.002017: the clinical trial, at the latest 15 days after receipt of information on their occurrence.
p.002017: Art. 139. (1) The assignor may fulfill its obligations under Art. 138, para. 1 and 3, such
p.002017: submit reports to the European Adverse Reaction Database.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) When the clinical trial is conducted outside
p.002017: Member States, the contracting entity shall submit reports of suspected unexpected serious adverse reactions
p.002017: reactions in the European Adverse Reactions Database.
p.002017: (3) (Amended, SG No. 102/2012, effective 21.12.2012) The format and content of
p.002017: reports of adverse reactions are specified in the ordinance under Art. 82, para. 3.
p.002017: (4) The contracting authority shall inform the researchers conducting the clinical trial with
p.002017: medicinal product, for any suspected unexpected serious adverse reaction,
p.002017: related to the investigational medicinal product, regardless of its origin.
p.002017: Art. 140. (1) The contracting authority shall provide the BDA and the respective commission once a year
p.002017: ethics list of all suspected serious side effects that are
p.002017: occurred during the previous period, and a safety report of the test participants.
p.002017: (2) (Amended, SG No. 102/2012, effective 21.12.2012) The form and content of
p.002017: the report shall be specified in the ordinance under Art. 82, para. 3.
p.002017: Art. 141. (1) The Executive Agency for Medicines shall document each provided under
p.002017: the order of art. 138, para. 1 and 3 information on suspected unexpected serious adverse reactions
p.002017: drug reactions of tested medicinal products.
p.002017: (2) The executive medicine agency shall immediately enter the information under para. 1 c
p.002017: European database of adverse reactions.
p.002017: Section VIII.
p.002017: Notification of completion of clinical trial
p.002017: Art. 142. (1) The assignor shall notify in writing the BDA and the relevant ethics committee about
p.002017: the completion of the test on the territory of the Republic of Bulgaria.
p.002017: (2) The notification must be submitted within 90 days of the completion of the survey in a format,
p.002017: defined in the ordinance under art. 82, para. 3.
p.002017: (3) Unless otherwise stated in the protocol approved by the relevant Ethics Committee,
p.002017: completion of the test is considered the last visit of a participant.
p.002017: (4) When the test is terminated prematurely, the contracting authority shall notify the BDA and
p.002017: the relevant ethics committee, within 15 days of the decision, stating the reasons
p.002017: for that.
p.002017: Art. 143. The contracting authority shall submit to the BDA and to the relevant ethics committee
p.002017: final clinical trial report.
p.002017: Art. 144. (1) The Executive Agency for Medicinal Products shall enter data in the European Clinical Trials Database
p.002017: for each clinical trial in the territory of the Republic of Bulgaria - application submitted, decision of
p.002017: ethics committee, permission to conduct,
p.002017: significant changes, completion of the study and records of inspections carried out.
p.002017: (2) At the request of another Member State, the European Medicines Agency or
p.002017: from the European Commission, the BDA provides additional information beyond the one provided in the
p.002017: European Clinical Trials Database.
p.002017: (3) In the performance of his duties under para. 1 The BDA adheres to the published guidelines
p.002017: of the European Commission.
p.002017: Chapter Four "a".
p.002017: NON-INTERVENTIONAL STUDIES (NEW, PREVIOUS SECTION IX
p.002017: "NON-INTERVENTIONAL STUDY" - SG, issue. 12 OF 2011, IN EFFECT OF
p.002017: 08/02/2011)
p.002017: Art. 145. (1) (Supplemented, SG No. 12/2011, effective 08.02.2011) Non-interventional study shall be conducted with
p.002017: medicinal products authorized for use in the Republic of Bulgaria when tested for obtaining
p.002017: additional information on the product prescribed in the usual manner in accordance with the conditions laid down in
p.002017: the marketing authorization. Participants in non-interventional studies are not administered diagnostic or
p.002017: follow-up procedures, other than usual practice, are used to analyze the data obtained
p.002017: epidemiological methods.
p.002017: (2) (Am. - SG, iss. 12 in 2011, in force since 08.02.2011, repealed - SG, iss. 102 in 2012, in
p.002017: with effect from 21.12.2012)
...
p.002017: radiobiology or radiochemistry - for radiopharmaceuticals or for medicinal products,
p.002017: exposed to ionizing radiation;
p.002017: 3. with recognized specialty in clinical hematology, medical microbiology, virology or
p.002017: immunology - for the production of immunological medicinal products - vaccines, toxins, sera, for
p.002017: biotech products and for medicinal products derived from
p.002017: human plasma or human blood.
p.002017: Art. 150. (1) The person under art. 146 submits to the BDA an application in the form approved by
p.002017: the director of the agency.
p.002017: (2) Together with the application under para. 1 the applicant shall also submit:
p.002017: 1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
p.002017: specialty, work record, criminal record or similar document, if not
p.002017: Bulgarian citizen, and employment contract for the persons under Art.
p.002017: 148, item 2 and art. 149;
p.002017: 2. copies of contracts for the assignment of production and / or control of the applications for
p.002017: production of products - in the cases of art. 151;
p.002017: 3. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union,
p.002017: or in a State party to the Agreement on the European Economic Area, an up-to-date document
p.002017: registration under national law issued by a competent authority
p.002017: authority of the country concerned;
p.002017: 4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force
p.002017: from 02.01.2013) a list of production activities and dosage forms that will
p.002017: produce;
p.002017: 5. schematics of the premises for production, control and storage and file of
p.002017: production capacity;
p.002017: 6. environmental impact assessment in the manufacture of medicinal products
p.002017: products in the cases provided for in the Environmental Protection Act;
p.002017: 7. permission from the Nuclear Regulatory Agency when the application relates to
p.002017: production of radiopharmaceuticals or medicinal products subject to ionization
p.002017: radiation during their production;
p.002017: 8. permission to use the premises for production, control and storage,
p.002017: issued by the order of the Spatial Planning Act, or other substitute document;
p.002017: 9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 10. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) In the manufacture of narcotic substances and dosage forms containing
p.002017: such substances are also complied with the requirements of the Drug Control Act and
p.002017: precursors.
p.002017: (4) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the persons under para. 2, Vol. 1,
p.002017: when they are Bulgarian citizens.
p.002017: Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
...
p.002017: the provisions of Art. 150 and 151, with a deadline for issue:
p.002017: 1. 14 days - in the cases under Art. 156, para. 1, items 1, 2 and 7;
p.002017: 2. (amend. - SG 60/11, in force from 05.08.2011) 30 days - in the cases of art. 156, para.
p.002017: 1, Vols 4 - 6.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) When the changes under art. 156, para.
p.002017: 1, items 4 - 6 cannot be evaluated on documents, the BDA carries out an on-site inspection. In these cases
p.002017: the term under para. 1, item 2 shall stop running until the check is completed.
p.002017: (3) The expenses for carrying out on-site inspections under para. 2 shall be at the expense of the applicant.
p.002017: (4) For carrying out on-site inspections under para. 2 the applicant pays a fee of
p.002017: determined in the tariff under Art. 21, para. 2.
p.002017: Art. 158. (1) The Executive Agency for Medicines shall keep a register under Art. 19, para. 1, item 1 of
p.002017: production permits issued, which contains:
p.002017: 1. number and date of the manufacturing authorization;
p.002017: 2. the name, seat and address of management of the person who has been authorized to
p.002017: production;
p.002017: 3. address of the premises for production, control and storage of the medicines;
p.002017: 4. (amend. - SG 102/02, in force from 02.01.2013) the medicinal products and
p.002017: the forms for which authorization has been granted;
p.002017: 5. name of the person under art. 148, Vol. 2;
p.002017: 6. names of the persons under art. 149;
p.002017: 7. date of deletion from the register of production authorization and the reason for doing so.
p.002017: (2) The data from the register of issued production authorizations shall be published on
p.002017: BDA's website on the Internet.
p.002017: (3) At the request of the European Commission or a regulatory authority of a Member State
p.002017: The BDA provides information on the manufacturing authorization issued.
p.002017: Art. 159. (1) The holder of a permit for production of rent under an employment contract
p.002017: at least one qualified person under Art. 148, item 2, which is permanently at his disposal.
p.002017: (2) The qualified person under para. 1 shall meet the following requirements:
p.002017: 1. have a master's degree in medicine, pharmacy, chemistry, biotechnology or biology;
p.002017: 2. have at least two years of practical experience in pharmaceutical production
p.002017: and / or in conducting a qualitative and quantitative analysis of the medicinal products and active agents
p.002017: substances.
p.002017: (3) Where the holder of the authorization to manufacture a medicinal product
p.002017: meets the requirements of para. 2, it may fulfill the obligation of a qualified person.
p.002017: (4) (New, SG No. 102/2012, effective 21.12.2012) The qualified person
p.002017: is responsible for indicating that the packaging of the medicinal product is labeled with
p.002017: safety under Art. 168, para. 8.
p.002017: (5) (Renumbered from Paragraph (4), SG No. 102/2012, effective 21.12.2012) The qualified person shall issue a certificate for
p.002017: release of each batch certifying that the batch of medicinal product is manufactured and
p.002017: controlled in accordance with the requirements of
p.002017: the marketing authorization under this law.
p.002017: (6) (Renumbered from Paragraph 5, SG No. 102/2012, effective 21.12.2012) The qualified person shall issue a certificate for
p.002017: release of each batch certifying that the batch is a medicinal product intended for clinical use
p.002017: testing, is manufactured and controlled in accordance with the requirements of Good Manufacturing Practice, p
p.002017: production dossier of
p.002017: the product and the information provided under Art. 110, para. 1, Vol. 4.
p.002017: (7) (Renumbered from Paragraph 6, SG No. 102/2012, effective 21.12.2012)
p.002017: a person shall keep a register of the certificates of release for each batch of
p.002017: the medicinal product.
p.002017: (8) (Renumbered from Paragraph (7), amend. - SG 102/02, in force from 21.12.2012)
p.002017: the register under para. 7 shall be kept for at least 5 years after the last entry and be submitted
p.002017: of the inspection bodies upon request.
p.002017: (9) (Renumbered from Paragraph (8), SG No. 102/2012, in force since 21.12.2012)
p.002017: proceedings for violations committed in the performance of the duties of the qualified person, BDA
p.002017: orders the holder of the authorization to
p.002017: to temporarily remove a qualified person from office.
p.002017: (10) (Renumbered from Paragraph 9, SG No. 102/2012, effective 21.12.2012) The criteria and
p.002017: the requirements for the qualification and training of the persons under Art. 148, item 2 shall be determined in Art
p.002017: the ordinance under Art. 152.
p.002017: Art. 160. (1) The holder of a manufacturing authorization shall:
p.002017: 1. ensure that production operations are carried out in accordance with the requirements
p.002017: of Good Manufacturing Practice and in accordance with the information approved by the BDA under Art.
p.002017: 27, para. 1, items 7 and 8, and in the case of medicinal products for clinical trial, in accordance with
p.002017: the information under Art. 110, para. 1, item 4, provided to the Agency by the contracting authority;
p.002017: 2. (amend. - SG 102/2012, in force from 02.01.2013) use only active substances,
p.002017: which are manufactured in accordance with the requirements of Good Manufacturing Practice for
p.002017: active substances;
p.002017: 2a. (new - SG 102/2012, in force from 02.01.2013) make sure that the excipients,
p.002017: used in medicinal products are manufactured in accordance with good manufacturing practice
p.002017: for excipients determined on the basis of a formal
p.002017: risk assessment in accordance with applicable guidelines adopted by the European Commission;
p.002017: 3. provide permanently qualified production and control personnel in accordance with
p.002017: the requirements of the ordinance under Art. 152;
p.002017: 4. (amend. - SG 12/11, in force from 08.02.2011) has only medicinal products
p.002017: products authorized to be used, subject to the requirements of this Act;
p.002017: 5. (repealed, SG No. 12/2011, effective 08.02.2011)
p.002017: 6. notify immediately the control bodies in case of change of the qualified person
p.002017: under Art. 148, Vol. 2;
p.002017: 7. ensure at all times access of the control bodies to the premises and
p.002017: documentation;
p.002017: 8. provide to the qualified person under Art. 148, item 2 the necessary conditions for
p.002017: performance of his duties;
p.002017: 9. (new - SG 102/2012, in force from 02.01.2013) inform immediately the BDA and the holder of the permit for
p.002017: use if he / she receives information that the medicinal products fall within the scope of his authorization
p.002017: production, are falsified or there are doubts about falsification, regardless of whether these medicinal products
p.002017: products have been distributed within the legal supply chain or illegally,
p.002017: including through illicit sale through the information society services;
p.002017: 10. (new - SG 102/2012, in force from 02.01.2013) check whether
p.002017: the manufacturers, importers or traders from which it receives the active substances are
p.002017: registered by the competent authority of the Member State in which they are established;
p.002017: 11. (New, SG No. 102/2012, effective 02.01.2013) verify the authenticity and
p.002017: the quality of the active substances and of the excipients.
p.002017: (2) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing permit shall exercise
p.002017: audits at the sites for the production and marketing of active substances for compliance with Good Manufacturing
p.002017: practice and Good distribution practice. The holder of the manufacturing authorization may
p.002017: contract with a third party yes
p.002017: performed the audit on his behalf and on his behalf.
p.002017: (3) (New, SG No. 102/2012, effective 02.01.2013) The holder of the permit
p.002017: document the undertakings under para. 1, items 2 and 2a measures.
p.002017: (4) (Renumbered from Paragraph (2), SG No. 102/2012, effective 02.01.2013) The holder of a permit for
p.002017: manufacture keeps the samples and the documentation for the active medicinal products manufactured by him
p.002017: substances and medicinal products intended for clinical use
p.002017: tests, under the conditions and in the order specified in the ordinance under art. 152.
p.002017: (5) (Renumbered from Paragraph (3), SG No. 102/2012, in force from 02.01.2013) In the case of a medicinal product
p.002017: product for clinical trial, the holder of the manufacturing authorization shall ensure that
p.002017: all production operations shall be carried out in accordance with
p.002017: the information provided by the contracting authority to the BDA in accordance with the ordinance under Art. 82, para. 3.
p.002017: (6) (Renumbered from Paragraph (4), SG No. 102/2012, effective 02.01.2013)
p.002017: each transaction is kept for 5 years and contains the date, name of the medicinal product
p.002017: product, quantity delivered, name and address of consignee, and batch number.
p.002017: (7) (Renumbered from Paragraph (5), SG No. 102/2012, effective 02.01.2013)
p.002017: a production authorization provides and maintains a system for blocking and withdrawing from the market
p.002017: medicinal products that have shown non-compliance with quality requirements.
p.002017: (8) (Renumbered from Paragraph (6), SG No. 102/2012, effective 02.01.2013)
p.002017: a manufacturing authorization is required to block and withdraw the medicinal products shown
p.002017: non-compliance with the requirements for quality, efficiency and safety, in accordance with the ordinance of
p.002017: Art. 274, para. 1.
p.002017: (9) (Renumbered from Paragraph (7), SG No. 102/2012, effective 02/01/2013)
p.002017: a manufacturing authorization is required to update production methods in accordance
p.002017: with the development of new technologies and the development of test drug products.
p.002017: (10) (New - SG, iss. 12 in 2011, in force since 08.02.2011, previous para 8, amended - SG, iss. 102 in 2012, in force since
p.002017: 02.01.2013) Based on the manufacturing authorization issued under
p.002017: the order of this section, its holder may import the auxiliaries necessary for
p.002017: the manufacture of the medicinal products referred to in the marketing authorization
p.002017: production.
p.002017: Art. 160a. (New, SG No. 60/2011, effective 05.08.2011) (1) The Executive Director of the BDA
p.002017: by an order revokes the issued production permit when the conditions under art. 148 and they are not
...
p.002017: testing may only be carried out by natural or legal persons registered as traders under the legislation
p.002017: of a Member State that are
p.002017: have received an import permit issued by the BDA Executive Director.
p.002017: (2) In order to obtain an import permit, the person under para. 1 must have:
p.002017: 1. (amend. - SG 102/2012, in force from 02.01.2013) at any time with at least one
p.002017: a qualified person who meets the requirements of Art. 159, para. 2 and 10;
p.002017: 2. (amend. - SG 102/2012, in force from 02.01.2013) with a laboratory for quality control in
p.002017: compliance with the requirements of the ordinance under Art. 152 and storage facilities for medicinal products, and
p.002017: clinical trial medicinal products provided with
p.002017: the necessary technical equipment, in accordance with the requirements of the ordinance under Art. 198.
p.002017: Art. 162. (1) In order to obtain an import permit, the person under Art. 161, para. 1 submits to the BDA
p.002017: an application in accordance with a model approved by the Executive Director of the Agency.
p.002017: (2) To the application under para. 1 shall apply:
p.002017: 1. (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 60 from 2011, in force since 05.08.2011)
p.002017: details of the Trader or Cooperative Unique Identification Code of the Commercial Register, and of the companies,
p.002017: registered in a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: Economic Space - Document for current registration under national law, issued by
p.002017: competent
p.002017: authority of the country concerned;
p.002017: 2. (amend. - SG 102/02, in force from 02.01.2013) list of the medicinal products
p.002017: products and forms to be imported;
p.002017: 3. (suppl. - SG 71/08, in force from 12.08.2008) a copy of the production permit,
p.002017: issued by the regulatory authority of the exporting country and a certificate attesting the conformity of
p.002017: conditions for production, control and storage with
p.002017: standards at least equivalent to those of Good Manufacturing Practice;
p.002017: 4. documents certifying the circumstances under Art. 159, para. 1 and 2 for
p.002017: the qualified person;
p.002017: 5. data on the address of a laboratory on the territory of the Republic of Bulgaria for performing full quantitative and
p.002017: qualitative analysis of at least the active substances and of all other tests and verifications for the demonstration of
p.002017: the quality of each imported batch of medicinal product in accordance with the requirements of the marketing authorization
p.002017: use in accordance with this law and the address of
p.002017: storage facilities;
p.002017: 6. a contract which defines the responsibilities of each party in respect of compliance with
p.002017: the principles of Good Manufacturing Practice by the contractor and the manner in which the qualified person under Art.
p.002017: 161, para. 2, item 1 shall perform its duties in the cases,
p.002017: when the person under Art. 161, para. 1 does not have its own laboratory;
p.002017: 7. document for payment of the fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 71/2008, effective 12.08.2008) Upon receipt of an application under para. 1 BDA evaluates the submitted
p.002017: documentation and perform on - site verification of the laboratory for
p.002017: control and storage facilities for medicinal products and medicinal products intended for use
p.002017: a clinical trial to determine their compliance with the requirements of
p.002017: Good manufacturing practice and Good distribution practice.
...
p.002017: produced or not in another Member State before being placed on the market in the Republic of Bulgaria is
p.002017: underwent a complete qualitative and quantitative analysis of at least the active substances and all were performed
p.002017: necessary tests and checks in accordance with the requirements for the granting of a marketing authorization under
p.002017: the order of this law.
p.002017: (2) When a batch of a medicinal product imported from a third country is subject to the analyzes under para. 1 into another
p.002017: Member State and shall be accompanied by a batch release certificate signed by another qualified person,
p.002017: no controls are required
p.002017: tests on the territory of the Republic of Bulgaria.
p.002017: (3) Where a consignment of a medicinal product is imported from a third country with which the European Community
p.002017: has signed an agreement for mutual recognition of the certificate of good manufacturing practice,
p.002017: the qualified person issues a batch release certificate based on the accompanying batch
p.002017: documentation without having to carry out
p.002017: control tests on the territory of the Republic of Bulgaria.
p.002017: (4) The qualified person under para. 1 shall issue a certificate of release for each consignment imported, certifying that
p.002017: the batch of medicinal product on the territory of the Republic of Bulgaria intended for clinical trial is
p.002017: manufactured and controlled in accordance with standards equivalent to Good Manufacturing Practice, p
p.002017: the manufacturing dossier of the product and for each batch of medicinal products all the necessary analyzes were carried out and
p.002017: quality tests in accordance with the information provided to the BDA by the contracting authority,
p.002017: according to the ordinance under art. 82, para. 3.
p.002017: (5) The qualified person under para. 1 shall issue a certificate of release for each batch of medicinal product used for
p.002017: comparison in a clinical trial on the territory of the Republic of Bulgaria imported from a third country and not accompanied
p.002017: from a document certifying that it is manufactured and controlled in accordance with standards,
p.002017: equivalent to Good manufacturing practice, including when this medicinal product
p.002017: has been issued
p.002017: marketing authorization.
p.002017: (6) (amend. - SG 71/08, in force from 12.08.2008) It is not required to carry out control tests of
p.002017: the territory of the Republic of Bulgaria, when in another Member State the requirements of para. 4 or 5 and
p.002017: the medicinal product intended for clinical trial is accompanied by a certificate of release for
p.002017: the batch issued by another
p.002017: qualified person.
p.002017: (7) The qualified person under para. 1 shall keep records of each lot imported
p.002017: medicinal product for at least 5 years and present it at the request of the control authorities.
p.002017: (8) The holder of the import authorization shall provide and maintain a locking system and
p.002017: withdrawal from the market of medicinal products which have shown non - compliance with the requirements for
p.002017: quality.
p.002017: (9) The holder of an import authorization shall be obliged to block and withdraw the medicinal products
p.002017: products which have shown non - compliance with the safety and efficacy requirements according to
p.002017: the ordinance under Art. 274, para. 1.
p.002017: (10) (Amended, SG No. 12/2011, effective 08.02.2011) The provisions of Art. 160, para. 1, vol.
p.002017: 4 and 7 shall also apply to import license holders.
...
p.002017: 4. (amend. - SG 102/02, in force from 02.01.2013) the medicinal products and
p.002017: the forms for which authorization has been granted;
p.002017: 5. name of the person under art. 161, para. 2, Vol. 1;
p.002017: 6. date of deletion from the register of the import authorization and the grounds thereof.
p.002017: (2) Data from the register shall be published on the BDA website on the Internet.
p.002017: Section III.
p.002017: Production, import and wholesale trade in active substances (New, SG No. 102/2012, in
p.002017: with effect from 02.01.2013)
p.002017: Art. 167a. (New, SG No. 102/2012, effective 02/01/2013) Production, import or
p.002017: Wholesale trade in active substances may only be carried out by natural or legal persons,
p.002017: registered as traders under the legislation of a Member State and entered in the register under Art. 167g.
p.002017: Art. 167b. (New, SG No. 102/2012, effective 02/01/2013) (1) For entry in
p.002017: the register under Art. 167d the applicant submits to the BDA an application in the form approved by the executive
p.002017: Director of the BDA, which contains:
p.002017: 1. name, seat and address of management of the person under art. 167a;
p.002017: 2. a list of the active substances to be imported, manufactured or marketed;
p.002017: 3. the activities that the person under art. 167a will perform;
p.002017: 4. the address of the premises and the data on the technical equipment for the implementation of
p.002017: the activities of the persons under Art. 167a.
p.002017: (2) To the application under para. 1 shall apply:
p.002017: 1. data on the unique identification code of the trader and for the companies registered
p.002017: in a Member State - a document for current registration under national law issued
p.002017: by a competent authority of the country concerned;
p.002017: 2. document for paid fee under Art. 21, para. 2.
p.002017: (3) Within 60 days of receipt of the application and documentation under para. 1 and 2 of the BDA
p.002017: basis of risk assessment:
p.002017: 1. enter the person under Art. 167a in the register under Art. 167d, of which he informs him or
p.002017: 2. notify of the date of inspection for conformity assessment of
p.002017: the conditions for carrying out the activities under Art. 167a with the requirements of Good Manufacturing
p.002017: practice of art. 152, para. 1 and the Good Distribution Practices of Active Substances under Art. 198.
p.002017: (4) Where, as a result of the inspection under para. 3, item 2 BDA has established compliance with
p.002017: the requirements of Good Manufacturing Practice under Art. 152, para. 1 and Good Distributor
p.002017: active substance practices under Art. 198, it shall enter the applicant in the register under Art. 167g for which it
p.002017: informs.
p.002017: (5) The expenses for carrying out the inspection under para. 3, item 2 shall be at the expense of the applicant.
p.002017: (6) For carrying out the inspection under para. 3, item 2 the applicant shall pay a fee of
p.002017: determined in the tariff under Art. 21, para. 2.
p.002017: (7) In the cases of para. 3, item 1 and para. 4 the applicant may commence the activity
p.002017: after entry in the register under Art. 167g.
p.002017: Art. 167c. (New, SG No. 102/2012, effective 02/01/2013) When, within the term of art. 167b,
p.002017: para. 3 The BDA did not inform that an inspection would be carried out, the applicant could start
p.002017: carrying out the activity.
p.002017: Art. 167g. (New, SG No. 102/2012, effective 02.01.2013) (1) The Executive
...
p.002017: 2. a list of the active substances that are imported, manufactured or marketed;
p.002017: 3. the activities that the person under art. 167a will perform;
p.002017: 4. address of the premises where the activities are carried out;
p.002017: 5. notes on the entered circumstances.
p.002017: (2) The Executive Agency for Medicines shall enter into the database under Art. 147
p.002017: information on registered importers, manufacturers and wholesalers of active
p.002017: substances.
p.002017: Art. 167d. (New - SG 102/02, in force from 02.01.2013) (1) The person under art. 167a
p.002017: submit to the BDA annually by 31 January a notification of changes in the information,
p.002017: entered in the register under Art. 167g.
p.002017: (2) When changes occur that may affect the quality of or
p.002017: the safety of the active substances that are produced, imported or distributed by the individual
p.002017: under Art. 167a shall notify the BDA immediately.
p.002017: Art. 167f. (1) (New, SG No. 102/2012, effective 02.01.2013) The production, the import and
p.002017: wholesale of active substances on the territory of the Republic of Bulgaria, including active substances
p.002017: substances intended for export shall be carried out in accordance with
p.002017: Good manufacturing practice and Good distribution practices for active substances.
p.002017: (2) Importers may import active substances only if the following conditions are met:
p.002017: 1. the active substances were manufactured in accordance with Good standards
p.002017: manufacturing practices that are at least equivalent to those established by the European
p.002017: union, and
p.002017: 2. (In force from 02.07.2013) The active substances shall be accompanied in writing
p.002017: confirmation by the competent authority of the exporting country that:
p.002017: (a) Good manufacturing practice standards applicable to the site for
p.002017: production of the exported active substances are at least equivalent to those established by
p.002017: The European Union;
p.002017: (b) the production site concerned is subject to regular control and is effectively implemented by the Good
p.002017: manufacturing practice, including repeated and unannounced inspections, to ensure the protection of
p.002017: public health at least equivalent to that of
p.002017: The European Union, and
p.002017: (c) in the event of non-compliance, the exporting country will
p.002017: inform the BDA immediately.
p.002017: (3) (In force from 02.07.2013) The requirement of para. 2, item 2 shall not apply if the state
p.002017: exporter is included in the list under Art. 111b of Directive 2001/83 / EC.
p.002017: Art. 167g. (New, SG No. 102/2012, effective 02.07.2013) (1) Exceptionally, when necessary to
p.002017: ensure the availability of medicinal products, the importer may import the active substance without the written request
p.002017: confirmation of art. 167f, para. 2, item 2 for a period not longer than the validity of the certificate of Good
p.002017: manufacturing practice where the manufacturing site of the active substance in the exporting country was
p.002017: inspected by a regulatory authority of a Member State and found to comply with the principles and guidelines
p.002017: for good
p.002017: manufacturing practice.
p.002017: (2) In the cases of para. 1 The BDA shall notify the European Commission.
p.002017: Art. 167h. (New, SG No. 102/2012, effective 02.01.2013) Holders of authorizations for
p.002017: proceedings, including those performing the activities of art. 168b, para. 2, are considered producers in the sense
p.002017: of § 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
p.002017: caused by a defect in the goods,
p.002017: provided for therein.
p.002017: Chapter Six.
p.002017: PACKAGING AND PACKAGE LEAFLET
p.002017: Art. 168. (1) The packaging of a medicinal product shall consist of primary and / or secondary
p.002017: packing and leaflet for the patient.
p.002017: (2) (amend. - SG 61/11, in force from 10.11.2011)
p.002017: medicinal products containing substances specified in the list under Art. 3, para. 2, item 2 of the Law on
p.002017: control of drugs and precursors is diagonally marked with two red bars and the secondary
p.002017: packaging of medicinal products containing substances from the list under Art. 3, para. 2, item 3 of the Control Act
p.002017: narcotic drugs and precursors - with two blue bars. The packaging must contain an indication that
p.002017: the medicinal product is only available at
p.002017: special medical prescription.
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products included in
p.002017: the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains information
p.002017: with the following text: "This medicinal product is subject to additional monitoring". A text in front of the text is placed
...
p.002017: of the product, and / or
p.002017: 2. other specific conditions of use.
p.002017: (2) The Medicines Executive Agency may not indicate the exact category of
p.002017: the medicinal product under Art. 172, but according to the criteria of Art. 174 and 175 determine whether
p.002017: the medicinal product is classified as a prescription only product.
p.002017: Art. 177. Medicinal products that do not meet the requirements of Art. 173, 174 and
p.002017: 175 and the criteria set out in the ordinance under Art. 178, are granted without medical prescription.
p.002017: Art. 178. The criteria for classification of medicinal products and the requirements for
p.002017: the documentation for making a change in the classification shall be laid down in an ordinance of
p.002017: the Minister of Health.
p.002017: Art. 179. (1) The Executive Agency for Medicines shall prepare and publish it on the page
p.002017: your online list of prescription medicines
p.002017: the territory of the Republic of Bulgaria.
p.002017: (2) The list under para. 1 is updated annually.
p.002017: Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
p.002017: or the certificate of registration, the BDA shall review and, where necessary, amend the classification according to
p.002017: the requirements of Art. 173 and the criteria specified
p.002017: in the ordinance under art. 178.
p.002017: Art. 181. Where a change in the classification of a medicinal product on the basis of
p.002017: significant pre-clinical or clinical trials, no subsequent applicant or marketing authorization holder
p.002017: may be invoked within one year from the date of the variation authorization issued by a regulatory authority of a country
p.002017: State upon filing
p.002017: an application to change the classification of the same substance.
p.002017: Art. 182. The European Medicines Agency shall be notified annually by the Executive Agency for Medicinal Products
p.002017: the Commission and the regulatory authorities of the other Member States for changes to the
p.002017: Art. 179.
p.002017: Chapter Eight.
p.002017: PHARMACEUTICAL SAFETY TRACKING
p.002017: Section I.
p.002017: General Provisions (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 183. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the drug agency organizes and maintains a drug tracking system
p.002017: safety to fulfill the obligations under this Chapter.
p.002017: (2) The system of para. 1 is used to gather information on the risks of medicinal products
p.002017: for patients' health and public health. The information covers adverse drug reports
p.002017: reactions when using the medicinal product in accordance with the approved summary of product characteristics, and
p.002017: misuse and use information that is inconsistent with the approved summary
p.002017: product characteristics, including information on side effects observed with
p.002017: execution of
p.002017: professional duties.
p.002017: (3) The Executive Agency for Medicines shall validate, process and classify the information under para.
p.002017: 2, conducts a scientific analysis of the data collected with a view to assessing the potential for reduction and
p.002017: risk prevention and take the necessary action
p.002017: with regard to the authorization of the medicinal product.
...
p.002017: drafts an opinion on regulatory actions regarding the authorization of
p.002017: use within a schedule drawn up in accordance with the severity and degree of danger.
p.002017: (4) The Medicines Executive Agency implements the recommendations in the opinion of
p.002017: the coordination group of art. 77, para. 2 or in the decision of the European Commission provisional
p.002017: and / or final measures.
p.002017: Art. 188. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for
p.002017: The European Medicines Agency, the regulatory authorities of the other Member States, shall be informed by the European Medicines Agency
p.002017: The European Commission at least 24 hours prior to the public disclosure of information regarding concerns
p.002017: with the monitoring of the safety of a medicinal product, unless the protection of
p.002017: public health requires
p.002017: immediate disclosure of information.
p.002017: (2) The Medicines Executive Agency shall publish information relating to the active substances contained in
p.002017: medicinal products authorized in other countries
p.002017: Member States, using a harmonized draft communication and timetable for publication,
p.002017: proposed by the European Medicines Agency.
p.002017: (3) In the cases of para. 1 and 2 information containing personal data or representing
p.002017: trade secrets shall be deleted unless such disclosure is necessary for safeguarding
p.002017: of public health.
p.002017: Art. 189. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the medicines agency may delegate some of the rights and obligations under this chapter to
p.002017: regulatory authority of another Member State by concluding an agreement.
p.002017: (2) In the cases of para. 1 The BDA informs the European Commission, the European Medicines and Regulatory Agency
p.002017: authorities of the other Member States for the delegation of powers and publish a communication to the
p.002017: Internet portal under Art. 185, para. 1 or on the Internet
p.002017: your page.
p.002017: Art. 190. (amend. - SG 102/02, in force from 21.12.2012) (1) The holder of
p.002017: a marketing authorization is required to have a drug tracking system
p.002017: safety to fulfill its obligations under this Chapter.
p.002017: (2) The holder of a marketing authorization through the system of para. 1 makes a scientific assessment of the information collected
p.002017: on the safety of medicinal products, consider the possibility of minimizing or
p.002017: risk prevention and take the necessary
p.002017: measures.
p.002017: (3) The Marketing Authorization Holder shall implement an adequate and effective quality system to ensure
p.002017: compliance of the system under para. 1 with the requirements of this law. The minimum requirements for the
p.002017: quality is defined in the Implementing Regulation (EU)
p.002017: № 520/2012.
p.002017: (4) The marketing authorization holder shall regularly audit the system under para.
p.002017: 1. Information on the main findings of the audit shall be noted in the system's main documentation and shall serve
p.002017: to draw up a plan for the implementation of appropriate corrective actions. This one
p.002017: information may be deleted after complete corrective action.
p.002017: Art. 191. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the marketing authorization designates a qualified person with the appropriate qualification responsible for
...
p.002017: 1. summaries of data on the benefit / risk balance of the medicinal product,
p.002017: including the results of all studies, with a view to their potential impact on
p.002017: the marketing authorization;
p.002017: 2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
p.002017: available data, including clinical trial data for unauthorized indications and target groups,
p.002017: which are not included in the summary of
p.002017: product;
p.002017: 3. all data on the volume of sales of the medicinal product and any other information with which
p.002017: the holder of the marketing authorization is in possession of the volume of prescriptions, including approximate ones
p.002017: number of persons who used the medicinal product
p.002017: or exposed to it for another reason.
p.002017: (2) The content and format of the electronic periodic updated reports on
p.002017: safety is determined by Implementing Regulation (EU) No 520/2012.
p.002017: (3) The information under para. 1 shall be collected and stored in a register established in the order of a member
p.002017: 25a of Regulation (EC) No 726/2004 of the European Parliament and of the Council, and is accessible to the BDA.
p.002017: Art. 194i. (New, SG No. 102/2012, effective 21.12.2012) The holders of
p.002017: marketing authorizations / certificates for registration of medicinal products under Art. 28, 30, 35
p.002017: and 37 submit periodic safety update reports only when:
p.002017: 1. submission of a report is a condition under Art. 55a or 56, entered in the authorization for
p.002017: use / registration certificate, or
p.002017: 2. The Executive Agency for Medicinal Products or a regulatory authority of another Member State shall so request
p.002017: on the basis of safety considerations for the medicinal product or
p.002017: due to the absence of periodic safety update reports for the active substance contained in
p.002017: the medicinal product authorized
p.002017: use / registration certificate.
p.002017: Art. 194k. (New, SG No. 102/2012, effective 21.12.2012) (1) In the authorization for
p.002017: use / registration certificate is determined by the frequency of submission of periodic
p.002017: updated safety reports.
p.002017: (2) The filing dates of the reports depending on the frequency under para. 1 are calculated by
p.002017: the date of issue of the marketing authorization / registration certificate.
p.002017: (3) Periodic safety update reports shall be submitted through the following
p.002017: time intervals, except where reporting frequency is a condition of
p.002017: issuing the marketing authorization / registration certificate or is
p.002017: determined in accordance with Art. 194l, 194m and 194h:
p.002017: 1. every 6 months from the date of issue of the marketing authorization / certificate
p.002017: for the registration of a medicinal product by the date of its placing on the market;
p.002017: 2. every 6 months during the first two years from the date of placing on the market of
p.002017: the medicinal product;
p.002017: 3. once a year for the next two years;
p.002017: 4. once every three years after the fourth year from the date of placing on the market of
p.002017: the medicinal product.
p.002017: (4) Outside the cases under para. 3, periodic safety update reports are issued
p.002017: shall submit immediately upon request to the BDA or to a regulatory authority of a Member State.
p.002017: (5) Paragraphs 3 and 4 shall also apply to medicinal products authorized for use only
p.002017: the territory of the Republic of Bulgaria, which are not covered by Art. 194l.
p.002017: Art. 194l. (New, SG No. 102/2012, effective 21.12.2012) Where medicinal products which
p.002017: contain the same active substance or a combination of the same active substances, have been obtained separately
p.002017: marketing authorizations / registration certificate, frequency and filing dates for periodic updates
p.002017: safety reports may be modified and harmonized in order to carry out a uniform assessment of those reports.
p.002017: Art. 194m. (New, SG No. 102/2012, effective 21.12.2012) (1) The filing dates of
p.002017: the periodic safety update reports for the medicinal products under Art. 194l
p.002017: calculated according to the European Union reference date.
p.002017: (2) The European Union reference date under para. 1 is:
p.002017: 1. the date of the first authorization for use in the European Union of the medicinal product
p.002017: a product containing the relevant active substance or the corresponding combination of active substances
p.002017: substances, or
p.002017: 2. the earliest known date of authorization of the medicinal product,
p.002017: containing the relevant active substance or the corresponding combination of active substances, if
p.002017: the date referred to in item 1 cannot be determined.
p.002017: Art. 194n. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the permit
...
p.002017: has been authorized under Regulation (EC) No 726/2004 of the European Parliament and of the European Parliament
p.002017: The Council, and is designated as such by the committee under Art. 56a, para. 1, v. 1.
p.002017: Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases under Art. 194o, para. 2 and 3 BDA,
p.002017: respectively, the rapporteur from the Republic of Bulgaria within 60 days from the date of receipt of the periodic
p.002017: an updated safety report shall prepare an evaluation report and send it electronically to the European
p.002017: the Medicines Agency and the regulatory authorities of the Member States. The Marketing Authorization Holder receives
p.002017: the evaluation report from
p.002017: European Medicines Agency.
p.002017: (2) Within 30 days of receipt of the report under para. 1 holder of the authorization for
p.002017: Member States' regulatory authorities or authorities may submit their comments
p.002017: to the European Medicines Agency and to the BDA.
p.002017: (3) Within 15 days from the date of receipt of the comments under para. 2 BDA updates
p.002017: the evaluation report, taking into account all the objections presented, and forwarding it to the committee
p.002017: under Art. 56a, para. 1, item 1 for approval and recommendation.
p.002017: (4) The European Medicines Agency has included the evaluation report adopted and
p.002017: the recommendation of the Committee under Art. 56a, para. 1, item 1 in the register under Art. 194h, para. 3 and sends it to
p.002017: the holder of the marketing authorization.
p.002017: Art. 194 (New, SG No. 102/2012, effective 21.12.2012) Where the Republic of Bulgaria is not
p.002017: rapporteur in the procedure under Art. 194o, para. 2, the BDA may submit comments within the term under Art. 194p, para. 2 to
p.002017: The European Medicines Agency and the regulatory authority of the European Medicines Agency
p.002017: the Member State that produced the assessment report.
p.002017: Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
p.002017: updated reports on the safety of medicinal products under Art. 194l and when none of the authorizations for
p.002017: the use of these products has not been issued under Regulation (EC) No 726/2004 of the European Parliament and of the Council,
p.002017: the coordination group of art. 77, para. 2 within 30 days from the date of receipt of the recommendation by the committee under Art. 56a,
p.002017: para. 1, item 1 issues an opinion on the preservation, modification, suspension or termination of
p.002017: relevant marketing authorizations, including a timetable for the implementation of the opinion.
p.002017: (2) Where the represented Member States in the coordination group under Art. 77, para. 2
p.002017: they agree on the actions to be taken, the BDA implements
p.002017: the decision taken.
p.002017: (3) Where the opinion under para. 1 is to suspend or terminate the authorization for
p.002017: The BDA Executive Director issues an order.
p.002017: (4) Where in the opinion under para. 1 recommended changes to the marketing authorization issued by the holder of
p.002017: the marketing authorization submitted to the BDA an application for change including an updated summary
p.002017: product features and leaflet within
p.002017: the specified timetable for implementation.
p.002017: (5) When agreement cannot be reached within the coordination group under Art. 77, para. 2, the position of
...
p.002017: wholesale only of medicinal products for which import authorization has been granted.
p.002017: Art. 197. The persons under art. 195 must have:
p.002017: 1. suitable premises, equipment and facilities and suitable means of transport,
p.002017: ensuring the proper storage, distribution and transportation of medicinal products
p.002017: products in accordance with the requirements of Good Distribution Practice;
p.002017: 2. Qualified staff and responsible Master of Pharmacy for at least two years
p.002017: seniority in the specialty whose obligations are defined in the ordinance under Art. 198.
p.002017: Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for
p.002017: The good distribution practices of medicinal products and active substances are adopted by ordinance of
p.002017: the Minister of Health and with guidelines adopted by
p.002017: The European Commission.
p.002017: Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
p.002017: 1. an application containing the name, seat and registered office of
p.002017: the trader; address and description of the premises and facilities for the storage of medicinal products
p.002017: products;
p.002017: 2. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: country;
p.002017: 3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar document
p.002017: of the person, if not a Bulgarian citizen, a diploma for higher education and a document for seniority
p.002017: of the responsible master pharmacist under Art. 197, v. 2 and
p.002017: a copy of his employment contract;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 6. a document certifying the legal basis for the use of the premises;
p.002017: 7. (amend. - SG 98/10, in force from 01.01.2011) conclusion of RII after verification
p.002017: on the spot that the health requirements of the wholesale premises are met in accordance with
p.002017: the ordinance under Art. 198;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
p.002017: 1. a copy of the wholesale marketing authorization issued by a regulatory authority of a country
p.002017: member;
p.002017: 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.002017: 3. address of the premises for storage of the medicinal products on the territory of
p.002017: Member States.
p.002017: (3) In the wholesale of narcotic substances and pharmaceutical forms,
p.002017: containing such substances, the requirements of the Control Act also apply
p.002017: drugs and precursors.
p.002017: (4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Agency
p.002017: for nuclear regulation.
p.002017: (5) (New - SG 103 2017, in force from 01.01.2018)
p.002017: the medicines shall establish ex officio the circumstances regarding the criminal record of the person under para. 1, Vol. 3,
p.002017: when he is a Bulgarian citizen.
p.002017: Art. 200. The Drug Enforcement Agency evaluates the documentation and performs it
p.002017: on - the - spot verification of the sites indicated in the application for their compliance with
p.002017: requirements for Good Distribution Practice.
p.002017: Art. 201. (1) The Executive Agency for Medicines shall notify the applicant in writing,
p.002017: when it finds deficiencies in the documentation submitted.
p.002017: (2) In the cases of para. 1 the term under Art. 202, para. 1 stops running.
p.002017: Art. 202. (1) Within 90 days from the date of submission of the application under Art. 199, para. 1
p.002017: the Executive Director of the BDA issues the permit for wholesale trade or makes it motivated
p.002017: refusal.
p.002017: (2) The refusal under para. 1 shall be subject to appeal by the order of the Administrative Procedure
p.002017: code.
...
p.002017: (2) In the cases of para. 1, the packaging of the medicinal products shall be labeled
p.002017: the "sample".
p.002017: (3) To the persons under para. 1, item 1, no more than two samples of the same dosage form may be supplied
p.002017: the medicinal product in one calendar year in the smallest existing packaging of the manufacturer, and of
p.002017: higher medical schools and medical schools
p.002017: colleges - only in quantities necessary for the purposes of training.
p.002017: (4) The holder of the marketing authorization and / or the person under Art. 26, para. 2 keep a record
p.002017: for all persons who have supplied the samples, the type, quantity and time of delivery and
p.002017: make this information available to inspection bodies on request.
p.002017: Art. 211. (1) Wholesalers must have a blocking and withdrawal system
p.002017: of medicinal products which have shown non-compliance with the requirements for quality, safety and health
p.002017: efficiency.
p.002017: (2) The holder of a wholesale trade permit shall be obliged to block and withdraw
p.002017: medicinal products which have shown non - compliance with the requirements for quality, safety and health
p.002017: efficiency according to the procedure specified in the ordinance under Art. 274, para. 1.
p.002017: Art. 212. (1) The Executive Director of the BDA shall notify the European Commission, the regulatory authorities of
p.002017: other Member States and the European Medicines Agency for wholesale marketing authorizations for
p.002017: suspended or revoked permissions for
p.002017: the reasons for this.
p.002017: (2) (amend. - SG 102/2012, in force from 02.01.2013) Where the executive director of the BDA
p.002017: establish that the person under Art. 195, para. 1 does not fulfill the obligations under Art. 207, para. 1, Vol. 2 - 14, he informs
p.002017: the regulatory authority of the Member State which granted the authorization
p.002017: wholesale, and the European Commission.
p.002017: (3) Where the regulatory body under para. 2 temporarily suspend or revoke permission for
p.002017: wholesale trade of the person under art. 195, para. 1, it shall notify the BDA Executive Director and
p.002017: The European Commission.
p.002017: Art. 212a. (New, SG No. 102/2012, effective 02/01/2013) (1) (Amended, SG No. 18/2012)
p.002017: 2014) Mediation in the field of medicinal products can physically and
p.002017: legal entities registered as commercial intermediaries within the meaning of the Commercial Law of
p.002017: The Republic of Bulgaria, which are registered for carrying out this activity by the BDA.
p.002017: (2) The persons under para. 1, who wish to register as intermediaries, shall file with the BDA
p.002017: notification according to a model approved by the BDA Executive Director, containing:
p.002017: 1. name, seat and address of management;
p.002017: 2. contact details.
p.002017: (3) To the notification under para. 2 shall apply:
p.002017: 1. data on the unique identification code;
p.002017: 2. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
p.002017: (4) The Executive Agency for Medicines shall enter in the public register the persons,
p.002017: mediators in the field of medicinal products.
p.002017: (5) The persons under para. 1 may mediate in the field of medicines
p.002017: products after submission of the notification under para. 2 in the BDA.
p.002017: (6) The persons under para. 1 shall notify the BDA within 7 days from the occurrence of a change in any of the
p.002017: the circumstances under para. 2.
p.002017: Art. 212b. (New - SG 102/02, in force from 02.01.2013) (1) The persons under art. 212a, para.
p.002017: 1 shall:
...
p.002017: the authorization number of the medicinal product in the Member State of origin
p.002017: performs parallel imports;
p.002017: 5. statement on establishing the circumstances under art. 217, v. 1;
p.002017: 6. a copy of the leaflet for the patient and a sample of the medicinal product as it is
p.002017: sell in the Member State from which the parallel importation takes place, a translation of the contents of
p.002017: the leaflet in Bulgarian, accompanied by a declaration that the translation is in conformity with the original
p.002017: the leaflet;
p.002017: 7. a proposal for a leaflet for the patient for the parallel medicinal product, accompanied by a declaration,
p.002017: that the contents of the package leaflet are identical to the contents of the product leaflet authorized for use in
p.002017: The Republic of Bulgaria, with the exception of the following
p.002017: data:
p.002017: (a) the name and management address of the parallel importer;
p.002017: (b) the name of the manufacturer, where different for the two products;
p.002017: (c) a period of stability when different for the two products;
p.002017: (d) excipients, where different in the two products;
p.002017: 8. in the case of repackaging:
p.002017: a) (amend. - SG 71/08, in force from 12.08.2008) a sample of the medicinal product
p.002017: as it will be marketed in Bulgaria;
p.002017: (b) a copy of the contract between the parallel importer and the importer
p.002017: partial production activity - packaging, labeling;
p.002017: (c) a certificate of Good Manufacturing Practice when repackaging processes take place
p.002017: carry out outside the territory of the Republic of Bulgaria;
p.002017: d) when performed by the person under Art. 213 - a copy of the manufacturing authorization,
p.002017: issued by the regulatory authority of the Member State where the repackaging takes place;
p.002017: 9. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) Where between the medicinal product for
p.002017: There are differences in parallel imports and the product authorized for use on the territory of the Republic of Bulgaria
p.002017: (in the composition of excipients and others), the person under para. 1 presents evidence that they did not
p.002017: reflect the therapeutic properties of the drug
p.002017: product for parallel imports.
p.002017: (4) In the cases of para. 3 the person under para. 1 indicates on the packaging and the package leaflet
p.002017: the patient of the parallel medicinal product differences.
p.002017: (5) Where the person under Art. 213 carries out repackaging and / or labeling of the medicinal product
p.002017: a product in Bulgarian on the territory of the Republic of Bulgaria, it must have
p.002017: manufacturing authorization issued by the BDA Executive Director.
p.002017: (6) The parallel imported product is used subject to the conditions of the authorization granted for
p.002017: use of the medicinal product on the territory of the Republic of Bulgaria.
p.002017: Art. 216. (1) The permit for parallel import into the territory of the Republic
p.002017: Bulgaria shall be issued within 45 days from the date of submission of the documentation to the BDA.
p.002017: (2) When the BDA requests additional documentation from the applicant, the term under para. 1 stops
p.002017: run until the requested information is received.
p.002017: (3) When requested by the BDA of the regulatory authority of the Member State from which it is carried out
p.002017: parallel import, information related to the granting of the import authorization
p.002017: medicinal product, the term under para. 1 is extended by 45 days.
p.002017: (4) If, within the term of para. 3 The BDA did not receive the requested documentation, the issuing procedure
p.002017: of a parallel import permit on the territory of the Republic of Bulgaria shall be terminated.
p.002017: (5) Licenses issued for parallel imports into the territory of
p.002017: The Republic of Bulgaria is published on the BDA website on the Internet.
p.002017: (6) The authorization for parallel importation shall be for a period of 5 years. New permission
p.002017: shall be issued in accordance with Art. 215.
p.002017: (7) The authorization for parallel importation shall not be automatically terminated when the holder of the authorization
p.002017: for the use of the medicinal product placed on the market in the Republic of Bulgaria, withdraw it from
p.002017: non - hazardous reasons for
p.002017: population health.
p.002017: Art. 217. The holder of the parallel import authorization shall be obliged to:
p.002017: 1. notify the holder of the marketing authorization for the medicinal product placed on
p.002017: the market on the territory of the Republic of Bulgaria for its intention to carry out parallel imports and
p.002017: upon request, provide him with a sample of the medicinal product in parallel;
p.002017: 2. keep for 5 years the following documentation: name and address of the person to whom he / she is
p.002017: delivered in parallel the imported medicinal product, date of delivery, delivered quantity
p.002017: and batch number;
p.002017: 3. submit to the BDA:
p.002017: (a) an updated patient leaflet for the parallel imported product in accordance with
p.002017: changes have occurred in the granted marketing authorization in the Republic of Bulgaria
...
p.002017: open pharmacies to sell medicinal products to citizens.
p.002017: (2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, curative
p.002017: establishments for hospital care and medical establishments under art. 10 of the Law on medical establishments does not
p.002017: pharmacies can be opened to sell medicinal products to citizens.
p.002017: Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009)
p.002017: The requirements for the location and the premises of the pharmacy are laid down in the ordinance of
p.002017: Art. 219, para. 2.
p.002017: (2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in
p.002017: (requirements from 05.08.2011) Requirements to the device and premises of pharmacies under Art. 228, para.
p.002017: 5 shall be determined in the ordinance under para. 1.
p.002017: Art. 228. (amend. - SG 71/08, in force from 26.07.2008) (1) (amend. - SG 60/11, in force from 26.07.2008)
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
p.002017: director of the BDA on the basis of a model application to
p.002017: applicable:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a country Party
p.002017: Agreement on the European Economic Area - Document for the up - to - date registration of the European Economic Area
p.002017: national legislation issued by the competent authority of the relevant
p.002017: the state of the persons under art. 222, para. 1;
p.002017: 2. employment contract or contract for management of the pharmacy, concluded with the master pharmacist
p.002017: or with a pharmacist assistant;
p.002017: 3. a copy of the act for the creation of the persons under Art. 222, para. 4;
p.002017: 4. documents certifying that the requirements of Art. 224 Hours;
p.002017: 5. (suppl. - SG 103/07, in force from 01.01.2018) criminal record of
p.002017: Master of Pharmacy, respectively of the Assistant Pharmacist appointed as Head of Pharmacy,
p.002017: if they are not Bulgarian citizens;
p.002017: 6. medical certificate of the Master of Pharmacy, respectively
p.002017: assistant pharmacist appointed as pharmacy manager;
p.002017: 7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
p.002017: 7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued
p.002017: from the relevant RI;
p.002017: 8. document for paid fee in the amount determined in the tariff under art. 21, para. 2.
p.002017: (2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
p.002017: medicinal products are checked to see if the diploma of the master pharmacist / assistant pharmacist is presented
p.002017: issued by the relevant competent authority
p.002017: institution.
p.002017: (3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies under Art.
p.002017: 222, para. 4 and 6 shall be opened and closed at the request of the person representing the medical establishment.
p.002017: (4) (Renumbered from Paragraph (3), SG No. 60/2011, effective 05.08.2011)
p.002017: pharmacy in which medicinal products containing narcotic substances are marketed
p.002017: and the requirements of the Drugs and Precursors Control Act.
p.002017: (5) (New - SG, iss. 102 in 2009, in force since 22.12.2009, previous para 4 - SG, iss. 60 in 2011, in force since
p.002017: 08/05/2011) Authorization for retail sale of medicinal products in a pharmacy opened in a population
p.002017: a place with a population of less than 10,000 inhabitants is issued on the basis of
p.002017: application form to which shall be attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) the documents under para. 1, items 1 - 7a and
p.002017: a document issued by the mayor of the respective municipality certifying the number of residents of
p.002017: the respective settlement;
p.002017: 2. (amend. - SG 102/02, in force from 02.01.2013) document for paid fee in
p.002017: 50 per cent of the fee determined in the tariff under Art. 21, para. 2 for the authorization of
p.002017: retail trade of medicinal products under Art. 222, para. 1.
p.002017: (6) (Renumbered from Paragraph (4), Suppl. - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 98)
p.002017: from 2010, in force from 01.01.2011, previous para. 5, amend. - SG, issue. 60 of 2011, effective 05.08.2011
p.002017: d.) The application and documents under para. 1 and 5 shall be submitted to the BDA.
p.002017: (7) (Renumbered from Paragraph (5), amend. - SG 102/09, in force from 22.12.2009, amended - SG, issue 98
...
p.002017: goods relevant for human health as defined in
p.002017: the ordinance under Art. 243, and medical devices.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) Right to trade in
p.002017: retailing medicinal products by opening a drugstore have all the physical and legal
p.002017: persons registered under the Law of Commerce or under the law of a Member State.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore
p.002017: must be a healthcare professional who:
p.002017: 1. is not deprived of the right to practice his profession;
p.002017: 2. has not been convicted of offenses related to the exercise of his profession, for
p.002017: crimes against property and economy or intentional crimes against
p.002017: personality;
p.002017: 3. have at least one year of experience in the specialty.
p.002017: Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened
p.002017: after registration in the respective RIC.
p.002017: (2) (amend. - SG 60/11, in force from 05.08.2011) The persons under art. 238, para. 2 filed in
p.002017: the relevant REI application for registration, to which the following documents are attached:
p.002017: 1. (amend. - SG 60/11, in force from 05.08.2011) data on the Unified
p.002017: Merchant or Cooperative identification number from the Commercial Register and for companies incorporated in a country
p.002017: - a Member State of the European Union or in a State Party to the Agreement on the European Union
p.002017: economic space - document for current registration under national legislation,
p.002017: issued by the competent authority of the relevant
p.002017: the state of the persons under art. 238, para. 1;
p.002017: 2. (suppl. - SG 103 2017, in force from 01.01.2018) document on education and
p.002017: criminal record of the person designated as the drug store manager, if not
p.002017: Bulgarian citizen;
p.002017: 3. the medical certificate of the person under item 2;
p.002017: 4. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force
p.002017: from 05/08/2011)
p.002017: 6. document for paid state fee in the amount determined in the tariff under Art. 21, para. 2.
p.002017: (3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para. 2 REI
p.002017: carries out an inspection on compliance with the requirements of the ordinance under Art. 243. Where it is found that they are not
p.002017: the requirements of the ordinance under Art. 243, within 7 days of carrying out the inspection, the RZI shall give
p.002017: prescribes and sets a time limit for
p.002017: their removal.
p.002017: (4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt
p.002017: of the application and the documents under para. 2, the Director of the RII shall notify the person in writing of
p.002017: incompleteness found in them and determines the term for their elimination.
p.002017: (5) (New, SG No. 60/2011, effective 05.08.2011) To file an application for
p.002017: registration of a drugstore or for making a change under Art. 242 the respective RIC collects fees
p.002017: in the amount determined by the tariff under Art. 21, para. 2.
p.002017: (6) (New - SG 103 2017, in force from 01.01.2018)
...
p.002017: 6. (new, SG No. 48/2015) ninety days when an application for inclusion is submitted
p.002017: in the Positive Medicinal Product List for a new international non-patent
p.002017: name;
p.002017: 7. (new, SG No. 48/2015) sixty days, when an application for
p.002017: maintaining the reimbursement status of the included medicinal product in the Positive Medicinal Product
p.002017: list.
p.002017: (2) For the medicinal products under Art. 262, para. 5 the council shall act within thirty
p.002017: days when an application for price approval under Art. 261a, para. 1 and turn on
p.002017: product in the Positive Medication List.
p.002017: (3) The time limits under para. 1 and 2 shall commence on the date of submission of the application in the order of
p.002017: the ordinance under Art. 261a, para. 5.
p.002017: Art. 259c. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012,
p.002017: (in force since 21.12.2012)
p.002017: Art. 259g. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012,
p.002017: (in force since 21.12.2012)
p.002017: Art. 260. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012,
p.002017: public authorities, officials and applicants under this Chapter are
p.002017: shall be obliged to assist the council and its staff in the execution of the delegated tasks
p.002017: their duties.
p.002017: Art. 261. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 05.08.2011)
p.002017: 12/21/2012) (1) The members of the council and its employees shall be obliged not to disclose circumstances and
p.002017: facts made known to them in the course of or in connection with the performance of their official duties under this Act, except under
p.002017: a written request from a public authority when
p.002017: this is provided by law.
p.002017: (2) In connection with their obligations under para. 1 persons sign a model declaration,
p.002017: approved by the Chairman of the Board.
p.002017: Section II.
p.002017: Regulation and registration of the prices of medicinal products. Algorithms for treatment with
p.002017: medicinal products (New, SG No. 102/2012, effective 21.12.2012)
p.002017: Art. 261a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102/2012)
p.002017: 21.12.2012) (1) The Council regulates the prices of medicinal products included in the Positive Medicinal Product
p.002017: list under Art. 262, para. 1 and paid with public funds, in accordance
p.002017: with the lowest reference prices from Member States.
p.002017: (2) The Council shall regulate the marginal prices of medicinal products to be granted under
p.002017: medical prescription, other than those under para. 1 according to the lowest reference prices of
p.002017: Member States.
p.002017: (3) The Council registers maximum retail selling prices for medicinal products
p.002017: non-prescription products.
p.002017: (4) The price determined in accordance with the procedure of para. 1, is also the marginal cost of medicinal products at
p.002017: retail.
p.002017: (5) The Council of Ministers, upon a proposal by the Minister of Health, shall determine by an ordinance the conditions and rules for
p.002017: regulation of the prices of the medicinal products under para. 1, to regulate the marginal prices of medical allowances
p.002017: prescription of medicinal products under para. 2 at retail, as well as the terms and conditions for registering
p.002017: prices of
p.002017: non-prescription medicinal products.
p.002017: Art. 262. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 of 2012, in force since 05.08.2011)
p.002017: 21.12.2012) (1) (amend. - SG 15/2013, in force from 01.01.2014)
...
p.002017: healthcare on
p.002017: proposal of the BDA Executive Director.
p.002017: (2) Donations shall be made in accordance with the rules of Good Donation Practice of
p.002017: World Health Organization.
p.002017: (3) Where within 10 days from the receipt of the application under para. 1 BDA does not
p.002017: replied in writing to the donor, it is considered that there is tacit agreement to perform
p.002017: the donation.
p.002017: (4) The medical establishments and the Bulgarian Red Cross shall notify the BDA of the received
p.002017: donations of medicinal products within 7 days of receipt.
p.002017: (5) At the end of each quarter, the BDA shall send information to the Ministry of Finance
p.002017: healthcare for the donations made under para. 4.
p.002017: (6) To make a donation of a medicinal product at the request of a medical establishment,
p.002017: intended for the treatment of a particular patient in a life-threatening condition, the donor
p.002017: notify the BDA within 7 days of its completion.
p.002017: (7) The donations under para. 6 may not exceed the amount required for a single use
p.002017: course of treatment.
p.002017: Art. 269. (1) The control under art. 267 is performed through inspections and laboratory tests.
p.002017: (2) The inspections and laboratory tests under para. 1 shall be carried out:
p.002017: 1. in connection with the granting of authorizations for use, production, import and certificates
p.002017: by the order of this law;
p.002017: 2. in connection with the supervision of the market of medicinal products;
p.002017: 3. at the request of the European Commission, of the European Agency of the European Communities
p.002017: medicines or by the competent authority of another Member State;
p.002017: 4. upon application by a manufacturer, importer or holder of an authorization for
p.002017: use out of the cases under item 1.
p.002017: (3) (amend. - SG 102/2012, in force from 21.12.2012)
p.002017: medicines carries out inspections:
p.002017: 1. to manufacturers of medicinal products located in the territory of the Republic
p.002017: Bulgaria, per Member State or in third countries;
p.002017: 2. to importers and wholesalers of medicinal products;
p.002017: 3. at the premises of the manufacturers, importers and wholesalers of the active
p.002017: substances located on the territory of the Republic of Bulgaria;
p.002017: 4. at the premises of manufacturers or wholesalers of active substances,
p.002017: located in third countries as well as manufacturers or importers of excipients;
p.002017: 5. at the premises of the holders of marketing authorization
p.002017: products and intermediaries in the field of medicinal products, registered in accordance with Art.
p.002017: 212a;
p.002017: 6. as part of the certification procedure relating to the monographs of
p.002017: The European Pharmacopoeia;
p.002017: 7. to manufacturers of starting materials at the written request of the manufacturer.
p.002017: (4) The Medicines Executive Agency shall carry out inspections of manufacturers of
p.002017: medicinal products established in a third country in connection with an application for
p.002017: obtaining a marketing authorization or import.
p.002017: (5) (Amended, SG No. 102/2012, effective 21.12.2012) The inspections under para. 3 and 4 are
p.002017: carried out in accordance with guidelines adopted by the European Commission.
p.002017: (6) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines
p.002017: participate, at the request of the European Commission, the European Medicines Agency or a Member State, in
p.002017: carrying out inspections under para. 3 in the European Union or in the third
p.002017: countries.
p.002017: (7) (Amended, SG No. 102/2012, effective 21.12.2012)
p.002017: medicines cooperates and exchanges information with the European Medicines Agency at
p.002017: planning and carrying out the inspections under para. 3.
p.002017: (8) (New, SG No. 102/2012, in force since 21.12.2012)
p.002017: medicines cooperates with the European Medicines Agency in coordinating
p.002017: inspections in third countries.
p.002017: Art. 269a. (New, SG No. 102/2012, effective 21.12.2012) (1) The officials of
p.002017: Art. 267, para. 3 prepare a report for each inspection carried out under Art. 269, para. 3 and 4 for compliance with
p.002017: principles and guidelines for Good Manufacturing Practice or Good Distribution
p.002017: practices, or to comply with the requirements of Chapter Eight, and the requirements of this Act.
p.002017: (2) The report under para. 1 shall be provided to the verified person who may submit
p.002017: notes on it.
p.002017: (3) Upon receiving a reasoned request, the BDA shall electronically send the reports on
p.002017: para. 1 of the competent authority of another Member State or of the European Agency for the European Union
p.002017: medicines.
p.002017: Art. 269b. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002017: Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good Distributor
p.002017: practices, where applicable, issued by the BDA to the manufacturer, importer or wholesaler
p.002017: Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice in
p.002017: up to 90 days from
p.002017: carrying out the inspection.
p.002017: (2) When, as a result of an inspection under Art. 269, para. 3 found that the manufacturer,
p.002017: the importer or wholesaler of the medicinal products or the active substances does not comply
p.002017: the requirements of the law and / or the principles and guidelines of Good Manufacturing Practice and / or of
p.002017: Good distribution practices, the BDA issues an opinion on
p.002017: discrepancy.
p.002017: (3) The Executive Agency for Medicines shall enter into the database under Art. 147 issued
p.002017: certificates under para. 1 and information under para. 2.
p.002017: Art. 269c. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
p.002017: Art. 270, para. 1, item 5 it is established that the holder of the marketing authorization does not comply with the requirements of
p.002017: Chapter Eight, the BDA prescribes the removal of
p.002017: inconsistencies.
p.002017: (2) In the cases of para. 1 The BDA shall notify the Member States, the European Agency for the Protection of Energy
p.002017: medicines and the European Commission.
p.002017: right:
...
p.002017: The BDA issues an order for revocation of the issued permit.
p.002017: (4) (amend. - SG 102/2012, in force from 02.01.2013) In case of non-fulfillment of the obligation for
p.002017: notification under art. 235, para. 3 for the termination of the activity by the holder of an authorization for
p.002017: retail trade of medicinal products
p.002017: the BDA Executive Director issues an order for revocation of the issued permit.
p.002017: (5) The orders under para. 1 - 4 are subject to appeal in the order of
p.002017: The Code of Administrative Procedure and the appeal does not suspend their enforcement.
p.002017: Art. 294. Who violates the provisions of this law or its implementing regulations,
p.002017: outside the cases under Art. 281 - 293, shall be punished by a fine from 1000 to 3000 levs, and in case of a repeated fine
p.002017: committing the same offense - with a fine of 3000 to 5000 BGN.
p.002017: Art. 295. (1) (amend. - SG 98/10, in force from 01.01.2011) The violations on this
p.002017: Act shall be established by acts drawn up by state inspectors of the BDA, respectively by the Health Insurance Fund.
p.002017: (2) The violations under Art. 289 shall be established by officials designated by
p.002017: the Minister of Health.
p.002017: (3) (amend. - SG 98/10, in force from 01.01.2011) The penal decrees shall be issued by the Minister
p.002017: of Health, by the Chief State Health Inspector, by the Executive Director of the BDA and by
p.002017: the directors of the SIC, depending on the subordination of
p.002017: the official who found the infringement.
p.002017: Art. 296. Drafting of acts, issuing, appealing and executing
p.002017: the penal decrees shall be executed in accordance with the procedure of the Administrative Offenses Act and
p.002017: penalties.
p.002017: Art. 297. In the cases of Art. 281, 282, 283, 284, 285 and 287, the penal authority shall also order
p.002017: withdrawal of medicinal products subject to the offense in favor of the State,
p.002017: under the conditions and in the order specified in an ordinance of the Minister of Health.
p.002017: Additional provisions
p.002017: § 1. For the purposes of this Act:
p.002017: 1. (amend. - SG 102/02, in force from 02.01.2013) "Active substance" shall be any substance or
p.002017: a mixture of substances intended for use in the manufacture of a medicinal product which when used
p.002017: in its manufacture they become the active ingredient of this product, intended for the exercise of
p.002017: pharmacological, immunological or metabolic action for the purpose of restoring, correcting or altering
p.002017: physiological functions
p.002017: or to make a medical diagnosis.
p.002017: 2. "Bioequivalence" is present when the medicinal products are pharmaceutical
p.002017: equivalent or pharmaceutical alternatives, and if their bioavailability after administration in
p.002017: the same molar dose is similar to such an extent that its effects in terms of efficacy and
p.002017: safety is substantially similar.
p.002017: 3. "Bioavailability" is the rate and extent at which the active substance or the therapeutically active part of it is absorbed
p.002017: of the dosage form and becomes available at the site of action. When the drug substance is intended to
p.002017: exercise a systemic therapeutic effect, bioavailability means the speed and degree at which a drug substance or
p.002017: therapeutically
...
p.002017: the investigational medicinal product (s) that are relevant for the test of the product or product
p.002017: products on people.
p.002017: 5. "Valid documentation" shall mean documentation which in content and completeness corresponds to
p.002017: the requirements laid down in a particular procedure under this Act.
p.002017: 6. "Substance with well established use in medical practice" is a substance for
p.002017: the following criteria may apply:
p.002017: (a) the period of proof of well-established use in medical practice is not less than 10 years from
p.002017: the date of the first systematic and documented use of the substance as a medicinal product in
p.002017: The European Union or the European Economic Community
p.002017: space;
p.002017: (b) quantitative aspects of the use of the substance, taking into account the degree of medical use
p.002017: practice, the degree of geographical use and the degree of tracking through the safety system,
p.002017: including pre-market research and scientific research published thereafter
p.002017: epidemiological literature
p.002017: studies and, in particular, comparative epidemiological studies;
p.002017: (c) a high level of scientific interest in the use of the substance (number of scientific
p.002017: publications) and unity in the scientific community in scientific evaluations.
p.002017: 7. "Secondary packaging" is a packaging which does not come in direct contact with
p.002017: the medicinal product.
p.002017: 8. "Contracting Authority" means a natural or legal person, institution or organization which
p.002017: is responsible for initiating, managing and / or financing the clinical trial.
p.002017: 9. "Generic medicinal product" is a medicinal product which has the same qualitative and
p.002017: quantitative composition with respect to the active substances and the same dosage form as the reference
p.002017: medicinal product, and its bioequivalence with the reference medicinal product has been demonstrated to be appropriate
p.002017: bioavailability tests. The various immediate-release oral dosage forms are considered to be one
p.002017: and the same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of
p.002017: active substance are considered to be the same active substance, unless they differ significantly in their nature
p.002017: safety and / or efficiency.
p.002017: 10. "Principal Investigator" is the doctor or dentist appointed by the contracting authority, who direct
p.002017: the overall conduct of the clinical trial in accordance with the approved protocol and the Good Guideline
p.002017: clinical practice and responsible for the work of
p.002017: the researchers.
p.002017: 11. "Defined daily dose" is an average daily maintenance dose of a drug
p.002017: product for use in adults according to the primary indication of the medicinal product.
p.002017: 12. "Good clinical practice" is the set of internationally recognized ethical and
p.002017: scientific quality requirements to be met when planning, conducting, reporting and
p.002017: reporting of clinical trials.
p.002017: 13. "Good laboratory practice" is a system of internationally recognized rules
p.002017: in terms of planning conditions, processes of organizing, executing, tracking and
p.002017: documentation of laboratory tests.
p.002017: 14. "Good manufacturing practice" is a system of internationally recognized business rules that covers all
p.002017: production sides - personnel, premises, facilities, materials, documentation, quality control, and aims
p.002017: to ensure safety, efficiency and
p.002017: according to the specification.
p.002017: 15. (suppl. - SG 71/08, in force from 12.08.2008) "Member State" is a state,
p.002017: Member State of the European Union or a State Party to the Agreement on the European Union
p.002017: economic space.
p.002017: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002017: 17. "Immunological medicinal product" is a medicinal product containing vaccines, toxins, serums or allergens. IN
p.002017: the range of vaccines, toxins and serums include agents used to create active immunity or to
...
p.002013: Second COUNCIL DIRECTIVE 75/319 / EEC of 20 May 1975 on cohesion
p.002013: of laws, regulations and administrative provisions concerning medicinal products (repealed)
p.002013: COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 of 19 June 2012
p.002013: the year of the pharmacovigilance activities provided for in the Regulation
p.002013: (EC) No 726/2004 of the European Parliament and of the Council and in a Directive
p.002013: 2001/83 / EC of the European Parliament and of the Council
p.002013: COMMISSION REGULATION (EC) No 1234/2008 of 24 November
p.002013: consideration of changes to the terms of marketing authorizations for medicinal products for
p.002013: human use and veterinary medicinal products
p.002013: REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: 13 November 2007 on advanced therapy medicinal products and amending
p.002013: Directive 2001/83 / EC and Regulation (EC) No 726/2004
p.002013: REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: 12 December 2006 on medicinal products for pediatric use and amending
p.002013: Regulation (EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC and
p.002013: Regulation (EC) No 726/2004
p.002013: REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.002013: 31 March 2004 establishing Community procedures for the authorization and control of medicinal products for
p.002013: human and veterinary use and on the creation of a European one
p.002013: Medicines Agency (Consolidated Version)
p.002013: COMMISSION REGULATION (EC) No 1084/2003 of 3 June 2003 examining changes to the conditions
p.002013: of the marketing authorizations for medicinal products for human use and veterinary medicinal products granted
p.002013: by a competent authority of
p.002013: Member State (repealed)
p.002013: REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (EC) No 141/2000
p.002013: December 16, 1999 for orphan drugs
p.002013: COUNCIL REGULATION (Council of the European Community) No 2309/93 of 22 July 1993 establishing
p.002013: the Community procedure for granting authorizations (licenses) and the supervision of medicinal products
p.002013: funds used in human and veterinary medicine
p.002013: medicine, and a European Medicines Assessment Agency is set up (repealed)
p.002013: COUNCIL REGULATION (EEC) No 1768/92 of 18 June 1992
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.002017: use and prohibit the use of the respective medicinal product in the territory of the Republic of Bulgaria until
p.002017: acceptance of the final
p.002017: answer.
p.002017: (5) (New, SG No. 18/2014) In the cases of para. 4 The BDA informs the European
p.002017: the Commission, the European Medicines Agency and the other Member States for their reasons
p.002017: decision no later than the next business day.
p.002017: Art. 80. (amend. - SG 12/11, in force from 08.02.2011) The conditions and the procedure for carrying out
p.002017: changes to the authorizations granted under this section shall be governed by Regulation (EC) No 1234/2008 of the European Communities
p.002017: November 2008 on the examination of changes in the conditions of marketing authorizations for medicinal products
p.002017: products for human use and
p.002017: veterinary medicinal products (OJ L 334/7 of 12 December 2008).
p.002017: to be:
p.002017: Chapter Four.
p.002017: CLINICAL TESTS
p.002017: Section I.
p.002017: general provisions
p.002017: Art. 81. Clinical testing of medicinal products on humans may be carried out,
p.002017: 1. detect or confirm clinical, pharmacological or pharmacodynamic properties
p.002017: effects of one or more tested medicinal products;
p.002017: 2. identify adverse reactions to one or more tested medicinal products;
p.002017: 3. examines the absorption, distribution, metabolism and excretion of one or
p.002017: more tested medicinal products and / or to ascertain their safety and / or
p.002017: efficiency.
p.002017: Art. 82. (1) Clinical trial on humans shall be conducted in compliance with the basic ones
p.002017: principles for the protection of human rights and human dignity in all
p.002017: a biomedical study according to the Declaration of Helsinki.
p.002017: (2) (amend. - SG 71/08, in force from 12.08.2008) All clinical trials of medicinal products
p.002017: on humans, including bioavailability and bioequivalence tests are planned,
p.002017: conduct and report in accordance with the Good Rules
p.002017: clinical practice, the requirements of this Act and of Regulation (EC) No 1901/2006.
p.002017: (3) The rules for Good Clinical Practice shall be laid down in an ordinance of the Minister of Health
p.002017: healthcare.
p.002017: Art. 83. (1) The rights, safety and health of the participants in the clinical trial shall be
p.002017: place the interests of science and society at stake.
p.002017: (2) Available preclinical and / or clinical data for the investigational medicinal product
p.002017: should be sufficient to justify the conduct of a clinical trial.
p.002017: Art. 84. (1) The clinical trial must be scientifically substantiated and clear and detailed
p.002017: described in the test report.
p.002017: (2) When developing the documentation and conducting a clinical trial of a medicinal product
p.002017: the contracting authority and the researcher take into account all available guidance published by the European Commission and
p.002017: European Medicines and Scientific Agency
p.002017: committees to it.
p.002017: Art. 85. (1) Clinical testing of medicinal products on humans shall be conducted at
p.002017: adherence to the necessary quality assurance procedures for each aspect of
p.002017: the clinical trial.
p.002017: (2) All information from a clinical trial shall be recorded, processed and stored by
p.002017: a way of ensuring that it is accurately reported, interpreted and validated, while protecting
p.002017: the personal data of the participants.
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.002017: 15. (suppl. - SG 71/08, in force from 12.08.2008) "Member State" is a state,
p.002017: Member State of the European Union or a State Party to the Agreement on the European Union
p.002017: economic space.
p.002017: 16. "Label" is information on the primary or secondary packaging of the medicinal product.
p.002017: 17. "Immunological medicinal product" is a medicinal product containing vaccines, toxins, serums or allergens. IN
p.002017: the range of vaccines, toxins and serums include agents used to create active immunity or to
p.002017: establish a state of immunity or induce passive immunity. Allergens are medicinal products that are
p.002017: intended to identify or stimulate a specific targeted change in the immunological response
p.002017: to an allergic agent.
p.002017: 18. "Bioequivalence study" is a clinical trial aimed at proving that two
p.002017: medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative, and
p.002017: when their bioavailability after application in the same
p.002017: the molar dose is similar to a degree which is a condition of equivalent efficacy and safety.
p.002017: 19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and extent of
p.002017: in which the active substance or the therapeutically significant portion of the test drug reaches
p.002017: from the dosage form to the systemic
p.002017: blood circulation.
p.002017: 20. "Tested medicinal product" means the dosage form of the active substance or placebo to be tested
p.002017: or used as a comparison in a clinical trial, including authorized products
p.002017: for use, but are used for unauthorized use or for the purpose of obtaining additional information on
p.002017: the authorized form, or they are
p.002017: completed (in medicinal or packaged form) in a way other than the approved form.
p.002017: 21. "Researcher" means the doctor or dentist designated by the sponsor and the principal investigator,
p.002017: who practically conducts the clinical trial under the direction of the principal investigator according to
p.002017: the approved protocol and the Good Clinical Practice Guide at the Research Center for
p.002017: the clinical trial. If the clinical trial is conducted by a team, the investigator is the supervisor responsible for
p.002017: team and is called the Principal Investigator.
p.002017: 22. "Informed consent" is a statement of will that must be written, dated and signed in order to participate in
p.002017: a clinical trial taken completely free after being duly informed of its nature,
p.002017: significance, consequences and risks and properly documented by any person who is able to consent
p.002017: or when the person is not
p.002017: able to give his consent - from his legal representative.
p.002017: 23. "Whale" means any substance which is usually dissolved, suspended, before use,
p.002017: dilute or combine with radionuclides, resulting in the finished radioactive
p.002017: medicine.
p.002017: 24. "Clinical trial of a medicinal product" means any human study intended to
p.002017: the clinical, pharmacological and / or other pharmacodynamic effects of one or
...
Orphaned Trigger Words
p.002017: 1. the control activity of the BDA;
p.002017: 2. payment of activities under art. 21, para. 1, items 1 and 2, in cases where their implementation is
p.002017: assigned by the BDA under a contract to other persons;
p.002017: 3. (repealed, SG No. 38/2012, effective 01.07.2012)
p.002017: 4. creating, maintaining and maintaining the registers of art. 19, para. 1;
p.002017: 5. maintaining electronic data interchange systems with the regulatory authorities of
p.002017: the other Member States, the European Commission and the European Medicines Agency;
p.002017: 6. (suppl. - SG 102/2012, in force from 21.12.2012) information and publishing
p.002017: activity related to the quality, efficacy and safety of medicinal products and
p.002017: pharmacovigilance monitoring;
p.002017: 7. securing the activity of the specialized commissions under Art. 47, para. 1 and 2 and the board
p.002017: under Art. 251, para. 3;
p.002017: 8. (repealed, SG No. 38/2012, effective 01.07.2012)
p.002017: 9. participation in international and national inter-laboratory tests;
p.002017: 10. (amend. - SG 60/11, in force from 05.08.2011, repealed - SG, issue 38 of 2012, in force
p.002017: from 01.07.2012)
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended and supplemented, SG No. 12/2011, effective 08.02.2011
p.002017: , amended - SG, issue. 60 of 2011, effective 05.08.2011, as amended. - SG, issue. 102 of 2012, effective 21.12.2012
p.002017: d.) The financial resources under Art. 114, para. 4 and Art. 259, para. 5 se
p.002017: spend on:
p.002017: 1. (repealed, SG No. 60/2011, effective 05.08.2011)
p.002017: 2. activities of the Pharmacopoeia Committee;
p.002017: 3. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012, in force
p.002017: since 21.12.2012) activities of the Transparency Committee, the Central Ethics Committee and the
p.002017: Ethics Committee for Multicenter Testing;
p.002017: 4. (repealed, SG No. 38/2012, effective 01.07.2012)
p.002017: 5. (suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 12 of 2011, in force
p.002017: from 08.02.2011, amended - SG, issue. 60 of 2011, effective 05.08.2011, repealed. - SG, issue. 38 of 2012, c
p.002017: with effect from 01.07.2012)
p.002017: Chapter Three.
p.002017: MARKETING OF MEDICINAL PRODUCTS
p.002017: Section I.
p.002017: General
p.002017: Art. 23. (1) (amend. - SG 71/08, in force from 12.08.2008) An industrially produced medicinal product or
p.002017: a medicinal product obtained by a method involving an industrial process may be marketed only after
p.002017: obtaining a marketing authorization or having obtained a registration certificate issued in accordance with
p.002017: this Act, or in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council, and subject to compliance
p.002017: the requirements of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on
p.002017: medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20 / EC,
p.002017: Directive 2001/83 / EC and Regulation (EC) No 726/2004, hereinafter referred to as "Regulation (EC) No 1901/2006", and
p.002017: Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on the
p.002017: advanced therapy medicinal products and amending Directive 2001/83 / EC and Regulation (EC) No 726/2004 (OJ,
p.002017: L 324/121
p.002017: of 10 December 2007).
p.002017: (2) Authorization for use within the meaning of para. 1 is also required for a radionuclide generator,
p.002017: radionuclide precursor and for the whale.
p.002017: (3) The types of procedures within the meaning of para. 1 are:
p.002017: 1. centralized;
p.002017: 2. Mutual recognition / decentralized procedure;
...
p.002017: sales in accordance with Art. 68, para. 1, item 6 and declare whether undertaken
p.002017: from it actions under para. 2 shall be due to any of the grounds under Art. 276 or under Art. 277.
p.002017: (4) (Amended, SG No. 18/2014) Upon termination of the sales of the medicinal product
p.002017: product as a result of unforeseen circumstances the holder of the marketing authorization
p.002017: use / the registration certificate for a medicinal product shall notify the BDA in writing
p.002017: within 7 days of the establishment of the circumstances.
p.002017: d) At
p.002017: Art. 54a. (New, SG No. 60/2011, effective 05.08.2011) (1) (amend. - SG 18/04) receiving a signal
p.002017: in the Executive Agency for Cessation Drugs
p.002017: sales of a medicinal product, except in cases under Art. 54, para. 2 and 4, the agency
p.002017: carries out verification within 30 days of receiving the alert.
p.002017: (2) When carrying out the inspection under para. 1 The BDA may request information from the authorization holder
p.002017: for use and / or by the person under Art. 26, para. 2 on the suspension of sales of
p.002017: the particular medicinal product, as well as by the marketers of
p.002017: wholesale of medicinal products on the available quantities of the product.
p.002017: (3) The Executive Agency for Medicines shall publish on its website the Internet
p.002017: the results of the examination.
p.002017: Art. 55. (1) The authorization for use / the certificate for registration of a medicinal product
p.002017: the product is issued by the BDA Executive Director for a period of 5 years.
p.002017: (2) (suppl. - SG 71/08, in force from 12.08.2008) After the expiration of the term under para. 1
p.002017: the marketing authorization / the marketing authorization can
p.002017: shall be renewed by the BDA on the basis of an assessment of the benefit / risk ratio in accordance with Art. 59a.
p.002017: (3) (amend. - SG 71/08, in force from 12.08.2008) The permission for
p.002017: the use / registration certificate may be terminated before the expiry of the term
p.002017: para. 1, if the holder requests it in writing from the BDA Executive Director, stating
p.002017: the reasons.
p.002017: (4) (Supplemented, SG No. 71/2008, effective 12.08.2008)
p.002017: the use / registration certificate shall be valid indefinitely after its renewal, except in
p.002017: the cases under para. 5.
p.002017: (5) (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 21.12.2012)
p.002017: Where there are good reasons for pharmacovigilance, including
p.002017: due to the exposure of the medicinal product to an insufficient number of patients, the BDA may require the holder of
p.002017: the marketing authorization
p.002017: to submit an application for its renewal for another 5 years in accordance with Art. 59a.
p.002017: (6) (amend. - SG 71/08, in force from 12.08.2008) At the expiry of the term of the permit
p.002017: for use / registration certificate or when they are terminated, the medicinal product may
p.002017: be sold until the quantities available in the country are exhausted, but no more than one year
p.002017: with effect from the date of expiry or termination respectively, except where
p.002017: the reasons for termination are related to
p.002017: the safety of the medicinal product.
p.002017: (7) The Executive Director of the BDA revokes the authorization for
p.002017: use / registration certificate of a medicinal product when:
p.002017: 1. its holder has not placed the medicinal product on the market within three years from the date
p.002017: of the marketing authorization, or
p.002017: 2. sales of the medicinal product are suspended for a period of three
p.002017: successive years after its launch.
p.002017: (8) The order under para. 7 is subject to appeal by the order of the Administrative Procedure
p.002017: code.
p.002017: (9) By way of exception and in the interest of public health, the provision of para. 7 may not
p.002017: shall apply if the marketing authorization holder indicates
p.002017: reasonable grounds. In these cases, the BDA Executive Director shall give reasons for his decision.
p.002017: (10) The marketing authorization holder pays an annual fee,
p.002017: determined in the tariff under Art. 21, para. 2, to maintain the marketing authorization issued.
p.002017: Art. 55a. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive
p.002017: the BDA Director may issue a marketing authorization / registration certificate to
p.002017: a medicinal product which includes one or more of the following conditions:
p.002017: 1. take certain measures to ensure the safe use of
p.002017: the medicinal product to be included in the risk management system;
p.002017: 2. conduct post-marketing safety studies;
p.002017: 3. to comply with the registration obligations set out in Chapter Eight, or
p.002017: reporting of suspected adverse reactions;
p.002017: 4. to comply with any other conditions or restrictions in order to be safe and efficient
p.002017: use of the medicinal product;
p.002017: 5. existence of an adequate system for monitoring the pharmacovigilance;
p.002017: 6. conduct post-marketing efficacy studies where there are concerns,
p.002017: related to the efficacy of the medicinal product, which can only be authorized after
p.002017: as the medicinal product is placed on the market.
p.002017: (2) The Marketing Authorization / Registration Certificate shall specify the time limits for
p.002017: fulfillment of the conditions under para. 1, where applicable.
p.002017: (3) The grounds for imposing the condition under para. 1, item 6 shall be determined by a delegated act under
p.002017: Article 22b of Directive 2001/83 / EC, taking into account the scientific guidelines developed in
p.002017: the guidance under Art. 194a.
p.002017: (4) The requirements for conducting post-marketing efficacy studies are
p.002017: set out in a guidance document issued by the European Medicines Agency.
p.002017: Art. 56. (amend. - SG 102/2012, in force since 21.12.2012) (1) By way of exception after consultation with the applicant
p.002017: the BDA's Executive Director may issue a marketing authorization / registration certificate under
p.002017: a condition where the applicant can demonstrate that he has not provided comprehensive data on efficacy and safety
p.002017: of the medicinal product
p.002017: under normal conditions of use for one of the following reasons:
p.002017: 1. the indications for which the medicinal product is intended are so rare
p.002017: found that the applicant was not able to produce complete supporting evidence, or
p.002017: 2. the state of scientific knowledge at present is such that it cannot be represented
p.002017: comprehensive data, or
p.002017: 3. the collection of such data is contrary to generally accepted medical principles
p.002017: ethics.
p.002017: (2) The marketing authorization / registration certificate under para. 1 is issued to one
p.002017: of the following conditions:
p.002017: 1. the applicant / holder to execute a program of studies for the period under para. 3, such
p.002017: the results of these studies serve to reassess the benefit-risk balance;
p.002017: 2. the medicinal product has a prescription only mode, and in certain cases it may be
p.002017: used only under strict medical supervision in a hospital for hospital care, and in the case of
p.002017: radiopharmaceutical - only under the control of
p.002017: authorized person;
p.002017: 3. the package leaflet and any medical information accompanying the medicinal product should be
p.002017: provided text that draws attention to health professionals that some of the available
p.002017: data on the medicinal product are subject to follow-up
p.002017: studies.
p.002017: (3) The marketing authorization / registration certificate under para. 1 shall be issued for a term
p.002017: one year and each subsequent year may be extended on the basis of an estimate of
p.002017: the fulfillment of the conditions under para. 2.
p.002017: Art. 56a. (New, SG No. 102/2012, effective 21.12.2012) (1) Upon issuance of
p.002017: the marketing authorization / registration certificate of the BDA may oblige the holder
p.002017: of the permit / certificate to hold:
p.002017: 1. post-marketing safety study if there are concerns about identified or
p.002017: potential risks or lack of pharmacovigilance monitoring information for the individual
p.002017: medicine; when the same risks apply to other medicinal products, after consulting the Committee for Medicinal Products
p.002017: pharmacovigilance risk assessment established by Article 56 (1) (aa) of
p.002017: Regulation (EC) No 726/2004 of the European Parliament and of the Council, the BDA recommends to the relevant holder of
p.002017: marketing authorization to conduct a joint safety study with others
p.002017: holders concerned;
p.002017: 2. post-marketing efficacy study where knowledge of the disease or
p.002017: the clinical methodology used gives grounds to revise the efficacy estimates,
p.002017: the conclusions drawn at the date of issue of the authorization.
p.002017: (2) The Executive Agency for Medicinal Products shall notify the holder of
p.002017: the authorization for use / the registration certificate for the obligation under para. 1 such as
p.002017: justify the reasons and state the objectives of the study and the time limits for conducting it.
p.002017: (3) Within 30 days from receipt of the notification under para. 2 holder of
p.002017: the Marketing Authorization / Registration Certificate may request the BDA to provide it
p.002017: of the opportunity to submit information regarding the obligations under para. 1.
p.002017: (4) Upon receipt of the request under para. 3 The BDA sets a deadline for submission of the
p.002017: the information from the holder of the marketing authorization / registration certificate.
p.002017: (5) The Executive Agency for Medicines after analyzing the information under para. 3 can:
p.002017: 1. to confirm the obligation under para. 1, or
p.002017: 2. cancel it.
p.002017: (6) The Executive Agency for Medicinal Products shall notify the holder of the decision taken
p.002017: under para. 5.
p.002017: (7) In the cases of para. 5, item 1, the Executive Director of the BDA shall make official changes
p.002017: the marketing authorization / marketing authorization issued to the medicinal product, such as
p.002017: includes as a condition the obligation under para. 1.
p.002017: (8) The grounds for imposing the obligations under para. 1, item 2 shall be determined by a delegated act
p.002017: under Art. 22b of Directive 2001/83 / EC.
p.002017: Art. 56b. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of
p.002017: the marketing authorization / registration certificate is included in its system for
p.002017: risk management all conditions under art. 55a, 56 and 56a.
p.002017: (2) In the cases of para. 1 the holder of the marketing authorization / certificate
p.002017: registration submits to the BDA notification of a change in the risk management system.
p.002017: Art. 56c. (New, SG No. 102/2012, effective 21.12.2012)
p.002017: medicines sends information to the European Medicines Agency about the medicines they have issued
p.002017: permissions under Art. 55a, 56 and 56a.
p.002017: Art. 57. (1) The BDA Executive Director shall refuse to issue a permit for
p.002017: use or registration certificate of a medicinal product when, after evaluation of
p.002017: the file under Art. 27 - 32 it was found that:
p.002017: 1. the benefit / risk balance is unfavorable, or
p.002017: 2. the efficacy of the medicinal product is not convincingly protected by the applicant, or
p.002017: 3. the quantitative and qualitative composition of the medicinal product does not correspond to
p.002017: descriptions in the dossier.
p.002017: (2) (Supplemented, SG No. 71/2008, effective 12.08.2008) The Executive Director of the BDA shall refuse
p.002017: granting a marketing authorization or a marketing authorization for a medicinal product when
p.002017: some of the data in the file do not meet the requirements of Art. 27
p.002017: - 32 or the ordinance under Art. 42.
p.002017: (3) The Executive Director of the BDA shall refuse registration of a traditional plant
p.002017: medicinal product when, after evaluation of the documentation, it is found that the product does not conform
p.002017: of the conditions under Art. 37, para. 1, the data in the file do not correspond to Art. 38 or:
p.002017: 1. the quantitative and qualitative composition does not correspond to those described in the dossier;
p.002017: 2. the medicinal product may be harmful if used correctly;
p.002017: 3. the data on traditional use are insufficient, especially when
p.002017: pharmacological properties or efficacy have not been demonstrated on a long-term basis
p.002017: use and experience;
p.002017: 4. the pharmaceutical quality of the medicinal product is not sufficiently substantiated.
p.002017: Art. 58. The marketing authorization holder is responsible for completeness
p.002017: the accuracy of the data in the file.
p.002017: Art. 59. (1) Refusal of the BDA Executive Director to issue a permit for
p.002017: use / registration certificate of a medicinal product may be appealed in the order of
p.002017: Code of Administrative Procedure.
p.002017: (2) The refusal of the BDA Executive Director and the reasons for it shall be published on
p.002017: the agency's website on the internet.
...
p.002017: the authorities of the countries concerned and the applicant, the assessment report, together with the approved summary description
p.002017: of the product and with the approved mock - up of the packaging and
p.002017: the patient leaflet;
p.002017: 2. closes the procedure and notifies the applicant and the countries concerned, if any
p.002017: the countries concerned have approved it.
p.002017: (2) Within 30 days of the closing of the procedure under para. 1, item 2, the BDA Executive Director issues a permit for
p.002017: use of the medicinal product on the territory of the Republic of Bulgaria with the approved summary of the characteristics of
p.002017: product, package layout and package leaflet
p.002017: for the patient.
p.002017: (3) Where the Republic of Bulgaria is a reference country under Art. 75, BDA:
p.002017: 1. within 120 days from the date of submission of valid documentation, send to the regulatory authorities
p.002017: the authorities of the countries concerned and the applicant, the draft assessment report, the draft summary of the
p.002017: the product and the design of the packaging and leaflet layout
p.002017: for the patient;
p.002017: 2. closes the procedure and notifies the applicant and the countries concerned, if any
p.002017: the countries concerned have approved it.
p.002017: (4) Within 30 days of the closing of the procedure under para. 3, item 2 the BDA Executive Director issues a permit for
p.002017: use of the medicinal product on the territory of the Republic of Bulgaria with the approved summary of the characteristics of
p.002017: product, package layout and package leaflet
p.002017: for the patient.
p.002017: Art. 77. (1) When the BDA does not approve the submitted documentation under Art. 74, para. 3 or under Art. 75, para. 3 for reasons
p.002017: for a potential serious risk to the health of the population, prepare a detailed report with reasons for the reference
p.002017: Member State, to the other countries concerned and to
p.002017: of the applicant.
p.002017: (2) The disputed issues under para. 1 shall be considered by the Coordination Group of States
p.002017: member states. The applicant may submit his position on the issues under consideration in writing or
p.002017: verbally.
p.002017: (3) The Executive Agency for Medicines shall participate in the Coordination Group under para. 2
p.002017: until the reference country closes the procedure.
p.002017: (4) Within 30 days of receipt of notification of closure of the procedure by the reference country
p.002017: the BDA Executive Director issues a marketing authorization for the medicinal product with the approved summary
p.002017: product characteristics, packaging layout and
p.002017: the leaflet for the patient.
p.002017: Art. 78. (1) When in a procedure before the Coordination Group under Art. 77, para. 2 Member States do not agree,
p.002017: the issues at issue are being considered by the Committee for Medicinal Products for Human Use at
p.002017: European Arbitration Medicines Agency
p.002017: procedure. A copy of the documentation shall be sent to the applicant.
p.002017: (2) The applicant shall submit to the European Medicines Agency the dossier for the medicinal product
p.002017: product and the summary of product characteristics.
p.002017: (3) In the cases of para. 1, if the BDA has approved the evaluation report, the draft brief
p.002017: product and package layout and package leaflet for the patient provided by
p.002017: the country of reference, the Executive Director of the BDA may, at the request of the applicant, issue
p.002017: permission to use the medicinal product before completing the arbitration procedure under para. 1.
p.002017: (4) Upon completion of the arbitration procedure, the BDA Executive Director
...
p.002017: Art. 85. (1) Clinical testing of medicinal products on humans shall be conducted at
p.002017: adherence to the necessary quality assurance procedures for each aspect of
p.002017: the clinical trial.
p.002017: (2) All information from a clinical trial shall be recorded, processed and stored by
p.002017: a way of ensuring that it is accurately reported, interpreted and validated, while protecting
p.002017: the personal data of the participants.
p.002017: Art. 86. (1) All persons conducting a clinical trial must have the appropriate one
p.002017: professional qualification, training and experience to fulfill the test-related requirements
p.002017: tasks in accordance with the Good Clinical Practice rules.
p.002017: (2) A clinical trial of a medicinal product shall be carried out under the supervision of a physician or dentist with
p.002017: recognized medical specialty in the relevant field who is familiar with the preclinical and / or available
p.002017: clinical data on the product and its risks;
p.002017: the study procedures.
p.002017: (3) During a clinical trial for the medical care provided to the participant
p.002017: in the test, and in making medical decisions, it is the responsibility of the appropriate physician
p.002017: qualification or doctor in dental medicine.
p.002017: Art. 87. (1) (amend. - SG 59/10, in force from 31.07.2010, amended - SG, issue 60 from 2011)
p.002017: 08/05/2011) Clinical trial can be performed in hospitals, centers for
p.002017: mental health, skin and venereal disease centers, complex oncology centers,
p.002017: diagnostic and consulting centers, medical
p.002017: Centers, Dental Centers and Dental Authorized Centers
p.002017: activity / certificate for registration under the procedure of the Medical Institutions Act.
p.002017: (2) A clinical trial may be conducted only in a medical establishment, in which order
p.002017: of Art. 103 has an ethics committee established and entered in the BDA's register.
p.002017: (3) The head of the medical establishment where the clinical trial will be conducted
p.002017: of the medicinal product, agrees to the participation of the principal investigator and to
p.002017: conducting the test.
p.002017: Art. 88. (1) Clinical trial on humans shall be performed with:
p.002017: 1. medicinal products not authorized for use in the Republic of Bulgaria;
p.002017: 2. medicinal products authorized in the Republic of Bulgaria when used
p.002017: test for an unauthorized indication, for a dosage form other than the authorized one, in
p.002017: an unprecedented group of patients or to obtain additional information.
p.002017: (2) Authorized for use in the Republic of Bulgaria within the meaning of para. 1, item 2 are medicinal
p.002017: products which have been authorized under this Act or under Regulation (EC)
p.002017: No 726/2004 of the European Parliament and of the Council.
p.002017: Art. 89. (1) A clinical trial on humans shall be conducted with medicinal products which
p.002017: produced, maintained and stored in accordance with the rules of good manufacturing practice
p.002017: of medicinal products under development and research.
p.002017: (2) The rules of Good manufacturing practice for medicinal products in the process of
p.002017: development and research are determined in the ordinance under art. 152.
p.002017: (3) For a clinical trial, a medicinal product may be offered
p.002017: pharmacological-toxicological studies in accordance with the requirements of the Good
p.002017: laboratory practice.
p.002017: Art. 90. A clinical trial may be initiated and conducted when:
p.002017: 1. the expected therapeutic benefits for the trial participants, for the current and
p.002017: future patients and health benefits justify the foreseeable risks;
p.002017: 2. the physical and mental integrity of the participant in
...
p.002017: 08/02/2011)
p.002017: Art. 145. (1) (Supplemented, SG No. 12/2011, effective 08.02.2011) Non-interventional study shall be conducted with
p.002017: medicinal products authorized for use in the Republic of Bulgaria when tested for obtaining
p.002017: additional information on the product prescribed in the usual manner in accordance with the conditions laid down in
p.002017: the marketing authorization. Participants in non-interventional studies are not administered diagnostic or
p.002017: follow-up procedures, other than usual practice, are used to analyze the data obtained
p.002017: epidemiological methods.
p.002017: (2) (Am. - SG, iss. 12 in 2011, in force since 08.02.2011, repealed - SG, iss. 102 in 2012, in
p.002017: with effect from 21.12.2012)
p.002017: (3) (Am. - SG, iss. 12 in 2011, in force since 08.02.2011, repealed - SG, iss. 102 in 2012, in
p.002017: with effect from 21.12.2012)
p.002017: (4) (New - SG, iss. 12 in 2011, effective as of 08.02.2011, repealed - SG, iss. 102 in 2012, in
p.002017: with effect from 21.12.2012)
p.002017: (5) (New - SG, iss. 12 in 2011, effective as of 08.02.2011, repealed - SG, iss. 102 in 2012, in
p.002017: with effect from 21.12.2012)
p.002017: (6) (New - SG, iss. 12 in 2011, effective as of 08.02.2011, repealed - SG, iss. 102 in 2012, in
p.002017: with effect from 21.12.2012)
p.002017: Art. 145a. (New, SG No. 102/2012, effective 21.12.2012) (1) Non-interventional post-marketing studies
p.002017: for safety purposes shall be carried out at the initiative of the holder of the marketing authorization or in execution of
p.002017: the conditions under Art. 55a and 56a and are related to
p.002017: collecting pharmacovigilance data from patients and healthcare professionals.
p.002017: (2) Where the collection of patient data is planned for the study, it should be
p.002017: obtained their consent. Patients' personal data are processed with respect
p.002017: the requirements of the Personal Data Protection Act.
p.002017: (3) Medical professionals do not receive financial or other incentives to participate in
p.002017: non - interventional safety studies other than compensation for time spent and
p.002017: funds.
p.002017: Art. 145b. (New, SG No. 102/2012, effective 21.12.2012) (1) During the conduct of
p.002017: the study under Art. 145c, para. 1 and Art. 145f, para. 1, the Marketing Authorization Holder monitors
p.002017: of the data received and take into account their impact on
p.002017: the benefit / risk ratio for the medicinal product.
p.002017: (2) The marketing authorization holder shall notify the BDA of any new one
p.002017: information that could affect the benefit / risk balance of the medicinal product.
p.002017: (3) The obligation under para. 2 shall not exempt the holder of the marketing authorization from
p.002017: the requirement of Art. 194h for providing the information under para. 2 and through the periodic ones
p.002017: updated safety reports.
p.002017: Art. 145c. (New, SG No. 102/2012, effective 21.12.2012) (1) When the study is conducted only on
p.002017: the territory of the Republic of Bulgaria in fulfillment of an obligation under Art. 56a, the holder of the authorization for
p.002017: use drafts of the study protocol in the BDA. The draft minutes, together with
p.002017: written consent under Art. 145a, para. 2, it does
p.002017: submit to the committees under art. 103, para. 1 or 2, where applicable.
p.002017: (2) The Executive Director of the BDA within 60 days from the date of receipt of the BDA
p.002017: the documentation under para. 1 shall send the marketing authorization holder a notification of
p.002017: approve the study or make a reasoned refusal.
...
p.002017: all activities except for the conclusion of a contract for the purchase or sale of medicinal products
p.002017: of wholesale, which do not involve physical holding and which are independently negotiated
p.002017: and on behalf of another
p.002017: legal or natural person.
p.002017: 48. (amend. - SG 102/2012, in force since 21.12.2012) "Post-marketing safety study" is any
p.002017: a study relating to an authorized medicinal product to identify itself,
p.002017: characterize or determine the degree of safety risk, confirm the profile of
p.002017: the safety of the medicinal product
p.002017: or to evaluate the effectiveness of risk management measures.
p.002017: 49. "Potential serious risk to public health" exists when there is a high degree of probability
p.002017: use of the medicinal product to cause irreversible, irreversible and irreversible negative effects
p.002017: consequences. The evaluation process identifies the risk of harm to the health of the population and
p.002017: its actual exposure to the wide use of the product. The serious health risk in the context of
p.002017: use of
p.002017: a particular medicinal product may be evaluated under the following conditions:
p.002017: (a) efficacy - the data presented for therapeutic efficacy in relation to what is proposed
p.002017: indications / indications, of the proposed target group / patient groups and of the proposed dosage indicated in
p.002017: the draft leaflet for the patient does not scientifically protect in
p.002017: full extent of efficiency claims;
p.002017: (b) safety - assessment of preclinical / pharmacological safety and clinical data
p.002017: Security cannot conclusively defend the conclusion that all potential safety parties with respect to
p.002017: target / patient groups are accurately and comprehensively reflected in the proposed patient leaflet or the absolute
p.002017: degree of risk is
p.002017: unacceptable;
p.002017: c) quality - the proposed production method and control methods cannot
p.002017: they guarantee the absence of a material defect in the quality of the product which may be affected by
p.002017: product safety and / or efficacy;
p.002017: (d) benefit / risk ratio - the benefit / risk assessment is unfavorable,
p.002017: given the nature of the identified risk / risks and the potential benefit of the proposed
p.002017: indications / indications and target group / groups of patients.
p.002017: 50. "Representative of the person referred to in Article 26 (1) or of the holder of a marketing authorization" is a person,
p.002017: established on the territory of the Republic of Bulgaria, determined by the person under Art. 26, para. 1 or by the holder of
p.002017: the marketing authorization to represent it before
p.002017: regulatory authorities on the territory of the Republic of Bulgaria.
p.002017: 51. An "acceptable level of safety" is present when the submitted data is accepted
p.002017: at statistically significant safety according to clinical trials conducted at
p.002017: compliance with Good Clinical Practice.
p.002017: 52. "Manufacture of a medicinal product" are all operations related to the procurement of materials, theirs
p.002017: processing in the production process, including packaging and labeling, quality control,
p.002017: batch release, storage, shipping and
p.002017: the control associated with these operations.
p.002017: 53. "Clinical Trial Protocol" is a document that describes the purpose (s), project (s),
p.002017: methodology, statistical processing and organization of the test. The protocol includes
p.002017: and any subsequent amendments thereto.
p.002017: 54. "Placing on the market" is the distribution of a medicinal product in a commercial one
p.002017: network on the territory of the Republic of Bulgaria beyond the direct control of the owner of the
p.002017: the marketing authorization.
p.002017: 55. "Primary packaging" means packaging that comes into direct contact with
p.002017: the medicinal product.
p.002017: 56. "Radiopharmaceutical" is a medicinal product which, when ready for use,
p.002017: contains one or more radionuclides (radioactive isotopes) for medical purposes.
...
p.002017: with the "Law on Medicinal Products in Human Medicine".
p.002017: 2. In Art. 21, para. 3 the words "The Law on Medicines and Pharmacies in Human Medicine" are
p.002017: replaced by "Medicinal Products in Human Medicine" Act.
p.002017: § 32. In the Law on Control over Narcotic Substances and Precursors (promulgated, SG, issue 30
p.002017: since 1999; amend. 63 of 2000, issue. 74, 75 and 120 of 2002; 56 of 2003, issue. 76, 79 and 103 of
p.002017: 2005, issue. 30, 75 and 82 of 2006) the following amendments are made:
p.002017: 1. In Art. 32, para. 3 the words "The Law on Medicines and Pharmacies in Human Medicine" are
p.002017: replaced by "Medicinal Products in Human Medicine" Act.
p.002017: 2. In Art. 33, para. 1, item 1 the words "the Law on Medicines and Pharmacies in Human Medicine" shall be
p.002017: replaced by "Medicinal Products in Human Medicine" Act.
p.002017: 3. In Art. 34 after the word "issue" the words "master pharmacist" shall be deleted.
p.002017: 4. In Art. 39, para. 2 the words "Article 55, item 2 of the Human Medicines and Pharmacies Act
p.002017: medicine "shall be replaced by" Art. 197, item 2 of the Human Medicinal Products Act
p.002017: medicine ".
p.002017: 5. In Art. 44a para. 3 is repealed.
p.002017: 6. In Art. 44b the words "master pharmacist," shall be deleted.
p.002017: 7. In § 1, item 14 of the supplementary provision, the words "the Law on Medicines and Pharmacies in
p.002017: human medicine "shall be replaced by the" Human Medicinal Products Act ".
p.002017: § 33. In the Law on blood, blood donation and blood transfusion (promulgated, SG 102/03)
p.002017: d .; amend. 70 of 2004, issue. 30 and 65 of 2006) in Art. 8, para. 4 the words "The Medicines Act and
p.002017: drugstores in human medicine "are replaced by" the Human Medicines Act
p.002017: medicine ".
p.002017: § 34. In the Environmental Protection Act (promulgated, SG No. 91/2002; amended, SG No. 98/2002; amend., SG No. 86/2006)
p.002017: 2003, issue. 70 of 2004, issue. 74, 77, 88, 95 and 105 of 2005; 30, 65, 82,
p.002017: 99, 102 and 105 of 2006) in Art. 140 the words "pharmaceuticals and medical devices within the meaning of § 1, item 40
p.002017: of the additional provisions of the Medicinal Products and Pharmacies Act for human use "shall be replaced by
p.002017: "medicinal products within the meaning of the
p.002017: medicinal products in human medicine and medical devices ".
p.002017: § 35. In the Food Act (promulgated, SG No. 90/1999; amended, SG No. 102/2003, No. 70/96)
p.002017: 2004, issue. 87, 99 and 105 of 2005; 30, 31, 34, 51, 55 and 96 of 2006) in Art. 2, para. 3 item 4 is amended
p.002017: like this:
p.002017: "4. medicinal products within the meaning of the Human Medicinal Products Act
p.002017: medicine ".
p.002017: § 36. Until the entry into force of the acts under § 19 issued by the normative acts under
p.002017: the implementation of the repealed Law on Medicines and Pharmacies in Human Medicine apply,
p.002017: insofar as they do not contravene this law.
p.002017: § 37. The law shall enter into force on the day of its promulgation in the State Gazette, p
p.002017: with the exception of § 22, which shall take effect one year after the entry into force of this Act.
p.002017: The law was adopted by the 40th National Assembly on March 30, 2007 and was stamped with
p.002017: the official seal of the National Assembly.
p.002017: Transitional and Final Provisions
p.002017: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002017: PRODUCTS IN HUMAN MEDICINE
p.002017: (Official Gazette, SG 71/08, IN EFFECT OF 12.08.2008)
p.002017: § 65. (1) Issued in accordance with the repealed Law on Medicines and Pharmacies in Human Medicine (promulgated, SG, issue 36 of
p.002017: 1995; amend. 61 of 1996, issue. 38 of 1998, issue. 30 of 1999, issue.
...
p.002017: and other medical activities funded in 2010 through the Ministry of Health budget
p.002017: health care and through the activities delegated by the state through the budget of the municipalities, are paid with the funds under
p.002017: Art. 1, para. 2, line 5.
p.002017: (2) The activities, medicinal products and medical devices under para. 1 shall be paid at
p.002017: the procedure and methodology laid down by the Minister of Health.
p.002017: (3) The funds under Art. 1, para. 2, line 5 are transferred monthly until the end of the current one
p.002017: month.
p.002017: § 7. The Supervisory Board of the National Health Insurance Fund is entitled to
p.002017: makes internal offsetting changes in loans between cost elements and
p.002017: the transfers under Art. 1, para. 2, which are within the approved budget.
p.002017: § 8. The Supervisory Board of the National Health Insurance Fund pursuant to Art. 26,
p.002017: para. 2 of the Health Insurance Act is entitled to spend the funds from the reserve for
p.002017: unforeseen and urgent expenses under Art. 1, para. 2, line 3.
p.002017: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002017: § 15. The law shall enter into force on January 1, 2011, with the exception of § 10, which shall enter into force on
p.002017: the day of its publication in the State Gazette.
p.002017: Transitional and Final Provisions
p.002017: TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
p.002017: (Promulgated - SG, issue 98 of 2010, in force since 01.01.2011)
p.002017: § 106. In the Law on Medicinal Products in Human Medicine (promulgated, SG No. 31/2007; amended, No. 19)
p.002017: since 2008; Constitutional Court Decision No. 5 of 2008 - issue no. 65 of 2008
p.002017: d .; amend. 71 of 2008, issue. 10, 23, 41, 88 and 102 of 2009 and issue no. 59 of 2010) everywhere the words "regional
p.002017: inspections for / protection and control of public health "," the regional inspection for protection and control of
p.002017: public health "and" RIPCPH "are replaced respectively by
p.002017: "regional health inspections", "regional health inspectorate" and "RHI".
p.002017: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002017: § 121. The law shall enter into force on January 1, 2011, except for:
p.002017: 1. Paragraphs 1, 16, 20, 29, 30, 32, 33, 34, 35, 42, 44, § 56, Vol. 1 and 2, § 65, 68, 70, 76, 80, 81, 90,
p.002017: 92, 96, § 102, Vol. 3, 4, 5, 7 and 8, § 105, Vol. 1, 3 and 5, § 107, Vol. 1, 2, 3, 4, 6, letter "a", Vols. 7, 10, 11, 13 and 15,
p.002017: letter "a", § 109, 110, 112, 113, § 115, item 5, § 116, item 4 and 6, § 117, item 5 and 7 and § 118, item 1, which are included in
p.002017: force from the day of promulgation of the law in the State Gazette;
p.002017: 2. paragraph 102, items 1, 2 and 6, which shall take effect from 1 March 2011;
p.002017: 3. paragraphs 22, item 1 (concerning Article 36, paragraph 1, second sentence), § 37, § 48, item 2, § 51 and 59,
p.002017: which shall enter into force on 1 July 2011;
p.002017: 4. Paragraph 107, point 15, letter "b", which shall take effect on 30 September 2011.
p.002017: Transitional and Final Provisions
p.002017: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002017: PRODUCTS IN HUMAN MEDICINE
p.002017: (Official Gazette of the Republic of Bulgaria, issue 12 of 2011, effective 08.02.2011)
p.002017: § 24. Valid applications submitted and notifications of changes to permits granted
p.002017: uses prior to the entry into force of this Act shall be considered so far.
p.002017: § 25. The Minister of Health shall adapt the ordinance in accordance with this law
p.002017: under Art. 42 within three months of its entry into force.
p.002017: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.002017: § 27. The law shall enter into force on the day of its promulgation in the State Gazette.
...
p.002000: December 2010) and Directive 2011/62 / EU of the European Parliament and of the Council of 8 June 2011 amending
p.002000: Directive 2001/83 / EC on the Community code relating to medicinal products for human use
p.002000: as regards the prevention of the entry into the legal chain of counterfeit medicinal products
p.002000: delivery (OB, L 174/74 of 1 July 2011).
p.002000: Transitional and Final Provisions
p.002000: TO THE AMENDING ACT TO THE MEDICINAL ACT
p.002000: PRODUCTS IN HUMAN MEDICINE
p.002000: (Official Gazette of the Republic of Bulgaria, issue 102 of 2012, effective 21.12.2012)
p.002000: § 119. (1) After January 2, 2013, manufacturers, importers and wholesalers of
p.002000: active substances shall submit to the BDA by March 2, 2013 an application and registration documents under
p.002000: the order of art. 167b.
p.002000: (2) Manufacturers and importers who have manufactured or imported actively
p.002000: substances based on the manufacturing / import licenses issued by them until 2 January 2013, no
p.002000: pay a fee for their entry in the register under Art. 167g.
p.002000: (3) Until 2 March 2013, the persons under para. 2 carry out the production and import activities of
p.002000: active substances on the basis of their manufacturing / import authorizations.
p.002000: § 120. The persons who mediate in the field of medicines
p.002000: products and which started their business before January 2, 2013, are registered under the terms and conditions
p.002000: in accordance with Art. 212a by March 2, 2013
p.002000: § 121. Authorization procedures that have commenced prior to the entry into force of this Act
p.002000: use shall be completed under the conditions and in the manner provided therein.
p.002000: § 122. (1) Holders of marketing authorizations shall not apply a management system
p.002000: of the risk under Art. 192, para. 1, item 2 for medicinal products that have been granted marketing authorization
p.002000: use before 21 July 2012, except in the cases of para. 2.
p.002000: (2) The Executive Agency for Medicinal Products may impose an obligation on the marketing authorization holder to
p.002000: establish and implement a risk management system when it considers that a medicinal product is available
p.002000: concerns that may affect the benefit / risk balance. In this case, the BDA requires from
p.002000: the Marketing Authorization Holder shall also provide a detailed description of the management system of the
p.002000: the risk that
p.002000: intends to introduce for the respective medicinal product.
p.002000: (3) In the cases of para. 2 The BDA shall notify the authorization holder in writing of
p.002000: use, stating the reasons for the obligation and the time limit for the submission of the
p.002000: the detailed description of the risk management system.
p.002000: (4) Within 30 days from receipt of the notification under para. 3 the holder of
p.002000: the marketing authorization may require the BDA to provide an opportunity to submit a
p.002000: information on the imposed obligation under para. 2.
p.002000: (5) Upon receipt of the request under para. 4 The BDA sets a deadline for submission of the
p.002000: information from the Marketing Authorization Holder.
p.002000: (6) On the basis of the information provided, the BDA may confirm the imposed
p.002000: obligation under para. 2 or cancel it.
p.002000: (7) The Executive Agency for Medicinal Products shall notify the holder of the decision taken
p.002000: under para. 6.
p.002000: (8) When the BDA confirms the obligation, the Executive Director issues it ex officio
p.002000: modification of the marketing authorization by including in it the obligation imposed
p.002000: under para. 2.
p.002000: § 123. Holders of marketing authorizations for medicinal products issued
p.002000: before July 21, 2012, fulfill the obligation under Art. 192, para. 1, item 1 with effect from 21 July 2015.
p.002000: or from the date of renewal of the marketing authorization for the medicinal product concerned in
p.002000: whichever comes first.
p.002000: § 124
p.002000: finish up to date.
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| army | Soldier |
| authority | Relationship to Authority |
| children | Child |
| crime | Illegal Activity |
| criminal | criminal |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| employees | employees |
| faith | Religion |
| family | Motherhood/Family |
| gender | gender |
| helsinki | declaration of helsinki |
| illegal | Illegal Activity |
| illness | Physically Disabled |
| incapable | Mentally Incapacitated |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| infant | Infant |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| military | Soldier |
| minor | Youth/Minors |
| mothers | Mothers |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| orphan | orphan |
| parent | parents |
| parents | parents |
| party | political affiliation |
| physically | Physically Disabled |
| placebo | participants in a control group |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| unemployed | Unemployment |
| union | Trade Union Membership |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| army | ['military'] |
| crime | ['illegal'] |
| disability | ['disabled'] |
| disabled | ['disability'] |
| drug | ['substance'] |
| education | ['educational'] |
| educational | ['education'] |
| illegal | ['crime'] |
| illness | ['physically'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| liberty | ['restricted'] |
| military | ['army'] |
| parent | ['parents'] |
| parents | ['parent'] |
| physically | ['illness'] |
| restricted | ['liberty'] |
| substance | ['drug'] |
Trigger Words
capacity
consent
developing
ethics
harm
justice
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input