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Valid from 04/13/2007 01/31/2020 1:00 PM
Refresh DV. Issue 31 of 13 April 2007, amend. DV. Issue 19 of February 22, 2008, amend. DV. 65 of 22 July 2008, amend. Vasil Bozhkov was arrested
DV. No. 71 dated August 12, 2008, amend. DV. Issue 10 of February 6, 2009, amend. DV. 23 of 27 March 2009, amend. DV. in United Arab Emirates
41 of 2 June 2009, amend. DV. Issue 88 of November 6, 2009, amend. DV. issue 102 of December 22, 2009, amend. DV.
emirates
Issue 59 of July 31, 2010, amend. DV. No.98 of December 14, 2010, amend. DV. Issue 9 of January 28, 2011, amend. DV. issue 12
of February 8, 2011, as amended. DV. Issue 60 of August 5, 2011, amend. DV. No. 61 of 9 August 2011, amended. DV. Issue 38 of 18 01/02/2020 08:46
May 2012, ed. and ext. DV. Issue 60 of August 7, 2012, amend. and ext. DV. Issue 102 of 21 December 2012, amend. DV.
issue 15 of February 15, 2013, suppl. DV. Issue 1 of 3 January 2014, amended. and ext. DV. 18 of March 4, 2014, amend. DV.
Issue 12 of February 13, 2015, amend. and ext. DV. Issue 48 of 27 June 2015, amend. DV. 43, dated 7 June 2016, amend. DV. Lighter penalties for
Issue 85 of 24 October 2017, Suppl. DV. 103 of December 28, 2017, amend. and ext. DV. Issue 84 of 12 October
2018, Suppl. DV. Issue 91 of November 2, 2018, amend. and ext. DV. Issue 102 of December 11, 2018, amend. DV. 17 of 26 minors to be more
February 2019, ed. and ext. DV. issue 64 of 13 August 2019 heavy and not be
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Laurence Van Den Acker:
"Personalization as
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Project: 602-01-67 / 07/27/2006 2020-01-31
Chapter One.
GENERAL
Section I.
general provisions
Art. 1. This Act regulates the terms and conditions for:
1. authorizing the use or registration of industrially produced or manufactured methods,
involving an industrial process, medicinal products intended for human use;
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2. (amend. - SG 102/2012, in force from 21.12.2012) authorizing the production and import of medicinal products
products; Job: Trainee
2a. (new - SG 102/02, in force from 21.12.2012) production, import and wholesale trade with active Sofia, Law Firm, 01/28/2020
substances;
3. authorization and conduct of clinical trials;
4. wholesale and retail trade in medicinal products; Job: Legal Counsel / Senior Legal Counsel
5. parallel import of medicinal products;
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5a. (new - SG 102/2012, in force since 21.12.2012) mediation in the field of medicinal
products;
5b. (new, SG No. 18/2014) export of medicinal products under the order of heading nine "b"; View All Post More
6. advertising of medicinal products;
7. monitoring the safety of medicinal products placed on the market;
8. the classification of the manner of prescribing and dispensing of medicinal products;
9. control of production and import, wholesale and retail, conducting clinical
tests, advertising and the safety monitoring system for commercially available medicinal products
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products;
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10. the pricing of medicinal products;
11. drawing up a positive medical list. residential
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by propensity at 1 Feb 13:45 6 posts
Fenced part of a foreign property
Art. 2. This law aims to create conditions that ensure the marketing of medicinal products
products that meet the requirements of quality, safety and efficiency. by milen73 on Jan 31 20:11 2 posts
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Art. 3. (1) (amend. - SG 71/08, in force from 12.08.2008) A medicinal product in human medicine shall be:
1. any substance or combination of substances presented as having properties for treatment or
prevention of human diseases, or
2. any substance or combination of substances that may be used or administered to humans for the purpose of:
(a) restoration, correction or alteration of physiological functions through pharmacological, immunological
or metabolic action, or
b) making a medical diagnosis.
(2) A substance is any substance the origin of which may be:
1. human (human blood, human blood products and others);
2. animal (microorganisms, animal organs, extracts, secretions, toxins, blood products, etc.);
3. plant (microorganisms, plants, parts of plants, plant extracts, secretions, etc.);
4. chemical (elements, natural chemical materials, synthetic or semi-synthetic substances, etc.).
Art. 4. Where a product meets both the characteristics of a medicinal product and a product,
regulated by another law, the requirements of that law shall apply.
Art. 5. Medicinal products shall be classified according to the anatomical-therapeutic-chemical classification in
compliance with World Health Organization (WHO) requirements.
Art. 6. This law shall not apply to:
1. hermetically sealed radionuclides;
2. blood, plasma or blood cells of human origin, with the exception of plasma obtained by method,
involving an industrial process.
Art. 7. (1) Production, import, wholesale and retail trade, advertising and medical treatment are allowed,
prevention and diagnosis only with medicinal products authorized
The order of:
1. this law, or
2. Regulation (EC) No 726/2004 of the European Parliament and of the Council.
(2) It is prohibited to import, trade, treat, prevent and diagnose medicinal products with
expired.
(3) Holding a permit or certificate of use, production and clinical trials of
medicinal products issued pursuant to this Act shall not be grounds for discharge
in accordance with applicable law.
Art. 8. No marketing authorization is required under this Act for:
1. a medicinal product prepared according to a prescription in a pharmacy;
2. a medicinal product prepared by pharmacopoeial formulation in a pharmacy;
3. intermediates intended for manufacturing processing by a person who has been authorized
proceedings under this law;
4. active and auxiliary substances;
5. medicinal products under development and / or testing;
6. medicinal products intended for export;
7. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
advanced therapy medicinal product to be prepared for a specific individual patient
prescription according to specific quality standards and is applied at a health establishment
the exclusive professional responsibility of the doctor.
Art. 8a. (New, SG No. 102/2012, effective 21.12.2012) In the manufacture of medicinal products,
intended solely for export, of intermediates, active substances and excipients
apply the relevant provisions of Chapter Five.
Art. 9. (1) Treatment of a particular patient may be administered with a medicinal product which is not authorized under
the order of Chapter Three, by special order of a medical establishment for hospital care under conditions and in order,
determined by an ordinance of the Minister of Health.
(2) The head of the medical institution shall be responsible for the implementation of the treatment under para. 1.
(3) (New, SG No. 84/2018, effective 12.10.2018) Treatment with a compassionate medicinal product
use according to Art. 83 of Regulation (EC) No 726/2004 of the European Parliament and of the Council is implemented
under the conditions and in the order determined by the ordinance under para. 1.
Art. 10. (1) The Minister of Health on a motivated proposal of the Chief State Health
an inspector, in agreement with the Executive Director of the Executive Agency for Medicinal Products (BDA), may
an order to authorize treatment for a fixed term with a medicinal product not authorized in accordance with Chapter
third, when an epidemic caused by pathogenic micro-organisms or toxins is reported in the country, or
the alleged or confirmed spread of chemical agents or nuclear radiation and is not appropriate
authorized medicinal product.
(2) In the cases of para. 1, Marketing Authorization Holders, Manufacturers and Medical
professionals are not liable for civil or administrative penalties for the consequences of
use of an unauthorized indication of a medicinal product or a medicinal product which is not authorized
in the order of Chapter Three.
(3) The provision of para. 2 does not exclude liability for defective goods under the Law on Protection of
users.
Art. 11. (1) The Minister of Health may, for reasons connected with the protection of the health of the population,
ordering the BDA Executive Director to authorize a medicinal product for use,
which has not been authorized for use on the territory of the Republic of Bulgaria and for which no application has been submitted
for authorization but authorized in another Member State.
(2) In the cases of para. 1, the Executive Director of the BDA or a person authorized by him:
1. inform the holder of the authorization to use the medicinal product for the initiation of a procedure
on the authorization of the product for use;
2. enter as the holder in the issued permit the person under item 1;
3. require from the regulatory authority of the Member State which granted the marketing authorization a copy of the evaluation
a report and a copy of the marketing authorization.
(3) (Supplemented, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines shall be obliged to
Ensure compliance with the label, patient package leaflet, classification, advertising and tracking
the safety of the marketed medicinal product under para. 1 with the requirements of this law.
The information on the packaging and the package leaflet of the medicinal product under para. 1 does not have to be
in Bulgarian.
(4) The BDA Executive Director shall inform the European Commission of the permits issued under para. 1 for
the name and address of the authorization holder as well as the date of their termination.
Art. 12. (1) The official pharmacopoeia in the Republic of Bulgaria is the European Pharmacopoeia.
(2) The official pharmacopoeia may be supplemented by the requirements of the Bulgarian Pharmacopoeia.
(3) The Minister of Health shall determine with an order the dates of entry into force of the current edition
of the official pharmacopoeia and its supplements.
(4) The order under para. 3 shall be published in the State Gazette and published on the Internet site of the BDA.
Art. 13. (1) Monographs of the European Pharmacopoeia are obligatory for all substances, preparations and
dosage forms contained therein. In cases where there are no monographs in the European
pharmacopoeia, the requirements of the current editions of the pharmacopoeia of the Member States, the USA and
Japan, if they comply with the general rules of the European Pharmacopoeia.
(2) Where the specification contained in a monograph of the European Pharmacopoeia or in another
national pharmacopoeia is insufficient to ensure the quality of the substance or dosage form,
The BDA may require supplementation of the specification by the applicant / holder of the marketing authorization.
Chapter Two.
MANAGEMENT AND FINANCING BODIES
Section I.
Authorities
Art. 14. (1) Medicinal policy is a part of the state health policy in the Republic of Bulgaria and is
carried out by the Minister of Health.
(2) The Minister of Health shall:
1. is a national coordinator for the problems of medicinal products;
2. participate in international bodies and organizations performing activities in the field of pharmaceuticals
products;
3. (repealed, SG No. 60/2011, effective 05.08.2011, new - SG No. 102/2012, effective 21.12.2012)
organizes the provision of public information to patients' organizations and organizations
consumers about actions taken against counterfeiting of medicinal products;
4. performs other activities specified by law.
(3) (Repealed, SG No. 60/2011, effective 05.08.2011)
Art. 15. (1) A Pharmacopoeial Committee shall be established with the Minister of Health as an advisory body on
the issues of the current pharmacopoeia.
(2) On the proposal of the BDA Executive Director, the Minister of Health shall designate with
order of the composition of the Pharmacopoeia Committee and of the expert groups attached thereto, and approves the regulations for
their activity.
(3) The activities of the Pharmacopoeia Committee shall be financed by the budget of the Ministry of Health.
Art. 16. (1) (Supplemented, SG No. 91/2018) A Supreme Council shall be established at the Minister of Health.
pharmacy, which includes five representatives appointed by the Minister of Health, five
representatives of the Bulgarian Pharmaceutical Union, one representative of the Bulgarian Association of Pharmaceuticals
Assistant Pharmacists, two representatives of the National Health Insurance Fund (NHIF) and one each
representative of the faculties of pharmacy at medical colleges. The Minister of
healthcare is chairman of the non-voting council.
(2) The High Pharmacy Council is an advisory body that deliberates and gives opinions on:
1. the main directions and priorities in the field of pharmacy;
2. ethical problems of pharmacy;
3. draft legislative acts related to pharmacy;
4. scientific priorities in the field of pharmacy;
5. programs for organizing public educational campaigns in the field of medicinal products.
(3) (Repealed, SG No. 60/2011, effective 05.08.2011)
(4) The organization and activities of the Supreme Pharmacy Council shall be governed by regulations issued by the Minister.
of Health at the proposal of the High Pharmacy Council.
Art. 17. (1) The Executive Agency for Medicines shall be a specialized body to the Minister of Health
healthcare to oversee the quality, safety and efficacy of medicines.
(2) (Amended, SG No. 15/2013, effective 01/01/2014) The Executive Agency for Medicines shall be legally
budget support person based in Sofia to the Minister of Health.
(3) The Executive Agency for Medicines shall be managed and represented by an Executive Director, who shall
appoint by the order of the Law on Administration.
(4) The structure, functions and organization of work of the BDA shall be laid down in the Rules of Procedure adopted by
The Council of Ministers.
(5) The Medicines Executive Agency shall:
1. issues authorizations for the manufacture of medicinal products;
2. issues marketing authorizations and certificates for registration of medicinal products;
3. (suppl. - SG 71/08, in force from 12.08.2008) issue licenses and certificates for wholesale trade
with medicinal products;
4. issue permits for parallel import of medicinal products;
5. (amend. - SG 60/11, in force from 05.08.2011) issue, refuse or terminate marketing authorizations
retail of medicinal products;
5a. (new - SG 102/2012, in force from 21.12.2012) shall enter the manufacturers, importers and traders of
wholesale of active substances;
5b. (new - SG 102/2012, in force from 21.12.2012) keep a register of the persons, carrying out
mediation in the field of medicinal products;
6. issue permits for conducting clinical trials of medicinal products;
7. assess the quality, efficacy and safety of medicinal products in connection with
authorizing them for use;
8. issue marketing authorizations for medicinal products;
9. control production, import, storage, wholesale and retail, clinical
testing, safety and advertising of medicinal products;
10. perform laboratory analysis on suspected deviation in the quality, efficiency and safety of
medicinal products and take the measures provided for by law;
10a. (new - SG 102/2012, effective 21.12.2012) performs the functions of a competent body for
pharmacovigilance monitoring;
11. (amend. - SG 102/02, in force from 21.12.2012) organize and maintain a system for tracking of
drug safety;
12. issue certificates under the WHO certification scheme;
12a. (new, SG No. 18/2014) issue certificates of Good Distribution Practice;
13. issue certificates of Good Manufacturing Practice;
14. (amend. - SG 18/04) advise investment projects for construction of new and / or
reconstruction of existing facilities related to the manufacture of medicinal products in accordance
with the rules of Good Manufacturing Practice;
15. performs the functions of coordinator and advisory body on quality issues,
the efficacy and safety of medicinal products;
16. performs consulting, scientific, information and publishing activities in the field of pharmaceuticals
sector;
17. coordinates and participates in activities related to the European Pharmacopoeia and in the development of
The Bulgarian Pharmacopoeia;
18. participate in activities in the field of medicinal products related to the work of the European Agency
on Medicines, European Directorate for Quality of Medicines and Health, international
bodies and organizations, as well as with the implementation of international treaties to which the Republic of Bulgaria is
country;
18a. (new - SG 102/2012, in force since 21.12.2012) participate in the international harmonization and
standardization of technical measures regarding pharmacovigilance monitoring, sub
the coordination of the European Medicines Agency;
18b. (new, SG No. 102/2012, effective 21.12.2012) establish and maintain a national Internet portal for
medical products;
19. performs other activities specified by law.
(6) (amend. - SG 98/10, in force from 01.01.2011) The Executive Agency for Medicines shall coordinate
its activities with the Regional Health Inspectorates (RICs) in the field of drug control.
(7) (New, SG No. 102/2012, effective 21.12.2012) The implementation of the measures under this Act related to
preventing the entry and distribution of counterfeit medicinal products,
carries out in cooperation between the BDA and the customs authorities.
(8) (New, SG No. 84/2018, effective 12.10.2018) The Executive Agency for Medicines may
carries out joint checks with the National Revenue Agency, the Customs Agency, the National Revenue Agency
Health Insurance Fund, the Ministry of Health and the National Board of Prices and
reimbursement of medicinal products in the exercise of their control functions
on medicinal products.
Art. 17a. (New, SG No. 60/2011, effective 05.08.2011) Regional Health Inspectorates shall issue
drugstore registration certificates.
Art. 17b. (New, SG No. 18/2014) (1) An Expert Council shall be established to the Executive Director of the BDA.
retail of medicinal products, which includes three representatives of the Bulgarian
pharmaceutical union, one representative of the faculties of pharmacy at medical colleges
and four BDA representatives. The composition of the Board shall be determined by order of the Executive Director
of the BDA, coordinated with the Minister of Health.
(2) The council under para. 1 is an advisory unit which:
1. prepares opinions on applications and documents submitted to the BDA. 228, para. 1 and 5, which he presents to
the Executive Director of the BDA;
2. make motivated proposals to the Minister of Health through the BDA Executive Director for
improving public access to medicines.
(3) The organization and activity of the expert council under para. 1 shall be governed by a regulation issued by
the Executive Director of the BDA at the proposal of the Board.
(4) The members of the expert council under para. 1 shall not receive remuneration for attending council meetings.
(5) The expert council under para. 1 shall be reported annually to the Minister of Health.
Art. 17c. (New, SG No. 18/2014) May not be members of the expert council. 17b, para. 1 person,
which:
1. owners, members of management and controlling bodies of commercial companies or sole traders with
subject of activity manufacture, import, wholesale or retail of medicinal products;
2. partners or shareholders holding more than 5 per cent of the capital of commercial companies with the object of
activity manufacturing, importing, wholesaling or retailing of medicinal products or working in labor
contract in these companies.
Section II.
Registers
Art. 18. (Repealed, SG No. 60/2011, effective 05.08.2011)
Art. 19. (1) The Executive Agency for Medicines shall keep and keep registers of:
1. (amend. - SG 102/12, in force from 21.12.2012) manufacturers and importers of medicinal products
products on the territory of the Republic of Bulgaria and the qualified persons under art. 148, item 2 and under Art. 161, para.
2, Vol. 1;
2. (amend. - SG 102/02, in force from 21.12.2012) manufacturers, importers and wholesalers of
active substances;
3. the authorized and registered medicinal products on the territory of the Republic of Bulgaria;
4. wholesalers of medicinal products on the territory of the Republic of Bulgaria;
4a. (new - SG 102/2012, in force from 21.12.2012) intermediaries in the field of medicinal products;
5. (amend. - SG 60/11, in force from 05.08.2011) the issued licenses for retail trade with
medical products;
6. approved clinical trials;
7. the licenses issued for parallel import.
8. (New, SG No. 18/2014, repealed, SG No. 84/2018, effective 12.10.2018)
(2) (amend. - SG 84/08, in force from 12.10.2018) The data from the registers under para. 1, items 1 - 7 are published in
14 days from the issuance of the relevant authorization on the BDA website on the Internet.
(3) The Executive Agency for Medicines shall maintain systems for the electronic exchange of data with the regulatory authorities
authorities of other Member States, the European Commission and the European Medicines Agency.
Art. 19a. (New, SG No. 60/2011, effective 05.08.2011) (1) The respective SICs shall keep and maintain public
registers for their drugstore registration certificates.
(2) Within 7 days from the issuance of a certificate for registration of a drugstore, the respective RHI shall send to
Ministry of Health information about the issued act.
(3) The Ministry of Health shall maintain and maintain on its website a public national
register of issued drug registration certificates.
Section III.
Financing
Art. 20. (1) The activity of the BDA shall be financed by budgetary funds and income from own activity.
(2) (Amended, SG No. 15/2013, in force from 01.01.2014) The budgetary funds shall be provided by a subsidy from
the state budget through the budget of the Ministry of Health.
Art. 21. (1) The Executive Agency for Medicines shall be the administrator of own-source revenues which
are formed by:
1. chemical-pharmaceutical expertise;
2. laboratory analyzes and tests;
3. evaluation of documentation and issuance of permits, certificates, certificates and other documents,
referred to in this Act;
4. evaluation of the renewal, modification and deletion of the marketing authorization and the certificate of use
registration of a medicinal product;
5. maintenance of the marketing authorizations or the registration certificates of a medicinal product;
6. fines and pecuniary sanctions imposed by penal decrees issued for violations of this
law;
7. consulting, publishing and research activities in the field of the pharmaceutical sector;
8. coordination of investment projects for construction of new ones and / or reconstruction of existing ones
facilities related to the manufacture of medicinal products;
9. carrying out inspections in relation to conformity assessment of the production conditions with
the requirements of Good Manufacturing Practice;
10. (new - SG 84 2018, in force from 12.10.2018) carrying out inspections of authorized for conducting
clinical trials;
11. (new, SG No. 84/2018) effective inspections related to the issuance of
Certificate of Good Manufacturing Practice or Good Distributor Practice at the request of
the inspected person;
12. (prev. Item 10 - SG, iss. 84 in 2018), effective from 12.10.2018) other sources.
(2) (amend. - SG 84/08, in force from 12.10.2018) In carrying out the activities under para. 1, Vols 1 - 5 and 7 -
11 The BDA collects fees in the amount determined in a tariff approved by the Council of Ministers.
(3) (New - SG 71/08, in force from 12.08.2008) In the tariff under para. 2 are defined lower and different
by fees for carrying out the authorization, use and production procedures for
medicinal products for small and medium - sized enterprises in the pharmaceutical sector within the meaning of the Law on
small and medium-sized enterprises.
Art. 22. (1) The financial resources under art. 21 is spent on:
1. the control activity of the BDA;
2. payment of activities under art. 21, para. 1, items 1 and 2, in cases where their implementation is assigned by the BDA under
contract of others;
3. (repealed, SG No. 38/2012, effective 01.07.2012)
4. creating, maintaining and maintaining registers of post offices. 19, para. 1;
5. maintaining electronic data exchange systems with the regulatory authorities of other Member States, p
The European Commission and the European Medicines Agency;
6. (suppl. - SG 102/2012, in force from 21.12.2012) information and publishing activity related to
the quality, efficacy and safety of medicinal products and the monitoring of medicinal products
safety;
7. (Supplemented, SG No. 84/2018) (*)) securing the activity of the specialized commissions. 47, para. 1 and 2,
the commission under art. 103, para. 1 and the Council under Art. 251, para. 3;
8. (repealed, SG No. 38/2012, effective 01.07.2012)
9. participation in international and national inter-laboratory tests;
10. (amend. - SG 60/11, in force from 05.08.2011, repealed - SG 38/2012, effective from 01.07.2012)
(2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended and supplemented, SG No. 12/2011, effective 08.02.2011) ,
ed. - SG, issue. 60 of 2011, effective 05.08.2011, as amended. - SG, issue. 102 of 2012, effective 21.12.2012, amend. - SG,
pcs. 84 of 2018 (*)) The financial resources under art. 259, para. 5 is spent on:
1. (repealed, SG No. 60/2011, effective 05.08.2011)
2. activities of the Pharmacopoeia Committee;
3. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012, in force since 21.12.2012, amended -
SG, issue 84 of 2018 (*)) activities of the Transparency Committee.
4. (repealed, SG No. 38/2012, effective 01.07.2012)
5. (suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 12 from 2011, in force since 08.02.2011, amended -
SG, issue 60 of 2011, effective 05.08.2011, repealed. - SG, issue. 38 of 2012, effective 01.07.2012)
Chapter Three.
MARKETING OF MEDICINAL PRODUCTS
Section I.
General
Art. 23. (1) (amend. - SG 71/08, in force from 12.08.2008) Manufactured medicinal product
or a medicinal product obtained by a method involving an industrial process may be placed on the market
only after obtaining a marketing authorization or receiving a registration certificate,
issued under this Act or under Regulation (EC) No 726/2004 of the European Parliament and of
Council, and subject to Regulation (EC) No 1901/2006 of the European Parliament and of the Council
of 12 December 2006 on medicinal products for pediatric use and amending Regulation
(EEC) No 1768/92, Directive 2001/20 / EC, Directive 2001/83 / EC and Regulation (EC) No 726/2004,
hereinafter referred to as Regulation (EC) No 1901/2006, and of Regulation (EC) No 1394/2007 of the European Parliament and of
Council of 13 November 2007 on advanced therapy medicinal products and amending
Directive 2001/83 / EC and Regulation (EC) No 726/2004 (OJ, L 324/121 of 10 December 2007).
(2) Authorization for use within the meaning of para. 1 is also required for a radionuclide generator, a radionuclide
a precursor and a whale.
(3) The types of procedures within the meaning of para. 1 are:
1. centralized;
2. Mutual recognition / decentralized procedure;
3. national.
(4) (New - SG 71/08, in force from 12.08.2008) On the territory of the Republic of Bulgaria may be
only medicinal products marketed by the Marketing Authorization Holder / Marketing Authorization Holder
for registration is established in the territory of a Member State.
Art. 24. (1) (amend. - SG 71/08, in force from 12.08.2008) Permission for use is not required for
radiopharmaceuticals prepared immediately before use by authorized users
radionuclide generators, radionuclide precursors or kits in accordance with the instructions of
their manufacturer.
(2) The products of para. 1 shall be prepared by qualified persons in laboratories or institutes received
permission to carry out such activity under the Safe Use of Nuclear Act
energy.
(3) The preparation, use and application of the products under para. 1 is performed according to the medical one
standard for nuclear medicine.
Art. 25. (1) Criteria for determining a medicinal product intended for treatment, prevention or
the diagnosis of rare diseases is covered by Regulation (EC) No 141/2000 of the European Parliament and of the Council
Council.
(2) The conditions and procedure for issuing a marketing authorization for the medicinal products under para. 1 se
set out in Regulation (EC) No 726/2004 of the European Parliament and of the Council.
Art. 26. (1) (amend. - SG 71/08, in force from 12.08.2008) Permission for use of a medicinal product,
certificate for registration of homeopathic medicinal product under Art. 35 or a certificate for
registration of a traditional herbal medicinal product under Art. 37 on the territory of the Republic of Bulgaria
is issued by the BDA Executive Director to a natural or legal person established on
the territory of a Member State.
(2) Where the person under para. 1 is not established on the territory of the Republic of Bulgaria, it defines its own
representative.
(3) The holder of the marketing authorization shall be responsible for the medicinal products placed on the market
products. The determination of a person under para. 2 shall not exempt the holder of the marketing authorization from
liability under the legislation in force in the Republic of Bulgaria.
Section II.
Requirements to the marketing authorization documentation
Art. 27. (1) (amend. - SG 71/08, in force from 12.08.2008) For issuance of a permit for use of
medicinal product the person under Art. 26, para. 1 shall submit to the BDA an application in the form, accompanied by a file in
electronic common technical document format, containing:
1. name and address of management / permanent address of the applicant and the postal representative. 26, para. 2; when
the applicant is a person other than the manufacturer or manufacturers - the address of the production sites;
2. name of the medicinal product;
3. data on the qualitative and quantitative composition of the medicinal product, indicating the international
a non-patent name recommended by the WHO, if any, or the corresponding chemical
name;
4. therapeutic indications, contraindications and side effects;
5. (amend. - SG 71/08, in force from 12.08.2008) dosage, dosage form, method of administration and
route of administration and proposed shelf life;
6. precautions and safety measures for the storage of the product, for its administration to patients and
in the event of disposal of the product waste, accompanied by an indication of the potential risks of
the medicinal product for the environment;
7. description of the production method;
8. description of the control methods used by the manufacturer;
8a. (new - SG 102/2012, in force from 02.01.2013) declaration that the results of the audit are 160, para. 2,
conducted by the manufacturer of the medicinal product confirm that the active substance is manufactured in
compliance with the principles and guidelines for Good Manufacturing Practice; the declaration shall state
the date on which the audit was conducted;
9. assessment of the potential risk of the medicinal product for the environment on a case-by-case basis and measures,
intended to limit it;
10. results from:
(a) pharmaceutical (physico-chemical, biological or microbiological) tests;
(b) preclinical (toxicological and pharmacological) studies;
(c) clinical trials;
11. a statement that they have been complied with in clinical trials conducted outside the territory of the Member States
ethical principles of Good Clinical Practice;
12. (amend. - SG 102/2012, in force from 21.12.2012) summary of the traceability system
drug safety, which includes the following elements:
a) the name of the qualified person under Art. 191, Curriculum Vitae - Education acquired by professional experience in
the field of pharmacovigilance monitoring and the qualification for fulfilling his duties
in the order of Chapter Eight;
(b) any Member State in which the qualified person fulfills his duties;
c) address, telephone, fax, e-mail address of the person under letter "a";
(d) the address at which the basic document of the medication traceability system is stored
safety;
12a. (new - SG 102/2012, in force since 21.12.2012) declaration by the applicant that he has at his disposal
the necessary means to fulfill the obligations of Chapter Eight;
13. (amend. - SG 102/2012, in force from 21.12.2012) risk management plan with description of the system
for risk management to be introduced by the applicant for the medicinal product concerned, together with a summary of
the plan;
14. a brief description of the product according to Art. 34;
15. layout of the primary and secondary packaging of the product and a leaflet in accordance with
the requirements of Chapter Six;
16. a copy of the manufacturing authorization issued by the regulatory authority of the country in which it is located
carry out the production accompanied by a certificate of good manufacturing practice or a certificate,
certifying that the manufacture of the medicinal product and of its active substances is
performed in accordance with standards at least equivalent to Good Manufacturing standards
practice;
17. a copy of the document by which the medicinal product is designated for treatment, prophylaxis or diagnosis
rare diseases, accompanied by a copy of the opinion of the European Medicines Agency;
18. copies of any marketing authorization issued in another Member State or in a third country for
the medicinal product for which authorization is sought;
18a. (new - SG 102/2012, in force since 21.12.2012) copy of the summary of the safety data,
including data contained in, and where relevant, periodic safety update reports
suspected adverse reactions have been reported;
19. a list of the Member States in which an application for a marketing authorization has been submitted
medicine;
20. (amend. - SG 71/08, in force from 12.08.2008) a copy of the summary of product characteristics,
proposed by the person under Art. 26, para. 1, or a copy of the summary of product characteristics approved by
a regulatory authority of a Member State (s) already authorized;
21. a copy of the refusal of the marketing authorization in a Member State or in a third country,
accompanied by motives; information on suspension or termination of the authorization
for use;
22. a copy of the proposed leaflet for the patient, accompanied by a summary of the results of the evaluation of
the level of readability of the contents of the package leaflet from a patient-selected target group,
or a copy of a leaflet approved by a regulatory authority of a Member State which has already granted a marketing authorization;
23. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2;
24. (new - SG 71/08, in force from 26.07.2008) the documents shall be sent. 7 of Regulation (EC) No 1901/2006.
(2) (Supplemented, SG No. 18/2014) The documents under para. 1, items 18 and 18a with respect to the Member States, respectively
under item 19, shall be submitted only in the procedures under section VII.
(3) For radionuclide generators to the data of para. 1 the following documents shall be submitted additionally:
1. a description of the system together with a detailed description of the components and which may affect the composition
or the quality of daughter radionuclides;
2. the qualitative and quantitative characteristics of the eluate or sublimate.
(4) Documents and data from pharmaceutical, preclinical and clinical trials shall be accompanied by
summary reports prepared by experts with the necessary technical and professional qualifications. To
the reports shall be accompanied by a CV of the experts who produced the report.
(5) The dossier of the medicinal product shall be submitted in Bulgarian and / or English.
(6) (New, SG No. 102/2012, effective 21.12.2012) The risk management system of para. 1, v. 13
should be proportionate to the identified and potential risks of the medicinal product and of
the need to collect safety data from post-marketing studies.
(7) (New, SG No. 102/2012, in force since 21.12.2012) The holder of the marketing authorization
updates the data from the file under para. 1. The order of Chapter Three, Section 1, shall apply to any change to the dossier
VI, where applicable.
Art. 28. (1) (amend. - SG 71/08, in force from 12.08.2008) 26, para. 1 insofar as it does not violate
industrial and commercial property rights, does not submit to the BDA the data under Art. 27, para. 1, item 10, letters "b"
and "c" if it can prove that the medicinal product referred to in the application is generic of the reference
a medicinal product which has been authorized or has been authorized for use in a Member State, not less than
for 8 years.
(2) The holder of the authorization for use of the generic product under para. 1 can't put it on the market,
before the expiry of 10 years from the date of the first authorization to use the reference medicinal product.
(3) The person under art. 26, para. 1, subject to the conditions of para. 1 and 2 may apply to the BDA for
authorization to use a generic reference product and when the reference product is not
was granted marketing authorization in the territory of the Republic of Bulgaria
(4) In the cases of para. 3 the person under art. 26, para. 1 shall indicate in the application under Art. 27, para. 1 the Member State in which
the reference product is authorized or has been authorized.
(5) In the cases of para. 3 The BDA requires the regulatory authority of the Member State referred to in the application under
Art. 27, para. 1, confirmation of the information under para. 4, the quantitative and qualitative composition of the reference
product and, if necessary, additional documentation.
(6) The Executive Agency for Medicines shall make available to a regulatory authority of a State upon request
Member State in which the application for a generic reference product has been authorized
or has been authorized for use on the territory of the Republic of Bulgaria, the necessary information under para. 5th c
within one month from the date of request.
(7) The ten-year period under par. 2 may be extended by up to one year at the request of the holder
of the marketing authorization of the reference medicinal product, if during the first 8 years of its granting
the marketing authorization was granted to the holder of the reference medicinal product for the same product
authorization of a new therapeutic indication with significant clinical advantages over existing ones
healing options are scientifically sound.
(8) (New - SG 12/11, in force from 08.02.2011) When originally issued for a medicinal product
marketing authorization in accordance with Art. 23, for any change in the amount of active substance, c
the dosage form, in the amount in the package, in the route of administration of the medicinal product, and for
any other modification or extension of the marketing authorization shall also be granted
as required by this Act or the original marketing authorization is supplemented. All these
authorizations are considered to belong to a single global marketing authorization
product for the purposes of applying this Article.
Art. 29. (1) The person under art. 26, para. 1 presents in the BDA the results of the necessary preclinical and / or clinical
tests where the medicinal product referred to in the application:
1. cannot be defined as generic, or
2. bioavailability tests do not prove bioequivalence, or
3. (suppl. - SG 71/08, in force from 12.08.2008) there is a change in the active substance or substances in
the amount of active substance or substances per dosage unit, the therapeutic indication, of
the dosage form, the route of administration relative to the reference medicinal product.
4. (repealed, SG No. 71/2008, effective 12.08.2008)
(2) Where the biological medicinal product referred to in the application is similar to a reference biological
medicinal product does not qualify as a generic medicinal product
due to a different production method or different starting materials compared to the reference or
other reasons, the applicant submits to the BDA the results of the required preclinical and / or clinical
tests related to these conditions.
(3) In the cases of para. 1 and 2 the documentation specified in the ordinance post shall also be submitted. 42.
Art. 30. (1) The person under art. 26, para. 1, in so far as it does not infringe industrial or commercial property rights,
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,
defined in the ordinance under art. 42 that the active substance included in the proposed authorization
for use a medicinal product is well established in medical practice, is recognized
efficiency and an acceptable level of safety. In these cases, the test results and tests may
to be replaced by the relevant scientific publications.
(2) The person under para. 1 presents the results of the necessary preclinical and clinical trials in the case of
a medicinal product containing active substances with well-established use that has not been used
in the proposed combination for therapeutic purposes. In this case, no documentation is provided regarding
of each individual active substance.
(3) When an active substance within the meaning of para. 1 has a proven new therapeutic indication based on
significant preclinical or clinical data related to the new indication, once a year
a subsequent applicant cannot rely on the data for the new indication of the active substance.
Art. 31. In the case where a medicinal product contains active substances used in the authorized composition
for use medicinal products but not used in the proposed combination for therapeutic purposes, the person
under Art. 26, para. 1 presents the results of the preclinical and clinical trials related to this
combination. In this case, the applicant does not provide documentation on the safety and efficacy of
each individual active substance.
Art. 32. The marketing authorization holder may authorize the use of a medicinal product
the pharmaceutical, preclinical and clinical records contained in the dossier
product, when evaluating subsequent applications for medicinal products of the same quality and quality
a quantitative composition in terms of the active substances and of the same dosage form.
Art. 33. Conducting the necessary studies and tests to prepare documentation for
marketing authorization and the subsequent practical requirements for marketing authorization
medicinal products under Art. 28 and 29 is not a violation of the patent or of the supplementary protection certificate
of a medicinal product.
Art. 34. (1) The summary of product characteristics shall contain the following information:
1. name of the medicinal product, quantity of active substance per unit dose, medicinal product
form;
2. quantitative and qualitative composition with respect to the active substances and those of the excipients,
information for which it is essential for the correct application of the product; the common name is used
or the chemical description;
3. dosage form;
4. clinical data:
(a) therapeutic indications;
(b) dosage and route of administration for adults and children;
c) contraindications;
(d) special warnings and precautions for use; for immunological medicinal products -
precautions for those who work with them and apply them to patients, and precautions that
should be taken by the patient;
(e) interactions with other medicinal products or other forms of interaction;
(f) use in pregnancy or lactation;
(g) effects on the ability to drive and use machines;
h) side effects;
i) overdose (symptoms, antidotes, emergency measures);
5. pharmacological data:
a) pharmacodynamic properties;
b) pharmacokinetic properties;
(c) preclinical safety data;
6. pharmaceutical data:
(a) a list of excipients;
(b) major incompatibilities;
c) shelf life; shelf life after reconstitution of the medicinal product (if necessary) or after
opening the primary packaging for the first time;
(d) special storage instructions;
(e) the nature and composition of the packages;
(f) specific instructions for the disposal of the remainder of the medicinal product or of waste material from
him;
7. the holder of the marketing authorization;
8. registration number;
9. date of first authorization or renewal of the authorization;
10. date on which the content of the summary of product characteristics was changed;
11. for radiopharmaceuticals - comprehensive information on internal radiation dosimetry;
12. for radiopharmaceuticals - detailed instructions for extemporaneous preparation and quality control and, where applicable
applicable, the maximum storage time during which the relevant intermediate such as eluate or
ready-to-use pharmacist conforms to its specification.
(2) In the summary of product characteristics, no. 28 - 33 the parts of
the summary of product characteristics of the reference medicinal product for indications and dosage forms,
which were under patent protection at the time the generic product was on the market.
(3) The requirements for the form and content of the summary of product characteristics are laid down in
the ordinance under Art. 42.
(4) (New, SG No. 102/2012, effective 21.12.2012) The summary of the characteristics of medicinal products,
included in the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains
information with the following text: "This medicinal product is subject to additional monitoring". In front of
the text shall be marked in black in accordance with Art. 23 (5) of Regulation (EC) No 726/2004
The European Parliament and the Council, accompanied by an explanatory note.
(5) (new - SG 102/2012, in force since 21.12.2012) The summary of the characteristics of the medicinal products
it contains standard text that encourages medical professionals to report any suspects
adverse reaction according to the models of art. 185, para. 2, Vol. 4.
Section III.
Specific requirements for homeopathic medicinal products
Art. 35. (1) A certificate for registration of a homeopathic medicinal product shall be issued under the simplified
procedure if it meets the following conditions:
1. is administered orally or externally;
2. no specific therapeutic is indicated on its packaging or other information related to it
indications;
3. it is diluted sufficiently to guarantee the safety of the product and contains no more than one
ten thousandth of the mother's tincture or more than one hundredth of the smallest dose used in
allopathy, of the active substances whose presence in the allopathic medicinal product makes it obligatory
doctor's prescription.
(2) For the issuance of a certificate for registration of a homeopathic medicinal product, the person shall send. 26, para. 1
submit to the BDA an application in the form which may indicate a series of medicinal products,
obtained from the same homeopathic source or from the same sources.
(3) To demonstrate the pharmaceutical quality and homogeneity of batches of the medicinal product to
the application under para. 2, the following documentation shall be attached:
1. (amend. - SG 71/08, in force from 12.08.2008) scientific name or pharmacopoeial name
of the homeopathic source or sources together with the different routes of administration, dosage forms and
degree of dilution;
2. a file describing the method of obtaining and controlling the homeopathic source or sources,
demonstrating homeopathic use based on appropriate bibliography;
3. file of production and control methods for each dosage form and description of the methods of
dilution and potentiation;
4. production authorization accompanied by a certificate of good manufacturing practice or by
a certificate proving that the product is manufactured under conditions equivalent to the Good requirements
manufacturing practice;
5. copies of authorizations or marketing authorizations obtained for the same products in other Member States;
6. layout of the primary and / or secondary packaging of the product;
7. product stability data.
(4) The data requirements under para. 3 shall be determined in the ordinance of the post. 42.
Art. 36. (1) For homeopathic medicinal products other than those specified in Art. 35, para. 1, apply
the provisions of Art. 27 - 32.
(2) For homeopathic medicinal products under para. 1 person posted 26, para. 1 does not present results from
pre-clinical and clinical trials, where it can demonstrate bibliographic data from the scientific literature,
that the homeopathic use of the medicinal product or homeopathic constituents
his, have been established safety.
(3) In the cases of para. 2 of the bibliographic data must be established:
1. the homeopathic nature of the raw materials used and their traditional use in the application
testimony;
2. the harmlessness of the homeopathic medicinal product with respect to the degree of dilution of each
the ingredients.
Section IV.
Specific requirements for traditional herbal medicinal products
Art. 37. (1) A certificate for registration of a traditional herbal medicinal product shall be issued under
simplified procedure if it fulfills the following conditions:
1. there are therapeutic indications inherent in the use of traditional herbal medicinal products; and
according to its composition and purpose, it is intended for use without medical prescription and monitoring;
2. is administered only in a fixed quantity of the medicinal substance in unit dose and at
a certain dosage;
3. is administered orally, by inhalation (inhalation) or intended for external use;
4. the period of traditional use according to art. 38, para. 1, item 5 has expired;
5. the data on the traditional use of the medicinal product prove that it is not harmful for the determined ones
conditions of use and the pharmacological effect or efficacy of the medicinal product have been established
through its many years of use and experience.
(2) The Executive Agency for Medicines may apply the procedure under para. 1 versus vegetable
a medicinal product containing vitamins or minerals, the safety of which has been documented and
whose action against the herbal medicinal products in the product in relation to its specific
indications is ancillary.
Art. 38. (1) To issue a certificate of registration of a traditional herbal medicinal product
the person under Art. 26, para. 1 shall submit an application to the BDA, accompanied by the following documentation:
1. the data referred to in Art. 27, para. 1, items 1 - 9 and item 10, letter "a";
2. (amend. - SG 71/08, in force from 12.08.2008) a brief description of the product, except for
the data under Art. 34, para. 1, Vol. 5;
3. in the case of a herbal medicinal product within the meaning of Art. 37, para. 2 or the combined vegetable
medicinal product - the information under art. 37, para. 1, item 5 for the combination; when the individual active substances
the combined product is not sufficiently known, data on the traditional use of each is provided
from them;
4. a copy of the marketing authorization or the registration certificate of the herbal medicinal product,
issued by a Member State or a third country and / or a copy of the refusal, accompanied by the reasons for the decision;
5. (amend. - SG 71/08, in force from 12.08.2008) bibliographic data or expert opinions which
prove that the herbal medicinal product for which application for registration is submitted, or
the corresponding product has at least 30 years of use in world medical practice, by
which have been in use in the territory of a Member State for at least 15 years before the date on which the application is submitted
registration;
6. bibliographic data on product safety, accompanied by an expert report;
7. a copy of the manufacturing authorization, accompanied by a certificate of good manufacturing practice or
with a certificate proving that the product was manufactured under conditions equivalent to the Good requirements
manufacturing practice.
(2) The Executive Agency for Medicinal Products may request from the applicant additional information for evaluation
of the safety of the medicinal product under para. 1.
(3) The Executive Agency for Medicinal Products may request an opinion from the Committee on Herbs
medicinal products to the European Medicines Agency regarding the accuracy of the data under para. 1,
item 5 by providing him with the necessary parts of the dossier of the medicinal product.
(4) The submitted data under para. 1, item 5 shall also be valid in cases where during the 30-year period of use in
medical practice:
1. the relevant medicinal product of the product for which the application for registration was submitted was on
the market without authorization or registration for use, or
2. where the number of ingredients in the medicinal product for which an application for registration is submitted is
reduced or reduced in unit dosage.
Art. 39. (1) Where the herbal medicinal product has been on the Community market for less than 15 years, but
meets the conditions of Art. 37, para. 1, the BDA shall submit for the opinion the documentation under Art. 38, para. 1 on
Committee for Herbal Medicinal Products of the European Medicines Agency.
(2) The Executive Agency for Medicines shall take a final decision after the publication of the monograph
by the committee under para. 1 for compliance of the product with the registration criteria for traditional use.
(3) In the cases of para. 1 the term under Art. 44 stops running.
Art. 40. The Medicines Executive Agency may require the applicant for a herbal medicinal product
product to submit documentation under Art. 27 - 32 or under Art. 35.
Art. 41. (1) (amend. - SG 71/08, in force from 12.08.2008) The Executive Agency for Medicines
publish on its website a list of herbal substances, preparations or combinations thereof,
used in traditional herbal medicinal products prepared by the Committee on Herbs
medicinal products to the European Medicines Agency. The list contains for each plant
substance therapeutic indications, active ingredient content per unit dose and dosage route of
introduction and other information necessary for the safe use of the herbal substance such as
traditional medicinal product.
(2) Where the product for registration in the application for registration for traditional use contains a vegetable
substance, preparation or combination thereof listed in para. 1, the applicant does not provide the data,
referred to in Art. 38, para. 1, Vols 4 - 6.
(3) When the herbal substance, the preparation or the combination thereof are excluded from the list under para. 1,
the holder of the registration certificate of the herbal medicinal product must submit to
BDA full documentation under Art. 38 within three months of the change.
(4) In case the holder of the registration certificate of the herbal medicinal product does not
fulfilled the obligation under para. 3, the BDA shall terminate the product registration certificate.
Section V.
Authorization procedure for medicinal products and
registration of homeopathic and traditional herbal products
Art. 42. The requirements for the data and documents from the file under Art. 27 - 32, Art. 35, para. 3, Art. 36, para. 2 and Art. 38
shall be determined in an ordinance of the Minister of Health.
Art. 43. (1) Within 30 days from the date of submission of the documentation, mail. 27 - 32, Art. 35, para. 3 or under Art. 38
The BDA shall verify the completeness of the parts of the dossier accompanying the application and their compliance with
the requirements for granting the marketing authorization or the registration certificate under this Act.
(2) In case it does not identify incompleteness or inconsistencies in the submitted documentation, the BDA shall notify in writing
of the applicant, within the period under par. 1 that the documentation is valid. The notification shall indicate the date from which
the term under Art. 44.
(3) When establishing incompleteness and / or inconsistencies in the documentation under para. 1, the BDA shall notify in writing
submit additional information and / or provide an oral or written explanation to the applicant
incompleteness and non-compliance found within 14 days from the date of notification.
(4) When the requirements of para. 3 have not been fulfilled within the set deadline, the BDA informs the applicant in writing that
application is not valid. In this case, the BDA shall return the submitted documentation within 14 days and
restores 75 percent of the fee paid by the applicant.
(5) When the requirements of para. 3 have been fulfilled within the set deadline, the BDA informs the applicant in writing that
the documentation is valid, indicating in the notification the date from which the term under Art. 44.
Art. 44. The procedure for granting a marketing authorization or registration for a medicinal product begins
from the date specified in the notification under Art. 43, para. 2, respectively under Art. 43, para. 5, and ends by 210
days.
Art. 45. (1) When an application for authorization for use or registration of a medicinal product is submitted to the BDA
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
the marketing authorization was granted for the same medicinal product, the BDA would notify the applicant in writing
implementation of the procedure under Art. 74.
(2) Where an application for marketing authorization or registration of a medicinal product has been submitted to the BDA,
for which in accordance 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 is under evaluation; the BDA does not review the documentation under Art. 27 - 32 or Art.
35, para. 3, or under Art. 38 and shall notify the applicant in writing of the application of the postal procedure. 75.
(3) For the implementation of the provisions of para. 1 and 2 the medicinal product is defined as the same authorized in
another Member State, or as a product under evaluation in another Member State,
when both medicinal products:
1. have the same qualitative and quantitative composition as regards the active substance (s);
they are available in the same dosage form, with differences in excipients being allowed, if not
affects safety and efficacy, and when
2. belong to one company, or apply for medicinal products by persons belonging to one
to the same company or associations of companies, or where they apply for medicinal products
application by persons who have entered into a license or other agreement or are acting together,
related to the marketing of the medicinal product concerned in the various Member States.
Art. 46. ​​(1) When evaluating the BDA documentation:
1. may test the finished product, the intermediate, or the starting materials for
the medicinal product, and send them for testing in a laboratory by the official system
drug control laboratories in a Member State to determine whether the control methods of analysis,
used by the manufacturer and described in the dossier satisfy the requirements;
2. confirm, after on-the-spot verification or on the basis of documents, that the manufacturers of medicinal products from
third countries shall carry out the production in accordance with the data described in Art. 27, para. 1, item 7, and / or
carry out the control in accordance with the methods described in Art. 27, para. 1, Vol. 8;
3. checks the production establishment specified in the application when the manufacturer (s) of
medicines from third countries were, by way of exception, assigned to another manufacturer
certain stages of the manufacture or control of the medicinal product.
(2) When the BDA carries out an on-site inspection of a production site, the term shall begin. 44 stops running until
drawing up a report with the results of the verification.
(3) In the cases of para. 1, items 2 and 3 the manufacturers shall pay a fee in the amount specified in the tariff mail. 21, para.
2.
Art. 47. (1) The following shall be created to the Executive Director of the BDA as consultative bodies
specialized committees:
1. Committee for Medicinal Products;
2. Committee on Immunological Medicinal Products;
3. Committee for Homeopathic Medicinal Products;
4. Committee for Herbal Medicinal Products;
5. Radiopharmaceuticals Commission;
6. (new - SG 71/08, in force from 12.08.2008) Committee for Medicinal Products with Annex to
pediatrics;
7. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
Committee for Medicinal Products for Advanced Therapies;
8. (new - SG 102/2012, in force since 21.12.2012)
drug safety.
(2) If necessary, the Executive Director of the BDA may establish other specialized committees
beyond the ones specified in para. 1.
(3) Specialist committees shall include specialists with scientific achievements and practical experience in the
the relevant fields of application of medicinal products.
(4) External experts with scientific knowledge and expertise may also be attracted to the permanent composition of the committees.
hands-on experience in the specific drug group.
(5) The Executive Director of the BDA shall determine by an order the composition of the committees for a term of three years, the amount
of their remuneration and approves rules of procedure for their work.
(6) By 30 January each year, the Executive Director of the BDA shall approve the lists of experts outside
the composition of the commissions under para. 1 after approval by the Minister of Health.
(7) The Executive Director of the BDA may release a member of a specialized commission for early termination
his request for failure to fulfill his obligations for more than three months or in bad faith
performing its functions.
(8) The composition of the commissions and the list of experts under para. 6 are announced on the BDA website on the Internet.
Art. 48. (1) The members of the specialized commissions under Art. 47, para. 1 and the experts under Art. 47, para. 4 sign
a declaration obliging them not to:
1. disclose data and circumstances that became known to them in the course of or in connection with the performance of their activity;
2. participate in activities related to the production or wholesale and retail of medicines
products.
(2) In case the persons under para. 1 have participated in any of the stages of preparation of the documentation required
to authorize the use of the medicinal product, they may not participate in the meetings of the medicinal product
specialized commission under art. 47.
(3) The persons under para. 1 shall not vote in decisions on matters which they or the members of
their family has commercial, financial or other interests.
Art. 49. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 200 days from the date of receipt of
valid documentation of the BDA together with the relevant commission under Art. 47, para. 1 evaluates the quality,
the safety and efficacy of the medicinal product and produces an evaluation report with comments from
the results of the pharmaceutical and preclinical tests, clinical trials, of the
risk management and the safety monitoring system for the medicinal product concerned.
The evaluation report prepared shall be submitted to the BDA Executive Director.
(2) (New, SG No. 102/2012, effective 21.12.2012) The report under para. 1 is updated when new
information relevant to the evaluation of the quality, safety and efficacy of the medicinal product.
(3) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21.12.2012) Where the medicinal product contains
genetically modified organisms, the BDA provides the Ministry of Environment and Water
the necessary documentation from the dossier of the medicinal product and requires an opinion within 60 days
relation to the potential environmental risk. The sixty-day period is within the term of para. 1.
(4) (Renumbered from Paragraph 3, SG No. 102/2012, effective 21.12.2012) In the cases of radiopharmaceuticals, the BDA
provide the necessary documentation from the dossier of the medicinal product and request an opinion within 60 days
days from the Nuclear Regulatory Agency regarding product quality and safety.
The sixty-day period is within the term of para. 1.
(5) (Renumbered from Paragraph (4), amend. - SG 102/02, in force from 21.12.2012) Where the Ministry of Environment
environment and waters and the Nuclear Regulatory Agency shall not be pronounced in the established under para. 3 and 4 terms, be
considers their opinion to be positive.
Art. 50. (1) When the BDA establishes discrepancies in the file with the requirements for issuing a permit for
use or certificate of registration under this Act shall notify the applicant in writing to submit
additional information related to the documentation under Art. 27 - 32 or under Art. 35, para. 3, or under Art. 38, and / or
to provide an oral or written explanation of the incompleteness and non-compliance found within 180 days of
the date of notification.
(2) In the cases of para. 1 the term under Art. 44 ceases to run from the date of notification until the submission of the
the information requested.
(3) The BDA Executive Director shall terminate the procedure for granting a marketing authorization or
certificate of registration of a medicinal product where:
1. the applicant has not provided the information under para. 1 within the specified period;
2. the persons under art. 26, para. 1 request termination in writing and.
Art. 51. Within 10 days of the preparation of the evaluation report, mail. 49, para. 1 Executive Director of the BDA
issues a marketing authorization / registration certificate or makes a motivated one
refusal.
Art. 52. (1) (amend. - SG 102/2012, in force from 21.12.2012) Within 5 days from the date of issue of
the marketing authorization / registration certificate in the register of art. 19, para. 1, item 3 shall be entered
the following permit / certificate information:
1. registration number;
2. number and date of the marketing authorization / registration certificate of the medicinal product;
3. name of the medicinal product;
4. the international non-patent name of each active substance;
5. name and address of the holder of the marketing authorization / registration certificate;
5a. (new, SG No. 102/2012, effective 21.12.2012) 55a, 56 and 56a, recorded in
the marketing authorization / registration certificate;
6. date of change of the Marketing Authorization / Registration Certificate;
7. date of termination of the marketing authorization / registration certificate;
8. other data.
(2) The authorization for use / the registration certificate of the medicinal product 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 mail. 19, para. 1, Vol. 3.
Art. 53. (amend. - SG 102/2012, in force from 21.12.2012) (1) The Executive Agency for Medicines
shall publish on its website within 14 days of the granting of the authorization
use / certificate for registration of the data under art. 52, para. 1, the approved summary of the
product and leaflet information.
(2) The Executive Agency for Medicines shall publish on its website the assessment report under Art. 49,
para. 1 with the reasons for the decision, deleting the data constituting a trade secret.
(3) The report under para. 2 shall be accompanied by a summary of a language comprehensible to the public. The summary contains
section on the conditions of use of the medicinal product.
Art. 54. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of the permit for
use / the registration certificate of the medicinal product shall notify the BDA in writing of the date of
the actual marketing of the medicinal product in the Republic of Bulgaria.
(2) (Amended, SG No. 18/2014) The holder of the marketing authorization / registration certificate
of the medicinal product shall be notified in writing to the BDA at least two months before the sale ceases
of a medicinal product, whether temporary or permanent.
(3) (Amended, SG No. 18/2014) The holder of the marketing authorization / registration certificate
of medicinal product shall indicate the reasons for discontinuation of sales in accordance with Art. 68, para. 1, vol.
6 and declares whether the actions taken by him under para. 2 are due to any of the grounds of post. 276 or
under Art. 277.
(4) (Amended, SG No. 18/2014) Upon termination of the sales of the medicinal product as a result of
unforeseen circumstances the holder of the marketing authorization / registration certificate for
medicinal product shall notify the BDA in writing within 7 days of the establishment of the circumstances.
Art. 54a. (New, SG No. 60/2011, effective 05.08.2011) (1) (amend. - SG 18/04) Upon receipt of
a signal to the Drug Enforcement Agency to suspend the sale of a medicinal product, p
except for the cases under art. 54, para. 2 and 4, the Agency shall carry out the check within 30 days of receipt of
signal.
(2) When performing the inspection under para. 1 The BDA may request information from the authorization holder
for use and / or by the person under Art. 26, para. 2 on the suspension of sales of the particular
medicinal product as well as the wholesalers of medicinal products regarding the available quantities of
product.
(3) The Medicines Executive Agency shall publish its page on the Internet of the results of
the check carried out.
Art. 55. (1) The authorization for use / the registration certificate of a medicinal product shall be issued by
the Executive Director of the BDA for a period of 5 years.
(2) (suppl. - SG 71/08, in force from 12.08.2008) After the expiration of the term under para. 1 permission for
the use / registration certificate of the medicinal product may be renewed by the BDA on the basis of
of assessment of the benefit / risk ratio in accordance with Art. 59a.
(3) (amend. - SG 71/08, in force from 12.08.2008) The authorization for use / the certificate for
registration may be terminated before the expiry of the term under para. 1 if the owner requests it
in writing by the BDA Executive Director, stating the reasons.
(4) (suppl. - SG 71/08, in force from 12.08.2008) The marketing authorization / the certificate for use
registration shall be held indefinitely after its renewal, except in the cases of para. 5.
(5) (amend. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 21.12.2012)
the existence of valid reasons for pharmacovigilance, including
due to the exposure of the medicinal product to an insufficient number of patients, the BDA may require from
the Marketing Authorization Holder should apply for its renewal for another 5 years in a row
of Art. 59a.
(6) (amend. - SG 71/08, in force from 12.08.2008) At the expiry of the term of the permit for
use / certificate of registration or termination of the medicinal product may be
sold until the stock is available in the country, but not more than one year from the date
on the expiry or termination, respectively, except where the reasons for termination
are related to the safety of the medicinal product.
(7) The Executive Director of the BDA withdraws the Marketing Authorization / License
registration of a medicinal product when:
1. its holder has not placed the medicinal product on the market within three years from the date of issue of the medicinal product
the marketing authorization, or
2. sales of the medicinal product have been discontinued for a period of three consecutive years
placing it on the market.
(8) The order under para. 7 is subject to appeal in accordance with the Administrative Procedure Code.
(9) By way of exception and in the interest of public health, the provision of para. 7 may not apply if
the marketing authorization holder gave good reasons. In these
cases, the BDA Executive Director gives reasons for his decision.
(10) The marketing authorization holder shall pay an annual fee in the amount set out in the postal tariff.
21, para. 2, to maintain the marketing authorization issued.
Art. 55a. (New, SG No. 102/2012, effective 21.12.2012) (1) The BDA Executive Director may
has granted marketing authorization / marketing authorization for the medicinal product they are in
one or more of the following conditions are included:
1. take certain measures to ensure the safe use of the medicinal product which
be included in the risk management system;
2. conduct post-marketing safety studies;
3. comply with the obligations for registration or reporting of the obligations specified in Chapter Eight
suspected side effects;
4. to comply with any other conditions or restrictions with a view to the safe and efficient use of
the medicinal product;
5. existence of an adequate system for monitoring the pharmacovigilance;
6. to conduct post-marketing efficacy studies where there are concerns
the efficacy of the medicinal product, which can only be authorized after the medicinal product
the product is placed on the market.
(2) The marketing authorization / registration certificate shall specify the time limits for the implementation of the
the conditions under para. 1, where applicable.
(3) The grounds for imposing the condition under para. 1, item 6 shall be determined by a delegated act referred to in Article 22b of the Directive
2001/83 / EC, taking into account the scientific guidelines developed in the guidance document. 194a.
(4) The requirements for conducting post-marketing efficacy studies are laid down in a guide,
issued by the European Medicines Agency.
Art. 56. (amend. - SG 102/2012, in force since 21.12.2012) (1) By way of exception after consultation with
the applicant, the BDA's Executive Director may issue a marketing authorization / certificate
registration provided that the applicant can demonstrate that he has not provided exhaustive information on
the efficacy and safety of the medicinal product under normal conditions of use due to one of the
the following reasons:
1. the indications for which the medicinal product is intended are so rare that the applicant does not
may submit complete evidence, or
2. the state of scientific knowledge at present is such that no comprehensive data can be provided,
or
3. the collection of such data is contrary to the generally accepted principles of medical ethics.
(2) The marketing authorization / registration certificate under para. 1 shall be issued in one of the following
conditions:
1. the applicant / holder to execute a program of studies for the period under para. 3, taking the results of these
studies serve to reassess the benefit-risk balance;
2. the medicinal product is available only on prescription, in certain cases
can only be used under strict medical supervision in a hospital care facility, and in
case of radiopharmaceutical - only under the control of an authorized person;
3. the package leaflet and any medical information accompanying the medicinal product should be
provided text to pay attention to health professionals that some of the available data on
the medicinal product is subject to subsequent studies.
(3) The marketing authorization / registration certificate under para. 1 shall be issued for one year and for
each subsequent year may be extended on the basis of an assessment of the fulfillment of the conditions under par. 2.
Art. 56a. (New, SG No. 102/2012, effective 21.12.2012) (1) Upon issuance of the permit for
the use / registration certificate of the BDA may oblige the holder of
the permit / certificate to hold:
1. post-marketing safety study if there are concerns about identified or potential
risks or lack of pharmacovigilance monitoring information for that person
medicine; when the same risks apply to other medicinal products, after consultation with
The Pharmacovigilance Risk Assessment Committee established by Article 56,
paragraph 1 (aa) of Regulation (EC) No 726/2004 of the European Parliament and of the Council, BDA
recommends that the relevant Marketing Authorization Holder carry out a joint study on
safety with other affected authorization holders;
2. post-marketing efficacy study when knowledge of the disease or clinical use
the methodology justifies the revision of the efficacy assessments that are drawn from
the date of issue of the authorization.
(2) The Executive Agency for Medicinal Products shall notify the holder of the authorization in writing
use / registration certificate for the obligation under para. 1, justifying the reasons and indicating
the objectives of the study and the time limits for conducting it.
(3) Within 30 days from receipt of the notification under para. 2 the holder of the authorization for
the use / registration certificate may require the BDA to provide a presentation opportunity
of information regarding the obligations under para. 1.
(4) Upon receipt of the request under para. 3 The BDA sets a deadline for submitting the information from
the holder of the marketing authorization / registration certificate.
(5) The Executive Agency for Medicines after analyzing the information under para. 3 can:
1. to confirm the obligation under para. 1, or
2. cancel it.
(6) The Executive Agency for Medicinal Products shall notify the holder of the decision taken under para. 5.
(7) In the cases of para. 5, item 1, the Executive Director of the BDA officially changes the issued permit for
use / registration certificate of the medicinal product, including as a condition
the obligation under para. 1.
(8) The grounds for imposing the obligations under para. 1, item 2 shall be determined by a delegated act of post. 22b from
Directive 2001/83 / EC.
Art. 56b. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the authorization for
the use / registration certificate includes all conditions in its risk management system
under Art. 55a, 56 and 56a.
(2) In the cases of para. 1 the holder of the marketing authorization / registration certificate submits to
BDA notification of change in risk management system.
Art. 56c. (New, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines shall send
information to the European Medicines Agency about the issued authorizations under art. 55a, 56 and 56a.
Art. 57. (1) The BDA Executive Director shall refuse to issue a marketing authorization or a certificate.
for registration of a medicinal product when, after evaluation of the dossier under Art. 27 - 32 it was found that:
1. the benefit / risk balance is unfavorable, or
2. the efficacy of the medicinal product is not convincingly protected by the applicant, or
3. the quantitative and qualitative composition of the medicinal product does not correspond to those described in the dossier.
(2) (Supplemented, SG No. 71/2008, effective 12.08.2008) The Executive Director of the BDA shall refuse to issue
of a marketing authorization or a marketing authorization for a medicinal product where some of the particulars in the
the file does not meet the requirements of Art. 27 - 32 or the ordinance under Art. 42.
(3) The Executive Director of the BDA shall refuse registration of a traditional herbal medicinal product,
when, after evaluation of the documentation, it is found that the product does not meet the conditions under Art. 37, para. 1,
the data in the file do not correspond to Art. 38 or:
1. the quantitative and qualitative composition does not correspond to those described in the dossier;
2. the medicinal product may be harmful if used correctly;
3. the data on traditional use are insufficient, especially when the pharmacological properties or
efficacy has not been demonstrated based on years of use and experience;
4. the pharmaceutical quality of the medicinal product is not sufficiently substantiated.
Art. 58. The Marketing Authorization Holder is responsible for the completeness and accuracy of
the data in the file.
Art. 59. (1) Refusal of the Executive Director of the BDA to issue a Marketing Authorization / Certificate
for registration of a medicinal product may be appealed under the procedure of the Administrative Procedure
code.
(2) The refusal of the BDA Executive Director and the reasons for it shall be published on the Agency's website
in Internet.
Art. 59a. (New, SG No. 71/2008, effective 12.08.2008) (1) (Amended, SG No. 102/2012, effective from
21.12.2012) In the cases under Art. 55, para. 2 and 5, but no later than 9 months before the expiration of
the marketing authorization / registration certificate is submitted by the holder to the BDA
renewal, accompanied by a summary dossier on quality, safety and efficiency,
including evaluation of data contained in reports of suspected adverse reactions and
periodic safety update reports submitted in accordance with Chapter Eight and all
approved changes after the granting of the marketing authorization / registration certificate.
(2) The requirements for the data and documents from the file under para. 1 shall be specified in the ordinance of the post. 42.
(3) Within 120 days of receipt of the application and documentation under para. 1 BDA evaluates quality,
the safety and efficacy of the medicinal product and shall prepare an evaluation report which it shall submit to the
the BDA Executive Director.
(4) When establishing incompleteness and / or inconsistencies in the submitted documentation under para. 1, the BDA informs
the holder of the Marketing Authorization / Registration Certificate in writing and gives instructions for
their removal. The holder of the Marketing Authorization / Registration Certificate removes
incompleteness and / or discrepancies in the documentation within 30 days from the date of receipt
the notification.
(5) Within 10 days of receipt of the evaluation report under para. 3 the BDA Executive Director issues
authorization for renewal of the Marketing Authorization / Marketing Authorization
product or reasoned refusal.
Art. 59b. (New, SG No. 71/2008, effective 12.08.2008) (1) The Executive Director of the BDA shall refuse
renewal of the marketing authorization / marketing authorization of the medicinal product when
after evaluation of the file under Art. 59a, para. 1 found that:
1. the medicinal product is harmful when used correctly, or
2. lack of therapeutic efficacy, or
3. the benefit / risk balance is unfavorable when used correctly, or
4. the quantitative and qualitative composition of the medicinal product does not correspond to that described in the dossier, or
5. the data in the file under art. 59a, para. 1 are incorrect, or
6. the control of the medicinal product and / or the ingredients and the intermediate stages of the manufacturing process
no other requirement or the fulfillment of which the manufacturing authorization was granted has been fulfilled,
or
7. some of the data in the file do not meet the requirements of Art. 59a, para. 1 and 2.
(2) Refusal of the BDA Executive Director to renew the Marketing Authorization / Certificate for use
registration of a medicinal product may be appealed in accordance with the Administrative Procedure Code.
(3) The refusal of the BDA Executive Director and the reasons shall be published on the BDA website.
Art. 59c. (New, SG No. 60/2011, effective 05.08.2011; amend. - SG 102/2012, effective 01.04.2013)
The Drug Enforcement Agency notifies the National Board of Pricing and Reimbursement
the medicinal products for the withdrawn and revoked marketing authorizations, and for the refusals made for
Renewal of marketing authorizations for medicinal products within 7 days of the granting of a marketing authorization
the relevant act.
Section VI.
Changes to the marketing authorization issued
Art. 60. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of a permit for use of
a medicinal product is obliged to notify the BDA of any change in the conditions under which it is issued
the permission.
(2) (amend. - SG 12/11, in force from 08.02.2011) The changes may be of type IA, type IB, type II,
extension of the marketing authorization and emergency restrictive safety measures.
(3) (amend. - SG 12/11, in force from 08.02.2011) Conditions and criteria for classification of changes
shall be determined by the ordinance under Art. 42.
(4) (amend. - SG 12/11, in force from 08.02.2011) Change, which is not an extension of the scope and
the classification of which remains uncertain after the application of the conditions and criteria of the ordinance under Art. 42,
is considered to be a type IB change by default.
(5) (New, SG No. 12/2011, effective 08.02.2011) As an exception to para. 4 a change that does not occur
extension and the classification of which remains uncertain after the application of the conditions and
the criteria of the ordinance under Art. 42 shall be considered a Type II change in the following cases:
1. at the request of the holder of the marketing authorization, reflected in the application for change;
2. when the BDA after assessment of the validity of the notification begins. 63 considered that change might have occurred
significant impact on the quality, safety or efficacy of the medicinal product.
Art. 61. (amend. - SG 12/11, in force from 08.02.2011) (1) For any change of type IA, type IB, type II or
The marketing authorization holder submits the extension to the BDA
separate notification, respectively application.
(2) When a change leads to a change in the summary of product characteristics of the packaging
and / or in the package leaflet, these changes are accepted as part of the requested change and are not filed separately
application.
(3) The Marketing Authorization Holder may group the changes when:
1. notifies simultaneously the same type IA changes under the conditions of one or more authorizations for
use;
2. declares at the same time several changes to the terms of the marketing authorizations belonging to
the global marketing authorization under Art. 28, para. 8 of the medicinal product, provided that the relevant
changes occur in one of the following cases:
(a) one of the changes in the group is the extension of the marketing authorization;
(b) one of the changes in the group is a type II change, and all other changes in the group are changes that are
a consequence of the Type II change;
c) one of the changes in the group is a change type IB, and all other changes in the group are changes that are
a consequence of the type IB change;
(d) any changes to the group shall relate only to changes of an administrative nature in the brief
product characteristics, patient package leaflet or packaging;
(e) all changes in the group are changes in the active substance master documentation, the main one
vaccine antigen documentation or plasma basic documentation;
(f) all changes to the group are in relation to a project designed to refine the production process
and the quality of the medicinal product concerned or its active substance (s);
(g) all changes in the group are changes affecting the quality of the pandemic influenza vaccine;
h) all changes in the group are changes in the pharmacovigilance system heading eight;
(i) any changes to the group are the result of a specific emergency safety measure and are filed with
in accordance with Art. 66;
(k) all changes in the group are related to the inclusion of information on a particular pharmacotherapeutic class;
(l) all changes in the group result from the evaluation of the periodic safety report;
(m) any changes to the group are the result of a post-authorization study,
conducted under the supervision of the Marketing Authorization Holder;
n) all changes in the group are due to the fulfillment of a condition in the authorization for use of mail. 56;
3. the requested changes in the conditions of the same marketing authorization do not fall in the cases under item 2, at
provided that the BDA agrees to apply the same procedure to these changes.
(4) When grouping changes under para. 3, items 2 and 3 the holder of the marketing authorization shall submit to the BDA:
1. a single notification where at least one of the changes is type IB and all others are type IA or type IB;
2. a single application where the major change is type II and none of the other changes is an extension of
the scope of the marketing authorization;
3. a single application where the major change is the extension of the marketing authorization.
(5) Along with the application, respectively, the notification under para. 1 or 4, the holder of the authorization for
use feeds:
1. documentation related to the changes, determined by the ordinance post. 42;
2. a document for payment of a fee in the amount determined by the postal tariff. 21, para. 2.
(6) The Executive Director of the BDA shall approve the models of application, respectively notification under para. 1 and
4, which are published on the BDA website.
Art. 62. (amend. - SG 12/11, in force from 08.02.2011) (1) The holder of the marketing authorization
may notify type IA changes within 12 months after their application except for
changes that require immediate notification.
(2) The type IA changes, which require immediate notification, shall be determined by the ordinance under Art. 42.
(3) In the cases of para. 2, the Marketing Authorization Holder notifies the Type IA change
immediately after administration and.
(4) Within 30 days from receipt of the notification under para. 1, respectively under para. 3, the BDA informs
of the marketing authorization holder:
1. whether the change (s) are accepted / accepted or not; when the change / changes are not accepted / accepted,
state the reasons for this, and
2. whether the change (s) lead to a change in the data in the issued marketing authorization; when
a change in the issued marketing authorization is required; Art. 64a.
(5) The Marketing Authorization Holder shall immediately suspend the application of
the relevant change (s) type IA upon receipt of the notification under para. 4, item 1 for
rejection.
Art. 63. (amend. - SG 12/11, in force from 08.02.2011) (1) When the notification for change type IB
meets the requirements of Art. 61, the BDA informs the holder of the marketing authorization that
the notification is valid and indicates the date from which the term under para. 2 starts flowing.
(2) Within 30 days of receiving a valid notification, the BDA shall evaluate the submitted documentation and
notify the holder of the marketing authorization:
1. whether he approves the change or not; where the change is not approved, the reasons shall be given, and
2. whether the change leads to a change in the data in the issued marketing authorization; when needed
change in the issued marketing authorization, Art. 64a.
(3) When, within the term of para. 2 The BDA found inconsistencies in the submitted documentation with the requirements of the law
and the ordinance under Art. 42, it notifies the holder of the marketing authorization.
(4) Within 30 days from receipt of the notification under para. 3 the Marketing Authorization Holder
may modify or supplement the documentation.
(5) When, within the term of para. 4 the Marketing Authorization Holder did not submit an amended or
supplementary documentation, the BDA shall terminate the procedure and notify the holder of the authorization for
use.
(6) Within 30 days from receipt of the changed documentation under para. 4 The BDA notifies the holder of
marketing authorization:
1. whether he approves the change or not; where the change is not approved, the reasons shall be given, and
2. whether the change leads to a change in the data in the issued marketing authorization; when needed
change in the marketing authorization issued, Art. 64a.
(7) The Marketing Authorization Holder applies the approved type IB variation upon receipt of the
notification under para. 2, item 1, respectively under para. 6, item 1 for approval of the change.
Art. 64. (amend. - SG 12/11, in force from 08.02.2011) (1) When the application for change of type II corresponds
of the requirements of Art. 61, the BDA shall notify the holder of the marketing authorization that the application is
valid, indicating the date from which the period under par. 2 starts flowing.
(2) Within 60 days of receipt of a valid application, the BDA shall prepare an evaluation report on the change.
(3) The term under para. 2 can be:
1. reduced in cases of emergency related to the safe use of the medicinal product, or
2. prolonged up to 90 days in case of a change which changes or adds a therapeutic indication.
(4) When the BDA establishes inconsistencies in the submitted documentation with the requirements of the law and the ordinance under
Art. 42, it notifies the holder of the marketing authorization and sets a time limit for granting it
additional information and documentation.
(5) In the cases of para. 4 the term under para. 2 stops running until additional information is presented and
documentation.
(6) Within 15 days of preparation of the evaluation report, the BDA Executive Director shall:
1. approve the change or give a reasoned refusal and notify the authorization holder thereof
use;
2. inform the holder of the marketing authorization whether the approved change leads to a change of the
the data in the marketing authorization issued; when it is necessary to change the issued permit for
use, Art. 64a.
(7) The holder of the marketing authorization may apply the type II variation approved only after
the issuance of a change permit under Art. 64a.
Art. 64a. (New, SG No. 12/2011, effective 08.02.2011) The Executive Director of the BDA shall issue
authorization to change the marketing authorization in time:
1. thirty days from the date of notification. 62, para. 4, Vol. 2, Art. 63, para. 2, item 2, respectively Art. 63, para. 6, vol.
2 or Art. 64, para. 6, item 2, when the respective change leads to an extension by 6 months of the term specified by the member
13 (1) and (2) of Council Regulation (EEC) No 1768/92 of 18 June 1992 establishing a
additional certificate for protection of medicinal products, in accordance with Art. 36 of Regulation (EC) No
1901/2006;
2. sixty days from the issuance of the notification under Art. 62, para. 4, item 2 - for type IA changes, which do not require
immediate notification;
3. sixty days from the issuance of the notification under Art. 64, para. 6, item 2 - for type II changes;
4. one hundred and eighty days - in all other cases.
Art. 64b. (New - SG 12/2011, in force from 08.02.2011) (1) In case of changes related to changes in
the active substance for the purpose of the annual update of influenza vaccines, the holder of
the marketing authorization shall be submitted to the BDA by an application accompanied by the documentation specified in the Ordinance on
Art. 42. Within 7 days the BDA shall check the completeness of the submitted documentation.
(2) When the application meets the requirements of para. 1, the BDA shall notify the holder of the authorization for
use that the application is valid, indicating the date from which the period under par. 3 starts to flow.
(3) Within 45 days of receipt of a valid application, the BDA evaluates the documentation and prepares an evaluation report.
report.
(4) The Executive Agency for Medicinal Products may require the marketing authorization holder to
provided clinical and stability data for the medicinal product. The owner of
the marketing authorization shall submit the requested data to the BDA within 12 days from the expiry of the term under para. 3.
(5) The Executive Agency for Medicines shall evaluate the documentation and take a final decision within 10 days
days from receipt of the data under para. 4, by granting permission for change or refusal.
Art. 65. (1) When the holder of the marketing authorization establishes a health risk in the use of
the medicinal product, it shall take urgent restrictive measures and immediately notify the BDA in writing.
(2) The Executive Agency for Medicines shall decide on the measures within 24 hours from the notification.
(3) When the BDA does not make its decision within the term under para. 2, the measures are considered to be approved.
(4) When the BDA determines that there is a risk to human health from the use of the medicinal product,
orders the marketing authorization holder to take immediate restrictive measures.
(5) In the cases of para. 1 and 4, the marketing authorization holder agrees with
BDA manner and time limits for implementation of the measures taken.
(6) The marketing authorization holder shall submit it to the Executive Director
of BDA application for change in accordance with Art. 64 not later than 15 days after the date of taking over
measures.
Art. 66. (1) (amend. - SG 12/11, in force from 08.02.2011) The holder of a permit for use of
the medicinal product is applying for an extension of the marketing authorization
at:
1. change of active substance (s):
(a) replacement of a chemically active substance with a different complex / derivative including salt / ester with the same
the therapeutic part, wherein the efficacy / safety characteristics do not differ significantly;
b) replacement with different isomer, different mixture of isomers, replacement of mixture with isolated isomer (e.g.
single enantiomer racemate), whereby the efficacy / safety characteristics are not
differ significantly;
(c) replacement of a biologically active substance with one having a slightly different molecular structure when
which does not differ significantly in performance / safety characteristics, except
changes in the active substance of a seasonal, pre-pandemic or pandemic influenza vaccine
human use;
(d) modification of the vector used to produce the antigen or starting material, including a new one
a major cell bank from another source, with no performance / safety features
differ significantly;
(e) a new radiopharmaceutical ligand or binding mechanism in which the characteristics of
efficiency / safety do not differ significantly;
(f) a change in the extraction solvent or in the ratio of plant matter / plant preparation,
in which the efficacy / safety characteristics do not differ significantly;
2. change in the amount of active substance, dosage form and route of administration:
(a) change in bioavailability;
(b) a change in pharmacokinetics, such as a change in the rate of release;
(c) modification or addition of a new amount of the active substance / activity;
(d) modifying or adding a new dosage form;
(e) Modification or addition of a new route of administration - parenteral administration should be done
differentiation between intraarterial, intravenous, intramuscular, subcutaneous and other routes of
introduction.
(2) The application under para. 1 shall be submitted together with the documentation under Art. 27, para. 1, item 10, related to the changes under para.
1.
(3) The requirements to the documentation under para. 2 shall be specified in the ordinance of the post. 42.
(4) The name of the medicinal product in the extended marketing authorization
the original marketing authorization does not change.
(5) The granting of an authorization to extend the scope of an already granted marketing authorization to
medicinal product is carried out under the conditions and in accordance with Art. 49 - 51.
Art. 67. (1) The holder of the marketing authorization for the medicinal product shall submit an application for issuance
of a new marketing authorization for:
1. the addition or removal of one or more active substances, including antigenic components, for
vaccines;
2. a change in the quality of the active substance indicated in the dossier which changes substantially
the safety and efficacy characteristics of the medicinal product, and the modified substance is determined
as new;
3. adding a new one or changing the existing indication for treatment, prophylaxis or diagnosis in
another therapeutic area.
(2) (New, SG No. 71/2008, effective 12.08.2008) The holder of the marketing authorization for
the medicinal product applies for a new marketing authorization when the application is made
Renewal of the marketing authorization was not filed within the time limit under Art. 59a, para. 1.
(3) (Renumbered from Paragraph (2), SG No. 71/2008, effective 12.08.2008) The application shall be accompanied by
documentation specified in the ordinance under Art. 42.
(4) (Renumbered from Paragraph (3), Supplemented, SG No. 71/2008, effective 12.08.2008). 1 and 2 shall apply
the procedure under Art. 49 - 51.
Art. 68. (amend. - SG 102/2012, in force from 21.12.2012) (1) The holder of a permit for
the use / registration certificate of the medicinal product is obliged to:
1. take into account the achievements of scientific and technical progress and make any necessary changes in
the documentation under Art. 27, para. 1, items 7 and 8 in order to manufacture and control the medicinal product according to
conventional scientific methods; the changes are made in the order of chapters three and five;
2. immediately submit to the BDA any new information that may require a change in the data and documents
under Art. 27 - 32 and in the summary of product characteristics;
3. immediately inform the BDA of any prohibition or restriction imposed by regulatory authorities on others
countries where the medicinal product is placed on the market for the reasons why it was imposed
measures, as well as any other new information that may affect the benefit and risk assessment of
the relevant medicinal product; the information includes both positive and negative results
from clinical trials or other studies of all indications and populations, whether or not they are
included in the marketing authorization, as well as data on the use of the medicinal product where this medicinal product is used
use is outside the terms of the Marketing Authorization;
4. store and update the medicinal product information with current scientific knowledge, including
the conclusions of the evaluation and the recommendations published on the European Medicines Portal
products established in accordance with Article 26 of Regulation (EC) No 726/2004 of the European Parliament and of the
The Council;
5. distributes the medicinal product with the last approved summary of product characteristics and package leaflet
for the patient;
6. (New, SG No. 18/2014) inform the BDA of any action taken by him in connection with a temporary
suspension of the marketing of a particular medicinal product; withdrawal from the market of a specific medicinal product
medicinal product, request for termination of the marketing authorization or stated intention for
failure to renew the marketing authorization, and indicate the reasons why it was taken
action; in such cases, the marketing authorization holder shall declare whether it has been taken by him
actions are due to any of the grounds under Art. 276 or under Art. 277;
7. (New, SG No. 18/2014) inform the BDA if the actions under item 6 have been undertaken in a third country and
due to any of the grounds under Art. 276 or under Art. 277;
8. (new - SG 18/2014) inform the European Medicines Agency when the actions under items 6 and 7
have been undertaken on the basis of Art. 276 and 277;
9. (new, SG No. 18/2014) provide sufficient quantities of the medicinal product to satisfy the
the health needs of the population of the Republic of Bulgaria;
10. (new - SG 84 2018, in force from 12.10.2018) submit to the BDA, weekly or at change of
the circumstances, through the specialized electronic system of art. 217b, para. 1 information for:
a) the quantities delivered on the territory of the Republic of Bulgaria indicated by medicinal products,
included in the Positive Medicinal List for which the Marketing Authorization Holder is located;
(b) wholesalers to whom the quantities of medicinal products referred to in (a) have been delivered;
(c) the date on which the deliveries made under (a) and (b) were made;
(d) the quantities available in the stores indicated by medicinal products included in the Positive Medicinal Product
a list of which the marketing authorization holder holds.
(2) The holder of the marketing authorization / registration certificate is obliged upon request by
BDA to submit:
1. data in support of the positive benefit / risk ratio for the medicinal product;
2. (amend. - SG 18/04) data on the volume of sales of the medicinal product and any other
information available to the marketing authorization holder regarding the volume of medicinal products
product prescriptions;
3. a copy of the basic documentation of the system for monitoring the pharmacovigilance.
(3) The holder of the marketing authorization shall submit to the BDA the documentation under para. 2, item 3 in 7-day
term of receipt of the request.
Art. 69. (1) The holder of the authorization for use of a vaccine or immunological medicinal product,
intended for immunization, before the release of each batch of the product on the market is required
in the BDA:
1. a sample of the final product and / or a sample of the bulk product / non-spilled product;
2. production and quality control protocols;
3. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
(2) The holder of the authorization for the use of new immunological medicinal products or of
immunological medicinal products manufactured with new or modified technologies or with technologies new to
individual producer, fulfills the obligations under para. 1 for the specific period indicated in the authorization for
use.
(3) Within 60 days from the date of submission of the complete set of documents, the BDA shall evaluate the
the protocols for the production and quality control of live vaccines, immunological and new immunological
medicinal products and testing of samples provided at an accredited laboratory to determine
whether the medicinal products under para. 1 and 2 are manufactured in accordance with approved specifications.
(4) Upon a positive result of the test, the BDA shall issue a batch release certificate.
(5) The conditions, procedure and requirements for the documentation for issuing an exemption certificate
of the batch for the products of para. 1 and 2 shall be determined in an ordinance of the Minister of Health.
(6) When the assessment and testing under para. 3 for the respective batch of medicinal products were made by
official laboratory for the control of medicinal products in another Member State, the holder of
the marketing authorization provided for in the BDA was the batch release certificate
products issued by the regulatory authority of the Member State.
(7) In the cases of para. 6 The BDA does not carry out the activities under para. 3 and 4.
Art. 70. (1) The holder of a marketing authorization for a medicinal product obtained from human blood or
human plasma, prior to placing each batch of the product on the market, is required to submit to the BDA:
1. a sample of the final product and / or a sample of the bulk product / non-spilled product;
2. production and quality control protocols;
3. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
(2) Within 60 days from the date of submission of the complete set of documents, the BDA shall carry out an evaluation of
the protocols for the production and quality control of the medicinal product obtained from human blood or
human plasma, and testing of the samples provided at an accredited laboratory to determine whether
the medicinal product under para. 1 is manufactured in accordance with approved specifications.
(3) Upon a positive result of the test, the BDA shall issue a batch release certificate.
(4) The conditions, the order, and the requirements for the documentation for issuance of exemption certificate
of the batch for the products of para. 1 shall be determined in the ordinance under Art. 69, para. 5.
(5) When the assessment and testing under para. 2 for the respective batch of medicinal product were made by
official laboratory for the control of medicinal products in another Member State, the holder of
the marketing authorization provides for the batch release certificate for the medicinal product,
issued by the regulatory authority of the Member State.
(6) In the cases of para. 5 BDA does not carry out the activities under para. 2 and 3.
Art. 71. (1) The holder of the marketing authorization shall be obliged to maintain a blocking and withdrawal system.
from the market for medicinal products that do not meet the quality, safety and quality requirements
efficiency.
(2) The marketing authorization holder shall be obliged to block and withdraw medicinal products,
have shown non-compliance with the requirements for quality, efficiency and safety, in accordance with the ordinance under Art.
274, para. 1.
Art. 72. (Repealed, SG No. 102/2012, effective 21.12.2012)
Art. 73. (1) The holder of the marketing authorization may transfer the rights to the marketing authorization
use of the medicinal product by another legal entity or by non-legal entities
persons established in the territory of the Member States.
(2) The Marketing Authorization Holder submits an application to the BDA, to which it attaches documentation,
defined in the ordinance under Art. 42, indicating a proposal for a transfer date.
(3) In case of finding incompleteness in documentation under para. 2 The BDA shall notify in writing the holder of
the marketing authorization provided for the additional information required within 30 days. The time limit is
para. 5 shall stop running from the date of notification until the requested information has been provided.
(4) If, within the term of para. 3 the Marketing Authorization Holder did not complete the documentation, procedure
the transfer of the marketing authorization shall cease.
(5) Within 30 days from the date of submission of the application under para. 2 the BDA Executive Director issues
change permit approving the transfer. The change authorization shall also indicate the date
of the transfer of the marketing authorization.
(6) The new marketing authorization holder fully assumes the rights and obligations of the previous
the marketing authorization holder.
(7) When transferring the marketing authorization for a medicinal product under the procedure of para. 1 - 6 his term is not
is changing.
Section VII.
Mutual recognition procedure and decentralized procedure
Art. 74. (1) When the person under Art. 26, para. 1 has been granted marketing authorization in another Member State for
the same medicinal product within the meaning of Art. 45, para. 3, which has applied for a permit for
use to the BDA, it shall submit a request to the regulatory authority of the Member State designated by it in the application,
hereinafter referred to as the "reference country", to draw up an evaluation report or to update an existing one.
(2) With the application the person under para. 1 submits to the BDA a dossier identical to that submitted in the reference
State and in the other Member States referred to in the application, hereinafter referred to as the countries concerned.
(3) The Executive Agency for Medicinal Products and the applicant shall receive, ex officio, from the regulatory body of
the reference country under para. 1 the evaluation report together with the approved summary of product characteristics and c
approved layout of the package and the package leaflet for the patient.
(4) The Executive Agency for Medicines shall consider the documents under para. 3 and inform in writing
the country of reference for the decision taken within 90 days of the date of receipt.
(5) Within 30 days of receipt of notification of completion of the procedure by the reference country
the BDA Executive Director issues a marketing authorization for the medicinal product on the territory of
Republic of Bulgaria with the approved summary of product characteristics, package layout and package leaflet
patient.
Art. 75. (1) When the person under Art. 26, para. 1 submits an application simultaneously to the BDA and other Member States
of a marketing authorization for a medicinal product for which a marketing authorization has not been granted
the territory of a Member State, it shall indicate in the application the regulatory authority of the Member State called
hereinafter referred to as the "reference country" to draft the evaluation report, draft summary
product characteristics and design of the patient package and package leaflet.
(2) With the application the person under para. 1 submits to the BDA a dossier identical to that submitted in all other countries
Member States referred to in the application, hereinafter referred to as the countries concerned.
(3) The Executive Agency for Medicinal Products and the applicant shall receive, ex officio, from the regulatory body of
reference country draft evaluation report, draft summary of product characteristics and design
on the mock-up of the package and the package leaflet for the patient.
(4) The Executive Agency for Medicines shall consider the documents under para. 3 and inform in writing
the country of reference for the decision taken within 90 days of the date of receipt.
(5) Within 30 days of receipt of notification of completion of the procedure by the reference country
the BDA Executive Director issues a marketing authorization for the medicinal product on the territory of
Republic of Bulgaria with the approved summary of product characteristics, package layout and package leaflet
patient.
Art. 76. (1) When the Republic of Bulgaria is a reference country under Art. 74, BDA:
1. within 90 days from the date of submission of valid documentation, send to the regulatory authorities of
the countries concerned and the applicant's assessment report, together with the approved summary of the
the product and the approved mock-up of the package and the package leaflet for the patient;
2. closes the procedure and notifies the applicant and the States concerned, if all States concerned are
approved.
(2) Within 30 days of the closing of the procedure under para. 1, item 2 the BDA Executive Director issues
marketing authorization for the medicinal product on the territory of the Republic of Bulgaria with the approved summary
product characteristics, package layout and package leaflet for the patient.
(3) Where the Republic of Bulgaria is a reference country under Art. 75, BDA:
1. send within 120 days from the date of submission of valid documentation to the regulatory authorities of
the countries concerned and the applicant draft assessment report, draft summary of the
the product and design of the package layout and the package leaflet for the patient;
2. closes the procedure and notifies the applicant and the States concerned, if all States concerned are
approved.
(4) Within 30 days of the closing of the procedure under para. 3, item 2 the BDA Executive Director issues
marketing authorization for the medicinal product on the territory of the Republic of Bulgaria with the approved summary
product characteristics, package layout and package leaflet for the patient.
Art. 77. (1) When the BDA does not approve the submitted documentation, mail. 74, para. 3 or under Art. 75, para. 3 on
Consideration of a potential serious risk to public health, prepares a detailed report with reasons for
the Member State of reference, the other countries concerned and the applicant.
(2) The disputed issues under para. 1 shall be considered by the Member States Coordination Group. The applicant
may submit its position on the issues under consideration in writing or orally.
(3) The Executive Agency for Medicines shall participate in the Coordination Group under para. 2 until close of
the reference country procedure.
(4) Within 30 days of receipt of notification of closure of the procedure by the reference country
the BDA Executive Director issues a marketing authorization for the approved medicinal product
summary of product characteristics, package layout and package leaflet for the patient.
Art. 78. (1) When in a procedure before the Coordination Group under Art. 77, para. 2 Member States did not reach
consent, the issues at issue are being considered by the Committee for Medicinal Products for Human Use at
European Medicines Agency under arbitration procedure. A copy of the documentation shall be sent to
of the applicant.
(2) The applicant shall submit to the European Medicines Agency the dossier for the medicinal product and the summary
product characteristics.
(3) In the cases of para. 1, if the BDA approved the evaluation report, the draft summary of the
the product and layout of the package and the package leaflet provided by the reference country,
the BDA's Executive Director may, at the request of the applicant, issue a marketing authorization to
the medicinal product before completing the arbitration procedure under para. 1.
(4) Upon completion of the arbitration procedure, the BDA Executive Director shall bring the issued
authorization for use under para. 3 in accordance with the decision of the European Commission.
Art. 79. (1) Where the regulatory authorities of one or more Member States have adopted different decisions
with regard to the marketing authorization or the same medicinal product
suspending or withdrawing it, the BDA referred the matter to the Committee for Medicinal Products for
human use by the European Medicines Agency for arbitration.
The applicant or the holder of the Marketing Authorization may refer the matter to the Committee
medicinal products for human use by the European Medicines Agency for the administration of
arbitration at its discretion.
(2) (Repealed, SG No. 102/2012, effective 21.12.2012)
(3) (amend. - SG 102/2012, in force from 21.12.2012) In the cases of para. 1 BDA or the applicant / holder
of the Marketing Authorization is granted to the European Medicines Agency
all available information on the relevant matter.
(4) (Repealed, SG No. 60/2011, effective 05.08.2011)
(5) (Repealed, SG No. 60/2011, effective 05.08.2011)
Art. 79a. (New, SG No. 60/2011, effective 05.08.2011) (1) Subject to the decision of the European
Commission after the completion of the BDA arbitration procedure within 30 days of receipt of the notification:
1. issues, suspends or suspends a marketing authorization, or
2. Requests that changes be made to the permit issued to comply with the decision of
The European Commission.
(2) The Medicines Executive Agency shall notify the European Commission and the European Medicines Agency
the medicines for the issued act under para. 1.
Art. 79b. (New, SG No. 102/2012, effective 21.12.2012) (1) In cases where the interests of
The European Union and before deciding on the authorization of a medicinal product
product, its suspension, termination or change, BDA, applicant or
the holder of the marketing authorization may refer the matter to the committee referred to in Art. 79, para. 1 for implementation
to arbitration.
(2) In the cases of para. 1 where referral is the result of an evaluation of tracking data
the safety of an authorized medicinal product, the matter is referred to the
Art. 56a, para. 1, item 1 and the procedure of art. 194h or 194h.
(3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall apply the procedure Chapter Eight,
Section IV, when it is necessary to implement one of the measures referred to in Art. 194y, para. 2 and 3.
(4) (New, SG No. 18/2014) Notwithstanding para. 1 - 3, when emergency action is needed to protect
public health at some stage of the arbitration procedure, the BDA may suspend the action of
the marketing authorization and prohibit the use of the relevant medicinal product within the territory of
The Republic of Bulgaria pending the adoption of the final decision.
(5) (New, SG No. 18/2014) In the cases of para. 4 The BDA informs the European Commission, the European Commission
the Medicines Agency and the other Member States for the reasons for their decision no later than the next
working day.
Art. 80. (amend. - SG 12/11, in force from 08.02.2011) The conditions and the procedure for making changes in
the authorizations granted under this section shall be governed by Regulation (EC) No 1234/2008 of the European Commission
24 November 2008 on the examination of changes in the conditions of marketing authorizations for
medicinal products for human use and veterinary medicinal products (OJ, L 334/7 of 12 December
2008).
Chapter Four.
CLINICAL TESTS
Section I.
general provisions
Art. 81. (Amended, SG No. 84/2018) (1) (1) A clinical trial on the territory of the Republic of Bulgaria may
shall be held after obtaining a permit issued under the terms and conditions of Regulation (EU) No
536/2014 of the European Parliament and of the Council of 16 April 2014 on the clinical trials of
medicinal products for human use and repealing Directive 2001/20 / EC (OJ L 158/1 of 27 May 2014
d.), hereinafter referred to as "Regulation (EU) No 536/2014", and this Act.
(2) The Executive Agency for Medicinal Products shall carry out the activities of reporting, respectively affected
country and additionally affected country within the meaning of Regulation (EU) No 536/2014, and is national
contact point of art. 83 of Regulation (EU) No 536/2014.
Art. 82. (Amended, SG No. 84/2018) (1) (1) For issuing a permit for conducting a clinical trial and
for granting authorization for a substantial change to an authorized clinical trial, the sponsor shall submit
application and dossier pursuant to Chapter IV of Regulation (EU) No 536/2014 through the European Union (EU) Portal on
Art. 80 of Regulation (EU) No 536/2014.
(2) To submit an application under para. 1 and for evaluation of the documentation attached to it, the assignor
shall pay a fee in the amount determined by the tariff under Art. 21, para. 2.
Art. 83. (Amended, SG No. 84/2018) (*) The Commission under Art. 103, para. 1 assesses the ethical aspects of
the clinical trial and the substantial modification of the clinical trial under the terms and conditions of
Regulation (EU) No 536/2014 and prepares a reasoned opinion which it submits to the BDA.
Art. 84. (Amended, SG No. 84/2018) (1) (1) The Executive Agency for Medicines shall issue a permit for
clinical trial, authorization of clinical trial under certain conditions, authorization of substantial
change of clinical trial, permission to substantially change clinical trial in certain
conditions or refuses authorization under the terms and conditions of Regulation (EU) No 536/2014.
(2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
Art. 85. (Amended, SG No. 84/2018) (*) By an ordinance of the Minister of Health shall determine:
1. the conditions and procedure for submission of data and information by the BDA and the Ethical Commission for Clinical
tests in the EU Portal under Art. 80 of Regulation (EU) No 536/2014;
2. the access of the BDA and the Ethical Committee for Clinical Trials to the EU Database. 81 of
Regulation (EU) No 536/2014;
3. the terms and procedure for submitting the opinions by post. 83 and the order of interaction between the BDA and
Ethics Committee for Clinical Trials;
4. the documents and particulars of Annex I and Annex II to Regulation (EU) No 536/2014, to be evaluated by
BDA and the Ethical Committee for Clinical Trials, as well as the language in which they are presented.
Art. 86. (1) (Supplemented, SG No. 84/2018) (*) All persons conducting a clinical trial must have
relevant professional qualifications, training and experience to fulfill the test-related requirements
tasks in accordance with the Good Clinical Practice rules under Regulation (EU) No 536/2014.
(2) A clinical trial of a medicinal product shall be carried out under the supervision of a physician or physician
dental medicine with recognized medical specialty in the relevant field, which is familiar with the available
preclinical and / or clinical data on the product and the risks and procedures of the study.
(3) During the clinical trial, the medical care provided to the trial participant and
medical decision-making is the responsibility of a physician with an appropriate qualification or a dentist
medicine.
Art. 87. (1) (amend. - SG 59/10, in force from 31.07.2010, amended - SG, issue 60 of 2011, in force since 05.08.2011
g., add. - SG, issue. 84 of 2018, effective 12.10.2018) Clinical trial may be conducted in therapeutic
hospitals, mental health centers, venereal disease centers,
complex oncology centers, dialysis centers, diagnostic and consulting centers, medical centers
centers, dental centers and medical-dental centers, as well as in individual and group practices for
primary and specialized medical care, licensed for activity / certificate of
registration according to the procedure of the Medical Institutions Act.
(2) (New, SG No. 84/2018, effective 12.10.2018) Clinical trial of medicinal products,
containing narcotic substances can only be carried out in hospitals,
mental health centers, centers for skin and venereal diseases and complex oncology
centers, in the structure of which a pharmacy, licensed under Art. 33, para. 1 of the Law on
control of narcotic drugs and precursors, or who have contracted with another drug
an establishment in the structure of which a pharmacy has been opened, holding a license under Art. 33, para. 1 of the Law
for drug and precursor control.
(3) (Renumbered from Paragraph (2), amend. - SG 84/08, in force from 12.10.2018) Clinical trial may be
conducts only in a medical establishment in which there is a designated contact person under Art. 107a, para. 1.
(4) (Renumbered from Paragraph (3), SG No. 84/2018, effective 12.10.2018)
the clinical trial of a medicinal product will be agreed to the participation of the principal
researcher and for conducting the test.
Art. 88. (1) Clinical trial on humans shall be performed with:
1. medicinal products not authorized for use in the Republic of Bulgaria;
2. medicinal products authorized for use in the Republic of Bulgaria when tested for unauthorized use
indication for a dosage form other than the authorized one in a group of patients not previously studied or
for more information.
(2) Authorized for use in the Republic of Bulgaria within the meaning of para. 1, item 2 are medicinal products received
authorization for use under this Act or under Regulation (EC) No 726/2004 of the European Union
Parliament and Council.
Art. 89. (Repealed, SG No. 84/2018)
Art. 90. (Repealed, SG No. 84/2018) (Amended, SG No. 17/2019)
Art. 91. The contracting authority and the principal investigator take out insurance covering their liability for
non-material and property damage caused during or in the course of the clinical trial
of the participants.
Art. 92. (1) (Amended, SG No. 84/2018) (*) The contracting authority shall be liable in case of health damage.
or death caused during or on the occasion of the clinical trial when the trial is
carried out in accordance with the requirements and procedures of the approved protocol.
(2) (Amended, SG No. 84/2018) (*) The Principal Investigator shall be liable in the event of damage to
health or death caused during or in connection with the conduct of a clinical trial when not
the requirements and procedures of the approved protocol are complied with.
Art. 93. (Am. - SG, iss. 84 in 2018. (*)) (1) When the clinical trial is conducted only in the territory of
The Republic of Bulgaria or on the territory of the Republic of Bulgaria and on the territory of a third country,
the contracting authority appoints a representative on the territory of the Republic of Bulgaria for the specific clinical
testing.
(2) The person under para. 1 is the addressee of the communication with the contracting authority provided for in Regulation (EU) No 536/2014.
Art. 94. The sponsor shall provide free of charge the tested medicinal product / products and each device,
necessary for its implementation.
Art. 95. (Repealed, SG No. 84/2018)
Art. 96. (1) (Amended, SG No. 84/2018) (*) Clinical testing of medicinal products shall be allowed only on
a person who has given his or her written informed consent.
(2) (Repealed, SG No. 84/2018)
(3) (Amended, SG No. 84/2018) (*) Informed consent under Chapter V of Regulation (EU) No 536/2014 may
gives only a capable person who understands the nature, significance, scope and potential risks of
the clinical trial. Informed consent to participate in a clinical trial may be withdrawn at
anytime.
(4) (Amended, SG No. 84/2018) (*) Informed consent under Chapter V of Regulation (EU) No 536/2014 for
an invalid adult is given by his legal representative. The consent of the legal representative
must represent the intended will of the participant and may be withdrawn at any time without
negative consequences for the participant.
(5) In the cases under Art. 162, para. 3 of the Health Act informed consent is given by the court-appointed person.
(6) The incapable adult shall be provided with information about the test, the possible risks and
benefits in accordance with his ability to understand.
(7) The explicit desire of the incapable adult to refuse to participate or to withdraw at any time
the time of the clinical trial should be taken into account by the investigator and, if necessary, by the investigator
the principal investigator.
Art. 97. (1) (Amended, SG No. 84/2018) (*) A clinical trial on a minor shall be conducted after
obtaining the written informed consent of both parents or guardians of the person at
compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3.
(2) The consent of the parents and guardians must represent the presumed will of the minor
and may be withdrawn at any time without negative consequences for the minor.
(3) The express wish of the minor to refuse to participate or to withdraw at any time from
the clinical trial should be considered by the investigator and, if necessary, by the principal
Explorer.
(4) (Amended, SG No. 84/2018) (*) A clinical trial on a minor shall be conducted after
obtaining written informed consent from the person or both parents or the guardian of
compliance with Chapter V of Regulation (EU) No 536/2014 and Art. 96, para. 3. When one parent is unknown,
died or deprived of parental rights, or not granted such rights in cases of divorce,
written informed consent is given by the minor and the parent who exercises
parental rights.
(5) The consent of the minor, the parents or the guardian may be withdrawn at any time
time without negative consequences for the minor.
(6) The express wish of the minor to withdraw at any time from the clinical trial must
to be taken into account by the researcher and, if necessary, by the principal investigator.
(7) The information of the minor or the minor shall be provided to the juvenile or minor
risks and benefits in a way that is understandable to him by a doctor who has experience with minors.
Art. 98. (Repealed, SG No. 84/2018)
Art. 99. (Repealed, SG No. 84/2018)
Section II.
Clinical trial with vulnerable patient groups (Repealed, SG No. 84/2018)
Section II.
A clinical trial with vulnerable patient groups
Art. 100. (Repealed, SG No. 84/2018)
Art. 101. (Repealed, SG No. 84/2018)
Art. 102. (Repealed, SG No. 84/2018)
Section III.
Ethical Committee for Clinical Trials (Title Amended, SG No. 84/2018)
12/10/2018)
Section III.
Ethics Committees
Art. 103. (amend. - SG 84/08, in force from 12.10.2018) (1) To the Minister of Health shall be
establish an Ethical Committee for Clinical Trials, the composition of which is determined by an order of the Minister of
and includes regular and reserve members. The reserve members shall attend the meetings of the
commission and have the right to vote in the absence of regular members.
(2) The commission under para. 1 consists of 7 to 12 regular members, including the Chair and the Deputy
a chairman with the qualifications and experience to review and evaluate scientific, medical and ethical
aspects of the proposed clinical trial. Requirements for the qualification of members of the Commission
under para. 1, as well as the terms and procedure for determining the composition of the commission shall be settled by
the rules of art. 106, para. 1.
(3) The commission under para. 1 includes at least two full-time non-medical members -
representatives of both sexes.
(4) For the needs of its work, the commission under para. 1 can attract external specialists.
(5) Only the members of the commission under para. 1, which are not in conflict of interest, are not specifically involved
testing and are independent of the client, the medical establishment where the clinical trial is being conducted,
and by the principal investigator, may participate in the assessment under Art. 83 as well as to vote and participate in
the discussion.
(6) For external specialists under para. 4, non-conflicting interests may be attracted, no
participate in a specific trial and are independent of the sponsor, the healthcare facility where it is held
the clinical trial, and from the lead investigator.
(7) The members of the commission under para. 1 and the external specialists under para. 4 may not have a private interest or
benefits that could affect their impartiality in the assessment under Art. 83.
(8) To certify the circumstances under para. 5-7 members of the commission under para. 1 and the external ones
specialists under para. 4 shall sign a declaration in accordance with the order and model specified in the regulations under Art. 106, para. 1.
Art. 104. (Repealed, SG No. 84/2018, effective 12.10.2018)
Art. 105. (1) (Amended, SG No. 84/2018, effective 12.10.2018)
103, para. 1 lasts 4 years.
(2) (Amended, SG No. 84/2018, effective 12.10.2018) Every two years, one-second of the members of
the commission under art. 103, para. 1 is being updated.
(3) (Amended, SG No. 84/2018, effective 12.10.2018) Member of the Commission 103, para. 1 cannot be
appointed to the same committee for more than two consecutive terms.
Art. 106. (amend. - SG 84/08, in force from 12.10.2018) (1) The Minister of Health shall approve
Rules on the terms and conditions of work of the Commission under Art. 103, para. 1.
(2) The Commission under Art. 103, para. 1 shall develop and adopt written standard operating procedures in accordance
with Good Clinical Practice rules.
(3) The meetings of the Commission under Art. 103, para. 1 are closed.
Art. 107. (Repealed, SG No. 84/2018)
Art. 107a. (New, SG No. 84/2018) (1) (1) The heads of the medical establishments in which they are carried out
clinical trials, identify the person or persons to contact.
(2) The person or persons for contact under para. 1 have the qualifications and experience to monitor
the clinical trials conducted at the hospital for compliance with the Good Clinical Rules
practice.
(3) The requirements for the qualification of the contact persons under para. 1 shall be settled in the postal regulations. 106, para. 1.
(4) In case of deviations from the approved protocol and / or side effects during the course of
clinical trial not reported under Regulation (EU) No 536/2014, contact person at
para. 1 shall notify the BDA and the Commission under Art. 103, para. 1.
Art. 108. (Repealed, SG No. 84/2018)
Section IV.
Permission to conduct a clinical trial
Art. 109. (Repealed, SG No. 84/2018)
Art. 110. (Repealed, SG No. 84/2018)
Art. 111. (Repealed, SG No. 84/2018)
Art. 112. (Repealed, SG No. 84/2018)
Art. 113. (Repealed, SG No. 84/2018)
Art. 114. (1) (Amended, SG No. 84/2018, effective 12.10.2018) 83
the assignor submits an application to the commission under art. 103, para. 1.
(2) (Repealed, SG No. 84/2018)
(3) (Repealed, SG No. 84/2018)
(4) (New, SG No. 12/2011, effective 08.02.2011, repealed - SG, iss. 84 of 2018 (*))
Art. 115. (Repealed, SG No. 84/2018)
Art. 116. (Repealed, SG No. 84/2018)
Art. 117. (Repealed, SG No. 84/2018)
Art. 118. (Repealed, SG No. 84/2018)
Art. 119. (Repealed, SG No. 84/2018)
Art. 120. (Repealed, SG No. 84/2018)
Art. 121. (Repealed, SG No. 84/2018)
Art. 122. (Repealed, SG No. 84/2018)
Art. 123. (Repealed, SG No. 84/2018)
Art. 124. (Repealed, SG No. 84/2018)
Art. 125. (Repealed, SG No. 84/2018)
Section V.
Changes (Repealed, SG No. 84/2018)
Section V.
Changes
Art. 126. (Repealed, SG No. 84/2018)
Art. 127. (Repealed, SG No. 84/2018)
Art. 128. (Repealed, SG No. 84/2018)
Art. 129. (Repealed, SG No. 84/2018)
Art. 130. (Repealed, SG No. 84/2018)
Art. 131. (Repealed, SG No. 84/2018)
Section VI.
Suspension of clinical trial (Repealed, SG No. 84/2018)
Section VI.
Suspension of clinical trial
Art. 132. (Repealed, SG No. 84/2018)
Art. 133. (Repealed, SG No. 84/2018)
Art. 134. (Repealed, SG No. 84/2018)
Section VII.
Safety Tracking (Repealed, SG No. 84/2018)
Section VII.
Safety monitoring
Art. 135. (Repealed, SG No. 84/2018)
Art. 136. (Repealed, SG No. 84/2018)
Art. 137. (Repealed, SG No. 84/2018)
Art. 138. (Repealed, SG No. 84/2018)
Art. 139. (Repealed, SG No. 84/2018)
Art. 140. (Repealed, SG No. 84/2018)
Art. 141. (Repealed, SG No. 84/2018)
Section VIII.
Notification of the completion of the clinical trial (Repealed, SG No. 84/2018)
Section VIII.
Notification of completion of clinical trial
Art. 142. (Repealed, SG No. 84/2018)
Art. 143. (Repealed, SG No. 84/2018)
Art. 144. (Repealed, SG No. 84/2018)
Chapter Four "a".
NON-INTERVENTIONAL STUDIES (NEW, PREVIOUS SECTION IX
"NON-INTERVENTIONAL STUDY" - SG, issue. 12 OF 2011, IN EFFECT OF 08/02/2011)
Art. 145. (1) (Supplemented, SG No. 12/2011, effective 08.02.2011) Non-interventional study shall be conducted with
medicinal products authorized for use in the Republic of Bulgaria when tested for obtaining
additional information on the product, prescribed in the usual manner in accordance with the conditions,
set out in the Marketing Authorization. Non-interventional study participants are not administered
diagnostic or follow-up procedures other than normal practice, such as for the analysis of results
data are used epidemiological methods.
(2) (Am. - SG, iss. 12 in 2011, effective as of 08.02.2011, repealed - SG, iss. 102 in 2012, in force since 21.12.2012)
(3) (Am. - SG, iss. 12 in 2011, in force since 08.02.2011, repealed - SG, iss. 102 in 2012, in force since 21.12.2012)
(4) (New, SG No. 12/2011, effective 08.02.2011, repealed - SG 102/2012, effective 21.12.2012)
(5) (New, SG No. 12/2011, effective 08.02.2011, repealed - SG 102/2012, effective 21.12.2012)
(6) (New, SG No. 12/2011, effective 08.02.2011, repealed - SG 102/2012, effective 21.12.2012)
Art. 145a. (New, SG No. 102/2012, effective 21.12.2012) (1) Non-interventional post-marketing
safety studies shall be carried out at the initiative of the marketing authorization holder or at
fulfillment of the conditions of art. 55a and 56a and are related to the collection of pharmacovigilance data from
patients and healthcare professionals.
(2) (Amended, SG No. 17/2019) Where the collection of patient data is planned in the study,
to obtain their consent. Patients' personal data are processed as required
for the protection of personal data.
(3) Medical professionals do not receive financial or other incentives to participate in
non-interventional safety studies other than time and expense compensation.
Art. 145b. (New, SG No. 102/2012, effective 21.12.2012) (1) During the conduct of the study on
Art. 145c, para. 1 and Art. 145f, para. 1, the marketing authorization holder monitors
the data obtained and take into account their impact on the benefit / risk balance of the medicinal product.
(2) The Marketing Authorization Holder shall notify the BDA of any new information that may
affects the benefit / risk ratio of the medicinal product.
(3) The obligation under para. 2 shall not exempt the holder of the marketing authorization from the requirement of Art.
194h for providing the information under para. 2 and through periodic safety update reports.
Art. 145c. (New, SG No. 102/2012, effective 21.12.2012) (1) (Amended, SG No. 84/2018)
12.10.2018) When the survey is conducted only in the territory of the Republic of Bulgaria in pursuance of
obligation under art. 56a, the holder of the marketing authorization shall submit to the BDA a draft of the protocol of
the study. The draft protocol, together with the written consent of art. 145a, para. 2, is also presented in
the commission under art. 103, para. 1.
(2) The Executive Director of the BDA within 60 days from the date of receipt of the documentation under para. 1
sends notification of approval of the study to the Marketing Authorization Holder or makes
motivated refusal.
(3) The BDA Executive Director shall refuse to conduct the study with one or more of the reasons for
Art. 145f, para. 2, Vol. 2.
(4) (Amended, SG No. 84/2018, effective 12.10.2018) 103, para. 1 within 60 days from the date
of receiving the documentation under para. 1 shall send the holder of the marketing authorization
positive or negative opinion.
(5) (Amended, SG No. 84/2018, effective 12.10.2018) The conduct of the study may commence after
obtaining approval from the BDA and a positive opinion from the committee under Art. 103, para. 1.
(6) To evaluate the documentation under para. 1 The BDA collects a fee in the amount specified in the tariff mail. 21, para. 2.
Art. 145g. (New, SG No. 102/2012, effective 21.12.2012) (1) (Amended, SG No. 84/2018)
12.10.2018) The Marketing Authorization Holder applies the planned material changes to the
in the cases under Art. 145c, para. 1 after their prior approval by the BDA and the Commission.
103, para. 1.
(2) (amend. - SG 84/08, in force from 12.10.2018) The holder of the marketing authorization shall submit
in the BDA and in the committee under Art. 103, para. 1 the documentation related to the changes and the reasons for it.
(3) The Executive Director of the BDA within 30 days from receipt of the documentation under para. 2 approves
the amended protocol or issues a reasoned refusal and notifies the marketing authorization holder.
(4) (Amended, SG No. 84/2018, effective 12.10.2018) 103, para. 1 within 30 days from the date
of receiving the documentation under para. 2 shall send the marketing authorization holder
positive or negative opinion.
(5) The BDA Executive Director shall refuse the changes under para. 1 with one or more of the reasons given in
Art. 145f, para. 2, Vol. 2.
(6) (amend. - SG 84/08, in force from 12.10.2018) The holder of the marketing authorization may
apply the changes under para. 1 after obtaining the approval of the BDA and a favorable opinion from the Commission on
Art. 103, para. 1.
(7) To evaluate the documentation under para. 1 The BDA collects a fee in the amount specified in the tariff mail. 21, para. 2.
Art. 145d. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
submit a final report of the BDA study within 12 months after the completion of the BDA collection
data. A summary of the results of the study shall be attached to the report.
(2) The Marketing Authorization Holder may submit a reasoned request to the BDA to postpone
term under para. 1 at least three months before the date of submission of the final report referred to in
protocol.
(3) The Executive Agency for Medicines shall approve or make a reasoned refusal of the request under para. 2 and
notifies the marketing authorization holder.
(4) When the holder of the marketing authorization based on the report under para. 1 thought it was
necessary change of the marketing authorization, he submits to the BDA an application for change in the order of chapter
third, section VI.
(5) The Executive Director of the BDA shall, by order, suspend or terminate the authorization for
use when the BDA based on the report under para. 1 and after consultation with the authorization holder for
use shall consider the suspension or termination of the marketing authorization.
Art. 145f. (New, SG No. 102/2012, effective 21.12.2012) (1) When the study is conducted as on
the territory of the Republic of Bulgaria and of the territory of other Member States for medicinal products
products authorized under Regulation (EC) No 726/2004 of the European Parliament and of the Council or
the order of Chapter Three, Section VII, in the performance of its duties 55a or under Art. 56a, the holder of
the marketing authorization shall be submitted to the committee under art. 56a, para. 1, item 1 of the draft protocol.
(2) Within 60 days from the date of receipt of the documentation under para. 1 Committee 56a, para. 1, v. 1
prepares an opinion and sends to the marketing authorization holder:
1. notification of approval, or
2. a reasoned refusal when:
(a) find that the study promotes the use of the medicinal product, and / or
(b) consider that the design of the study will not achieve the objectives of the report, and / or
(c) the study is of a clinical trial nature.
(3) (amend. - SG 84/08, in force from 12.10.2018) In the cases of para. 2, item 1 the holder of the permit
submit a notice to the BDA for use.
(4) (Amended, SG No. 84/2018, effective 12.10.2018) 103, para. 1 within 15 days of the date
upon receipt of the notification under para. 3 sends the Marketing Authorization Holder positively
or negative opinion.
(5) (Amended, SG No. 84/2018, effective 12.10.2018) The conduct of the study may commence after
receiving a positive opinion from the commission under art. 103, para. 1.
(6) The content and format of the protocol under para. 1 are governed by Implementing Regulation (EU) No 520/2012
Regulation of 19 June 2012 on the implementation of pharmacological activities
vigilance provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and in a Directive
2001/83 / EC of the European Parliament and of the Council (OJ L 159/5 of 20 June 2012), hereinafter referred to as 'the European Parliament and of the Council'
"Implementing Regulation (EU) No 520/2012".
Art. 145g. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization for
the cases under Art. 145f, para. 1 applies planned significant changes to the study protocol after
their prior approval by the committee under Art. 56a, para. 1, v. 1.
(2) The holder of the marketing authorization shall submit to the committee referred to in Art. 56a, para. 1, item 1 of the documentation,
changes, and the reasons for that.
(3) (Amended, SG No. 84/2018, effective 12.10.2018) 56a, para. 1, item 1 approved
the changes in the protocol, the holder of the marketing authorization shall notify the BDA and the commission under art. 103,
para. 1.
(4) (amend. - SG 84/08, in force from 12.10.2018) The holder of the marketing authorization may
apply the changes under para. 1 after receiving a positive opinion from the commission under Art. 103, para. 1.
Art. 145h. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
submit electronically to the Committee under Art. 56a, para. 1, item 1 final report, accompanied by a summary of
the results of the survey, within 12 months of the completion of data collection.
(2) The Marketing Authorization Holder may submit a reasoned request to the Committee. 56a, para.
1, item 1 for postponement of the term under para. 1 at least three months before the final submission date
the report referred to in the minutes.
(3) The Committee under Art. 56a, para. 1, item 1 approves or makes a reasoned refusal of the request under para. 2 and notify
the holder of the marketing authorization.
(4) The content and format of the report under para. 1 are governed by Implementing Regulation (EU) No 520/2012.
Art. 145i. (New, SG No. 102/2012, effective 21.12.2012) 56a, para. 1, item 1 on the basis of
the report under Art. 145h, para. 1 and after consulting the marketing authorization holder issues a reasoned one
recommendation on the authorization of the medicinal product and sends it to:
1. The Committee for Medicinal Products for Human Use 5 of Regulation (EC) No 726/2004
The European Parliament and the Council, or
2. the coordination group of art. 77, para. 2.
(2) In the cases of para. 1, item 2, when the committee under art. 56a, para. 1, item 1 recommended change, suspension or
suspension of the marketing authorization, coordination group represented by Member States, c
The survey conducted conducted an opinion on the necessary actions to be taken
undertake with regard to the marketing authorization, including a timetable for its implementation.
(3) When the Member States represented in the coordination group reach consensus on the opinion
under para. 2, it shall be published on the European Internet portal for medicinal products under Art. 68, para. 1, item 4 and se
sends the marketing authorization holder.
(4) The BDA Executive Director in accordance with the opinion under para. 2 stops or
terminates the marketing authorization.
(5) Where in the opinion under para. 2 recommended changes to the marketing authorization issued,
the Marketing Authorization Holder submits to the BDA within the specified implementation schedule
an application for change pursuant to Chapter Three, Section VI, incorporating an updated summary of the
product and leaflet.
(6) Where agreement cannot be reached within the coordination group, the position of
the majority of the Member States are referred to the European Commission, which decides on
modification, suspension or revocation of the marketing authorization granted by the relevant regulatory authority
Member State authorities.
(7) The decision under para. 6 is published on the European Medicines Portal. 68, para.
1, item 4 and shall be sent to the holder of the marketing authorization.
(8) The Executive Agency for Medicinal Products applies the provisional and / or definitive measures of the Decision on Medicinal Products
para. 6 and inform the European Medicines Agency and the European Commission.
(9) In the cases of para. 1, item 1 The Committee for Medicinal Products for Human Use, in accordance with
the recommendation of the committee under art. 56a, para. 1, item 1 issues an opinion on the retention, amendment,
suspension or termination of the marketing authorization, including a timetable for
implementation of the opinion. The opinion shall be published on the European Medicines Portal
products of art. 68, para. 1, item 4 and shall be sent to the holder of the marketing authorization.
(10) Where in the opinion under para. 9 is a position for regulatory action under
as regards marketing authorizations, the European Commission shall decide to amend, suspend or
suspension of the marketing authorizations granted under Regulation (EC) No 726/2004 of the European Union
Parliament and the Council.
Art. 145k. (New, SG No. 102/2012, effective 21.12.2012) (1) (Amended, SG No. 84/2018)
12.10.2018) Non-interventional studies in the territory of the Republic of Bulgaria are conducted at
conditions and in the order determined by an ordinance of the Minister of Health.
(2) When conducting non-interventional studies under para. 1 indicates the source of funding.
Chapter Five.
MANUFACTURE AND IMPORTATION OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES (TITLE I).
AMENDED. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
Section I.
Production
Art. 146. (1) (amend. - SG 102/02, in force from 02.01.2013) The production of all kinds of medicinal
products within the meaning of this Act and of medicinal products intended for clinical trial may
to carry out on the territory of the Republic of Bulgaria only natural or legal persons registered
as traders in the territory of a Member State who have been granted a manufacturing authorization granted by
the Director of the Executive Agency for Medicines.
(2) A production permit shall also be required in the cases where the products under para. 1 are intended for
wear.
(3) (amend. - SG 71/08, in force from 12.08.2008) Production permit is also required for persons,
who simultaneously or individually perform one of the following activities: full or partial production,
various processes of packaging, packaging, repackaging, labeling, quality control and
release of batches of medicinal products and medicinal products intended for clinical use
testing.
(4) (Repealed, SG No. 71/2008, effective 12.08.2008)
(5) No manufacturing authorization is required when the processes of packaging, mixing or packaging are carried out
they carry out a prescription or pharmacopoeial prescription at a pharmacy.
Art. 147. (amend. - SG 102/2012, in force from 02.01.2013) The Executive Agency for Medicines shall introduce
information on marketing authorizations for medicinal products and certificates of Good
manufacturing practice in the European Union database.
Art. 148. To obtain a manufacturing authorization, the person mailed. 146 must have:
1. with personnel with appropriate qualification, depending on the specificity of the species produced
medicines and dosage forms;
2. at any time with at least one qualified person eligible for post. 159;
3. premises for production, control and storage of the medicinal products, provided with the necessary
technical equipment and control laboratories.
Art. 149. Heads of production and quality control of medicinal products in
manufacturing enterprises are persons:
1. who have a master's degree in pharmacy, chemistry
or "biology" and at least two years of practical experience in pharmaceutical manufacturing;
2. which meet the requirements of item 1 and have an additional recognized specialty in radiobiology or
radiochemistry - for radiopharmaceuticals or for medicinal products subject to ionizing radiation;
3. with recognized specialty in clinical hematology, medical microbiology, virology or immunology
- for the production of immunological medicinal products - vaccines, toxins, serums, for biotechnological products
products and for medicinal products derived from human plasma or from human blood.
Art. 150. (1) The person under art. 146 shall submit to the BDA an application in accordance with a model approved by the Director of the Agency.
(2) Together with the application under para. 1 the applicant shall also submit:
1. (suppl. - SG 103/07, in force from 01.01.2018) diploma for higher education, document for the acquired
specialty, work record, criminal record or similar person document, if not
is a Bulgarian citizen, and an employment contract for the persons under Art. 148, item 2 and art. 149;
2. copies of contracts for the assignment of production and / or control of the products declared for production - in
the cases under Art. 151;
3. (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 60/2011, in force from 05.08.2011) data
for the Unique Identification Code of the Merchant or Cooperative of the Commercial Register, and for the companies,
registered in a Member State of the European Union, or in a State Party to the
European Economic Area - a document for current national registration
legislation issued by a competent authority of the country concerned;
4. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012, in force since 02.01.2013)
a list of the manufacturing activities and the dosage forms to be manufactured;
5. schemes of the premises for production, control and storage and file of the production capacity;
6. assessment of the environmental impact of the manufacture of medicinal products in accordance with the provisions of Art
Environmental Protection Act cases;
7. permission from the Nuclear Regulatory Agency when the application concerns the production of
radiopharmaceuticals or medicinal products subject to ionizing radiation during manufacture
them;
8. permission to use the premises for production, control and storage, issued in accordance with the procedure of
The Spatial Planning Act, or any other substitute document;
9. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
10. a document for payment of a fee in the amount specified in the tariff mail. 21, para. 2.
(3) In the manufacture of narcotic substances and dosage forms containing such substances,
also comply with the requirements of the Narcotic Drugs and Precursors Control Act.
(4) (New - SG 103 2017, in force from 01.01.2018) The Executive Agency for Medicines shall establish
ex officio the circumstances regarding the criminal record of the persons under para. 2, item 1, when they are Bulgarian citizens.
Art. 151. When any of the stages of manufacture or control tests in the manufacturing process occur
carry out by contract in another object on the territory of the Republic of Bulgaria or outside it, the persons under art. 146 are
shall indicate the location of this site and a copy of the contract in which they are determined
the responsibilities of each Party in respect of compliance with the requirements of Good Manufacturing
practice of medicinal products and the obligations of the qualified person under art. 148, Vol. 2.
Art. 152. (amend. - SG 102/2012, in force from 02.01.2013) (1) The principles and requirements for Good
manufacturing practice for all types of medicinal products, clinical medicinal products
testing and of active substances shall be determined by an ordinance of the Minister of Health and by acts and
guidelines adopted by the European Commission.
(2) Principles and requirements for official risk assessment to establish Good Manufacturing
practice for excipients shall be determined by the ordinance under para. 1 and with guidelines adopted by the European
commission.
Art. 153. (1) Upon receipt of an application under Art. 150 BDA evaluates the submitted documentation and performs
on-site inspection of the production, control and storage sites, including in the cases under Art. 151,
to establish the correspondence between the submitted documentation and the conditions of production, control
and storage of manufacturing starting materials and finished medicinal products and conformity
them with the requirements of Good Manufacturing Practice.
(2) The costs of carrying out on-site inspections under para. 1 shall be at the expense of the applicant.
(3) For carrying out on-site inspections under para. 1, the applicant shall pay a fee in the amount specified in the tariff
under Art. 21, para. 2.
Art. 154. (1) When the BDA establishes incompleteness in the submitted documentation and / or inconsistency between
the content of the documentation submitted and the status of the site or the qualification requirements
shall notify the applicant in writing and give written instructions.
(2) In the cases of para. 1 the term under Art. 155, para. 1 stops running until the object or documentation is brought
as required.
Art. 155. (1) (Amended, SG No. 84/2018, effective 12.10.2018) The Executive Director of the BDA within 60 days
from the date of submission of the application under Art. 150
1. issue a manufacturing authorization, or
2. make a reasoned refusal.
(2) (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 02.01.2013)
A production authorization shall be issued only for the production activities specified in the application and
dosage forms and medicinal products intended for clinical trial and for the premises where
production, control and storage will be carried out.
(3) The acts of para. 1 shall be served on the applicant.
(4) The manufacturing authorization is open-ended.
(5) The refusal under para. 1, item 2 shall be subject to appeal in accordance with the Administrative Procedure Code.
Art. 156. (1) The holder of a manufacturing authorization shall submit an application upon change of:
1. the person under art. 148, Vol. 2;
2. the persons under art. 149;
3. (repealed, SG No. 60/2011, effective 05.08.2011)
4. the location or conversion of any of the production, control or storage sites;
5. (amend. - SG 60/11, in force from 05.08.2011) production activities;
6. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012, in force since 02.01.2013)
the dosage forms produced;
7. (amend. - SG 60/11, in force from 05.08.2011) the commercial registration.
(2) To the application under para. 1, the documents related to the change, which are specified in the ordinance, shall be attached
under Art. 152.
(3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days from the occurrence of change of
the equipment shall be notified in writing by the holder of the manufacturing authorization to the BDA.
(4) (New, SG No. 60/2011, effective 05.08.2011) The holder of a manufacturing permit shall file in
BDA notification at the start of production of each new authorized medicinal product.
(5) (Renumbered from Paragraph (3), SG No. 60/2011, effective 05.08.2011)
shall terminate if its holder ceases its activity, for which it is obliged to notify the BDA in writing.
Art. 157. (1) When issuing the permit permitting the change, the provisions of Art.
150 and 151, with a deadline for issue:
1. 14 days - in cases of post. 156, para. 1, items 1, 2 and 7;
2. (amend. - SG 60/11, in force from 05.08.2011) 30 days - in the cases of post. 156, para. 1, Vols 4 - 6.
(2) (amend. - SG 60/11, in force from 05.08.2011) When you change the post. 156, para. 1, items 4 - 6 can not
are evaluated by documents, the BDA carries out an on-site inspection. In these cases, the term under para. 1, item 2 stops running until
completion of verification.
(3) The expenses for carrying out on-site inspections under para. 2 shall be at the expense of the applicant.
(4) For carrying out on-site inspections under para. 2, the applicant shall pay a fee in the amount specified in the tariff
under Art. 21, para. 2.
Art. 158. (1) The Executive Agency for Medicines shall keep a register of mail. 19, para. 1, item 1 of the issued
production authorizations containing:
1. number and date of the manufacturing authorization;
2. the name, seat and address of management of the person who has obtained the manufacturing authorization;
3. address of the premises for production, control and storage of the medicines;
4. (amend. - SG 102/02, in force from 02.01.2013) the medicinal products and the forms for which it has been received
the authorization;
5. name of the person under art. 148, Vol. 2;
6. names of the persons under art. 149;
7. date of deletion from the register of production authorization and the reason for doing so.
(2) The data from the register of issued production authorizations shall be published on the BDA website in
Internet.
(3) Upon request from the European Commission or a regulatory authority of a Member State, the BDA shall provide
information on the production authorization issued.
Art. 159. (1) The holder of a permit for production of rent under an employment contract at least one
Qualified person under Art. 148, item 2, which is permanently at his disposal.
(2) The qualified person under para. 1 shall meet the following requirements:
1. have a master's degree in medicine, pharmacy, chemistry, biotechnology or biology;
2. have at least two years of practical experience in pharmaceutical manufacturing and / or manufacturing
of qualitative and quantitative analysis of medicinal products and active substances.
(3) When the holder of the marketing authorization for a medicinal product meets the requirements of
para. 2, it may fulfill the obligation of a qualified person.
(4) (New, SG No. 102/2012, effective 21.12.2012) The qualified person shall be responsible for
the packaging of the medicinal product the safety indicators according to art. 168, para. 8.
(5) (Renumbered from Paragraph (4), SG No. 102/2012, effective 21.12.2012) The qualified person shall issue a certificate
to release any batch certifying that the batch of medicinal product is manufactured and
controlled in accordance with the requirements of the marketing authorization under this Act.
(6) (Renumbered from Paragraph 5, SG No. 102/2012, effective 21.12.2012, amended - SG No. 84/2018 (*))
The qualified person shall issue a certificate of release to each lot, certifying that the lot
medicinal product intended for clinical trial is manufactured and controlled in accordance with
the requirements of Good Manufacturing Practice, with the manufacturing file of the product and with the documentation
for the investigational medicinal product under Regulation (EU) No 536/2014.
(7) (Renumbered from Paragraph 6, SG No. 102/2012, effective 21.12.2012) The Qualified Person shall keep a register of
certificates issued for the release of each batch of the medicinal product.
(8) (Prev. Para 7, amend. - SG 102/02, in force from 21.12.2012) The data from the register under para. 7 se
kept for at least 5 years after the last entry and shall be submitted to the inspection bodies at
request.
(9) (Renumbered from Paragraph 8, SG No. 102/2012, effective 21.12.2012)
administrative criminal proceedings for violations committed in the performance of the duties of
the qualified person, the BDA orders the holder of the manufacturing authorization to remove
on a temporary basis by a qualified person.
(10) (Renumbered from Paragraph 9, SG No. 102/2012, effective 21.12.2012) Criteria and requirements for
the qualification and training of the persons under art. 148, item 2 shall be determined in the ordinance under Art. 152.
Art. 160. (1) The holder of a manufacturing authorization shall:
1. (amended, SG No. 84/2018) (*) ensure the production operations in accordance with
the requirements of the Good Manufacturing Practice and in accordance with the information approved by the BDA under Art.
27, para. 1, items 7 and 8, and in the case of medicinal products for clinical trial, in accordance with
the documentation for the tested medicinal product in accordance with Regulation (EU) No 536/2014;
2. (amend. - SG 102/2012, in force from 02.01.2013) use only active substances which are manufactured
in accordance with the requirements of Good Manufacturing Practice for Active Substances;
2a. (new - SG 102/2012, in force from 02.01.2013) make sure that the auxiliary substances used in
the medicinal products are manufactured in accordance with the relevant good manufacturing practices for
excipients determined on the basis of a formal risk assessment in accordance with the applicable ones
guidelines adopted by the European Commission;
3. provide permanently qualified production and control personnel as required by
the ordinance under Art. 152;
4. (amend. - SG 12/11, in force from 08.02.2011) has only medicinal products which have
authorization for use, subject to the requirements of this law;
5. (repealed, SG No. 12/2011, effective 08.02.2011)
6. notify immediately the control bodies in case of change of qualified person post. 148, Vol. 2;
7. provide access to the premises and documentation at all times to the control bodies;
8. provide to the qualified person under Art. 148, item 2 the necessary conditions for fulfilling the obligations
his;
9. (New - SG, iss. 102 in 2012) shall inform immediately the BDA and the holder of
the marketing authorization if it receives information that the medicinal products covered by the
its manufacturing authorization, are falsified or there are suspected falsifications,
whether or not these medicinal products were distributed within the legal chain
delivery or in an illegal manner, including through illegal sale through the services of
the information society;
10. (new - SG 102/2012, in force from 02.01.2013) check whether the manufacturers, importers or
traders from whom it receives active substances are registered by the competent authority of the Member State,
in which they are established;
11. (new - SG 102/2012, in force from 02.01.2013) shall check the authenticity and quality of the active and
of excipients.
(2) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing authorization
performs audits at the sites for the production and marketing of active substances in order to comply with the Good
manufacturing practice and Good distribution practice. The holder of the manufacturing authorization
may contract with a third party to perform the audit on his behalf and on his behalf.
(3) (New, SG No. 102/2012, effective 02.01.2013) The holder of the manufacturing authorization
documents the undertakings under para. 1, items 2 and 2a measures.
(4) (Renumbered from Paragraph (2) - SG, No. 102 of 2012, in force since 02.01.2013, amend. - SG, iss. 84 in 2018. (*))
of a manufacturing authorization shall keep the samples and the documentation of the medicinal products manufactured by him
products and active substances under the conditions and in the order specified in the ordinance under Art. 152, para. 1.
(5) (Renumbered from Paragraph (3), SG No. 102/2012, effective as of 02/01/2013, repealed - SG, iss. 84 in 2018 (*))
(6) (Renumbered from Paragraph (4), SG No. 102/2012, effective 02.01.2013) The documentation for each concluded transaction
is stored for 5 years and contains the date, the name of the medicinal product, the quantity delivered, the name and
recipient address and batch number.
(7) (Renumbered from Paragraph 5, SG No. 102/2012, effective 2 January 2013) The holder of a permit for
production provides and maintains a system for blocking and withdrawal of medicinal products from the market,
showed non-compliance with quality requirements.
(8) (Renumbered from Paragraph 6, SG No. 102/2012, effective 2 January 2013) The holder of a permit for
the production is obliged to block and withdraw the medicinal products which have shown non-compliance with
the requirements for quality, efficiency and safety, in accordance with the ordinance under Art. 274, para. 1.
(9) (Renumbered from Paragraph 7, SG No. 102/2012, effective 2 January 2013) The holder of a permit for
production is obliged to update production methods in accordance with the development of new ones
technologies and the development of test drug products.
(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
02.01.2013) Based on the manufacturing authorization issued pursuant to this section, the holder
it may import the excipients necessary for the manufacture of the medicinal products
products specified in the manufacturing authorization.
Art. 160a. (New, SG No. 60/2011, effective 05.08.2011) (1) The Executive Director of the BDA with an order
withdraw the issued production permit when the conditions under Art. 148 and were not observed
the requirements of Good Manufacturing Practice, determined in accordance with Art. 152.
(2) The Executive Director of the BDA shall, with an order, terminate the manufacturing authorization:
1. at the written request of its holder;
2. upon termination of the activities for which it was issued;
3. upon deletion of the registration of the trader;
4. at the death of the individual - sole trader.
(3) The order under para. 1 may be appealed in accordance with the Administrative Procedure Code, such as
the appeal does not suspend enforcement.
Section II.
Import of medicinal products (Title amend. - SG 102/02, in force from 02.01.2013)
Art. 161. (1) (amend. - SG 102/02, in force from 02.01.2013) Imports into the territory of the Republic of Bulgaria
from a third country of all types of medicinal products and medicinal products intended for
clinical trial may only be performed by natural or legal persons registered as traders
under the law of a Member State which has been granted an import authorization by the executive
director of the BDA.
(2) In order to obtain an import permit, the person under para. 1 must have:
1. (amend. - SG 102/2012, in force from 02.01.2013) at any time with at least one qualified person,
which meets the requirements of Art. 159, para. 2 and 10;
2. (amend. - SG 102/2012, in force from 02.01.2013) with a laboratory for quality control in compliance
with the requirements of the ordinance under Art. 152 and storage facilities for medicinal products, and
clinical trial medicinal products with the necessary technical equipment, c
compliance with the requirements of the ordinance under Art. 198.
Art. 162. (1) For obtaining a permit for import the person shall mail. 161, para. 1 submits an application to the BDA on
model approved by the Executive Director of the Agency.
(2) To the application under para. 1 shall apply:
1. (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 60/2011, in force from 05.08.2011) data
for the Unique Identification Code of the Merchant or Cooperative of the Commercial Register, and for the companies,
registered in a Member State of the European Union, or in a State Party to the
European Economic Area - a document for current national registration
legislation issued by a competent authority of the country concerned;
2. (amend. - SG 102/2012, in force from 02.01.2013) list of the medicinal products and the forms which will
are imported;
3. (suppl. - SG 71/08, in force from 12.08.2008) a copy of the production permit issued by
the regulatory authority of the exporting country and a certificate attesting the eligibility of the exporting country
production, control and storage with standards at least equivalent to Good standards
manufacturing practice;
4. documents certifying the circumstances under Art. 159, para. 1 and 2 for the qualified person;
5. data on the address of a laboratory on the territory of the Republic of Bulgaria for completion of a complete
quantitative and qualitative analysis of at least the active substances and of all other tests and tests for
demonstration of the quality of each imported batch of medicinal product in accordance with the requirements of
the marketing authorization under this law and the address of the storage premises;
6. a contract which defines the responsibilities of each party in respect of compliance with
the principles of Good Manufacturing Practice by the contractor and the way in which the qualified person
under Art. 161, para. 2, item 1 shall perform its duties when the person sends. 161, para. 1 does not have
with its own laboratory;
7. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
(3) (New, SG No. 71/2008, effective 12.08.2008) Upon receipt of an application under para. 1 BDA evaluates
the documentation submitted and perform an on-site inspection of the control laboratory and premises
storage of medicinal products and medicinal products intended for clinical trial for
establishing their compliance with the requirements of Good Manufacturing Practice and Good
distribution practice.
(4) (Renumbered from Paragraph (3), SG No. 71/2008, effective 12.08.2008) Where the premises for production are
located in a third country with which the European Community has a mutual agreement signed
recognition of certificates of good manufacturing practice, the persons under art. 161, para. 1 apply to
the application address of any premises for the production of medicinal products, active substances or
medicinal products intended for clinical trial, name, headquarters and management address
of the person who has obtained the manufacturing authorization, a certificate certifying compliance with the conditions
for production, control and storage with standards equivalent to those approved by
the requirements of Good Manufacturing Practice, and the name of the qualified person.
(5) (Renumbered from Paragraph (4), amend. - SG 71/08, in force from 12.08.2008) In cases other than para. 4, BDA
carry out, where necessary, on - the - spot verification of compliance with the documentation
conditions for the manufacture, control and storage of medicinal products in the exporting country. At
establishing conformity with Good Manufacturing Practice the BDA issues a certificate.
(6) (Renumbered from Paragraph (5), amend. - SG 71/08, in force from 12.08.2008)
the on-site inspection under para. 5 are at the expense of the importer.
(7) (Renumbered from Paragraph (6), amend. - SG 71/08, in force from 12.08.2008) For carrying out on-site inspection
under para. 3 or under par. 5 the applicant shall pay a fee in the amount specified in the tariff under Art. 21, para. 2.
Art. 163. (1) The qualified person under art. 161, para. 2, item 1 issues a certificate of release to each
batch certifying that the imported batch of medicinal product is from a third country, whether or not
the product is manufactured or not in another Member State before being placed on the market in
The Republic of Bulgaria is subject to a complete qualitative and quantitative analysis, at least of the active ones
substances, and all necessary tests and checks have been carried out in accordance with the requirements for
granting a marketing authorization under this law.
(2) When a batch of a medicinal product imported from a third country is subject to the analyzes under para. 1 c
another Member State and shall be accompanied by a batch release certificate signed by another Member State
Qualified person, no control tests required in the territory of the Republic
Bulgaria.
(3) Where a batch of a medicinal product is imported from a third country with which the European Community is present
signed agreement on mutual recognition of the certificate of good manufacturing practice,
the qualified person issues a batch release certificate based on the accompanying person
the batch of documentation without having to carry out control tests on the territory of the Republic
Bulgaria.
(4) (Repealed, SG No. 84/2018)
(5) (Repealed, SG No. 84/2018)
(6) (Am. - SG, iss. 71 in 2008, effective from 12.08.2008, repealed - SG, iss. 84 of 2018 (*))
(7) The qualified person under para. 1 shall keep records of each batch of medicinal product imported
for at least 5 years and submit it to the control authorities upon request.
(8) The holder of an import authorization provides and maintains a system for blocking and withdrawing from the market
medicinal products that have shown non-compliance with quality requirements.
(9) The holder of the import authorization is obliged to block and withdraw the medicinal products which have shown
non-compliance with the requirements for safety and efficacy according to the ordinance under Art. 274, para. 1.
(10) (amend. - SG 12/11, in force from 08.02.2011) The provisions of Art. 160, para. 1, items 4 and 7 shall also apply
as regards the holders of the import authorization.
(11) The holder of the import authorization shall provide the qualified person with a post. 161, para. 2, Vol. 1
the conditions necessary for the performance of his duties and shall notify the inspection bodies immediately
its change.
(12) When instituting administrative criminal proceedings for infringements committed under
the fulfillment of the obligations of the qualified person, the BDA shall order the authorization holder
to remove temporarily qualified person from office.
Art. 163a. (New, SG No. 12/2011, effective 08.02.2011) (1) When the BDA establishes incompleteness and deficiencies
in the documentation submitted, it shall notify the applicant in writing and give written instructions.
(2) In the cases of para. 1 the term under Art. 164, para. 1 stops running until documentation in
compliance with requirements.
Art. 164. (1) The BDA Executive Director shall issue an import permit within 30 days from the date of submission
of the application under Art. 162 or reasonably refused.
(2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
(3) The import permit shall be issued only for the medicinal products specified in the application, their forms
active substances for both the specified medicinal products for clinical trial and for
the premises where the control and storage will be carried out.
(4) The import authorization is open-ended.
Art. 165. (1) The holder of an import permit from a third country shall submit to the BDA an application upon change of:
1. the person under art. 161, para. 2, Vol. 1;
2. (amend. - SG 102/02, in force from 02.01.2013) the medicinal products and the forms for which it was issued
the import authorization;
3. the address of the laboratory under Art. 161, para. 2, Vol. 2;
4. the court registration of the trader.
(2) To the application under para. 1, the documents related to the change set out in the ordinance post shall apply.
152.
Art. Article 166. (1) The provisions of Art.
164, the term for its issuance being:
1. in the cases of art. 165, para. 1, items 1, 2 and 4 - up to 14 days;
2. in the cases of art. 165, para. 1, item 3 - up to 30 days.
(2) When the change under Art. 165, para. 1, item 3 cannot be evaluated on documents, the BDA checks on
place. In these cases, the term under para. 1, item 2 shall stop running until the check is completed.
(3) The expenses for carrying out on-site inspections under para. 2 shall be at the expense of the applicant.
(4) For carrying out on-site inspections under para. 2, the applicant shall pay a fee in the amount specified in the tariff
under Art. 21, para. 2.
Art. 167. (1) The Executive Agency for Medicines shall keep a register of mail. 19, para. 1, item 2 of the issued
import licenses containing:
1. number and date of the import authorization;
2. name, registered office and address of management of the person who has received the import permit;
3. address of the premises for control and storage of the medicinal products;
4. (amend. - SG 102/02, in force from 02.01.2013) the medicinal products and the forms for which it has been received
the authorization;
5. name of the person under art. 161, para. 2, Vol. 1;
6. date of deletion from the register of the import authorization and the grounds thereof.
(2) Data from the register shall be published on the BDA website on the Internet.
Section III.
Production, import and wholesale of active substances (New, SG No. 102/2012,
(effective from 02/01/2013)
Art. 167a. (New, SG No. 102/2012, effective 02.01.2013) Manufacture, import or wholesale of
active substances may only be carried out by natural or legal persons registered as traders under
the legislation of a Member State and entered in the register under Art. 167g.
Art. 167b. (New - SG 102/2012, in force from 02.01.2013) (1) For entry in the register no. 167g
the applicant submits to the BDA an application in accordance with a model approved by the BDA Executive Director, which contains:
1. Name, registered office and address of management of the person mailed. 167a;
2. a list of the active substances to be imported, manufactured or marketed;
3. the activities that the person under art. 167a will perform;
4. address of the premises and data on the technical equipment for carrying out the activity of the persons under
Art. 167a.
(2) To the application under para. 1 shall apply:
1. particulars of the trader's unique identification code and of the companies incorporated in a Member State -
document for current registration under national law, issued by a competent authority of
the country concerned;
2. document for paid fee under Art. 21, para. 2.
(3) Within 60 days of receipt of the application and documentation under para. 1 and 2 of the BDA on the basis of an evaluation of
risk:
1. enter the person under Art. 167a in the register under Art. 167d, of which he informs him or
2. notify of the date of the inspection of conformity to the conditions for
performing the activities under Art. 167a with the requirements of Good manufacturing practice 152, para. 1 and
of the Good Distribution Practices of Active Substances under Art. 198.
(4) Where, as a result of the inspection under para. 3, item 2 BDA has established compliance with the requirements of the Good
production practice under Art. 152, para. 1 and Good Distributive Practices of Active Substances
198, it shall enter the applicant in the register under Art. 167d, of which he informs him.
(5) The expenses for carrying out the inspection under para. 3, item 2 shall be at the expense of the applicant.
(6) For carrying out the inspection under para. 3, item 2 the applicant shall pay a fee in the amount specified in the tariff under
Art. 21, para. 2.
(7) In the cases of para. 3, item 1 and para. 4, the applicant may commence its activity after the entry
in the register of art. 167g.
Art. 167c. (New, SG No. 102/2012, effective 02.01.2013) 167b, para. 3 BDA does not
Notify that an inspection will be carried out, the applicant may start the activity.
Art. 167g. (New - SG 102/2012, in force from 02.01.2013) (1) The Executive Agency for Medicines shall lead
a public register of importers, manufacturers and wholesalers of active substances containing:
1. Name, registered office and address of management of the person mailed. 167a;
2. a list of the active substances that are imported, manufactured or marketed;
3. the activities that the person under art. 167a will perform;
4. address of the premises where the activities are carried out;
5. notes on the entered circumstances.
(2) The Executive Agency for Medicines shall enter into the database under Art. 147 registered information
importers, manufacturers and wholesalers of active substances.
Art. 167d. (New, SG No. 102/2012, effective 02/01/2013) (1) 167a submits to the BDA annually by
31 January notification of changes in the information entered in the register under Art. 167g.
(2) When changes occur that may affect the quality or safety of the active
substances produced, imported or distributed, the person under Art. 167a shall notify the BDA immediately.
Art. 167f. (1) (New, SG No. 102/2012, in force from 02.01.2013) Production, import and wholesale trade
with active substances on the territory of the Republic of Bulgaria, including active substances intended for use
for export, is carried out in accordance with Good Manufacturing Practice and Good Distribution Practices
for active substances.
(2) Importers may import active substances only if the following conditions are met:
1. the active substances have been manufactured in accordance with Good Manufacturing Practice standards,
which are at least equivalent to those established by the European Union, and
2. (In force from 02.07.2013) The active substances shall be accompanied by a written confirmation from the competent person
authority of the exporting country that:
(a) Good manufacturing practice standards applicable to the exported production site
active substances are at least equivalent to those established by the European Union;
(b) the production site concerned is subject to regular control and is effectively implemented by the Good
manufacturing practices, including repeated and unannounced inspections, to ensure the protection of
public health at least equivalent to that of the European Union, and
(c) in the event of non-compliance, the exporting country will immediately inform the BDA.
(3) (In force from 02.07.2013) The requirement of para. 2, item 2 shall not apply if the exporting country is included in
the list under Art. 111b of Directive 2001/83 / EC.
Art. 167g. (New, SG No. 102/2012, effective 02.07.2013) (1) Exceptionally, when necessary to
ensure the availability of medicinal products, the importer may import the active substance without the written request
confirmation of art. 167f, para. 2, item 2 for a period not longer than the validity of the certificate of Good
manufacturing practice where the manufacturing site of the active substance in the exporting country was
inspected by a regulatory authority of a Member State and found to comply with the principles and guidelines for
Good manufacturing practice.
(2) In the cases of para. 1 The BDA shall notify the European Commission.
Art. 167h. (New, SG No. 102/2012, effective 02.01.2013) Holders of manufacturing authorizations,
including those who perform the activities of art. 168b, para. 2 shall be considered as producers within the meaning of
§ 13, item 3 of the additional provisions of the Consumer Protection Act and bear liability for damages,
caused by a defect in the goods provided for therein.
Chapter Six.
PACKAGING AND PACKAGE LEAFLET
Art. 168. (1) The packaging of a medicinal product shall consist of a primary and / or secondary packaging and a leaflet for
patient.
(2) (amend. - SG 61/11, in force from 10.11.2011) The secondary packaging of medicinal products,
containing substances specified in the list under Art. 3, para. 2, item 2 of the Drug Control Act
substances and precursors, is marked diagonally with two red strips, and the outer packaging of medicinal
products containing substances from the list under Art. 3, para. 2, item 3 of the Drug Control Act
substances and precursors - with two blue bands. The package must contain an indication that the medicinal product
the product is only available on special medical prescription.
(3) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products included in
the list under Art. 23 of Regulation (EC) No 726/2004 of the European Parliament and of the Council, contains
information with the following text: "This medicinal product is subject to additional monitoring". In front of
the text shall be marked in black in accordance with Article 23 (5) of Regulation (EC) No 726/2004
The European Parliament and the Council, accompanied by an explanatory note.
(4) (amend. - SG 102/2012, in force from 21.12.2012) The leaflet of the medicinal products shall include
a standard text asking patients to report to healthcare professionals or directly
of the BDA any suspected adverse reaction according to the models of Art. 185, para. 2, Vol. 4.
(5) When the medicinal product is authorized for use on the territory of the Republic of Bulgaria, on
its secondary packaging is labeled for separate collection and recycling in accordance with the Law on
waste management and implementing acts.
(6) Where the medicinal product is authorized, its name shall be given on the outer carton,
the dosage form and the content of the active substance in the dosage unit are also indicated with Braille
alphabet.
(7) The requirements of para. 6 shall not apply to vaccines and medicinal products in hospital packaging.
(8) (New, SG No. 102/2012, in force since 21.12.2012) On the outer packaging, or, if there is none, on
The primary packaging of medicinal products, with the exception of radiopharmaceuticals, shall include:
1. an individual identifier for safety features that enables traders
wholesale and retail:
(a) verify the authenticity of the medicinal product;
(b) identify the individual packaging;
2. a means of checking whether the medicinal product has been tampered with.
Art. 168a. (New, SG No. 102/2012, effective 21.12.2012) (1) On the packaging of a medicinal product,
which is granted on medical prescription, safety indicators according to art. 168, para. 8, p
except where the medicinal product is included in the list established by the European Union
commission with delegated act under art. 168b.
(2) The packaging of a medicinal product, which is available without a prescription, shall not be affixed
safety indicators under art. 168, para. 8, except where the medicinal product is
included in the list determined by the European Commission by a delegated act under art. 168b, after being judged to be
at risk of counterfeiting.
(3) The Medicines Executive Agency shall notify the European Commission of:
1. for medicinal products which are available without a prescription for which it has been established
risk of counterfeiting;
2. for medicinal products for which it has been established that there is no risk of counterfeiting, taking into account
the following criteria:
(a) the price and sales volume of the medicinal product;
(b) the number and incidence of cases of counterfeit medicinal products registered within the
The European Union and in third countries, and a change in the number and frequency of such cases historically;
(c) specific characteristics of the medicinal products concerned;
(d) the severity of the disease to be treated;
(e) other potential risks to public health.
Art. 168b. (New, SG No. 102/2012, effective 21.12.2012) (1) The rules on indicators for
safety under Art. 168, para. 8 shall be determined by the European Commission by means of delegated acts of Article 54a,
paragraph 2 of Directive 2001/83 / EC.
(2) The safety indicators shall not be eliminated or partially or completely closed, unless they are
the following conditions are met:
1. the holder of the manufacturing authorization before partially or completely removing or closing it
safety, checks that the medicinal product concerned is authentic and has not been
forged;
2. the holder of a production permit in compliance with the requirements of Art. 168, para. 8 can replace
safety indicators with their equivalent in terms of the ability to guarantee
authentication, identification and provision of evidence of tampering with the medicinal product
product.
(3) Safety indicators shall be considered equivalent if:
1. satisfy the requirements laid down in the delegated acts referred to in Article 54a (2) of the Directive
2001/83 / EC, and
2. are equally effective in allowing authentication and identification of
medicinal products and providing evidence of counterfeiting.
(4) The replacement under para. 2, item 2 shall be carried out without opening the primary packaging of the medicinal product and in
compliance with Good Manufacturing Practice for Medicinal Products.
(5) The Drug Enforcement Agency oversees the replacement of the
safety.
Art. 169. (1) The information on the packaging and the package leaflet of the medicinal product must be complete
compliance with the data in the summary of product characteristics approved by the BDA at the time of the issuance of the BDA
the marketing authorization and meet the requirements set out in the ordinance under Art. 170.
(2) The information on the packaging and the leaflet may be in several languages, but necessarily one
should be Bulgarian. The content of the information in different languages ​​must be identical.
(3) The name of the medicinal product shall be written in Bulgarian and the international name
non-patent name of the medicinal substance is given in accordance with the Anatomical Therapeutic
the chemical classification of WHO. The name and address of the marketing authorization holder may be
written in Latin.
(4) The information on the packaging and the package leaflet must be in a patient-friendly language, legible and
be indelible.
(5) (New, SG No. 18/2014) The leaflet must be designed in such a way that it is clear and comprehensible,
allowing the patient to take appropriate action, medically as needed
specialists.
Art. 170. (1) (Former text of Art. 170 - SG, issue 102 of 2012, effective 21.12.2012) Requirements to
the packaging and leaflets of the medicinal products shall be laid down in an ordinance of the Minister of Health
healthcare.
(2) (New - SG, iss. 102 in 2012; effective from 21.12.2012, supplemented - SG, iss. 18 of 2014) Where a medicinal product,
authorized for use under this Act, is not intended for direct delivery to the patient or is not
available on the market in the Republic of Bulgaria, the BDA may authorize its use when some of the data,
defined in the ordinance under para. 1 are not affixed to the package or package leaflet.
(3) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 2 information on the packaging and
the leaflet may not be provided in Bulgarian.
(4) (New, SG No. 102/2012, effective 21.12.2012) The terms and procedure for delivery of medicinal products
products under para. 2 shall be determined by the ordinance under art. 198.
Chapter seven.
CLASSIFICATION OF MEDICINAL PRODUCTS
Art. 171. (1) Depending on the method of dispensing, medicinal products shall be classified as:
1. prescription medicinal products;
2. medicinal products dispensed without a prescription.
(2) (Supplemented, SG No. 71/2008, effective 12.08.2008)
determined by the BDA in the Marketing Authorization / Registration Certificate or the Marketing Authorization
parallel import of the medicinal product into the territory of the Republic of Bulgaria.
(3) The person under art. 26, para. 1 specifies the mode of dispensing of the medicinal product in the application for
Marketing Authorization / Registration Certificate, Modification of the Marketing Authorization or
its renewal.
Art. 172. The medicinal products of art. 171, para. 1, item 1 are divided into the following categories:
1. medicinal products with restricted medical prescription, intended for use in certain medicinal products only
specialized areas;
2. medicinal products - subject to special medical prescription;
3. medicinal products for multiple or single dispensing under the same medical prescription.
Art. 173. Medicinal products that meet the following requirements are prescribed on medical prescription:
1. may present a direct or indirect danger to human health, even if used correctly, if
apply without medical supervision;
2. they are frequently and very widely applied incorrectly and as a result can be a danger to
human health;
3. contain substances the activity and / or side effects of which subsequently require
additional study;
4. usually prescribed by a doctor for parenteral administration.
Art. 174. Medicinal products are subject to special medical prescription when they meet one of the
the following conditions:
1. contain narcotic substances within the meaning of the Drug Control Act; and
precursors in permissible quantities;
2. if used improperly, they can create a significant risk of abuse, lead to a medicinal product
dependency or use for illegal purposes;
3. contain new medicinal substances whose characteristics are not sufficiently known for this reason
a preventive cause may be attributed to the group of medicinal products under item 2.
Art. 175. Medicinal products are subject to limited medical prescription when they meet one of the
the following conditions:
1. restricted to hospital use only because of limited experience in use or in the interest of
public health;
2. intended for the treatment of conditions which can only be diagnosed in
medical institutions, although their implementation and monitoring of the course of treatment may be
carry out in other health establishments;
3. they are intended for the treatment of outpatients, but their use can be serious
side effects requiring specialist prescription and monitoring during treatment.
Art. 176. (1) The Executive Agency for Medicines may not approve the mail requested by the applicant. 26, para.
1 medication delivery regimen based on an assessment of:
1. the maximum single dose, the maximum daily dose, the amount of active substance in a single dose
unit, dosage form, specific type of immediate packaging of the product, and / or
2. other specific conditions of use.
(2) The Medicines Executive Agency may not specify the exact category of medicinal product under
Art. 172, but according to the criteria of Art. 174 and 175 determine whether the medicinal product is to be classified as
product available only on prescription.
Art. 177. Medicinal products which do not meet the requirements of the EMA. 173, 174 and 175 and the criteria,
defined in the ordinance under art. 178, are granted without medical prescription.
Art. 178. The classification criteria for medicinal products and the requirements for the dossier
making changes in the classification shall be determined in an ordinance of the Minister of Health.
Art. 179. (1) The Executive Agency for Medicines shall prepare and publish its page on an internet list
of medicinal products subject to medical prescription on the territory of the Republic
Bulgaria.
(2) The list under para. 1 is updated annually.
Art. 180. In the presence of new data on a medicinal product for which a marketing authorization has been granted
or a certificate of registration, the BDA shall review and, where necessary, amend the classification
according to the requirements of Art. 173 and the criteria specified in the ordinance post. 178.
Art. 181. Where a change in the classification of a medicinal product is authorized
significant preclinical or clinical trials, following applicant or marketing authorization holder
use may not be invoked within one year from the date of the variation authorization issued by
a regulatory authority of a Member State, when applying for a change in the classification of the same
substance.
Art. 182. The Medicines Executive Agency shall inform the European Commission and the regulatory authorities on an annual basis
authorities of other Member States for changes in the list under Art. 179.
Chapter Eight.
PHARMACEUTICAL SAFETY TRACKING
Section I.
General Provisions (New, SG No. 102/2012, effective 21.12.2012)
Art. 183. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
organizes and maintains a pharmacovigilance monitoring system for the implementation of the
the obligations under this Chapter.
(2) The system of para. 1 is used to gather information on the risks of medicinal products
for patients' health and public health. The information covers unwanted messages
drug reactions when using a medicinal product in accordance with the approved summary
characteristics, as well as misuse and use information that is not in accordance with the approved one
summary of product characteristics, including information on the side effects observed
in the performance of professional duties.
(3) The Executive Agency for Medicines shall validate, process and classify the information under para. 2,
makes a scientific analysis of the data collected with a view to assessing the options for reduction and prevention
risk and take the necessary action with regard to the marketing authorization
product.
(4) The Executive Agency for Medicines shall carry out audits of the system under para. 1 and every two years
sends a report to the European Commission on the results thereof.
(5) The Medicines Executive Agency shall implement an adequate and effective quality system in order
ensure compliance of the system under para. 1 with the requirements of this law. The minimum requirements for
the quality system is defined by Implementing Regulation (EU) No 520/2012.
Art. 184. (Amended, SG No. 102/2012, effective 21.12.2012) (1) Medical specialists shall be obliged to
notify immediately the holder of the marketing authorization or the BDA of any suspected serious
adverse reaction and provide additional follow-up information upon request
of the case.
(2) Patients may report undesirable effects at any time on medical grounds
specialists or the BDA.
(3) In the cases of para. 1 and 2, where the communication concerns a biological medicinal product prescribed,
distributed or sold on the territory of the Republic of Bulgaria, it must be clearly identified
from the notifier with his trade name and batch number or this information to be provided at
additional tracking.
Art. 185. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
maintains a national medicines portal linked to the European Medicines Portal
the medicinal products under Art. 68, para. 1, Vol. 4.
(2) The Executive Agency for Medicines shall make available through the portal under para. 1 at least the following
information:
1. the public evaluation reports under art. 53, para. 2 and their summaries;
2. the summary of product characteristics and leaflets;
3. a summary of the risk management plans for the medicinal products authorized for use
the territory of the Republic of Bulgaria;
4. specimens of standardized forms for reporting suspected adverse reactions from
medical professionals and patients drawn up in accordance with the requirements of Article 25 of Regulation (EC)
No 726/2004 of the European Parliament and of the Council;
5. an updated list of medicinal products referred to in Article 23 of Regulation (EC) No 726/2004 of the European Union
Parliament and the Council;
6. communications providing information to the general public about safety concerns from
the use of a medicinal product;
7. instructions for all ways and forms for reporting suspected adverse reactions from
medical professionals and patients.
Art. 186. (Amended, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines
carries out the following activities for medicinal products placed on the market of the Republic of Bulgaria:
1. monitoring the outcome of the risk reduction measures for the medicinal product contained in the plan
risk management;
2. monitoring of the result of the fulfillment of conditions specified in Art. 55a, 56 or 56a;
3. evaluation of the update of the risk management system;
4. monitoring of the "EudraVigilance" database established in accordance with Article 24 of Regulation (EC) No
Regulation (EC) No 726/2004 of the European Parliament and of the Council on new risks or changes to those already identified and on
change in benefit / risk ratio.
Art. 187. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
inform the European Medicines Agency and the Marketing Authorization Holder
identifying signals for new risks or for changing identified risks, or when changing
the benefit / risk ratio of the medicinal product.
(2) The Committee under Art. 56a, para. 1, item 1 analyzes and prioritizes validated alerts for new risks or for
change in already established and change in benefit / risk ratio.
(3) Where the Committee under Art. 56a, para. 1, item 1 recommends follow-up, the coordination group of art.
77, para. 2 or the Committee for Medicinal Products for Human Use, respectively, draws up an opinion on
regulatory actions for the marketing authorization within the timeframe set out in
according to the severity and degree of danger.
(4) The Medicines Executive Agency shall implement the recommendations recommended in the coordination opinion
a group under Art. 77, para. 2 or in the decision of the European Commission provisional and / or definitive measures.
Art. 188. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
inform the European Medicines Agency, the regulatory authorities of the other Member States and
The European Commission, at least 24 hours before the public disclosure of concerns,
related to the monitoring of the safety of a medicinal product, except where the protection of
public health requires immediate disclosure.
(2) The Executive Agency for Medicinal Products shall publish information relating to active substances containing
in medicinal products authorized in other Member States, using harmonized
draft communication and timetable for publication proposed by the European Medicines Agency.
(3) In the cases of para. 1 and 2 the information containing personal data or constituting a trade secret shall be
deleted unless publication of this information is necessary for the protection of public health.
Art. 189. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines may
delegate some of the rights and obligations under this chapter to a regulatory authority of another Member State
by concluding an agreement.
(2) In the cases of para. 1 The BDA informed the European Commission, the European Medicines Agency and the European Medicines Agency
the regulatory authorities of the other Member States for the delegation of powers and publish a communication
on the Internet portal under Art. 185, para. 1 or on your website.
Art. 190. (amend. - SG 102/02, in force from 21.12.2012) (1) The holder of the marketing authorization is
obliged to have a pharmacovigilance monitoring system to fulfill the
your obligations under this chapter.
(2) The holder of a marketing authorization through the system of para. 1 makes a scientific assessment of the collected
information on the safety of medicinal products, assesses the potential for
minimize or prevent risk and take the necessary measures.
(3) The marketing authorization holder shall implement an adequate and effective quality system in order to
ensure compliance of the system under para. 1 with the requirements of this law. The minimum requirements for
the quality system is defined by Implementing Regulation (EU) No 520/2012.
(4) The marketing authorization holder shall regularly audit the system under para. 1. Information about
the main findings of the audit shall be noted in the main documentation of the system and shall be used to prepare
a plan for the implementation of appropriate corrective actions. This information may be deleted after
overall implementation of corrective actions.
Art. 191. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
designates a qualified person with an appropriate qualification responsible for drug monitoring
safety.
(2) The person under para. 1 is established in the territory of a Member State and is permanent and continuous on
placement of the Marketing Authorization Holder.
(3) To support the activity of the qualified person, the holder of the marketing authorization shall designate
a person established in the territory of the Republic of Bulgaria. The appointment of such person shall not relieve him
the qualified person under para. 1 of his responsibilities under this chapter.
(4) The Marketing Authorization Holder shall submit the data to the BDA. 27, para. 1, item 12, letters "a" - "c"
for the persons under para. 1 and 3.
(5) The holder of the marketing authorization shall notify the BDA of any change in the data under para. 4.
(6) The holder of the marketing authorization shall submit the data under para. 4 for the qualified person of
European Medicines Agency.
Art. 192. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization shall be
shall:
1. maintains and makes available on request from the BDA the basic document of the traceability system
drug safety;
2. apply a risk management system for each medicinal product;
3. monitor the outcome of the measures contained in the risk management plan, or
4. monitors the result of the fulfillment of the terms of the post. 55a, 56 or 56a;
5. update the risk management system;
6. monitors the data from the system under Art. 190, para. 1 to identify new risks or
change the identified risks, and determine if changes in the ratio have occurred
benefit / risk for the monitored medicinal product.
(2) The content and procedure for maintaining the basic documentation of the traceability system
pharmacovigilance is determined by Implementing Regulation (EU) No 520/2012.
Art. 193. (amend. - SG 102/2012, in force from 21.12.2012) The holder of the marketing authorization
inform the BDA and the European Medicines Agency of any new signals identified
risks, or to change the identified risks, or to change the benefit / risk ratio of
medicine.
Art. 194. (Amended, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
at the same time or before providing the public with new information on concerns related to
monitoring the safety of a medicinal product authorized in the territory of
The Republic of Bulgaria, informs the BDA, the European Medicines Agency and the European Commission.
(2) The information under para. 1 must be objective and not misleading.
(3) Before disseminating information relating to pharmacovigilance,
the holder of the marketing authorization shall coordinate it in advance with the BDA, except in the cases under para.
1.
(4) For carrying out the evaluation of the information under para. 3 a fee shall be paid in the amount specified in the tariff
under Art. 21, para. 2.
Art. 194a. (New, SG No. 102/2012, effective 21.12.2012) (1) The principles and requirements of the Good
pharmacovigilance practices are defined in a guidance document issued by
European Medicines Agency.
(2) In carrying out pharmacovigilance monitoring activities, the holder of
the marketing authorization complies with the good practice under para. 1.
Section II.
Collection and reporting of information on suspected adverse reactions
(New, SG No. 102/2012, effective 21.12.2012)
Art. 194b. (New, SG No. 102/2012, effective 21.12.2012) The holder of the marketing authorization in
fulfillment of its obligations under Art. 190 is required to document all suspected reports
adverse reactions observed within the European Union or in third countries,
reported spontaneously by medical professionals or by patients or arising from the process
conducting post-marketing studies.
Art. 194c. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
submit electronically to the "EudraVigilance" database under Art. 24 of Regulation (EC) No
Serious suspected adverse reactions reported to the European Parliament and the Council,
occurred within the territory of the European Union and in third countries, within 15 days of the date of receipt
of the message.
(2) The Marketing Authorization Holder submits to the EudraVigilance database electronically
reports of all suspected adverse reactions other than those specified in para. 1, occurred
within the territory of the European Union, within 90 days of the date of receipt of the communication.
(3) The Marketing Authorization Holder monitors publications in specialized medical literature
and report to the EudraVigilance database any suspected adverse reaction described in the
except for suspected adverse reactions from active medicinal products
substances listed in Article 27 of Regulation (EC) No 726/2004 of the European Parliament and of the
Council and described in literature, monitored by the European Medicines Agency.
(4) The marketing authorization holder establishes procedures for the collection of accurate and reliable data,
allowing the scientific evaluation of reports of suspected adverse reactions. The owner of
the marketing authorization collects follow-up information regarding these communications and provides
updated data in "EudraVigilance".
(5) The form and content of the reports under para. 1 - 3 are laid down in Implementing Regulation (EU) No
520/2012.
Art. 194 (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
register in the system under art. 183 all reports of suspected adverse reactions,
occurred on the territory of the Republic of Bulgaria by medical specialists and patients, and requires, at
need, additional information from case tracking.
(2) Where reports of suspected adverse reactions occurring within the territory of
The Republic of Bulgaria has been submitted by the Marketing Authorization Holder, which he provides
additional information from case tracking upon request from the BDA.
Art. 194d. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
submits to the EudraVigilance database electronically all serious suspects
undesirable effects occurring on the territory of the Republic of Bulgaria within 15 days from the date
on receipt.
(2) The Drug Enforcement Agency submits electronically to the EudraVigilance database
reports of all suspected adverse reactions other than those specified in para. 1, occurred
within the territory of the Republic of Bulgaria, within 90 days from the date of receipt of the notification.
(3) The Drug Enforcement Agency submits reports electronically to the EudraVigilance database
suspected adverse reactions occurring on the territory of the Republic of Bulgaria as a result of
misuse of a medicinal product. The Medicines Executive Agency shall inform thereof
Ministry of Health and professional organizations of medical specialists.
(4) Any body or institution to which information about a suspected adverse drug has been received
a reaction occurring on the territory of the Republic of Bulgaria informs the BDA about this.
(5) The content and format of the communications and reports under para. 1 - 3 are determined by the Regulation for
Implementation (EU) No 520/2012.
Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
receives the information submitted by the Marketing Authorization Holder for serious suspects
adverse reactions occurring within the European Union or in a third country through
the EudraVigilance database.
(2) The requirements for monitoring information in the EudraVigilance database are laid down in a Regulation.
Implementing Regulation (EU) No 520/2012.
Art. 194g. (New - SG 102/2012, in force since 21.12.2012) In the process of exchange of information of the BDA,
the Marketing Authorization Holders and the European Medicines Agency are cooperating with the European Medicines Agency
detecting duplicate reports of suspected adverse reactions.
Section III.
Periodic Safety Update Reports (New, SG No. 102/2012, in force)
from 21.12.2012)
Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization is
obliged to provide the European Medicines Agency electronically with periodic updates
safety reports containing:
1. summaries of data on the benefit / risk balance of the medicinal product, including
the results of all studies, with a view to their potential impact on the Marketing Authorization;
2. scientific evaluation of the benefit / risk ratio of the medicinal product; evaluation is based on all
available data, including clinical trial data for unauthorized indications and target groups,
not included in the summary of product characteristics;
3. all data on the volume of sales of the medicinal product and any other information with which
the holder of the marketing authorization is in possession of the volume of prescriptions, including
approximate number of persons who have used or are exposed to the medicinal product
another reason.
(2) The content and format of the electronic periodic safety update reports shall be
set out in Implementing Regulation (EU) No 520/2012.
(3) The information under para. 1 shall be collected and stored in a register established pursuant to Article 25a of the Regulation
(EC) No 726/2004 of the European Parliament and of the Council, and is available to the BDA.
Art. 194i. (New, SG No. 102/2012, effective 21.12.2012) Holders of authorizations for
use / certificates for registration of medicinal products under Art. 28, 30, 35 and 37 submit periodically
updated safety reports only in cases where:
1. submission of a report is a condition under Art. 55a or 56, entered in the Marketing Authorization / Certificate
registration, or
2. The Executive Agency for Medicinal Products or a regulatory authority of another Member State shall so request
based on safety considerations for the medicinal product or due to lack of periodic medicines
updated safety reports for the active substance contained in the medicinal product at
who has been granted marketing authorization / registration certificate.
Art. 194k. (New, SG No. 102/2012, effective 21.12.2012) (1) In the marketing authorization / certificate
the frequency of submission of periodic safety update reports shall be determined for registration.
(2) The filing dates of the reports depending on the frequency under para. 1 shall be calculated from the date of issue
of the Marketing Authorization / Registration Certificate.
(3) Periodic safety update reports shall be submitted at the following time intervals, p
except where the frequency of submission of reports is a condition for authorization
for use / registration certificate or determined in accordance with Art. 194l, 194m and 194h:
1. every 6 months from the date of issue of the marketing authorization / registration certificate
medicinal product by the date of its placing on the market;
2. every 6 months during the first two years from the date of placing on the market of the medicinal product;
3. once a year for the next two years;
4. once every three years after the fourth year from the date on which the medicinal product is placed on the market.
(4) Outside the cases under para. 3, periodic safety update reports shall be submitted immediately to
a request from the BDA or a regulatory authority of a Member State.
(5) Paragraphs 3 and 4 shall also apply to medicinal products authorized only in the territory of
Republic of Bulgaria, which are not covered by Art. 194l.
Art. 194l. (New, SG No. 102/2012, effective 21.12.2012) Where medicinal products containing
the same active substance, or combination of the same active substances, have been obtained separately
marketing authorizations / registration certificate, frequency and filing dates for periodic applications
updated safety reports may be modified and harmonized in order to carry out
uniform evaluation of these reports.
Art. 194m. (New, SG No. 102/2012, effective 21.12.2012) (1) The filing dates of the periodicals
updated safety reports for the medicinal products under Art. 194l are calculated according to
European Union reference date.
(2) The European Union reference date under para. 1 is:
1. the date of the first authorization for use in the European Union of the medicinal product containing
the active substance concerned or the corresponding combination of active substances, or
2. the earliest known date of the marketing authorizations for the medicinal product containing
the relevant active substance or the corresponding combination of active substances, if the date referred to in point 1,
could not be determined.
Art. 194n. (New, SG No. 102/2012, effective 21.12.2012) (1) The holder of the marketing authorization
of medicinal products under Art. 194l may submit a reasoned request to the Committee for Medicinal Products
products for human use, respectively to the coordination group under Art. 77, para. 2 to determine
reference date of the European Union or change of frequency of submission of periodicals
updated safety reports on one of the following grounds:
1. reasons for public health;
2. to avoid duplicate assessment;
3. to achieve international harmonization.
(2) The Committee for Medicinal Products for Human Use, or the Coordination Group of Post Offices. 77,
para. 2 after consultation with the committee under Art. 56a, para. 1, item 1 approves the request or makes a reasoned refusal.
(3) The filing frequency and the reference date of the European Union shall be determined in consultation with
the committee under Art. 56a, para. 1, item 1 of:
1. The Committee for Medicinal Products for Human Use - where at least one of the Marketing Authorizations
for medicinal products containing the active substance concerned, is granted in accordance with
the centralized procedure provided for in Chapter 1 of Title II of Regulation (EC) No 726/2004 of the European Parliament and of the Council
Parliament and the Council, or
2. the coordination group of art. 77, para. 2 - for cases other than those specified in item 1.
(4) The list of European Union reference dates for medicinal products has been sent. 194l and
the harmonized frequency for submitting their periodic safety update reports
publish on the European Internet portal under Art. 68, para. 1, Vol. 4.
(5) The holder of the marketing authorization after the publication of the data under para. 4 presents in the BDA
application for a change of the marketing authorization for the medicinal product concerned. Any change to
filing dates and frequency of submission of periodic safety update reports,
specified in the marketing authorizations shall take effect 6 months after the date of their publication.
Art. 194o. (New, SG No. 102/2012, effective 21.12.2012) (1) The Executive Agency for Medicines
evaluates periodic safety update reports for medicinal products to determine whether
there are new risks, or a change in the identified risks, or a change in the benefit / risk balance.
(2) The Medicines Executive Agency shall carry out a uniform assessment of the periodic updated reports
on the safety of medicinal products for which the Republic of Bulgaria has fulfilled the functions of
reference country within the meaning of Art. 76, and is designated by the coordination group under Art. 77, para. 2.
(3) A rapporteur from the Republic of Bulgaria shall participate in the single evaluation of the periodic up-to-date reports
safety for medicinal products where at least one of the products is authorized for use in the order of
Regulation (EC) No 726/2004 of the European Parliament and of the Council, and has been designated as such by the Committee.
56a, para. 1, v. 1.
Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases of no. 194o, para. 2 and 3 BDA,
respectively, the rapporteur from the Republic of Bulgaria within 60 days from the date of receipt of the periodic
an updated safety report shall prepare an evaluation report and send it electronically to
The European Medicines Agency and the regulatory authorities of the Member States. The owner of
the marketing authorization was received by the European Medicines Agency.
(2) Within 30 days of receipt of the report under para. 1 the holder of the marketing authorization or
Member States' regulatory authorities may submit their comments to the European Agency
on medicines and to the BDA.
(3) Within 15 days from the date of receipt of the comments under para. 2 The BDA updates the evaluation report, such as
takes into account all the objections presented, and sends it to the committee under Art. 56a, para. 1, item 1 for approval and
recommendation.
(4) The European Medicines Agency shall include the evaluation report adopted and the committee recommendation.
56a, para. 1, item 1 in the register under Art. 194h, para. 3 and send it to the Marketing Authorization Holder.
Art. 194 (New, SG No. 102/2012, effective 21.12.2012) Where the Republic of Bulgaria is not a rapporteur in
the procedure under Art. 194o, para. 2, the BDA may submit comments within the deadline. 194p, para. 2 to the European
the Medicines Agency and the regulatory authority of the Member State that prepared the assessment report.
Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
updated reports on the safety of medicinal products under Art. 194l and when none of
the marketing authorizations for these products were not granted under Regulation (EC) No 726/2004
The European Parliament and the Council, the coordination group under Art. 77, para. 2 within 30 days from the date of
receiving the recommendation from the committee under Art. 56a, para. 1, item 1 issues an opinion on conservation,
modification, suspension or termination of relevant marketing authorizations, including a schedule for
implementation of the opinion.
(2) Where the Member States represented in the coordination group have 77, para. 2 agreed
on the actions to be taken, the BDA implements the decision taken.
(3) When the opinion under para. 1 is for suspension or termination of the marketing authorization, the executive
the BDA director issues an order.
(4) Where in the opinion under para. 1 recommended changes to the marketing authorization issued,
the marketing authorization holder submits to the BDA an application for change including an updated one
a summary of the product characteristics and a leaflet, within the specified implementation schedule.
(5) Where agreement cannot be reached within the postal coordination group. 77, para. 2,
the position of the majority of the Member States is submitted to the European Commission, which accepts
a decision to modify, suspend or terminate the marketing authorizations granted by them
Member States' regulatory authorities.
(6) The Executive Agency for Medicinal Products shall apply the provisional and / or definitive measures of the Decision on Medicinal Products
para. 5.
Art. 194t. (New, SG No. 102/2012, effective 21.12.2012) (1) In case of a single assessment of periodic
updated reports on the safety of medicinal products under Art. 194l and when at least one of
the marketing authorizations were granted under Regulation (EC) No 726/2004 of the European Parliament and of the European Parliament
The Council, the Committee for Medicinal Products for Human Use, within 30 days of receipt of the
the recommendation of the committee under Art. 56a, para. 1, item 1 issues an opinion on the retention, amendment, suspension
or the termination of the relevant marketing authorizations, including a timetable for
implementation of the opinion.
(2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
of the Marketing Authorizations, European Commission:
1. adopt a decision to change, suspend or terminate the marketing authorizations issued in accordance with
Regulation (EC) No 726/2004 of the European Parliament and of the Council;
2. adopt a decision recommending the change, suspension or termination of the marketing authorizations,
issued by the relevant regulatory authorities of the Member States.
(3) The Executive Agency for Medicinal Products shall apply the provisional and / or definitive measures of the decision on
para. 2, Vol. 2.
Section IV.
Emergency procedure at European Union level (New, SG No. 102/2012, in force from
12/21/2012)
Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Emergency procedure at European Union level
can be initiated by the European Commission, the European Medicines Agency or a country
state.
(2) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate an urgent procedure under the procedure
of this section by informing the regulatory authorities of the other Member States the European Agency
on medicines and the European Commission, when for reasons related to drug monitoring
safety, consider that a medicinal product placed on the Bulgarian market is necessary
take any of the following measures:
1. suspension or termination of the marketing authorization;
2. prohibition of distribution of a medicinal product;
3. issuing a refusal to renew the marketing authorization.
(3) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall initiate the procedure under para. 2 when
has been informed by the Marketing Authorization Holder that for traceability reasons
drug safety, suspends the distribution of the medicinal product or has taken, or
intends to take action to withdraw it from the market or not to take action on
renewal of the marketing authorization.
(4) (Amended, SG No. 18/2014) The Executive Agency for Medicinal Products may initiate the procedure under para.
2 and where it considers that for reasons of pharmacovigilance,
new contraindications must be added or reduced for a medicinal product
the recommended dose or indication should be limited.
(5) (Amended, SG No. 18/2014) The Executive Agency for Medicines shall submit to the European Agency
on medicines and regulatory authorities of other Member States all scientific information with which
it shall have, as well as the data evaluation carried out, the reasons for initiating the procedure in accordance with this
section.
(6) (Amended, SG No. 18/2014) In the cases of para. 2 - 4 The European Medicines Agency notifies the BDA of
initiation of the procedure when safety concerns also apply to other medicinal products
products that belong to the same therapeutic group or that contain the same active substance
substance with the product specified in the information under para. 5, or where this medicinal product is authorized for
use in another or in other Member States.
(7) (amend. - SG 18/04) In the cases of para. 4, when no emergency measures are required, BDA
apply the procedure under Art. 77 or 79b.
(8) (New, SG No. 18/2014) The Executive Agency for Medicines shall inform the holder of the
the marketing authorization for initiating the procedure under this section.
Art. 194f. (New, SG No. 102/2012, effective 21.12.2012) (1) In the cases of no. 194y, para. 2, when judged,
that urgent public health measures need to be taken, the BDA may temporarily
suspend the marketing authorization and prohibit the use of the medicinal product in the territory of
Until the adoption of a final decision under Art. 194h or 194h.
(2) The Medicines Executive Agency shall notify the European Medicines Agency, the European Medicines Agency
the Commission and the regulatory authorities of the other Member States for the measures taken under para. 1 within one
working day from their implementation and state the reasons for this.
(3) Where the Medicines Executive Agency participates in the procedure under this section, at the request of the
The European Commission BDA takes the recommended provisional measures with regard to the authorization of
use of the medicinal product, or where the medicinal product is authorized for use in the order of
Regulation (EC) No 726/2004 of the European Parliament and of the Council - as regards the product itself,
completion of the procedure.
Art. 194x. (New, SG No. 102/2012, effective 21.12.2012) The Executive Agency for Medicines
publish a message on the national Internet portal under Art. 185, para. 1 for the way you are interested
Parties may submit information to the European Internet Portal under Art. 68, para. 1, item 4 for
the medicinal product - subject to the procedure under Art. 194y, and for the opportunity to participate in public
discussion, if any.
Art. 194s. (New, SG No. 102/2012, effective 21.12.2012) 56a, para. 1, item 1 until 60
make a reasoned recommendation within days of the announcement of the European portal procedure.
(2) The holder of the marketing authorization may, within the term of para. 1 to provide written comments.
(3) The recommendation under para. 1 shall be published on the European Mail Portal. 68, para. 1, item 4 and contains one
or more of the following:
1. no further study or action is needed at Community level;
2. the holder of the marketing authorization must carry out further investigation and analysis of
the data;
3. the marketing authorization holder must carry out a post-marketing safety study
with a subsequent evaluation of its results;
4. the Member State or the Marketing Authorization Holder applies measures to reduce
risk;
5. the marketing authorization must be suspended, terminated or a refusal renewed
his;
6. the marketing authorization must be modified.
(4) The specific measures under para. 3, item 4, as well as the conditions and restrictions that should be included in
the marketing authorization is indicated in the recommendation.
(5) In the cases of para. 3, item 6, when the changes are related to modification or addition of information in
The summary of product characteristics, on the packaging or package leaflet of the medicinal product, is recommended
include the wording of the changed or added information and where it should be
applied.
Art. 194h. (New, SG No. 102/2012, effective 21.12.2012) (1) Where, within the scope of the procedure, Art. 194y
does not include a medicinal product authorized under Regulation (EC) No 726/2004
The European Parliament and the Council, the coordination group under Art. 77, para. 2 based on the recommendation of
Art. 194f within 30 days from the date of receipt and issue an opinion on the retention, change,
suspension, termination of the relevant marketing authorizations or refusal of
their renewal, including a timetable for the implementation of the opinion.
(2) Where the opinion recommends the taking of postal measures. 194ts, para. 3, item 5, the executive
the BDA Director shall by order suspend or terminate the Marketing Authorization or refuse
its renewal.
(3) Where in the opinion under para. 1 recommended changes to the marketing authorization issued,
the marketing authorization holder submits to the BDA an application for change including an updated one
a summary of the product characteristics and a leaflet, within the specified implementation schedule.
(4) Where in the opinion under para. 1 it is recommended to take post measures. 194ts, para. 3, Vol. 2 - 4,
the holder of the marketing authorization takes the necessary action and informs the BDA and
the regulatory authorities of the other Member States.
(5) Where within the coordination group under Art. 77, para. 2 cannot be reached,
the position of the majority of the Member States is submitted to the European Commission, which accepts
decision recommending change, suspension or termination of the marketing authorization granted by
the relevant regulatory authorities of the Member States.
(6) The Drug Enforcement Agency shall implement the recommendations recommended in the decision under para. 5 temporary and / or
final measures.
Art. 194y. (New, SG No. 102/2012, effective 21.12.2012) (1) Where, within the scope of the procedure, Art. 194y
a medicinal product authorized under Regulation (EC) No 726/2004 of the European Union is included
Parliament and the Council, the Committee on Medicinal Products for Human Use, on the basis of the recommendation
under Art. 194ts, para. 3 within 30 days from the date of receipt and issue an opinion on retention,
modification, suspension, termination of the relevant marketing authorizations or refusal
their renewal, including a timetable for the implementation of the opinion.
(2) Where in the opinion under para. 1 is a position expressed for taking regulatory action on
of the Marketing Authorizations, European Commission:
1. Decides to change, suspend or terminate the validity of the marketing authorizations,
issued pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council;
2. adopt a decision recommending the change, suspension or termination of the validity of the permissions for
use issued by the relevant regulatory authorities of the Member States.
(3) The Medicines Executive Agency implements the recommendations made in the European Commission decision on
para. 2, item 2 provisional and / or final measures.
Art. 194p. (New, SG No. 102/2012, effective 21.12.2012) 194ts, para. 1, the opinion of
Art. 194h, para. 1 and the decision of the European Commission under Art. 194h, para. 5 and Art. 194h, para. 2 are published on
The European Internet Portal under Art. 68, para. 1, Vol. 4.
Chapter Nine.
WHOLESALE WHOLESALE OF MEDICINAL PRODUCTS AND MEDIATION IN THE AREA OF
MEDICINAL PRODUCTS (TITLE AMENDED - SG 71/08, IN EFFECT OF 12.08.2008,
AMENDED. - DV, BR. 102 FROM 2012, IN EFFECT OF 02/01/2013)
(Title "Section I. Wholesale trade in medicinal products", SG, issue 71 of 2008, in force since 12.08.2008)
Art. 195. (1) Wholesale trade in medicinal products may be carried out by natural and legal persons,
holders of an authorization issued by a regulatory authority of the Member State concerned.
(2) Where the person under para. 1 has warehouses on the territory of the Republic of Bulgaria, it may
Wholesale trade in medicinal products after obtaining authorization from the executive
director of the BDA.
Art. 196. (1) A manufacturer of medicinal products within the meaning of this Act may trade on
wholesale only of medicinal products for which a manufacturing authorization has been granted.
(2) An importer of medicinal products within the meaning of this Law may only wholesale trade with
medicinal products for which import authorization has been granted.
Art. 197. The persons under art. 195 must have:
1. suitable premises, equipment and facilities and suitable means of transport providing
the proper storage, distribution and transport of medicinal products in accordance with
the requirements of Good Distribution Practice;
2. Qualified staff and responsible Master of Pharmacy with at least two years of work experience
the specialty whose obligations are defined in the ordinance under Art. 198.
Art. 198. (amend. - SG 102/2012, in force from 02.01.2013) The principles and requirements for the Good
the distribution practices of medicinal products and active substances are adopted by an ordinance of the Minister
health and with guidelines adopted by the European Commission.
Art. 199. (1) The persons under art. 195, para. 2 submit to the BDA:
1. an application containing the name, registered office and address of management of the trader; address and description
premises and facilities for storage of medicinal products;
2. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
Union, or in a State Party to the Agreement on the European Economic Area - Document on
up-to-date registration under national law, issued by the competent authority of the relevant
country;
3. (suppl. - SG 103/07, in force from 01.01.2018) name, criminal record or similar
document of the person, if not a Bulgarian citizen, diploma for higher education and document for work experience
of the responsible master pharmacist under Art. 197, item 2 and a copy of his employment contract;
4. (repealed, SG No. 60/2011, effective 05.08.2011)
5. (repealed, SG No. 60/2011, effective 05.08.2011)
6. a document certifying the legal basis for the use of the premises;
7. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 84 of 2018, effective from 12.10.2018)
8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
(2) The persons under art. 195, para. 1 shall submit an application to the BDA together with:
1. a copy of the wholesale marketing authorization issued by a regulatory authority of a Member State;
2. name and address of the contact person on the territory of the Republic of Bulgaria;
3. the address of the premises for the storage of medicinal products in the territory of the Member States.
(3) In the wholesale trade in narcotic substances and in dosage forms containing such substances,
the requirements of the Narcotic Drugs and Precursors Control Act also apply.
(4) In the case of wholesale trade in radiopharmaceuticals, an opinion shall also be submitted to the Nuclear Regulatory Agency.
(5) (New, SG No. 103/2017, effective 01/01/2018) The Executive Agency for Medicines shall establish
ex officio the circumstances regarding the criminal record of the person under para. 1, item 3, when he is a Bulgarian citizen.
Art. 200. The Executive Agency for Medicines shall evaluate the documentation and carry out an on-the-spot check
the sites mentioned in the application to establish their compliance with the requirements for the Good
distribution practice.
Art. 201. (1) The Executive Agency for Medicines shall notify the applicant in writing when it finds out
incompleteness in the documentation submitted.
(2) In the cases of para. 1 the term under Art. 202, para. 1 stops running.
Art. 202. (1) (amend. - SG 84/08, in force from 12.10.2018) Within 60 days from the date of submission of
the application under Art. 199, para. 1, the Executive Director of the BDA shall issue a permit for wholesale or
makes a reasoned refusal.
(2) The refusal under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code.
Art. 203. Within 15 days from the date of submission of the documentation 199, para. 2 the Executive Director
of the BDA issues a certificate of registration for wholesale trade in the territory of the Republic of Bulgaria on
the person under Art. 195, para. 1.
Art. 204. (1) The permit for wholesale of medicinal products shall be indefinite.
(2) The authorization under Art. 202 or the certificate under Art. 203 shall be terminated if the holder so requests
in writing by the BDA Executive Director.
(3) The person under art. 195 is obliged to notify the BDA in writing within 7 days after termination of its activity under
wholesale of medicines. In such cases, the BDA Executive Director shall terminate
licenses / certificates issued for wholesale of medicinal products.
Art. 205. (1) The Executive Agency for Medicines shall keep a register of the marketing authorizations issued to
wholesale of medicinal products under Art. 202, para. 1, which contains:
1. number and date of authorization;
2. name, seat and address of management of the person who has received the permit;
3. address of the premises for storage of the medicinal products;
4. the data for the responsible master pharmacist under Art. 197, Vol. 2;
5. list of medicines containing narcotic substances, radiopharmaceuticals, immunological medicinal products
products and medicinal products derived from human plasma and human blood;
6. date of cancellation of the permit from the register and the reason for it;
7. remarks on the entered circumstances.
(2) The Executive Agency for Medicines shall keep a register of the issued certified mail. 203 for
wholesale of medicinal products, which contains:
1. number and date of the certificate;
2. the number of the marketing authorization for medicinal products and the body which issued it;
3. name, seat and address of management of the person receiving the certificate;
4. details of the person under art. 199, para. 2, Vol. 2;
5. date of deletion of the certificate from the register and the reason for it;
6. notes on the entered circumstances.
(3) Data from the registers shall be published on the BDA website on the Internet.
(4) (New - SG 102/2012, in force from 02.01.2013) The Executive Agency for Medicines shall introduce in
the database under Art. 147 information on marketing authorizations for medicinal products.
(5) (New, SG No. 102/2012, effective 02.01.2013) Upon request by the European Commission or by
the BDA Member State shall provide information on the marketing authorization for medicinal products
products.
Art. 206. (1) In case of change of the circumstances, related to the issued permit for wholesale trade,
the holder submits an application to the BDA pursuant to Art. 199, to which the change related
documentation.
(2) The permit for change shall be issued under the conditions and by the order of art. 200 - 202. When changing
the storage premises the term under Art. 202, and in other cases the deadline is 14 days.
Art. 207. (1) The holder of a wholesale trade permit who conducts his business in the territory
of the Republic of Bulgaria shall be obliged to:
1. provides access at all times to the control bodies to the premises for storage of medicinal products
products;
2. trade only in medicinal products authorized under this Law;
3. trade in medicinal products whose packaging and leaflets are in accordance with the authorization granted
use, under the terms and procedure of this law and their expiry date;
4. obtains medicinal products only from manufacturers, importers or wholesalers of medicinal products
products authorized to carry out this activity under this law;
4a. (new - SG 102/2012, in force from 02.01.2013) check whether the received medicinal products from
the persons under item 4 are not falsified by checking the safety indicators on the secondary
package;
5. supply medicinal products to other holders of a wholesale, pharmacy and drug store authorization,
opened in accordance with this law;
5a. (new - SG 71/08, in force from 12.08.2008, amended - SG, iss. 84 from 2018, in force since 12.10.2018)
supplies medicinal products to meet their own needs:
a) medical establishments;
b) higher schools, which carry out medical activity according to Art. 2a of the Medical Institutions Act;
c) the institutions of art. 26, para. 1, items 1 and 3 of the Health Act for the health offices established therein;
(d) shipowners for the purpose of supplying medicinal products on board ships in accordance with
The Merchant Shipping Code;
6. supply doctors and dentists with medicinal products when there is no place in the settlement
a pharmacy, under the conditions and in the order laid down in an ordinance of the Minister of Health;
6a. (new - SG, issue 102 of 2012, in force since 02.01.2013, suppl. - SG, iss. 84 of 2018, in force since 12.10.2018)
shall enter in the delivery documents the batch number of the medicinal products delivered as well as the address of
delivery of medicinal products;
6b. (new - SG 102/2012, in force from 02.01.2013) has an emergency plan, which
contains effective measures to withdraw a medicinal product from the market by order of the BDA or
an initiative of the manufacturer or the holder of the marketing authorization for the medicinal product concerned
product;
6c. (new - SG 18/2014) ensure the supply of sufficient quantities of medicinal products for
meeting the health needs of the population of the Republic of Bulgaria;
7. (amend. - SG 102/2012, in force from 02.01.2013) store data for each transaction with received, delivered
or medically sold medicinal products in the form of sales invoices
either electronically or in any other form as follows:
(a) date of receipt and delivery;
(b) the name of the medicinal product;
(c) the quantity received, delivered or sold through mediation;
(d) the name and address of the person from whom the medicinal product was obtained or delivered;
(e) the batch number and the batch exemption certificate number issued by the qualified person
person under art. 148, item 2, respectively by the qualified person 161, para. 2, item 1, and certificate number for
batch release issued by the BDA - in the cases under Art. 69 and 70;
8. keep records of the purchases and / or sales of all medicinal products;
9. comply with the requirements of Good Distributor Practice as defined in the Ordinance Post. 198;
10. (new - SG 102/2012, in force from 02.01.2013) maintain a quality system defining
the responsibilities, processes and risk management measures associated with its business;
11. (new - SG 102/2012, in force from 02.01.2013) inform immediately the BDA and the holder of
the marketing authorization when he has established or suspects that the medicinal product he has received
or offered, forged;
12. (new - SG 102/2012, in force from 02.01.2013) check whether the wholesaler from whom it is
received the medicinal product, complies with the principles and guidelines for Good distribution practices under art.
198, as well as whether it holds a wholesale trade permit;
13. (new - SG 102/2012, in force from 02.01.2013) check whether the manufacturer or the importer, from
who has received the medicinal product has a manufacturing / import authorization;
14. (new - SG 102/2012, in force from 02.01.2013) check whether the mediator through whom he has received
the medicinal product complies with the requirements of this Chapter;
15. (New, SG No. 84/2018, effective 12.10.2018) provide the BDA daily through the postal system.
217b, para. 1 information for:
a) the quantities delivered to individuals and legal entities under items 5, 5a and 6 indicated by medicinal products
products included in the Positive Medicinal List;
b) the natural and legal persons under items 5, 5a and 6, to whom the quantities of medicinal products have been delivered
under the letter "a";
c) the quantities available in their stores indicated by the medicinal products included in the Positive
medication list;
(d) the quantities indicated by medicinal products included in the Positive Medicinal Products List for which
plans to export, and countries where exports are planned;
e) the quantities indicated by medicinal products included in the Positive Medicinal List of which it is
export made, and the country in which the export took place.
(2) The documentation under para. 1, items 7 and 8 shall be kept for at least 5 years and shall be made available upon request
control bodies.
Art. 208. (Supplemented, SG No. 71/2008), effective as of August 12, 2008, amended - SG, issue 102 of 2012, effective as of January 2, 2013,
ed. - SG, issue. 84 of 2018, effective 12.10.2018) The provisions of Art. 207, para. 1, items 2 - 15 and para. 2 and Art. 209a
apply also to the wholesalers of art. 203 as well as for importers and manufacturers trading with
their medicinal products.
Art. 209. For the wholesale of medicinal products containing narcotic substances or derived from blood,
immunological products and radiopharmaceuticals are subject to the special requirements of other laws.
Art. 209a. (New, SG No. 71/2008, effective 12.08.2008) (1) Wholesalers of medicinal products
can supply medicinal products:
1. other wholesalers of medicinal products;
2. pharmacies and drugstores;
3. The Ministry of Defense and the Ministry of the Interior, except for their own purposes
of their departmental medical establishments, as well as the State Agency of the State Reserve and wartime
stocks ";
4. The Ministry of Health with:
(a) vaccines, toxins and serums necessary for the implementation of the Immunization Calendar of the Republic
Bulgaria, as well as in emergency epidemic situations;
b) medicinal products intended for the treatment of diseases, which are paid under the Law on
health, as well as ensuring the implementation of national health programs.
5. (new - SG 60/2012, in force from 07.08.2012) medical establishments for outpatient care, concluded
contract with the National Health Insurance Fund, with the medicinal products needed to fulfill the
the health activities of art. 82, para. 2, item 3 of the Health Act.
(2) Physicians and dentists in settlements where there is no pharmacy may be supplied
with medicinal products from the wholesalers in accordance with the ordinance under Art. 207, para. 1, v. 6.
Art. 209b. (New - SG 102/2012, in force from 02.01.2013) (1) In the wholesale of medicinal products
in third countries the requirements of art. 207, para. 1, items 2, 5 and 6, as well as the requirements of Chapter Nine
"a".
(2) Where the medicinal product is obtained directly from a third country but is not imported into the territory of
Republic of Bulgaria, the requirements of Art. 207, para. 1, items 4 and 4a.
(3) (New, SG No. 18/2014) In the cases of para. 1 wholesalers certify with the relevant
documents that the medicinal products have been obtained from persons authorized or entitled to deliver
medicinal products in accordance with the applicable national legislation of the third country.
(4) (New, SG No. 18/2014) Where the wholesaler supplies medicinal products to third parties
States, it certifies with the relevant documents that the supplies are only for authorized persons
or the right to receive medicinal products intended for wholesale or delivery of
population in accordance with the applicable national legislation of the third country.
(5) (Renumbered from Paragraph (3), SG No. 18/2014) A wholesaler who supplies medicinal products to persons from
third countries entitled under the relevant national legislation to supply medicinal products
consumer products, issues a document certifying:
1. date of submission;
2. name and form of the medicinal product;
3. quantity delivered;
4. name and address of the person to whom the medicinal product was delivered;
5. lot number.
Art. 210. (amend. - SG 60/11, in force from 05.08.2011) (1) The holder of the marketing authorization
and / or the person under Art. 26, para. 2 may provide samples of authorized medicinal products to:
1. dentists and physicians;
2. Higher medical schools and medical colleges.
(2) In the cases of para. 1, a sample shall be affixed to the package of medicinal products.
(3) To the persons under para. 1, item 1, no more than two samples of the same medicinal product may be delivered
form of the medicinal product in one calendar year in the smallest existing packaging of
manufacturer, and of medical colleges and colleges only in the quantities required
for training purposes.
(4) The holder of the marketing authorization and / or the person has sent. 26, para. 2 keep records of all persons on
who have supplied samples for the type, quantity and time of delivery and, on request, provide these
data from control bodies.
Art. 211. (1) Wholesalers must have a system for blocking and withdrawing medicinal products.
products that have shown non-compliance with quality, safety and efficacy requirements.
(2) The holder of a wholesale marketing authorization shall be obliged to block and withdraw medicinal products.
products that have shown non-compliance with the quality, safety and efficacy requirements in the order specified
in the ordinance under art. 274, para. 1.
Art. 212. (1) The Executive Director of the BDA shall notify the European Commission, the regulatory authorities of
the other Member States and the European Medicines Agency for marketing authorizations for
wholesale, for the suspended or revoked permits and for the reasons therefor.
(2) (amend. - SG 102/2012, in force from 02.01.2013) When the executive director of the BDA establishes that
the person under Art. 195, para. 1 does not fulfill the obligations under Art. 207, para. 1, items 2 - 14, he notifies the regulatory body
the authority of the Member State which granted the wholesale authorization and the European Commission.
(3) Where the regulatory body under para. 2 suspend or revoke the wholesaler 's authorization
the person under Art. 195, para. 1, it shall notify the BDA Executive Director and the European Commission.
Art. 212a. (New, SG No. 102/2012, effective 2 January 2013) (1) (Amended, SG No. 18/2014) Mediation in
the field of medicinal products may be performed by natural and legal persons registered as
commercial intermediaries within the meaning of the Commercial Law of the Republic of Bulgaria, which are registered for
the performance of this activity by the BDA.
(2) The persons under para. 1, who wish to register as intermediaries, shall submit a model notification to the BDA,
approved by the BDA Executive Director, which contains:
1. name, seat and address of management;
2. contact details.
(3) To the notification under para. 2 shall apply:
1. data on the unique identification code;
2. a document for a paid fee in the amount specified in the tariff under Art. 21, para. 2.
(4) The Executive Agency for Medicinal Products shall enter in the public register the persons exercising
mediation in the field of medicinal products.
(5) The persons under para. 1 may mediate in the field of medicinal products after submission
of the notification under para. 2 in the BDA.
(6) The persons under para. 1 shall notify the BDA within 7 days from the occurrence of a change in any of the circumstances under
para. 2.
Art. 212b. (New, SG No. 102/2012, effective 02/01/2013) 212a, para. 1 shall:
1. carry out their activity only with authorized medicinal products;
2. Have a contingency plan that contains effective download measures
medicinal product from the market by order of the BDA or at the initiative of the manufacturer or the holder
of the marketing authorization for the medicinal product concerned;
3. to store data, including the following information for each transaction made through mediation
medical products:
(a) the date of the transaction;
(b) the name of the medicinal product;
(c) the quantity realized through mediation;
(d) the name and address of the persons who received and delivered the medicinal product;
(e) account number;
4. comply with the requirements of the Good Distribution Practice, adopted by the ordinance post. 198;
5. maintain a quality system that defines the responsibilities, processes and management measures of
the risks associated with its activities;
6. to immediately inform the BDA and the Marketing Authorization Holder when it has established or has
suspicion that the mediation product is counterfeit;
7. check that the trader holds a license for wholesale of medicinal products;
8. verify that the manufacturer or importer holds a manufacturing / import permit;
9. to keep the data under item 3 for a period of at least 5 years and to provide them at the request of the control bodies
organs.
(2) The requirements for mediation activities in the field of medicinal products shall be determined by
the ordinance under Art. 198 and in European Commission guidance.
Chapter Nine "a".
PARALLEL IMPORTS OF MEDICINAL PRODUCTS (PREVIOUS SECTION II - SG 71/00)
2008, IN EFFECT OF 12/08/2008)
Art. 213. (amend. - SG 71/08, in force from 12.08.2008) Parallel import of medicinal products of
the territory of the Republic of Bulgaria may be exercised by a natural or legal person registered under
Commercial law, under the law of a Member State, after obtaining a parallel permit
imports issued by the BDA Executive Director.
Art. 214. (1) A medicinal product authorized for use in another Member State may be imported in parallel
in the territory of the Republic of Bulgaria, when it is identical or similar to a medicinal product authorized for
use in the Republic of Bulgaria by the order of this law.
(2) (amend. - SG 71/08, in force from 12.08.2008, amend. - SG 12/2011, in force from 08.02.2011)
the meaning of para. 1 identical or similar medicinal product is one which has the same qualitative and quantitative value
composition with respect to the active substance (s) available in the same drug
form, available in the same primary packaging, with a similar graphic design to the packaging.
Art. 215. (1) (amend. - SG 71/08, in force from 12.08.2008) For obtaining a permit for
parallel import of a medicinal product into the territory of the Republic of Bulgaria by the person under Art. 213 lodges
an application to the BDA Executive Director stating the Member State from which it will perform
parallel import of a medicinal product.
(2) The following data and documents shall be attached to the application:
1. name, dosage form, quantity of active substance per unit dose of authorizations
use in the Republic of Bulgaria of a medicinal product;
2. name, dosage form, amount of active substance per unit dose of the medicinal product
product intended for parallel import;
3. (suppl. - SG 12/11, in force from 08.02.2011) the name of the holder of the marketing authorization and of
the manufacturer, if he is a person other than the holder of the marketing authorization, of the medicinal product,
intended for parallel imports;
4. the number of the marketing authorization for the medicinal product in the Republic of Bulgaria and the number of
the authorization to use the medicinal product in the parallel Member State
import;
5. statement on establishing the circumstances under art. 217, v. 1;
6. a copy of the leaflet for the patient and a sample of the medicinal product as sold in the country
Member from which parallel importation is made, translation of the contents of the leaflet into Bulgarian,
accompanied by a declaration that the translation is in accordance with the original of the leaflet;
7. a proposal for a leaflet for the patient of the parallel medicinal product, accompanied by
a statement that the contents of the package leaflet are identical to the contents of the product leaflet,
authorized for use in the Republic of Bulgaria, except for the following:
(a) the name and management address of the parallel importer;
(b) the name of the manufacturer, where different for the two products;
(c) a period of stability when different for the two products;
(d) excipients, where different in the two products;
8. in the case of repackaging:
a) (amend. - SG 71/08, in force from 12.08.2008) a sample of the medicinal product as it will be
launches on the market in Bulgaria;
(b) a copy of the contract between the parallel importer and the partial importer
manufacturing activity - packaging, labeling;
(c) a certificate of good manufacturing practice when the repackaging processes are carried out outside
the territory of the Republic of Bulgaria;
d) when performed by the person mailing. 213 - copy of the manufacturing authorization issued by the regulatory authority
the authority of the Member State where the repackaging takes place;
9. a document for payment of a fee in the amount specified in the tariff mail. 21, para. 2.
(3) (amend. - SG 71/08, in force from 12.08.2008) Where between the medicinal product for parallel import
and the product authorized for use on the territory of the Republic of Bulgaria, there are differences (in the composition of
excipients, etc.), the person under para. 1 presents evidence that they do not affect
the therapeutic qualities of the parallel import medicinal product.
(4) In the cases of para. 3 the person under para. 1 indicates on the package and in the package leaflet the patient in parallel
the imported medicinal product differences.
(5) Where the person under Art. 213 carries out repackaging and / or labeling of the medicinal product in Bulgarian
language in the territory of the Republic of Bulgaria, it must have a production permit issued
by the BDA Executive Director.
(6) The parallel imported product is used under the conditions of the marketing authorization issued
the medicinal product on the territory of the Republic of Bulgaria.
Art. 216. (1) The permit for carrying out parallel import on the territory of the Republic of Bulgaria shall be
issues within 45 days from the date of submission of the documentation to the BDA.
(2) When the BDA requests additional documentation from the applicant, the term under para. 1 stops running until received
of the information requested.
(3) Where the BDA requires the regulatory authority of the Member State from which parallel imports are made,
information related to the granting of the marketing authorization for the imported medicinal product
para. 1 is extended by 45 days.
(4) If, within the term of para. 3 The BDA did not receive the requested documentation, the authorization procedure for
parallel import into the territory of the Republic of Bulgaria shall be terminated.
(5) Licenses issued for parallel import into the territory of the Republic of Bulgaria shall be issued
posted on the BDA's website.
(6) The authorization for parallel importation shall be for a period of 5 years. A new permit is issued in the order
of Art. 215.
(7) The authorization for parallel importation shall not be automatically terminated when the holder of the
the marketing authorization for the medicinal product placed on the market in the Republic of Bulgaria,
withdraw it for reasons unrelated to the danger to the health of the population.
Art. 217. The holder of the parallel import authorization shall be obliged to:
1. notify the holder of the marketing authorization for the medicinal product placed on the market in
the territory of the Republic of Bulgaria for its intention to carry out parallel imports upon request
provides a sample of the medicinal product in parallel;
2. keep the following documentation for a period of 5 years: name and address of the person to whom it was delivered in parallel
the medicinal product imported, the date of delivery, the quantity delivered and the batch number;
3. submit to the BDA:
(a) an updated patient leaflet for the parallel imported product, in accordance with changes that have occurred in the
the authorization for use of the medicinal product authorized in the Republic of Bulgaria;
b) (amend. - SG 71/08, in force from 12.08.2008) a statement that the contents of the leaflet under letter "a"
is identical to the contents of the product leaflet authorized for use in the Republic of Bulgaria, p
except for the data under Art. 215, para. 2, item 7, letters "a" - "d";
4. document and report to the holder of the marketing authorization and to the BDA all communications on
suspected side effects of the imported medicinal product;
5. (new - SG 84 2018, effective 12.10.2018) provide to the BDA weekly or upon change of
the circumstances through the specialized electronic system of art. 217b, para. 1 information for:
a) the quantities imported in the territory of the Republic of Bulgaria in parallel indicated by medicinal products
products on the Positive Medicinal List that are the holder of the parallel authorization
import;
b) the mail delivered to individuals and legal entities. 207, para. 1, items 5, 5a and 6 the quantities indicated under
medicinal products included in the Positive Medicinal List;
c) the natural and legal persons under Art. 207, para. 1, items 5, 5a and 6, to which the quantities have been delivered
medicinal products under letter "a";
(d) the date on which the importation / delivery was made under letters "a" and "b";
(e) the quantities available in the stores indicated by medicinal products included in the Positive Medicinal Product
a list of holders of the parallel import authorization.
Chapter Nine "b".
EXPORTS OF MEDICINAL PRODUCTS. SPECIALIZED ELECTRONIC SYSTEM FOR
FOLLOW-UP AND ANALYSIS OF THE MEDICINAL PRODUCTS (NEW, SG 18/14
G., TITLE. AMENDED. - DV, BR. 84 FROM 2018, IN EFFECT ON 12/10/2018)
Chapter Nine "b".
EXPORT OF MEDICINAL PRODUCTS (NEW, SG No. 18/2014)
Art. 217a. (New, SG No. 18/2014) (1) Export of medicinal products from the territory of the Republic
Bulgaria may be a natural or legal person holding a wholesale marketing authorization
with medicinal products or a manufacturing authorization holder.
(2) The holder of a manufacturing authorization may export only the ones produced by him
medical products.
(3) For the purposes of this Chapter, exports are also intra-Community supplies within the European Union.
(4) (amend. - SG 84/08, in force from 12.10.2018) Medicinal products included in the Positive
medicinal list for which a shortage has been established in accordance with Art. 217b, cannot be exported for the term
contained in the list under Art. 217c, para. 1.
Art. 217b. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018) (1)
Specialized electronic system for tracking and analyzing the medicinal products included in
The positive drug list, administered and maintained by the Executive Agency
medicines.
(2) The creation and maintenance of the specialized electronic system under para. 1 is done on the basis of
on the following principles:
1. ensuring the accuracy and accuracy of the data submitted and stored;
2. providing an appropriate data exchange environment;
3. ensuring regulated access to the data in the electronic information system in compliance
the requirements of the law;
4. ensuring interoperability and information security.
(3) The specialized electronic system of para. 1 contains:
1. the information under art. 54, Art. 54a, Art. 68, para. 1, Vol. 10, Art. 207, para. 1, Vol. 15, Art. 217, item 5 and art. 232a provided
by the persons concerned;
2. information provided by the National Health Insurance Fund about the quantities indicated
on paid medicinal products included in the Positive Medicinal List for the previous one month;
3. information provided by the Ministry of Health about the quantities indicated under
paid medicinal products included in the Positive Medicinal List for the previous one month.
(4) On the basis of the information under para. 3 through the specialized electronic system of para. 1 is performed
shortage analysis of medicinal products included in the Positive Medicinal List, of
the territory of the Republic of Bulgaria under the conditions and in the order specified in the ordinance under para. 8.
(5) The shortage under para. 4 of the medicinal products included in the Positive Medicinal List are established,
when performing the analysis under par. 4 was found to be available on the territory of the Republic of Bulgaria
the quantities of the medicinal product concerned are less than 65 per cent of the quantities required for
meeting the health needs of the population for a period of one month, calculated on the basis of
the average monthly consumption of the respective medicinal product for the previous 6 months.
(6) The specialized electronic system under para. 1 supports an automated interface for providing
the information under para. 3 and to send messages.
(7) The right of access to the specialized electronic system under para. 1 have the institutions and persons under para. 3
solely for the purpose of providing information specified by this Act and are responsible for
the accuracy of the information provided, as well as its timely delivery.
(8) The conditions and procedure for providing, storing and performing analysis of the information under para. 3, as
and for the administration, maintenance and access to the specialized electronic system under para. 1 se
determined by an ordinance of the Minister of Health.
(9) The Medicines Executive Agency is obliged to provide the network and information
security of the specialized electronic system under para. 1 subject to the obligation of secrecy
of the information received under para. 3.
Art. 217c. (New, SG No. 18/2014, declared as unconstitutional SRKS No. 1 of 2015 - SG, issue 12 of
2015, as amended. - SG, issue. 84 of 2018, effective 12.10.2018) (1) A list of medicinal products is hereby established,
included in the Positive Medicinal List for which there is a shortage in the territory of the Republic
Bulgaria, which is being prepared, updated and maintained by the Bulgarian Medicines Executive Agency.
(2) The list under para. 1 shall be prepared on the basis of the analysis performed in accordance with Art. 217b, para. 4 and is published on
the website of the Executive Agency for Medicinal Products.
(3) The list of medicinal products for which a shortage has been established pursuant to Art. 217b, para. 5, is prepared
by name of the medicinal product included in the Positive Medicinal List, internationally
non-patent name, amount of active substance, dosage form and quantity in pack.
(4) The list under para. 1 is being updated:
1. weekly;
2. in case of change of circumstances related to the import and / or export of medicinal products included in
Positive drug list.
(5) Upon updating the list in the order of para. 4, item 1, as well as in the cases when the circumstances under
para. 4, item 2, based on the information provided under Art. 68, para. 1, Vol. 10, Art. 207, para. 1, item 15 and art. 217, v. 5,
through the specialized electronic system of art. 217b, para. 1 a message shall be sent to the persons under Art. 68, para.
1, Art. 207, para. 1, Art. 217 and Art. 232a for the updated list. The list shall be published immediately on the Internet
the page of the Executive Agency for Medicines.
(6) In the cases of para. 4 the list under para. 1 shall be forwarded by the BDA and the Customs Agency by official order.
(7) After the inclusion of medicinal products in the list under para. 1 they may not be exported for the period for which they are
contain in the list.
Art. 217g. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018)
the medicines agency checks the persons who are obliged to provide information on
the order of this chapter.
Chapter Ten.
RETAIL TRADE OF MEDICINAL PRODUCTS
Art. 218. Retail trade in medicinal products shall be carried out only in pharmacies and drug stores in accordance with this
law, except in cases under Art. 232, para. 2.
Art. 219. (1) (amend. - SG 71/08, in force from 12.08.2008, suppl. - SG, iss. 23 in 2009, in force since 30.03.2009
g., add. - SG, issue. 41 of 2009, in force since 02.06.2009, as amended. - SG, issue. 60 of 2011, effective 05.08.2011)
The pharmacy is a health establishment that performs the following activities: storage, preparation, packaging,
controlling, consulting, prescribing, and prescribing, non-prescribing
use in the Republic of Bulgaria of medicinal products, medical devices, dietary foods for
special medical purposes and infant formulas and follow-on formulas and nutritional supplements, cosmetic and
hygiene products.
(2) (amend. - SG 60/11, in force from 05.08.2011) The structure, the order and the organization of the work of
pharmacies, the nomenclature of medicinal products, are laid down in an ordinance of the Minister of Health
healthcare.
(3) (amend. - SG 71/08, in force from 12.08.2008, repealed - SG, iss. 23 of 2009, in force from 30.03.2009)
Art. 220. (1) The activities under art. 219, para. 1 are performed by the Master of Pharmacy.
(2) (suppl. - SG 71/08, in force from 12.08.2008) The master pharmacist shall be obliged to fulfill the issued
prescription, including for the formulations of the trunk and pharmacopoeial form
formulation, according to the procedure specified in the ordinance under Art. 221, para. 1.
(3) (amend. - SG 102/2012, in force from 02.01.2013) The assistant-pharmacist may perform all
activities under art. 219, para. 1 under the control of a pharmacist, except for: dispensing a medicinal product
prescribing, monitoring and consulting products related to medicinal products.
Art. 221. (1) (Former text of Art. 221 - SG 71/08, in force from 12.08.2008)
Health determines in an ordinance the medical professionals who can issue prescriptions, the order for
prescribing medicinal products, the time limit for implementation, as well as the cases and the order in which the master-
the pharmacist may refuse to comply with a prescription.
(2) (New, SG No. 71/2008, effective 12.08.2008, amended, SG No. 9/2011) Bulgarian citizens and
foreigners who are allowed to reside in the country when traveling outside the Republic of Bulgaria
to carry or export medicinal products intended for their treatment, on terms and conditions,
defined in the ordinance under para. 1.
(3) (New, SG No. 71/2008, effective 12.08.2008, amended, SG No. 9/2011) Foreigners to whom is
issued a short-stay visa on the territory of the Republic of Bulgaria, may hold
medicinal products intended only for their treatment, in the quantities specified in the ordinance under para. 1.
(4) (New, SG No. 1/2014, effective 03.01.2014) The requirements for medical prescriptions which are
issued at the request of a patient who intends to use them in another Member State; and
the recognition and enforcement of those issued in another Member State shall be subject to conditions and conditions
order determined by the ordinance under para. 1.
(5) (New, SG No. 1/2014, effective 03.01.2014) Reimbursement of expenses for medicinal products
medical prescriptions performed in another Member State shall be carried out under the conditions and in order,
determined by the ordinance under Art. 80s, para. 4 of the Health Insurance Act.
Art. 222. (1) (Declared unconstitutional by RKS No. 5 of 2008 - SG, issue 65 of 2008, amended - SG, issue 71 of
2008, effective 26.07.2008) There is a physical right to trade in medicinal products
or a legal entity registered as a trader under Bulgarian law or legislation
of a Member State that has concluded an employment or pharmacy management contract with a master-
pharmacist, and in the cases provided for by law - with an assistant pharmacist, such as in the territory of the Republic
Bulgaria can open no more than 4 pharmacies.
(2) (New, SG No. 71/2008, effective 26.07.2008) Where the person under para. 1 is a Master of Pharmacy and is
pharmacy manager, no submission of employment contract or management contract required
the pharmacy.
(3) (Renumbered from Paragraph (2), amend. - SG 71/08, in force from 26.07.2008) The master pharmacist under para. 1 is
manager of the pharmacy and must work in it.
(4) (Renumbered from Paragraph (3), SG No. 71/2008, effective 26.07.2008) Right to open a pharmacy to satisfy
have their own needs:
1. the medical establishments under art. 5 of the Law on medical establishments providing hospital care;
2. medical establishments for hospital care;
3. (amend. - SG 59/10, in force from 31.07.2010) the centers for mental health, the centers for skin and
venereal diseases and complex oncology centers;
4. hospices with a hospital under Art. 10, item 5 of the Medical Institutions Act.
(5) (New, SG No. 60/2011, effective 05.08.2011) For the satisfaction of their own needs the medical
establishments under para. 4, which do not have an open pharmacy, can be obtained from a pharmacy at a medical establishment,
has obtained a retail authorization for medicinal products under the conditions and in the order specified by
the ordinance under Art. 219, para. 2.
(6) (Repealed, previous para. 4 - SG, iss. 71 in 2008, effective from 26.07.2008, previous para.
2011, in force since 05/08/2011) Pharmacies of outpatient medical establishments at
The Ministry of Defense and the Ministry of Interior may be managed by an Assistant-
pharmacist at the proposal of the relevant department and after the permission of the executive
director of the BDA.
Art. 223. (1) A master pharmacist or an assistant pharmacist may be the head of only one pharmacy and
necessarily work in it.
(2) (amend. - SG 12/11, in force from 08.02.2011) Master pharmacist or assistant pharmacist,
who runs a pharmacy cannot be hired under a sole proprietorship or
a business company manufacturing, importing, wholesaling or retailing medicinal products
products.
(3) The person under para. 1, authorized to trade in medicinal products, no
may own or participate in manufacturing, importing or trading companies
wholesale of medicinal products, including in affiliated companies within the meaning of
Trade Law.
Art. 224. The pharmacy manager must:
1. is a master pharmacist, respectively assistant pharmacist, in the cases provided for by law;
2. is not deprived of the right to practice the profession;
3. has not been convicted of crimes related to the exercise of his profession, of crimes against
property and economy or intentional crime against the individual;
4. has at least one year of experience as a master pharmacist.
Art. 225. (amend. - SG 71/08, in force from 26.07.2008) (1) In a settlement on whose territory there is no
opened a pharmacy, the right to carry out retail trade in medicinal products has a person under Art. 222, para. 1,
who has entered into an employment or pharmacy management contract with an assistant pharmacist or with
Master of Pharmacy with less than one year of work experience.
(2) The assistant pharmacist or the master pharmacist under para. 1 is a pharmacy manager and a must
works in it.
(3) (New, SG No. 60/2011, effective 05.08.2011) Assistant Pharmacist - Head of Pharmacy
para. 1 may perform the following activities: preservation and release without a prescription of
medicinal products, medical devices and dietary products authorized for use in the Republic of Bulgaria
special-purpose foods and infant formulas and follow-on formulas,
cosmetic and sanitary products.
Art. 226. (1) Pharmacies may be opened on the territory of outpatient medical establishments
sale of medicinal products to citizens.
(2) On the territory of health establishments under Art. 21, para. 2 of the Health Act, medical establishments for
hospital care and medical establishments under art. 10 of the Medical Establishments Act cannot be found
pharmacies to sell medicinal products to citizens.
Art. 227. (1) (Former text of Article 227 - SG, issue 102 of 2009, effective 22.12.2009) The requirements for
the location and the premises of the pharmacy shall be determined in the ordinance under Art. 219, para. 2.
(2) (New - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 60 in 2011, in force since 05.08.2011)
Requirements for the device and premises of pharmacies under Art. 228, para. 5 shall be determined in the ordinance under para.
1.
Art. 228. (Amended, SG No. 71/2008, effective 26.07.2008) (1) (Amended, SG No. 60/2011)
08/05/2011) Authorization for retail sale of medicinal products in a pharmacy is issued by the Executive
Director of the BDA on the basis of an application form to which shall be attached:
1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
Union, or in a State Party to the Agreement on the European Economic Area - Document on
up-to-date registration under national law, issued by the competent authority of the relevant
the state of the persons under art. 222, para. 1;
2. employment contract or contract for management of the pharmacy, concluded with a master pharmacist or an assistant;
pharmacist;
3. a copy of the act of creation of the persons of the post. 222, para. 4;
4. documents certifying that the requirements of Art. 224 Hours;
5. (suppl. - SG 103/07, in force from 01.01.2018) certificate of criminal record of the master pharmacist,
respectively to the assistant pharmacist appointed as the head of the pharmacy, if they are not Bulgarian citizens;
6. the medical certificate of the master pharmacist, respectively of the assistant pharmacist appointed for
pharmacy manager;
7. (Supplemented, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 48/2015)
7a. (new - SG 60/11, in force from 05.08.2011) hygienic conclusion issued by the respective Health Insurance Fund;
8. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
(2) (New, SG No. 60/2011, effective 05.08.2011) When issuing a permit for retail trade with
medicinal products are checked to see if the diploma of the master-
the pharmacist / pharmacist assistant is issued by the relevant competent institution.
(3) (Renumbered from Paragraph (2), amend. - SG 60/11, in force from 05.08.2011) Pharmacies no. 222, para. 4 and 6 are
open and close at the request of the person representing the medical establishment.
(4) (Renumbered from Paragraph (3), SG No. 60/2011, effective 05.08.2011) Opening of a pharmacy in which they are available
medicinal products containing narcotic substances are also subject to the requirements of the Control Act
on drugs and precursors.
(5) (New - SG, iss. 102 in 2009, in force since 22.12.2009, previous para 4 - SG, iss. 60 in 2011, in force since
08/05/2011) Authorization for retail sale of medicinal products in a pharmacy which is opened in
a settlement with a population of less than 10,000 inhabitants shall be issued on the basis of an application in accordance with a specimen to which
apply:
1. (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 84 of 2018, effective from 12.10.2018)
the documents under para. 1, Vol. 1 - 7a;
2. (amend. - SG 102/02, in force from 02.01.2013) document for paid fee in the amount of 50 percent of
the fee determined in the tariff under Art. 21, para. 2 for the granting of a permit for retail trade with
medicinal products under Art. 222, para. 1.
(6) (Renumbered from Paragraph (4), Suppl. - SG, iss. 102 in 2009, in force since 22.12.2009, amended - SG, iss. 98 in 2010, in force since
01.01.2011, previous para. 5, amend. - SG, issue. 60 of 2011, effective 05.08.2011) The application and the documents under
para. 1 and 5 shall be submitted to the BDA.
(7) (Renumbered from Paragraph (5), amend. - SG 102/09, in force from 22.12.2009, amended - SG, issue 98 from 2010, in force from
01.01.2011, previous para. 6, amend. - SG, issue. 60 of 2011, effective 05.08.2011) Regional Health
inspections shall issue a hygienic conclusion within 14 days of the date of application.
(8) (New, SG No. 48/2015; Supplemented, SG No. 91/2018) On the day the application under para. 1 and 5
The BDA sends an official request to the Governing Board of the Bulgarian Pharmaceutical Union for issuance
of a certificate for entry in the national electronic register of the members of the Bulgarian
pharmaceutical union - for the master pharmacist, pharmacy manager, and to the board of directors of
Bulgarian Association of Assistant Pharmacists - Assistant Pharmacist, Pharmacy Manager at
cases stipulated by law, as well as providing information on penalties imposed in the order
of the Professional Organization of Master Pharmacists and the Health Act.
(9) (New, SG No. 48/2015) The Managing Board shall submit the documents under para. 8 within 5 working days of
receipt of the request.
(10) (New - SG 103 2017, in force from 01.01.2018) The Executive Agency for Medicines shall establish
ex officio the circumstances regarding the criminal record of the persons under para. 1, item 5, when they are Bulgarian citizens.
Art. 229. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, repealed - SG No. 60/2011, effective 05.08.2011
d)
(2) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 102/2009, effective 22.12.2009, amended -
SG, issue 60 of 2011, in force since 05.08.2011, suppl. - SG, issue. 18 of 2014) Within one month of receipt of the
the documentation under Art. 228, para. 6, the Executive Director of the BDA, following the opinion of the Expert Council on
retail trade of medicinal products, issues a permit for retail trade with
medicinal products at a pharmacy or make a reasoned refusal to grant an authorization. The permission or
the refusal shall be served on the applicant.
(3) (amend. - SG 60/11, in force from 05.08.2011) Within 15 days from receipt of the documentation on
Art. 228, para. 6 The BDA verifies the documents submitted and notifies the applicant in writing
identified inconsistencies or incompleteness. In these cases, the term under para. 2 stops running from the day of
notification until the deficiencies are rectified.
(4) (New - SG 71/08, in force from 12.08.2008) In case within 60 days from the date of
the notification under para. 3 the applicant has not remedied any inconsistencies or incompleteness found,
the procedure for granting a marketing authorization for a medicinal product or for modifying it
the authorization granted shall be terminated.
(5) (Renumbered from Paragraph 4, SG No. 71/2008, effective 12.08.2008, amended - SG No. 60/2011)
08/08/2011) The refusal of the BDA Executive Director to issue a permit is subject to appeal
in accordance with the Administrative Procedure Code.
Art. 229a. (New, SG No. 23/2009, effective 30.03.2009) (1) (amend. - SG 41/09, in force from 30.03.2009)
02.06.2009, amend. - SG, issue. 98 of 2010, effective January 1, 2011, as amended. - SG, issue. 60 of 2011, effective 05.08.2011
d) The Executive Agency for Medicinal Products shall ex officio send to the Health Insurance Fund at the location of the respective
pharmacy with issued permit under art. 229, para. 2, which includes the retail trade of food
supplements, dietary foods for special medical purposes, infant formulas and follow-on foods, copy of
the permission for entry in the register of art. 14, para. 1 of the Food Act.
(2) (amend. - SG 41/09, in force from 02.06.2009) Pharmacies engaged in retail trade with
nutritional supplements, dietary foods for special medical purposes, infant formulas and follow-on foods,
are subject to control under the Food Act.
Art. 230. (1) (amend. - SG 60/11, in force from 05.08.2011) The Executive Agency for Medicines shall keep
register of licenses issued for retail trade in medicinal products under Art. 229, para. 2 which
contains:
1. number and date of authorization;
2. (suppl. - SG 71/08, in force from 12.08.2008) name, type of the trader, seat and address of
management of the authorized person;
3. (amend. - SG 12/11, in force from 08.02.2011) name, unique civil number of the head of
pharmacy;
4. pharmacy address;
5. the activities to be performed in the pharmacy;
6. the date of termination of the permit and deletion from the register and the reason for it;
7. remarks on entered circumstances.
(2) (amend. - SG 60/11, in force from 05.08.2011) Data from the register shall be published on the page of
Executive Agency for Medicines on the Internet.
Art. 231. (1) Upon change of the entries in the register under Art. 230, para. 1, items 2 - 5 circumstances of the person receiving
permit for retail trade in medicinal products, submits an application in accordance with Art.
228, para. 1, to which the documents related to the change are attached.
(2) (New, SG No. 60/2011, effective 05.08.2011) In the case of a change of the name and
type of the trader, address of the pharmacy and manager of the pharmacy a new application shall be submitted in accordance with Art. 228,
para. 1 and pay the fee for the authorization of retail sale of medicinal products in a pharmacy,
determined in the tariff under Art. 21, para. 2.
(3) (New - SG 60/11, in force from 05.08.2011) A person who has received a permit for retail trade with
medicinal products in accordance with Art. 228, para. 5, may make a change under Art. 230, para. 1, item 4 only in Art
a settlement with a population of up to 10,000 inhabitants.
(4) (New, SG No. 60/2011, effective 05.08.2011) Where the person under para. 3 wants to make a change to
Art. 230, para. 1, item 4 in a settlement with a population of more than 10,000 inhabitants, it pays the fee for the issuance of
permit for retail sale of medicinal products in a pharmacy specified in the tariff under Art. 21, para. 2.
(5) (Renumbered from Paragraph (2), SG No. 60/2011, effective 05.08.2011) Upon issuance of the permit, by which
allows the change under para. 1, the provisions of Art. 229
Art. 232. (1) Doctors and dentists may store medicinal products on a list,
designated by the Minister of Health.
(2) Where there is no pharmacy in the settlement, the persons under para. 1 may store and sell medicinal products
products only if they have been authorized to do so in the order specified by an ordinance of the Minister of Transport
healthcare.
Art. 232a. (New, SG No. 84/2018, effective 12.10.2018) Holders of a marketing authorization for
retail with medicinal products and persons under art. 207, para. 1, items 5a and 6 shall be provided daily to the BDA through
the specialized electronic system of art. 217b, para. 1 information for:
1. the quantities delivered to them indicated by medicinal products included in the Positive Medicinal List;
2. the quantities awarded / sold indicated by the medicinal products included in the Positive
medication list;
3. their available quantities indicated by medicinal products included in the Positive Medicinal List.
Art. 233. The pharmacy manager is responsible for the activities referred to in Art. 219, para. 1.
Art. 234. (1) It shall be prohibited to sell medicinal products through vending machines other than medicinal ones
products listed in the list specified in the ordinance under Art. 219, para. 2.
(2) The automatic machines under para. 1 may be owned only by the postmen. 222 and Art. 238, para. 2.
(3) The sale of medicinal products shall be prohibited.
(4) It shall be prohibited to sell on the Internet medicinal products subject to medical prescription.
(5) (New, SG No. 60/2011, effective 05.08.2011) Medicinal products without medical prescription may
to be sold online only by a pharmacy or drugstore authorized under the terms and conditions of
this law and the ordinance under art. 219, para. 2, respectively under Art. 243.
(6) (New, SG No. 102/2012, effective 02.01.2013) The pharmacies and drugstores of para. 5 posted on
the website through which they trade medicinal products without a prescription,
a common logo that is recognizable throughout the European Union.
(7) (New, SG No. 102/2012, effective 02.01.2013) The requirements to the general logo under para. 6 are determined by
delegated act of art. 85c (3) of Directive 2001/83 / EC.
Art. 234a. (New - SG 102/2012, in force from 02.01.2013) (1) The Executive Agency for Medicines
publish and maintain on its website:
1. information on national legislation applicable to the marketing of medicinal products for
Internet sales, including information that there may be differences between
Member States as regards the classification of medicinal products and the conditions for
their delivery;
2. information on the purpose of the common logo;
3. a list of persons offering medicinal products for sale on the Internet, as well as their addresses
websites;
4. general information about the risks associated with medicinal products delivered to consumers through
Internet in violation of the ordinance under Art. 234, para. 5.
(2) The website of the BDA under para. 1 is linked to the European Agency for Europe website
medicines.
Art. 234b. (New, SG No. 102/2012, effective 02.01.2013) The Executive Agency for Medicines shall participate
in information campaigns conducted by the European Commission and the European Medicines Agency
on the risk of counterfeit medicinal products.
Art. 235. (1) The permit for carrying out retail trade in medicinal products shall be mailed. 229, para. 2 se
terminate with termination of the activity of the persons under art. 222 and 225.
(2) (amend. - SG 60/11, in force from 05.08.2011) The Executive Director of the BDA shall terminate
authorization to trade in medicinal products:
1. at the request of the person who has received a permit for retail trade;
2. when it is established that the head of the pharmacy does not meet the requirements specified in Art. 224 and 225.
(3) (amend. - SG 60/11, in force from 05.08.2011) Within 14 days termination of the activity under para. 1
the persons under art. 222 and 225 shall notify the BDA in writing.
Art. 236. (1) The pharmacy may not be closed for more than 30 days within one calendar year
due to the absence of the manager and.
(2) (Suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 12 of 2011, in force since 08.02.2011, amended -
SG, issue 60 of 2011, effective 05.08.2011) When the pharmacy manager is unable to perform
obligations due to sick leave, sickness and pregnancy
birth or adoption and parental leave in accordance with the Labor Code, the pharmacy may
work for no more than two years under the direction of another Master of Pharmacy, respectively
assistant pharmacist, in the cases of art. 225, which meets the requirements of post. 224. In these cases, yes
issues permission from the BDA Executive Director.
(3) The permit under para. 2 shall be issued within 30 days.
Art. 237. In case of termination of the activity of the person who has been authorized to open a pharmacy, the medicines
the products may be sold to persons who have been authorized to wholesale medicinal products
products.
Art. 238. (1) (amend. - SG 71/08, in force from 12.08.2008) Medicinal products which are dispensed without
prescription, can be sold in a drugstore. Drugstores can also sell products and goods
relevant to human health as defined in the ordinance under Art. 243, and medical devices.
(2) (amend. - SG 71/08, in force from 12.08.2008) Right to carry out retail trade in medicinal products
products, opening a drugstore, have all natural and legal persons registered under the Commercial
law or under the law of a Member State.
(3) (amend. - SG 71/08, in force from 12.08.2008) The head of the drugstore shall be medical
specialist who:
1. is not deprived of the right to practice his profession;
2. has not been convicted of crimes related to the exercise of his profession, of crimes against
property and economy or intentional crimes against the individual;
3. have at least one year of experience in the specialty.
Art. 239. (1) (Amended, SG No. 60/2011, effective 05.08.2011) Drugstores shall be opened upon registration in
the relevant REI.
(2) (amend. - SG 60/11, in force from 05.08.2011) 238, para. 2 shall be submitted to the relevant RHI
application for registration, to which the following documents are attached:
1. (amend. - SG 60/11, in force from 05.08.2011) data on the Trader's Unique Identification Code
or the cooperative in the Commercial Register, and for companies incorporated in a Member State of the European Union
Union, or in a State Party to the Agreement on the European Economic Area - Document on
up-to-date registration under national law, issued by the competent authority of the relevant
the state of the persons under art. 238, para. 1;
2. (suppl. - SG 103/07, in force from 01.01.2018) document for education and criminal record of
the person designated as the head of the drugstore, if not a Bulgarian citizen;
3. the medical certificate of the person under item 2;
4. (repealed, SG No. 60/2011, effective 05.08.2011)
5. (amend. - SG 98/10, in force from 01.01.2011, repealed - SG, issue 60 from 2011, in force since 05.08.2011)
6. document for paid state fee in the amount specified in the tariff mail. 21, para. 2.
(3) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application under para.
2 The Regional Inspectorate shall carry out an inspection on compliance with the requirements of the ordinance under Art. 243. Where
establish that the requirements of the ordinance under Art. 243, within 7 days from the completion of the inspection
The RII prescribes and sets a time limit for their removal.
(4) (New, SG No. 60/2011, effective 05.08.2011) Within 14 days of receipt of the application and
the documents under para. 2, the Director of the RII shall notify the person in writing of the incompleteness found therein and
sets a time limit for their removal.
(5) (New, SG No. 60/2011, effective 05.08.2011) For filing an application for registration of a drugstore
or to effect a change under Art. 242 the respective SIC collects fees in the amount determined by the tariff under
Art. 21, para. 2.
(6) (New - SG 103 2017, in force from 01.01.2018) The Bulgarian Food Safety Agency
establish ex officio the circumstances regarding the criminal record of the person under para. 2, item 2, when it is Bulgarian
citizen.
Art. 240. (amend. - SG 60/11, in force from 05.08.2011) (1) Within 14 days from carrying out the inspection
under Art. 239, para. 3 or by eliminating incomplete mail. 239, para. 4, the Director of the SIC issues
a drugstore registration certificate or a reasoned refusal to issue a drugstore.
(2) (New, SG No. 102/2012, effective 21.12.2012) The Director of the RZI shall reasonably refuse to issue
certificate of registration of the person under art. 238, para. 2 when:
1. none of the documents under Art. 239, para. 2;
2. within the term of art. 239, para. 4 the applicant did not remove the incompleteness found.
(3) (New, SG No. 102/2012, effective 21.12.2012) When, within the term of para. 1 the director of the RZI has not issued
drugstore registration certificate or did not make a reasoned refusal, it is considered to be available
silent agreement.
(4) (New, SG No. 102/2012, effective 21.12.2012) In the cases of para. 3 the applicant can start
performing the requested activities in compliance with Art. 29 of the Administrative Restriction Act
regulation and administrative control over the economic activity.
(5) (Renumbered from Paragraph (2), SG No. 102/2012, effective 21 December 2012) 1
it is subject to appeal under the Administrative Procedure Code.
Art. 240a. (New, SG No. 102/2012, effective 21.12.2012) (1) The Director of the respective SIC shall terminate
with order registration of drugstore:
1. at the request of the person who has received a certificate for registration of a drugstore;
2. by termination of the activity of the person under art. 238, para. 2, of which it notifies the relevant RIC.
(2) Within 14 days of termination of the activity under para. 1, item 2 the person of post. 238, para. 2 notifies in writing
the relevant REI.
Art. 241. (1) (amend. - SG 60/11, in force from 05.08.2011) A register of
issued certificates for registration of a drugstore, which contains:
1. number and date of the certificate issued;
2. seat and address of the person who has received a drugstore registration certificate;
3. name, personal data and address of the head of the drugstore;
4. address of the drugstore;
5. date of termination of the registration and the reason for it;
6. notes on the entered circumstances.
(2) (amend. - SG 60/11, in force from 05.08.2011) Data from the register shall be published on the website of
the relevant RII on the Internet.
Art. 241a. (New, SG No. 60/2011, effective 05.08.2011) The National Register of Issuers
Certificates for registration of a drugstore under Art. 19a, para. 3 contains:
1. the name of the respective RHI which issued the registration certificate;
2. number and date of the issued certificate;
3. seat and address of the person who has received a drugstore registration certificate;
4. name of the head of the drugstore;
5. address of the drugstore;
6. date of termination of the registration and the reason for it.
Art. 242. In case of change of address of the drugstore or the head, the person, who has received a certificate for
opening and submits an application in accordance with Art. 239, para. 2 and the documents related to the change.
Art. 243. The terms and conditions for the organization of work in the drugstore shall be laid down in an ordinance of the Minister of Medicine.
healthcare.
Chapter eleven.
ADVERTISING OF MEDICINAL PRODUCTS
Art. Article 244. (1) Advertising of medicinal products shall be any form of information, presentation, promotion or
proposals to promote the prescription, sale or use of the medicinal product; and
includes:
1. advertising aimed at the population;
2. advertising intended for medical specialists;
3. visit of medical sales representatives to medical specialists;
4. providing samples of medicinal products;
5. sponsorship of promotional meetings and scientific congresses attended by medical professionals,
including the reimbursement of their travel and stay expenses in the country in which they are located
conducts the event.
(2) Does not constitute advertising of medicinal products:
1. text on the immediate packaging and in the package leaflet approved in the authorization procedure for
use;
2. correspondence regarding a specific issue or problem related to a medicinal product;
3. information messages and instructions on changes in packaging, warnings for unwanted ones
drug reactions as part of general product safety measures, commercial catalogs
and price lists, provided that they do not include drug-related advertising data
product;
4. statements relating to human health or diseases where they do not directly or indirectly
direct treatment, prevention or diagnosis with medicinal products;
5. vaccination campaigns conducted by the Ministry of Health of the population when
related materials do not contain data for a specific medicinal product.
Art. 245. (1) The holder of the marketing authorization shall be obliged to establish a scientific unit for
dissemination of information on medicinal products for which it has been authorized
the order of this law.
(2) The marketing authorization holder shall be obliged to:
1. ensure that the advertising of the medicinal product is presented to the general public or the medical community
specialists in a form that complies with the requirements of this Chapter and in accordance with the authorization issued
for advertising by the BDA;
2. has data and materials from all advertising campaigns undertaken in the course of his activity,
including information about the ad groups they are targeted for, how they should be implemented,
as well as the start date of the ad campaign
3. ensure the training of medical sales representatives;
4. Execute exactly and in due time the instructions of the advertising control officials.
(3) The medical sales representatives shall report to the scientific units under para. 1 any information
about the use of the medicinal products they advertise, especially with regard to information on
side effects reported to them by healthcare professionals.
Art. 245a. (New - SG 71/08, in force from 12.08.2008) Advertising is allowed only on medicinal products
products for which a marketing authorization has been granted under this Act.
Art. Article 246. (1) The content of the advertisement shall be consistent with the data of the approved at the permission
for a summary of the product characteristics and to present only those indicated in
authorization to use indications.
(2) The advertising of a medicinal product should only target its proper use by presenting
objectively therapeutic indications of the medicinal product without exaggerating the potential for
treatment, prophylaxis or diagnosis with the medicinal product.
(3) Advertising must not contain misleading information.
(4) (New, SG No. 71/2008, effective 12.08.2008) The advertisement may not contain a proposal and / or
a promise of a gift and / or other material or non-material benefit.
(5) (New, SG No. 71/2008, effective 12.08.2008) Medical specialist or person posing for
a health care professional may not advertise, directly or indirectly, medicinal products in
print and / or electronic media and the Internet.
Art. 247. Only medicinal products which are available without medicinal products may be advertised to the public
prescription.
Art. 248. (Supplemented, SG No. 71/2008, effective 12.08.2008) 247 adverts are allowed
vaccination campaigns conducted by marketing authorization holders, subject to compliance
the requirements of Art. 251 and under the conditions and in the order specified in the ordinance under Art. 249.
Art. 248a. (New, SG No. 71/2008, effective 12.08.2008) Advertising on the Internet of
prescription drugs, with the exception of ad campaigns
vaccination, carried out in accordance with Art. 248 and approved by the competent authorities.
Art. 249. Requirements for advertising of medicinal products shall be determined by an ordinance of the Minister of Health
healthcare.
Art. 250. An application for marketing authorization for a medicinal product shall be submitted by the holder of the medicinal product
the marketing authorization for the medicinal product or its authorized person.
Art. 251. (1) To authorize the advertisement, the person shall send. 250 shall submit to the BDA an application in accordance with a model approved by
the Executive Director of the Agency, accompanied by:
1. advertising project;
2. a notarized power of attorney from the holder of the marketing authorization when the application is submitted
filed by another person;
3. the literary sources of the quotations, tables or other materials used, if any;
4. document for payment of the fee in the amount specified in the tariff of the post. 21, para. 2.
(2) The advertising projects under para. 1, item 1 must be clear, with comprehensible text, in cases where there is one, and yes
they allow all elements and text and illustrations to be evaluated.
(3) An Expert Council on Advertising shall be established at the BDA. It includes doctors and specialists with
hands-on experience in advertising. The Executive Director of the BDA shall determine the composition of the Board with an order
of the Council, to which one representative of the Committee on Professional Ethics of the Bulgarian shall be included
medical union, the Bulgarian Dental Union and the Bulgarian Pharmaceutical Union, the size of
the remuneration of its members and approves rules of procedure for its work. In the composition of
counseling may also include representatives of patient organizations.
(4) The council under para. 3 prepares expertise on the advertising project and prepares an opinion to the executive
director of the BDA.
(5) In case of finding inconsistencies of the advertising with the requirements of this law within 7 days from the date
of filing the application under para. 1 The BDA gives written instructions for their removal within one month from
the date of the notification. The time limit for ruling ceases to run from the date of notification to
eliminate inconsistencies.
(6) In case the applicant fails to comply with the instructions within one month from the date of notification under para. 5,
the authorization procedure is terminated.
Art. 252. (1) Within one month from the submission of the documentation, mail. 251, para. 1 based on
the opinion under Art. 251, para. 4, the BDA Executive Director authorizes the advertisement or does it by order
a reasoned refusal to notify the Marketing Authorization Holder.
(2) (New, SG No. 60/2011, effective 05.08.2011) When, within the term of para. 1 Executive Director of
The BDA did not authorize the advertisement or did not make a reasoned refusal, it is assumed that it is silent
consent to the project of advertising under Art. 251, para. 1, item 1 and it may be distributed.
(3) (Renumbered from Paragraph (2), SG No. 60/2011, effective 05.08.2011) The refusal of the Executive Director
it is subject to appeal under the Administrative Procedure Code.
Art. 253. (1) The issued permission of the advertisement under Art. 252, para. 1 refers to a specific medicinal product
within the period of validity of his marketing authorization.
(2) When changes have been made to the marketing authorization for a medicinal product that lead to changes
in an authorized advertisement for this product, the Marketing Authorization Holder applies to the BDA
change.
Art. 254. Upon change of the permitted advertisement the person shall send. 250 shall submit an application in accordance with Art. 251.
Art. 254a. (New, SG No. 60/2011, effective 05.08.2011) (1) Advertising intended for medical use
specialists, it is not allowed in accordance with Art. 250 - 252.
(2) The advertisement under para. 1 shall be distributed upon notification to the BDA to which the project is attached
of advertising, and in compliance with the requirements of this chapter and the ordinance under Art. 249.
Art. 255. (1) It is prohibited to distribute samples of medicinal products containing narcotic drugs
substances within the meaning of the Narcotic Drugs and Precursors Control Act.
(2) It is prohibited to provide samples of medicinal products directly from the medical commercial ones
representatives under Art. 244, para. 1, item 3 of the population.
Art. 256. Samples of medicinal products shall be made available to medical specialists on terms and conditions,
defined in the ordinance under art. 249.
Art. 257. (1) The medical commercial representatives of art. 244, para. 1, item 3 must have received training,
organized by the marketing authorization holder who assigned them to possess scientific
knowledge and be able to provide accurate and complete information about the medicinal product that
present.
(2) The medical sales representatives must have a brief during each visit
product characteristics and data on the prices of the medicinal product and the conditions for its payment, and
to make them available on request.
(3) When presenting medicinal products to medical specialists, medical commercial
representatives may not offer gifts and other material and non-material benefits.
Chapter twelve.
ADJUSTMENT OF THE PRICES OF THE MEDICINAL PRODUCTS (HEADING, SG 102/02)
2012)
Section I.
National Council for Prices and Reimbursement of Medicinal Products (New - SG, iss.
102 of 2012, in force since 21.12.2012)
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)
(1) (Amended, SG No. 43/2016) A National Council for Prices and Prices shall be established with the Minister of Health.
reimbursement of medicinal products, hereinafter referred to as "tips". The Council is a legal entity of
budget support - a secondary budget allocator. It has the status of a state commission with
headquarters in Sofia.
(2) The activity of the council shall be financed from the state budget through the budget of the Ministry of Public Administration
healthcare.
(3) The Council is a collegial body and consists of a chairman and six members, three of whom are doctors or
Master of Pharmacy, two lawyers and two economists, all with a minimum of 5 years of experience
years. The Chairman and the members of the Council are elected and dismissed by a decision of the Council of Ministers
at the proposal of the Minister of Health. The chairman directs the activity of the council and it
represents.
(4) The members of the council may not occupy a position or carry on business post. 19, para. 6 of the Law on
the administration.
(5) The activity of the council shall be assisted by an administration whose structure and organization of work are
determine by regulation, adopted by the Council of Ministers.
Art. 259. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
(1) The Council:
1. approve, refuse to approve, amend or delete the price of medicinal products by mail. 261a, para. 1;
2. approve, refuse to approve, amend or delete the marginal price of medicinal products by mail. 261a,
para. 2;
3. register, refuse to register, amend or delete the prices of medicinal products without
medical prescription under Art. 261a, para. 3;
4. (Am. - SG, iss. 48 in 2015; amend. - SG, iss. 102 from 2018, effective from 01.01.2019, amended and supplemented - SG, iss. 64 from
2019) adopt, revoke or amend pharmacotherapeutic guidelines that include assessment criteria
of the result of the therapy applied and algorithms for drug treatment in agreement with
the relevant expert council on medical specialty or medical activity under art. 6a, para. 1, item 1 of
Health Law. Pharmacotherapeutic guidelines are adopted by regulations and promulgated in the State
newspaper ";
5. include, modify or exclude medicinal products from the Positive Medicinal List;
6. (New - SG, iss. 102 in 2018) effective assessment of the health technologies of
medical products;
7. (prev. Item 6 - SG, iss. 102 in 2018, effective from 01.01.2019) maintains and updates the Positive
medication list;
8. (new, SG No. 48/2015, prev. Item 7 - SG, issue 102 of 2018, effective from 01.01.2019)
the reimbursement status of the medicinal products every three years after their inclusion in the Positive
medication list;
9. (new, SG No. 48/2015, prev. Item 8, amended - SG, No. 102/2018, in force from 01.01.2019)
assistance in negotiating discounts in the cases under Art. 45, para. 10, 13 and 21 of the Health Act
insurance for medicinal products for which applications for inclusion in the Positive Medicinal Product have been submitted
list;
10. (new - SG 102 2018, in force from 01.01.2019) determine the medicinal products for which
traces the effect of the therapy, the term, as well as the medical establishments in which it is performed, under conditions, according to
order and criteria set out in the ordinance under Art. 261a, para. 5;
11. (New, SG No. 102/2018) effect information, publishing and
research, research related to pricing, reimbursement and drug policy.
(2) The Council shall keep public registers of:
1. the approved prices of the medicinal products shall be sent. 261a, para. 1;
2. the approved marginal prices of the medicinal products shall be sent. 261a, para. 2;
3. the registered prices of the medicinal products shall be sent. 261a, para. 3.
(3) The Council shall exercise control over the sale of approved medicinal products, the marginal price
price and registered price.
(4) The Council accepts the written applications for approval or price registration or for inclusion,
exclusion and alteration of medicinal products from the Positive Medicinal List under this Chapter shall be carried out
inspections and studies on them and make informed decisions.
(5) The Council shall collect fees in the amounts specified in the postal tariff. 21, para. 2, to submit applications for:
1. approval, registration or change in the approved or registered price of a medicinal product;
2. (amend. - SG 48/2015) inclusion, change or maintenance of the reimbursement status of a person included in
the list under Art. 262, para. 1 medicinal product;
3. (new, SG No. 102/2018) effective assessment of health technologies.
Art. 259a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG No. 102/2012, effective 21.12.2012
(d) (1) The meetings of the Council shall be regular if they are attended by more than half of the total number of
its members.
(2) The Council shall act by a majority of more than half of its total members.
(3) (New, SG No. 102/2018, in force from 01.01.2019)
representative / representatives of NHIF, Ministry of Health and BDA when performed
health technology assessment.
(4) (Renumbered from Paragraph (3), SG No. 102/2018) Effective on 01.01.2019
interested parties to be notified of the date and time of the meeting at which
the request made will be considered.
Art. 259b. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102 of 2012, effective 21.12.2012
(d) (1) The Council shall act within:
1. sixty days, when an application for price approval under Art. 261a, para. 1 and turn on
the medicinal product in the Positive Medicinal List;
2. thirty days, when an application for change or deletion of a positive drug is submitted
product list;
3. thirty days when the application for approval, change or deletion of a postage price is submitted. 261a,
para. 2;
4. thirty days, when an application for registration, change or deletion of a post price has been submitted. 261a,
para. 3;
5. thirty days for approval / registration of the price of the medicinal products for which it has been received
parallel import authorization;
6. (new - SG 48/15, amend. - SG 102/2018) one hundred and eighty days when
an application for inclusion in the Positive Medicines List of a new medicinal product has been submitted
an international non-proprietary name that is subject to health technology assessment;
7. (new, SG No. 48/2015) sixty days when an application for maintaining the reimbursement has been submitted
status of included medicinal product in the Positive Medicinal List;
8. (new - SG 102/2018) ninety days when the application for
expanding the indications for a product that is not currently on the Positive Medicinal List
paid;
9. (new - SG 102/2018) ninety days when an application for assessment has been submitted
of health technology.
(2) For the medicinal products under Art. 262, para. 5 the council shall act within thirty days, when it is
application for price approval under art. 261a, para. 1 and including the product in the Positive
medication list.
(3) The time limits under para. 1 and 2 shall commence on the date of submission of an application in accordance with the procedure of the postal order.
261a, para. 5.
Art. 259c. (New, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 102/2012, effective 21.12.2012
d)
Art. 259g. (New, SG No. 60/2011, effective 05.08.2011, repealed, SG No. 102/2012, effective 21.12.2012)
Art. 260. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
The authorities, officials and applicants under this chapter are obliged to assist the
the Board and its employees in the performance of their assigned duties.
Art. 261. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
(1) The members of the council and its employees shall be obliged not to disclose circumstances and facts that have occurred.
known to them upon or in connection with the performance of their official duties under this Act, except in writing
a request from a public authority when provided for by law.
(2) In connection with their obligations under para. 1 persons sign a declaration in the form approved by
the chairman of the board.
Section II.
Regulation and registration of the prices of medicinal products. Treatment algorithms
with medicinal products. Health Technology Assessment. (New, SG No. 102/2012)
force dated 21.12.2012, title ext. - SG, issue. 102 of 2018, effective January 1, 2019)
Section II.
Regulation and registration of the prices of medicinal products. Treatment algorithms
with medicinal products (New, SG No. 102/2012, effective 21.12.2012)
Art. 261a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102 of 2012, effective 21.12.2012
d. (1) The Council shall regulate the prices of the medicinal products included in the Positive Medicinal List under Art.
262, para. 1 and paid with public funds, in accordance with the lowest country reference prices
member states.
(2) the Council regulates the marginal prices of medicinal products subject to medical prescription,
beyond those of para. 1 according to the lowest reference prices of Member States.
(3) The Council registers maximum retail selling prices for medicinal products to be marketed
without a prescription.
(4) The price determined in accordance with the procedure of para. 1, is also the marginal price of medicinal products when sold to
retail.
(5) The Council of Ministers, upon a proposal by the Minister of Health, shall determine by an ordinance the conditions and
the rules for regulating the prices of the medicinal products under para. 1 to regulate the marginal prices of
prescribing medicinal products under para. 2 at retail, as well as
the conditions and procedure for registering the prices of medicinal products, which are available without medical treatment
prescription.
Art. 262. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
(1) (amend. - SG 15/2013, in force from 01.01.2014) The positive medical list shall be prepared and maintained.
from the board and includes prescription drugs and paid for with
the budget of the NHIF, from the state budget outside the scope of compulsory health insurance, from the budget
of the medical establishments under art. 5 of the Medical Institutions Act and the budget of the medical establishments with
state and / or municipal participation under Art. 9 and 10 of the Medical Institutions Act.
(2) (amend. - SG 102/08, in force from 01.01.2019) The positive medical list includes medicinal
products classified by pharmacological groups according to the anatomical-therapeutic-chemical code
classification, with the corresponding international non-patent names belonging to them
names, with the corresponding defined daily dose / therapeutic course, price under Art. 261a, para. 1, limit
price of medicinal products at retail sale, reference value for defined daily use
dose / therapeutic course, packing value calculated on the basis of reference / therapeutic
a defined daily dose course, pay level, therapeutic indications, and an international
diseases (ICD). For medicinal products, the reference value is established on the basis of
a defined defined daily dose or therapeutic course, or concentration or volume.
(3) (amend. - SG 102/08, in force from 01.01.2019) The Positive medicinal list shall include
medicinal products to which the international non-patent name to which it belongs
the medicinal product / combination (for combined medicinal products) is to be paid by the public
health insurance fund with the same therapeutic indications in at least 5 countries specified in the Ordinance on
Art. 261a, para. 5.
(4) (Supplemented, SG No. 48/2015, amended, SG No. 102/2018) Effective January 1, 2019
The positive drug list is selected according to evidence of efficacy, therapeutic
efficacy, safety and analysis of pharmacoeconomic indicators such as for medicinal products with
a new international non-proprietary designation also evaluates healthcare technology. The assessment of
Health technologies shall be carried out under the conditions and in the order determined by the ordinance under Art. 261a, para. 5.
(5) (amend. - SG 102/08, in force from 01.01.2019) Where one or more medicinal products with
the same international non-patent name, dosage form and concentration of the active substance,
already included in the relevant part of the Positive Medicinal List, no assessment under para. 4.
(6) The positive medical list includes:
1. medicinal products intended for the treatment of diseases, which are paid in accordance with the Law on
health insurance;
2. medicinal products paid from the budget of the medical establishments under art. 5 of the Law on Healing
establishments and from the budget of medical establishments with state and / or municipal participation 9 and 10 of the Law on
medical establishments;
3. medicinal products intended for the treatment of AIDS, infectious diseases, diseases
outside the scope of the Health Insurance Act, paid in accordance with Art. 82, para. 1, item 8 of the Law on
health as well as vaccines for compulsory immunizations and immunizations, vaccines for special indications and
in exceptional circumstances, specific sera, immunoglobulins;
4. the marginal price of the medicinal products under Art. 261a, para. 4 by elements.
(7) The Ministry of Health and the NHIF may submit proposals to the council by post. 258, para. 1 for
review of included medicinal products in the Positive Medicinal List under conditions and in order,
defined in the ordinance under art. 261a, para. 5.
(8) The National Health Insurance Fund shall pay for the medicinal products under para. 6, item 1 under the conditions and under
the order of the ordinance under art. 45, para. 9 of the Health Insurance Act.
(9) (New, SG No. 18/2014, Supplemented, SG No. 48/2015) Conditions, rules and criteria for inclusion,
changes and / or exclusion of medicinal products from the Positive Medication List and to maintain
the reimbursement status of the medicinal products shall be determined in the ordinance under Art. 261a, para. 5.
(10) (New, SG No. 48/2015, amend. - SG 102/08, in force from 01.01.2019) Medicinal Products
under Art. 45, para. 10, 13 and 21 of the Health Insurance Act, for which no discounts have been agreed, do not
are included in the Positive Medication List. Discount contracts come to the board of
the order specified in the ordinance under Art. 261a, para. 5.
(11) (New, SG No. 48/2015, amend. - SG 102/2018) Medicinal Products,
for which in the procedure under Art. 259, para. 1, item 8 does not prove a positive assessment upon their inclusion, does
are excluded from the Positive Medication List.
(12) (New, SG No. 84/2018, effective 12.10.2018, amended - SG No. 102/2018, effective 01/01/2019)
The Ministry of Health pays the medicinal products under para. 6, item 3 with a new international
a non-patent name, if it has been concluded before being included in the Positive Drug List
preliminary framework agreement between the Ministry of Health and the holder of the
the marketing authorization / authorized representative of the maximum value to which
the relevant medicinal product may be delivered to the Ministry of Health in the order of
Public Procurement Law. The agreement is binding on the parties. The agreements
act in the council in the order determined by the ordinance of art. 261a, para. 5.
(13) (New, SG No. 102/2018) The medicinal products under para. 6, item 3 with a new one
international non-patent name for which no prior framework agreement has been concluded under para.
12 are not included in the Positive Medication List.
Art. 262a. (New, SG No. 60/2011, effective 05.08.2011, repealed - SG No. 102/2012, effective 21.12.2012,
new - SG, iss. 102 of 2018, effective January 1, 2019) (1) Assessment of health technologies under Art. 262, para. 4 do not
performs for generic medicinal products and for medicinal products containing active / active
substance / substances with well-established use in medical practice.
(2) Health products shall be evaluated for medicinal products included in the Positive Medicinal List
technologies where an extension of therapeutic indications has been requested and has not yet been paid for
by public funds, under conditions and in the order determined by the ordinance under Art. 261a, para. 5.
(3) The Ministry of Health and the NHIF may reasonably request an assessment of the
the health technologies of medicinal products included in the Positive Medicinal List under conditions and conditions
order determined by the ordinance under art. 261a, para. 5.
Art. 262b. (New, SG No. 102/2018, effective 01/01/2019) (1) The assessment of health technologies shall include:
1. analysis of the health problem;
2. comparative analysis of the therapeutic efficacy, efficacy and safety of the medicinal product;
3. analysis of pharmaco-economic indicators;
4. analysis of budgetary impact.
(2) The assessment of health technologies shall be carried out according to the following criteria:
1. presence or absence of alternative treatment of the disease;
2. presence or absence of a medicinal alternative for the treatment of the disease;
3. efficacy and therapeutic efficacy of treatment - evaluation of therapeutic benefit, extension
life expectancy and improving the quality of life, reducing complications from the basic
illness;
4. number of potential patients;
5. safety of the medicinal product - frequency and severity of adverse reactions, need for administration of
additional prophylactic or therapeutic measures to prevent side effects;
6. Pharmaco-economic indicators - costs for therapy with the medicinal product and comparison of costs
for therapy with the alternatives available, cost-benefit ratio, economic evaluation of the additional
benefits;
7. Health Technology Benefits Presented through Earned Year of Life (LYG), Year of Life Considered
with quality (QALY), or in the absence of output data, by providing intermediate ones;
8. analysis of the budgetary impact on the basis of the expected number of patients;
9. estimation of the expenditure of public funds for a 5-year period;
10. analysis of the health perspective for the institution that pays for the public treatment
funds, or public outlook;
11. moral and ethical considerations (for specific disease groups).
Art. 262c. (New, SG No. 102/2018, effective 01/01/2019) (1) Monitoring of the effect of therapy on
Art. 259, para. 1, item 10 shall be carried out by medical establishments, determined by the National Council for prices and
reimbursement of medicinal products.
(2) The National Health Insurance Fund and the Ministry of Health shall carry out an analysis of
the information collected by the medical establishments under para. 1 under the conditions and according to the procedure specified in the ordinance under Art.
261a, para. 5.
Art. 263. (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 15 in 2013, in force since 01.01.2014)
With state budget funds outside the scope of compulsory health insurance can be
pay for prescription medicines not included in the list under Art.
262, para. 1 required for the prevention or treatment of epidemic outbreaks, epidemics, pandemics, and
in the presence of suspected or confirmed distribution of chemical or biological agents; or
nuclear radiation.
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)
(1) (Supplemented, SG No. 18/2014) Upon termination of the sales under Art. 54, para. 3 per medicinal product,
which is included in the Positive Medicinal List and, where relevant, internationally
non - patent name is not authorized by this law for any other medicinal product the proprietor of
the marketing authorization is notified in writing to the Ministry of Health and the National Council for Health
prices and reimbursement of medicinal products.
(2) (Supplemented, SG No. 18/2014) The holder of the marketing authorization shall notify in writing
The Ministry of Health and the National Council on Drug Price and Reimbursement
products and in the event of discontinuation of sales of a medicinal product for which the price is for
setting a benchmark within the relevant international non - patent name; and
dosage form.
(3) Where the product under para. 1 and 2 is intended for the treatment of diseases payable in the order of
The Health Insurance Act, the marketing authorization holder also informs the NHIF in
the terms under para. 4.
(4) The holder of the marketing authorization shall be obliged to make the notification under para. 1 not later than
18 months before the date of cessation of sales, and in the cases under par. 2 - no later than three months
before the date of discontinuation of sales.
(5) (Supplemented, SG No. 18/2014) Until the termination of the sales under para. 1 and 2 of the authorization holder
is obliged to provide sufficient quantities of the relevant medicinal product for use in order to satisfy
health needs, except in cases where the suspension is due to any of the grounds under Art.
276 or under Art. 277.
(6) After the expiry of the terms under para. 4, the Marketing Authorization Holder submits an application and
the relevant documents to exclude the medicinal product from the Positive Medicinal List.
(7) Where, following the cessation of sales of the medicinal product, the holder of the authorization for
use has not fulfilled its obligation under par. 6, the council under art. 258, para. 1 ex officio excludes him from
Positive drug list.
Art. 265. (1) The Council of Ministers shall establish a Transparency Committee.
(2) (Supplemented, SG No. 60/2011, effective 05.08.2011) The composition of the Transparency Committee shall be determined by
The Council of Ministers on a proposal from the Minister of Health. It is mandatory to include
representatives of the Ministry of Health, the Ministry of Labor and Social Policy,
of the BDA, the NHIF, the Bulgarian Medical Association, the Bulgarian Dental Union, the Bulgarian
pharmaceutical union and patient organizations and the pharmaceutical industry.
(3) (Am. - SG, iss. 60 in 2011, in force since 05.08.2011, amended - SG, iss. 102 in 2012, in force since 21.12.2012)
A person who is a member of the Transparency Committee cannot also be a member of the National Board of Prices and
reimbursement of medicinal products.
(4) The Council of Ministers shall determine by rules the terms and conditions for the work of the Transparency Commission.
Art. 266. (1) (amend. - SG 60/11, in force from 05.08.2011, amended - SG, issue 102 from 2012)
12/21/2012) The Transparency Committee is an authority against which decisions of the National can be appealed
advice on prices and reimbursement of medicinal products.
(2) Decisions of the Transparency Committee shall be taken by a two-thirds majority of the panel and.
(3) The decisions under par. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
the appeal does not suspend their enforcement.
Art. 266a. (New, SG No. 60/2011, effective 05.08.2011) (1) When the treatment of a relevant disease is
without an alternative in the country, an authorized medicinal product may be administered to a particular patient
for use in a Member State of the European Union, authorized for use under this Act, but not
distributes on the Bulgarian market.
(2) (amend. - SG 102/08, in force from 01.01.2019) Annually at the proposal of the medical establishments for
hospital care and after the opinion of the relevant expert council in the relevant medical specialty
or medical activity under Art. 6a, para. 1, item 1 of the Health Act the Minister of Health
approve the list of medicinal products under para. 1, which contains the following information:
1. anatomical-therapeutic-chemical classification code;
2. an international non-patent name to which the product belongs;
3. disease according to the international disease code;
4. the dosage form and the amount of active substance;
5. additional information.
(3) The list under para. 2 is published on the website of the Ministry of Health on the Internet.
(4) The conditions and the order for inclusion, change or exclusion of medicinal products in the list under para. 2 se
determine with the ordinance under art. 9, para. 1.
(5) The medicinal product under para. 1 shall be delivered by special order to a hospital establishment for hospital care
under the conditions and in the order determined by the ordinance of art. 9, para. 1.
(6) The head of the medical establishment under para. 5 shall be responsible for the implementation of the treatment under para. 1.
Chapter thirteen.
STATE CONTROLS ON MEDICINAL PRODUCTS
Art. 267. (1) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, effective from
12/21/2012) The Ministry of Health manages the state control over the medicinal products
products. Immediate guidance is provided by the Chief State Health Inspector, from
the chairman of the council under Art. 258, para. 1, by the Executive Director of the BDA and by the Directors of the Health Insurance Fund, who
are state drug control inspectors.
(2) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, in force since 21.12.2012)
Bodies for state control over medicinal products are the council under Art. 258, para. 1, BDA and RZI.
(3) (amend. - SG 98/10, in force from 01.01.2011, suppl. - SG, iss. 102 from 2012, in force since 21.12.2012)
The direct control is exercised by officials - inspectors and experts designated by
orders of the chairman of the council under art. 258, para. 1, to the director of the BDA or to the director of the respective
RZI.
(4) In exercising their control functions, the bodies under para. 1 may request the assistance of
the bodies of the Ministry of Interior.
Art. 267a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102 of 2012, effective 21.12.2012,
ed. - SG, issue. 102 of 2018, effective as of 01.01.2019) Medical Supervision Executive Agency implements
monitoring compliance with approved pharmacotherapeutic guidelines and evaluating
the effectiveness of the therapy in accordance with the criteria of Art. 259, para. 1, Vol. 4.
Art. 268. (1) The Executive Agency for Medicines shall exercise control over:
1. (suppl. - SG 102/2012, in force from 02.01.2013) the conformity of the premises, facilities and
the conditions for the manufacture, control, storage and marketing of medicinal products and active substances, and for
compliance with the requirements of Good Manufacturing Practice of Medicinal Products and Good
distribution practice;
2. (amend. - SG 102/2012, in force from 02.01.2013) the activity of the holders of a permit for
use by manufacturers, importers, wholesalers of medicinal products and active substances,
to intermediaries in the field of medicines, pharmacies and drugstores;
3. the quality, safety and efficacy of the medicinal products;
4. clinical trials of medicinal products and monitoring of compliance with the requirements of the Good
clinical practice;
5. the medical information related to their authorization for use and advertising;
6. (amend. - SG 102/02, in force from 21.12.2012) the system for monitoring of pharmacovigilance
of marketing authorization holders and compliance with Good Practice requirements for
pharmacovigilance monitoring.
(2) (amend. - SG 98/10, in force from 01.01.2011, amended - SG, issue 102 of 2018, in force since 01.01.2019)
Regional health inspectorates control:
1. on premises, facilities, conditions for storage and trade in medicinal products;
2. on the activity of the wholesalers, pharmacies and drugstores located on the territory of
the area concerned;
3. for compliance with the approved prices, the marginal prices, the registered prices of the medicinal products at
retail sale of pharmacies and drugstores located in the respective area.
(3) (New, SG No. 102/2018, in force from 01.01.2019). 258, para. 1 exercises control:
1. for observance of the approved prices, the marginal prices and the registered prices of the medicinal products at
their sale by wholesalers of medicinal products;
2. on the activity of the holders of the marketing authorization for medicinal products regarding compliance
of their obligations determined by the ordinance under Art. 261a, para. 5.
(4) (Renumbered from Paragraph (3), SG No. 102/2018, effective from 01.01.2019)
projects for the construction of new and / or remodeling of existing sites related to the production of
medicinal products in accordance with the rules of good manufacturing practice for medicinal products.
Art. 268a. (New, SG No. 60/2011, effective 05.08.2011) (1) (Amended, SG No. 84/2018)
12/10/2018) Donations of medicinal products from marketing authorization holders, manufacturers,
wholesalers and retailers and the Bulgarian Red Cross can only be made after filing
notification from the donor to the BDA following a model approved by the Minister of Health on proposal
of the BDA Executive Director.
(2) Donations shall be made in accordance with the World Health Donation Good Practice Rules
organization.
(3) (Repealed, SG No. 84/2018, effective 12.10.2018)
(4) The medical establishments and the Bulgarian Red Cross shall notify the BDA of the received donations of medicinal products.
products within 7 days of receipt.
(5) At the end of each quarter, the BDA sends information to the Ministry of Health about
the donations made under para. 4.
(6) To make a donation of a medicinal product at the request of a medical establishment intended for
treatment of a particular patient in a life-threatening condition, the donor notifies the BDA within 7 days
since its implementation.
(7) The donations under para. 6 may not exceed the amount required for a single course of treatment.
Art. 269. (1) The control under art. 267 is performed through inspections and laboratory tests.
(2) The inspections and laboratory tests under para. 1 shall be carried out:
1. in connection with the issuance of authorizations for use, production, import and certificates under the procedure of this law;
2. in connection with the supervision of the market of medicinal products;
3. upon request by the European Commission, the European Medicines Agency or by a party
to the competent authority of another Member State;
4. upon application by a manufacturer, importer or holder of a marketing authorization outside
the cases under item 1.
(3) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall carry out
Inspections:
1. to manufacturers of medicinal products located on the territory of the Republic of Bulgaria;
Member State or in third countries;
2. to importers and wholesalers of medicinal products;
3. on the premises of manufacturers, importers and wholesalers of active substances located
on the territory of the Republic of Bulgaria;
4. at the premises of manufacturers or wholesalers of active substances located in third places
countries as well as manufacturers or importers of excipients;
5. at the premises of the marketing authorization holders and the intermediaries
in the field of medicinal products, registered in accordance with Art. 212a;
6. as part of a certification procedure relating to monographs of the European Pharmacopoeia;
7. to manufacturers of starting materials at the written request of the manufacturer.
(4) The Medicines Executive Agency shall carry out inspections of manufacturers of medicinal products,
established in a third country in connection with an application for a marketing authorization or
import.
(5) (Amended, SG No. 102/2012, effective 21.12.2012) The inspections under para. 3 and 4 are performed in accordance
with guidelines adopted by the European Commission.
(6) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall participate in
a request from the European Commission, the European Medicines Agency or a Member State to perform
of inspections under para. 3 in the European Union or in third countries.
(7) (amend. - SG 102/2012, in force from 21.12.2012) The Executive Agency for Medicines shall cooperate
and exchanges information with the European Medicines Agency when planning and carrying out inspections
para. 3.
(8) (New, SG No. 102/2012, effective 21.12.2012) The Executive Agency for its Medicines
cooperates with the European Medicines Agency in coordinating inspections in third countries.
Art. 269a. (New, SG No. 102/2012, effective 21.12.2012) (1) 267, para. 3 draw up
report on each inspection carried out under Art. 269, para. 3 and 4 on compliance with the principles and guidelines for
Good manufacturing practice, either for Good Distributor Practices or for compliance with the requirements of
Chapter Eight, as well as the requirements of this law.
(2) The report under para. 1 shall be provided to the verified person, who may submit observations thereon.
(3) Upon receiving a substantiated request, the BDA shall electronically send the reports under para. 1 on
the competent authority of another Member State or of the European Medicines Agency.
Art. 269b. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
Art. 269, para. 3 is established in accordance with Good Manufacturing Practice, respectively Good
distributor practices, where applicable, are issued by the BDA to the manufacturer, importer or trader.
wholesale Certificate of Good Manufacturing Practice, respectively Certificate of Good Distributor Practice
within 90 days of the inspection.
(2) When, as a result of an inspection, 269, para. 3 it was found that the manufacturer, the importer
or the wholesaler of the medicinal product or the active substance does not comply with the law
and / or the principles and guidelines for Good Manufacturing Practice and / or Good Distribution
practices, the BDA issues a non-compliance statement.
(3) The Executive Agency for Medicines shall enter into the database under Art. 147 issued certificates under para.
1 and information under para. 2.
Art. 269c. (New, SG No. 102/2012, effective 21.12.2012) (1) Where as a result of an inspection under
Art. 270, para. 1, item 5 it is established that the holder of the marketing authorization does not comply with the requirements of the head
eighth, the BDA provides prescriptions for the correction of inconsistencies.
(2) In the cases of para. 1 The BDA shall notify the Member States, the European Medicines Agency and the European Medicines Agency
The European Commission.
Art. 270. (1) Within the limits of their competence, officials shall send. 267, para. 3 have the right:
1. (amend. - SG 102/2012, in force from 02.01.2013) access to all documents related to the subject of
inspection, as well as documents related directly or indirectly to a violation of this Act or of
the legislation of the Member States implementing the requirements of Directive 2001/83 / EC, regardless of
the format of the document;
2. order each person to provide information on violations under item 1, which are known to him;
2a. (new - SG 102/2012, in force from 02.01.2013) to inspect the production and commercial
facilities of manufacturers of medicinal products, active or auxiliary substances, as well as laboratories,
used by the holders of a manufacturing or import license;
3. to inspect at any time the sites to be inspected and to request, verify and make copies
from all documents related to the overall activity of the controlled site;
4. take samples of medicinal products, active substances and excipients for laboratory testing;
5. (amend. - SG 102/02, in force from 21.12.2012) to inspect the premises, archives, documents and
the main documentation of the holder 's pharmacovigilance monitoring system
the marketing authorization or persons entrusted with the activities of Chapter Eight;
6. (new - SG 102/2012, in force since 21.12.2012) to carry out an inspection on compliance with
approved prices, marginal prices or registered prices for the sale of medicinal products;
7. (Renumbered from Item 6, SG No. 102/2012, effective 21.12.2012) to draw up acts for establishing
administrative violations.
(2) (Repealed, SG No. 102/2012, effective 21.12.2012)
(3) (amend. - SG 98/10, in force from 01.01.2011) The Executive Director of the BDA or the respective
the Director of the SIC is entitled, depending on the submission of the offending official,
Yes:
1. order in writing the offender to suspend the violation under para. 1, Vol. 1;
2. requires the offender to declare that he will cease the violation under para. 1, item 1 and, if necessary, yes
obliged him to make the declaration public;
3. order the termination or prohibition of any violation under para. 1, item 1 and if necessary to do
the order for termination or prohibition of the public domain infringement.
(4) (New, SG No. 102/2012, effective 21.12.2012) The Chairman of the Council shall mail. 258, para. 1 is right
to order in writing the offender to suspend the violation found during the inspection under para. 1, v. 6.
Art. 271. (1) (amend. - SG 98/10, in force from 01.01.2011) Regional health inspections shall be entitled
Yes:
1. stop construction and issue prescriptions when they find violations of hygiene standards and
requirements in the construction execution process; illegal construction of sites and facilities
for the production, storage and sale of medicinal products shall notify the National Directorate
building control or technical service of the municipality;
2. prohibit the commissioning and stop the operation of sites and facilities in case of violation
the requirements and hygiene standards for the production, storage and sale of medicines
products - until the elimination of the infringements;
3. (amend. - SG 71/08, in force from 12.08.2008) block medicinal products in the presence of
documented information on: non-compliance with quality requirements; medicinal products imported
or produced in violation of this law; medicinal products that are available in packs of leaflets,
who do not meet the requirements of this law; and send samples of them to the BDA;
4. give conclusions about the compliance of the objects of control with the statutory requirements;
5. issue orders, prescriptions and instructions within their competence, which are obligatory
for all persons in the territory of the area concerned.
(2) (amend. - SG 98/10, in force from 01.01.2011) The compulsory administrative measures under para. 1 or more
Art. 270, para. 3 shall be imposed by an order of the director of the RII.
(3) The orders under para. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
the appeal does not suspend their enforcement.
Art. 272. (1) The Executive Agency for Medicines shall:
1. (suppl. - SG 102/2012, in force from 02.01.2013) prohibits the commissioning and stops
the operation of sites and facilities in violation of the rules of Good Manufacturing Practice of
medicinal products and active substances as well as good distribution practices until the elimination of
violations;
2. prohibit the manufacture, import, export and trade in medicinal products, directly or indirectly
threaten human health and order that they be destroyed, recycled or used for others
goals;
2a. (new - SG 102/2012, in force from 02.01.2013) shall delete from the register the persons engaged in activity
in mediation with medicinal products, in case of non-compliance with the obligations under Art. 212b.
3. temporarily suspend the operation of wholesale and retail outlets for medicinal products when
the conditions under which the relevant authorization was granted are not fulfilled;
4. block medicinal products in the presence of documented information about: non-compliance with
the requirements for quality, efficiency and safety; medicinal products imported or manufactured in
violation of this law, as well as medicinal products that are available in packs of leaflets that do not
meet the requirements of this law; order withdrawals from pharmacies and drugstores as needed,
from wholesalers, manufacturers and health establishments, and informs
The Ministry of Health;
5. (amend. - SG 84/2018) (*) revoke the issued clinical trial permit, suspend the holding
of the clinical trial or obliges the contracting authority to submit a substantive change to
the clinical trial of established infringements of Regulation (EU) No 536/2014 under the terms and procedures,
provided for therein;
5a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 02.01.2013)
orders the blocking, withdrawal and destruction of counterfeit medicinal products and medicinal products
products of unknown origin;
5b. (new - SG 60/11, in force from 05.08.2011) carries out checks on the donations made.
268a, para. 1;
6. issue orders, instructions and instructions within its competence, which are obligatory
for all persons;
7. (new - SG 60/11, in force from 05.08.2011) place medicinal products and active medicinal products under prohibition
substances in doubt in the deviation of their quality by affixing signs in the sites
for production.
(2) The compulsory administrative measures under para. 1 or under Art. 270, para. 3 shall be imposed by order of the director
of the BDA.
(3) The orders under para. 2 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
the appeal does not suspend their enforcement.
Art. 272a. (New, SG No. 102/2012, effective 02.01.2013) (1) By delegated acts, no. 52b, paragraph 2
Directive 2001/83 / EC lays down the necessary measures to prevent the placing on the market of
medicinal products introduced into the European Union but not intended for the marketing of
The European Union, for which there are sufficient grounds for suspecting that they have been falsified.
(2) The Medicines Executive Agency shall take the necessary measures in accordance with the delegated ones
acts under para. 1 to prevent the release of medicinal products introduced into the European Union
Union, but not intended to be placed on the European Union market for which there are sufficient grounds for
suspected of being counterfeit.
(3) The customs authorities shall notify the BDA of the introduction on the territory of the Republic of Bulgaria of
medicinal products under para. 1 with a view to taking measures under para. 2.
Art. 273. (1) The conditions and the order for taking the samples, performing the tests and paying for them shall be
determined in an ordinance of the Minister of Health.
(2) When challenging the results of laboratory tests, repeated tests shall be made. They
shall be made upon written request from the interested party made within 7 days from the date of
obtaining the result of the original test.
(3) The repeated tests under para. 2 shall be carried out by experts designated by the BDA Executive Director,
who did not participate in the original test in the presence of an authorized representative of
the interested party.
Art. 274. (1) The conditions and the order for blocking and withdrawal of medicinal products which have shown non-compliance with
the requirements for quality, safety and efficiency shall be laid down in an ordinance of the Minister of Agriculture and Forestry
healthcare.
(2) The conditions and procedure for the destruction, processing or use for other purposes of medicinal products
products are defined in an ordinance of the Minister of Health.
Art. Article 275. (1) In exercising control, the BDA shall take all necessary measures to ensure
proper validation of the processes of production and purification of medicinal products obtained from
human blood or human plasma, consistency in batch quality and guarantee as far as possible
the technology allows for the absence of specific viral contamination.
(2) Manufacturers shall notify the BDA of the method used to reduce or eliminate pathogens
viruses that can be transmitted through medicinal products derived from human blood or human
plasma.
(3) The Executive Agency for Medicines shall test or send for testing to another official agency
laboratory for the control of medicinal products in the Republic of Bulgaria or in another Member State samples from
bulk / non - spilled product and / or medicinal product for testing or in the course of evaluating an application for
authorization for use under Art. 46, para. 1, item 2 or after issuing a marketing authorization.
Art. 276. The Executive Director of the BDA shall, by order, suspend, revoke, suspend or amend
the authorization to use the medicinal product / registration when it is established that:
1. there is an unacceptable side effect when used properly, or
2. lack of therapeutic efficacy (therapeutic efficacy is lacking when it is found that they cannot
the declared therapeutic results are obtained when authorized), or
3. the benefit / risk balance is unfavorable when used correctly, or
4. the quantitative and qualitative composition of the medicinal product does not correspond to the one declared at
the marketing authorization, or
5. the data from the file under art. 27 - 32 are incorrect, or
6. (amend. - SG 71/08, in force from 12.08.2008) the data from the file 27 - 32 are not completed or not
have been modified in accordance with the requirements of Chapter Three, Section VI, or
6a. (new - SG 102/2012, in force since 21.12.2012) the conditions of posting are not fulfilled. 55a, 56 or 56a,
or
6b. (new - SG 102/2012, in force since 21.12.2012) the manufacture of the medicinal product is not
performed in accordance with the described method of production under Art. 27, para. 1, item 7, or
7. (amend. - SG 102/2012, in force since 21.12.2012) no control tests have been carried out or they have not been carried out.
carry out in accordance with the methods specified in Art. 27, para. 1, item 8, or
8. the particulars on the packaging and / or in the package leaflet are not in accordance with those approved at the time of issue
the marketing authorization;
9. (new - SG 71/08, in force from 12.08.2008) the holder of the marketing authorization has not fulfilled
obligations under Article 45 (1) of Regulation (EC) No 1901/2006.
Art. 277. (1) The Executive Director of the BDA, regardless of the measures, shall be sent. 276, prohibits by order
supplying the medicinal product and ordering its blocking and withdrawal when:
1. (amend. - SG 102/2012, in force since 21.12.2012) there is an unacceptable adverse reaction, or
2. lack of therapeutic efficacy, or
3. (amended, SG No. 102/2012, effective 21.12.2012) the benefit / risk balance is unfavorable, or
4. the quantitative and qualitative composition of the medicinal product does not correspond to the one declared at
the marketing authorization, or
5. the control of the medicinal product and / or the ingredients and the intermediate stages of the manufacturing process
has not been completed or does not meet the requirements under which the manufacturing authorization was granted.
(2) The BDA Executive Director may impose a prohibition under para. 1 and only with respect to specific
batches of the medicinal product.
Art. 278. (1) The Executive Director of the BDA shall, by order, suspend or revoke the permit for
use of a group or all medicinal products for which they are not manufactured
the requirements under which the manufacturing authorization is granted are fulfilled.
(2) The Executive Director of the BDA shall, in addition to the postal measures. 276 may temporarily suspend imports of
group or all medicinal products from third countries or withdraw the import authorization granted to
group or all medicinal products when they do not comply with the requirements of Chapter Five.
(3) The Executive Director of the BDA shall, in addition to the postal measures. 276 may temporarily suspend or suspend by order
withdraw the authorization to manufacture a group or all medicinal products not in the group
compliance with the requirements of Chapter Five.
Art. 279. (1) The orders under art. 276, 277 or 278 shall be served on the marketing authorization holder,
respectively to the manufacturer or importer.
(2) The orders under para. 1 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
the appeal does not suspend their enforcement.
Art. 280. (1) In establishing violations of the provisions, head eleven, respectively, of the ordinance
under Art. 249, the Executive Director of the BDA orders the suspension of the distribution of
advertising.
(2) With the order under para. 1, the BDA Director may oblige the advertiser to publish or to publish
disseminate, in agreement with the BDA, the allegations in advertising by the same means and in the same
format and volume.
(3) The order under para. 2 shall be subject to appeal in accordance with the Administrative Procedure Code.
Chapter fourteen.
ADMINISTRATIVE PENALTY PROVISIONS
Art. 281. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG, No. 102 of 2012)
01/02/2013) Who manufactures, imports, sells, stores or makes available for use in the Republic of Bulgaria
medicinal products that are not authorized for use, except in cases under Art. 8, 9 and 10, as well as those with
non-established origin, if not subject to more severe punishment, shall be punished by a fine of BGN 25,000 to BGN 50,000.
(2) The same punishment shall be imposed on the persons who produce, import, sell or allow
use in the Republic of Bulgaria medicinal products that do not meet the requirements of the active one
pharmacopoeia and the conditions of their authorization.
(3) When the violations under para. 1 and 2 relate to unauthorized medicinal products containing
narcotics, or when they are repeated if the acts do not constitute a crime,
the permit issued under this law shall be revoked.
(4) Medical professionals who manufacture, sell or supply unauthorized uses
medicinal products are deprived of the right to practice their profession for a period of 6 months to two years.
(5) The punishment under para. 4 shall be imposed by order of the Minister of Health on the proposal of
the BDA Executive Director.
Art. 282. (1) Who sells medicinal products in packages or leaflets for a patient who does not meet
the requirements of this law shall be punished by a fine of 750 to 1500 levs, and in case of repeated performance of the same
violation - with a fine from 1500 to 3000 BGN.
(2) A person who sells medicinal products without leaflets to the patient shall be punished by a fine of BGN 750 up to 1500,
repeated infringement - with a fine from 1500 to 3000 BGN.
Art. 283. (1) Who imports, trades or makes available medicinal products which have expired,
shall be liable to a fine of from BGN 10,000 to BGN 20,000.
(2) Who breaks the primary / secondary packaging or sells / supplies the offending medicinal products
primary / secondary packaging, punishable by a fine of 750 to 1500 levs, and for repeated violation - a fine of 1500
up to 3000 BGN
Art. 284. (1) Who manufactures, imports or wholesale medicinal products or sells medicinal products
products, without permission, are fined BGN 50,000.
(2) (suppl. - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 of 2012, in force since 02.01.2013)
Who manufactures, imports or wholesale medicinal products or sells medicinal products in
breach of the authorization or sell, store or supply medicinal products that are
of unidentified origin shall be liable to a fine of BGN 25,000 to BGN 50,000.
(3) (suppl. - SG 71/08, in force from 12.08.2008) In the cases of para. 1 and 2 the bodies of state control
stop the operation of the site by order.
(4) The order under para. 3 shall be subject to appeal in accordance with the Administrative Procedure Code, such as
the appeal shall not suspend its execution.
Art. 284a. (New, SG No. 102/2012, effective 02.01.2013) Who produces, imports, exports, stores,
sells or provides counterfeit medicinal products, and mediates the purchase and sale
falsified medicinal products shall be liable to a fine of BGN 25,000 to BGN 50,000.
Art. 284b. (New, SG No. 102/2012, effective 02.01.2013) Holder of a production permit,
who does not fulfill his obligations under Art. 160, shall be punished by a pecuniary sanction from 5000 to 10 000 levs, a
for repeated infringement - with a pecuniary sanction from BGN 10,000 to BGN 20,000.
Art. 284c. (1) (New - SG, iss. 102 in 2012, in force since 02.01.2013, previous text Art. 284c, suppl. - SG, iss. 84 from
2018, effective 12.10.2018) The holder of a wholesale marketing authorization for medicinal products which
does not fulfill its obligations under Art. 207, para. 1, items 1 - 3, items 4a - 14 and para. 2, shall be punished by a pecuniary sanction of
2000 to 5000 levs, and in case of repeated infringement - with a property sanction from 5000 to 10
BGN 000
(2) (New, SG No. 84/2018, effective 12.10.2018) Holder of a wholesale trading permit
medicinal products, which is supplied with medicinal products by persons other than those specified in Art. 207,
para. 1, item 4, shall be punished by a pecuniary sanction of BGN 25,000 to BGN 50,000, and in the case of a repeated execution of the same
violation - with a property sanction from BGN 50,000 to BGN 100,000
Art. 284g. (New, SG No. 84/2018, effective 12.10.2018) Who fails to fulfill his / her obligations 68,
para. 1, items 9 and 10, shall be punished by a fine in the amount of BGN 50,000 to BGN 100,000, and in the case of repeated commission of the same
violation - with a fine of BGN 100,000 to BGN 150,000.
Art. 284d. (New, SG No. 84/2018, effective 12.10.2018) Who carries out the export of medicinal products,
included in the list under Art. 217c, para. 1, shall be punished by a fine in the amount of BGN 50,000 to BGN 100,000, and for a repeated fine
committing the same offense - with a fine of BGN 100,000 to BGN 150,000.
Art. 284f. (New, SG 84/2018, effective 12.10.2018) Who does not fulfill or does not fulfill in the specified
within the time limits, the obligation to provide information under Art. 217b, para. 3, item 1, shall be punished by a fine in Art
amount from BGN 50,000 to BGN 100,000, and in the case of repeated infringement - with a fine of BGN 100
000 to 150 000 BGN
Art. 284g. (New, SG No. 84/2018, effective 12.10.2018) Who provided information 217b, para. 3,
item 1 with incomplete and / or inaccurate content shall be punished with a fine in the amount of 5000 to 10 000 BGN, and in case of repeated
committing the same offense - with a fine of BGN 10,000 to BGN 15,000.
Art. 284s. (New, SG No. 84/2018, effective 12.10.2018) For failure to fulfill the obligations, mail. 217b,
para. 9 of the Executive Director of the BDA, respectively an official of the BDA, shall be fined
50,000 to 100,000 BGN, and in the case of repeated infringement - a fine of 100,000 to 150
BGN 000
Art. 285. (1) Whoever trades in medicinal products without a batch release certificate shall be punished with
a fine of BGN 5,000 to 10,000 and, in the case of a repeated infringement, a fine of 10,000 to 20,000 BGN
(2) (Amended, SG No. 60/2011, effective 05.08.2011) Wholesale wholesaler supplying drugstores
prescription medicinal products are punishable by a financial penalty of 2500
up to BGN 5,000, and in the case of a repeated violation - with a fine of between BGN 5,000 and 10,000.
(3) Qualified person allowed to sell lots of medicinal products without
certificate for release of each individual batch, is punished with a fine from 2500 to 5000 levs.
Art. 285a. (New, SG No. 60/2011, effective 05.08.2011, amended - SG, No. 102 of 2012)
12/21/2012) Marketing Authorization Holder who did not notify the Minister of Health of
suspension of sales under Art. 264, shall be punished by a pecuniary sanction of from 25,000 to 50,000 BGN.
Art. 285b. (New, SG No. 102/2012, effective 21.12.2012) Who produces, imports, exports, sells, or
stores active substances in violation of the requirements of this law, shall be punished by a fine from 10,000 to 20
BGN 000
Art. 285c. (New, SG No. 18/2014, amended, SG No. 84/2018, effective 12.10.2018)
medicinal products in quantities greater than the quantities under Art. 207, para. 1, item 15, letter "d" shall be punished by Art
a fine of BGN 50,000 to BGN 100,000, and in the case of a repeated infringement, a fine of BGN 50,000
from 100,000 to 150,000 BGN
Art. 286. (1) (Supplemented, SG No. 84/2018) (*) For clinical trials conducted in violation of this Act, or
of Regulation (EU) No 536/2014, if committed does not constitute a crime, of the perpetrators
or who have committed this violation, will be fined $ 5,000 to $ 10,000, and upon re-admission or
committing the same offense - a fine of 10,000 to 20,000 BGN.
(2) To medical specialists who have admitted or committed violations under para. 1 may also be required
punishment "deprivation of the right to exercise their profession" from 6 months to two years.
(3) The measure under para. 2 shall be imposed by the Minister of Health upon proposal of the Executive Director
of the BDA.
Art. 287. (1) (Supplemented, SG No. 71/2008, effective 12.08.2008, amended - SG No. 60/2011, effective 05.08.2011
(d) Who is retailing medicinal products without a marketing authorization / certificate
this, or works in violation of his issued permit / certificate, shall be punished with a fine of 5000 to 10
BGN 000
(2) (New, SG No. 84/2018, effective 12.10.2018) Retailer who supplies medicinal products
products from the list under Art. 217c, para. 1 wholesaler or other person in violation of the requirements of
this law, or the by-laws implementing it, shall be punished by a fine, as appropriate
property sanction from 10,000 to 20,000 BGN, and in the case of repeated violation - from 25,000 to 35,000 BGN.
(3) (Renumbered from Paragraph (2), SG No. 84/2018) Effective from 12.10.2018. 1 shall also be imposed on the persons,
who are retailing a pharmacy or drugstore after the termination of the business
the permit / certificate.
(4) (amend. - SG 71/08, in force from 12.08.2008, suppl. - SG, iss. 60 in 2011, in force since 05.08.2011,
previous para. 3 - SG, iss. 84 of 2018, effective 12/10/2018) Who sells or stores in a drugstore
medicinal products subject to medical prescription or products and goods relevant to
human health beyond those specified in the ordinance under Art. 243, shall be punished by the fine under para. 1, and when re
committing the same infringement shall be revoked the issued certificate for registration of a drugstore.
(5) (Renumbered from Paragraph (4), amend. - SG 84/08, in force from 12.10.2018). 1, 2 and 3 bodies of
state control over medicinal products shall stop the operation of the facility by order.
(6) (repealed - SG 71/08, in force from 12.08.2008, previous para 5, amended - SG, iss. 84 of 2018, in force from
12.10.2018) The order under par. 5 shall be subject to appeal in accordance with the Administrative Procedure Code,
and the appeal does not suspend its execution.
Art. 287a. (New - SG 71/08, in force from 12.08.2008) (1) Medical specialist working at
retailers of medicinal products without a permit / certificate
this is fined from 2500 to 5000 BGN.
(2) The punishment under para. 1 shall also be imposed on a person under para. 1 that works in a pharmacy or drugstore after discontinuation
the validity of the permit / certificate and.
(3) In case of more than two violations under para. 1 and 2, the Minister of Health may deprive
the relevant healthcare professional entitled to practice for up to two years.
Art. 287b. (New, SG No. 102/2012, effective 02.01.2013) Who conducts trade in medicinal products
products on the Internet in violation of the requirements of this law and the ordinance under Art. 234, para. 5, shall be punished by
fine from $ 5,000 to $ 10,000
Art. 288. (1) A retailer of medicinal products who has authorized the activities specified in Art. 219, yes
are carried out by an incapacitated person, punishable by a pecuniary sanction of BGN 5,000 to 10,000;
repeated infringement shall be revoked the issued authorization for retail trade.
(2) In the cases of para. 1, the state control bodies shall stop the operation of the site with an order.
Art. 289. (1) (Previous text of Art. 289 - SG, iss. 60 in 2012, in force since 07.08.2012, amended - SG, iss. 102 in 2018)
who sells medicinal products at no established or registered price or at
prices, other than those established by the order of this law, shall be punished with a fine from 1500 to 3000 levs, and in case of repeated
committing the same offense - with a fine from 2500 to 4000 BGN.
(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)
Holder of a marketing authorization that fails to fulfill an obligation specified in the ordinance under Art. 261a,
para. 5, shall be punished by a pecuniary sanction from 5000 to 10 000 levs, and in the case of repeated commission of the same
violation - with a property sanction from BGN 10,000 to BGN 20,000
(3) (New, SG No. 102/2012, effective 21.12.2012, repealed - SG No. 102/2018, effective 01/01/2019)
Art. 289a. (New, SG No. 60/2011, effective 05.08.2011) (1) (Amended, SG No. 102/2012, effective from
21.12.2012, amend. - SG, issue. 102 of 2018, effective January 1, 2019) Who works in violation of the approved
pharmacotherapeutic guidelines or evaluates the outcome of therapy in deviation from
the criteria under 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
violation - with a fine from 2000 to 3000 BGN.
(2) (amend. - SG 102/08, in force from 01.01.2019) The violations under para. 1 shall be established by acts,
made up of officials designated by the Executive Director of the Executive Agency
Medical Supervision, and penal orders are issued by the Executive Director of the Executive
Medical Supervision Agency.
Art. 290. (1) (amend. - SG 71/08, in force from 12.08.2008) Who advertises medicinal products which
are not authorized for use under this law, shall be liable to a fine of BGN 10,000 to BGN 20,000.
(2) (New, SG No. 71/2008, effective 12.08.2008) Who advertises a product by attributing it and / or
directs to the properties related to the prevention, diagnosis or treatment of human diseases, punishable by
fine from BGN 10,000 to BGN 20,000
(3) (Renumbered from Paragraph (2), SG No. 71/2008, effective 12.08.2008) Who advertises medicinal products in
violation of this law, shall be punished by a fine of BGN 10,000 to BGN 20,000.
(4) (Renumbered from Paragraph (3), Amended, SG No. 71/2008, effective 12.08.2008). 1 - 3 is also imposed on
the persons who allowed the broadcast, publication and distribution of the advertisement.
Art. 290a. (New, SG No. 71/2008, effective 12.08.2008) Medical specialist or person presenting
is a healthcare professional who directly or indirectly advertises medicinal products in
the printed and / or electronic media, as well as on the Internet, are fined from 1000 to 5000 BGN,
repeated violation - from 3,000 to 10,000 BGN
Art. 290b. (New, SG No. 60/2011, effective 05.08.2011) Who makes a donation of medicinal products
in violation of Art. 268a, para. 1, shall be punished by a fine of from 1000 to 3000 levs, and in case of repeated performance of the same
violation - with a fine from 3000 to 5000 BGN.
Art. 290c. (New - SG 102/2012, in force since 21.12.2012) The holder of a marketing authorization which
conducts non-interventional studies in violation of this law, is punished by a property sanction of
BGN 5,000 to 10,000, and in the case of repeated infringement - with a property sanction of 10,000 to 20
BGN 000
Art. 290g. (New, SG No. 102/2012, effective 21.12.2012) Holder of a marketing authorization which does not
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
re-committing the same offense - with a property sanction of BGN 10,000 to BGN 20,000.
Art. 290d. (New - SG 102/2012, in force since 21.12.2012) The holder of a marketing authorization which
does not fulfill the obligations under Art. 190 - 192, 194b, 194c, 194h and 194i, shall be punished by a pecuniary sanction of
BGN 5,000 to 10,000, and in the case of repeated infringement - with a property sanction of 10,000 to 20
BGN 000
Art. 290s. (New, SG No. 102/2012, effective 21.12.2012) Holder of a marketing authorization that does not
fulfills the obligations under Art. 193 and 194, shall be punished by a pecuniary sanction from 2000 to 5000 levs, and at
re-committing the same offense - with a property sanction from 5000 to 10 000 BGN.
Art. 291. (1) (Supplemented, SG No. 60/2011, effective 05.08.2011, Supplemented, SG No. 60/2012, effective 07.08.2012
, amended - SG, issue. 102 of 2012, in force since 21.12.2012, suppl. - SG, issue. 84 of 2018, effective 12.10.2018) Where
the violations under Art. 281 - 284a, Art. 284g - 284z, 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 made by legal persons or sole traders, are imposed
property penalties of not less than three times the estimated minimum size of
the respective fines and not exceeding the triple the size of the respective maximum amounts of the respective fines
fines.
(2) (suppl. - SG 60/2012, in force from 07.08.2012) For violations of post. 289, para. 1 the property sanction
shall be in nine-fold amount of the excess amount if it exceeds the maximum amount of the sanction under para. 1.
(3) The imposition of a pecuniary sanction shall not preclude the imposition of a fine on the guilty officials.
(4) The imposition of pecuniary sanctions does not preclude the imposition of measures provided for
legal capacity of medical specialists and qualified persons.
Art. 292. (1) Who does not comply with the order, prescription or instruction of the state control bodies under Art
this law, except in cases under Art. 270, para. 1, item 2 and para. 3, shall be punished by a fine from 1500 to 3000 levs.
(2) For failure to comply with an order under Art. 270, para. 1, item 2 and para. 3 guilty persons are liable to a fine of 500
up to 1000 BGN
Art. 293. (1) (amend. - SG 102/02, in force from 02.01.2013, amended - SG, issue 84 of 2018)
12.10.2018) Failure to comply with the conditions under which the permits / certificates for
manufacture, import, parallel import, wholesale and retail of medicines in a pharmacy,
as well as in the cases under Art. 281, para. 1 - 3, Art. 283, para. 1, Art. 284c, para. 2 and Art. 287, para. 2 the Executive Director
The BDA issues an order for their withdrawal.
(2) (Am. - SG, iss. 102 in 2012, in force since 02.01.2013, amended - SG, iss. 84 of 2018, in force since 12.10.2018).
non-compliance with the conditions under which a drugstore registration certificate was issued, as well as in cases
under Art. 287, para. 4, the director of the respective RIC issues an order for revocation of the certificate.
(3) In case of non-fulfillment of the obligation for notification under Art. 204, para. 3 for termination of activity by
on the part of the wholesaler of medicinal products, the BDA Executive Director issues an order for
revocation of the issued permit.
(4) (New - SG, iss. 84 in 2018) In case of non-fulfillment of the requirements for export of
medicinal products of Chapter Nine "b" by the wholesaler of the pharmaceutical executive
BDA director issues an order for revocation of authorization when the wholesaler re-commits
violation of art. 284e and 285c or where he systematically fails to fulfill his post obligations. 207, para. 1, v. 15.
(5) (amend. - SG 102/00, in force from 02.01.2013, previous para 4 - SG, iss. 84 of 2018, in force from
12.10.2018) In case of non-fulfillment of the obligation for notification under Art. 235, para. 3 to terminate
the activity of the holder of a marketing authorization for a medicinal product
The Executive Director of the BDA issues an order revoking the authorization.
(6) (Renumbered from Paragraph (5), amend. - SG 84/08, in force from 12.10.2018). 1 - 5 are subject to
appeal in accordance with the Administrative Procedure Code, and the appeal does not suspend their enforcement.
Art. 294. Who violates the provisions of this law or the regulations on its implementation, except in cases of post.
281 - 293, shall be punished by a fine of from 1000 to 3000 levs, and in the case of repeated commission of the same violation - by a fine of
3000 to 5000 BGN
Art. 295. (1) (amend. - SG 98/10, in force from 01.01.2011, amended - SG, issue 102 of 2018)
01.01.2019) The violations under this law shall be established by acts drawn up by officials under Art. 267,
para. 3.
(2) (Supplemented, SG No. 84/2018, effective 12.10.2018, repealed - SG No. 102/2018)
(3) (amend. - SG 98/10, in force from 01.01.2011, amended - SG, issue 102 of 2018, effective from 01.01.2019)
The penal decrees are issued by the Minister of Health, by the Chief State Health
inspector, by the chairman of the council under Art. 258, para. 1, by the BDA Executive Director and the Directors
of the RHI, depending on the submission of the offending official.
(4) (new - SG 102/08, in force from 01.01.2019) The penal decrees may also be issued by
other officials authorized by the persons under para. 3, as the chairman of the council under Art. 258, para. 1
may authorize another committee member.
Art. 296. Drafting acts, issuing, appealing and executing criminal decrees
are carried out in accordance with the Law on Administrative Offenses and Penalties.
Art. 297. (Amended, SG No. 84/2018, effective 12.10.2018) (1) In the cases of Art. 281, 282, 283, 284, 285 and 287
the penal authority also orders the withdrawal in favor of the State of the medicinal products subject to the
the committed offense, under the conditions and in the order specified in the Administrative Offenses Act and
penalties and in accordance with Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 February
October 2013 establishing the Union Customs Code (OJ, L 269/1 of 10 October 2013) and
Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed implementing rules
rules for the implementation of certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the
Of the Council establishing the Union Customs Code (OJ, L 343/558 of 29 December 2015).
(2) The medicinal products under para. 1 shall be destroyed under the conditions and in the order of the ordinance post. 274, para. 2.
Additional provisions
§ 1. For the purposes of this Act:
1. (amend. - SG 102/02, in force from 02.01.2013) А
"substance" means any substance or mixture of
substances intended for use in the manufacture of a medicinal product which when used
in its manufacture, they become the active ingredient of this product, intended for the exercise of
pharmacological, immunological or metabolic action for the purpose of restoring, correcting or altering
physiological functions or for medical diagnosis.
2. "Bioequivalence" is present when the medicinal products are pharmaceutically equivalent or
pharmaceutical alternatives, and if their bioavailability after administration at the same molar dose are
similar to such an extent that their efficacy and safety effects are significant
similar.
3. "Bioavailability" means the speed and degree at which the active substance or the therapeutically active part thereof
absorb from the dosage form and become available at the site of action. When the drug substance is
intended to exert a systemic therapeutic effect, bioavailability means speed and degree, c
which the drug substance or the therapeutically active part thereof is released from the dosage form and
goes into general circulation.
4. (Amended, SG No. 84/2018) (*) "Researcher's Brochure" is a Researcher's Brochure within the meaning of Art.
2 (2), point 23 of Regulation (EU) No 536/2014.
5. "Valid documentation" shall mean documentation that in content and completeness meets the requirements,
provided for in a particular procedure under this Act.
6. "Substance with well established use in medical practice" is a substance for which it can be used
apply the following criteria:
(a) the period of proof of well-established use in medical practice shall be not less than 10
years from the date of the first systematic and documented use of the substance as a medicinal product
product in the European Union or in the European Economic Area;
(b) quantitative aspects of the use of the substance, taking into account the extent of use in the substance
medical practice, the extent of geographical use and the degree of traceability through
the safety system, including studies carried out before and afterwards and
published scientific literature on epidemiological studies and in particular comparative epidemiological studies
studies;
(c) a high level of scientific interest in the use of the substance (number of scientific publications) and unity in
scientific circles in scientific evaluations.
7. "Secondary packaging" is a packaging which does not come into direct contact with the medicinal product.
8. (Amended, SG No. 84/2018) (*) "Assignor" shall be a sponsor within the meaning of Art. 2 (2) (14)
Regulation (EU) No 536/2014.
9. "Generic medicinal product" is a medicinal product which has the same qualitative and quantitative value
composition with respect to the active substances and the same dosage form as the reference dosage form
product, and its bioequivalence with the reference medicinal product has been demonstrated by appropriate tests for
bioavailability. The various immediate-release oral dosage forms are considered to be one and the same
same dosage form. The various salts, esters, ethers, isomers, mixtures of isomers, complexes or
active substance derivatives are considered to be the same active substance unless they differ significantly
for its safety and / or efficacy.
10. (Amended, SG No. 84/2018) (*) "Principal Investigator" is a Principal Investigator within the meaning of Art. 2,
paragraph 2, point 16 of Regulation (EU) No 536/2014.
11. "Defined daily dose" is an average daily maintenance dose of a medicinal product that is
administered to adults according to the primary indication of the medicinal product.
12. (Amended, SG No. 84/2018) (*) "Good clinical practice" is a good clinical practice within the meaning of Art. 2,
paragraph 2, point 30 of Regulation (EU) No 536/2014.
13. "Good laboratory practice" is a system of internationally recognized rules regarding conditions
for the planning, processes of organizing, executing, tracking and documenting the laboratory
tests.
14. "Good manufacturing practice" is a system of internationally recognized business rules that covers
all sides of production - personnel, premises, facilities, materials, documentation, quality
control, and aims to ensure safety, efficiency and compliance with the specification.
15. (Supplemented, SG No. 71/2008, effective 12.08.2008) State
"Member" means a Member State of the European Union
union or country party to the Agreement on the European Economic Area.
16. "Label" is information on the primary or secondary packaging of the medicinal product.
17. "Immunological medicinal product" means a medicinal product containing vaccines, toxins, sera or
allergens. The scope of vaccines, toxins and serums includes agents used to create
active immunity, or to establish a state of immunity, or to induce passive immunity. Allergens
are medicinal products that are intended to identify or stimulate a specific
targeted change in the immunological response to the allergic agent.
18. "Bioequivalence study" is a clinical trial aimed at proving that two
medicinal products are bioequivalent if they are pharmaceutically equivalent or pharmaceutically equivalent
alternative, and when their bioavailability after administration at the same molar dose is similar to the extent that
is a requirement for equivalent efficacy and safety.
19. "Bioavailability study" is a clinical trial aimed at demonstrating the speed and
the extent to which the active substance or the therapeutically significant portion of the investigational medicinal product is tested
reach from the dosage form into the systemic circulation.
20. (amend. - SG 84/2018) (*) "Tested medicinal product" is a tested medicinal product within the meaning of
of Art. 2 (2) (5) of Regulation (EU) No 536/2014.
21. (Amended, SG No. 84/2018) (*) "Researcher" shall be a researcher within the meaning of Art. 2 (2) (15)
Regulation (EU) No 536/2014.
22. (amended, SG No. 84/2018) (*) "Informed consent" is informed consent within the meaning of Art. 2,
paragraph 2, point 21 of Regulation (EU) No 536/2014.
23. "Kit" means any substance which is usually dissolved, suspended, diluted or diluted before use
combines with radionuclides, resulting in the finished radioactive medicinal product.
24. (amended, SG No. 84/2018) (*) "Clinical trial of a medicinal product" is a clinical trial of
the meaning of Art. 2 (2) (2) of Regulation (EU) No 536/2014.
25. "Clinical advantage" is a significant therapeutic or diagnostic benefit of a drug
product compared to a medicinal product that has already been authorized.
25a. (new, SG No. 84/2018, effective 12.10.2018) Conflict
"interests" is a conflict of interests under
within the meaning of Chapter Eight, Section I of the Anti-Corruption and Removal of Illegal Act
the property acquired.
26. (Repealed, SG No. 84/2018)
27. "Patient leaflet" is a leaflet containing user information to accompany
the medicinal product.
27a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 21.12.2012)
"Advanced therapy medicinal product" means a medicinal product as defined in Article 2 of Regulation (EC) No
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on medicinal products for
advanced therapy and amending Directive 2001/83 / EC and Regulation (EC) No 726/2004.
27b. (new - SG 84 2018, in force from 12.10.2018) Medicinal
"product for compassionate use" is
medicinal product for palliative use within the meaning of Art. 83 (2) of Regulation (EC) No 726/2004
of the European Parliament and of the Council.
28. "Medicinal product obtained from human plasma or from human blood" is a medicinal product manufactured
from human blood components and by a method involving an industrial process. These include albumin,
immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, other plasma
fractions or combinations thereof.
29. "Medicinal product intended for the treatment, prevention and diagnosis of rare diseases" is
a product that:
(a) is intended for the diagnosis, prophylaxis or treatment of life - threatening diseases; or
progressively chronic diseases affecting no more than 5 in 10,000 people in the territory
on the side, or
(b) is intended for the diagnosis, prevention or treatment of life-threatening diseases and of serious
chronic health conditions (diseases with a high rate of disease - related illnesses)
disability and disability) and evidence is provided that the sale of the product does not provide
satisfactory returns to justify the necessary investment for research and development
development without incentives for the product creator, and
(c) where there is no satisfactory method of diagnosis, prophylaxis or treatment of the condition, or
if there is such a method, the proposed medicinal product has significantly more advantages than it and the benefit to
affected by this condition.
30. "Dosage form" is an acceptable structure containing the active substance (s),
which may or may not include excipients obtained by the administration of certain
technological operations, providing the desired healing effect and storage stability over the shelf life.
31. (amend. - SG 71/08, in force from 12.08.2008) L.
"located within the territory of a Member State" means
a legal entity registered under the civil or commercial law of a Member State or
established by a regulation having its registered office and registered office in a Member State or in
State party to the Agreement on the European Economic Area.
32. "Highway formulation" is a prescription for a medicinal product prepared in a pharmacy prescribed by
a medical specialist or an approved prescription for a particular patient.
33. "International non-patent name" means the recommended name of the active substance,
approved and published by WHO.
34. "Medical specialists" are doctors, dentists, masters-pharmacists, medical
nurses, midwives, medical assistants, paramedics and pharmacy assistants.
35. "Medical sales representative" is a person who has received special training and possesses scientific
knowledge of providing accurate and complete information about the medicinal product it is advertising.
35a. (new - SG 1/2014, in force from 03.01.2014) Medical
"prescription" is a prescription of
medicinal product or medical device issued by a person practicing regulated medical
a profession within the meaning of § 1, item 1 of the additional provisions of the Professional Recognition Act
qualifications and who has the legal right to do so in the Member State where the medical is issued
prescription.
36. (Repealed, SG No. 84/2018)
36a. (New, SG No. 84/2018, effective 12.10.2018) Network
"and information security" is the protection of
information from unauthorized or accidental access, use, disclosure to third parties, change
or destruction.
37. "Medicinal product name" means the name given to the product, which may be:
a) freely chosen name (trade name);
b) (amend. - SG 12/11, in force from 08.02.2011) generally accepted together with the trademark or name of
the holder of the marketing authorization;
c) (amend. - SG 12/11, in force from 08.02.2011) scientific name together with the trademark or the name of
the holder of the marketing authorization.
38. "Scientific literature" is a publication / publications of research results in specialized
international scientific publications.
38a. (new, SG No. 84/2018, effective 12.10.2018) Shortage
"the medicinal product" is the shortage of
medicinal products included in the Positive Medicinal List established by the specialized drug
electronic system in accordance with Art. 217b.
39. "New active substance" is:
(a) a chemical, biological or radiopharmaceutical substance which has not been authorized for use as
medicinal product in the European Union;
(b) an isomer, a mixture of isomers, a complex or derivative, or a salt of a chemical that has been authorized for
use as a medicinal product in the European Union but differs in safety and health
its efficacy from a previously authorized substance;
(c) a biological substance that has been authorized for use as a medicinal product in the European Union, but
is of different molecular structure, of different origin with respect to the starting material or is obtained
through a different production process;
d) a radiopharmaceutical substance whose radionuclides or molecular bonds (respectively ligands) which are not
have been authorized as a medicinal product in the European Union, or the pairing mechanism of
molecules and radionuclides has not been authorized in the European Union.
40. (amended, SG No. 84/2018) (*) "Adverse event" is any adverse change in the health status.
a condition observed when administering a medicinal product to a patient which is not necessarily causative
related to this treatment.
41. (Am. - SG, iss. 102 in 2012, in force since 21.12.2012, amended - SG, iss. 84 of 2018. (*))
reaction "is any adverse and unintended response to a medicinal product. The types of adverse drug reactions
reactions are:
a) (amended, SG No. 84/2018) (*) "unexpected" - adverse reaction not mentioned in the summary
a characteristic of the product or whose character, weight or output does not correspond to those specified in the summary
product characteristics;
(b) "suspected" - an adverse reaction for which the notifier or marketing authorization holder
use implies a possible cause and effect relationship with the medicinal product being administered;
c) "serious" - any adverse effect on a health condition that has caused the death
exit, immediate danger to life, hospitalization or prolongation of hospitalization,
significant or permanent damage, disability and congenital anomalies;
(d) combinations of reactions under letters "a", "b" and "c".
42. "Common name" means the international non-patent name of a medicinal or ancillary medicinal product
substance (INN) recommended by the WHO; if not, the name in the European Pharmacopoeia is used, if and
there is no other pharmacopoeial name; when there is no pharmacopoeial name, the usual accepted name is used.
42a. (new - SG 102/02, in force from 21.12.2012) Main
"system documentation for
Drug Safety Tracking "is a detailed description of the drug tracking system
the pharmacovigilance used by the holder of the marketing authorization in respect of one or
more authorized medicinal products.
42b. (new - SG 48/2015) "Assessment of health technologies" is:
(a) a form of research policy examining the short and long term
results related to the implementation of health technologies and aims to provide information on
alternative health strategies;
(b) a multidisciplinary activity that systematically assesses technical characteristics, safety,
clinical efficacy and effectiveness, cost, value effectiveness, organizational, social,
the legal and ethical implications of the administration of medicinal products in health care and focus
on the value - clinical and economic, the analysis being comparable to existing or most
the good alternative at the moment.
43. "Batch" means the specified quantity of the drug produced according to established reproducible
technological scheme providing the necessary batch homogeneity with respect to the required ones
benchmarks.
43a. (New, SG No. 102/2012, effective 21.12.2012) Plan
"risk management" is a detailed description
of the risk management system.
44. "Maintenance of a marketing authorization for a medicinal product" includes all necessary activities with
in order to maintain the current registration status of the medicinal product, including
drug safety monitoring.
44a. (new - SG 48/2015) "Maintenance of reimbursement status" is an evaluation of a medicinal product on the basis of
Based on evidence of efficacy, therapeutic efficacy, safety and pharmacovigilance analysis
Economic Indicators.
45. "Benefit" is the positive result / therapeutic efficacy of the medicinal product for the individual patient,
a group of patients or the public. The quantified estimate of expected benefit includes an estimate
calculating the probability of this positive result.
46. ​​(amend. - SG 102/02, in force from 02.01.2013)
"excipient" means any constituent of a medicinal product
product other than the active substance and the packaging material.
47. "Post-marketing study" means any study conducted with the use of the medicinal product in
within the approved summary of product characteristics after authorization.
47a. (new - SG 102/2012, in force from 02.01.2013) Mediation
"in the field of medicines
"products" are all activities aimed at concluding a contract for the purchase or sale of "
medicinal products, other than wholesale, which do not include physical holding and which do
express in negotiation independently and on behalf of another legal or natural person.
48. (Amended, SG No. 102/2012, effective 21.12.2012)
"ostmarketing safety study" is anyone
a study relating to an authorized medicinal product conducted in order to identify itself,
characterize or determine the degree of safety risk, confirm the profile of
the safety of the medicinal product or to evaluate the effectiveness of the risk management measures.
49. A "potential serious risk to public health" exists when there is a high degree of
the likelihood that the use of a medicinal product will cause irreversible, irreversible and irreversible
negative consequences. The evaluation process identifies the risk of causing harm to
population health and actual exposure and wide exposure to the product. The serious one
health risk in the context of the use of a particular medicinal product may be assessed at
the following conditions:
(a) efficacy - the data presented for therapeutic efficacy in relation to what is proposed
indications / indications, of the proposed target group / patient groups and of the proposed dosage indicated in
the patient leaflet draft does not fully protect the efficacy claims;
(b) safety - the assessment of preclinical toxicity / pharmacological safety data; and
clinical safety cannot convincingly defend the conclusion that all potential parties to
the safety of the target group / patient groups is accurately and comprehensively reflected in
the proposed leaflet for the patient or the absolute degree of risk is unacceptable;
(c) quality - the proposed production method and control methods cannot guarantee the absence of
a material defect in the quality of the product which may affect the safety and / or efficacy of
product;
d) benefit / risk ratio - the benefit / risk assessment is unfavorable given the nature of the
the identified risk / risks and the potential benefit of the proposed indication (s) and target
group / groups of patients.
50. "Representative of the person referred to in Article 26 (1) or of the holder of a marketing authorization" is a person,
established on the territory of the Republic of Bulgaria, determined by the person under Art. 26, para. 1 or by the holder
of the marketing authorization to represent it before the regulatory authorities in the territory of the Republic
Bulgaria.
51. An "acceptable level of safety" is present when the data presented is accepted statistically
reliable safety according to clinical trials conducted in accordance with Good Clinical Practice.
52. "Manufacture of a medicinal product" means all operations related to the procurement of materials,
their processing in the production process, including packaging and labeling, quality
control, batch release, storage, shipping and related operations.
53. (Amended, SG No. 84/2018) (*) "Clinical Trial Protocol" is a protocol within the meaning of Art. 2, paragraph
2, point 22 of Regulation (EU) No 536/2014.
54. "Placing on the market" means the distribution of a medicinal product on the market in the territory of
Republic of Bulgaria beyond the direct control of the marketing authorization holder.
55. "Primary packaging" means packaging that comes into direct contact with the medicinal product.
56. "Radiopharmaceutical" is a medicinal product which, when ready for use, contains one or more
radionuclides (radioactive isotopes) included for medical purposes.
57. "Radionuclide generator" means any system that includes a fixed mother radionuclide from which
obtains a daughter radionuclide which is recovered by elution or other methods and used in
radiopharmaceuticals.
58. "radionuclide precursor" means any other radionuclide produced for the radioactive labeling of another
substance just before its introduction into the patient's body.
59. "Herbal medicinal product" is a medicinal product which contains as medicinal substances one
or more herbal substances or one or more herbal preparations or one or more herbal preparations
substances in combination with one or more herbal preparations.
60. "Vegetable substances" are mainly plants or parts of plants, algae, fungi, lichens, which are whole,
broken or cut, and used in the raw state, usually in the dried state, but sometimes also
fresh. Some exudates which have not undergone specific treatment also apply to
plant substances. The plant matter must be of a specific botanical science
name of the plants from which they originate according to the binominal system (genus, species, variety and
author).
61. "Herbal preparation" is the product obtained after extraction, distillation, squeezing,
fractionation, purification, concentration or fermentation of the plant substance. The vegetable
preparation can also be ground or powdered vegetable substances, tinctures, extracts, ethereal
oils, processed vegetable fluids / juices.
62. "Rare diseases" are diseases that are characterized by a frequency of spread of
high from 5 in 10,000 people.
63. "Reference medicinal product" is a medicinal product authorized under Art. 23 in accordance with
the requirements of Art. 27.
64. "Defined daily dose reference value" for an international non-patent name with
the corresponding dosage form of the anatomic therapeutic classification of the drugs is the lowest
a defined daily dose value based on the defined daily dose values ​​for
different medicinal products for the relevant international non-patent name with the corresponding
dosage form according to the anatomic therapeutic classification of medicines.
65. "Therapeutic course reference value" is the lowest therapeutic course value set at
base on the values ​​of the therapeutic course of medicines under the international non - patent name with
appropriate dosage form.
66. "Risk in use of a medicinal product" is:
(a) patient's health risk or quality-related population health risk,
the safety or efficacy of the medicinal product;
(b) the risk of adverse effects on the environment.
67. "Serious adverse event" is any adverse change in health status that has occurred
cause of death, imminent danger of life, hospitalization or prolongation of life expectancy
hospitalization, significant or permanent disability, disability and congenital anomalies.
68. "Batch Release Certificate" is a document that is issued by a qualified person to
manufacturer or importer for each individual batch and include requirements in accordance with
the specification, as well as all the results of the batch release tests.
69. "Supplemental protection certificate" is a document which provides additional patent protection to
medicinal product not more than 5 years after the date of expiry of the basic patent.
69a. (new, SG No. 102/2012, effective 21.12.2012) System
"risk management" is a system of measures
and pharmacovigilance monitoring activities for identification,
characterizing, preventing or minimizing the risks associated with a medicinal product,
including an assessment of the effectiveness of these activities and measures.
69b. (new, SG No. 102/2012, effective 21.12.2012) System
"to track the drug
safety "is a system used by the Marketing Authorization Holder and the BDA for the implementation of the
the tasks and responsibilities of Chapter Eight to monitor the safety of
the authorized medicinal products and the detection of any change in the benefit / risk ratio.
69c. (new, SG No. 84/2018, effective 12.10.2018)
"is a violation committed three or more
times within one year of the entry into force of the first penal decree whereby the offender
the same type of offense is punished.
70. "Emergency restrictive safety measures" are temporary changes to product information under
relation to one or more parts of the summary of product characteristics, indications, manner of
application, contraindications and warnings resulting from new information related to
safe use of the medicinal product.
71. "Spontaneous message" is a voluntarily sent message for a suspected adverse reaction to
the use of the medicinal product by the Marketing Authorization Holder, the market surveillance authorities
medicinal products or other organizations not derived from research or other organized
information collection system.
72. "Shelf life of a medicinal product" is the interval of time when, if stored
the prescribed conditions, the medicinal product meets the requirements of the specification developed on
the basis of stability studies of several batches of finished form.
73. (amend. - SG 71/08, in force from 12.08.2008) p
"an appropriate herbal medicinal product
"medicinal product" is a product which contains the same active substances, regardless of the composition of
excipients intended for the same purpose with an equivalent amount of the medicinal product
substance / substances, with the same dosage and with the same or similar route of administration as the product, for
who has applied.
74. An "adverse reaction message" is documented information about one or more
suspected adverse reactions associated with the use of one or more medicinal products by one
patient. For the validity of the adverse reaction message, they are required
minimum identifier identifier data (initials or address or profession / specialty) of
the patient (initials or age, or date of birth or gender), the adverse reaction / event, and
the suspected medicinal product.
75. (Amended, SG No. 84/2018) (*) "Substantial change in the protocol of the clinical trial" is significant
change within the meaning of Art. 2 (2) (13) of Regulation (EU) No 536/2014.
75a. (new, SG No. 102/2012, effective 21.12.2012) Substantial
"changes to the
non-interventional post-marketing research "are changes that affect safety,
the physical or mental integrity of the patients or the results of the study and theirs
interpretation.
76. (amend. - SG 71/08, in force from 12.08.2008)
"reta country" is a non-state country -
Member State of the European Union or not a State Party to the Agreement on the European Economic
space.
77. "Wholesale" means all activities for the acquisition, storage, supply, import or export of
medicinal products, except in the case of the supply of medicinal products directly to
the population.
78. (Amended, SG No. 84/2018) (*) "Participant" shall be a participant within the meaning of Art. 2 (2) (17)
Regulation (EU) No 536/2014.
79. (Repealed, SG No. 84/2018)
80. "Pharmacopoeia" is a collection of approved specifications and related production requirements,
testing, storage and labeling of active substances, excipients, dosage forms,
materials for packaging and components of the medicinal product.
81. "Pharmacopoeial formulation" is a prescription for a medicinal product prepared in a pharmacy by a formulation
operating pharmacopoeia and intended for delivery to patients at the same pharmacy.
81a. (new - SG 71/08, in force from 12.08.2008, amended - SG, issue 102 from 2012, in force since 02.01.2013)
"Counterfeit medicinal product" means any medicinal product in which it is misrepresented:
(a) its identity, including particulars of the immediate packaging or its immediate packaging, its name or
content with respect to any of its constituents, including excipients, and
the amount of active substance per unit dose;
(b) its source, including its manufacturer, the country in which it is manufactured, the country in which it is produced
placed on the market, or the holder of his marketing authorization, or
(c) the timing, including records and documents, of the supply chain used.
It is not considered to be a counterfeit medicinal product with inadvertent tolerance in
quality as well as a medicinal product placed on the market in violation of intellectual property rights
property.
82. "Homeopathic medicinal product" is a medicinal product made from substances called homeopathic
source, according to the European Pharmacopoeia manufacturing procedures, and in the absence thereof -
according to the national pharmacopoeia of a Member State.
83. "Price calculated on the basis of a benchmark" is the price established for each medicinal product,
included in the Positive Medicinal List calculated on the basis of the established reference value for
defined daily dose or therapeutic course.
84. (Repealed, SG No. 84/2018)
85. "Misuse of medicinal products" is a persistent or occasional intentional overuse of
medicinal products accompanied by harmful physical or psychological effects.
86. (new - SG 41/09, in force from 02.06.2009)
"are children under 12 months of age.
87. (new - SG 41/09, in force from 02.06.2009) Food
"infant formulas" means foods intended for infants
specific nutritional use of infants during their first months, which alone are sufficient
satisfy the nutritional needs of these infants until the introduction of a suitable supplement
food.
88. (new - SG 41/09, in force from 02.06.2009) Transitional
"food" means food intended for
specific nutritional use of infants in the introduction of appropriate supplemental food and which
are the staple liquid food from the progressively increasing variety of foods in these
infants.
89. (new - SG 12/11, in force from 08.02.2011) Change
"Type IA" is a change with minimal impact
or without affecting the quality, safety or efficacy of the medicinal product concerned.
90. (new - SG 12/11, in force from 08.02.2011) Change
"type IB" is a change that is neither type IA,
neither a change of type II nor an extension of the marketing authorization.
91. (New, SG No. 12/2011, effective 08.02.2011) Change
"type II" is a change that does not occur
extending the scope of the marketing authorization and which may have a significant impact on
the quality, safety or efficacy of the medicinal product concerned.
92. (new, SG No. 102/2012, effective 21.12.2012) Delegated
"act" is an act within the meaning of Art. 290 of
Treaty on the Functioning of the European Union.
§ 2. The name of the BDA shall be written in Latin as follows: "Bulgarian Drug Agency".
§ 3. The Council of Ministers shall determine the terms and conditions for the acquisition, storage and updating of
medicinal products stored by the State Agency for State Reserves and Wartime Stocks.
§ 4. (Supplemented, SG No. 18/2014) This Act introduces the provisions of Directive 2001/83 / EC of the European Union.
Parliament and the Council on the approval of the Community code relating to medicinal products for human use,
as last amended by Directive 2004/27 / EC of the European Parliament and of the Council and Directive 2012/26 / EU
of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83 / EC
on pharmacovigilance (OJ L 299/1 of 27 October 2012).
§ 5. The data protection periods for the reference medicinal products shall be applied in accordance with the provisions
of Art. 89 of Regulation (EC) No 726/2004 of the European Parliament and of the Council and Art. 2 of Directive 2004/27 / EC
of the European Parliament and of the Council.
§ 5a. (New, SG No. 60/2011, effective 30.09.2011) (1) (Amended, SG No. 102/2012, effective 01.04.2013,
ed. - SG, issue. 85 of 2017) Ministry of Health, National Price Council and
reimbursement of medicinal products, the Executive Agency for Medicines and Regional Health
inspections shall provide an opportunity for the submission of information and the acceptance of applications and documents
this Act electronically under the terms and conditions of the Electronic Document and Electronic Act
certification services and the eGovernment Act.
(2) The provision of information and the acceptance of applications and documents electronically shall be carried out
after providing the appropriate technical and organizational conditions, as well as the relevant software
products.
Transitional and Final Provisions
§ 6. The Law on Medicines and Pharmacies in Human Medicine (promulgated, SG No. 36/1995; No. 61/1996)
Constitutional Court Decision No. 10 of 1996; amend. 38 of 1998, issue. 30 of 1999, issue. 10 of 2000, issue.
37 of 2000 - Decision No. 3 of the Constitutional Court of 2000; amend. 59 of 2000, issue. 78 of 2000 -
Constitutional Court Decision No. 7 of 2000; amend. 41 of 2001, issue. 107 and 120 of 2002; ref., issue 2 of
2003; amend. 56, 71 and 112 of 2003; 70 and 111 of 2004, nos. 37, 76, 85, 87, 99 and 105 of 2005; 30, 31,
34, 75 and 105 of 2006) shall be repealed, with the exception of the provision of Art. 10, para. 2, which shall apply until
one year from the date of entry into force of this Act.
§ 7. (1) The marketing authorizations for medicinal products issued prior to the entry into force of this Act under
national procedures, which are also authorized in the Member States under a centralized procedure, are
shall cease with effect from 1 January 2007.
(2) The marketing authorizations for medicinal products issued prior to the entry into force of this Act under
national procedure shall be aligned with its requirements at the date of renewal.
(3) Authorizations for the use of medicinal products covered by Regulation (EC) No
726/2004 of the European Parliament and of the Council and have been authorized for use under the repealed Act
medicines and pharmacies in human medicine as substantially similar products, but are not authorized for
use in the European Union under a centralized procedure shall cease.
(4) Medicinal products authorized for use in the European Union by a centralized procedure which
a national marketing authorization has been terminated in accordance with para. 1, can be sold in the territory
of the Republic of Bulgaria in packs and leaflets in accordance with the terminated national authorization for
use for a period not exceeding one year from the date of termination.
§ 8. (1) The approved marginal prices and the registered prices in the order of the repealed Medicines Act and
pharmacies in the human medicine of medicinal products authorized for use in the European Union
centralized procedure whose national marketing authorization is terminated pursuant to § 7, para. 1,
shall remain in force for a period of one year from the date of termination.
(2) The approved marginal prices and the registered prices in the order of the repealed Medicines and Pharmacies Act
in the human medicine of medicinal products other than those of para. 1 shall remain in force until 31 December
2007
§ 9. (1) Applications for marketing authorization, renewal, amendment of an authorization granted to
the entry into force of this Act shall be considered and concluded under the conditions and in the order provided for therein.
(2) The applications and documentation submitted for the authorization of medicinal products which
fall within the scope of the procedure under Art. 74, respectively under Art. 75, shall be aligned with the requirements
of this law within three months of its entry into force.
(3) When, within the term of para. 2 the application and documentation under para. 2 are not aligned with
the requirements of this law, the procedure for considering them is terminated.
§ 10. (1) The clinical trials, approved until the entry into force of this Act, shall be completed according to the present
ed.
(2) Applications for conducting a clinical trial on the territory of the Republic of Bulgaria shall be submitted,
shall be considered and concluded under the conditions and by the order of this law, after the entry into force of the ordinance under Art.
82, para. 3.
(3) Applications for changes to authorized clinical trials submitted prior to the entry into force of this Act shall be
they shall be considered and concluded under the conditions and in the order provided for therein.
§ 11. Applications for the authorization of manufacturing and wholesale of medicinal products,
filed prior to the entry into force of this Act shall be considered and terminated under the terms and procedure,
provided for therein.
§ 12. (1) Manufacturers of medicines authorized to manufacture under the procedure of the repealed Act
for medicines and pharmacies in human medicine, bring their manufacturing operations in line with the
the requirements of this Act with respect to the qualified person under Art. 148, item 2 within three months of
the entry into force of this law.
(2) Manufacturers welded to the entry into force of this Act shall operate on the basis of
issued to them under the repealed Human Medicines and Pharmacies Act.
§ 13. (1) The persons who have received a permit for wholesale of medicines under the procedure of the repealed Act
medicines and pharmacies in human medicine, bring their activities in accordance with the requirements of this one
law within 12 months of its entry into force.
(2) Until the granting of a permit for wholesale of medicinal products under the procedure of this Act, but no more
later than the expiration of the term under par. 1, the persons under para. 1 shall operate on the basis of the issued by
order of the repealed Law on Medicines and Pharmacies in Human Medicine
medicines.
(3) By issuing a permit for wholesale of medicinal products under the procedure of this Act, respectively
with the expiry of the term under para. 1, issued pursuant to the repealed Humane Medicines and Pharmacies Act
medicine authorization to wholesale drugs is terminated.
§ 14. (1) The persons who have received a permit for wholesale of medicines under the procedure of the repealed Act
medicines and pharmacies in the human medicine industry may import medicinal products from
the territory of the Republic of Bulgaria from third countries on the basis of this authorization pending the receipt of
import permit under the procedure of this law, but not later than 12 months after its entry into force.
(2) Within one month from the entry into force of this Act the persons under para. 1 shall submit to the BDA notification of
the person who will perform the functions of a qualified person within the meaning of Art. 161, para. 2, Vol. 1.
§ 15. The period of validity of the wholesale marketing authorizations for medical devices issued in accordance with
the repealed Law on Medicines and Pharmacies in Human Medicine, extends ex officio until December 31
2007
§ 16. (Repealed, SG No. 71/2008, effective 12.08.2008)
§ 17. (1) The drugstores welded up until the entry into force of this Act shall operate on the basis of
certificates issued to them under the repealed Law on Medicines and Pharmacies in Human Medicine.
(2) Applications for issuance of certificates for registration of drugstores submitted before the entry into force of
this law shall be considered and concluded under the conditions and in the order provided for therein.
§ 18. (1) (amend. - SG 71/08, in force from 14.04.2008, amended - SG, issue 10 of 2009, effective from 29.01.2009 )
The positive medical list under this law shall be drawn up in accordance with the procedure provided therein and shall enter into force on 31
March 2009
(2) (amend. - SG 71/08, in force from 14.04.2008) Until the entry into force of the list under para. 1 active
Positive Medication List is the Positive Medicinal List adopted by the Ordinance on the definition of
positive medical list in the Republic of Bulgaria (promulgated, SG No. 113/2003; amended, No. 18/2004; issue 4 of
2005 and issue. 8, 107 and 112 of 2007).
(3) (New, SG No. 71/2008, effective 14.04.2008; amend. - SG 23/09, in force from 30.03.2009)
two months after the entry into force of the list under para. 1 medical care providers prescribe
and the NHIF pays the medicinal products according to the medicinal list of the NHIF adopted by Decision No. RD-CC-
04-127 of 27 December 2007 laying down the conditions to be fulfilled by the contractors of
medical assistance, the procedure for concluding contracts with them and other conditions under Art. 55, para. 2, items 2, 4, 6 and 7 of
The Health Insurance Act.
§ 19. (1) Within three months from the entry into force of this Act:
1. The Council of Ministers shall amend the Rules of Procedure of the Executive Agency for
medicines in accordance with this law;
2. the Minister of Health issues the ordinance under Art. 82, para. 3.
(2) Within 6 months from the entry into force of this Act, the Council of Ministers shall also adopt the Minister of
Health issues other legislative acts.
§ 20. After the expiry of the first two years of the term of office of the members of the committees, the post. 103, 107, 259 and 261, respectively
lots shall be determined by half of the members whose term of office is terminated.
§ 21. (amend. - SG 71/08, in force from 14.04.2008) Within two years from the entry into force of this law
The BDA is taking the necessary steps to accredit its drug control laboratory
products and active substances from the European Directorate for Quality of Medicines and Health.
§ 22. (Effective 14.04.2008) In the Health Insurance Act (promulgated, SG No. 70/1998; amended, Nos. 93 and 153
from 1998, issue. 62, 65, 67, 69, 110 and 113 of 1999, issue. 1, 31 and 64 of 2000; 41 of 2001, issue. 1, 54, 74, 107, 112,
119 and 120 of 2002; 8, 50, 107 and 114 of 2003 28, 38, 49, 70, 85 and 111 of 2004; 39 45 45 76 99 99
103 and 105 of 2005; 17, 18, 30, 33, 34, 59, 95 and 105 of 2006; 11 of 2007, issue. 26 of 2007 - Decision No
3 of the Constitutional Court of 2007) the following amendments are made:
1. In Art. 45:
(a) paragraphs 4, 5, 6 and 7 are repealed;
(b) paragraph 8 is amended as follows:
"(8) The conditions and procedure for payment of medicinal products included in the Positive Medicinal List under
Art. 262 of the Law on Medicinal Products in Human Medicine, Medical Devices and Dietary Products
foods for special medical purposes shall be governed by an ordinance of the Minister of Health. "
2. In Art. 55, para. 2, item 7 shall be amended as follows:
"7. the lists of medical devices and dietary foods for special medical purposes and the prices to which the NHIF
fully or partially pays them; conditions for prescribing and receiving medicines, medical
articles and dietetic foods for special medical purposes. "
§ 23. In the Law on Medical Institutions (promulgated, SG No. 62/1999; Amended, SG No. 88 and 113, 1999; Amendments No. 114/1999)
1999; amend. 36, 65 and 108 of 2000; pcs. 51 of 2001 - Decision No. 11 of the Constitutional Court of 2001;
amend. 28 and 62 of 2002, issue. 83, 102 and 114 of 2003; 70 of 2004, issue. 46, 76, 85, 88 and 105 of 2005; 30,
34, 59 and 105 of 2006) the following additions are made:
1. In Art. 17, para. 4:
"(4) Clinical trials of medicinal products may be carried out at the diagnostic and consulting center
products under the Law on Medicinal Products in Human Medicine. "
2. In Art. 26, para. 4:
"(4) Clinical trials of medicinal products may be conducted at the dispensary under the terms of the
medicinal products in human medicine. "
§ 24. In § 14 of the transitional and final provisions of the Law on Amendments to the Law on Professional
organizations of doctors and dentists (SG, issue 76 of 2005) the following amendments and additions shall be made:
1. The current text becomes para. 1 and is amended as follows:
"(1) Individual and group dental care, dental and medical practices
dental centers that are registered as dealers under the Commerce Act or as cooperatives under the
Cooperatives Act, bring their names in line with § 2 of that law and record the change
in the commercial register, the BULSTAT register and in the respective regional health center by 31
December 2007 "
2. Para. 2, 3 and 4:
"(2) Individual dental care practices that are not registered as traders under
Commercial Law, align their names with § 2 of this Act and record the change in
register BULSTAT and in the respective regional health center within the term of para. 1.
(3) The entry of the change of the name for the practices and centers under para. 1 in the Commercial Register and
register BULSTAT is performed as follows:
1. by July 1, 2007 - in accordance with the Commercial Act, the Cooperatives Act and the BULSTAT Register Act;
2. from July 1, 2007 - under the procedure of the Commercial Register Act.
(4) State fees for recording the changes under para. 1 and 2 are not due. "
§ 25. In the Law on Patents and Registration of Utility Models (promulgated, SG No. 27/1993; amend. 83 of 1996)
, issue. 11 of 1998, issue. 81 of 1999, issue. 45 and 66 of 2002; 17, 30 and 64 of 2006) in Art. 20 item 7 shall be repealed.
§ 26. In the Law on the Professional Organization of Master Pharmacists (promulgated, SG No. 75/2006; amended, No. 105
from 2006) in Art. 5 item 9 is amended as follows:
"9. give opinions on opening pharmacies in accordance with Article 228, Paragraph 1, Item 9 of the Law on Medicinal Products in
human medicine. "
§ 27. In § 1, item 7 of the additional provision of the Law on Integration of Persons with Disabilities (promulgated, 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) sentence
the second is amended as follows: "Medical devices are not auxiliaries, devices and equipment".
§ 28. In the Law on Excise Duties and Tax Warehouses (promulgated, SG No. 91/2005; Amended, SG No. 105/2005, No. 30, 34)
63, 81, 105 and 108 of 2006) in Art. 22, para. 3, item 2 the words "The Law on Medicines and Pharmacies in Humane
medicine "shall be replaced by the" Medicinal Products in Human Medicine Act ".
§ 29. In the Law on Genetically Modified Organisms (promulgated, SG No. 27/2005; amend. SG 88/99, SG No. 27/2005).
30 of 2006) in Art. 2, para. 2, item 3 the words "the Law on Medicines and Pharmacies in the Human Medicine" shall be replaced
with the "Law on Medicinal Products in Human Medicine".
§ 30. In the Consumer Protection Act (promulgated in the State Gazette, issue 99 of 2005; amend., Issue 30, 51, 53, 59, 105 and 108 of 2006
d.) in Art. 186, para. 2, item 4 the words "the Law on Medicines and Pharmacies in Human Medicine" shall be replaced by
"The Law on Medicinal Products in Human Medicine".
§ 31. In the Health Act (promulgated in the State Gazette, issue 70 of 2004; amend., Issue 46, 76, 85, 88, 94 and 103 of 2005, issue 18, 30, 34,
59, 71, 75, 81, 95 and 102 of 2006), the following amendments are made:
1. In Art. 4 the words "the Law on Medicines and Pharmacies in Human Medicine" are replaced by "the Law on
medicinal products in human medicine ".
2. In Art. 21, para. 3 the words "the Law on Medicines and Pharmacies in Human Medicine" are replaced by "the Law on
medicinal products in human medicine ".
§ 32. In the Law on Control of Narcotic Substances and Precursors (promulgated, SG No. 30/1999; amended, No. 63)
from 2000, issue. 74, 75 and 120 of 2002; 56 of 2003, issue. 76, 79 and 103 of 2005; 30, 75 and 82 of 2006)
make the following changes:
1. In Art. 32, para. 3 the words "the Law on Medicines and Pharmacies in Human Medicine" are replaced by "the Law on
medicinal products in human medicine ".
2. In Art. 33, para. 1, item 1 the words "the Law on Medicines and Pharmacies in Human Medicine" shall be replaced by "the Law
for medicinal products in human medicine ".
3. In Art. 34 after the word "issue" the words "master pharmacist" shall be deleted.
4. In Art. 39, para. 2 the words "Article 55, item 2 of the Law on Medicines and Pharmacies in Human Medicine" shall be replaced by
"Article 197, item 2 of the Law on Medicinal Products in Human Medicine".
5. In Art. 44a para. 3 is repealed.
6. In Art. 44b the words "master pharmacist," shall be deleted.
7. In § 1, item 14 of the additional provision the words "the Law on Medicines and Pharmacies in Human Medicine"
are replaced by the "Medicinal Products for Human Use Act".
§ 33. In the Law on blood, blood donation and blood transfusion (promulgated, SG No. 102/2003; amended, No. 70/2004)
, issue. 30 and 65 of 2006) in Art. 8, para. 4 the words "Law on Medicines and Pharmacies in Human Medicine" shall be
replaced by "Medicinal Products in Human Medicine" Act.
§ 34. In the Environmental Protection Act (promulgated, SG No. 91/2002; amended, SG No. 98/2002; amend., SG No. 86/2006)
2003, issue. 70 of 2004, issue. 74, 77, 88, 95 and 105 of 2005; 30, 65, 82, 99, 102 and 105 of 2006) in Art. 140
the words "pharmaceuticals and medical devices within the meaning of § 1, item 40 of the Supplementary
provisions of the Medicines and Pharmacies in Human Medicine Act "are replaced by" medicinal products,
within the meaning of the Human Medicinal Products and Medical Devices Act. "
§ 35. In the Food Act (promulgated, SG No. 90/1999; amended, SG No. 102/2003, No. 70/2004, Nos. 87, 99, and 105)
2005, issue. 30, 31, 34, 51, 55 and 96 of 2006) in Art. 2, para. 3 item 4 is amended as follows:
"4. medicinal products within the meaning of the Human Medicinal Products Act."
§ 36. Until the enactment of the acts referred to in § 19, the enacted normative acts for the implementation of repeals
The Law on Medicines and Pharmacies in Humane Medicine applies insofar as they do not contravene this Act.
§ 37. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of § 22, which
shall enter into force one year after the entry into force of this Act.
-------------------------
The law was adopted by the 40th National Assembly on March 30, 2007 and was affixed with the official seal of
National Assembly.
Transitional and Final Provisions
TO THE AMENDING ACT TO THE MEDICINAL ACT
PRODUCTS IN HUMAN MEDICINE
(Official Gazette, SG 71/08, IN EFFECT OF 12.08.2008)
§ 65. (1) Issued pursuant to the repealed Law on Medicines and Pharmacies in Human Medicine (promulgated, SG,
pcs. 36 of 1995; amend. 61 of 1996, issue. 38 of 1998, issue. 30 of 1999, issue. 10, 37, 59 and 78 of 2000; 41 of
2001, issue. 107 and 120 of 2002; 2, 56, 71 and 112 of 2003; 70 and 111 of 2004, nos. 37, 76, 85, 87, 99 and 105
from 2005, issue. 30, 31, 34, 75 and 105 of 2006; Adm., Issue 31 of 2007) authorizations for medicinal products
products falling within the scope of repealed Council Regulation (EC) No 2309/93 of 22 July 1993, by
which establishes a Community procedure for the granting of licenses and the supervision of
medicines used in human and veterinary medicine and a European Agency is set up
for the evaluation of medicinal products but not authorized in other Member States
the procedure established by the repealed Council Directive 87/22 / EEC of 22 December 1986 on the
approximation of national measures related to the marketing of high-tech medical therapies
products, in particular those obtained by biotechnology or by Regulation (EC) No 2309/93, are hereby terminated.
(2) Issued after November 20, 2005 under the repealed Law on Medicines and Pharmacies in the Human
medicine authorizations for the use of medicinal products that fall within the scope of Regulation (EC) No
Regulation (EC) No 726/2004 of the European Parliament and of the Council but which are not authorized under a centralized procedure,
they stop.
§ 66. (1) Master pharmacists and assistant pharmacists who have been authorized to open
pharmacy as sole traders, medical establishments, and municipalities authorized to open
of a pharmacy under the repealed Law on Medicines and Pharmacies in Human Medicine, carry out
their activity based on their permits.
(2) The applications for the issue of a marketing authorization submitted by this Law before the entry into force of this Act
retail of medicinal products shall be examined under the conditions and in the manner provided for therein.
(3) Outside the cases under para. 1 the persons authorized to enter into force of this Act, who have received authorization for
opening a pharmacy, bring its business in line with its requirements within one year of
its entry into force.
(4) The persons under para. 3 submit to the Ministry of Health an application for re-registration, to which
apply:
1. application for authorization of retail sale of medicinal products by the persons of origin. 222,
para. 1, according to the model approved by the Minister of Health;
2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration of
the person under Art. 222, para. 1;
3. copy of the Law on Medicines and Pharmacies in the Human Medicine issued under the repealed order
permission to open a pharmacy;
4. a certified copy of the employment contract or contract for the management of the pharmacy manager -
in cases where such is required;
5. declaration by the persons under art. 222, para. 1 that the conditions under which the authorization was granted were maintained
retail trade in medicinal products of the persons under para. 2;
6. document for a one-time fee of BGN 100
§ 67. Persons who have submitted prior to the entry into force of this law applications for re-registration under the procedure of revoked §
16 of the transitional and final provisions that will carry out their activities as required
of this law shall be submitted to the Ministry of Health within three months of its entry into force
the following documents:
1. an application in accordance with a model approved by the Minister of Health;
2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration
or a certified copy of a similar document under the national law of a Member State of the European Union
union, or under the law of another country party to the EEA Agreement
space, according to Art. 222, para. 1;
3. an employment contract or a pharmacy management contract concluded with a master pharmacist or assistant;
pharmacist.
§ 68. (1) Master pharmacist or assistant pharmacist who has received a permit for opening a pharmacy in accordance with the procedure
to the repealed § 16 of the transitional and final provisions, may transpose the one issued
permission of a person under art. 222, para. 1.
(2) For carrying out the transfer the persons under para. 1 filed with the Ministry of Health
application to which they attach:
1. application for authorization of retail sale of medicinal products by the persons of origin. 222,
para. 1, according to the model approved by the Minister of Health;
2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration of
the person under Art. 222, para. 1;
3. copy of the Law on Medicines and Pharmacies in the Human Medicine issued under the repealed order
pharmacy permit or re-registration permit pursuant to the repealed § 16 of the
transitional and final provisions;
4. a certified copy of the employment contract or management contract of the pharmacy manager;
5. declaration by the persons under art. 222, para. 1 that the conditions under which the authorization was granted were maintained
retail trade in medicinal products of the persons under para. 1.
(3) The transfer under para. 1 may be completed within one year from the entry into force of this Act.
§ 69. The drugstores welded upon the entry into force of this Act shall continue to operate
on the basis of their registration certificates.
§ 70. The Committee on the Positive Medicinal List, which was appointed before the entry into force of this law, shall exercise
until its determination of the new and composition in accordance with Art. 261, para. 6.
§ 71. The products that fall within the scope of Art. 37 - traditional herbal medicinal products, and are
placed on the market in the country at the date of entry into force of this Act shall be complied with
its requirements no later than April 30, 2011.
§ 72. (1) Until December 31, 2008, the file under Art. 27 for the authorization of a medicinal product under
Mutual recognition or decentralized procedure may be submitted in the format "Common
technical document ".
(2) By December 31, 2009, the file under Art. 27 for the authorization of a medicinal product under
national procedure may be submitted in the format "Common Technical Document".
...................................
§ 75. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of the provision
of § 64, item 2, effective April 14, 2008, and the provisions of § 9, item 4, §§ 41, 42 and 43, which enter into force.
effective from 26 July 2008.
Final provisions
TO AMENDING LAW ON THE MEDICINAL PRODUCTS ACT IN HUMAN
MEDICINE
(Official Gazette of the Republic of Bulgaria, Issue 10 of 2009, Effective 29.01.2009)
§ 2. The law shall enter into force on January 29, 2009.
Transitional and Final Provisions
TO THE AMENDING ACT TO THE MEDICINAL ACT
PRODUCTS IN HUMAN MEDICINE
(Official Gazette of the Republic of Bulgaria, Issue 23 of 2009, Effective 30.03.2009)
§ 4. The persons who have received a permit under Art. 229, para. 2, including performing
nutritional supplements can also retail diet foods for special
medical purposes.
§ 5. Within two months of the entry into force of this law, the Ministry of Health ex officio
sends to the respective RIPCPH by location of pharmacies for entry in the register under Art. 14, para. 1 of
Food Act a copy of the authorizations under Art. 229, para. 2 issued prior to the entry into force of this Act.
...................................
§ 7. The law shall enter into force on March 30, 2009.
Transitional and Final Provisions
TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
(Promulgated - SG, issue 41 of 2009, effective 02.06.2009)
§ 92. (1) The persons who have received a permit under Art. 229, para. 2 of the Law on
medicinal products in human medicine, including the marketing of food supplements,
they can also trade in infant formulas and follow-on foods.
(2) Within two months of the entry into force of this Act the Ministry of Health ex officio
sends to the respective RIPCPH at the location of pharmacies operating and retailing
infant formulas and follow-on formulas 1, for entry in the register under Art. 14, para. 1 of the Food Act
copy of the permits under art. 229, para. 2 of the Law on Medicinal Products in Human Medicine, issued
until this law enters into force. "
...................................
§ 96. The law shall enter into force on the day of its promulgation in the State Gazette, except for:
1. paragraphs 3, 5, 6 and 9, which shall take effect from 1 January 2009;
2. Paragraphs 26, 36, 38, 39, 40, 41, 42, 43, 44, 65, 66, 69, 70, 73, 77, 78, 79, 80, 81, 82, 83, 88, 89 and 90 that go into
with effect from 1 July 2009;
3. paragraph 21, which shall take effect from 1 June 2010.
Final provisions
TO THE LAW FOR SUPPLEMENTATION OF THE MEDICINAL PRODUCTS ACT
HUMAN MEDICINE
(Official Gazette of the Republic of Bulgaria, issue 88 of 2009, effective 06.11.2009)
§ 2. The law shall enter into force on the day of its promulgation in the State Gazette.
Transitional and Final Provisions
TO THE AMENDING ACT TO THE MEDICINAL ACT
PRODUCTS IN HUMAN MEDICINE
(Official Gazette, issue 102 of 2009, effective 22.12.2009)
§ 4. (1) Master-pharmacists and assistant-pharmacists who were welded until the law came into force
received a permit for opening a pharmacy in the settlements under Art. 228, para. 4 in the order of the repealed Law
on medicines and pharmacies in human medicine (promulgated, SG No. 36/1995; Decision No. 10 of
The Constitutional Court of 1996 - no. 61 of 1996; amend. 38 of 1998, issue. 30 of 1999, issue. 10 of 2000;
Decision No. 3 of the Constitutional Court of 2000 - issue no. 37 of 2000; amend. 59 of 2000; Decision # 7 of
Constitutional Court of 2000 - no. 78 of 2000; amend. 41 of 2001, issue. 107 and 120 of 2002, repr. 2 of
2003; amend. 56, 71 and 112 of 2003; 70 and 111 of 2004, nos. 37, 76, 85, 87, 99 and 105 of 2005; 30, 31,
34, 75, 80 and 105 of 2006, rev. 31 of 2007) and who did not apply for re - registration within the deadline of
§ 66, para. 3 of the Law on Amendment and Supplementation of the Law on Medicinal Products in Human Medicine
(SG, issue 71 of 2008), bring their activity in compliance with the requirements of this law within 31
January 2010
(2) The persons under para. 1 submit to the Ministry of Health an application for re-registration, to which
apply:
1. application for authorization of retail sale of medicinal products by the persons of origin. 222,
para. 1 in accordance with the model approved by the Minister of Health;
2. an up-to-date certificate for entry in the commercial register, respectively a document for current registration of
the person under Art. 222, para. 1;
3. copy of the Law on Medicines and Pharmacies in the Human Medicine issued under the repealed order
permission to open a pharmacy;
4. a certified copy of the employment contract or contract for the management of the pharmacy manager -
in cases where such is required;
5. declaration by the persons under art. 222, para. 1 that the conditions under which the authorization was granted were maintained
retail trade in medicinal products of the persons under para. 1;
6. a document issued by the mayor of the respective municipality, certifying the number of residents of the respective
populated place;
7. document for a one-time fee of BGN 100
§ 5. Within three months of the entry into force of this law, the Minister of Health shall also amend
complements the ordinance under Art. 219, para. 2.
§ 6. The law shall enter into force on the day of its promulgation in the State Gazette.
Transitional and Final Provisions
TO THE LAW AMENDING AND SUPPLEMENTING THE LAW ON HEALTH INSTITUTIONS
(Official Gazette, issue 59 of 2010, effective 31.07.2010)
§ 77. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of:
1. paragraphs 9 (concerning Article 19, Paragraph 4), 53, 60 and 66 (concerning Article 98, Paragraphs 5 and 6), which shall enter into force on 1 January.
2011;
2. paragraph 75, which shall take effect from 30 September 2011.
Transitional and Final Provisions
TO THE BUDGET ACT OF THE NATIONAL HEALTH INSURANCE CASH
2011
(Promulgated - SG, issue 98 of 2010, in force since 01.01.2011)
§ 5. (1) In 2011, activities for the diagnosis and treatment of malignant diseases and patients with
renal insufficiency of dialysis treatment, including the provision of medicines and
medical devices, as well as other medical activities financed through the budget in 2010
of the Ministry of Health and through government delegated activities through the budget of the Ministry of Health
the municipalities shall be paid with the funds under art. 1, para. 2, line 5.
(2) The activities, medicinal products and medical devices under para. 1 shall be paid in accordance with the procedure and methodology,
designated by the Minister of Health.
(3) The funds under art. 1, para. 2, line 5 are transferred monthly by the end of the current month.
§ 7. The Supervisory Board of the National Health Insurance Fund has the right to carry out internal
compensated changes in loans between the elements of expenses and transfers under Art. 1, para. 2 that are in
within the approved budget.
§ 8. The Supervisory Board of the National Health Insurance Fund on the grounds of art. 26, para. 2 of the Law on
health insurance is entitled to spend on the contingency reserve
under Art. 1, para. 2, line 3.
...................................
§ 15. The law shall enter into force on January 1, 2011, with the exception of § 10, which shall enter into force on the day of
its publication in the State Gazette.
Transitional and Final Provisions
TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
(Promulgated - SG, issue 98 of 2010, in force since 01.01.2011)
§ 106. In the Law on Medicinal Products in Human Medicine (promulgated, SG No. 31/2007; amended, SG No. 19/2006)
2008; Constitutional Court Decision No. 5 of 2008 - issue no. 65 of 2008; amend. 71 of 2008, issue. 10, 23, 41,
88 and 102 of 2009 and issue no. 59 of 2010) throughout the words "the Regional Inspections for Conservation and Control of
Public Health "," Regional Inspectorate for Public Health Protection and Control "and" RIPCPH "
are replaced by "Regional Health Inspectorates", "Regional Health Inspectorate" and "RHI" respectively.
...................................
§ 121. The law shall enter into force on January 1, 2011, except for:
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, 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", Vol. 7, 10, 11, 13 and 15, letter "a ", § 109, 110, 112, 113, § 115, vol.
5, § 116, items 4 and 6, § 117, items 5 and 7 and § 118, item 1, which come into force from the day of promulgation of the law in
"State Gazette";
2. paragraph 102, items 1, 2 and 6, which shall take effect from 1 March 2011;
3. paragraphs 22, item 1 (concerning Article 36, paragraph 1, second sentence), § 37, § 48, item 2, § 51 and 59, which come into force as of 1
July 2011;
4. Paragraph 107, point 15, letter "b", which shall take effect on 30 September 2011.
Transitional and Final Provisions
TO THE AMENDING ACT TO THE MEDICINAL ACT
PRODUCTS IN HUMAN MEDICINE
(Official Gazette of the Republic of Bulgaria, issue 12 of 2011, effective 08.02.2011)
§ 24. Submitted valid applications and notifications of changes to the marketing authorizations prior to entry
by virtue of this law are dealt with so far.
§ 25. The Minister of Health shall, in accordance with this law, adjust the ordinance under Art. 42 until
three months after its entry into force.
...................................
§ 27. The law shall enter into force on the day of its promulgation in the State Gazette.
Transitional and Final Provisions
TO THE AMENDING ACT TO THE MEDICINAL ACT
PRODUCTS IN HUMAN MEDICINE
(Official Gazette, SG No. 60/2011, IN force from 05.08.2011)
§ 66. (1) The manufacturers under § 12, para. 2 of the transitional and final provisions are set out in
compliance with the requirements of Art. 148 and Good Manufacturing Practice, determined in accordance with Art. 152
within 6 months of the entry into force of this Act.
(2) After the expiration of the term under para. 1 The BDA shall verify compliance with
the requirements of Art. 148 and Good Manufacturing Practice, determined in accordance with Art. 152.
(3) When, after carrying out the inspection under para. 2 The BDA found that the conditions for production, control and
storage of starting materials for manufacturing and finished medicinal products does not comply with
it shall notify the person concerned in writing of the requirements of this Act and of Good Manufacturing Practice
under para. 1 and gives written instructions.
(4) In case, within 60 days from the date of notification, the respective person under para. 1 not on the side
found inconsistencies, the Executive Director of the BDA withdraws the issued in the order of revocation
Law on Medicines and Pharmacies in Human Medicine (promulgated SG 36/95; Decision No 10 of
The Constitutional Court of 1996 - no. 61 of 1996; amend. 38 of 1998, issue. 30 of 1999, issue. 10 of 2000;
Decision No. 3 of the Constitutional Court of 2000 - issue no. 37 of 2000; amend. 59 of 2000; Decision # 7 of
Constitutional Court of 2000 - no. 78 of 2000; amend. 41 of 2001, issue. 107 and 120 of 2002; ref., issue 2 of
2003; amend. 56, 71 and 112 of 2003; 70 and 111 of 2004, nos. 37, 76, 85, 87, 99 and 105 of 2005; 30, 31,
34, 75, 80 and 105 of 2006; Adm., Issue 31 of 2007) production permit under the conditions of Art. 160a.
(5) When, after carrying out the inspection under para. 2 it is established that the respective person under para. 1 did not
brought in accordance with the requirements of Art. 148 and Good Manufacturing Practice under Art. 152, BDA
withdraws a production permit issued under the conditions of Art. 160a.
(6) When, after carrying out the inspection under para. 2 it is established that the respective person under para. 1 was reduced to
compliance with the requirements of Art. 148 and Good Manufacturing Practice under Art. 152, the BDA issued a new one
a permit for production under this law after:
1. submission of an application and documentation under Art. 150 and 151, and
2. presentation of a document for a paid fee of 1500 BGN.
(7) When, within one month from the completion of the inspection under para. 2 the person under para. 6 has not submitted an application
and documentation under Art. 150 and 151, the production permit issued pursuant to the repealed Law on
medicines and pharmacies in human medicine are being discontinued.
§ 67. (1) Issuance or amendment proceedings opened and not completed before the entry into force of this Act
of marketing authorizations for medicinal products are reviewed and completed in the past
without submitting a proposal by the High Pharmacy Council.
(2) Within two months of the entry into force of this Act, the Ministry of Health shall provide
of the Executive Agency for Medicinal Products with the Receiving and Transmission Protocol of the completed files
production.
(3) Within two months of the entry into force of this Act, the Ministry of Health shall provide
of the Executive Agency for Medicinal Products with the protocol of acceptance kept by the Ministry of Health
register of authorizations for retail trade of medicinal products in the
pharmacy.
(4) After issuing a permit in accordance with the procedure of para. 1 The Ministry of Health sends in three days
term ex officio to the Executive Agency for Medicinal Products a copy of it for entry in the register of
the authorizations for retail trade of medicinal products.
(5) Upon completion of the proceedings under para. 1 The Ministry of Health provides to
The Drug Enforcement Agency has a transcript of their records.
§ 68. (1) Applications for issuance or change of certificates for registration of drugstores submitted by
the entry into force of this Act shall be considered under the conditions and in the order provided for therein.
(2) Within one month of the entry into force of this Act, the Executive Agency for Medicines
submit to the relevant Regional Health Inspectorate, with an acceptance protocol, the applications and
the documents submitted for the proceedings for the issue of certificates for registration of drugstores, and
archive of completed proceedings.
(3) Within one month of the entry into force of this Act, the Executive Agency for Medicines
provides the Ministry of Health with a protocol of reception and transmission, guided by the BDA
register of issued drug registration certificates.
(4) Within one month of the submission of the register under para. 3 Ministry of Health
draws up and publishes on its page the national register of the issued before this law enters into force
drugstore registration certificates.
§ 69. (1) Within three months of the entry into force of this Act, the procedures for approval or
the registration of prices of medicinal products is carried out so far by the Price Committee
of medicinal products.
(2) After the expiration of the term under para. 1 The Committee on Medicinal Products Prices shall submit to
Committee on Prices and Reimbursement with Receipt Protocol of the applications and documents submitted
for the procedures under para. 1, as well as the archive of the completed procedures for approval or registration of
prices of medicinal products.
(3) After the expiration of the term under para. 1 The Committee on Medicinal Products Prices shall submit to
Committee on Pricing and Reimbursement with the Transmission Protocol kept by the Commission registers of
the issued decisions for approval or registration of prices of medicinal products.
§ 70. (1) Within three months of the entry into force of this Act, the procedures for inclusion, exclusion and / or
Changes to the Positive Drug List medicinal products are made to date by
Positive Drug List Committee.
(2) After the expiration of the term under para. 1 The Committee on the Positive Medicinal List shall submit it to the Commission
on prices and reimbursement with the transceiver protocol, the applications and documents submitted for
the procedures under para. 1, as well as an archive of completed procedures for turning on, off and / or changes to
Medicinal products from the Positive Medicinal List.
§ 71. State fees paid under the procedures under § 69, para. 1 and § 70, para. 1 shall be spent to secure
relevant administrative proceedings as well as the activities of the Transparency Committee.
§ 72. (1) The prices determined in accordance with Art. 258, para. 1, of medicinal products which, upon entry into force
of this law are included in the Positive Medicinal List and are considered as their marginal prices at
their retail sale in accordance with Art. 258, para. 3.
(2) Within three months of the entry into force of this Act, the Committee on Medicinal Products Prices
ex officio deletes the established marginal prices of medicinal products from the register of marginal prices
under para. 1.
(3) Until 31 December 2012, marketing authorization holders may not change the price of
medicinal product with the exception of the reduction and for products which, by the time this law enters into force
had a certain price but were not included in the Positive Medicinal List.
§ 73. (1) With the entry into force of this Act, the established marginal prices of the medicinal products granted
on prescription, and the registered prices of non-medical medicinal products
prescription, shall be considered their registered prices under Art. 258, para. 2.
(2) Outside the cases under para. 1, with the entry into force of this law, the established marginal prices of medicinal products
products that belong to an international non-proprietary name that is included in the Positive
medicinal products, with the exception of the products listed in Annex 2 to the list, shall also be considered as medicinal products.
marginal prices for retail sale and may not be modified until the adoption of the Ordinance on
Art. 258, para. 5.
(3) Within three months of the entry into force of this Act, the Committee on Medicinal Products Prices
prepares the register under Art. 261, para. 3, in which he shall enter the prices under para. 1.
§ 74. Within three months of the entry into force of this law, the Commission on the Positive Medical List
aligns the Positive Medicinal List with the requirements of Art. 262, para. 5, Vols. 1 - 3.
§ 75. The Council of Ministers shall, within three months of the entry into force of this law, determine the composition of
Committee on Prices and Reimbursement.
§ 76. Within three months of the entry into force of this Act:
1. The Minister of Health shall amend and supplement the ordinances under Art. 82, para. 3, Art. 219, para. 2 and Art. 243 c
compliance with this law.
2. The Council of Ministers shall adopt the ordinance under Art. 258, para. 5 and amend the tariff under Art. 21, para. 2 and Device
regulations of the Ministry of Health in accordance with this law.
...................................
§ 84. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of § 65, which
shall enter into force on 30 September 2011.
Transitional and Final Provisions
TO THE AMENDING LAW AND AMENDMENTS TO THE LAW ON CONTROL
DRUGS AND PRECURSORS
(Official Gazette, SG No. 61/2011, effective 10.11.2011)
§ 54. This law shall enter into force three months after its promulgation in the State Gazette.
Transitional and Final Provisions
TO THE LAW AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
(Official Gazette of the Republic of Bulgaria, issue 38 of 2012, effective 01.07.2012)
§ 84. (In force from May 18, 2012) Within one month of the promulgation of this law in the State Gazette:
1. The Council of Ministers shall bring the Classifier of posts in administration in line with that
law;
2. the competent authorities shall bring the statutory acts of the respective administration in accordance with
this law.
§ 85. (1) Legal relations with the persons from the administrations under the Radio and Television Act, the Law on Radio and Television
the Independent Financial Audit Act, the Electronic Communications Act, the Financial Supervision Commission Act,
Law on Access and Disclosure of Documents and Declaration of Affiliation of Bulgarian Citizens to
State Security and Intelligence Services of the Bulgarian People's Army, Forfeiture Act
of the State of property acquired through criminal activity, the Prevention and Establishment Act
conflict of interest, Social Security Code, Health Insurance Act,
support to farmers and the Roads Act are governed by the terms and procedures of §
36 of the transitional and final provisions of the Act amending the State Act
employee (SG, issue 24 of 2006).
(2) The act of appointment of the civil servant shall:
1. assigns a minimum rank for the position assigned to the posts in the administration in the administration
post, unless the employee holds a higher rank;
2. determines the individual basic monthly salary.
(3) The additional necessary funds for social security contributions of the persons under para. 2 shall be provided within
the cost of wages, salaries and social security contributions to the budgets of the authorizing officers concerned
with appropriations.
(4) The Council of Ministers shall make the necessary changes to the extra-budgetary account of the State Fund
"Agriculture" arising from this law.
(5) The governing bodies of the National Social Security Institute and the National Health Insurance Fund
to make necessary changes to the respective budgets arising from this law.
(6) Unused employment leave shall be maintained and shall not be offset by cash benefits.
benefits.
§ 86. (1) Within one month from the entry into force of this Act, the individual basic monthly salary of
the employee shall be determined in such a way that the same is reduced by the tax due and the mandatory social security contributions
at the expense of the insured person, if they were due, should not be lower than the gross received so far
monthly salary, reduced by the obligatory mandatory social security contributions at the expense of the insured person,
if they were due, and the tax due.
(2) In the gross salary under para. 1 shall include:
1. the basic monthly salary or basic monthly salary;
2. additional remuneration, which shall be paid on a continuous basis together with the due monthly base
salary or basic monthly remuneration and depend only on the time worked.
§ 87. The law shall enter into force on July 1, 2012, with the exception of § 84, which shall enter into force on the day of promulgation.
of the law in the State Gazette.
Transitional and Final Provisions
TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
INSURANCE
(Prom. - SG 60/06, in force from 07.08.2012)
§ 44. The law shall enter into force on the day of its promulgation in the State Gazette.
Additional provisions
TO THE AMENDING ACT TO THE MEDICINAL ACT
PRODUCTS IN HUMAN MEDICINE
(Official Gazette of the Republic of Bulgaria, issue 102 of 2012, effective 21.12.2012)
§ 118. This Act introduces the requirements of Directive 2010/84 / EU of the European Parliament and of the Council of
15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83 / EC
validation of the Community code relating to medicinal products for human use (OB, L 348/74 of
and Directive 2011/62 / EU of the European Parliament and of the Council of 8 June
amending Directive 2001/83 / EC on the Community code relating to medicinal products
for human use with regard to the prevention of the entry of counterfeit medicinal products
legitimate supply chain products (OB, L 174/74 of 1 July 2011).
Transitional and Final Provisions
TO THE AMENDING ACT TO THE MEDICINAL ACT
PRODUCTS IN HUMAN MEDICINE
(Official Gazette of the Republic of Bulgaria, issue 102 of 2012, effective 21.12.2012)
§ 119. (1) After 2 January 2013, manufacturers, importers and wholesalers of active substances
submit to the BDA until March 2, 2013 an application and documents for entry in accordance with Art. 167b.
(2) Manufacturers and importers who manufactured or imported active substances on the basis of
Production / import licenses issued before 2 January 2013 do not pay a fee for their entry in
the register under Art. 167g.
(3) Until 2 March 2013, the persons under para. 2 shall carry out activities for the production and import of active substances at
basis of production / import licenses issued to them.
§ 120. The persons who mediate in the field of medicinal products and have started
their activity before January 2, 2013, shall be registered under the conditions and in accordance with Art. 212a by 2 March
2013
§ 121. Authorization procedures for use before the law has entered into force shall be completed
under the conditions and in the manner provided therein.
§ 122. (1) Holders of marketing authorizations shall not apply a risk management system for mail. 192,
para. 1, item 2 for medicinal products which were authorized before 21 July 2012, except
in the cases of para. 2.
(2) The Executive Agency for Medicinal Products may impose an obligation on the marketing authorization holder
use to create and implement a risk management system when it deems it for a drug
product has concerns that may affect the benefit / risk ratio. In this case, the BDA
requires the marketing authorization holder to also provide a detailed description of the system for
risk management that it intends to introduce for the respective medicinal product.
(3) In the cases of para. 2 The BDA shall inform the marketing authorization holder in writing, stating
the reasons for imposing the obligation and the time limit for submitting the detailed description of the system
Risk Management.
(4) Within 30 days from receipt of the notification under para. 3 the Marketing Authorization Holder
may ask the BDA to provide information on what has been imposed
obligation under para. 2.
(5) Upon receipt of the request under para. 4 The BDA sets a deadline for submitting the information from
the holder of the marketing authorization.
(6) On the basis of the information provided, the BDA may confirm the imposed obligation under para. 2 or yes
cancel it.
(7) The Executive Agency for Medicinal Products shall notify the holder of the decision taken under para. 6.
(8) When the BDA confirms the obligation, the Executive Director officially issues a change in the authorization.
for use, including in it as a condition the imposed obligation under para. 2.
§ 123. Holders of marketing authorizations for medicinal products issued before 21 July 2012,
fulfill the obligation under Art. 192, para. 1, item 1 with effect from 21 July 2015 or from the date of renewal of
the authorization to use the respective medicinal product, whichever is the date
occurred earlier.
§ 124. The non-interventional studies which began before the enactment of this law shall be completed according to
the current order.
§ 125. (1) Until the conditions and the term of post. 2, item 3 of Directive 2010/84 / EU holders of
marketing authorizations send reports of serious adverse reactions that have occurred to
the territory of the Republic of Bulgaria, to the BDA and to the European Medicines Agency within 15 days from
receiving them.
(2) The Executive Agency for Medicines shall check the fulfillment of the obligation under para. 1.
(3) Where the communication relates to a serious adverse reaction occurring within the territory of
third country, holders of marketing authorizations within the period of para. 1 shall notify the European Agency
on medicines.
§ 126. (1) Holders of marketing authorizations shall submit periodically updated reports to the BDA on
safety in accordance with the time intervals under Art. 194k, para. 3 for the medicinal products they are on
granted marketing authorizations before 21 July 2012 and for which the frequency and filing dates of
Periodic safety update reports are not listed as conditions in the Marketing Authorization.
(2) The provision of para. 1 shall apply until a different frequency or other filing date is given
the reports in the marketing authorization or until the date and frequency are determined in accordance with Art. 194l - 194n.
§ 127. (1) The holders of marketing authorizations shall submit periodically updated reports on
safety under Art. 194h, para. 1 in the register under Art. 194h, para. 3 after the expiration of 12 months from the date on which
The European Medicines Agency has announced its functioning.
(2) Until the term of para. 1, the marketing authorization holders shall submit the periodic
updated safety reports of the BDA and of the regulatory authorities of the other Member States in which
the medicinal product concerned is authorized.
§ 128. Holders of authorization / certificate for retail sale of medicinal products in a pharmacy
or drugstore under Art. 234, para. 5 place on the website the logo under Art. 234, para. 6 within one year
from the date of publication of the act under Art. 85c (3) of Directive 2001/83 / EC.
§ 129. The Executive Agency for Medicines shall carry out the first audit of the postal system. 183, para. 1 and
shall send the European Commission a report on its results by 21 September 2013 at the latest.
§ 130. (1) By March 20, 2013, the proceedings initiated and closed by the Price and Reimbursement Commission
are completed by her in the previous order.
(2) After 1 April 2013, the pending procedures before the Committee on Prices and Reimbursement are being finalized
by the National Council on Prices and Reimbursement of Medicinal Products under the Terms and Conditions thereof
law.
(3) By 31 March 2013, the Price and Reimbursement Commission shall provide the National Price and Reimbursement Committee with
reimbursement of medicinal products with a protocol of acceptance of applications and documents,
filed for the procedures under para. 1, as well as the archive of completed procedures.
(4) By 31 March 2013, the Price and Reimbursement Commission shall provide the National Price and Reimbursement Committee with
reimbursement of medicinal products with a transcript of the records kept by the Commission.
§ 131. (1) By March 20, 2013, the fees for submitting price confirmation / price caps,
registration of prices for medicinal products to include, exclude or change medicinal products
products on the Positive Medicinal List are collected by the Ministry of Health in size,
determined in the tariff under Art. 21, para. 2.
(2) The funds collected by March 20, 2013 under para. 1 shall be expended for the activities of the Commission
prices and reimbursement of the Transparency Committee.
§ 132. Within three months of the entry into force of this Act, the Council of Ministers on a proposal from
the Minister of Health:
1. appoints the chairman and members of the National Council for the prices and reimbursement of medicines
products;
2. approve the rules of procedure of the National Council for Prices and Reimbursement of Medicinal Products.
§ 133. (1) Within two months from the entry into force of this law, the Council of Ministers shall amend the tariff under Art.
21, para. 2.
(2) By 1 April 2013 the Council of Ministers shall adopt the ordinance under Art. 261a, para. 5.
§ 134. The obligations under art. 159, para. 4, Art. 168, para. 8, Art. 168a and 168b begin to run three years
after the date of publication of the delegated acts under art. 54a of Directive 2001/83 / EC in the Official Journal
newspaper "of the European Union.
...................................
§ 138. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of:
1. paragraph 9, item 1, letter "a", § 29 - 36, § 38 - 43, § 44 regarding Art. 167a, 167b, 167c, 167d, 167d, art. 167f, para. 1 and
para. 2, item 1 and art. 167s, § 65 - 76, § 98, Vol. 1 and 2, § 101, Vol. 1, letters "a" and "b", § 102, 103, 106 - 108, 111, 116, § 117, Vol. 1,
letters "a", "f", "g" and "l", which shall take effect from 2 January 2013;
2. paragraphs 20 and 117, item 2, which shall enter into force on 1 April 2013;
3. paragraph 44 concerning Art. 167f, para. 2, item 2 and para. 3 and Art. 167g, effective July 2, 2013.
Transitional and Final Provisions
TO THE PUBLIC FINANCE LAW
(Promulgated - SG, issue 15 of 2013, in force since 01.01.2014)
§ 123. The law shall enter into force on January 1, 2014, with the exception of § 115, which shall enter into force on January 1, 2013, and
§ 18, § 114, § 120, § 121 and § 122, effective February 1, 2013.
Transitional and Final Provisions
TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
(Official Gazette, SG No. 1/2004, IN EFFECT OF 03/01/2014)
§ 18. Within one month from the entry into force of this law, the Minister of Health shall
in accordance with it the ordinance under art. 221, para. 1 of the Law on Medicinal Products in Human Medicine.
§ 19. The law shall enter into force on the day of its promulgation in the State Gazette.
Transitional and Final Provisions
TO THE LAW FOR AMENDMENT AND SUPPLEMENT OF THE HEALTH ACT
INSURANCE
Transitional and Final Provisions
(Official Gazette, SG 48/15)
§ 46. (1) Within three months from the entry into force of this law, medical scientific companies shall submit
of the National Council for Medicinal Products Price and Reimbursement guidelines and algorithms for
Art. 259, para. 1, item 4 of the Law on Medicinal Products in Human Medicine.
(2) When, within the term of para. 1, medical scientific companies do not provide guidelines and algorithms for mailing.
259, para. 1, item 4 of the Law on Medicinal Products in Human Medicine, the National Council for Prices and
reimbursement of medicinal products arranges for their preparation by national consultants or by
other medical professionals with experience in the field.
(3) The National Council for Medicinal Products Prices and Reimbursement shall approve the guidelines and
the algorithms of art. 259, para. 1, item 4 of the Law on Medicinal Products in Human Medicine within three
months from the expiry of the term under para. 1.
§ 47. (1) Within three months from the entry into force of this law, the Minister of Health shall issue
the ordinance under Art. 262, para. 4 of the Law on Medicinal Products in Human Medicine.
(2) Within 6 months of the entry into force of this law, the Positive Medicinal List may be included
medicinal products with new international non - patent names, without evaluation of
health technologies.
Transitional and Final Provisions
TO THE LAW TO SUPPLEMENT THE LIMITATION OF LAW
ADMINISTRATIVE REGULATION AND ADMINISTRATIVE CONTROL
ECONOMIC ACTIVITY
(Official Gazette, No. 103 OF 2017, IN EFFECT OF 01/01/2018)
§ 68. This Act shall enter into force on 1 January 2018.
Transitional and Final Provisions
TO THE AMENDING ACT TO THE MEDICINAL ACT
PRODUCTS IN HUMAN MEDICINE
(Official Gazette, SG 84/08, IN EFFECT OF 12/10/2018)
§ 70. Clinical trials of medicinal products authorized until this law enters into force,
containing narcotic substances are carried out in the establishments for which licenses have been obtained
conducting relevant clinical trials to date.
§ 71. (1) The Minister of Health shall determine the composition of the commission under Art. 103, para. 1 within three
months from the entry into force of this Act.
(2) The Commission under Art. 103, para. 1 is the successor to the Ethics Committee for Multicenter Testing.
(3) The Commission under Art. 103, para. 1 shall also deliver opinions on pending proceedings before ethics committees,
created to the medical establishments in the present order.
(4) Until the composition of the commission under Art. 103, para. 1 Ethics Committee for Multicenter Testing
continues to operate in the past.
§ 72. (1) The Central Ethics Committee shall cease its activity after all proceedings have been completed,
formed before her.
(2) The chairman of the Central Ethics Committee shall transmit the archive with a transceiver protocol
of the Central Ethics Committee, determined by an order of the Minister of Health
person from the Ministry of Health within one month after the termination of the activity of the
Central Ethics Committee.
§ 73. (1) The heads of the medical establishments in which clinical trials are carried out in accordance with this
law, designate a contact person in accordance with the requirements of Art. 107a within three months of entry
by virtue of Art. 107a.
(2) The Ethics Committees set up by the medical establishments in accordance with the previous procedure, continue to
carry out their activities until the appointment of a contact person under Art. 107a, para. 1.
(3) After designation of a contact person, mail. 107a, para. 1 the functions of the Ethics Committees set up by
The medical establishments according to the previous procedure are carried out by the contact person under Art. 107a, para. 1, p
except for giving an opinion under art. 83, which is carried out by the commission under art. 103, para. 1.
(4) The archives of the ethics committees set up by the medical establishments under the previous procedure shall be transmitted and
stored in the respective hospital.
§ 74. Within 6 months from the publication of the notification under Art. 82 (3) of Regulation (EU) No
536/2014 clinical trials shall be authorized and carried out in accordance with the conditions and procedure in force, except in cases
under Art. 98 of Regulation (EU) No 536/2014.
§ 75. (1) The Executive Agency for Medicines shall establish the specialized electronic mail system. 217b,
para. 1 in accordance with the requirements of this law within 4 months after its entry into force.
(2) The first List of Medicinal Products included in the Positive Medicinal List for which it is
established shortage on the territory of the Republic of Bulgaria, shall be prepared in compliance with the requirements of Art.
217c, determining the shortage of medicinal products on the basis of the quantities required for
meeting the health needs of the population for a period of one month, calculated on the basis of
the average monthly consumption of the respective medicinal product for the previous 6 months by
the specialized electronic system in accordance with Art. 217b.
(3) For the preparation of the first list under Art. 217c, para. 1 the information under Art. 217b, para. 3, items 1 - 3 are provided for
the previous 6 months from the day of creation of the specialized electronic system under para. 1 which
is publicly disclosed on the BDA website. The information shall be provided within two months
since the creation of the specialized electronic system under para. 1.
(4) The list under para. 2 shall be forwarded by the BDA and the Customs Agency by official order.
(5) The Ministry of Health shall assist the BDA in the establishment of the specialized one
electronic system of art. 217b, para. 1.
§ 76. By-laws for the implementation of this Act shall be adopted and issued accordingly
comply with the requirements of this law within three months of its entry into force.
§ 77. Notifications of export of medicinal products included prior to the entry into force of this Act
in the Positive Medicinal List under Art. 262, para. 1, the territory of the Republic of Bulgaria shall also be considered
finish up to date.
§ 78. The law shall enter into force on the day of its promulgation in the State Gazette, with the exception of § 5, §§ 7 - 12, §
14 - 21, § 27 - 30, § 31, Vol. 2, § 32, § 39 - 41, § 56, § 60 and § 66, Vol. 1 - 8, 10, 12, 15 - 17, 19 - 22 which shall enter into force on
months after publication of the notification under art. 82 (3) of Regulation (EU) No 536/2014.
Transitional and Final Provisions
TO THE BUDGET ACT OF THE NATIONAL HEALTH INSURANCE CASH
2019
Transitional and Final Provisions
(Promulgated - SG, No. 102 FROM 2018, IN EFFECT OF 01/01/2019)
§ 43. The law shall enter into force on January 1, 2019, except:
1. paragraph 29, item 13, letter "b", items 14 and 15, § 30 and § 42, item 2, which come into force on the day of promulgation of
the law in the State Gazette;
2. paragraph 28, items 6 - 12 and items 14 - 19, § 35, item 3, with the exception of Art. 7a, para. 4 and Art. 7c, para. 4, items 5 and 6, items 8 - 22 and so on.
36 - 40, § 41, items 2 - 8, item 9, letters "a" and "c" and item 10, which come into force on April 1, 2019;
3. paragraph 29, item 5, letter "a" on words "and through the budget of the Ministry of Health for
payment for medical devices, aids, gadgets and equipment for people with
9, letter "a" on words "as well as medical devices, accessories, devices
and facilities for people with disabilities ", item 9, letter" d "on words" and accessories,
facilities and facilities for persons with disabilities "and for words" as well as persons,
carrying out activities for provision and repair of medical devices, auxiliaries,
facilities and equipment for persons with disabilities registered as traders and entered in the register of
persons carrying out activities for provision and repair of auxiliaries, devices,
facilities and medical devices for persons with disabilities "and item 9, letter" e "regarding paragraph 15, item 3 and paragraph 16
on the words "as well as persons engaged in the provision and repair of auxiliaries,
devices, equipment and medical devices for persons with disabilities registered as dealers and
entered in the register of persons performing activities for providing and repairing auxiliaries,
facilities, equipment and medical devices for people with disabilities - to pay for medical
articles, aids, appliances and facilities for disabled people ", item 25, letter" a "- paragraph 1, item 13
on the words "aids, devices and equipment for the disabled" and item 25 (b)
regarding para. 4 on the words "and persons engaged in the activities of providing and repairing medical
Merchant-registered items, accessories, gadgets and equipment for disabled people
and entered in the register of persons performing activities for provision and repair of auxiliary means,
devices, equipment and medical devices for people with disabilities "i" and accessories,
facilities and facilities for persons with disabilities ", § 36 and § 37 regarding Article 14, paragraph 8, item 2, letter" b ", which
shall enter into force on 1 January 2020.
Relevant European legislation
Directives:
COMMISSION DIRECTIVE 2017/1572 of 15 September 2017 supplementing the Directive
2001/83 / EC of the European Parliament and of the Council as regards the principles and guidelines for good
manufacturing practice for medicinal products for human use
DIRECTIVE 2012/26 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012
amendment of Directive 2001/83 / EC as regards pharmacovigilance
DIRECTIVE 2011/62 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 amending
of Directive 2001/83 / EC on the Community code relating to medicinal products for human use
use with regard to the prevention of entry of counterfeit medicinal products into
legal supply chain
DIRECTIVE 2010/84 / EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010
amendment concerning the pharmacovigilance of Directive 2001/83 / EC on the approval of
Community code on medicinal products for human use
DIRECTIVE 2005/36 / EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 September 2005 on the
recognition of professional qualifications
COMMISSION DIRECTIVE 2005/28 / EC of 8 April 2005 laying down the principles
detailed guidelines for good clinical practice with regard to medicinal products for human use,
intended for research as well as manufacturing authorization requirements
or imports of such products
DIRECTIVE 2004/27 / EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending
of Directive 2001/83 / EC on the Community code relating to medicinal products for human use
use
DIRECTIVE 2004/24 / EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending
of Directive 2001/83 / EC on the Community code relating to medicinal products for human use
use with respect to traditional herbal medicinal products
DIRECTIVE 2004/10 / EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on the
harmonization of laws, regulations and administrative provisions related to the implementation of the
the principles of good laboratory practice and the verification of their application in
chemicals (codified version)
COMMISSION DIRECTIVE 2003/63 / EC of 25 June 2003 amending Directive 2001/83 / EC to
The European Parliament and the Council establishing a Community code relating to medicinal products
for human use
DIRECTIVE 2001/83 / EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001
the adoption of a Community code relating to medicinal products for human use
DIRECTIVE 2001/20 / EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the
approximation of the laws, regulations and administrative provisions of the Member States relating to
the application of good clinical practice in conducting clinical trials of medicinal products
products for human use (abolished)
COUNCIL DIRECTIVE 93/16 / EEC of 5 April 1993 on the facilitation of the free movement of persons
doctors and the mutual recognition of their diplomas, certificates and other official documents for
professional qualification (cancel)
COUNCIL DIRECTIVE 89/381 / SEE of 14 June 1989 extending the scope of the Directives
65/65 / EEC and 75/319 / EEC on the approximation of laws, regulations and administrative provisions
on medicinal products and laying down special provisions for medicines obtained by
human blood or plasma (rev.)
COUNCIL DIRECTIVE 89/105 / EEC of 21 December 1988 on the transparency of measures,
regulating the prices of medicinal products for human use and their inclusion in the scope of
national health insurance systems
COUNCIL DIRECTIVE 87/18 / EEC of 18 December 1986 on the harmonization of laws,
regulations and administrative provisions concerning the application of the principles of good
laboratory practice and verification of their application to chemical analyzes (rev.)
COUNCIL DIRECTIVE 85/433 / EEC of 16 September 1985 on the mutual recognition of diplomas,
certificates and other official documents for professional qualification in the field of pharmacy,
including measures to facilitate the effective exercise of the right of establishment with respect to
certain activities in the field of pharmacy (repeal)
Second COUNCIL DIRECTIVE 75/319 / EEC of 20 May 1975 on the approximation of the laws,
medicines regulations and administrative provisions (repealed)
Regulations:
COMMISSION DELEGATED REGULATION (EU) 2017/1569 of 23 May 2017 supplementing the Regulation
(EU) No 536/2014 of the European Parliament and of the Council by laying down the principles and guidelines for good
manufacturing practice for tested medicinal products for human use and provisions for
conducting inspections
COMMISSION Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing the
Directive 2001/83 / EC of the European Parliament and of the Council as regards the principles and guidelines for
good manufacturing practice for active substances for medicinal products for human use
REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014
on the clinical trials of medicinal products for human use and repealing the Directive
2001/20 / EC
COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012 of 19 June 2012 concerning the classification of certain goods in the Combined Nomenclature
performing the pharmacovigilance activities provided for in Regulation (EC) No
Regulation (EC) No 726/2004 of the European Parliament and of the Council and of Directive 2001/83 / EC of the European Parliament and of the Council
Council
REGULATION (EC) No 469/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 on the
supplementary protection certificate for medicinal products (codified version)
COMMISSION REGULATION (EC) No 1234/2008 of 24 November 2008 on the examination of
changes in the terms of marketing authorizations for medicinal products for human use and
veterinary medicinal products
REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007
on advanced therapy medicinal products and amending Directive 2001/83 / EC and Regulation
(EC) No 726/2004
REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006
on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92,
Directive 2001/20 / EC, Directive 2001/83 / EC and Regulation (EC) No 726/2004
REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004
establishing Community procedures for the authorization and control of medicinal products for human and
veterinary use and to set up a European Medicines Agency
COMMISSION REGULATION (EC) No 1085/2003 of 3 June 2003 examining changes to the
the terms of the marketing authorizations for medicinal products for human use and veterinary use
medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (repealed)
COMMISSION REGULATION (EC) No 1084/2003 of 3 June 2003 examining changes to the
the terms of the marketing authorizations for medicinal products for human use and veterinary use
medicinal products supplied by a competent authority of a Member State (repealed)
COMMISSION REGULATION (EC) No 847/2000 of 27 April 2000 laying down provisions for the
application of the criteria for designating a medicinal product as an orphan medicinal product and for
defining the terms "similar medicinal product" and "clinical superiority"
REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 1999
orphan drugs
COUNCIL REGULATION (Council of the European Community) No 2309/93 of 22 July 1993 establishing
the Community procedure for granting authorizations (licenses) and the supervision of medicinal products
used in human and veterinary medicine, and a European Assessment Agency is established
Medicines (Repealed)
COUNCIL REGULATION (EEC) No 1768/92 of 18 June 1992 establishing a certificate for the
additional protection of medicinal products (repealed)
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