0A4F4F9BD490A749D5437F821CF06DF1
Medicinal Products in Human Medicine Act, Chapter 4, Articles 91 and 92 (2016)
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator crime:
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p.(None):
p.(None):
p.(None): Art. 280. (1) In case that infringement of the provisions of chapter eleventh, respectively of the regulation according
p.(None): to Art. 249 are established, executive director of the BDA shall order termination of the proliferation of advertising.
p.(None): (2) By the order according to para 1 the executive director of the BDA can oblige the advertiser to publish or
p.(None): proliferate in a manner coordinated with the BDA a disclaimer of the statements in the advertising through the same
p.(None): media and in the same format and volume.
p.(None): (3) The order according to para 2 shall be subject to appeal under the terms of the Administrative Procedure Code.
p.(None):
p.(None): Chapter fourteen.
p.(None): ADMINISTRATIVE PENAL PROVISIONS
p.(None):
p.(None): Art. 281. (1) 9amend. – SG, 102/2012, in force from 02.01.2013) Whoever manufactures, imports, sells, stores, or
p.(None): provides for use in Republic of Bulgaria medicinal products, which have no marketing authorisation, except for the
p.(None): cases according to Art. 8, 9, and 10, if he/she is not a subject to heavier punishment, shall be penalised with a fine
p.(None): from BGN 25,000 to BGN 50,000, if not subject to more severe penalty.
p.(None): (2) The same penalty shall also be imposed on the persons who manufacture, import, sell, or permit the use in Republic
p.(None): of Bulgaria of medicinal products, which do not comply with the requirements of the acting pharmacopoeia and the
p.(None): conditions of their marketing authorisation.
p.(None): (3) Where the infringements according to para 1 and 2 are associated with unauthorised medicinal products containing
p.(None): narcotic substances or in case repeated perpetration the authorisation issued under the terms of this Act shall
p.(None): be bereaved provided that the deed shall not constitute a crime.
p.(None): (4) Medical specialists who manufacture, sell, or provide for use unauthorised medicinal products shall be deprived of
p.(None): the right to exercise the profession for a term of 6 months to two
p.(None):
p.(None): years.
p.(None): (5) The penalty according to para 4 shall be imposed by and order of the Minister of
p.(None): Health according to a proposal by the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 282. (1) Whoever sells medicinal products in packaging or with patient information leaflets, which do not comply
p.(None): with the requirements of this Act, shall be penalised with a fine from BGN 750 to BGN 1,500 and in case of a repeated
p.(None): perpetration of the same infringement - with a fine from BGN 1,500 o BGN 3,000.
p.(None): (2) Whoever sells medicinal products without patient information leaflets shall be penalised with a fine from
p.(None): BGN 750 to BGN 1,500 and in case of a repeated perpetration of the same infringement - with a fine from BGN 1,500 to
p.(None): BGN 3,000.
p.(None):
p.(None):
p.(None): Art. 283. (1) Whoever imports, trades with, or provides for same medicinal products with expired validity term shall be
p.(None): penalised with a fine from BGN 10 000 to BGN 20 000.
p.(None): (2) Whoever breaks the primary/secondary packaging or sells/provides medicinal products with broken
p.(None): primary/secondary packaging shall be penalised with a fine from BGN 750 to BGN 1500 and in case of a repeated
p.(None): infringement with a fine from BGN 1,500 to BGN 3,000.
p.(None):
p.(None):
p.(None): Art. 284. (1) Whoever manufactures, imports, or conducts wholesale with medicinal products, or sells without
p.(None): respective authorisation or in infringement of an issued authorisation shall be penalised with a fine from BGN 50,000.
...
p.(None): fine from BGN 10,000 to BGN 20,000.
p.(None): (2) (Amend. – SG, 60/2011, in force from 5. 8. 2011) A wholesaler who supplies drugstores with medicinal
p.(None): products upon doctor's prescription, outside the lists approved by the Minister of Health shall be penalised with a
p.(None): property sanction from BGN 2500 to 5000 and in case of repeated infringement with a fine from BGN 5,000 to BGN 10,000.
p.(None): (3) A qualified person who has permitted sale of batches of medicinal products without certificate of batch release of
p.(None): any separate batch shall be penalised with a fine from BGN 2,500 to BGN 5,000.
p.(None):
p.(None):
p.(None): Art. 285a. (New – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012) Holder of an authorisation for use, who
p.(None): fails to notify the Minister of health for termination of the sales under Art. 264 shall be punished by a property
p.(None): sanction of BGN 25 000 to 50 000.
p.(None):
p.(None):
p.(None): Art. 285b. (new – SG, 102/2012, in force from 21.12.2012) Anyone, who manufactures, imports, exports, sells or keeps
p.(None): active substances in violation of this act, shall be punished by a fine BGN 10 000 to 20 000.
p.(None):
p.(None):
p.(None): Art. 285c. (new – SG 18/14) A holder of a permit for wholesale of medicinal products failing to notify BDA of carrying
p.(None): out export of medicinal products under Art. 217a, par. 4 shall be punished with a fine, respectively with a proprietary
p.(None): sanction from BGN50 000 to BGN100 000, and in case of repeated the same violation – from BGN100 000 to BGN200 000.
p.(None):
p.(None):
p.(None): Art. 286. (1) In case of clinical trials conducted in infringement of this Act, provided no crime has been committed,
p.(None): the guilty persons shall be penalised with a fine from BGN 5,000 to BGN 10000 and in case of repeated permission or
p.(None): commitment of the same infringement – with a fine from BGN 10000 to BGN 20000.
p.(None): (2) Medial specialists who have permitted or committed infringements according to para 1 can be imposed the penalty of
p.(None): "deprived of the right to exercise the profession" for a term from 6 months to two years.
p.(None): (3) The measure according to para 2 shall be imposed by the Minister of Health according to a proposal by
p.(None): the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 287. (1) (Supl.. - SG 71/2008 in force from 12.08.2008, amend. – SG, 60/2011, in force from 5. 8. 2011)
p.(None): Whoever conducts retail trade in medicinal products without having respective authorisation/certificate, or
p.(None): works in violation of his/her issued authorisation/certificate, shall be penalised by a fine from BGN 5,000 to BGN
p.(None): 10,000.
p.(None): (2) The penalty according to para 1 shall also be imposed on persons who conduct retail trade in pharmacy or drugstore
p.(None): after the authorisation/certificate has ceased to be in effect.
p.(None): (3) (Supl. - SG 71/2008 in force from 12.08.2008, amend. – SG, 60/2011, in force from
p.(None):
p.(None): 5. 8. 2011) Whoever sells, or stores in a drug store medicinal products, prescribed by doctor’s prescription, or
p.(None): products or goods of human health significance, outside the ones, determined in the ordinance under Art. 243,
p.(None): shall be punished by the fine under para 1, and in repeated perpetration of the infringement the issued
p.(None): registration of the drug store will be deprived of.
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Searching for indicator illegal:
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p.(None): 2a. (new – SG, 102/2012, in force from 02.01.2013) be certain that the assisting substances, put in the
p.(None): medicinal products are manufactured in compliance with the appropriate Good manufacturing practices for assisting
p.(None): substances, determined on the basis of an official risk assessment in compliance with the applicable directives,
p.(None): adopted by the European Commission;
p.(None): 3. ensure on a permanent basis qualified personnel for the production and control according to the
p.(None): requirements the regulation according to Art. 152;
p.(None): 4. (amend. – SG 12/11, in force from 08.02.2011) only dispose of medicinal products, which have marketing authorisation
p.(None): fulfilling the requirements of this Act;
p.(None): 5. (revoked – SG 12/11, in force from 08.02.2011);
p.(None): 6. immediately notify the control bodies in case of substitution of the qualified person according to Art. 148, point
p.(None): 2;
p.(None): 7. ensure access of the control bodies to the premises and the documentation at any
p.(None): time;
p.(None): 8. ensures to the qualified person according to Art. 148, point 2 the required condition
p.(None): to fulfill his obligations.
p.(None): 9. (new – SG, 102/2012, in force from 02.01.2013) inform immediately the BDA and the use authorisation holder, if
p.(None): information is received that the medicinal products, which fall in the scope of hi/her manufacture automation, are
p.(None): falsified or there are suspects for falsification, notwithstanding of the fact whether these medicinal products
p.(None): have been disseminated within the
p.(None):
p.(None): frames of the legal supply or an illegal way, including through illegal sale through the services of the information
p.(None): society;
p.(None): 10 (new – SG, 102/2012, in force from 02.01.2013) check if the manufacturers, importers or traders, from whom he/she
p.(None): receives active substances have been register by the competent body of the Member state in which they are established;
p.(None): 11. (new – SG, 102/2012, in force from 02.01.2013) check up the authenticity and quality of the active and assisting
p.(None): substances.
p.(None): (2) (new – SG, 102/2012, in force from 02.01.2013) The manufacturing authorisation holder shall perform audits in
p.(None): the production sites and trade with active substances for observation of the Good manufacturing practice
p.(None): and the Good distribution practice. The manufacture authorisation holder may sign a contract with a third person
p.(None): to carry out the audit on his/her behalf and on his/her account.
p.(None): (3) (new – SG, 102/2012, in force from 02.01.2013) The manufacturing authorisation holder shall document the undertaken
p.(None): under Para.. 1, p. 2 and 2a measures.
p.(None): (4) (former Para. 2 – SG, 102/2012, in force from 01.01.2013)The manufacturing authorisation holder shall
p.(None): keep the samples of and the documentation for the manufactured medicinal products, active substances, and
p.(None): medicinal products intended for clinical trials under the conditions and under the terms laid down in the regulation
p.(None): according to Art. 152.
p.(None): (5) (former Para. 3 – SG, 102/2012, in force from 01.01.2013)The In case of a medicinal product intended for clinical
p.(None): trials, the manufacturing authorisation holder shall guarantee that all manufacturing operations shall be carried out
...
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
p.(None): 2. medicinal products, which are frequently and very widely administered in a wrong manner and as a result of that can
p.(None): represent a threat for the people’s health;
p.(None): 3. medicinal products containing substances the activity and/or adverse drug reactions of which require subsequent
p.(None): additional study;
p.(None): 4. medicinal products, which are usually prescribed by a physician for potential administration.
p.(None):
p.(None):
p.(None): Art. 174. Medicinal products shall be subject to special medical prescription wherever
p.(None):
p.(None): these meet one of the following conditions:
p.(None): 1. contain narcotic substances within the meaning of the Control on Drugs and Precursors Act in admissible
p.(None): for use quantities;
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
p.(None): 3. contain new medicinal substances the characteristics of which are not sufficiently known and therefore these
p.(None): can be assigned to the group of medicinal products according to point 2.
p.(None):
p.(None):
p.(None): Art. 175. Medicinal products shall be subject to limited medical prescription wherever these meet one of the following
p.(None): conditions:
p.(None): 1. are limited to administration in hospital conditions only due to limited experience with their use or in the
p.(None): interest of public health;
p.(None): 2. are intended for treatment of pathological conditions, which can only be diagnosed in therapeutic establishments,
p.(None): irrespective that their administration and follow-up in the course of treatment can be carried out in other healthcare
p.(None): establishments;
p.(None): 3. are intended for treatment of out-patients but their use can cause serious adverse drug reactions, which can require
p.(None): specialist prescribing and monitoring in the course of treatment.
p.(None):
p.(None):
p.(None): Art. 176. (1) The BDA can refuse to approve the dispensing regime of a medicinal product requested by the
p.(None): applicant according to Art. 26, para 1, on the grounds of assessment of:
p.(None): 1. the maximum single dose, maximum daily dose, quantity of the active substance in one dose unit, pharmaceutical
p.(None): form, specific appearance of the primary product packaging, and/or
p.(None): 2. other specific conditions of use.
p.(None): (2) The BDA can refuse to indicate the exact category of a medicinal product according to Art. 172 but pursuant to the
...
p.(None): confirmed prices, limit prices or registered prices during sale of medicinal products;
p.(None): 7. (former Art. 6 - SG, 102/2012, in force from 21.12.2012) draw up statements of administrative
p.(None): infringements.
p.(None): (2) (repealed - SG, 102/2012, in force from 21.12.2012).
p.(None): (3) (amend., - SG 98/10, in force from 01.01.2011) The Executive Director of BDA of the corresponding director of
p.(None): RHI, depending of the administrative person, who determined the violence, has right to:
p.(None): 1. order in written form to the violator to cease the violation according to Para. 1, point
p.(None): 1;
p.(None): 2. requires from the violator to declare that it will cease the violation according to Para.
p.(None): 1, point 1 and when it is necessary to makes the declaration matter publicly available.
p.(None): 3. to order cease or prohibition of each violation according to Para. 1, point 1 and when it is necessary to order for
p.(None): cease or prohibition of violation matter publicly available.
p.(None): (4) (new - SG, 102/2012, in force from 21.12.2012). The Council chairperson under Art. 258, Para. 1 shall have the
p.(None): right to order in writing to the violator to stop the violation, found during the inspection under Para. 1, p. 6.
p.(None):
p.(None):
p.(None): Art. 271. (1) (amend., - SG 98/10, in force from 01.01.2011) The regional health inspectorates shall be
p.(None): entitled to:
p.(None): 1. stop construction and issue directions where violations of hygienic norms and requirements have been
p.(None): established in the course of construction; notify the Directorate for
p.(None):
p.(None): National Construction Control or the municipal technical office in case of illegal construction of sites and
p.(None): equipment for manufacture, storage, and sale of medicinal products shall be established;
p.(None): 2. prohibit the commissioning and stop the operation of sites and equipment in case of violation of the hygienic norms
p.(None): for the manufacture, storage, and sale of medicinal products – until the elimination of the violations;
p.(None): 3. block medicinal products in case of available documented information of discrepancies with the
p.(None): quality requirements; medicinal products imported or manufactured in infringement of this Act; as well as medicinal
p.(None): products, which are offered in packaging non- complying with the requirements of this Act; order the recall of such
p.(None): medicinal products from pharmacies and drugstores, wholesale warehouse, manufacturers, and
p.(None): healthcare establishments in case of necessity and notify for that the Ministry of Health;
p.(None): 4. give conclusions of the compliance of the controlled sites with the legal determined requirements;
p.(None): 5. issue orders, directions, and instructions in the field of their competency, which shall be obligatory for all
p.(None): persons on the territory of the respective district.
p.(None): (2) ()amend., - SG 98/10, in force from 01.01.2011 The compulsory administrative measures according to para
p.(None): 1 or pursuant to art.270, para 3 shall be imposed by an order of the director of RHI,
p.(None): (3) The orders according to para 2 shall be subject to appeal under the terms of the Administrative Proceeding Code
p.(None): whereas the appeal shall not stop their execution.
p.(None):
p.(None):
p.(None): Art. 272. (1) The BDA shall:
p.(None): 1. (suppl. – SG, 102/2012, in force from 02.01.2013) prohibit the commissioning and stop the operation of sites and
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Political / criminal
Searching for indicator criminal:
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p.(None): 2. The Council of Ministers shall adopt the Ordinance under Art. 258, Para. 5 and shall amend the tariff under Art. 21,
p.(None): Para. 2 and the Rules of procedure of the Ministry of Health in compliance with this Act.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 84. This Act shall come into force from the day of its publication in the State Gazette, with the exception of § 65,
p.(None): which shall come into force from 30 September 2011.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.(None):
p.(None): (PROM. - SG 38/12, IN FORCE FROM 01.07.2012)
p.(None):
p.(None): § 84. (In force from 18.05.2012) Within one month after the promulgation of this Act in the State Gazette:
p.(None): 1. The Council of Ministers shall adjust the Classified of positions in administration to the provision of this Act;
p.(None): 2. the competent bodies shall adjust the structural acts of the respective administration to the provisions of this
p.(None): Act.
p.(None):
p.(None):
p.(None): § 85. (1) The legal relationships with the persons from administrations under the Radio and Television Act, Independent
p.(None): Financial Audit Act, Electronic Communications Act, Financial Supervision Commission Act, Act on Access to and
p.(None): Disclosure of the Documents and Announcing Affiliation of Bulgarian Citizens with the State Security Service and
p.(None): the Intelligence Services of the Bulgarian Popular Army, Act on Seizure in Favour of the State of
p.(None): Property, Acquired through Criminal Activity Act on Prevention and Findings of Conflict of Interests, Code of Social
p.(None): Insurance, Health Insurance Act, Agricultural Producers Assistance Act, Roads Act shall be regulated subject to
p.(None): compliance with the provisions and following the procedure of § 36 of the Transitional and Conclusive Provisions of the
p.(None): Act amending and supplementing the Civil Servants Act (SG 24/06).
p.(None): (2) By the act of appointment of a civil servant:
p.(None): 1. the minimum rank for the occupied position shall be conferred, as determined in the Classified of positions in the
p.(None): administration, unless the servant hold a higher rank;
p.(None): 2. individual monthly salary shall be fixed.
p.(None): (3) Additionally required funds for insurance contributions of the persons under par. 2 shall be provided within the
p.(None): cost of salaries, remunerations and insurance contributions within the budgets of the respective administrators of
p.(None): budget credits.
p.(None): (4) Council of Ministers must make necessary adjustments in the out-of-budget account of State Fund "Agriculture",
p.(None): arising out of this Act.
p.(None): (5) Managing bodies of National Social Insurance Institute and of National Health Insurance Fund must make
p.(None): necessary adjustments in the respective budgets, arising out of this
p.(None):
p.(None): Act.
p.(None): (6) The non-used leaves regulated in the employment agreement shall be kept and shall
p.(None): not be compensated with a financial benefit.
p.(None):
p.(None):
p.(None): § 86. (1) Within one month after entering of this Act into force the individual basic monthly salary of the employee
p.(None): shall be determined in such a way that the salary after the due tax and the obligatory insurance contributions
p.(None): chargeable to the insured person, where they have been payable, shall not be less than the gross monthly salary
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Political / political affiliation
Searching for indicator party:
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p.(None): advertising of medicinal products;
p.(None): 10. carry out laboratory analysis in case of doubt of deviation in the quality, efficacy, and safety of the medicinal
p.(None): products and shall undertake the measures provided by law;
p.(None): 10a (new – SG, 102/2012, in force from 21.12.2012) carries out the functions of a competent body for
p.(None): vigilance medicinal safety;
p.(None): 11. (amend. - SG, 102/2012, in force from 21.12.2012) organize and maintain a system for vigilance the medicinal
p.(None): safety;
p.(None): 12. issue certificates according to the certification system of the World Health Organisation;
p.(None): 12a. (new – SG 18/14) issue certificates of Good Distribution Practice;
p.(None): 13. Issue Good Manufacturing Practice certificates;
p.(None): 14. (amend. – SG 18/14) consult investment projects for the construction of new and/or refurbishing of existing sites
p.(None): relating to the manufacture of medicinal products in accordance with the rules of Good Manufacturing Practice;
p.(None): 15. execute the functions of national coordinator and consulting body on the issues relating to the
p.(None): quality, efficacy, and safety of medicinal products;
p.(None): 16. carry out consulting, scientific, information, and publishing activity in the domain of the medicinal sector;
p.(None): 17. coordinate and participate in activities relating to the European Pharmacopoeia and the development of the
p.(None): Bulgarian Pharmacopoeia;
p.(None): 18. take part in activities in the field of the medicinal products relating to the work of the European Medicines
p.(None): Agency, the European Directorate of the Quality of the Medicinal Products and Healthcare, of international bodies and
p.(None): organisations, as well as relating to the fulfillment of international treaties in which Bulgaria is a party to;
p.(None): 18a (new – SG, 102/2012, in force from 21.12.2012) participate in the international harmonisation and
p.(None): standardisation of the technical measures, referring to vigilance the medicinal safety under the coordination of the
p.(None): European Medicines Agency;
p.(None): 18b (new – SG, 102/2012, in force from 21.12.2012) establish and maintain a national internet portal for medicinal
p.(None): products;
p.(None): 19. carry out other activities provided by a law.
p.(None): (6) (amend., - SG 98/10, in force from 01.01.2011) The Bulgarian Drug Agency coordinates its activity with
p.(None): the Regional health inspectorates (RHI) in the field of the control on the medicinal products.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The implementation of this act measures, related to
p.(None): prevention of entering and dissemination of falsified medicinal products shall be carried out in cooperation
p.(None): between the Bulgarian Drug Agency and the customs authorities.
p.(None):
p.(None): Art. 17a (New – SG, 60/2011, in force from 05.08. 2011) The Regional health inspectorates shall issue
p.(None): authorisations for registration of drug stores.
p.(None):
p.(None):
p.(None): Art. 17b. (new – SG 18/14) (1) Expert drug retail trade council shall be set up subordinated to the
p.(None): Managing Director of the BDA including three representatives of Bulgarian Pharmaceutical Association, one
p.(None): representative of every Pharmaceutical department of Higher Medicinal Schools and four representatives of the BDA. The
...
p.(None): be:
p.(None): 1. persons with educational qualification master’s degree in pharmacy, chemistry, or biology and at least two-year
p.(None): practical experience in the pharmaceutical manufacture;
p.(None): 2. for the manufacture of radiopharmaceuticals or medicinal products subjected to ionizing radiation –
p.(None): persons who comply with the requirements according to point 1 and have an additionally recognised specialty in
p.(None): radiobiology or radiochemistry.
p.(None): 3. for the manufacture of immunological medicinal products including vaccines, toxins, sera, biotechnological products,
p.(None): and medicinal products obtained from human plasma or human blood – persons with recognised speciality in medical
p.(None): haematology, medical microbiology, virology, or immunology.
p.(None):
p.(None):
p.(None): Art. 150. (1) The person according to Art. 146 shall submit to the BDA a formal application as approved
p.(None): by the director of the Agency.
p.(None): (2) Together with the application according to para 1 the applicant shall also submit:
p.(None): 1. diploma, document for acquired speciality, document for length of service, certificate of clean court record, and
p.(None): employment contract for the persons according to Art. 148, point 2, and Art. 149;
p.(None): 2. copies of contracts of assignment of the manufacture and/or control of the products ordered for manufacture – in the
p.(None): cases according to Art. 151;
p.(None): 3.(amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code
p.(None):
p.(None): of the trader or cooperation from the Trade register, and for the companies, registered in a EU Member State or in a
p.(None): state – party on the Agreement for the EEA – a document for updated registration under the national legislation, issued
p.(None): by a competent body of the relevant state;
p.(None): 4. (amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 02.01.2013)) a list of
p.(None): the production activities and the medicinal forms, which will be manufactured;
p.(None): 5. schemes of the premises for the manufacture, control, and storage and a dossier of the manufacturing capacity;
p.(None): 6. assessment of the environmental impact during the manufacture of the medicinal products for the cases
p.(None): stipulated in the Environmental Protection Act;
p.(None): 7. authorisation by the Nuclear Regulatory Agency where the application concerns manufacture of
p.(None): radiopharmaceuticals or medicinal products subjected to ionised radiation during their manufacture;
p.(None): 8. authorisation for the use of the premises for manufacture, control, and storage issued according to order of the
p.(None): Spatial Development Act or another substituting document;
p.(None): 9. (amend., - SG 98/10, in force from 01.01.2011, repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 10. document for paid fee, in amount determined in the tariff to Art. 21, para 2.
p.(None): (3) For the manufacturing of narcotic substances and pharmaceutical forms containing such substances, the
p.(None): requirements of the Control on Drugs and Precursors Act shall be observed.
p.(None):
p.(None):
p.(None): Art. 151. Where some aspects of the stages of manufacture or control tests within the manufacturing process shall be
p.(None): carried in another site of the territory of Bulgaria or abroad under contract, the persons according to Art. 146 shall
...
p.(None): medicinal products, which he has an issued manufacturing authorisation for.
p.(None): (2) Importer of medicinal products within the meaning of this Act can only perform wholesale of the
p.(None): medicinal products, which he has an issued import authorisation for.
p.(None):
p.(None):
p.(None): Art. 197. The persons according to Art. 195 shall dispose of:
p.(None): 1. suitable premises, equipment and outfits, and transport vehicles ensuring correct storage, distribution,
p.(None): and transportation of the medicinal products in compliance with the requirements of the Good Distribution
p.(None): Practice;
p.(None): 2. personnel and responsible master-pharmacist with at least two years length of service in his speciality and whose
p.(None): obligations shall be laid down in the regulation according to Art. 198.
p.(None):
p.(None):
p.(None): Art. 198. (amend. – SG, 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.(None): Distribution Practice of medicinal products and of active substances shall be adopted by an ordinance of the Minister
p.(None): of Health and by directives, adopted by the European Commission.
p.(None):
p.(None):
p.(None): Art. 199. (1) The persons according to Art. 195, para 2, shall submit to the BDA:
p.(None): 1. application containing name, place of business and address of management of the trader; address and description of
p.(None): the premises and equipment for the storage of the medicinal products;
p.(None): 2. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification
p.(None):
p.(None): code of the trader of cooperation from the Trade Register and for the companies, registered in a EU Member State or
p.(None): a state – party on the EEA Agreement – a document for updated registration according to the national
p.(None): legislation, issued by a competent body of the relevant state;
p.(None): 3. name, certificate of clean court record, diploma for higher education and length of service for the responsible
p.(None): master - pharmacist according to Art. 197, point 2, and a copy of his/her employment contract;
p.(None): 4. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 5. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 6. document certifying the legal grounds for the use of the premises;
p.(None): 7. (amend., - SG 98/10, in force from 01.01.2011) conclusion of the Regional Health Inspectorates after inspection on
p.(None): the spot evidencing that the health requirements in the whole sale premises according to the regulation according to
p.(None): Art. 198.
p.(None): 8. document for paid fee as laid down in the tariff Art. 21, para 2.
p.(None): (2) The persons according to Art. 195, para 1, shall submit to the BDA an application accompanied by the following
p.(None): documents:
p.(None): 1. copy of the wholesale authorisation issued by a regulatory body of a Member State;
p.(None): 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.(None): 3. address of the premises for the storage of the medicinal products on the territory of the Member State.
p.(None): (3) In case of wholesale of narcotic substances, as well as pharmaceutical forms containing such
p.(None): substances, the requirements of the Control on Drugs and Precursors Act shall also be applied.
p.(None): (4) In case of wholesale of radiopharmaceuticals, an opinion of the Nuclear Regulatory Agency shall also be submitted.
p.(None):
p.(None):
...
p.(None): 3. keep data, including the following information about each deal with medicinal product, realised via intermediation:
p.(None): a) date of the deal;
p.(None): b) name of the medicinal product;
p.(None): c) the realised quantity vial intermediation;
p.(None): d) name and address of the persons, received, and delivered the medicinal product;
p.(None): e) lot number;
p.(None): 4. observe the requirements of the Good distribution practice, adopted by the ordinance under Art. 198;
p.(None): 5. maintain a quality system, determining the responsibilities, processes and management risk
p.(None): measures, related to his/her activity;
p.(None): 6. immediately inform BDA and the marketing authorisation holder, where he/she has
p.(None):
p.(None): found or suspects that the medicinal products – subject of the intermediation, has been falsified;
p.(None): 7. check whether the trader holds wholesale authorisation for trade with medicinal products;
p.(None): 8. check up whether the manufacturer or importer holds an authorisation for manufacture/import;
p.(None): 9. keep the data under p. 3 for the term of at least 5 years and provide them upon request of the control bodies.
p.(None): (2) The requirements to the intermediary activities in the area of the medicinal products shall be determined by the
p.(None): ordinance under Art. 198 and in the European Commission directives.
p.(None):
p.(None): Section .
p.(None): Parallel Import of Medicinal Products
p.(None):
p.(None): Art. 213. Parallel import of medicinal products on the territory of the Republic or Bulgaria can be performed by a
p.(None): natural or legal person registered according to the Commerce Act, the legislation of a Member State, or the
p.(None): legislation of a state party to the Agreement on the European Economic Area after receipt of a parallel import
p.(None): authorisation issued by the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 214. (1) A medicinal product authorised for use in another Member State, can be imported on the territory of the
p.(None): Republic of Bulgaria, provided that it is identical or similar to a medicinal product authorised for use in the
p.(None): Republic of Bulgaria under the terms of this Act.
p.(None): (2) (Amen. - SG 71/2008, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011) Within the meaning of
p.(None): Para 1, a medicinal product is identical or similar shall be the one, that has identical qualitative and
p.(None): quantitative composition with respect to the active substance(s), is supplied in the same pharmaceutical form,
p.(None): the same primary packaging, with the same graphic design of the packaging
p.(None):
p.(None):
p.(None): Art. 215. (1) (Amen. And suppl. - SG 71/2008, in force from 12.08.2008) To obtain authorisation to
p.(None): perform parallel import on the territory of the Republic of Bulgaria, the person according to Art. 213, para 1 shall
p.(None): submit to the executive director of BDA an application stating the Member State from which the parallel import of the
p.(None): medicinal product is to be effected from.
p.(None): (2) The following data and documents shall be appended to the application:
p.(None): 1. name, pharmaceutical form, quantity of the active substance in a dose unit of the medicinal product authorised for
p.(None): use in the Republic of Bulgaria;
...
p.(None): transitional food, as well as food supplements, cosmetic and sanitary-hygienic articles.
p.(None):
p.(None):
p.(None): Art. 226. (1) Pharmacies for selling medicinal products to citizens can be opened on the territory of healthcare
p.(None): establishments for outpatient care.
p.(None): (2) Pharmacies for selling medicinal products to citizens cannot be opened on the territory of healthcare
p.(None): establishments to Art. 21, para 2 of the Health Act, therapeutic establishments for hospital care, and
p.(None): healthcare establishments according to Art. 10 of the Medical Establishments Act.
p.(None):
p.(None):
p.(None): Art. 227. (1) (Prev. text of Art. 227 – SG 102/09, in force from 22.12.2009) The requirements relating
p.(None): to the location and to the premises of the pharmacy shall be laid down in the regulation according to Art. 219, para 2.
p.(None): (2) (New – SG 102/09, in force from 22.12.2009, amend. – SG, 60/2011, in force from
p.(None): 5. 8. 2011) The requirements to the structure and the premises of pharmacies as per Art. 228, para. 5 shall be set
p.(None): forth in an ordinance mentioned in para. 1.
p.(None):
p.(None):
p.(None): Art. 228. (Amen. - SG 71/2008, in force from 26.07.2008) (1) (amend. – SG, 60/2011, in force from 5. 8. 2011)
p.(None): Authorisation for retail trade with medicinal product shall be issued by the executive director of BDA, on the grounds
p.(None): of a formal application accompanied with the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 222, Para. 1;
p.(None): 2. labour contract or a contract for managing a pharmacy, signed with a Master of Pharmacy or assistant
p.(None): Pharmacist;
p.(None): 3. copy of the act for establishing the persons under Art. 222, para 4;
p.(None): 4. documents, evidencing that the requirements of Art. 224 have been observed;
p.(None): 5. certificate of court record of the Master of Pharmacy, respectively of the assistant pharmacist indicated as manager
p.(None): of the pharmacy;
p.(None): 6. medical certificate of the Master of Pharmacy or the assistant pharmacist, manager of the pharmacy;
p.(None): 7. (suppl. – SG, 60/2011, in force from 5. 8. 2011; revoked - SG 48/15)
p.(None): 7a. (new - SG, 60/2011, in force from 5. 8. 2011) hygiene conclusion, issued by the relevant RHI;
p.(None): 8. document for paid state fee in the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (2) (New - SG, 60/2011, in force from 5. 8. 2011) While issuing an authorisation for retail trade with medicinal
p.(None): products a check up shall be performed if the produced diploma of the Master Pharmacist /Assistant Pharmacist has been
p.(None): issued by the relevant competent institution.
p.(None): (3) (Former Para. 2, amend. - SG, 60/2011, in force from 5. 8. 2011) The pharmacies of
p.(None):
p.(None): the therapeutic establishments according to Art. 222, para 4 and 6 shall be opened and closed according to the request
p.(None): of the person representing the healthcare establishment;
p.(None): (4) (Former Para. 3, amend. - SG, 60/2011, in force from 5. 8. 2011) For opening a pharmacy, in which medicinal
...
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
p.(None): 3. has at least 1 year of professional experience in this field.
p.(None):
p.(None):
p.(None): Art. 239. (1) (amend. – SG, 60/2011, in force from 5. 8. 2011) Drugstores shall be opened after
p.(None): registration at the relevant RHI.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 238,
p.(None):
p.(None): para 2, shall submit to the RHI a registration application accompanied by the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 238, Para. 1;
p.(None): 2. education document and certificate of clean court record or the person appointed as manager of the drugstore;
p.(None): 3. medical certificate of the person according to point 2;
p.(None): 4. (repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 5. (amend., - SG 98/10, in force from 01.01.2011, repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 6. document for paid state fee to the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011).Within 14 day term from receiving the application under Para. 2,
p.(None): RHI shall perform an inspection on the observation of the requirements of the Ordinance under Art. 243.
p.(None): In the cases, where it is found that the requirements of the Ordinance under Art. 243 have not been observed,
p.(None): within 7 day term after the inspection the RHI shall give instructions and shall determine term for removing them.
p.(None): (4) (New – SG, 60/2011, in force from 5. 8. 2011). Within 14 day term from receiving the application and the
p.(None): documents under Para. 2, the director of RHI shall notify in writing the persons for finding irregularities
p.(None): in them and shall determine a term for their removal.
p.(None): (5) (New – SG, 60/2011, in force from 5. 8. 2011). For submitting a registration application for a drug
p.(None): store or for performing a change under Art. 242, the relevant RHI shall collect charges in the amount, determined by
p.(None): the tariff under Art. 21, Para. 2.
p.(None):
...
p.(None): substances in case of doubt in their quality by placing establishment signs in the production sites.
p.(None): (2) The compulsory measures according to Para. 1 shall or pursuant to Art. 270, Para. 3 shall be imposed by an order of
p.(None): the director of the BDA.
p.(None): (3) The orders according to Para. 2 shall be subject to appeal under the terms the Administrative
p.(None): Procedure Code, whereas the appeal shall not stop their execution.
p.(None):
p.(None):
p.(None): Art. 272a (new – SG, 102/2012, in force from 02.01.2013) (1) With delegated acts under Para. 52b, Para. 2 of
p.(None): Directive 2001/83/EC the needed measures shall be established for prevention setting in turnover medicinal
p.(None): products, introduced to the EU but intended for placing on the market of the EU for which there are sufficient grounds
p.(None): for suspect that they are falsified.
p.(None): (2) The BDA shall undertake the needed measures in compliance with the delegated acts under Para. 1 for prevention
p.(None): placing in turnover medicinal products, introduced to EU, but not intended for placing on the EU market, for which
p.(None): there a sufficient suspects that they are falsified.
p.(None): (3) The customs bodies shall notify BDA about introduction on the territory of the Republic of Bulgaria
p.(None): medicinal products under Para. 1 in view to undertaking measures under Para. 2.
p.(None):
p.(None):
p.(None): Art. 273. (1) The conditions and order for taking samples, conduct of teats, and payment thereof shall be laid down in
p.(None): a regulation of the Minister of Health.
p.(None): (2) Repeated tests shall be conducted in case of litigation of the results of conducted laboratory tests. These shall
p.(None): be conducted upon a written request by the interested party made within 7 days of the date of receipt of the results of
p.(None): the initial test.
p.(None): (3) The repeated tests according to para 2 shall be conducted by experts appointed by the executive director of the BDA
p.(None): who have not participated in the initial test and in the presence of a representative on the interested party.
p.(None):
p.(None):
p.(None): Art. 274. (1) The conditions and order for blocking and recall of medicinal products, which have shown
p.(None): discrepancies with the requirements to quality, efficacy, and safety shall be paid down in a regulation of the Minister
p.(None): of Health.
p.(None): (2) The conditions and order for destruction, reprocessing, and otherwise use of medicinal products shall be
p.(None): paid down in a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 275. (1) During exercising control, the BDA shall undertake all necessary measures to ensure correct validation of
p.(None): the processes of manufacture and purification of the medicinal products obtained from human blood or human
p.(None): plasma, consistency of batch quality, and guaranteeing the absence of specific viral contamination in so far as
p.(None): technology allows.
p.(None): (2) Manufacturers shall notify the BDA of the method used for decreasing or elimination of pathogenic viruses, which
p.(None): can be transmitted through medicinal products obtained from
p.(None):
p.(None): human blood or human plasma.
p.(None): (3) The BDA shall test or forward to another official laboratory for control of medicinal products in Republic of
p.(None): Bulgaria or another Member State samples of bulk product and/or medicinal product for a test or in the
p.(None): course of assessment of an application for marketing authorisation according to Art. 46, para 1, point 2, or
p.(None): after issuing a marketing authorisation.
p.(None):
p.(None):
p.(None): Art. 276. The executive director of the BDA shall temporarily stop, bereave, or amend by an order the marketing
p.(None): authorisation of a medicinal product or its registration where it shall be established that:
...
p.(None): active substance shall be regarded as the same active substance except if these are significantly
p.(None): different in respect of safety and/or efficacy.
p.(None): 10. "Principal researcher" shall mean an appointed by the contracting authority medical doctor or doctor in dental
p.(None): medicine who is managing the overall conduct of a clinical test in compliance with an approved protocol and the rules
p.(None): for Good Clinical Practice and is responsible for the work of the researchers.
p.(None): 11. "Defined daily dose" shall be the mean daily maintenance dose of a given medicinal product, which administered to
p.(None): adults according to the main indication of a medicinal product.
p.(None): 12. "Good clinical practice" shall mean the aggregate of internationally recognised ethical and scientific
p.(None): quality requirement, which shall be observed during the planning, conduct, accounting, and reporting of clinical
p.(None): trials.
p.(None): 13. "Good laboratory practice" shall mean a system of rules in respect if the conditions for planning, processes of
p.(None): organizing, conduct, follow up, and documenting of laboratory tests.
p.(None): 14. "Good manufacturing practice" shall mean a system of rules encompassing all aspects of manufacture:
p.(None): personnel, premises, equipment, materials, documentation, and quality control and has the purpose of ensuring safety,
p.(None): efficacy, and compliance with a specification.
p.(None): 15.. (Suppl. - SG 71/2008 in force from 12.08.2008) "Member State" shall mean a State Member of the European Union, or
p.(None): a State, party of the Agreement of the EEA.
p.(None): 16. "Labeling" shall mean information on the immediate or outer packaging of a medicinal product.
p.(None): 17. "Immunological medicinal product" shall mean a medicinal product, which contains vaccines, toxins, sera, or
p.(None): allergens. Agents used to create active immunity or establish a condition of immunity or invoke passive
p.(None): immunity shall be involved in the scope of vaccines, toxins, and sera. Allergens shall mean medicinal products,
p.(None): which are intended to identify or stimulate specific purposeful change in the immunological response to an allergens
p.(None): agent.
p.(None): 18. "Bioequivalence study" shall mean a clinical test aimed at proving that two medicinal
p.(None):
p.(None): products are bioequivalent provided that they are pharmaceutically equivalent or pharmaceutical alternatives and
p.(None): provided that their bioavailability after administration of the same molar dose are similar to a degree, which is a
p.(None): condition for equivalence in respect of efficacy and safety.
p.(None): 19. "Bioavailability study" shall mean a clinical test aimed at showing what is the rate and degree which an active
p.(None): substance or a therapeutically significant part of a studied medicinal product reach from the pharmaceutical form to
p.(None): the systemic circulation of the blood.
p.(None): 20. "Study medicinal product" shall mean a pharmaceutical form of an active substance or placebo, which are
p.(None): investigated or used as comparators in a clinical test including products with granted marketing authorisation but are
p.(None): used in an unauthorised indication or with a view of obtaining additional information for an authorised form, or are
...
p.(None): a) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases or chronic diseases taking
p.(None): progressive course, which affect not more than 5 of 10,000 people on the territory of a state or
p.(None): b) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases and severely health damaging
p.(None): chronic disease (diseases with high percentage of disease-related incapacity of work or disability) and are there is
p.(None): evidence appended that the sale of the product does ensure satisfactory return, which can justify the required
p.(None): investment for scientific research and development without having stimuli for the creator of the product, and
p.(None): c) where the is no satisfactory method of diagnostics, prophylaxis, or treatment of a given condition or where there is
p.(None): such method the proposed medicinal product has significantly more advantages and benefits for the people affected by
p.(None): this condition.
p.(None): 30. "Pharmaceutical form" shall mean an adequate for intake structure containing active substance(s), which can
p.(None): include or cannot include excipients and which is obtained through application of certain technological operations
p.(None): ensuring the desired healing effect and stability at storage within the expiry term.
p.(None): 31.. (Amen. - SG 71/2008 in force from 12.08.2008) "Any person, established on the territory of a Member State shall
p.(None): mean a legal subject registered according to the civil or trade legislation of a Member State or established pursuant
p.(None): to a normative act and having place of business in a Member State or a state - party of the European Economic Area.
p.(None): 32. "Magisterial formula" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): prescription of a medical specialist or according to an established recipe and intended for a definite patient.
p.(None): 33. "International non-proprietary name" shall mean a recommended name of an active substance approved and published by
p.(None): the World Health Organisation.
p.(None): 34. "Medical specialists" shall mean medical doctors, doctors in dental medicine, masters of pharmacy,
p.(None): nurses, midwives, medical laboratory assistants, medical auxiliaries and pharmacy assistants.
p.(None): 35. "Medical trade representative" shall mean a person who has passed special training and possessing scientific
p.(None): knowledge for the presentation of accurate and comprehensive information about the medicinal product he is
p.(None): advertising.
p.(None): 35a. (new – SG 1/14, in force from 03.01.2014)”Medical prescription” shall mean a prescription of a
p.(None): medicinal product, issued by a person who exercises a regulated medical profession within the meaning of § 1,
p.(None): item 1 of the Additional Provisions of the Recognition of Professional Qualifications Act and who is legally entitled
p.(None): to do so in the Member State in which the medical prescription is issued.
p.(None): 36. "Multicentre clinical test" shall mean a clinical test, which is conducted according to a single protocol but in
p.(None): more than one site and by more than one researcher. Researcher sites can be situated in the territory of one Member
p.(None): State, more than one Member State, and/or in Member States and third states.
...
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
...
p.(None): contain:
p.(None): 1. application for issuing authorisation for retail trade with medicinal products by the persons under Art. 222, para
p.(None): 1, according to a form, approved by the Minister of Health;
p.(None): 2. updated certificate for listing into the trade register, correspondingly a document for updated registration of the
p.(None): person under Art. 222, para 1;
p.(None): 3. copy of the issued authorisation for opening a pharmacy, as provided by the Act on the Medicines and Pharmacies in
p.(None): the Human Medicine
p.(None): 4. certified copy of the employment contract or a contract for assignment of management of the head of the pharmacy –
p.(None): in the cases, where such is required;
p.(None): 5. declaration of the persons under Art. 222, para 1, that the conditions have been met for issuing the authorisation
p.(None): for retail trade with medicinal products of the persons under para 2;
p.(None): 6. document for a single paid fee in the amount of BGN 100.
p.(None):
p.(None):
p.(None): § 67. The persons, who have filed by this Act comes into force application for re- registration as
p.(None): provided by the repealed § 16 of the Transitional and Final Provisions, who will perform their activity as provided by
p.(None): the requirements of this Act, shall file in the Ministry of Health within 3 months after its coming into force, the
p.(None): following documents:
p.(None): 1. application, according to a form, approved by the Minister of Health;
p.(None): 2.updated certificate for listing in the trade register, or a document for updated registration or a
p.(None): certified copy of a similar document according to the national legislation of an EU Member State or the legislation of
p.(None): another Member- State – party of the EEA, under Art. 222, para 1;
p.(None): 3. employment contract or a contract for management of the pharmacy, signed with a Master of Pharmacy of Assistant
p.(None): Pharmacist.
p.(None):
p.(None):
p.(None): § 68. (1) Master of Pharmacy of Assistant Pharmacist, who has received authorisation for opening a pharmacy, as
p.(None): provided by the repealed § 16 of the Transitional and Final Provisions may transfer the issued authorisation
p.(None): to a person under Art. 222, para 1.
p.(None): (2) For performing the transfer, the persons under para 1 shall file in the Ministry of Health an application, which
p.(None): shall contain:
p.(None): 1. an application for issuing authorisation for retail trade with medicinal products by the persons under Art. 222,
p.(None): para 1, according to a form, approved by the Minister of Health;
p.(None): 2. an updated certificate for listing in the trade register, or a document for updated registration of
p.(None): the persons under Art. 22, para 1;
p.(None): 3. copy of the issued, as provided by the Act on the Medicines and Pharmacies in the Human Medicine, authorisation for
p.(None): opening a pharmacy or authorisation for re-registration, as provided by the repealed § 16 of the Transitional and Final
p.(None): Provisions;
p.(None): 4. a certified copy of the employment contract or a contract for management of the head of the pharmacy;
p.(None): 5. a declaration of the persons under Art. 222, para 1 that the conditions, in which the authorisation for retail trade
p.(None): with medicinal products of the persons under para 1 have been met;
p.(None): (3) The transfer under para 1 may be done within the term of 1 year after this Act comes
p.(None):
p.(None): into force.
p.(None):
p.(None):
p.(None): § 69. The drugstores, status quo at the time of this Act’s coming into force shall continue to perform its activity on
...
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Searching for indicator vulnerable:
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p.(None): for the minor person.
p.(None): (6) The express will of the minor person to at any time withdraw from the clinical test must be taken into
p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
p.(None): contain contact details of an independent person for additional information.
p.(None):
p.(None): Section .
p.(None): Clinical Trials in Vulnerable Patient Groups
p.(None):
p.(None): Art. 100. A clinical test in minor or underage persons can be undertaken provided that:
p.(None): 1. the study protocol has been approved by the respective ethics committee after discussion of the
p.(None): clinical, moral, and psycho-social aspects of childhood age in which at least two paediatricians have participated;
p.(None): 2. there is an anticipated direct benefit of the clinical test for the patient group, which is to be included;
p.(None): 3. the study is directly associated with the clinical condition from which the minor or underage person is suffering;
p.(None): 4. the study medicinal product is designated for the diagnosis, treatment, or prophylaxis of diseases, which are
p.(None): specific for minor or underage persons;
p.(None): 5. the study is designated to be conducted in minor or underage persons;
p.(None):
p.(None): 6. the study purpose is to check data obtained in clinical trials in persons who are capable of giving
p.(None): informed consent or of data obtained by other research methods;
p.(None): 7. the results obtained from clinical trials in adults and the interpretation thereof cannot be considered also valid
p.(None): for minor or underage persons;
p.(None): 8. the study is planned in a manner that pain, inconvenience, fear, and other disease- associated foreseeable risks are
...
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): manufacture under the terms of this Act;
p.(None): 4. active and auxiliary substances;
p.(None): 5. medicinal products in the course of development and/or test;
p.(None): 6. medicinal products designated for export.
p.(None): 7. (new - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 21.12.2012) medicinal product
p.(None): for modern therapy, prepared for a certain patient upon an individual medical prescription, in reference to
p.(None): specific standards for quality and is applied in a medical institution to the explicit professional responsibility of
p.(None): the physician.
p.(None):
p.(None):
p.(None): Art. 8a (new – SG, 102/2012, in force from 21.12.2012) In manufacture of medicinal products, intended only for export,
p.(None): of intermediate products, active substances and of assisting substances , the relevant provisions of Chapter Five shall
p.(None): apply.
p.(None):
p.(None):
p.(None): Art. 9. (1) The treatment of a specific patient a medicinal product, which has not been authorised under the terms of
p.(None): chapter three, can be applied according to a special procedure for therapeutic establishment for hospital care under
p.(None): the terms and procedures as set out in an ordinance issued by the Minister of Health.
p.(None): (2) The manager of the healthcare establishment shall be responsible for the treatment according to para 1.
p.(None):
p.(None):
p.(None): Art. 10. (1) The Minister of Health can authorise for certain period of time treatment with a medicinal product which
p.(None): has not been authorised according to chapter three, by an order on the basis of reasoned proposal from chief state
p.(None): health inspector coordinated with the director Bulgarian Drug Agency (BDA) wherever there is a declared epidemic in the
p.(None): country caused by pathogenic microorganisms or toxins or there is suspected or confirmed dissemination of
p.(None): chemical agents or nuclear radiation and there is no suitable medicinal product authorised for use.
p.(None): (2) In the cases under para 1, the marketing authorisation holders, manufacturers, and medical specialists shall not
p.(None): bear civil or administrative and penal
p.(None): responsibility for the consequences of the use in an unauthorised indication of a medicinal product or of a
p.(None): medicinal product, which has not been authorised according to chapter three.
p.(None): (3) para 2 does not exclude the responsibility for defective products according to the Consumer Protection Act.
p.(None):
p.(None):
p.(None): Art. 11. (1) The Minister of Health may, due to reasons relating to the protection of the health of the population,
p.(None): instruct by way of order the Executive Director of the BDA to authorise the use of a medicinal product, which has not
p.(None): been authorised for use on the territory of the Republic of Bulgaria and for which no application for issuing
p.(None): of an authorisation has been submitted but which has been authorised in another Member State.
p.(None): (2) In the cases under para 1, the director of BDA, or his authorised representative shall:
p.(None): 1. inform the holder of the marketing authorisation for the medicinal product on the
p.(None):
p.(None): initiation of a procedure for the authorisation of the medicinal product for use;
p.(None): 2. register the person referred to in point 1 as a holder of the issued authorisation;
p.(None): 3. demand from the regulatory body of the Member State that has issued the marketing authorisation a copy of the
p.(None): assessment report and a copy of the marketing authorisation.
p.(None): (3) (suppl. – SG, 102/2012, in force from 21.12.2012) The Bulgarian Drug Agency shall be obliged to ensure
p.(None): compliance of the label, patient information leaflet, classification, advertising, and follow-up of the
p.(None): safety of the medicinal product released on the market according to Para. 1 with the requirements of this Act.
p.(None): The information on the packing and in the leaflet of the medicinal product under Para. 1 shall not be obligatorily in
p.(None): the Bulgarian language.
p.(None): (4) The Executive Director of BDA shall inform the European Commission about the authorisation issued according to para
p.(None): 1, the name and address of the authorisation holder, as well as about the date of termination of the validity thereof.
p.(None):
p.(None):
p.(None): Art. 12. (1) The official pharmacopoeia of the Republic of Bulgaria shall be the European Pharmacopoeia
p.(None): (2) The official pharmacopoeia may be supplemented with the requirements of the Bulgarian pharmacopoeia.
p.(None): (3) The Minister of Health shall determine by way of order the dates of entry into effect of the current edition of the
p.(None): official pharmacopoeia and the annexes thereof.
p.(None): (4) The order according to para 3 shall be promulgated in the State Gazette and published on the internet
p.(None): site of BDA.
p.(None):
p.(None):
p.(None): Art. 13. (1) The monographs of the European Pharmacopoeia shall be obligatory for all substances, preparations, and
p.(None): pharmaceutical forms contained therein. In the cases where there is no monographs in the European Pharmacopoeia, the
p.(None): requirements of the current editions of the pharmacopoeias of the Member States, the U.S.A, and Japan provided that
p.(None): these are in compliance with the general rules of the European Pharmacopoeia.
p.(None): (2) Where the specification contained in a monograph of the European Pharmacopoeia or other national pharmacopoeia
p.(None): is insufficient to ensure the quality of the substance or pharmaceutical form, the Bulgarian Drug
p.(None): Agency can require supplementation of the specification by the applicant/marketing authorisation holder.
p.(None):
p.(None): Chapter two.
p.(None): MANAGING AND FINANCING BODIES
p.(None):
p.(None): Section I. Managing Bodies
p.(None):
p.(None): Art. 14. (1) The medicinal product policy in the Republic of Bulgaria is part of the State health policy and is
p.(None): implemented by the Minister of Health.
p.(None): (2) The Minister of Health shall:
p.(None): 1. be the national coordinator for the problems of medicinal product;
p.(None): 2. take part in international bodies and organisations carrying out activities in the domain of the medicinal products;
p.(None): 3. (repealed – SG, 60/2011, in force from 05.08.2011 new – SG, 102/2012, in force from 21.12.2012) organize provision
p.(None): of public information to the patient organisations and to the
p.(None):
p.(None): consumers organisations about the actions, undertaken against falsification of medicinal products.
p.(None): 4. Carry out other activities set out by a law.
p.(None): When activities according para 2, point 3 carried out, the Ministry of Health collect taxes in amount, determined in
p.(None): tariff according to Art. 21, para 2.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None):
p.(None):
p.(None): Art. 15. (1) Pharmacopoeia Committee shall be established with the Minister of Health as a consulting body on issues
p.(None): relating to the current pharmacopoeia.
p.(None): (2) The Minister of Health shall, on the grounds of a proposal of the Executive Director of the BDA determine by an
p.(None): order the composition of the Pharmacopoeia Committee and the expert groups thereto and shall approve the regulation
p.(None): relating to their activity.
p.(None): (3) The activity of the Pharmacopoeia Committee shall be financed by the budget of the Ministry of Health.
p.(None):
p.(None):
p.(None): Art. 16. (1) Higher Council of Pharmacy shall be established to the Minister of Health as a consulting body on issues
p.(None): relating to pharmacy. It shall be composed by five representatives appointed by the Minister of Health, five
p.(None): representatives from Bulgarian Pharmaceutical Union, two representatives from National Health Insurance Fund (NHIF) and
p.(None): one representative from Faculty of pharmacy of the high medicinal schools. The Minister of Health is a chairman of the
p.(None): council without right of vote.
p.(None): (2) The Higher Council of Pharmacy is consultative body, which discuss and provide statements for:
p.(None): 1. Basic approaches and priorities in the pharmaceutical area;
p.(None): 2. Ethical problems of the pharmacy;
p.(None): 3. Projects for normative acts, related with the pharmacy;
p.(None): 4. The scientific priorities in the area of pharmacy;
p.(None): 5. Programs for organisation of social educational campaign in the area of medicinal products.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None): (4) The organisation and the activity of the Higher Council of Pharmacy are settled with ordinance issued by the
p.(None): Minister of Health, after proposal of Higher Council of Pharmacy.
p.(None):
p.(None):
p.(None): Art. 17. (1) The Bulgarian Drug Agency shall be a specialised body at the Minister of Health for the surveillance on
p.(None): the quality, safety, and efficacy of the medicinal products.
p.(None): (2) (amend. SG 15/13, in force from 01.01.2014) The Bulgarian Drug Agency shall be a legal entity budget financed with
p.(None): registered office in the city of Sofia with the Minister of Health.
p.(None): (3) The Bulgarian Drug Agency shall be managed and represented by an Executive Director who shall be appointed under
p.(None): the terms of the Administration Act.
p.(None): (4) The structure, functions, and work organisation of the Bulgarian Drug Agency shall be regulated by statutes adopted
p.(None): by the Council of Ministers.
p.(None): (5) The Bulgarian Drug Agency shall:
p.(None): 1. issue manufacture authorisation for medicinal products;
p.(None): 2. issue marketing authorisations and registration certificated for medicinal products;
p.(None): 3. issue authorisations for wholesale of medicinal products;
p.(None): 4. issue authorisations for parallel import of medicinal products;
p.(None):
p.(None): 5. (amend. – SG, 60/2011, in force from 05.08.2011), issue, refuse or terminate authorisations for retail
p.(None): trade with medicinal products;
p.(None): 5a (new – SG, 102/2012, in force from 21.12.2012) enters the producers, importers and wholesale traders with active
p.(None): substances;
p.(None): 5b (new – SG, 102/2012, in force from 21.12.2012) keeps register of the persons, carrying out
p.(None): intermediation activity in the area of the medicinal products;
p.(None): 6. issue authorisations to conduct clinical trials of medicinal products;
p.(None): 7. carry out assessment of the quality, efficacy, safety of medicinal products in relation with their marketing
p.(None): authorisations;
p.(None): 8. issue authorisations for the advertising of medicinal products;
p.(None): 9. exert control on the manufacture, import, storage, wholesale and retail trade, clinical trials, safety, and
p.(None): advertising of medicinal products;
p.(None): 10. carry out laboratory analysis in case of doubt of deviation in the quality, efficacy, and safety of the medicinal
p.(None): products and shall undertake the measures provided by law;
p.(None): 10a (new – SG, 102/2012, in force from 21.12.2012) carries out the functions of a competent body for
p.(None): vigilance medicinal safety;
p.(None): 11. (amend. - SG, 102/2012, in force from 21.12.2012) organize and maintain a system for vigilance the medicinal
p.(None): safety;
p.(None): 12. issue certificates according to the certification system of the World Health Organisation;
p.(None): 12a. (new – SG 18/14) issue certificates of Good Distribution Practice;
p.(None): 13. Issue Good Manufacturing Practice certificates;
p.(None): 14. (amend. – SG 18/14) consult investment projects for the construction of new and/or refurbishing of existing sites
p.(None): relating to the manufacture of medicinal products in accordance with the rules of Good Manufacturing Practice;
p.(None): 15. execute the functions of national coordinator and consulting body on the issues relating to the
p.(None): quality, efficacy, and safety of medicinal products;
p.(None): 16. carry out consulting, scientific, information, and publishing activity in the domain of the medicinal sector;
p.(None): 17. coordinate and participate in activities relating to the European Pharmacopoeia and the development of the
p.(None): Bulgarian Pharmacopoeia;
p.(None): 18. take part in activities in the field of the medicinal products relating to the work of the European Medicines
p.(None): Agency, the European Directorate of the Quality of the Medicinal Products and Healthcare, of international bodies and
p.(None): organisations, as well as relating to the fulfillment of international treaties in which Bulgaria is a party to;
p.(None): 18a (new – SG, 102/2012, in force from 21.12.2012) participate in the international harmonisation and
p.(None): standardisation of the technical measures, referring to vigilance the medicinal safety under the coordination of the
p.(None): European Medicines Agency;
p.(None): 18b (new – SG, 102/2012, in force from 21.12.2012) establish and maintain a national internet portal for medicinal
p.(None): products;
p.(None): 19. carry out other activities provided by a law.
p.(None): (6) (amend., - SG 98/10, in force from 01.01.2011) The Bulgarian Drug Agency coordinates its activity with
p.(None): the Regional health inspectorates (RHI) in the field of the control on the medicinal products.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The implementation of this act measures, related to
p.(None): prevention of entering and dissemination of falsified medicinal products shall be carried out in cooperation
p.(None): between the Bulgarian Drug Agency and the customs authorities.
p.(None):
p.(None): Art. 17a (New – SG, 60/2011, in force from 05.08. 2011) The Regional health inspectorates shall issue
p.(None): authorisations for registration of drug stores.
p.(None):
p.(None):
p.(None): Art. 17b. (new – SG 18/14) (1) Expert drug retail trade council shall be set up subordinated to the
p.(None): Managing Director of the BDA including three representatives of Bulgarian Pharmaceutical Association, one
p.(None): representative of every Pharmaceutical department of Higher Medicinal Schools and four representatives of the BDA. The
p.(None): members of the council shall be appointed by an order of the Managing Director of BDA agreed by the Minister of Health.
p.(None): (2) The council referred to in par. 1 is a consultancy unit, which shall:
p.(None): 1. issue opinions on the submitted to the BDA applications and documents under Art. 228, par. 1 and 5 which they are
p.(None): submitting to the Managing Director of BDA;
p.(None): 2. make justified proposals to the Minister of Health through the Managing Director of BDA for improvement of the
p.(None): access of individuals to drugs.
p.(None): (3) The organization and the activity of the expert council under par. 1 shall be regulated by regulations issued by
p.(None): the Managing Director of BDA upon council’s proposal.
p.(None): (4) The members of the expert council referred to in par. 1 shall not get paid for the participation in council
p.(None): meetings.
p.(None): (5) The expert council referred to in par. 1 shall report on their activity on an annual basis to the Minister of
p.(None): Health.
p.(None):
p.(None):
p.(None): Art. 17c. (new – SG 18/14) Cannot be members of the expert council referred to in Art.
p.(None): 17b, par.1 persons who are:
p.(None): 1. owners, members of managing and supervisory bodies of business companies or sole traders with a scope of business
p.(None): production, import, wholesale or retail trade with drugs;
p.(None): 2. partners or shareholders holding more than 5 per cent of the equity of business companies with a scope
p.(None): of business production, import, wholesale or retail trade with drugs or working under a full time employment agreement
p.(None): in such companies.
p.(None):
p.(None): Section II. Registers
p.(None):
p.(None): Art. 18. (Repealed - SG, 60/2011, in force from 05.08. 2011)
p.(None):
p.(None):
p.(None): Art. 19. (1) The Bulgarian Drug Agency shall keep registers of:
p.(None): 1. (amend. – SG, 102/2012, in force from 21.12.2012) manufacturers and importers of medicinal products on the territory
p.(None): of the Republic of Bulgaria and qualified persons according to Art. 148, point 2,and Art. 161, Para. 2, p. 1;
p.(None): 2. (amend. – SG, 102/2012, in force from 21.12.2012) the manufacturers, importers and the wholesale traders of active
p.(None): substances;
p.(None): 3. authorised/registered medicinal products on the territory of the Republic of Bulgaria;
p.(None): 4. wholesalers of medicinal products on the territory of the Republic of Bulgaria;
p.(None): 4a (new - SG, 102/2012, in force from 21.12.2012) the intermediation in the area of medicinal products;
p.(None): 5. (amend. - SG, 60/2011, in force from 05.08. 2011).the issued authorisations for retail
p.(None):
p.(None): trade with medicinal products;
p.(None): 6. authorised clinical trials;
p.(None): 7. issued authorisations for parallel import;
p.(None): 8. (new – SG 18/14) issued permits for the export of drugs subject to compliance with the provisions of Chapter Nine
p.(None): “b”.
p.(None): (2) The data of the registers according to Para. 1, points 1 to 5 and point 7 shall be published on the internet site
p.(None): of the Bulgarian Drug Agency.
p.(None): (3) The Bulgarian Drug Agency shall maintain systems for electronic data exchange with the regulatory bodies of
p.(None): other Member States, European Commission, and the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 19a. (New - SG, 60/2011, in force from 05.08. 2011) (1) The relevant Regional health inspectorates (RHI) shall
p.(None): keep and maintain public registers for the issued by them authorisations for registration of drug
p.(None): stores.
p.(None): (2) Within 7-day term from the issuance of an authorisation for registration of a drug store, the relevant RHI shall
p.(None): submit information to the Ministry of Health about the issued act.
p.(None): (3) The Ministry of Health shall keep and maintain on its internet site a public national register of the issued
p.(None): authorisations for registration of a drug store.
p.(None):
p.(None): Section III. Financing
p.(None):
p.(None): Art. 20. (1) The activity of the Bulgarian Drug Agency is financed from the budget funds and its own activity.
p.(None): (2) (amend. SG 15/13, in force from 01.01.2014) Budget funds shall be ensured by a subsidy from the state budget
p.(None): through the budget of the Ministry of Health.
p.(None):
p.(None):
p.(None): Art. 21. (1) The Bulgarian Drug Agency shall be the administrator of the revenues of its own activity, namely:
p.(None): 1. chemico-pharmaceutical examinations;
p.(None): 2. laboratory analyses and tests;
p.(None): 3. assessment of documentation and issue of authorisations, certificates, and other documents set forth in
p.(None): this Act;
p.(None): 4. evaluation by the renewal, variation and cease of marketing authorisation approval and certificate for registration
p.(None): of medicinal product;
p.(None): 5. maintenance of marketing authorisations of medicinal products;
p.(None): 6. fines and property sanctions imposed by penal ordinances issued for infringements of this Act;
p.(None): 7. consulting, publishing, and research activities in the field of the drug sector;
p.(None): 8. coordination of investment projects for the construction of new and/or refurbishing of existing sites relating to
p.(None): the manufacture of medicinal products;
p.(None): 9. conduct of inspections in connection with assessment of compliance of the manufacturing conditions with
p.(None): the requirements of Good Manufacturing Practice;
p.(None): 10 other sources.
p.(None): (2) During the execution of the activities according to para 1, points 1 – 5, points 7 – 9 the Bulgarian Drug Agency
p.(None): shall collect fees to the amounts as defined in a tariff adopted by the
p.(None):
p.(None): Council of Ministers.
p.(None): (3) (New - SG 71/2008, in force from 12.08.2008) The tariff under para 2 shall have determined lower and various in
p.(None): amount fees for realisation of the procedures on permission for usage, production and import of medicinal products for
p.(None): small and medium enterprises in the pharmaceutical sector in the meaning of the Small- and Medium-Size Enterprises Act.
p.(None):
p.(None):
p.(None): Art. 22. (1) The funds according to Art. 21 shall be spent for:
p.(None): 1. control activity of the BDA;
p.(None): 2. Payment of the activities according to Art. 21, Para. 1, p. 1 and 2, when The BDA is assigned their execution of
p.(None): another persons by contract;
p.(None): 3. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 4. establishment and maintenance and update of the registers according to Art. 19, Para.
p.(None): 1;
p.(None): 5. maintenance of systems for electronic data exchange with the regulatory bodies of
p.(None): the other Member States, with the European Commission, with and the European Medicines Agency;
p.(None): 6. (suppl. – SG, 102/2012, in force from 21.12.2012) information and publishing activities relating to the quality,
p.(None): efficacy, and safety of the medicinal products and vigilance medicinal safety;
p.(None): 7. provision of the activity of the specialised commissions according to Art. 47, Par. 1 and 2 and the council
p.(None): according to Art. 251, Para. 3;
p.(None): 8. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 9. participations in international and national inter-laboratory tests;
p.(None): 10. (amend. – SG. 60/2011, in force from 5. 8. 2011; revoked – SG 38/12, in force from 01.07.2012)
...
p.(None): by the executive director BDA to a natural or legal person established on the territory of a Member State or a state
p.(None): member of the European Economic Area.
p.(None): (2) Where the person according to para 1 is not established on the territory of the Republic of
p.(None): Bulgaria, it shall designate a representative.
p.(None): (3) The marketing authorisation holder takes responsibility for the medicinal products placed on the territory of the
p.(None): Republic of Bulgaria. The designation of a person according to para 2 shall not release the marketing authorisation
p.(None): holder from responsibility according to the acting legislation in Republic of Bulgaria.
p.(None):
p.(None): Section II.
p.(None): Requirements Relating to the Documentation for Granting a Marketing Authorisation
p.(None):
p.(None): Art. 27. (1) For granting a marketing authorisation of a medicinal product, the person
p.(None):
p.(None): according to Art. 26, para 1, shall submit to the BDA a formal application accompanied by a dossier in the format of
p.(None): the Common Technical Document, which shall contain:
p.(None): 1. name and address of management and/or permanent address of the applicant according to Art. 26, para 2;
p.(None): where the applicant is a person other than the manufacturer(s) – address of the manufacture sties;
p.(None): 2. name of the medicinal product;
p.(None): 3. qualitative and quantitative particulars of the medicinal product, including its international
p.(None): non-proprietary name (INN) recommended by the WHO, where an INN for the medicinal product exists, or the
p.(None): relevant chemical name;
p.(None): 4. therapeutic indications, contraindications and adverse drug reactions;
p.(None): 5. posology, pharmaceutical form, method and route of administration and expected shelf-life;
p.(None): 6. precautions and safety measures during storage of the medicinal product, its administration to patients
p.(None): and for the disposal of waste products together with an indication of potential risks for the environment;
p.(None): 7. description of the method of manufacture;
p.(None): 8. description of the control methods employed by the manufacturer;
p.(None): 8a (new – SG, 102/2012, in force from 02.01.2013) declaration, that the audit results under Art. 160, Para. 2,
p.(None): conducted by the manufacturer of the medicinal product confirm that the active substance has been produced in
p.(None): compliance with the principles and directives for good production practice; the declaration shall indicate the date on
p.(None): which the audit is conducted;
p.(None): 9. assessment of the potential risks presented by the medicinal product for the environment for every
p.(None): individual case and measures for the limitation thereof;
p.(None): 10. results of:
p.(None): a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.(None): b) preclinical (toxicological and pharmacological) tests;
p.(None): c) clinical trials;
p.(None): 11. declaration that the ethic principles of the Good Manufacturing Practice have been complied with in the clinical
p.(None): trials conducted outside the territory of the Member States;
p.(None): 12. (amend. – SG, 102/2012, in force from 21.12.2012) a summary of the system
p.(None): a) for vigilance the medicinal safety, which shall include the following elements:
...
p.(None): 1. change of the active substance(s):
p.(None): a. replacement of a chemical active substance by a different by a different salt/ester, complex/derivative, including
p.(None): the same therapeutic moiety, where the efficacy/safety characteristics are not significantly different.
p.(None): b. replacement by a different isomer, mixture of isomers, of a mixture by an isolated isomer (e.g. racemate with single
p.(None): enantiomer), where the efficacy/safety characteristics are not significantly different;
p.(None): c. replacement of a biological active substance with one of a slightly different molecular structure where the
p.(None): efficacy/safety characteristics are not significantly different, with the exception of changes to the active
p.(None): substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
p.(None):
p.(None): d. modification of the vector used to produce the antigen of the source material, including a new master cell bank from
p.(None): a different source, where the efficacy/safety characteristics are not significantly different;
p.(None): e. a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy/safety
p.(None): characteristics are not significantly different
p.(None): f. change to the extraction solvent of the ration of herbal drug to herbal drug preparation where the efficacy/safety
p.(None): characteristics are not significantly different.
p.(None): 2. Changes to strength, pharmaceutical form and route of administration:
p.(None): a. change of bioavailability;
p.(None): b. change of pharmacokinetics e.g. change in rate of release;
p.(None): c. change or addition of a new strength/potency;
p.(None): d. change or addition of a new pharmaceutical form; e.g. change or addition of a new route of administration– for
p.(None): parenteral application to differentiate between intraarterial, intravenous, intramuscular, subcutaneous and
p.(None): other routs of administration.
p.(None): (2) The application according to para 1 shall be accompanied by the documentation according to Art. 27, para 1, point
p.(None): 10, associated with variations according to para 1.
p.(None): (3) The requirements to the documentation according to para 2 shall be laid down in the regulation according to Art.
p.(None): 42.
p.(None): (4) The name of the medicinal product in the granted authorisation for enlargement of the scope of the initial
p.(None): marketing authorisation shall not be changed.
p.(None): (5) The granting of an authorisation for enlargement of the scope of a granted marketing authorisation of a medicinal
p.(None): product shall be performed under the conditions and under the terms of Art. 49 - 51.
p.(None):
p.(None):
p.(None): Art. 67. (1) The marketing authorisation holder of a medicinal product shall submit an application for granting a new
p.(None): marketing authorisation in case of:
p.(None): 1. addition or deletion of one or more active substances including antigenic components in case of vaccines;
p.(None): 2. change in the quality of the active substance indicated in the dossier, which essentially changes the safety and
...
p.(None): medicinal product; the information shall include the positive, as well as the negative results from the
p.(None): clinical tests or other researches of all indicators and populations, notwithstanding of the fact whether
p.(None): they are included in the use authorisation, as well as data for use of the medicinal product, where this use is
p.(None): outside the conditions of the use authorisation;
p.(None): 4. keep and update the information about the medicinal product with the current scientific knowledge, including the
p.(None): conclusions from the assessment and recommendations, published in the European internet portal for medicinal products,
p.(None): established under Art. 26 of Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 5. disseminate the medicinal product with the last approved short characteristic of the product and a leaflet for the
p.(None): patient.
p.(None): 6. (new – SG 18/14) inform BDA of every action undertaken by them, related to temporary suspension of
p.(None): offering on the market of a specific medicinal product, withdrawal from the market of a particular medicinal product,
p.(None): request for termination of a marketing authorisation or stated intention of non-renewal of the marketing authorisation,
p.(None): and also to indicate the reasons for which this action has been taken; in these cases the marketing authorisation
p.(None): holder declare whether the undertaken by them actions are due to any of the reasons under Art. 276 or Art. 277;
p.(None): 7. (new – SG 18/14) inform BDA, if the actions referred to in item 6 are undertaken in a third country and are due to
p.(None): any of the reasons referred to in Art. 276 or Art. 277;
p.(None): 8. (new – SG 18/14) inform European drug agency where the actions under items 6 and 7 are undertaken on the grounds of
p.(None): Art. 276 and 277;
p.(None): 9. (new – SG 18/14) provide sufficient quantities of medicinal products for satisfying the health care needs of the
p.(None): individuals in the Republic of Bulgaria.
p.(None): (2) The marketing authorisation/registration certificate holder shall be obliged to submit to the BDA upon request the
p.(None): following:
p.(None): 1. data in support of the positive benefit/risk ratio of the medicinal product;
p.(None): 2. (amend. – SG 18/14) information about the sales volume of the medicinal products and any other information available
p.(None): to the holder of the marketing authorisation regarding the medicinal prescriptions for the product;
p.(None): 3. a copy of the basic documentation of the vigilance system of the medicinal safety.
p.(None): (3) The marketing authorisation holder shall submit to BDA the documentation under Para. 2, p. 3 within 7 day term
p.(None): after receiving the request.
p.(None):
p.(None):
p.(None): Art. 69. (1) The marketing authorisation holder of a vaccine or immunological medicinal product designated for
p.(None): immunisation shall be obliged to submit to the BDA the following prior to the placing of any batch of the product on
p.(None): the market:
p.(None): 1. a sample of the finished product and/or a sample of the bulk/not finalised product;
p.(None): 2. protocols of the manufacturing and quality control;
p.(None): 3. document for paid fee as paid down in the tariff according to Art. 21, para 2.
p.(None): (2) The marketing authorisation holder of new immunological medicinal products or immunological medicinal
p.(None): products manufactured by new or altered technologies or by
p.(None):
...
p.(None): (2) The applicant shall submit to the European Medicines Agency the dossier of the medicinal product and the summary of
p.(None): product characteristics.
p.(None): (3) In the cases according to para 1, provided that the BDA has approved the assessment report, draft
p.(None): summary of product characteristics and packaging mock-up and package leaflet submitted by the Reference Member
p.(None): State, the executive director of the BDA may, upon a request of the applicant, grant a marketing authorisation of the
p.(None): medicinal product prior to the completion of the arbitrage procedure according to para 1.
p.(None): (4) After the accomplishment of the arbitrage procedure, the executive director of the BDA shall put the granted
p.(None): marketing authorisation according to para 3 into effect in compliance with the decision of the European Commission.
p.(None):
p.(None):
p.(None): Art. 79. (1) Where the regulatory authorities of one or several Member States have made different decisions with
p.(None): respect to the marketing authorisation of the same medicinal product or with respect to its temporary suspension
p.(None): or revocation, the BDA or the applicant/marketing authorisation holder may refer the issue to the
p.(None): Committee on Medicinal products in Human Medicine to the European Medicines Agency for application of the
p.(None): arbitrage procedure. The Applicant or the marketing authorisation holder may apply the question to the Committee for
p.(None): Human Medicinal Products at the European Evaluation Agency for applying arbitration procedure upon its
p.(None): evaluation.
p.(None): (2) (repealed – SG, 102/2012, in force from 21.12.2012)
p.(None): (3) (amend. – SG 18/14) Bulgarian drug agency shall apply the procedure of Chapter Eight, Section IV, where one of the
p.(None): measures referred to in Art. 194s, par. 2 and 3.
p.(None): (4) (new – SG 18/14) Notwithstanding the provision of par. 1 – 3, where urgent action for the protection of the public
p.(None): health is required at a certain stage of the arbitration procedure, BDA may suspend the effect of the marketing
p.(None): authorisation and to prohibit the use of the respective medicinal product in the Republic of Bulgaria until the
p.(None): adoption of the final decision.
p.(None): (5) (new- SG 18/14) In cases referred to in par. 4 BDA shall inform the European
p.(None):
p.(None): commission, the European Drug Agency and the other Member States of the reasons for their decision on the next work day
p.(None): at the latest.
p.(None):
p.(None):
p.(None): Art. 79a (New – SG, 60/2011, in force from 5. 8. 2011) Depending on the decision of the European Commission after
p.(None): finalisation of the arbitration procedure, the BDA within the term of 30 days from receiving the notification, shall:
p.(None): 1. issue, temporarily stop or terminate an authorisation for use, or
p.(None): 2. request amendments to be made in the issued authorisation for reaching compliance with the decision of the European
p.(None): Commission.
p.(None): (2) The BDA shall notify the European Commission and the European Agency on Medicines about the issued act
p.(None): under Para. 1.
p.(None):
p.(None):
p.(None): Art. 79b (new – SG, 102/2012, in force from 21.12.2012) (1) In the cases where interests of the EU have been
p.(None): affected and before decision taking for issuance of a marketing authorisation of a medicinal products, for
p.(None): its temporary termination, or its change, BDA, the applicant or the marketing authorisation holder may refer the
p.(None): issue to the Committee under Art. 79, Para. 1 for applying arbitration procedure.
p.(None): (2) In the cases under Para. 1, where the reference is as a result of a data assessment, related to vigilance of the
p.(None): medicinal safety of a medicinal product, permitted for use, the issue shall be referred to the committee under Art.
p.(None): 56a, Para. 1, p. 1 and the procedure under Art. 194x or 194y shall be applied.
p.(None): (3)Where undertaking of urgent actions are needed, the procedure of Chapter Eight, Section V shall be applied.
p.(None):
p.(None):
p.(None): Art. 80. (amend. – SG 12/11, in force from 08.02.2011) Terms and procedure for effecting variations to
...
p.(None): (4) The provisions of para 1 and 2 shall not apply provided that the protocol of the clinical test or the researcher’s
p.(None): brochure explicitly states that there is no requirement for an urgent report of a specific serious adverse event.
p.(None): (5) The researcher shall report to the contracting authority any adverse events or laboratory aberrations,
p.(None): which are defined in the study protocol as critical with respect to safety, within the timelines and format as required
p.(None): by the protocol.
p.(None):
p.(None):
p.(None): Art. 136. Where the outcome of an adverse event during the conduct of a clinical test is death, the researcher shall
p.(None): be obliged to submit to the contracting authority and the ethics committees any information requested
p.(None): additionally.
p.(None):
p.(None): Art. 137. The contracting authority shall keep detailed records of any serious adverse events provided to him by the
p.(None): researchers and shall present these upon request to the BDA or the regulatory bodies of the Member States where
p.(None): the clinical test is conducted in case of multicentre clinical test.
p.(None):
p.(None):
p.(None): Art. 138. (1) The contracting authority shall notify the BDA, the regulatory bodies of all Member States where the
p.(None): clinical test is conducted in case of a multicentre test, and the respective ethics committee of any
p.(None): suspected serious adverse drug reaction occurring in the course of the clinical test, which has resulted in death or
p.(None): has been life-threatening not later than 7 days of receipt of information thereof.
p.(None): (2) The contracting authority shall provide the bodies according to para 1 with additional information on the case
p.(None): within 8 days of the date of the notification sent.
p.(None): (3) The contracting authority shall notify the bodies according to para 1 of any other suspected unexpected serious
p.(None): drug reactions occurring in the course of the clinical test, which are different from those set out in para 1, not
p.(None): later than 15 days from the date of receipt of the information for their occurrence.
p.(None):
p.(None):
p.(None): Art. 139. (1) The contracting authority can fulfil his obligations according to Art. 138, para 1 and 3, by entering his
p.(None): reports in the European adverse drug reactions database.
p.(None): (2) Where the clinical test is also conducted in countries outside the Member States and the European Economic Area,
p.(None): the contracting authority shall enter his reports of suspected unexpected serious adverse drug reactions in
p.(None): the European adverse drug reactions database.
p.(None): (3) (amend. – SG, 102/2012, in force from 21.12.2012) The format and content of the reports for adverse drug reactions
p.(None): shall be determined by the regulation according to Art. 82, Para. 3.
p.(None): (4) The contracting authority shall inform the researchers conducting a clinical test with medicinal product about any
p.(None): suspected unexpected serious adverse drug reaction associated with the study medicinal product irrespective of its
p.(None): origin.
p.(None):
p.(None):
p.(None): Art. 140. (1) The contracting authority shall submit to the BDA and the respective ethics committee a list of all
p.(None): suspected serious adverse drug reactions occurring during the past period and a report about the safety of the study
p.(None): subjects once yearly.
p.(None): (2) (amend. – SG, 102/2012, in force from 21.12.2012) The format and content of the reports for adverse drug reactions
p.(None): shall be determined by the regulation according to Art. 82, Para. 3.
p.(None):
p.(None):
p.(None): Art. 141. (1) The BDA shall document any information about suspected unexpected serious adverse drug
p.(None): reactions of the study medicinal products provided under the terms of Art. 138, para 1 and 3.
p.(None): (2) The BDA shall immediately enter the information according to para 1 in the European adverse drug reactions
p.(None): database.
p.(None):
p.(None): Section V.
p.(None): Notification of Clinical Test Closure
p.(None):
p.(None): Art. 142. (1) The contracting authority shall notify in writing the BDA and the respective ethics committee of the
p.(None): closure of the clinical test on the territory of the Republic of Bulgaria.
p.(None): (2) The notification shall be submitted within 90 days of the closure of the clinical test in a format as defined by
p.(None): the regulation according to Art. 82, para 3.
p.(None): (3) Provided that nothing is otherwise stipulated in the protocol as approved by the respective ethics
p.(None): committee, the last subject visit shall be considered as end of study.
p.(None): (4) Where the study is prematurely terminated, the contracting authority shall notify the BDA and the respective ethics
p.(None): committee within 15 days of taking such decision providing the reasons thereof.
p.(None):
p.(None):
p.(None): Art. 143. The contracting authority shall submit a final report of the clinical test to the BDA and the respective
p.(None): ethics committee.
p.(None):
p.(None):
p.(None): Art. 144. (1) The BDA shall enter data of any clinical test conducted on the territory of the Republic of Bulgaria in
p.(None): the European clinical trials database: application submitted, ethics committee decision, authorisation, essential
p.(None): amendments, end of study, and data of any audit conducted.
...
p.(None):
p.(None): Art. 171. (1) Depending on the method of dispensing, the medicinal products shall be classified as follows:
p.(None): 1. medicinal products dispensed on medical prescription;
p.(None): 2. medicinal products dispensed without medical prescription.
p.(None): (2) The dispensing regime of a medicinal product shall be determined by the BDA in the marketing
p.(None): authorisation/registration certificate.
p.(None): (3) The person according to Art. 26, para 1, shall indicate the dispensing regime of a medicinal product in the
p.(None): application for marketing authorisation/registration certificate, variation of the marketing authorisation or its
p.(None): renewal.
p.(None):
p.(None):
p.(None): Art. 172. The medicinal products according to Art. 171, para 1, point 1, shall be divided in the following categories:
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
p.(None): 2. medicinal products, which are frequently and very widely administered in a wrong manner and as a result of that can
p.(None): represent a threat for the people’s health;
p.(None): 3. medicinal products containing substances the activity and/or adverse drug reactions of which require subsequent
p.(None): additional study;
p.(None): 4. medicinal products, which are usually prescribed by a physician for potential administration.
p.(None):
p.(None):
p.(None): Art. 174. Medicinal products shall be subject to special medical prescription wherever
p.(None):
p.(None): these meet one of the following conditions:
p.(None): 1. contain narcotic substances within the meaning of the Control on Drugs and Precursors Act in admissible
p.(None): for use quantities;
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
p.(None): 3. contain new medicinal substances the characteristics of which are not sufficiently known and therefore these
p.(None): can be assigned to the group of medicinal products according to point 2.
p.(None):
p.(None):
p.(None): Art. 175. Medicinal products shall be subject to limited medical prescription wherever these meet one of the following
p.(None): conditions:
p.(None): 1. are limited to administration in hospital conditions only due to limited experience with their use or in the
p.(None): interest of public health;
p.(None): 2. are intended for treatment of pathological conditions, which can only be diagnosed in therapeutic establishments,
p.(None): irrespective that their administration and follow-up in the course of treatment can be carried out in other healthcare
p.(None): establishments;
p.(None): 3. are intended for treatment of out-patients but their use can cause serious adverse drug reactions, which can require
p.(None): specialist prescribing and monitoring in the course of treatment.
p.(None):
p.(None):
p.(None): Art. 176. (1) The BDA can refuse to approve the dispensing regime of a medicinal product requested by the
p.(None): applicant according to Art. 26, para 1, on the grounds of assessment of:
p.(None): 1. the maximum single dose, maximum daily dose, quantity of the active substance in one dose unit, pharmaceutical
p.(None): form, specific appearance of the primary product packaging, and/or
p.(None): 2. other specific conditions of use.
p.(None): (2) The BDA can refuse to indicate the exact category of a medicinal product according to Art. 172 but pursuant to the
p.(None): criteria according to Art. 174 and Art. 175 shall determine whether a medicinal product shall be classified as a
p.(None): product dispensed only on medical prescription.
p.(None):
p.(None):
p.(None): Art. 177. Medicinal products, which do not meet the requirements according to Art. 173, 174, and 175 and the criteria
p.(None): laid down in the regulation according to Art. 178, shall be dispensed without medical prescription.
p.(None):
p.(None):
p.(None): Art. 178. The criteria for classification of medicinal products and the requirements to the documentation for changing
p.(None): the classification shall be determines by a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 179. (1) The BDA shall draw and publish on its internet site a list of the medicinal products, which shall be
p.(None): dispensed on the territory of the Republic of Bulgaria on medical prescription.
p.(None): (2) The list according to para 1 shall be updated annually.
p.(None):
...
p.(None): pharmaco-vigilance for implementation of the obligations under this Chapter.
p.(None): (2) The system under Para. 1 shall be used for collecting information about the risks of medicinal products for the
p.(None): patients’ health and for public health. The information shall cover reports for unwilling medicinal reactions in use of
p.(None): a medicinal product in compliance with the confirmed short characteristics, as well as information for misuse
p.(None): and use, which is not in compliance with the confirmed short characteristics of the product, including
p.(None): information for unwilling medicinal reactions, observed while fulfilling professional duties.
p.(None): (3) The BDA shall valid the process and classify the information under Para. 2, make scientific analysis of the
p.(None): collected data in view to an assessment of the possibilities for decreasing and preventing the risk and shall
p.(None): undertake the needed actions in relation to permit for use of the medicinal product.
p.(None): (4) The BDA shall carry out audits of the system under Para. 1 and every 2 years shall submit to the European
p.(None): Commission a report with the results from them.
p.(None): (5) The BDA shall apply an adequate and effective quality system in order to provide compliance of the system under
p.(None): Para. 1 with the requirements of this act. The minimal requirements for the quality system shall be
p.(None): determined by Implementation Regulation (EU) N 520/2012.
p.(None):
p.(None):
p.(None): Art. 184. (amend. – SG, 102/2012, in force from 21.12.2012) (1) Medical specialists shall be obliged to immediately
p.(None): report to the marketing authorisation holder or to the BDA any suspected serious or unexpected adverse drug
p.(None): reaction and to provide upon request additional information from the vigilance of the case.
p.(None): (2) The patients may report adverse medicinal reactions at any time to the medical
p.(None):
p.(None): specialists or to BDA.
p.(None): (3) In the cases under Para. 1 and 2 where the report refers to biological medicinal product, prescribed, disseminated
p.(None): or sold on the territory of the Republic of Bulgaria, it must be clearly identified by the reporter with its trade name
p.(None): and lot number or this information is provided during the additional vigilance.
p.(None):
p.(None):
p.(None): Art. 185. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall maintain national internet portal for
p.(None): medicinal products, connected to the European internet portal for medicinal products under Art. 68, Para. 1, p. 4.
p.(None): (2) The BDA shall provide through the portal under Para. 1 at least the following information:
p.(None): 1. the public assessment reports under Art. 53, Para. 2 and their summaries;
p.(None): 2. the short characteristics of the products and the leaflets;
p.(None): 3. summary of the risk management plans of the medicinal products, permitted for use on the territory of the Republic
p.(None): of Bulgaria;
p.(None): 4. standard forms for reporting of suspected adverse reactions by medical specialists and patients, drawn up with
p.(None): compliance with the requirements of Art. 25 of Regulation (EC) N 726/2004 of the European Parliament and of the
p.(None): Council;
p.(None): 5. updated list of the medicinal products under Art. 23 of Regulation (EC) N 726/2004 of the European Parliament and of
p.(None): the Council;
...
p.(None): 1. adopt as decision for change, termination or interruption of the marketing authorisations,
p.(None): issue under Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 2. adopt decision with a recommendation for change, termination or interruption of the marketing authorisations, issued
p.(None): by the relevant Member States regulatory bodies.
p.(None): (3) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 2, p. 2.
p.(None):
p.(None): Section IV.
p.(None): Urgent Procedure at European Union Level. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 194t. (new – SG, 102/2012, in force from 21.12.2012) (1) Urgent procedure at the level of the European Union may
p.(None): be initiated by the European Commission, by the European Medicines Agency or by a Member State.
p.(None): (2) (amend. – SG 18/14) The BDA shall initiate an urgent procedure under this section by notification of the regulatory
p.(None): bodies of the other Member States, the European Medicines Agency and the European Commission where upon
p.(None): considerations, related with pharmaco- vigilance considers, that for a certain medicinal product, placed on the
p.(None): Bulgarian market, one of the following measures are needed to be undertaken:
p.(None): 1. termination or interruption of the marketing authorisation;
p.(None): 2. prohibition of distribution of the medicinal product;
p.(None): 3. issuing a refusal for renewing the marketing authorisation.
p.(None): (3) (amend. – SG 18/14) The BDA shall initiate the procedure under Para. 2 where they are advised by the marketing
p.(None): authorisation holder that, for reasons related to tracing of drug safety, they terminate the distribution of the
p.(None): medicinal product or they have undertaken or they intend to undertake actions for its withdrawal from the market, or
p.(None): will not undertake actions for the renewal of the issued marketing authorisation.
p.(None): (4) (amend. – SG 18/14) The BDA may initiate the procedure under par. 2 in the cases where they consider that for
p.(None): reasons, related to tracing of drug safety, regarding a particular medicinal product new counter-indications may be
p.(None): added or the recommended dose should be reduced, or the indications shall be limited.
p.(None): (5) (amend. – SG 18/14) The BDA shall submit to the European Medicines Agency and to the regulatory authorities of the
p.(None): other Member States the entire scientific information, available to them, as well as the performed data assessment and
p.(None): the justifications for the initiation of the procedure pursuant to the provisions of this section.
p.(None): (6) (amend. – SG 18/14) In the cases referred to par. 2 - 4 the European Medicines Agency shall notify the BDA of the
p.(None): initiation of the procedure, where the concerns regarding safety are related also to other medicinal products,
p.(None): belonging to one and the same therapeutic group or contain the same active substance with the product, indicated in the
p.(None): information under
p.(None):
p.(None): par. 5 or where this medicinal product is permitted for use also in other Member States.
p.(None): (7) (amend. – SG 18/14) In the cases under Para. 4, where no urgent measures are required, BDA shall apply the
p.(None): procedure under Art. 77 or Art. 79b.
p.(None): (8) (new – SG 18/14) BDA shall inform the marketing authorisation holder of the initiation of the procedure under the
p.(None): provisions of this section.
p.(None):
p.(None):
p.(None): Art. 194u. (new – SG, 102/2-12, in force from 21.12.2012) (1) In the cases under Art. 194s, Para. 2, where BDA
p.(None): considers, that urgent measures are needed to be undertaken for protection of public health, BDA may temporary to
...
p.(None):
p.(None): shall be published on the internet site of the BDA.
p.(None): (6) The parallel import authorisation shall be valid for 5 years. New authorisation shall be issued under the terms of
p.(None): Art. 215.
p.(None): (7) The parallel import authorisation shall not be automatically cancelled where the marketing authorisation
p.(None): holder of the medicinal product launched on the market on the territory of the Republic of Bulgaria would withdraw it
p.(None): for reasons, which are not associated with a threat for the health of the population.
p.(None):
p.(None):
p.(None): Art. 217. The parallel import authorisation holder shall be obliged to:
p.(None): 1. notify the marketing authorisation holder of the medicinal product launched on the territory of the Republic of
p.(None): Bulgaria of his intention to effect parallel import and provide a sample of the parallel imported medicinal product
p.(None): upon request;
p.(None): 2. keep the following information for 5 years: name and address of the person whom the parallel imported medicinal
p.(None): product is to be delivered to, date of delivery, delivered quantity, and batch number;
p.(None): 3. submit in BDA:
p.(None): a) actualised patient’s leaflet of parallel imported product according with the variations in issued marketing
p.(None): authorisation of the approved medicinal product in Republic of Bulgaria;
p.(None): b)(Amen. - SG 71/2008, in force from 12.08.2008) declaration that the content of the leaflet according to letter "a"
p.(None): shall be identical with the content of the product leaflet, approved in Republic of Bulgaria except of the data
p.(None): according to Art. 215, para 2, point 7, letters "a" – "d";
p.(None): 4. document and report to the marketing authorisation holder and the BDA all reports of adverse drug reactions of the
p.(None): imported medicinal product.
p.(None):
p.(None): Chapter nine.
p.(None): "B" EXPORT OF MEDICINAL PRODUCTS (NEW – SG 18/14)
p.(None):
p.(None): Art. 217a. (new – SG 18/14) (1) Export of medicinal products from the territory of the Republic of Bulgaria may be done
p.(None): by a natural person or a legal entity holding a permit for wholesale with medicinal products or by a holder of a
p.(None): production license.
p.(None): (2) Holders of a production license may carry out export only of the medicinal products manufactured by them.
p.(None): (3) Within the meaning of this Chapter, export shall also be an intra-Community supply within the European Union.
p.(None): (4) Export of medicinal products included in the Positive Medicines List referred to in Art. 262, par. 1 from the
p.(None): territory of the Republic of Bulgaria shall take place upon notification of BDA in every individual case, where the
p.(None): export is being carried out by the holder of a permit for wholesale of drugs.
p.(None):
p.(None):
p.(None): Art. 217b. (new – SG 18/14) The notification referred to in Art. 217a, par. 4 shall be send to the Managing Director of
p.(None): BDA and shall contain the following information:
p.(None): 1. name and registered address of the person under Art. 217a, par. 1;
p.(None): 2. name, pharmaceutical form and active substance quantity in a dose unit of the medicinal product
p.(None): intended for export;
p.(None): 3. reference number of the permit for wholesale of medicinal products;
p.(None): 4. number of packages of the medicinal product intended for export;
p.(None):
p.(None): 5. the state of destination of the export.
p.(None):
p.(None):
...
p.(None): medicinal products under Art. 228, Para. 5, may make a change under Art. 230, Para. 1, p. 4 only in a populated place
p.(None): with population up to 10 000 citizens.
p.(None): (4) (New – SG, 60/2011, in force from 5. 8. 2011) Where the person under Para. 3 wishes to make a change under Art.
p.(None): 230, Para. 1, p. 4 in a populated place with population up to 10 000 citizens, he/she shall pay the charge for issuance
p.(None): an authorisation for retail trade with medicinal products in a pharmacy, determined by the tariff under Art. 21, Para.
p.(None): 2.
p.(None): (5) (Former Para. 2, - SG, 60/2011, in force from 5. 8. 2011) at issuing the authorisation allowing the change
p.(None): according to para 1, the provisions in Art. 229 shall be applied.
p.(None):
p.(None):
p.(None): Art. 232. (1) Physicians and physicians in dental medicine can keep medicinal products
p.(None):
p.(None): according to a list determined by the Minister of Health.
p.(None): (2) Where there is no pharmacy in a settlement, the persons according to para 1 can only keep and sell medicinal
p.(None): products provided that they have received authorisation therefore according to an order laid down in a regulation of
p.(None): the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 233. The manager of the pharmacy takes the responsibility for the activities according to Art. 219,
p.(None): para 1.
p.(None):
p.(None):
p.(None): Art. 234. (1) Prohibited shall be the sale of medicinal products through automatic machines except for
p.(None): the medicinal products indicated in a list determined to the regulation according to Art. 219, para 2.
p.(None): (2) The automatic machines according to para 1 can be possession only on the persons according to Art. 222 and Art.
p.(None): 238, para 2.
p.(None): (3) The bargain trade with drug products shall be prohibited
p.(None): (4) The sale of medicinal products dispensed on medical prescription via internet shall be prohibited.
p.(None): (5) (New – SG, 60/2011, in force from 5. 8. 2011) Medicinal products without doctor’s prescription may be sold on
p.(None): internet only by a pharmacy or drug store, which have received authorisation under the terms and conditions of this Act
p.(None): and the ordinance under Art. 219, Para. 2, or Art. 243.
p.(None): (6) (new – SG, 102/2012, in force from 02.01.2013) The pharmacies and drug stores under Para. 5 shall publish on the
p.(None): internet site, which is for their trade with medicinal products without doctor’s prescription a general logo,
p.(None): recognizable for the whole EU.
p.(None): (7) (new – SG, 102/2012, in force from 02.01.2013) The requirements to the general logo under Para. 6 shall be
p.(None): determined by a delegated act under Art. 85c, Para. 3 of Directive 2001/83/EC.
p.(None):
p.(None):
p.(None): Art. 234a (new – SG, 102/2012, in force from 02.01.2013) (1) The BDA shall publish and maintain on its internet site:
p.(None): 1. information about the national legislation, applicable for offering medicinal products for sale on internet,
p.(None): including information about the fact, that there may exist differences between the Member States in relation to the
p.(None): classification of the medicinal products and of the conditions for their delivery;
p.(None): 2. information about the purpose of the general logo;
p.(None): 3. list of the persons, offering medicinal products for sale on internet, as well as the addresses of their internet
p.(None): sites;
p.(None): 4. general information about the risks, related to the medicinal products, delivered to the consumers via internet in
p.(None): violation of the ordinance under Art. 234, Para. 5.
p.(None): (2) The BDA internet site under Para. 1 shall be connected with the internet site of the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 234b (new – SG, 102/2012, in force from 02.01.2013) The BDA shall participate in information campaigns, organised
p.(None): by the European Commission and the European Medicines Agency about the danger of falsified medicinal products.
p.(None):
p.(None): Art. 235. (1) The authorisation to carry out retail trade with medicinal products shall be cancelled with the
p.(None): termination of the activity of the persons according to Art. 222.
...
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 238, Para. 1;
p.(None): 2. education document and certificate of clean court record or the person appointed as manager of the drugstore;
p.(None): 3. medical certificate of the person according to point 2;
p.(None): 4. (repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 5. (amend., - SG 98/10, in force from 01.01.2011, repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 6. document for paid state fee to the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011).Within 14 day term from receiving the application under Para. 2,
p.(None): RHI shall perform an inspection on the observation of the requirements of the Ordinance under Art. 243.
p.(None): In the cases, where it is found that the requirements of the Ordinance under Art. 243 have not been observed,
p.(None): within 7 day term after the inspection the RHI shall give instructions and shall determine term for removing them.
p.(None): (4) (New – SG, 60/2011, in force from 5. 8. 2011). Within 14 day term from receiving the application and the
p.(None): documents under Para. 2, the director of RHI shall notify in writing the persons for finding irregularities
p.(None): in them and shall determine a term for their removal.
p.(None): (5) (New – SG, 60/2011, in force from 5. 8. 2011). For submitting a registration application for a drug
p.(None): store or for performing a change under Art. 242, the relevant RHI shall collect charges in the amount, determined by
p.(None): the tariff under Art. 21, Para. 2.
p.(None):
p.(None):
p.(None): Art. 240 (Amend. - SG, 60/2011, in force from 5. 8. 2011). Within 14 day term after the inspection under Art. 239,
p.(None): Para. 3 or after removing the irregularities under Art. 239, Para. 4, the director of the RDA shall issue a
p.(None): registration certificate for a drug store or shall give a grounded refusal for its issuance.
p.(None): (2) (new – SG, 102. 2012, in force from 2.1.2013) The director of the RDA shall provide grounded refusal to issue a
p.(None): registration certificate to the persons under Art. 238, Para. 2, where:
p.(None): 1. some of the documents under Art. 239, Para. 2 has not been produced;
p.(None): 2. within the term under Art. 239, Para. 4 the applicant has not removed the found incompleteness.
p.(None): (3) (new – SG, 102. 2012, in force from 21.12.2012) Where within the term under Para. 1 the RDA director has not issued
p.(None): a registration certificate of drug store or has not refused with a ground, it shall be accepted that there is a silent
p.(None): agreement.
p.(None): (4) (new – SG, 102. 2012, in force from 21.12.2012) IN the cases under Para. 3, the applicant may begin carrying out
p.(None): the actions, applied for while observing Art. 29 of the Act on Restriction of the Administrative Regulation and
p.(None): Administration Control on Economic Activity.
p.(None): (5) (former Para. 2 – SG, 102. 2012, in force from 21.12.2012) The refusal of the executive director of
p.(None): the RDA under Para. 1, to issue certificate of registration shall be subject to appeal under the terms of the
p.(None): Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 240a (new - SG, 102. 2012, in force from 21.12.2012) (1) The RDA director shall
p.(None):
p.(None): terminate by an order the registration of a drug store:
p.(None): 1. upon request of the persons, received a registration certificate for a drug store;
p.(None): 2. with termination of the person’s activity under Art. 238, Para. 2, for which he/she shall notify the relevant RDA.
p.(None): (2) Within 14-day term from termination of the activity under Para. 1, p. 2, the person under Art. 238, Para. 2 shall
p.(None): notify in writing the RDA.
p.(None):
p.(None):
p.(None): Art. 241. (1) (Amend. - SG, 60/2011, in force from 5. 8. 2011) The relevant RHI shall keep a record of the issued
p.(None): certificates for a drugstore authorisation, which shall contain:
p.(None): 1. number and date of the issued certificate;
p.(None): 2. place of business and address of management of the persons who have received certificates for registration of
p.(None): drugstore;
p.(None): 3. name, personal data, and address of the manager of the drugstore;
p.(None): 4. address of the drugstore;
p.(None): 5. date of cancelling the registration and reason therefore;
p.(None): 6. remarks relating to the inscribed circumstances.
p.(None): (2) (Amend. - SG, 60/2011, in force from 5. 8. 2011) Data of the register shall be published on the
p.(None): internet site of the relevant RHI.
p.(None):
p.(None):
p.(None): Art. 241a. (New - SG, 60/2011, in force from 5. 8. 2011) The National register of the issued registration certificates
p.(None): of a drug store under Art. 19a, Para. 3 shall contain:
p.(None): 1. name of the relevant RHI, issued the registration certificate;
p.(None): 2. number and date of the issued certificate;
p.(None): 3. seat and address of the persons, received the registration certificate for a drug store;
p.(None): 4. name of the drug store manager;
p.(None): 5. address of the drug store;
p.(None): 6. date of termination of the registration and ground for that.
p.(None):
p.(None):
p.(None): Art. 242. In case of change of the address of the drugstore of the manager, the person who has received the
p.(None): authorisation to open the pharmacy shall submit an application under the terms of Art. 239, para 2, and documents
p.(None): associated with the change.
p.(None):
p.(None):
p.(None): Art. 243. The conditions and order for the organisation of work in a drugstore shall be paid down in a regulation of
p.(None): the Minister of Health.
p.(None):
p.(None): Chapter eleven.
p.(None): ADVERTISING MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 244. (1) Advertising of medicinal products shall be any form of information, provision, promotion, or offers aimed
p.(None): at stimulating the prescribing, sale, or use of a medicinal product and shall include:
p.(None): 1. advertising intended for the population;
p.(None): 2. advertising, intended for medical specialists;
p.(None): 3. visit of a medical trade representative with medical specialists;
p.(None):
p.(None): 4. provision of samples to medicinal products;
p.(None): 5. sponsorship of promotional meetings and scientific congresses visited by medical specialists including taking
p.(None): their travel and stay expenses in the respective country where the event is taking place.
p.(None): (2) The following shall not be considered advertising of medicinal products:
p.(None): 1. text on the secondary packaging and in the patient information leaflet, which has been approved in the procedure for
p.(None): marketing authorisation;
p.(None): 2. correspondence on the occasion of a specific issue or problems associated with a given medicinal product;
p.(None): 3. informative announcements and instructions as to changes in the packaging, warnings for adverse drug
p.(None): reactions as a part of the overall safety measures for the medicinal product, trade catalogues and pricelists provided
p.(None): that these do not contain data of advertising character with respect to the medicinal product;
p.(None): 4. statements relating to human health or diseases provided that when these do not directly or indirectly bear on
p.(None): treatment, prophylaxis, or diagnostics with medicinal products;
p.(None): 5. campaigns carried out by the Ministry of Health for vaccination of the population where the associated materials do
p.(None): not contain data for a specific medicinal product.
p.(None):
p.(None):
p.(None): Art. 245. (1) The marketing authorisation holder shall be obliged to establish a scientific unit for the
p.(None): proliferation of information fir the medicinal products for which he has received marketing authorisation
p.(None): under the terms of this Act.
p.(None): (2) The marketing authorisation holder shall be obliged to:
p.(None): 1. guarantee that the advertising of a medicinal product is presented to the population and medical specialists in an
p.(None): appearance corresponding to the requirements of this chapter and in compliance with the advertising authorisation
p.(None): issued by the BDA;
p.(None): 2. have at his disposal data and materials of all advertising campaigns undertaken within the framework of his activity
p.(None): including information about the groups, which the advertising is intended for, about the method of its realisation, as
p.(None): well as the starting date of the advertising campaign;
p.(None): 3. guarantee the training of the medical trade representatives;
p.(None): 4. accurately and timely fulfil the instructions of the persons responsible for the control of advertising.
p.(None): (3) The medical trade representatives must report to the scientific units according to para 1 any information about the
p.(None): use of the advertised medicinal products, particularly with respect of the information of adverse drug reactions
p.(None): communicated to them by the medical specialists.
p.(None):
p.(None):
p.(None): Art. 245a. (New – SG. 71/2008, in force from 12. 08. 2008) Advertisement shall be admitted only of
p.(None): medicinal products, for which an authorisation has been issued under this Act.
p.(None):
p.(None):
p.(None): Art. 246. (1) The content of the advertising must comply with the data of the approved during the marketing
p.(None): authorisation procedure summary of product characteristics and only present the indications approved therein.
p.(None): (2) Advertising of a medicinal product must only bear on its correct use by objectively presenting the therapeutic
p.(None): indications of the medicinal product without exaggerating its therapeutic, prophylactic, and diagnostic
p.(None): capacities.
p.(None): (3) The advertising must not contain misleading information.
p.(None):
p.(None): (4) (New – SG. 71/2008, in force from 12.08.2008) The advertisement shall not contain proposal and/or promise for a
p.(None): gift and/or another property or non-property benefit.
p.(None): (5) (New – SG. 71/2008, in force from 12.08.2008) A medical specialist or a person, representing himself/herself as
p.(None): a medical specialist shall not perform direct or indirect advertisement of medicinal products in the printed
p.(None): and/or electronic media, as well as in internet.
p.(None):
p.(None):
p.(None): Art. 247. Advertising to the population shall only be allowed for medicinal products dispensed without
p.(None): medical prescription.
p.(None):
p.(None):
p.(None): Art. 248. Besides the cases according to Art. 247, advertising campaigns carried out by marketing authorisation
...
p.(None): control shall be exercised by officials – inspectors and experts appointed by orders of the Council
p.(None): chairpersons under Art. 258, Para. 1 and of the director of the BDA or the director of corresponding RHI depending on
p.(None): their subjection.
p.(None): (4) For the execution of their control functions, the bodies according to Para. 1 can request the
p.(None): assistance of the bodies of the Ministry of Interior.
p.(None):
p.(None):
p.(None): Art. 267a (New – SG, 60/2011, in force from 5. 8. 2011, amend. - SG 102/2012, in force from 21.12.2012) The Executive
p.(None): Agency Medical Audit shall perform control for observation of the confirmed phrmaco-therapeutic guides and performing
p.(None): evaluation of the effectiveness of the therapy in compliance with the criteria under art. 259, Para. 1, p. 4.
p.(None):
p.(None):
p.(None): Art. 268. (1) The BDA shall exercise control on:
p.(None): 1. (suppl. - SG 102/2012, in force from 21.12.2012)the compliance of the premises, equipment, and conditions
p.(None): for manufacture, control, storage, and trade in medicinal products and active substances and for the observation of the
p.(None): Good Manufacturing Practice for medicinal products and the Good Distribution Practice;
p.(None): 2. (amend. - SG 102/2012, in force from 21.12.2012) the activity of the manufacturers, importers, marketing
p.(None): authorisation holders, manufacturers, importers, wholesalers of medicinal products, and active substances of
p.(None): intermediaries in the area of medicinal products, pharmacies, and drugstores;
p.(None): 3. the quality, safety, and efficacy of the medicinal products;
p.(None): 4. the clinical trials with medicinal products and the control of the observation of the requirements of the Good
p.(None): Clinical Practice;
p.(None): 5. drug information associated with marketing and advertising authorisation;
p.(None): 6. (amend. - SG 102/2012, in force from 21.12.2012) the pharmaco-vigilance system of the marketing authorisation
p.(None): holders and for observation of the requirements of the Good practice for pharmaco-vigilance.
p.(None):
p.(None): (2) (amend., - SG 98/10, in force from 01.01.2011) The regional health inspectorates shall exercise control over the
p.(None): premises, equipment, and conditions for storage of and trade in medicinal products, as well as over the activity of the
p.(None): wholesalers, pharmacies, and drugstores situated on the territory of the respective region.
p.(None): (3) Investment projects for construction of new and/or refurbishment of existing sites associated with the manufacture
p.(None): of medicinal products in compliance with the rules for Good Manufacturing Practice of medicinal products shall be
p.(None): coordinated with the BDA.
p.(None):
p.(None):
p.(None): Art. 268a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) Donations of medicinal products from holders authorisation
p.(None): for use, producers, wholesale and retail traders and from the Bulgarian red cross may be done only after coordination
p.(None): of the donator with the BDA through producing an application according to a form, confirmed by the Minister of Health
p.(None): upon proposal of the executive director of BDA.
p.(None): (2) The donations shall be done while observing the rules for Good donation practice of the World Health Organisation.
p.(None): (3) Where within 10 day term from receiving the application under Para. 1, BDA fails to respond in writing to the
p.(None): donator, it shall be accepted, that there is a silent agreement for the donation.
p.(None): (4) The medical establishments and the Bulgarian red cross shall inform BDA for the received donations of medicinal
...
p.(None): Art. 274. (1) The conditions and order for blocking and recall of medicinal products, which have shown
p.(None): discrepancies with the requirements to quality, efficacy, and safety shall be paid down in a regulation of the Minister
p.(None): of Health.
p.(None): (2) The conditions and order for destruction, reprocessing, and otherwise use of medicinal products shall be
p.(None): paid down in a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 275. (1) During exercising control, the BDA shall undertake all necessary measures to ensure correct validation of
p.(None): the processes of manufacture and purification of the medicinal products obtained from human blood or human
p.(None): plasma, consistency of batch quality, and guaranteeing the absence of specific viral contamination in so far as
p.(None): technology allows.
p.(None): (2) Manufacturers shall notify the BDA of the method used for decreasing or elimination of pathogenic viruses, which
p.(None): can be transmitted through medicinal products obtained from
p.(None):
p.(None): human blood or human plasma.
p.(None): (3) The BDA shall test or forward to another official laboratory for control of medicinal products in Republic of
p.(None): Bulgaria or another Member State samples of bulk product and/or medicinal product for a test or in the
p.(None): course of assessment of an application for marketing authorisation according to Art. 46, para 1, point 2, or
p.(None): after issuing a marketing authorisation.
p.(None):
p.(None):
p.(None): Art. 276. The executive director of the BDA shall temporarily stop, bereave, or amend by an order the marketing
p.(None): authorisation of a medicinal product or its registration where it shall be established that:
p.(None): 1. there is an inadmissible adverse drug reaction during correct use or
p.(None): 2. there is lack of therapeutic efficacy (lack of therapeutic shall be where it has been established that the
p.(None): declared therapeutic results cannot be achieved at its marketing authorisation), or
p.(None): 3. the benefit/risk ratio is unfavourable during correct use, or
p.(None): 4. the quantitative and qualitative composition of a medicinal product does not comply with that declared at the
p.(None): marketing authorisation, or
p.(None): 5. the data in the dossier according to Art. 27 - 32 are untrue, or
p.(None): 6. (Amen. - SG 71/2008, in force from 12.08.2008) the data in the dossier according to Art. 27 - 32 have not been
p.(None): supplemented of amended in compliance with the requirements of Chapter Three, Section six, or
p.(None): 6a (new – SG, 102/2012, in force from 21.12.2012) the conditions under Art. 55a or 56a are not fulfilled, or
p.(None): 6b (new – SG, 102/2012, in force from 21.12.2012) the manufacture of the medicinal product has not been carried out in
p.(None): compliance with the described way of manufacture under Art. 27, Para. 1, p. 7, or
p.(None): 7. (amend. – SG, 102/2012, in force from 21.12.2012) the control tests are not conducted or they have not been
p.(None): conducted in compliance with the methods laid down in Art. 27, Para. 1,
p.(None): p. 8, or
p.(None): 8. the data on the packaging and/or leaflet is not in compliance with those approved at the issuing of the marketing
p.(None): authorisation.
p.(None): 9. (New - SG 71/2008, in force from 12.08.2008) the owner of the authorisation for use has not fulfilled the
p.(None): obligations under Art. 45, para 1 of Regulation (EC) N 1901/2006.
p.(None):
p.(None):
p.(None): Art. 277. (1) The executive director of the BDA irrespective of the measures according to Art. 276, shall prohibit by
p.(None): an order the supply with the medicinal product and shall order its blocking and recall from the market where:
p.(None): 1. (amend. – SG, 102/2012, in force from 21.12.2012) there is an inadmissible adverse drug reaction or
p.(None): 2. there is lack of therapeutic efficacy, or
p.(None): 3. (amend. – SG, 102/2012, in force from 21.12.2012) the benefit/risk ratio is unfavourable, or
p.(None): 4. the quantitative and qualitative composition of a medicinal product does not comply with that declared at the
p.(None): marketing authorisation, or
p.(None): 5. the control of the medicinal product and/or its ingredients and on the intermediate stages of the manufacturing
p.(None): process has not been done or the requirements under which the manufacture authorisation ahs been granted are not met.
p.(None): (2) The executive director of the BDA can also impose a ban according to para 1 on
p.(None):
p.(None): concrete batches of a medicinal product.
p.(None):
p.(None):
p.(None): Art. 278. (1) The executive director of the BDA shall, by an order, temporarily stop or bereave the marketing
p.(None): authorisation of a group of or all medicinal products, for which the requirements as regards the place
p.(None): manufacture for which the manufacturing authorisation has been granted are not met.
p.(None): (2) The executive director of the BDA besides the measures according to Art. 276, can, by an order, temporarily
p.(None): stop the import of a group of or all medicinal products from third countries or bereave the issued import
p.(None): authorisation for a group of or all medicinal products where these do not comply with the requirements of chapter five.
p.(None): (3) The executive director of the BDA besides the measures according to Art. 276, can, by an order, temporarily stop or
p.(None): bereave the manufacturing authorisation for a group of or all medicinal products, which are not in compliance with the
p.(None): requirements of chapter five.
p.(None):
p.(None):
...
p.(None): out export of medicinal products under Art. 217a, par. 4 shall be punished with a fine, respectively with a proprietary
p.(None): sanction from BGN50 000 to BGN100 000, and in case of repeated the same violation – from BGN100 000 to BGN200 000.
p.(None):
p.(None):
p.(None): Art. 286. (1) In case of clinical trials conducted in infringement of this Act, provided no crime has been committed,
p.(None): the guilty persons shall be penalised with a fine from BGN 5,000 to BGN 10000 and in case of repeated permission or
p.(None): commitment of the same infringement – with a fine from BGN 10000 to BGN 20000.
p.(None): (2) Medial specialists who have permitted or committed infringements according to para 1 can be imposed the penalty of
p.(None): "deprived of the right to exercise the profession" for a term from 6 months to two years.
p.(None): (3) The measure according to para 2 shall be imposed by the Minister of Health according to a proposal by
p.(None): the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 287. (1) (Supl.. - SG 71/2008 in force from 12.08.2008, amend. – SG, 60/2011, in force from 5. 8. 2011)
p.(None): Whoever conducts retail trade in medicinal products without having respective authorisation/certificate, or
p.(None): works in violation of his/her issued authorisation/certificate, shall be penalised by a fine from BGN 5,000 to BGN
p.(None): 10,000.
p.(None): (2) The penalty according to para 1 shall also be imposed on persons who conduct retail trade in pharmacy or drugstore
p.(None): after the authorisation/certificate has ceased to be in effect.
p.(None): (3) (Supl. - SG 71/2008 in force from 12.08.2008, amend. – SG, 60/2011, in force from
p.(None):
p.(None): 5. 8. 2011) Whoever sells, or stores in a drug store medicinal products, prescribed by doctor’s prescription, or
p.(None): products or goods of human health significance, outside the ones, determined in the ordinance under Art. 243,
p.(None): shall be punished by the fine under para 1, and in repeated perpetration of the infringement the issued
p.(None): registration of the drug store will be deprived of.
p.(None): (4) In the cases according to para 1 and 2, the bodies of the state control on the medicinal products
p.(None): shall stop the operation of the site by an order.
p.(None): (5) The order according to para 4 shall be subject to appeal under the terms of the Administrative Procedure Code;
p.(None): however, the appeal shall not stop its execution.
p.(None): (6) (Repealed - SG 71/2008 in force from 12.08.2008).
p.(None):
p.(None):
p.(None): Art. 287a. (New - SG 71/2008 in force from 12.08.2008). (1) Medical specialist, who works with persons,
p.(None): performing retail trade with medicinal products, without having authorisation/certificate for this, shall
p.(None): be punished by a fine of BGN 2500 to 5000
p.(None): (2) The punishment under para 1 shall be imposed on a person under para 1, who works in a pharmacy or a drugstore after
p.(None): termination of the action of the authorisation/certificate.
p.(None): (3)In case of established more than 2 violations under para 1 and 2, the Minister of Health may deprive the medical
p.(None): specialist of the right to exercise his/her profession for the term of up to 2 years.
p.(None):
p.(None):
p.(None): Art. 287b. (new – SG, 102/2012, in force from 02.01.2013) Anyone, who carries out trade with medicinal products on
p.(None): internet in violation of this act and the ordinance under Art. 234, Para. 5 shall be punished by a fine of BGN 5000 to
p.(None): 10 000.
p.(None):
p.(None):
p.(None): Art. 288. (1) A retailer in medicinal products who has permitted an incapable person to exercise activities, pointed
p.(None): out in Art. 219, shall be penalised with a property sanction from BGN 5,000 to BGN 10,000 and in case of repeated
...
p.(None): the triple amount of the stipulated maximum amounts of the respective fines.
p.(None): (2) (suppl. – SG 60.12, in force from 07.08.2012) For infringements according to Art. 289, para 1 the property
p.(None): sanction shall be the nine-fold amount of the overdrawn amount provided that it exceeds the maximum amount of
p.(None): the sanction according to para 1.
p.(None): (3) The imposing of a property sanction shall not exclude fining of the guilty officials.
p.(None): (4) The imposing of property sanctions shall not exclude the imposing of the stipulated measures regarding the right of
p.(None): the medical specialists and qualified persons.
p.(None):
p.(None):
p.(None): Art. 292. (1) Whoever shall not execute an order, directions, or instruction of the bodies of the state control, except
p.(None): in the cases pursuant to Art. 270, para 1, issue 2 and para 3 shall be penalised with a fine from BGN 1,500 to BGN
p.(None): 3,000.
p.(None): (2) For failure to execute an order, pursuant Art. 270, para 1, issue 2 and 3, the blamed persons shall be penalised
p.(None): with a fine of from BGN 500 to BGN1000.
p.(None):
p.(None):
p.(None): Art. 293. (1) (amend. – SG, 102/2012, in force from 02.01.2013)In cases according Art. 281, Para. 1-3, Art. 283, Para.
p.(None): 1, as and of non-observance of the condition under which the authorisations to retail trade with medicinal products in
p.(None): a pharmacy, the BDA executive director shall issue an order for the bereavement thereof.
p.(None): (2) In case of non-observance of the conditions under which the
p.(None): authorisations/certificates for registration of a drug store as well as in the cases under 287, Para. 3, the director
p.(None): of the BDA shall issue an order for the bereavement thereof.
p.(None): (3) In case of non-observance of the obligation to notify according to Art. 204, Para. 3, for the termination of the
p.(None): activity on the part of a wholesaler of medicinal products, the executive director of the BDA shall issue an order for
p.(None): the bereavement the issued authorisation.
p.(None): (4) (amend. – SG, 102/2012, in force from 02.01. 2013) In case of non-observance of the obligation to notify according
p.(None): to Art. 235, Para. 3, for the termination of the activity on the part of a holder of an authorisation to retail trade
p.(None): with medicinal products, the BDA executive director shall issue an order for bereavement of the issued authorisation.
p.(None): (5) The orders according to Para. 1 - 4 shall be subject to appeal under the terms of the Administrative Procedure
p.(None): Code, however, the appeal shall not stop their execution.
p.(None):
p.(None): Art. 294. Whoever infringes the provisions of this Act or the regulations for its implementation, except
p.(None): for the cases according to Art. 281-293, shall be penalised with a fine from BGN 1,000 to BGN 3,000 and in case of
p.(None): repeated perpetration of the same infringement – with a fine from BGN 3,000 to BGN 5,000.
p.(None):
p.(None):
p.(None): Art. 295. (1) (amend., - SG 98/10, in force from 01.01.2011) The infringements according to this Act shall be
p.(None): established by virtue of deeds drawn up by state inspectors of the BDA or of the RHI.
p.(None): (2) The infringements according to Art. 289 shall only be established by officials appointed by the
p.(None): Minister of Health.
p.(None): (3) (amend., - SG 98/10, in force from 01.01.2011) The penal ordinances shall be issued by the Minister of Health, the
...
p.(None): market in the European Union as a medicinal product but is different with respect to safety and efficacy from
p.(None): a formerly authorised substance;
p.(None): c) biological substance, which has been authorised to market in the European Union as a medicinal product but has
p.(None): different molecular structure, different origin with respect to the starting material, or has been obtained
p.(None): through a different manufacturing process;
p.(None): d) radiopharmaceutical substance the radionuclides or molecular bonds (ligands) of which have not been
p.(None): authorised in the European Union as a medicinal product or the mechanism of bonding in a couple of the molecules
p.(None): and radionuclides has not been authorised in the European Union.
p.(None): 40. "Adverse event" shall mean any untoward unfavorable change the health condition observed during the administration
p.(None): of a medicinal product in a patient or a clinical test subject and which has not necessarily a causal relationship with
p.(None): this treatment.
p.(None): 41. (amend. – SG, 102/2012, in force from 21.12.2012) "Adverse drug reaction" shall mean any untoward and unpredicted
p.(None): response to a medicinal product. In case of a clinical test
p.(None): – any untoward and unpredicted response to a study medicinal product irrespective of the administered
p.(None): dose. The types of adverse reactions shall be:
p.(None): a) "unexpected" – an adverse drug reaction, which has not been mentioned in the summary of product
p.(None): characteristics of the character, severity, and outcome of which do not comply with those mentioned in the
p.(None): summary of product characteristics. In case of a clinical test
p.(None): – an adverse drug reaction the character, severity, and outcome of which do not comply with the information for the
p.(None): study medicinal product mentioned in the researcher’s brochure;
p.(None): b) "suspected" – and adverse drug reaction fore which the reporter or the marketing authorisation holder supposes that
p.(None): there is a possible causal relationship with a taken medicinal product;
p.(None): c) "serious" – any unfavorable effect on the health condition, which has become the reason for a lethal outcome,
p.(None): immediate threat to life, hospitalisation, or prolongation if hospitalisation, significant or durable injury,
p.(None): disability, and innate anomalies;
p.(None): d) combination of reactions according to subsections "a", "b", and "c".
p.(None): 42. "Common name" shall mean the international non-proprietary name (INN) of a medicinal substance or
p.(None): excipient recommended by the World Health Organisation; if not any, the name in the European Pharmacopoeia shall be
p.(None): used; if there is no such name there, another pharmacopoeia name shall be used; if there is no pharmacopoeia name, the
p.(None): common name shall be used.
p.(None): 42a (new – SG, 102/2012, in force from 21.12.2012) "Basic documentation of a system of pharmaco-vigilance" is a detail
p.(None): description of the pharmaco-vigilance system, used by the marketing authorisation holder in relation or one or more
p.(None): authorised for use medicinal products.
p.(None): 42b. (new - SG48/15) "Health technology assessment" shall mesn:
p.(None): a) a form of policy on research that examines the short- and long-term outcomes related to the implementation of
p.(None): health technologies and aims to provide information concerning alternative health strategies;
p.(None): b) multidisciplinary activity that systematically evaluates technical specifications, safety, clinical efficacy and
...
p.(None): ratio.
p.(None): 70. "Urgent limitation safety measures" shall mean temporary changes in the product information with respect of one
p.(None): or more parts of the summary of product characteristics, indications, method of administration,
p.(None): contraindications, and warnings, which result from new information associated with the safe use of a medicinal product.
p.(None): 71. "Spontaneous report" shall mean a voluntarily report for a suspected adverse reaction during the use of
p.(None): a medicinal product forwarded to the marketing authorisation holder, to the bodies for supervision on the medicinal
p.(None): products, or to other organisations, which is not originating from a study or another organised system for data
p.(None): capturing.
p.(None): 72. "Expiry period of a medicinal product" shall mean the interval of time during which, if a medicinal product is
p.(None): stored under the prescribed conditions, it shall comply with the specification developed on the grounds of
p.(None): stability tests of several batches of the finished form.
p.(None): 73. (Amen. - SG 71/2008, in force from 12.08.2008) "Medicinal product equivalent to a herbal medicinal product"
p.(None): shall mean a product containing the same active substances irrespective of the composition of the excipients
p.(None): and which is intended for the same purpose, has equivalent quantity of the medicinal substance, the same dosage and the
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
...
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
p.(None): 91 (new – SG, 102/2012, in force from 21.12.2012) "Delegated act" is an act in the meaning of Art. 290 of the Treaty on
p.(None): the European Union.
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
p.(None):
p.(None): § 3. The Council of Ministers shall determine the conditions and order for the supply, storage and renewal of the
p.(None): medicinal products kept in the State Agency "State Reserve and War-time Reserves".
p.(None):
p.(None):
p.(None): § 4. (suppl. – SG 18/14) This Act shall implement the provisions of Directive 2001/83/EC of the European Parliament
p.(None): and the Council on the Community code relating to medicinal products for human use subsequently amended
p.(None): by Directive 2004/27/EC of the European Parliament and the Council and of Directive 2012/26/EU of the European
p.(None): Parliament and of the Council of 25 October 2012.
p.(None):
p.(None):
p.(None): § 5. The data protection periods for reference medicinal products shall be applied according to the
p.(None): provisions of Art. 89 of Regulation (EC) № 726/2004 of the European Parliament and the Council and Art. 2 of Directive
p.(None): 2004/27/EC of the European Parliament and the Council
p.(None):
p.(None):
p.(None): § 5a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG, 102/2012, in force from 21.12.2012) The Ministry
p.(None): of Health, the National Council on prices and reimbursement of medicinal products, the BDA and the Regional health
p.(None): inspectorates shall provide opportunity for giving information and accepting applications and documents under this Act
p.(None): electronically under the terms and conditions of the Electronic Document and Electronic Signature Act and
p.(None): the Electronic Government Act.
p.(None): (2) Providing information and accepting applications and documents in electronic way
p.(None):
p.(None): shall be done after providing the relevant technical and organisation conditions, as well as the relevant programme
p.(None): products.
...
p.(None): 15 days from their receiving.
p.(None): (2) The BDA shall check the fulfillment of the obligation under Para. 1.
p.(None): (3) Where the notification refers a serious reverse medicinal reaction, occurred on the territory of a third state, the
p.(None): marketing authorisation holders within the term under Para. 1 shall notify the European Medicines Agency.
p.(None):
p.(None):
p.(None): § 126. (1) The marketing authorisation holders shall submit to BDA periodic updated safety reports in compliance with
p.(None): the time intervals under Art. 194k, Para. 3 for the medicinal products, which have issued marketing authorisations
p.(None): before 21 June 2012 and for which the frequency and the dates a of submitting the periodic updated safety
p.(None): reports have not been entered as conditions in the marketing authorisations.
p.(None): (2) The provision of Para. 1 shall apply by determination of another frequency or other dates for submitting the
p.(None): reports in the marketing authorisation or by determining dates and frequency under Art. 194l-194n.
p.(None):
p.(None):
p.(None): § 127. (1) The marketing authorisation holders shall provide periodic updated safety reports under Art. 194h, Para. 1
p.(None): in the register under Art. 194h, Para. 3 after expiry of 12 months from the date on which the European Medicines Agency
p.(None): announces its functioning.
p.(None): (2) By the time the term under Para. 1 comes, the marketing authorisation holders shall produce periodic updated safety
p.(None): reports to BDA and to the regulatory bodies if the other Member States, in which the relevant medicinal products is
p.(None): permitted for use.
p.(None):
p.(None):
p.(None): § 128. The wholesale trade authorisation/certificate holders of medicinal products in a pharmacy or drug store under
p.(None): Art. 234, Para. 5 shall place on the internet site the logo under Art. 234, Para. 6 within the term of up to 1 year
p.(None): from the date of publication of the act under Art. 85a, Para. 3 of Directive 2001/83/EC.
p.(None):
p.(None):
p.(None): § 129. The BDA shall carry out the first audit of the system under Art. 183, Para. 1 and shall submit to the European
p.(None): Commission a report with the results from it by 21, September 2013 latest.
p.(None):
p.(None):
p.(None): § 130. (1) By 20 March 2013 the initiated and not finalised procedures before the Commission on Prices
p.(None): and Reimbursement shall be finalised by it under the current procedure.
p.(None): (2) After 1 April 2013 not finalised procedure before the Commission on Prices and Reimbursement shall be
p.(None): finalised by the National council on prices and reimbursement of medicinal products under the terms and
p.(None): procedure of this act.
p.(None): (3) Within the term of up to 31 March 2013 the Commission on Prices and
p.(None):
p.(None): Reimbursement shall produce to the National council on prices and reimbursement of medicinal products by a record
p.(None): protocol the applications and documents, submitted for the procedures under Para. 1 as well as the archive of the
p.(None): finalised procedures.
p.(None): (4) Within the term of up to 31 March 2013 Commission on Prices and Reimbursement shall produce to the National council
p.(None): on prices and reimbursement of medicinal products by a record protocol the kept registers by the Commission.
p.(None):
p.(None):
p.(None): § 131. (1) By 20 March 2013 the fees for submitting an application for confirmation of process / limit prices,
p.(None): registration of process of medicinal products, for inclusion, exclusion or changes of medicinal products in the
...
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p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011, repealed – SG, 102/2012, in force from 21.12.2012)
p.(None): (3) (repealed – SG, 102/2012, in force from 21.12.2012) (4) (repealed – SG, 102/2012, in force from 21.12.2012) (5)
p.(None): (repealed – SG, 102/2012, in force from 21.12.2012) (6) (repealed – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None):
p.(None): Art. 145a. (new - SG, 102/2012, in force from 21.12.2012) (1) Non-interventional pos- marketing safety studies shall be
p.(None): conducted upon initiative of the marketing authorisation holder or in fulfillment of the conditions of Art. 55a and 56a
p.(None): and are related to data collection of medicinal safety by patiednt and medical specialists.
p.(None):
p.(None): (2) Where with the study, collection of data is planned by patients, their consent must be received. The personal
p.(None): data of the patients shall be processed while observing the requirements of the Act on Personal Data
p.(None): Protection.
p.(None): (3) The medical specialists shall not receive financial or other benefits for participation in the non-interventional
p.(None): safety studies, unless compensations for the spent time and means.
p.(None):
p.(None):
p.(None): Art. 145b. (new – SG, 102/2012, in force from 21.12.2012) (1) During the study under Art. 145c, Para. 1 and Art. 145f,
p.(None): Para. 1 the holder of the marketing authorisation shall carry out monitoring of the obtained data and shall account for
p.(None): their impact over the correlation benefit- risk for the medicinal product.
p.(None): (2) The marketing authorisation holder shall announce to BDA about each new information, which could
p.(None): influence the correlation benefit-risk for the medicinal product.
p.(None): (3) The obligation under Para. 2 shall not liberate the marketing authorisation holder from the requirements of Art.
p.(None): 194h for providing the information under Para. 2 and through the periodic updated safety reports.
p.(None):
p.(None):
p.(None): Art. 145c. (new – SG, 102/2012, in force from 21.12.2012) (1) Where the study is conducted only on the
p.(None): territory of the Republic of Bulgaria in implementation of the obligation under Art. 56a, the holder of the marketing
p.(None): authorisation shall produce a draft protocol of the study to BDA. The draft protocol, with a written consent
p.(None): under Art. 145a, Para. 2 shall be produced also to the commissions under Art. 103, Para. 1 or 2, where
p.(None): applicable.
p.(None): (2) The BDA executive director, within the term of up to 60 days from the date of receiving the
p.(None): documentation under Para. 1, the marketing authorisation holder shall submit a notification of the study or shall give
p.(None): a grounded refusal.
p.(None): (3) The BDA executive director shall refuse conducting of the study with one or more of the grounds under Art. 145f,
p.(None): Para. 2, p. 2.
p.(None): (4) The commission under Art. 103, Para. 1 or the commissions under Art. 103, Para. 2 within the term of up to 60 days
p.(None): from the date of receiving the documentation under Para. 1 shall submit to the marketing authorisation holder a
p.(None): positive or negative opinion.
p.(None): (5) Conducting of the study may start after receiving approval by BDA and a positive opinion by the commission under
...
p.(None): (5) The expenses for performing the inspection under Para. 3, p. 2 shall be on the account of the
p.(None): applicant.
p.(None): (6) For the inspection under Para. 3, p. 2 the applicant shall pay a fee in the amount, determined by the tariff under
p.(None): Art. 21, Para. 2.
p.(None): (7) In the cases under Para. 3, p. 1 and Para. 4 the applicant may start to carry out his/her activity after
p.(None): registering in the register under Art. 167d.
p.(None):
p.(None):
p.(None): Art. 167c. (new – SG, 102/2012, in force from 02.01.2013) Where within the term under Art. 167b, Para. 3 BDA fails to
p.(None): notify, that an inspection will be carried out, the applicant may start carrying out the activity.
p.(None):
p.(None):
p.(None): Art. 167d. (new – SG, 102/2012, in force from 02.01.2013) (1) The BDA shall keep a public register of the importers,
p.(None): manufacturers and wholesale traders with active substances, which shall contain:
p.(None): 1. name management address of the person under Art. 167a;
p.(None): 2. list of the active substances to be imported, manufactured or traded;
p.(None): 3. the activities, which the person under Art. 167a will carry out;
p.(None): 4. 4. Premise address in which the activities will be carried out;
p.(None): 5. 5. Notes on the entered circumstances.
p.(None): (2) The BDA shall enter in the data base under Art. 147 the information about the registered importers,
p.(None): manufacturers and wholesale traders of active substances.
p.(None):
p.(None):
p.(None): Art. 167e. (new – SG, 102/2012, in force from 02.01.2013) (1) The person under Art. 167a shall submit to BDA yearly by
p.(None): 31 January a notification about changes in the information, entered in the register under Art. 167d.
p.(None): (2) In case of changes, which may influence the quality or safety of the active substances, which are manufactured,
p.(None): imported or disseminated, the person under Art. 167a shall notify the
p.(None):
p.(None): BDA immediately
p.(None):
p.(None):
p.(None): Art. 167f. (1) (new – SG, 102/2012, in force from 02.01.2013) The manufacture, import and wholesale trade of active
p.(None): substances on the territory of the Republic of Bulgaria, including active substances, intended for export, shall
p.(None): be carried out in compliance with the Good manufacturing practice and the Good dissemination practices for
p.(None): active substances.
p.(None): (2) The importers may import active substances only if the following conditions have been observed:
p.(None): 1. the active substances are manufactured in compliance with standards for Good manufacturing practice,
p.(None): which are at least equivalent to the ones, established in the European Union and
p.(None): 2. (in force from 02.07.2013) the active substances are accompanied by a written confirmation by the
p.(None): competent body of the state-importer, that:
p.(None): a) the standards for good manufacturing practice, applicable to the object for manufacture of the
p.(None): exported active substances are at least equivalent to the ones, established by the European Union;
p.(None): b) The relevant object for manufacture shall be subject to a regular control and in it effectively is applied the
p.(None): Good manufacturing practice, where this includes multiple and immediate inspections in view to guaranteeing
p.(None): protection of the public health, at least equal to the one in the European Union, and
...
p.(None): and which is intended for the same purpose, has equivalent quantity of the medicinal substance, the same dosage and the
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
...
p.(None): to BDA within the term of up to 2. March 2013 an application and entry documents under Art. 167b.
p.(None): (2)The manufacturers and importers, who have manufactured or imported active substances on the basis of their
p.(None): issued authorisations for manufacture/import by 2 January 2013, shall not pay fee for their entry into the register
p.(None): under Art. 167.
p.(None): (3) By 2 March 2013 the persons under Para. 2 shall carry out activities of manufacture and import of active
p.(None): substances, based on their issued authorisations for manufacture/import.
p.(None):
p.(None):
p.(None): § 120. Persons, who carry out intermediation in the area of medicinal products and have started their activity
p.(None): before 2 January 2013, shall be registered under the conditions and procedure of Art. 212a within the term of
p.(None): up to 2 March 2013.
p.(None):
p.(None):
p.(None): § 121. The started marketing authorisation procedures by the enforcement of this act shall be finalised under the terms
p.(None): and procedure, provided by it.
p.(None):
p.(None):
p.(None): § 122. (1) The marketing authorisations holders shall not apply a system for risk management under Art.
p.(None): 192, Para. 1, p. 2 for medicinal products, who have been issued marketing authorisations before 21, July
p.(None): 2012, apart from the cases under Para. 2.
p.(None): (2) The BDA may impose obligations of the marketing authorisation holder to establish and apply a risk management
p.(None): system, where he/she considers, that for a certain medicinal products there are suspects, which may influence
p.(None): the benefit/risk ratio. In this case BDA shall require from the marketing authorisation holder to produce a
p.(None): detailed description of the risk management system, which he/she intends to introduce for the relevant medicinal
p.(None): product.
p.(None): (3) In the cases under Para. 2, BDA shall notify in writing the marketing authorisation holder by pointing out the
p.(None): motives for imposing the obligation and the term for producing a detailed description of the risk management
p.(None): system.
p.(None): (4) Within 30-day term after receiving the notification under Para. 3, the marketing authorisation holder
p.(None): may request from BDA providing an opportunity for producing information about the imposed obligation under Para. 2.
p.(None): (5) After receiving the request under Para. 4, BDA shall determine and term for producing the information
p.(None): by the marketing authorisation holder.
p.(None): (6) Based on the produced information, BDA may confirm the imposed obligation under Para. 2 or withdraw it.
p.(None): (7) The BDA shall notify the holder about the decision, taken under Para. 6.
p.(None): (8) Where BDA confirms the obligation, the executive director shall issue officially a change of the marketing
p.(None): authorisation by including in it a condition for the imposed obligation under Para. 2.
p.(None):
p.(None):
p.(None): § 123. The marketing authorisation holders of medicinal products, issued before 21 June 2012, shall fulfill the
p.(None): obligation under Art. 192, Para. 1, p. 1 starting from 21 July 2015 or from the date of renewal of the marketing
p.(None): authorisation of the relevant medicinal product, depending on which of the two dates will come first.
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p.(None): 1. authorisation for use or registration of medicinal products designated for the human medicine, which are
p.(None): industrially manufactured or the manufacturing method, which includes industrial process;
p.(None): 2. (amend. – SG, 102, in force from 21.12.2012) authorisation of manufacturing and import of medicinal products;
p.(None): 2a (new – SG, 102/2012, in force from 21.12.2012) manufacturing, import and wholesale trade with active substances;
p.(None): 3. approval and conducting clinical trials;
p.(None): 4. wholesale of and retail trade in medicinal products;
p.(None): 5. parallel import of medicinal products;
p.(None): 5a (new – SG, 102/2012, in force from 21.12.2012) intermediation in the area of medicinal products
p.(None): 5b (new – SG 18/14) export of medicinal products according to the provisions of Chapter
p.(None):
p.(None): Nine
p.(None):
p.(None): “b”;
p.(None): 6. advertising medicinal products;
p.(None): 7. follow-up of the safety of the medicinal products released on the market;
p.(None): 8. classification of the method of prescribing and dispensing medicinal products;
p.(None): 9. control of the manufacture and import, wholesale and retail trade, conducting clinical
p.(None): trials, advertising, and the system for the follow-up of the safety the medicinal products released on the market;
p.(None): 10. pricing of medicinal products;
p.(None): 11. development of Positive Medicines List.
p.(None):
p.(None):
p.(None): Art. 2. The purpose of this Act is to create conditions for providing the release on the market of medicinal products,
p.(None): which comply with the requirements relating to quality, safety, and
p.(None):
p.(None): efficacy.
p.(None):
p.(None):
p.(None): Art. 3. (1) Medicinal product in human medicine shall be:
p.(None): 1.any substance or combination of substances, which are intended for treatment or prophylactic of diseases
p.(None): in humans, or
p.(None): 2. any substance or combination of substances, which may be used or applied to humans with the aim of:
p.(None): a) recovery, correction, or modification of physiological functions in humans by means of pharmacological,,
p.(None): immunological or metabolic action, or
p.(None): b) diagnostic purposes.
p.(None): (2) Substance is any matter, the origin or which could be:
p.(None): 1. human (human blood, human blood products, and others);
p.(None): 2. animal (microorganisms, animal organs, extracts, secretions, toxins, blood products, and others.);
p.(None): 3. vegetal (microorganisms, plants and parts thereof, plant extracts, secretions, and others.);
p.(None): 1 State Gazette
p.(None): 4. chemical (elements, natural chemical materials, synthetic and semi synthetic substances, and others).
p.(None):
p.(None):
p.(None): Art. 4. Where a product meets simultaneously the characteristics of both medicinal product and another
p.(None): product regulated by other law, the provisions of this Act shall apply.
p.(None):
p.(None):
p.(None): Art. 5. Medicinal products shall be classified according to the anatomic-therapeutic- chemical classification
p.(None): in accordance with the requirements of the World Health Organisation (WHO).
p.(None):
p.(None):
p.(None): Art. 6. This Act shall not be applicable to:
p.(None): 1. hermetically closed radionuclides;
p.(None): 2. blood, plasma, or blood cells derived by a method including an industrial process.
p.(None):
p.(None):
p.(None): Art. 7. (1) Only the manufacture of, import, wholesale and retail trade in, advertising of and treatment,
p.(None): prophylaxis, and diagnosis with medicinal products, which have received marketing authorisation, shall be
p.(None): permitted under terms of:
p.(None): 1. this Act or
p.(None): 2. Regulation (EC) N 726/2004 of the European Parliament and of the Council.
p.(None): (2) The import of, trade in, treatment, prophylaxis and diagnosis with medicinal products beyond their expiry date
p.(None): shall be prohibited.
p.(None): (3) Possession of a marketing authorisation or certificate of use, manufacture, and clinical trials of
...
p.(None): safety of the medicinal product released on the market according to Para. 1 with the requirements of this Act.
p.(None): The information on the packing and in the leaflet of the medicinal product under Para. 1 shall not be obligatorily in
p.(None): the Bulgarian language.
p.(None): (4) The Executive Director of BDA shall inform the European Commission about the authorisation issued according to para
p.(None): 1, the name and address of the authorisation holder, as well as about the date of termination of the validity thereof.
p.(None):
p.(None):
p.(None): Art. 12. (1) The official pharmacopoeia of the Republic of Bulgaria shall be the European Pharmacopoeia
p.(None): (2) The official pharmacopoeia may be supplemented with the requirements of the Bulgarian pharmacopoeia.
p.(None): (3) The Minister of Health shall determine by way of order the dates of entry into effect of the current edition of the
p.(None): official pharmacopoeia and the annexes thereof.
p.(None): (4) The order according to para 3 shall be promulgated in the State Gazette and published on the internet
p.(None): site of BDA.
p.(None):
p.(None):
p.(None): Art. 13. (1) The monographs of the European Pharmacopoeia shall be obligatory for all substances, preparations, and
p.(None): pharmaceutical forms contained therein. In the cases where there is no monographs in the European Pharmacopoeia, the
p.(None): requirements of the current editions of the pharmacopoeias of the Member States, the U.S.A, and Japan provided that
p.(None): these are in compliance with the general rules of the European Pharmacopoeia.
p.(None): (2) Where the specification contained in a monograph of the European Pharmacopoeia or other national pharmacopoeia
p.(None): is insufficient to ensure the quality of the substance or pharmaceutical form, the Bulgarian Drug
p.(None): Agency can require supplementation of the specification by the applicant/marketing authorisation holder.
p.(None):
p.(None): Chapter two.
p.(None): MANAGING AND FINANCING BODIES
p.(None):
p.(None): Section I. Managing Bodies
p.(None):
p.(None): Art. 14. (1) The medicinal product policy in the Republic of Bulgaria is part of the State health policy and is
p.(None): implemented by the Minister of Health.
p.(None): (2) The Minister of Health shall:
p.(None): 1. be the national coordinator for the problems of medicinal product;
p.(None): 2. take part in international bodies and organisations carrying out activities in the domain of the medicinal products;
p.(None): 3. (repealed – SG, 60/2011, in force from 05.08.2011 new – SG, 102/2012, in force from 21.12.2012) organize provision
p.(None): of public information to the patient organisations and to the
p.(None):
p.(None): consumers organisations about the actions, undertaken against falsification of medicinal products.
p.(None): 4. Carry out other activities set out by a law.
p.(None): When activities according para 2, point 3 carried out, the Ministry of Health collect taxes in amount, determined in
p.(None): tariff according to Art. 21, para 2.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None):
p.(None):
p.(None): Art. 15. (1) Pharmacopoeia Committee shall be established with the Minister of Health as a consulting body on issues
p.(None): relating to the current pharmacopoeia.
p.(None): (2) The Minister of Health shall, on the grounds of a proposal of the Executive Director of the BDA determine by an
p.(None): order the composition of the Pharmacopoeia Committee and the expert groups thereto and shall approve the regulation
...
p.(None):
p.(None): Section II.
p.(None): Requirements Relating to the Documentation for Granting a Marketing Authorisation
p.(None):
p.(None): Art. 27. (1) For granting a marketing authorisation of a medicinal product, the person
p.(None):
p.(None): according to Art. 26, para 1, shall submit to the BDA a formal application accompanied by a dossier in the format of
p.(None): the Common Technical Document, which shall contain:
p.(None): 1. name and address of management and/or permanent address of the applicant according to Art. 26, para 2;
p.(None): where the applicant is a person other than the manufacturer(s) – address of the manufacture sties;
p.(None): 2. name of the medicinal product;
p.(None): 3. qualitative and quantitative particulars of the medicinal product, including its international
p.(None): non-proprietary name (INN) recommended by the WHO, where an INN for the medicinal product exists, or the
p.(None): relevant chemical name;
p.(None): 4. therapeutic indications, contraindications and adverse drug reactions;
p.(None): 5. posology, pharmaceutical form, method and route of administration and expected shelf-life;
p.(None): 6. precautions and safety measures during storage of the medicinal product, its administration to patients
p.(None): and for the disposal of waste products together with an indication of potential risks for the environment;
p.(None): 7. description of the method of manufacture;
p.(None): 8. description of the control methods employed by the manufacturer;
p.(None): 8a (new – SG, 102/2012, in force from 02.01.2013) declaration, that the audit results under Art. 160, Para. 2,
p.(None): conducted by the manufacturer of the medicinal product confirm that the active substance has been produced in
p.(None): compliance with the principles and directives for good production practice; the declaration shall indicate the date on
p.(None): which the audit is conducted;
p.(None): 9. assessment of the potential risks presented by the medicinal product for the environment for every
p.(None): individual case and measures for the limitation thereof;
p.(None): 10. results of:
p.(None): a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.(None): b) preclinical (toxicological and pharmacological) tests;
p.(None): c) clinical trials;
p.(None): 11. declaration that the ethic principles of the Good Manufacturing Practice have been complied with in the clinical
p.(None): trials conducted outside the territory of the Member States;
p.(None): 12. (amend. – SG, 102/2012, in force from 21.12.2012) a summary of the system
p.(None): a) for vigilance the medicinal safety, which shall include the following elements:
p.(None): b) which is to be implemented and, where appropriate, description of the risk management system;
p.(None): c) name of the qualified person under Art. 191, a CV – education, acquired professional experience in the area of
p.(None): vigilance the medicinal safety and qualification for performing his/her duties under Chapter Eight;
p.(None): d) each Member state in which the qualified person fulfils his/her duties;
p.(None): e) address, tel. fax, e-amil address of the person under letter "a";
p.(None): f) address, at which the basic document is kept of the system for vigilance medicinal
p.(None): safety;
p.(None): 12a. (new - SG, 102/2012, in force from 21.12.2012) declaration by the applicant that
p.(None): he/she has the needed means for fulfilling the obligations under Chapter Eight;
...
p.(None): application according to Art. 27, para 1, the Member State where the reference product is or has been authorised to
p.(None): market.
p.(None): (5) In the cases according to para 3, the BDA shall request from the regulatory authority of the Member State indicated
p.(None): in the application according to Art. 27, para 1, a confirmation of the information according to para 4, the qualitative
p.(None): and quantitative composition of the reference product and, if necessary, additional documentation.
p.(None): (6) At the request of a regulatory authority of a Member State where the application for a medicinal product generic to
p.(None): a referent medicinal product, which is or has been authorised to market on the territory of the Republic of
p.(None): Bulgaria, is submitted, the BDA shall submit the requested information according to para 5 within one month from
p.(None): the request date.
p.(None): (7) The ten-year period according to para 2 may be extended by maximum one year at the request of the marketing
p.(None): authorisation holder of the reference medicinal product provided that during the first 8 years from the issue
p.(None): of the marketing authorisation of the reference medicinal product its marketing authorisation holder has
p.(None): received authorisation for a new therapeutic indication the significant clinical advantages of which versus the
p.(None): existing therapeutic opportunities are scientifically well-grounded.
p.(None): (8) (new – SG 12/11, in force from 08.02.2011) Where for a medicinal product an initial marketing authorisation has
p.(None): been issued according to Art. 23, regarding each change of the strength of the active substance, in the pharmaceutical
p.(None): form, of the quantity per package, of the administrative route of the medicinal product, as well as regarding
p.(None): all other changes or extensions of the range of the marketing authorisation, an authorisation according
p.(None): to the requirements of this Act shall be also issued or the initial marketing authorisation shall be
p.(None): supplemented. All these authorisations shall be considered belonging to a general marketing authorisation of the
p.(None): medicinal product for the purposes of application of this Article.
p.(None):
p.(None):
p.(None): Art. 29. (1) The person according to Art. 26, para 1, shall submit to the BDA the results of the required preclinical
p.(None): and/or clinical trials in the cases where the medicinal product indicated in the application:
p.(None): 1. cannot be defined as generic or
p.(None): 2. the bioavailability tests do not prove bioequivalence, or
p.(None): 3. there is a change in the active substance(s), therapeutic indications, pharmaceutical form, and/or posology compared
p.(None): with the reference medicinal product, or
p.(None): 4. is offered in dosage units, which are different compared with the reference medicinal product.
p.(None): (2) Where a biological medicinal product indicated in the application as similar to a reference biological
p.(None): medicinal product does not comply with the conditions to be determined as
p.(None):
p.(None): a generic medicinal product due to different method of manufacture or different starting materials compared with the
p.(None): reference product, or for other reasons, the applicant shall submit to the BDA the results of the required preclinical
p.(None): and/or clinical trials associated with these conditions.
p.(None): (3) In the cases according to para 1 and 2 the documentation as laid down in the regulation according
p.(None): to Art. 42 shall also be submitted.
p.(None):
p.(None):
p.(None): Art. 30. (1) The person according to Art. 26, para 1, insofar as he does not infringe the industrial and commercial
p.(None): property, shall not submit to the BDA the data according to Art. 27, para 1, point 10, letters "b" and "c" provided
p.(None): that he can prove that the conditions laid down in the regulation according to Art. 42 to the effect that the
p.(None): active substance included in the composition of the medicinal product applied for marketing authorisation has a
p.(None): well-established use in the medical practice and possesses acknowledged efficacy and acceptable safety level. In these
p.(None): cases, the results from the tests and tests may be replaced by the relevant scientific publications.
p.(None): (2) The person according to para 1 shall submit the results from the required preclinical and clinical trials in
p.(None): case that the medicinal product containing active substances with well- established use, which have not been
p.(None): used for therapeutic use in the proposed combination. In this case, the documentation relating to each active substance
p.(None): shall not be submitted.
p.(None): (3) Where an active substance within the meaning of para 1 has a proven new therapeutic indication on the
p.(None): basis of significant preclinical or clinical data associated with the new indication, the next applicant may not refer
p.(None): to the data for the new indication of the active substance more than once in a year.
p.(None):
p.(None):
p.(None): Art. 31. In case, when medicinal product containing active substances used in the composition of
p.(None): authorised medicinal products but which are not used in the proposed combination for therapeutic purposes,
p.(None): the person according to Art. 26, para 1, shall submit the results of the preclinical trials and clinical trials
p.(None): associated with this combination. In
p.(None): this case the applicant shall not submit documentation relating to the safety and efficacy of each separate active
p.(None): substance.
p.(None):
p.(None):
p.(None): Art. 32. The marketing authorisation holder of a medicinal product may authorise the use of the pharmaceutical,
p.(None): preclinical and clinical documentation contained in the dossier of the medicinal product for the assessment of
p.(None): subsequent applications for medicinal products with the same qualitative and quantitative composition with respect to
p.(None): the active substances and with the same pharmaceutical form.
p.(None):
p.(None):
p.(None): Art. 33. Conducting the necessary studies and tests for the purpose of preparing the documentation for marketing
p.(None): authorisation and the subsequent practical requirements in connection with the authorisation to market of
p.(None): medicinal products according to Art. 28 and Art. 29 shall not be regarded as breach of patent rights or to
p.(None): supplementary protection certificates of medicinal products.
p.(None):
p.(None):
p.(None): Art. 34. (1) The summary of product characteristics shall contain the following information:
p.(None):
p.(None): 1. name of the medicinal product, quantity of the active substance in a dose unit, and pharmaceutical form;
p.(None): 2. qualitative and quantitative composition in terms of the active substances and constituents of the
p.(None): excipient, the information of which is essential for proper administration of the medicinal product. The usual common
p.(None): name or chemical description shall be used;
p.(None): 3. pharmaceutical form;
p.(None): 4. clinical particulars:
p.(None): a) therapeutic indications,
p.(None): b) posology and method of administration for adults and, where necessary, for children,
p.(None): c) contra-indications,
p.(None): d) special warnings and precautions for use and, in the case of immunological medicinal products, any special
p.(None): precautions to be taken by persons handling such products and administering them to patients, together with
p.(None): any precautions to be taken by the patient,
p.(None): e) interaction with other medicinal products and other forms of interactions,
p.(None): f) use during pregnancy and lactation,
p.(None): g) effects on ability to drive and to use machines,
p.(None): h) undesirable effects,
p.(None): i) overdose (symptoms, antidotes, emergency measures).
p.(None): 5. pharmacological properties:
p.(None): a) pharmacodynamic properties,
p.(None): b) pharmacokinetic properties,
p.(None): c) preclinical safety data.
p.(None): 6. pharmaceutical particulars:
p.(None): a) list of excipients,
p.(None): b) major incompatibilities,
p.(None): c) shelf life, where necessary after reconstitution of the medicinal product or where the immediate packaging is opened
p.(None): for the first time,
p.(None): d) special precautions for storage,
p.(None): e) nature and contents of container,
...
p.(None): years of use in the medical practice:
p.(None): 1. the medicinal product, which is similar to the product which is applied for registration, has been marketed without
p.(None): authorisation or registration or
p.(None): 2. where the number of the components or the strength of the medicinal product, which is applied for registration, is
p.(None): decreased.
p.(None):
p.(None):
p.(None): Art. 39. (1) Where the product has been used in the Community for less than 15 years, but is otherwise eligible for
p.(None): simplified registration Art. 37, para 1, the BDA shall submit the documentation according to Art. 38, para
p.(None): 1, to the Committee on Herbal Medicinal Products for opinion.
p.(None): (2) The BDA shall make the final decision following the establishment of the monograph of the Committee according to
p.(None): para 1 on the compliance or the product with the criteria for registration for traditional use.
p.(None): (3) In the cases according to para 1 the term according to Art. 44 shall cease to run.
p.(None):
p.(None):
p.(None): Art. 40. The BDA may request from the applicant for herbal medicinal product to submit the documentation according to
p.(None): Art. 27 - 32 or according to Art. 35.
p.(None):
p.(None):
p.(None): Art. 41. (1) The BDA shall publish on its internet site a list of the herbal substances, preparations, or
p.(None): combinations thereof used in the traditional herbal medicinal products established by the Committee on Herbal
p.(None): Medicinal Products of the European Evaluation Agency. The list shall contain therapeutic indications, strength,
p.(None): posology and method of administration as well as other information, which is necessary for the safe use of the herbal
p.(None): substance as a traditional medicinal product.
p.(None): (2) Where the product proposed in the application for registration for traditional use contains herbal
p.(None): substance, preparation, or combination of products included in the list according to para 1, the applicant shall not
p.(None): submit the data according to Art. 38, para 1, points 4 - 6.
p.(None): (3) Where the herbal substance, preparation, or combination thereof are excluded from
p.(None):
p.(None): the list according to para 1, the holder of the registration certificate of a herbal medicinal product must submit to
p.(None): the BDA the full documentation according to Art. 38 within three months from the amendment.
p.(None): (4) In case the holder of the registration certificate of the herbal medicinal product does not fulfil the obligation
p.(None): according to para 3, the BDA shall cancel the registration certificate of the product.
p.(None):
p.(None): Section V.
p.(None): Procedure for Granting Marketing Authorisation of Medicinal Products and Registration of Homeopathic and Traditional
p.(None): Herbal Products
p.(None):
p.(None): Art. 42. The requirements relating to the dossier data and documentation according to Art. 27 - 32, Art. 35, para 3,
p.(None): Art. 36, para 2, and Art. 38 shall be laid dawn in a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 43. (1) Within 30 of the submission date of the documentation according to Art. 27- 32, Art. 35, para 3, or
p.(None): according to Art. 38, the BDA shall review the completeness of the parts of the dossier accompanying the
p.(None): application and their compliance with the requirements for granting a the marketing authorisation or the
p.(None): registration certificate according to this Act.
p.(None): (2) Where no incompleteness or discrepancies in the documentation according to para 1 are established, the BDA shall,
p.(None): within the term according to para 1 above, notify the applicant in writing that the documentation is valid. This
p.(None): notification shall state the date from which the time limit according to Art. 44 shall start to run.
p.(None): (3) Where incompleteness and/or discrepancies in the documentation according to para 1 are established, the BDA shall
...
p.(None): applicant in writing that the documentation is valid stating in the notification the date from which the term
p.(None): according to Art. 44 shall start to run.
p.(None):
p.(None):
p.(None): Art. 44. The procedure for granting marketing authorisation or registration certificate of a medicinal product shall
p.(None): start from the date indicated in the notification according to Art. 43, para 2, respectively Art. 43, para 5, and shall
p.(None): end within 210 days.
p.(None):
p.(None):
p.(None): Art. 45. (1) Where in the BDA has been submitted an application for marketing authorisation or
p.(None): registration of a medicinal product for which, according to Art. 27, para 1, point 18, there is information of a
p.(None): marketing authorisation granted in a Member State, the BDA shall notify the applicant in writing to implement the
p.(None): procedure according to Art. 74.
p.(None): (2) Where in the BDA has been submitted an application for marketing authorisation or registration of a medicinal
p.(None): product for which, according to Art. 27, para 1, point 19, there is
p.(None):
p.(None): information that the dossier of the same medicinal product is in a procedure of assessment in a Member State, the BDA
p.(None): shall not review the documentation according to Art. 27-32 or Art. 35, para 3, or according to Art. 38 and shall notify
p.(None): the applicant in writing to implement the procedure according to Art. 75.
p.(None): (3) For the implementation of the provisions of para 1 and 2, a medicinal product shall be deemed as the same as
p.(None): authorised in another Member State, or as a product in a procedure of assessment of the dossier in another Member State
p.(None): where both medicinal products:
p.(None): 1. have the same qualitative and quantitative composition with respect t the active substance(s) and are
p.(None): offered in the same pharmaceutical form, whereas admissible shall be differences in the excipients provided that this
p.(None): shall not affect the safety and efficacy, and where
p.(None): 2. belong to the same company or the application for the medicinal products is submitted by the same company or group
p.(None): of companies, or where the application for the medicinal products is submitted by persons who have concluded a
p.(None): license or other agreement or conduct joint activities relating to the placing on the market of the respective
p.(None): medicinal product in different Member States.
p.(None):
p.(None):
p.(None): Art. 46. (1) For the assessment of the documentation the BDA shall:
p.(None): 1. may conduct tests of the final product, intermediate product, or the starting materials of the medicinal product or
p.(None): forward these for tests in a laboratory in a Member State belonging to the system of official medicines control
p.(None): laboratories in order to establish whether the control methods of analysis used by the manufacturer and described in
p.(None): the dossier comply with the requirements;
p.(None): 2. confirm, following inspection on the spot or by documents, whether the manufacturers of medicinal products from
p.(None): third states conduct the manufacture in compliance with the data set out in Art. 27, para 1, point 7, and/or conduct
p.(None): the control in compliance with the methods set out in Art. 27, para 1, point 8;
p.(None): 3. inspect the manufacturing site indicated in the application where the manufacturer(s) has, by way of exception,
p.(None): assigned to another manufacturer to conduct certain stages of the manufacture or control of the medicinal product.
p.(None): (2) Where the BDA conducts an inspection on the spot of a manufacturing site, the term according to Art. 44 shall cease
...
p.(None): in writing to submit additional information associated with the documentation according to Art. 27-32 or
p.(None): according to Art. 35, para 3, or according to Art. 38, and or to present an oral or written explanation of
p.(None): the established incompleteness and discrepancies within 180 days of the notification date.
p.(None): (2) In the cases according to para 1, the term according to Art. 44 shall cease to run as from the notification date
p.(None): until the presentation of the requested information.
p.(None): (3) The executive director of the BDA shall terminate the procedure for granting a marketing authorisation
p.(None): or authorisation for registration of a medicinal product where:
p.(None): 1. the applicant has not submitted the information according to para 1 within the required time limit;
p.(None): 2. the persons according to Art. 26, para 1, request its termination in writing.
p.(None):
p.(None):
p.(None): Art. 51. Within 10 days of the establishment of the assessment report according to Art. 49, para 1, the executive
p.(None): director of the BDA shall issue a marketing authorisation/registration certificate of the medicinal product or make a
p.(None): motivated refusal.
p.(None):
p.(None):
p.(None): Art. 52. (1) (amend. – SG, 102/2012, in force from 21.12.2012) Within 5 days of granting, the marketing
p.(None): authorisation/registration certificate in the register according to Art. 19, Para. 1, point 3, which shall contain the
p.(None): following data for the certificate:
p.(None): 1. registration number;
p.(None): 2. number and date of the marketing authorisation/registration certificate of the medicinal product;
p.(None): 3. name of the medicinal product;
p.(None): 4. international non-proprietary name of any active substance;
p.(None): 5. name and address of the holder of the marketing authorisation/registration certificate; 5a (new - SG, 102/2012, in
p.(None): force from 21.12.2012) the conditions of Art. 55a, 56 and
p.(None): 56a, entered in the authorisation for use/registration certificate;
p.(None): 6. date of variation of the marketing authorisation/registration certificate;
p.(None): 7. date of termination of the marketing authorisation/registration certificate;
p.(None): 8. other data.
p.(None): (2) The marketing authorisation/registration certificate of the medicinal product shall be delivered to the person
p.(None): according to Art. 26, Para. 1, and shall enter into effect as from the date
p.(None):
p.(None): of its inscription in the register according to Art. 19, Para. 1, point 3.
p.(None):
p.(None):
p.(None): Art. 53. (1) (amend. – SG, 102/2012, in force from 21.12.2012) The BDA shall publish on its internet site data
p.(None): according to Art. 52, Para.1 for the marketing authorisation of the medicinal product granted and the
p.(None): approved summary of product characteristics and the datas of the leaflet.
p.(None): (2) The BDA shall publish o its internet site the assessment report under art. 49, Para. 1 with the motives of the
p.(None): decision taken while deleting the data, representing commercial secret.
p.(None): (3) The report under Para. 2 shall be accompanied by a summary in understandable by the public language. The summary
p.(None): shall contain a section, related to the conditions for use of the medicinal product.
p.(None):
p.(None):
p.(None): Art. 54. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of a marketing authorisation/registration
p.(None): certificate of a medicinal product shall notify the BDA in writing about the date of actual placing on the market of
...
p.(None): the medicinal product shall submit separate notifications, respectively applications to the BDA for each
p.(None): variation of type IA, type IB or type II or for extension of the range.
p.(None): (2) If a concrete variation leads to a change in the data of the summary characteristic of the product, of the
p.(None): labelling or of the leaflet, these changes shall be assumed as a part of the declared variation and about them separate
p.(None): application shall not be submitted.
p.(None): (3) Holder of the marketing authorisation may arrange the variations in groups, where:
p.(None): 1. notifies simultaneously of one and the same variations of type IA in the conditions of
p.(None):
p.(None): one or several marketing authorisations;
p.(None): 2. declares simultaneously several variations in the conditions of the marketing authorisations, belonging to
p.(None): a global marketing authorisation for the medicinal products as per Art. 28, Para 8, provided that the envisaged
p.(None): variations fall under one of the following cases:
p.(None): a) one of the variations in the group constitutes extension of the marketing authorisation;
p.(None): b) one of the variations in the group constitutes a variation of type II, and all the other variations appear as a
p.(None): consequence of the variation of type II;
p.(None): c) one of the variations in the group constitutes variation of type IB, and all the other variations appear as a
p.(None): consequence of the variation of IB
p.(None): d) all variations in the group relate solely to changes of administrative nature to the summary product
p.(None): characteristics, labelling and package leaflet;
p.(None): e) all variations in the group are changes to the Active Substance Master File, Vaccine Antigen Master File or Plasma
p.(None): Master File;
p.(None): f) all variations in the group relate to a project intended to improve the manufacturing process and the quality of the
p.(None): medicinal product concerned or its active substance(s);
p.(None): g) all variations in the group are changes affecting the quality of a human pandemic influenza vaccine;
p.(None): h) all variations in the group are changes to the pharmaco-vigilance system referred to in Chapter Eight;
p.(None): i) all variations in the group are consequential to a given urgent safety restriction and are submitted in accordance
p.(None): with Art. 66;
p.(None): k) all variations in the group relate to the implementation of a given class labelling;
p.(None): l) all variations of the group are consequential to the assessment of a given periodic update report on the safety;
p.(None): m) all variations in the group are consequential to a given post-authorisation study conducted under the
p.(None): supervision of the holder of the marketing authorisation;
p.(None): n) all variations in the group are consequential to a specific obligation carried out pursuant to Art. 56;
p.(None): 3. the declared variations to the terms of the same marketing authorisation do not fall within one of the cases
p.(None): specified in item 2, provided that the BDS agrees to subject those variations to the same procedure.
p.(None): (4) Where variations as per Para 3, items 2 and 3 are grouped, holder of the marketing authorisation shall submit to
p.(None): the BDA:
p.(None): 1. a single notification, where at least one of the variations is a variation of type IB and all variations are of type
p.(None): IA or of type IB;
p.(None): 2. a single application, if the main variation is of type II and none of the rest of variations is an extension of the
p.(None): marketing authorisation;
p.(None): 3. a single application, where the main variation is extension of the marketing authorisation.
...
p.(None): authorisation;
p.(None): 2. shall notify the holder of the marketing authorisation if the approved variation leads to amendment of the data in
p.(None): the issued marketing authorisation; where amendment of the issued marketing authorisation is needed, Art. 64a shall be
p.(None): applied.
p.(None): (7) The holder of the marketing authorisation shall apply the approved variation of type II only after the
p.(None): authorisation for amendment as per Art. 64a is issued.
p.(None):
p.(None):
p.(None): Art. 64a. (new – SG 12/11, in force from 08.02.2011) Executive Director of the BDA shall issue amendment of the
p.(None): decision granting the marketing authorisation within following time limits:
p.(None): 1.30 days following the issuance of the notification under Art. 62, Para 4, item 4, Art. 63, Para 2, item 2,
p.(None): respectively under Art. 63, Para 6, item 2 and under Art. 64, Para 6, item 2, where the respective variation leads
p.(None): to sex-months extension of the period, envisaged in Art. 13, Paragraphs 1 and 2 of Council Regulation No
p.(None): 1768/92 of 18 June 1992 concerning the provision of supplementary protection certificate as set out in Art. 36 of
p.(None): Regulation (EC) No 1901/2006;
p.(None): 2. 60 days following the issuance of the notification under Art. 62, Para 4, item 2 – in case of variations of type IA,
p.(None): which do not require immediate notification;
p.(None): 3. 60 days following the issuance of the notification under Art. 64, Para 6, item 2 – for variations of type II;
p.(None): 4. 180 days – in all other cases.
p.(None):
p.(None):
p.(None): Art. 64b. (new – SG 12/11, in force from 08.02.2011) (1) In case of variations concerning
p.(None):
p.(None): changes to the active substance for the purposes of the annual update of a human influenza vaccine, the holder of
p.(None): marketing authorisation shall submit application, with attached thereto documentation, as specified in the regulation
p.(None): envisaged in Art. 42. Within 7- days period, the BDA shall examine the completeness of the submitted documentation.
p.(None): (2) If the application concerned fulfils the requirements of Para 1, the BDA shall notify the holder of the marketing
p.(None): authorisation, shall acknowledge the receipt of valid application and state the date, from which the specified time
p.(None): limit in Para 3 starts.
p.(None): (3) Within 45- days period from the receipt of a valid application, the BDA shall assess the documentation and prepare
p.(None): an assessment report.
p.(None): (4) The BDA may request the holder of marketing authorisation to provide the clinical data and the stability data of
p.(None): the medicinal product. The holder of marketing authorisation shall submit to the BDA data required within 12 days
p.(None): following the elapse of the time limit stipulated in Para 3.
p.(None): (5) The BDA shall assess the documentation and take final decision within 10 days term from the receipt of the data
p.(None): referred to in Para1, by issuing authorisation for variation or rejection.
p.(None):
p.(None):
p.(None): Art. 65. (1) Where the marketing authorisation holder has established a risk for the health from the use of the
p.(None): medicinal product, he shall undertake urgent limiting measures and shall immediately notify the BDA in writing.
p.(None): (2) The BDA shall pass a judgment regarding the measures within 24 hours of the notification.
p.(None): (3) Where the BDA has not passed a judgment within the term according to para 2, it shall be presumed that the measures
p.(None): have been approved.
p.(None): (4) Where the BDA has established that there is a risk for the health of the population from the use of medicinal
p.(None): product, it shall order the marketing authorisation holder to immediately undertake limiting measures.
p.(None): (5) In the cases according to para 1 and 4, the marketing authorisation holder of the medicinal product shall
p.(None): coordinate the method and term of implementation of the undertaken measures with the BDA.
p.(None): (6) Marketing authorisation holder of the medicinal product shall submit to the executive director of The BDA a
p.(None): variation application under the terms Art. 64 not later than 15 from the date undertaking the measures.
p.(None):
p.(None):
p.(None): Art. 66. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of the marketing authorisation of a medicinal
p.(None): product shall submit an application for enlargement of the scope of the granted marketing authorisation in case of:
p.(None): 1. change of the active substance(s):
p.(None): a. replacement of a chemical active substance by a different by a different salt/ester, complex/derivative, including
p.(None): the same therapeutic moiety, where the efficacy/safety characteristics are not significantly different.
p.(None): b. replacement by a different isomer, mixture of isomers, of a mixture by an isolated isomer (e.g. racemate with single
p.(None): enantiomer), where the efficacy/safety characteristics are not significantly different;
p.(None): c. replacement of a biological active substance with one of a slightly different molecular structure where the
p.(None): efficacy/safety characteristics are not significantly different, with the exception of changes to the active
p.(None): substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
p.(None):
p.(None): d. modification of the vector used to produce the antigen of the source material, including a new master cell bank from
p.(None): a different source, where the efficacy/safety characteristics are not significantly different;
p.(None): e. a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy/safety
p.(None): characteristics are not significantly different
p.(None): f. change to the extraction solvent of the ration of herbal drug to herbal drug preparation where the efficacy/safety
p.(None): characteristics are not significantly different.
p.(None): 2. Changes to strength, pharmaceutical form and route of administration:
p.(None): a. change of bioavailability;
p.(None): b. change of pharmacokinetics e.g. change in rate of release;
p.(None): c. change or addition of a new strength/potency;
p.(None): d. change or addition of a new pharmaceutical form; e.g. change or addition of a new route of administration– for
p.(None): parenteral application to differentiate between intraarterial, intravenous, intramuscular, subcutaneous and
p.(None): other routs of administration.
p.(None): (2) The application according to para 1 shall be accompanied by the documentation according to Art. 27, para 1, point
p.(None): 10, associated with variations according to para 1.
p.(None): (3) The requirements to the documentation according to para 2 shall be laid down in the regulation according to Art.
p.(None): 42.
p.(None): (4) The name of the medicinal product in the granted authorisation for enlargement of the scope of the initial
p.(None): marketing authorisation shall not be changed.
p.(None): (5) The granting of an authorisation for enlargement of the scope of a granted marketing authorisation of a medicinal
p.(None): product shall be performed under the conditions and under the terms of Art. 49 - 51.
p.(None):
p.(None):
p.(None): Art. 67. (1) The marketing authorisation holder of a medicinal product shall submit an application for granting a new
p.(None): marketing authorisation in case of:
p.(None): 1. addition or deletion of one or more active substances including antigenic components in case of vaccines;
p.(None): 2. change in the quality of the active substance indicated in the dossier, which essentially changes the safety and
p.(None): efficacy characteristics of the medicinal product, and the changed substance is defined as a new one;
p.(None): 3. addition of a new or change in an existing therapeutic, prophylactic, or diagnostic indication in another
p.(None): therapeutic field.
p.(None): (2) (New - SG 71/2008, in force from 12.08.2008) The owner of the authorisation for use of the medicinal product shall
p.(None): file an application for issuing new authorisation for use, where the application for renewal of the authorisation for
p.(None): use was not filed within the term under Art. 59a, para 1.
p.(None): (3) (Former para 2 - SG 71/2008, in force from 12.08.2008) The application shall be accompanied by the documentation
p.(None): laid down in the regulation according to Art. 42.
p.(None): (4) (Former para 3 - SG 71/2008, in force from 12.08.2008) The procedure according to Art. 49 – 51 shall be applied in
p.(None): the cases according to para 1 and 2.
p.(None):
p.(None):
p.(None): Art. 68. (1) (amend. – SG, 102/2012, in force from 21.12.2012)The holder of the marketing
p.(None): authorisation/registration certificate of a medicinal product shall be obliged to:
p.(None): 1. report the achievements of the scientific-technical progress and introduce all the needed changes in the
p.(None): documentation under Art. 27, Para. 1, p. 7 and 8 in view the medicinal product to be produced and controlled under the
p.(None): commonly adopted new methods; the changes
p.(None):
p.(None): shall be made under Chapters Three and Five;
p.(None): 2. submit immediately to BDA any new information, which may affect the variation in the data and documents according to
p.(None): Art. 27 - 32 and in the summary of product characteristics;
p.(None): 3. inform immediately the BDA about any ban or limitation imposed by regulatory authorities of other
p.(None): states where the medicinal product is placed on the market, about the reasons standing behind those
...
p.(None): (7) The Council of Ministers, according to a proposal of the Minister of Health, shall determine the conditions and
p.(None): order for the work of the Central Ethics Committee by a regulation.
p.(None):
p.(None):
p.(None): Art. 108. (1) A member of the Central Ethics Committee cannot be appointed in the same committee for more than two
p.(None): consecutive mandates. The duration of a mandate shall be 4 years.
p.(None): (2) Half of the composition of the Central Ethics Committee shall be renewed every 2
p.(None): years.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): met:
p.(None): Section V.
p.(None): Authorisation to Conduct a Clinical Test
p.(None):
p.(None): Art. 109. A clinical test can be started provided that the following conditions have been
p.(None):
p.(None): 1. the respective ethics committee has given a positive opinion and
p.(None): 2. the executive director of BDA has issued a written authorisation for the conduct
p.(None): thereof where one of the study medicinal products is either:
p.(None): a) a medicinal product for gene therapy;
p.(None): b) a medicinal product for somato-cellular therapy;
p.(None): c) a medicinal product, which contains genetically modified organisms;
p.(None): d) a high technology medicinal product described in the Annex to Regulation (EC) 726/2004 of the European
p.(None): Parliament and the Council;
p.(None): e) a medicinal product, which contains biological substance(s) of human or animal origin or contains biological
p.(None): components of human or animal origin or the manufacturing process of which involves such components, or
p.(None): 3. the contracting authority has not been notified by the BDA in writing that the clinical test cannot be conducted
p.(None): within the time limit as set out by the law; for medicinal products outside those according to 2.
p.(None):
p.(None):
p.(None): Art. 110. (1) For obtaining opinion, the principal researcher or the coordinating researcher shall submit to
p.(None): the respective ethics committee according to Art. 103 the following documentation:
p.(None): 1. administrative documentation;
p.(None): 2. subject information;
p.(None): 3. documentation about the study protocol;
p.(None): 4. documentation about the study medicinal product(s);
p.(None): 5. documentation about the technical requirements and about the staff;
p.(None): 6. data about the financing and administrative organisation of the clinical test.
p.(None): (2) The content, form, and requirements to the documentation according to para 1 shall be determined in the regulation
p.(None): according to Art. 82, para 3.
p.(None):
p.(None): Art. 111. (1) The ethics committee shall establish an opinion taking into consideration the following:
p.(None): 1. importance of the clinical test;
p.(None): 2. positive assessment of the ratio between the anticipated benefits and risks according to Art. 90, para 1, and the
p.(None): motivation of the conclusions;
p.(None): 3. protocol of the clinical test;
...
p.(None): (2) Where the change according to Art. 165, para 1, point 3, cannot be assessed by documents, the BDA shall conduct
p.(None): inspections on the spot. In these cases the term according to para 1, point 2, shall cease to run until the
p.(None): accomplishment of the inspection.
p.(None): (3) The expenses for the conduct of the inspection on the spot according to para 2 shall be for the account of the
p.(None): account of the applicant.
p.(None): (4) For the conduct of the inspection on the spot according to para 2 the applicant shall pay a fee to the amount as
p.(None): laid down on the tariff according to Art. 21, para 2.
p.(None):
p.(None):
p.(None): Art. 167. (1) The BDA shall keep a register according to Art. 19, para 1, point 2, of the issued import authorisations,
p.(None): which shall contain:
p.(None): 1. number and date of the import authorisation;
p.(None): 2. name, place of business and address of management of the person, who has been granted import authorisation;
p.(None): 3. address of the premises for the control and storage of the medicinal products;
p.(None): 4. (amend. – SG, 102/2012, in force from 02.01.2013) the medicinal products, and forms for which the authorisation has
p.(None): been obtained;
p.(None): 5. name of the person according to Art. 161, para 2, point 1;
p.(None): 6. date of deletion of the import authorisation from the register and reason thereof.
p.(None): (2) Data from the register shall be published on the internet site of the BDA.
p.(None):
p.(None): Section III.
p.(None): PRODUCTION, IMPORT AND WHOLESALE TRADE WITH ACTIVE SUBSTANCES (NEW – SG, 102/2012, IN FORCE FROM 02.01.2013)
p.(None):
p.(None): Art. 167a. (new – SG, 102/2012, in force from 02.01.2013) Manufacture, import or wholesale trade with
p.(None): active substance may be carried out by natural or legal persons, registered as traders under the legislation of an EU
p.(None): Member State and entered in to the register under Art. 167.
p.(None):
p.(None):
p.(None): Art. 167b. (new – SG, 102/2012, in force from 02.01.2013) (1) For entering into the register under Art. 167d, the
p.(None): applicant shall submit to BDA an application according to a form, confirmed by the BDA executive director, which shall
p.(None): contain:
p.(None): 1. name, management central office of the person under Art. 167a;
p.(None): 2. a list of the active substances, which will be imported, manufactured or traded;
p.(None): 3. the activities, which the person under Art. 167a will carry out;
p.(None):
p.(None): 4. Premise addresses for the technical equipment for realizing the activity of the persons under Art. 167a;
p.(None): (2) The application under Para. 1 shall have attached:
p.(None): 1. data about the single identification code (SIC) of the trader and for the companies, registered in an EU Member
p.(None): State p a document for current registration under the national legislation, issued by a competent body of the
p.(None): relevant state;
p.(None): 2. document for a paid fee under Art. 21, Para. 2.
p.(None): (3) Within the term of 60 days after the application and the documents under Para. 1 and 2 are received, BDA, on the
p.(None): basis of the risk assessment shall:
p.(None): 1. enter the person under Art. 167a in the register under Art. 167d, for which shall notify,
p.(None): or
p.(None): 2. notify about the date of the inspection, carried out for establishing the compliance of
p.(None): the conditions for the activities under Art. 167a with the requirements of the Good manufacturing practice under Art.
...
p.(None): active substances.
p.(None): (2) The importers may import active substances only if the following conditions have been observed:
p.(None): 1. the active substances are manufactured in compliance with standards for Good manufacturing practice,
p.(None): which are at least equivalent to the ones, established in the European Union and
p.(None): 2. (in force from 02.07.2013) the active substances are accompanied by a written confirmation by the
p.(None): competent body of the state-importer, that:
p.(None): a) the standards for good manufacturing practice, applicable to the object for manufacture of the
p.(None): exported active substances are at least equivalent to the ones, established by the European Union;
p.(None): b) The relevant object for manufacture shall be subject to a regular control and in it effectively is applied the
p.(None): Good manufacturing practice, where this includes multiple and immediate inspections in view to guaranteeing
p.(None): protection of the public health, at least equal to the one in the European Union, and
p.(None): c) in case of a found failure to observe the requirements, the state exporter shall inform immediately the BDA.
p.(None): (3) (in force from 02.07.2013) The requirement of Para. 2, p. 2 shall not apply if the state exporter is included in
p.(None): the list under Art. 111b of Directive 2001/83/EC
p.(None):
p.(None):
p.(None): Art. 167g. (new – SG, 102/2012, in force from 02.07.2013) (1) As an exception, where it is needed to be provided
p.(None): availability of medicinal products, the importer may import the active substance without a written confirmation under
p.(None): Art. 167f, Para. 2, p. 2 for the term, not longer than the validity term of the certificate for Good manufacturing
p.(None): practice, where the object for manufacture of an active substance in the state exporter has been inspected by a regular
p.(None): body of a Member State and it has been found, that it observes the principle and directives for Good manufacturing
p.(None): practice.
p.(None): (2) In the cases of Para. 1, BDA shall notify the European Commission.
p.(None):
p.(None):
p.(None): Art. 167h. (new – SG, 102/2012, in force from 02.01.2013) manufacturing authorisation holders, including those, who
p.(None): fulfill the activities under Art. 168b, Para. 2 shall be considered as manufacturers in the meaning of § 13, p. 3 of
p.(None): the Additional Provisions of the Act on Consumer Protection and shall bare responsibility for harms, caused by goods
p.(None): defects, provided in it.
p.(None):
p.(None): Chapter six.
p.(None): PACKAGING AND LEAFLETS OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 168 (1) Medicinal product packaging consists of primary and/or secondary packaging and patient
p.(None): information leaflet.
p.(None): (2) (amend. - SG 61/11, in force from 10.11.2011) The secondary packaging of medicinal
p.(None):
p.(None): products containing substances specified in the list under Art. 3, para 2, item 2 of the Control on Drugs and
p.(None): Precursors Act shall be marked diagonally with two red strips and the secondary packaging of medicinal products
p.(None): containing substances specified in the list under Art. 3, para 2, item 2 of the Control on Drugs and Precursors Act –
p.(None): with two blue strips. The packaging shall obligatorily contain a notice that the medicinal product shall only be
p.(None): dispensed by special medical prescription.
p.(None): (3) (amend. – SG, 102/2012, in force from 21.12.2012) The leaflet of the medical products, included in
p.(None): the list under Art. 23 of Regulation (EC) N 7262004 of the European Parliament and of the Council
p.(None): contains information with the following text: "This medicinal product is subject to additional observation".
p.(None): Before the text a sign is placed in black cooler under Art. 23, Para. 5 of Regulation (EC) N 7262004 of the European
p.(None): Parliament and of the Council, accompanied by an explanatory note.
p.(None): (4) (amend. – SG, 102/2012, in force from 21,12,2012) The leaflet of the medicinal products shall included
p.(None): a standard text, by which the patients are invited to report to the medical specialists or directly to BDA about every
p.(None): suspected unwilling medicinal reaction according to the samples in Art. 185, Para. 2, p. 4.
p.(None): (5) Where a medicinal product is to be authorised for use on the territory of the Republic of Bulgaria, a marking for
p.(None): separate collection and recycling according to the Waste Management Act and the acts for the application thereof shall
p.(None): be placed in its secondary packaging.
p.(None): (6) Where a medicinal product is to be authorised for use, its name on the secondary packaging, pharmaceutical form,
p.(None): and content of active substance in a single dose shall also be printed in the Braille’s alphabet.
p.(None): (7) The requirements of para 6 are not applied for vaccines and medicinal products in hospital’s packages.
p.(None): (8) (new – SG, 102/2012, in force from 21.12.2012) On the secondary package (if there is no such) on the initial
p.(None): package of the medicinal products, with the exception of radio- pharmaceutics, the following shall be placed:
p.(None): 1. individual identification sign for indicators of safety, which gives opportunity for the wholesale and retail
p.(None): traders to:
p.(None): a) check up the authenticity of the medicinal product;
p.(None): b) to identify separate packages.
p.(None): 2. a means, which may check up the package of the medicinal product if it has been
p.(None): faked.
p.(None):
p.(None):
p.(None): Art. 168a. (new – SG, 102/2012, in force from 21.12.2012) (1). On the package of the medicinal product, which is
p.(None): prescribed by a doctor’s prescription, safety indicators shall be placed under Art. 168, Para. 8 with the
p.(None): exception of the cases, in which the medicinal product has been included in the list, determined by the European
p.(None): Commission by a delegated act under Art. 168b.
p.(None): (2) On the package of a medicinal product, which does not need doctor’s prescription, no safety indicators shall be
p.(None): placed under Art. 168, Para. 8, with the exception of the cases, in which the medicinal product is included in the
p.(None): list, determined by the European Commission by a delegated act under Art. 168b, after it has been assessed, that it may
p.(None): be put to a risk to be faked.
p.(None): (3) The BDA shall notify the European Commission:
...
p.(None): indicators with ones, equal to them in relation to the possibility for guaranteeing the authenticity,
p.(None): identification and provision of evidences for faking the medicinal product.
p.(None): (3) The safety indicators shall be considered as equal, if:
p.(None): 1. they meet the requirements, determined by the delegated acts under Art. 54a, Para. 2 of Directive 2001/83/EC and
p.(None): 2. they are so effected that they allow the check of authenticity and identification of the medicinal products and
p.(None): provide evidences for their being faked.
p.(None): (4) The replacement under Para. 2, p. 2 shall be made without opening the initial packing of the medicinal product and
p.(None): in compliance with the Good manufacturing practice for medicinal products.
p.(None): (5) The BDA shall carry out supervision on the replacement of the safety indicators.
p.(None):
p.(None):
p.(None): Art. 169. (1) The information of the packaging and the medicinal product leaflet must be in full compliance with the
p.(None): data in the summary of product characteristics approved by the BDA upon the issue of the marketing authorisation and
p.(None): must comply with the requirements set out in the regulation according to Art. 170.
p.(None): (2) The information on the packaging and leaflet can be in several languages but one of these must obligatorily be
p.(None): Bulgarian language. The content of the information in various languages must be identical.
p.(None): (3) The name of the medicinal product shall obligatorily be written in the Bulgarian language and the
p.(None): international non-proprietary name of the medicinal substance shall be written according to the
p.(None): Anatomic-Chemical-Therapeutic Classification of the WHO. The name
p.(None): and address of the marketing authorisation holder can be written in Latin.
p.(None): (4) The information of the packaging and leaflet must be in a language comprehensible for the patient and must be
p.(None): readable and indelible.
p.(None): (5) (new – SG 18/14) The leaflet must be produced so that to be clear and understandable, and to allow
p.(None): the patient to undertake adequate actions, where required, with the assistance of the health care specialists.
p.(None):
p.(None): Art.170. (1) (former text of Art. 170 – SG, 102/2012, in force from 01.03.2012) The requirements relating
p.(None): to the packaging and leaflets of medicinal products shall be determined by an ordinance of the Minister of Health.
p.(None): (2) (new - SG, 102/2012, in force from 01.03.2012; suppl. – SG 18/14) Where a medicinal product,
p.(None): permitted for use under this act, is not intended for direct supply to the patient or is not available on the market in
p.(None): the Republic of Bulgaria, BDA may permit its use, where some of the data, determined by the ordinance under
p.(None): Para. 1 has not been placed on the package or in the leaflet.
p.(None): (3) (new - SG, 102/2012, in force from 01.03.2012) In the cases under Para. 2, the information on the packing and in
p.(None): the leaflets may not be provided in the Bulgarian language.
p.(None): (4) (new - SG, 102/2012, in force from 01.03.2012) The conditions and procedure for supply of medicinal products under
p.(None): Para. 2 shall be determined by the ordinance under Art. 198.
p.(None):
p.(None): Chapter seven.
p.(None): CLASSIFICATION OF MEDICINAL PRODUCTS
p.(None):
...
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
p.(None): 3. contain new medicinal substances the characteristics of which are not sufficiently known and therefore these
p.(None): can be assigned to the group of medicinal products according to point 2.
p.(None):
p.(None):
p.(None): Art. 175. Medicinal products shall be subject to limited medical prescription wherever these meet one of the following
p.(None): conditions:
p.(None): 1. are limited to administration in hospital conditions only due to limited experience with their use or in the
p.(None): interest of public health;
p.(None): 2. are intended for treatment of pathological conditions, which can only be diagnosed in therapeutic establishments,
p.(None): irrespective that their administration and follow-up in the course of treatment can be carried out in other healthcare
p.(None): establishments;
p.(None): 3. are intended for treatment of out-patients but their use can cause serious adverse drug reactions, which can require
p.(None): specialist prescribing and monitoring in the course of treatment.
p.(None):
p.(None):
p.(None): Art. 176. (1) The BDA can refuse to approve the dispensing regime of a medicinal product requested by the
p.(None): applicant according to Art. 26, para 1, on the grounds of assessment of:
p.(None): 1. the maximum single dose, maximum daily dose, quantity of the active substance in one dose unit, pharmaceutical
p.(None): form, specific appearance of the primary product packaging, and/or
p.(None): 2. other specific conditions of use.
p.(None): (2) The BDA can refuse to indicate the exact category of a medicinal product according to Art. 172 but pursuant to the
p.(None): criteria according to Art. 174 and Art. 175 shall determine whether a medicinal product shall be classified as a
p.(None): product dispensed only on medical prescription.
p.(None):
p.(None):
p.(None): Art. 177. Medicinal products, which do not meet the requirements according to Art. 173, 174, and 175 and the criteria
p.(None): laid down in the regulation according to Art. 178, shall be dispensed without medical prescription.
p.(None):
p.(None):
p.(None): Art. 178. The criteria for classification of medicinal products and the requirements to the documentation for changing
p.(None): the classification shall be determines by a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 179. (1) The BDA shall draw and publish on its internet site a list of the medicinal products, which shall be
p.(None): dispensed on the territory of the Republic of Bulgaria on medical prescription.
p.(None): (2) The list according to para 1 shall be updated annually.
p.(None):
p.(None): Art. 180. Should new data of a medicinal product, which has a marketing
p.(None): authorisation/registration certificate issued, become available, the BDA shall reconsider and if necessary change the
p.(None): classification in accordance with the requirements of Art. 173 and the criteria laid down in the regulation according
p.(None): to Art. 178.
p.(None):
p.(None):
p.(None): Art. 181. In the cases where a change in the classification of a given medicinal product is authorised on the
p.(None): grounds of significant preclinical and clinical trials, next applicants or marketing authorisation holders
p.(None): cannot refer within one year of the date of authorisation of the change issued by a regulatory body of a member country
p.(None): when submitting an application for a change in the classification of the same substance.
p.(None):
p.(None):
p.(None): Art. 182. Annually the BDA shall notify the European commission and the regulatory bodies of the other Member States of
p.(None): changes occurred in the list according to Art. 179.
p.(None):
p.(None): Chapter eight.
p.(None): PHARMACO-VIGILANCE
p.(None):
p.(None): Section I.
p.(None): General Provisions. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 183. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall organize and maintain a system for
p.(None): pharmaco-vigilance for implementation of the obligations under this Chapter.
p.(None): (2) The system under Para. 1 shall be used for collecting information about the risks of medicinal products for the
p.(None): patients’ health and for public health. The information shall cover reports for unwilling medicinal reactions in use of
p.(None): a medicinal product in compliance with the confirmed short characteristics, as well as information for misuse
p.(None): and use, which is not in compliance with the confirmed short characteristics of the product, including
p.(None): information for unwilling medicinal reactions, observed while fulfilling professional duties.
p.(None): (3) The BDA shall valid the process and classify the information under Para. 2, make scientific analysis of the
p.(None): collected data in view to an assessment of the possibilities for decreasing and preventing the risk and shall
p.(None): undertake the needed actions in relation to permit for use of the medicinal product.
p.(None): (4) The BDA shall carry out audits of the system under Para. 1 and every 2 years shall submit to the European
p.(None): Commission a report with the results from them.
p.(None): (5) The BDA shall apply an adequate and effective quality system in order to provide compliance of the system under
...
p.(None): 2. scientific assessment of the correlation benefit/risk of the medicinal product; the assessment shall be
p.(None): based on all available data, including data from clinical tests for non- permitted indications and for
p.(None): target groups, which have not been included in the product short characteristics;
p.(None): 3. all the data about the volume of the sales of the medicinal product and any other information, which the marketing
p.(None): authorisation holder has about the volume of the prescriptions, including the approximate number of the persons, having
p.(None): used the medicinal product or exposed to its impact because of some other reason.
p.(None): (2) The contents and form of the electronic periodic upated vigilance reports shall be provided by the Implementation
p.(None): Regulation (EU) N 520/2012.
p.(None):
p.(None): (3) The information under Para. 1 shall e collected and stored in a regitr, established under Art. 25a of Regulation
p.(None): (EC) N 726/2004 of the European Parliament an of the Council and shall be accessible for BDA.
p.(None):
p.(None):
p.(None): Art. 194i. (new – SG, 102/2012, in force from 21.12.2012). The marketing authorisations holders for registration of
p.(None): medicinal products under Art. 28, 30, 35 and 37 shall submit periodic updated vigilance reports in cases, where:
p.(None): 1. submitting a report shall be a conditions under art. 55 or 56, entered in the marketing authorisation or
p.(None): registration certificate, or
p.(None): 2. The BDA or a regulatory body if another Member State shall require this on the basis of safety considerations of the
p.(None): medicinal product or because of a lack o periodic updated safety reports for the active substance, contained in
p.(None): the medicinal product, to which marketing authorisation or registration certificate has been issued.
p.(None):
p.(None):
p.(None): Art. 194k. (new – SG, 102/2012, in force from 21.12.2012). (1) The marketing authorisation/registration
p.(None): certificate shall determine frequency o submission of the periodic updated safety reports.
p.(None): (2) The dates of submission of the reports, depending on the frequency under Para. 1 shall be calculated from the
p.(None): date of issuance of the marketing authorisation/registration certificate.
p.(None): (3)The periodic updated safety reports shall be submitted during time intervals with the exception of the cases,
p.(None): where the frequency of submission of the reports is a condition for issuance of the marketing
p.(None): authorisation/registration certificate or it has been determined in compliance with Art. 194l, 194m and 194n:
p.(None): 1. every 6 months from the date of issuance of the marketing authorisation/registration certificate of a medicinal
p.(None): product till the date of its placement on the market;
p.(None): 2. every 6 months during the first 2 years from the date of placement on the market of the medicinal product;
p.(None): 3. once a year during the following 2 years;
p.(None): 4. once every 3 years after the 4th year from the date of placement on the market of the medicinal product;
p.(None): (4) Apart from the cases under Para. 3, the periodic updated safety reports shall be submitted immediately upon request
p.(None): of BDA or a regulatory body of a Member State.
p.(None):
p.(None):
p.(None): Art. 194l. (new – SG, 102/2012, in force from 21.12.2012) Where the medicinal products, which contain one and the same
p.(None): active substance, or combination lf one and the same active substances, have received separate marketing
p.(None): authorisations/ registration certificates, the frequency and the date of submitting of the periodic updated safety
p.(None): reports may be changed and harmonised in view to performing one assessment of these reports.
p.(None):
p.(None):
p.(None): Art. 194m. (new – SG, 102/2012, in force from 21.12.2012) (1) The dates of submission of the periodic updated
p.(None): safety reports for the medicinal products under art. 194l shall be calculated according to the reference date
p.(None): of the European Union.
p.(None): (2) The reference date of the EU under Para. 1 is:
p.(None): 1. the ate of the first marketing authorisation in the European Union of the medicinal
p.(None):
p.(None): product, containing the relevant active substance or the relevant combination of the active substances, or
p.(None): 2.the earliest of the known dates of the marketing authorisations of the medicinal product, containing the relevant
p.(None): active substance or the relevant combination of active substances, if the date, indicated in p. 1 cannot be found.
p.(None):
p.(None):
p.(None): Art. 194n. (new – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder of
p.(None): medicinal products under Art. 194l may submit a motivated request to the Committee of Medicinal Products for human use
p.(None): or to the coordination group under Art. 77, Para. 2 for defining the reference date of the EU or for change of the
p.(None): frequency of submitting periodic updated vigilance reports on one of the following grounds:
p.(None): 1. reasons, related to public health;
p.(None): 2. in order to be avoided duplicating of an assessment;
p.(None): 3. in order to be reached international harmonisation.
p.(None): (2) The Committee on Medicinal Products for human use, or the coordination group under Art. 77, Para. 2 after
p.(None): consultations with the committee under Art. 56a, Para. 1, p. 1 shall approve the request or shall make a motivated
p.(None): refusal.
p.(None): (3) The frequency of submitting and the reference ate of the EU shall be defined after consultation with the committee
p.(None): under Art. 56a, Para. 1. P. 1 by:
p.(None): 1.The Committee on Medicinal Products for human use – where at least on of the marketing authorisations
p.(None): for medicinal products, containing the relevant active substance has been provided in compliance with the centralised
p.(None): procedure, provided in Title II, Chapter 1 of Regulation (EC) N 726/2004 of the European Parliament and of the Council,
p.(None): or
p.(None): 2. the coordination group under Art. 77, Para. 2 – for cases, different from the ones, indicated in p. 1.
p.(None): (4) The list with the reference dates of the EU of the medicinal products under Art. 194l and the harmonised frequency
p.(None): for submitting their periodic updated vigilance reports shall be published on the European internet portal under Art.
p.(None): 68, Para. 1, p. 4.
p.(None): (5) The marketing authorisation holder after publication of the data under Para. 4 shall produce to BDA an
p.(None): application for change of the marketing authorisation of the relevant medicinal product. Each change of the
p.(None): dates of submitting the frequency of submission of the periodic updated safety reports, defined in the marketing
p.(None): authorisation, shall come into force 6 months after the date of their publication.
p.(None):
p.(None):
p.(None): Art. 194o. (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall assess the periodic updated safety reports
p.(None): fpr the medicinal products, in order to define whether there are new risks or change of the established risks or change
p.(None): of the correlation benefit/risk.
p.(None): (2) The BDA shall carry out single assessment of the periodic updated safety reports of the medicinal products for
p.(None): which the Republic of Bulgaria has fulfilled the functions of a reference state in the meaning of Art. 76 and has been
p.(None): defined by the coordination group under art. 77, Para. 2.
...
p.(None): 2. prohibition of distribution of the medicinal product;
p.(None): 3. issuing a refusal for renewing the marketing authorisation.
p.(None): (3) (amend. – SG 18/14) The BDA shall initiate the procedure under Para. 2 where they are advised by the marketing
p.(None): authorisation holder that, for reasons related to tracing of drug safety, they terminate the distribution of the
p.(None): medicinal product or they have undertaken or they intend to undertake actions for its withdrawal from the market, or
p.(None): will not undertake actions for the renewal of the issued marketing authorisation.
p.(None): (4) (amend. – SG 18/14) The BDA may initiate the procedure under par. 2 in the cases where they consider that for
p.(None): reasons, related to tracing of drug safety, regarding a particular medicinal product new counter-indications may be
p.(None): added or the recommended dose should be reduced, or the indications shall be limited.
p.(None): (5) (amend. – SG 18/14) The BDA shall submit to the European Medicines Agency and to the regulatory authorities of the
p.(None): other Member States the entire scientific information, available to them, as well as the performed data assessment and
p.(None): the justifications for the initiation of the procedure pursuant to the provisions of this section.
p.(None): (6) (amend. – SG 18/14) In the cases referred to par. 2 - 4 the European Medicines Agency shall notify the BDA of the
p.(None): initiation of the procedure, where the concerns regarding safety are related also to other medicinal products,
p.(None): belonging to one and the same therapeutic group or contain the same active substance with the product, indicated in the
p.(None): information under
p.(None):
p.(None): par. 5 or where this medicinal product is permitted for use also in other Member States.
p.(None): (7) (amend. – SG 18/14) In the cases under Para. 4, where no urgent measures are required, BDA shall apply the
p.(None): procedure under Art. 77 or Art. 79b.
p.(None): (8) (new – SG 18/14) BDA shall inform the marketing authorisation holder of the initiation of the procedure under the
p.(None): provisions of this section.
p.(None):
p.(None):
p.(None): Art. 194u. (new – SG, 102/2-12, in force from 21.12.2012) (1) In the cases under Art. 194s, Para. 2, where BDA
p.(None): considers, that urgent measures are needed to be undertaken for protection of public health, BDA may temporary to
p.(None): terminate the marketing authorisation and to ban the use of the medicinal product on the territory of the Republic of
p.(None): Bulgaria until a final decision is taken under Art. 194x or 194y.
p.(None): (2) The BDA shall notify the European Medicines Agency, the European Commission and the regulatory bodies of the other
p.(None): Member States about the measures, undertaken under Para. 1 within the term of up to 1 working day after their
p.(None): application and shall indicate the grounds for that.
p.(None): (3) Where the BDA participates in the procedure under this Section, upon request of the European Commission, BDA shall
p.(None): undertake the recommended temporary measures in relation to the marketing authorisation of the medicinal
p.(None): product, or where the medicinal product is permitted for use under Regulation (EC) N 726/2004 0f the European
p.(None): Parliament and of the Council – in relation to the very product, by the finalisation of the procedure.
p.(None):
p.(None):
...
p.(None): 7. check whether the trader holds wholesale authorisation for trade with medicinal products;
p.(None): 8. check up whether the manufacturer or importer holds an authorisation for manufacture/import;
p.(None): 9. keep the data under p. 3 for the term of at least 5 years and provide them upon request of the control bodies.
p.(None): (2) The requirements to the intermediary activities in the area of the medicinal products shall be determined by the
p.(None): ordinance under Art. 198 and in the European Commission directives.
p.(None):
p.(None): Section .
p.(None): Parallel Import of Medicinal Products
p.(None):
p.(None): Art. 213. Parallel import of medicinal products on the territory of the Republic or Bulgaria can be performed by a
p.(None): natural or legal person registered according to the Commerce Act, the legislation of a Member State, or the
p.(None): legislation of a state party to the Agreement on the European Economic Area after receipt of a parallel import
p.(None): authorisation issued by the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 214. (1) A medicinal product authorised for use in another Member State, can be imported on the territory of the
p.(None): Republic of Bulgaria, provided that it is identical or similar to a medicinal product authorised for use in the
p.(None): Republic of Bulgaria under the terms of this Act.
p.(None): (2) (Amen. - SG 71/2008, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011) Within the meaning of
p.(None): Para 1, a medicinal product is identical or similar shall be the one, that has identical qualitative and
p.(None): quantitative composition with respect to the active substance(s), is supplied in the same pharmaceutical form,
p.(None): the same primary packaging, with the same graphic design of the packaging
p.(None):
p.(None):
p.(None): Art. 215. (1) (Amen. And suppl. - SG 71/2008, in force from 12.08.2008) To obtain authorisation to
p.(None): perform parallel import on the territory of the Republic of Bulgaria, the person according to Art. 213, para 1 shall
p.(None): submit to the executive director of BDA an application stating the Member State from which the parallel import of the
p.(None): medicinal product is to be effected from.
p.(None): (2) The following data and documents shall be appended to the application:
p.(None): 1. name, pharmaceutical form, quantity of the active substance in a dose unit of the medicinal product authorised for
p.(None): use in the Republic of Bulgaria;
p.(None): 2. name, pharmaceutical form, quantity of the active substance in a dose unit of the medicinal product intended for
p.(None): parallel import;
p.(None): 3. (suppl. – SG 12/11, in force from 08.02.2011) name of the marketing authorisation holder and the manufacturer if a
p.(None): person different from the marketing authorisation holder, name of the medicinal product intended for parallel import;
p.(None): 4. number of the marketing authorisation of the medicinal product in the Republic of Bulgaria and number of the
p.(None): marketing authorisation of the medicinal product in the Member State where the parallel import is to be effected from;
p.(None): 5. declaration for establishment of circumstances pursuant 217, issue 1;
p.(None): 6. copy of the patient information leaflet and a sample of the medicinal product in the form in which it is sold in the
p.(None): Member State where the parallel import is to be effected from,
p.(None):
p.(None): translation of the patient information leaflet in the Bulgarian language accompanied by a declaration that
p.(None): the translation is in compliance with the original of the leaflet;
p.(None): 7. proposal for patient information leaflet of the parallel imported medicinal product accompanied by a
p.(None): declaration that the content of the leaflet is identical with the content of the medicinal product authorised in the
p.(None): Republic of Bulgaria except for the following data:
p.(None): a) name and address of management of the person effecting the parallel import;
p.(None): b) name of manufacturer where it is different for both products;
p.(None): c) stability period where it is different for both products;
p.(None): d) excipients where these are different in both products;
p.(None): 8. in case of repackaging:
p.(None): a) sample of the parallel import product;
...
p.(None): shall be identical with the content of the product leaflet, approved in Republic of Bulgaria except of the data
p.(None): according to Art. 215, para 2, point 7, letters "a" – "d";
p.(None): 4. document and report to the marketing authorisation holder and the BDA all reports of adverse drug reactions of the
p.(None): imported medicinal product.
p.(None):
p.(None): Chapter nine.
p.(None): "B" EXPORT OF MEDICINAL PRODUCTS (NEW – SG 18/14)
p.(None):
p.(None): Art. 217a. (new – SG 18/14) (1) Export of medicinal products from the territory of the Republic of Bulgaria may be done
p.(None): by a natural person or a legal entity holding a permit for wholesale with medicinal products or by a holder of a
p.(None): production license.
p.(None): (2) Holders of a production license may carry out export only of the medicinal products manufactured by them.
p.(None): (3) Within the meaning of this Chapter, export shall also be an intra-Community supply within the European Union.
p.(None): (4) Export of medicinal products included in the Positive Medicines List referred to in Art. 262, par. 1 from the
p.(None): territory of the Republic of Bulgaria shall take place upon notification of BDA in every individual case, where the
p.(None): export is being carried out by the holder of a permit for wholesale of drugs.
p.(None):
p.(None):
p.(None): Art. 217b. (new – SG 18/14) The notification referred to in Art. 217a, par. 4 shall be send to the Managing Director of
p.(None): BDA and shall contain the following information:
p.(None): 1. name and registered address of the person under Art. 217a, par. 1;
p.(None): 2. name, pharmaceutical form and active substance quantity in a dose unit of the medicinal product
p.(None): intended for export;
p.(None): 3. reference number of the permit for wholesale of medicinal products;
p.(None): 4. number of packages of the medicinal product intended for export;
p.(None):
p.(None): 5. the state of destination of the export.
p.(None):
p.(None):
p.(None): Art. 217c. (new – SG 18/14; declared anti-constitutional CCD No 1 of 2015 - SG 12/2015) (1) Upon receipt
p.(None): of a notification under Art. 217b, BDA shall request information about the medicinal product intended for export for a
p.(None): period of the last 6 months as from the day of the notification:
p.(None): 1. about the consumption of the respective medicinal product from the National Health Insurance Fund and/or from the
p.(None): Ministry of Health;
p.(None): 2. about the supplied quantities of the respective medicinal product to the Republic of Bulgaria by the holder of the
p.(None): marketing authorisation.
p.(None): (2) The persons referred to in par. 1 shall provide the information requested by BDA within 15 days after the request.
p.(None): (3) BDA shall analyze the information about the respective medicinal product, received subject to
p.(None): compliance with the provision of par. 2, and shall compare the information about the used quantities under par. 1, item
p.(None): 1 and the supplier quantities under par. 1, item 2 with the available information obtained pursuant to
p.(None): the provision of Art. 217b, item 4 about the number of packages intended for export.
p.(None): (4) Where within 30 days as from the date of receipt of the notification under Art. 217b, the Managing Director of BDA
p.(None): does not object in writing the export, it shall be deemed that there is a tacit consent to the export.
...
p.(None): and or/municipal participation, according to Art. 9 and 10 of the Medical Establishments Act with state participation.
p.(None): (2) Positive Medicines List shall include medicinal products classified by pharmacological
p.(None): groups according to the code of the anatomo-therapeutic- chemical classification with the respective
p.(None): international non-proprietary names, the names, attached to them, with the respective defined daily doses/therapeutic
p.(None): course , reference price (value) under Art. 261a, Para. 1, limit price of the medicinal products in their retail sale,
p.(None): referent value for the defined daily dose/therapeutic course, value of the package, calculated on the basis
p.(None): of the reference value/therapeutic course for a defined daily dose and level of payment, needed for their treatment,
p.(None): as well as sicknesses on the international code of sickness (ICS).
p.(None): (3) For the medicinal products for which there is not defined daily dose, the reference value shall be defined on the
p.(None): basis therapeutic course, concentration or volume.
p.(None): (4) (suppl. - SG 48/15) The medicinal products in the Positive Medicines List shall be selected according to proof for
p.(None): effectiveness, therapeutic efficiency, safety and analysis of the pharmaco-economic indicators, provided that for
p.(None): medicinal products with new international non- proprietary names shall also be carried out health technology
p.(None): assessment. Health technology assessment shall be carried out under conditions and procedures specified by the Minister
p.(None): of Health
p.(None): (5) Where on or more medicinal products with the same international non-patent name, medicinal form and
p.(None): concentration of active substance, with the exception of the medicinal products under Art. 29, have already
p.(None): been included in the relevant part of the Positive Medicines List, the assessment under Para. 4 shall not be made.
p.(None): (6) The Positive Medicines List shall include:
p.(None): 1. medicinal products for treatment of diseases paid under the terms of Health Insurance
p.(None): Act;
p.(None): 2. medicinal products paid by the budget of the healthcare establishments according to
p.(None): Art. 5 of the Medical Establishments Act and by the budget of the therapeutic establishments according to Art. 9 and
p.(None): 10 of the Medical Establishments Act with state and or municipality participation;
p.(None): 3. medicinal products intended for treatment of AIDS, of infection diseases, of treatment of diseases out of range of
p.(None): Health Insurance Act, paid under the terms of Art. 82, Para. 1, point 8 from the Health Act, as well as vaccines for
p.(None): obligatory immunisations and re-immunisations, vaccines on special indicators and in extraordinary circumstances,
p.(None): specific serums, immune globulins;
p.(None): 4. limit price of the medicinal products under Art. 261a, Para. 4 on elements.
p.(None):
p.(None): (7) The Ministry of Health and NHIF may make grounded proposals to the Council under Art. 258. Para. 1for
p.(None): re-examination of included medicinal products in the Positive Medicines List under the terms and conditions, determined
p.(None): by the Ordinance under Art. 261a, Para. 5.
p.(None): (8) The NHIF shall pay the medicinal products under Para. 6, p. 1,under the terms and conditions of the Ordinance under
p.(None): Art. 45, Para. 9 of the Health Insurance Act.
p.(None): (9) (new – SG 18/14; amend. - SG 48/15) The terms and conditions, the rules and the criteria for the inclusion,
...
p.(None): a member of the Transparency Commission shall not be a member of the Council.
p.(None): (4) The Council of Ministers determines with Rules the condition and the order for work of the Transparency Commission.
p.(None):
p.(None):
p.(None): Art. 266. (1) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) The
p.(None): Transparency Commission shall be a body before which decisions of the Council may be appealed.
p.(None): (2) The decisions of the Transparency Commission shall be taken by a majority of two thirds of its members.
p.(None): (3) The decisions of Para. 2 could be appealed under the terms of the Administrative Procedure Code and the appeal has
p.(None): no suspense effect.
p.(None):
p.(None):
p.(None): Art. 266a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) Where the treatment of a relevant sickness is without
p.(None): alternative in the country, for a concrete patient may be applied a medicinal products, which is authorised for use in
p.(None): an EU Member State, authorised for use under this Act, but is not sold on the Bulgarian market.
p.(None): (2) Annually, upon proposal of the medical establishments for hospital assistance after an opinion of the relevant
p.(None): national consultant on the profile of the sickness, the Minister of Health shall confirm a list of the medicinal
p.(None): products under Para. 1, which shall contain the following information:
p.(None): 1. code on the anatomy-therapeutic – chemical classification;
p.(None): 2. international non-patent name, to which the product belongs; 3.sickness according to international code of
p.(None): sicknesses; 4.medicinal form and quantity active substance;
p.(None): 5. additional information.
p.(None): (3) The list under Para. 2 shall be published on the internet site of the Ministry of Health.
p.(None): (4) The terms and conditions for inclusion, changes or exclusion of medicinal products in the list under Para. 2 shall
p.(None): be determined by the Ordinance under Art. 9, Para. 1.
p.(None):
p.(None): (5) The medicinal product under Para. 1 shall be supplied upon a special order of a medical establishment for hospital
p.(None): assistance under terms and conditions, determined by the Ordinance under Art. 9, Para. 1.
p.(None): (6) The head of the medical establishment under Para. 5 shall bear responsibility for applying the treatment under
p.(None): Para. 1.
p.(None):
p.(None): Chapter thirteen.
p.(None): STATE CONTROL ON THE MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 267. (1) (amend., - SG 98/10, in force from 01.01.2011, suppl. – SG 102/2012, in force from 21.12.2012) The
p.(None): Ministry of Health shall exercise the state control on the medicinal products. The immediate management shall be
p.(None): executed by the chief state health inspector, the Council chairperson under Art. 258, Para. 1, the executive director
p.(None): of the BDA, and the directors of the regional health inspectorates (RHI) who shall be state inspectors for the control
p.(None): of the medicinal products.
p.(None): (2) (amend., - SG 98/10, in force from 01.01.2011, suppl. – SG 102/2012, in force from 21.12.2012)) Bodies for state
p.(None): control of the medicinal products shall be the Council under Art. 258, Para. 1, BDA and RHI.
p.(None): (3) (amend., - SG 98/10, in force from 01.01.2011, suppl. – SG 102/2012, in force from 21.12.2012) The immediate
p.(None): control shall be exercised by officials – inspectors and experts appointed by orders of the Council
...
p.(None): Code, however, the appeal shall not stop their execution.
p.(None):
p.(None): Art. 294. Whoever infringes the provisions of this Act or the regulations for its implementation, except
p.(None): for the cases according to Art. 281-293, shall be penalised with a fine from BGN 1,000 to BGN 3,000 and in case of
p.(None): repeated perpetration of the same infringement – with a fine from BGN 3,000 to BGN 5,000.
p.(None):
p.(None):
p.(None): Art. 295. (1) (amend., - SG 98/10, in force from 01.01.2011) The infringements according to this Act shall be
p.(None): established by virtue of deeds drawn up by state inspectors of the BDA or of the RHI.
p.(None): (2) The infringements according to Art. 289 shall only be established by officials appointed by the
p.(None): Minister of Health.
p.(None): (3) (amend., - SG 98/10, in force from 01.01.2011) The penal ordinances shall be issued by the Minister of Health, the
p.(None): chief state health inspector, and the directors of the BDA and RHI depending on the subjection of the official, who has
p.(None): established the infringement.
p.(None):
p.(None):
p.(None): Art. 296. The drawing of the deeds and the issue, appeal and the execution of penal ordinances shall be made in
p.(None): compliance with the provisions of the Administrative Violations and Penalties Act.
p.(None):
p.(None):
p.(None): Art. 297. In the cases pursuant Art. 281, 282, 283, 284, 285 and 287 the penalty body enact a bereavement of the
p.(None): medicinal products for state benefit, the subject of the infringement by rules and order, determined in a regulation by
p.(None): the Minister of Health.
p.(None):
p.(None): Additional provisions
p.(None):
p.(None): § 1. Within the meaning of this Act:
p.(None): 1. "Active substance" shall mean any substance (ingredient) intended to be used for manufacturing of medicinal product,
p.(None): which during it production turns in active component of this product, intended for exercising pharmacologic,
p.(None): immunologic or metabolic action with the purpose of restoration, correction or change of physiologic functions or
p.(None): for putting a medical diagnosis.
p.(None): 2. "Bioequivalence" shall be in place where medicinal products are pharmaceutically equivalent or pharmaceutical
p.(None): alternatives and if their bio availabilities after administration of the same molar dose are similar to such extent
p.(None): that their effects with respect to efficacy and safety are essentially similar.
p.(None): 3. "Bioavailability" shall mean the rate and degree at which an active substance or its therapeutically active part is
p.(None): absorbed from the pharmaceutical form and it becomes available at its site of action. Where the medicinal substance is
p.(None): intended to exert a systemic therapeutic effect, bioavailability shall mean the rate and degree at which the medicinal
p.(None): substance or its therapeutically active part is released from the pharmaceutical form and passes into the total
p.(None): circulation.
p.(None): 4. "Researcher’s brochure" shall mean the aggregate of clinical and non clinical data of tests of medicinal product(s),
p.(None): which are relevant to the clinical test of the product(s) in man.
p.(None): 5. "Valid documentation" shall mean any documentation which is compliant with the requirements laid down in
p.(None): a give procedure pursuant to this Act both with respect to content and
p.(None):
p.(None): completeness.
p.(None): 6. "Substance with well established use in medical practice" shall mean a substance to which the following criteria can
p.(None): be applied:
p.(None): a) the period for proving the well established use in medical practice is not less than 10 years from the date of
p.(None): the first systematised and documented use of the substance as a medicinal product in the European Union or in
p.(None): the European Economic Area;
p.(None): b) quantitative aspects of the use of the substance, taking into consideration the degree of use in medical practice,
p.(None): the degree of use on geographical principle, and the degree of follow- up through the pharmaco-vigilance system
p.(None): including pre- and post marketing studies and published scientific literature for epidemiological studies
p.(None): and comparative epidemiological studies in particular;
p.(None): c) high degree of scientific interest in the use of the substance (number of scientific publications) and coherence
p.(None): in scientific assessments.
p.(None): 7. "Outer packaging" shall mean the packaging, which does not come in immediate contact with the medicinal
p.(None): product.
p.(None): 8. "Contracting authority" shall mean a natural or legal person, institution, or organisation responsible for the
p.(None): start-up, management, and/or financing of a clinical test.
p.(None): 9. "Generic medicinal product" shall mean a medicinal product, which has the same qualitative and quantitative
p.(None): composition as regards the active substances and the same pharmaceutical form as the reference medicinal
p.(None): product and its bioequivalence compared to the reference medicinal product has been proven in adequate
p.(None): bioavailability studies. Various immediate release oral pharmaceutical forms shall be regarded as the same
p.(None): pharmaceutical form. Various salts, esters, ethers, isomers, mixtures of isomers, complexes, or derivatives of an
p.(None): active substance shall be regarded as the same active substance except if these are significantly
p.(None): different in respect of safety and/or efficacy.
p.(None): 10. "Principal researcher" shall mean an appointed by the contracting authority medical doctor or doctor in dental
p.(None): medicine who is managing the overall conduct of a clinical test in compliance with an approved protocol and the rules
p.(None): for Good Clinical Practice and is responsible for the work of the researchers.
p.(None): 11. "Defined daily dose" shall be the mean daily maintenance dose of a given medicinal product, which administered to
p.(None): adults according to the main indication of a medicinal product.
p.(None): 12. "Good clinical practice" shall mean the aggregate of internationally recognised ethical and scientific
p.(None): quality requirement, which shall be observed during the planning, conduct, accounting, and reporting of clinical
p.(None): trials.
p.(None): 13. "Good laboratory practice" shall mean a system of rules in respect if the conditions for planning, processes of
p.(None): organizing, conduct, follow up, and documenting of laboratory tests.
p.(None): 14. "Good manufacturing practice" shall mean a system of rules encompassing all aspects of manufacture:
p.(None): personnel, premises, equipment, materials, documentation, and quality control and has the purpose of ensuring safety,
p.(None): efficacy, and compliance with a specification.
p.(None): 15.. (Suppl. - SG 71/2008 in force from 12.08.2008) "Member State" shall mean a State Member of the European Union, or
p.(None): a State, party of the Agreement of the EEA.
p.(None): 16. "Labeling" shall mean information on the immediate or outer packaging of a medicinal product.
p.(None): 17. "Immunological medicinal product" shall mean a medicinal product, which contains vaccines, toxins, sera, or
p.(None): allergens. Agents used to create active immunity or establish a condition of immunity or invoke passive
p.(None): immunity shall be involved in the scope of vaccines, toxins, and sera. Allergens shall mean medicinal products,
p.(None): which are intended to identify or stimulate specific purposeful change in the immunological response to an allergens
p.(None): agent.
p.(None): 18. "Bioequivalence study" shall mean a clinical test aimed at proving that two medicinal
p.(None):
p.(None): products are bioequivalent provided that they are pharmaceutically equivalent or pharmaceutical alternatives and
p.(None): provided that their bioavailability after administration of the same molar dose are similar to a degree, which is a
p.(None): condition for equivalence in respect of efficacy and safety.
p.(None): 19. "Bioavailability study" shall mean a clinical test aimed at showing what is the rate and degree which an active
p.(None): substance or a therapeutically significant part of a studied medicinal product reach from the pharmaceutical form to
p.(None): the systemic circulation of the blood.
p.(None): 20. "Study medicinal product" shall mean a pharmaceutical form of an active substance or placebo, which are
p.(None): investigated or used as comparators in a clinical test including products with granted marketing authorisation but are
p.(None): used in an unauthorised indication or with a view of obtaining additional information for an authorised form, or are
p.(None): made up (in a pharmaceutical form or packaged) in a manner, which is different from the authorised form.
p.(None): 21. "Researcher" shall mean an appointed by the contracting authority and the principal researcher medical doctor or
p.(None): doctor in dental medicine who practically conducts a clinical test under the management of a principal researcher in
p.(None): compliance with an approved protocol and the guidelines for Good Clinical Practice in an investigational site for the
p.(None): conduct of a clinical test. If a clinical test is not conducted by a team, the researcher shall be the manager
p.(None): responsible for the team and shall be called principal researcher.
p.(None): 22. "Informed consent" shall mean a decision to participate in a clinical test, which must be in writing, dated and
p.(None): signed and taken freely by any person capable of giving his consent or
p.(None): – where a person is incapable of giving his consent by his legal representative after being duly informed about the
p.(None): essence, importance, consequences and risks of a clinical test and documented in an adequate manner.
p.(None): 23. "Kit" shall mean any substance, which – usually before use – shall be dissolved, suspended, diluted, or combined
p.(None): with radionuclides as a result of which procedure the finished radioactive medicinal product is obtained.
p.(None): 24. "Clinical test of a medicinal product" shall mean any study in man intended for discovering or
p.(None): confirming clinical, pharmacological, and/or other pharmacodynamic effects of one or more study medicinal products, and
p.(None): /or for determination of the adverse reactions to one or more study medicinal products, and/or for studying the
p.(None): absorption, distribution, metabolism, and excretion of one or more study medicinal products with the purpose of
p.(None): establishing their safety and/or efficacy.
p.(None): 25. "Clinical advantage" shall mean a significant therapeutic or diagnostic advantage of a medicinal product compared
p.(None): to a medicinal product, which has already received marketing authorisation.
p.(None): 26. "Coordinating researcher" shall mean a researcher appointed for the purpose of coordinating the researchers or
p.(None): various sites participating in a multicentre test.
p.(None): 27. "Patient information leaflet" shall mean a leaflet accompanying a medicinal product and containing information for
p.(None): the customer.
p.(None): 27a. (New - SG 71/2008 in force from 12.08.2008, amend. – SG, 102/2012, in force from 21.12.2012) "Medicinal product
p.(None): for modern therapy" is a medicinal product, determined in Art. 2 of Regulation (EC) N 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on the medicinal products for modern therapy and amending Directive
p.(None): 2001/83/EC and Regulation (EC) № 726/2004.
p.(None): 28. "Medicinal product obtained from human plasma or human blood" shall mean a medicinal product produced
p.(None): from human blood constituents and by a method involving industrial process. The following shall be ascribed to this
p.(None): group: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, and other plasma
p.(None): fractions and combinations thereof.
p.(None): 29. "Medicinal product intended for treatment, prophylaxis, and diagnostics of rare
p.(None):
p.(None): diseases" shall mean a product, which:
p.(None): a) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases or chronic diseases taking
p.(None): progressive course, which affect not more than 5 of 10,000 people on the territory of a state or
p.(None): b) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases and severely health damaging
p.(None): chronic disease (diseases with high percentage of disease-related incapacity of work or disability) and are there is
p.(None): evidence appended that the sale of the product does ensure satisfactory return, which can justify the required
p.(None): investment for scientific research and development without having stimuli for the creator of the product, and
p.(None): c) where the is no satisfactory method of diagnostics, prophylaxis, or treatment of a given condition or where there is
p.(None): such method the proposed medicinal product has significantly more advantages and benefits for the people affected by
p.(None): this condition.
p.(None): 30. "Pharmaceutical form" shall mean an adequate for intake structure containing active substance(s), which can
p.(None): include or cannot include excipients and which is obtained through application of certain technological operations
p.(None): ensuring the desired healing effect and stability at storage within the expiry term.
p.(None): 31.. (Amen. - SG 71/2008 in force from 12.08.2008) "Any person, established on the territory of a Member State shall
p.(None): mean a legal subject registered according to the civil or trade legislation of a Member State or established pursuant
p.(None): to a normative act and having place of business in a Member State or a state - party of the European Economic Area.
p.(None): 32. "Magisterial formula" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): prescription of a medical specialist or according to an established recipe and intended for a definite patient.
p.(None): 33. "International non-proprietary name" shall mean a recommended name of an active substance approved and published by
p.(None): the World Health Organisation.
p.(None): 34. "Medical specialists" shall mean medical doctors, doctors in dental medicine, masters of pharmacy,
p.(None): nurses, midwives, medical laboratory assistants, medical auxiliaries and pharmacy assistants.
p.(None): 35. "Medical trade representative" shall mean a person who has passed special training and possessing scientific
p.(None): knowledge for the presentation of accurate and comprehensive information about the medicinal product he is
p.(None): advertising.
p.(None): 35a. (new – SG 1/14, in force from 03.01.2014)”Medical prescription” shall mean a prescription of a
p.(None): medicinal product, issued by a person who exercises a regulated medical profession within the meaning of § 1,
p.(None): item 1 of the Additional Provisions of the Recognition of Professional Qualifications Act and who is legally entitled
p.(None): to do so in the Member State in which the medical prescription is issued.
p.(None): 36. "Multicentre clinical test" shall mean a clinical test, which is conducted according to a single protocol but in
p.(None): more than one site and by more than one researcher. Researcher sites can be situated in the territory of one Member
p.(None): State, more than one Member State, and/or in Member States and third states.
p.(None): 37. "Name of a medicinal product" shall mean the name given to a medicinal product, which can be:
p.(None): a) a freely selected name (trade name);
p.(None): b) (amend. – SG 12/11, in force from 08.02.2011) a common name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation;
p.(None): c) (amend. – SG 12/11, in force from 08.02.2011) scientific name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation.
p.(None): 38. "Scientific literature" shall mean publication(s) of results from scientific research in specialised international
p.(None): scientific editions.
p.(None):
p.(None): 39. "New active substance" shall mean:
p.(None): a) chemical, biological, or radiopharmaceutical substance, which has not been authorised to market in
p.(None): the European Union as a medicinal product;
p.(None): b) isomer, mixture of isomers, complex or derivative or salt of a chemical substance, which has been authorised to
p.(None): market in the European Union as a medicinal product but is different with respect to safety and efficacy from
p.(None): a formerly authorised substance;
p.(None): c) biological substance, which has been authorised to market in the European Union as a medicinal product but has
p.(None): different molecular structure, different origin with respect to the starting material, or has been obtained
p.(None): through a different manufacturing process;
p.(None): d) radiopharmaceutical substance the radionuclides or molecular bonds (ligands) of which have not been
p.(None): authorised in the European Union as a medicinal product or the mechanism of bonding in a couple of the molecules
p.(None): and radionuclides has not been authorised in the European Union.
p.(None): 40. "Adverse event" shall mean any untoward unfavorable change the health condition observed during the administration
p.(None): of a medicinal product in a patient or a clinical test subject and which has not necessarily a causal relationship with
p.(None): this treatment.
p.(None): 41. (amend. – SG, 102/2012, in force from 21.12.2012) "Adverse drug reaction" shall mean any untoward and unpredicted
p.(None): response to a medicinal product. In case of a clinical test
p.(None): – any untoward and unpredicted response to a study medicinal product irrespective of the administered
p.(None): dose. The types of adverse reactions shall be:
p.(None): a) "unexpected" – an adverse drug reaction, which has not been mentioned in the summary of product
p.(None): characteristics of the character, severity, and outcome of which do not comply with those mentioned in the
p.(None): summary of product characteristics. In case of a clinical test
p.(None): – an adverse drug reaction the character, severity, and outcome of which do not comply with the information for the
p.(None): study medicinal product mentioned in the researcher’s brochure;
p.(None): b) "suspected" – and adverse drug reaction fore which the reporter or the marketing authorisation holder supposes that
p.(None): there is a possible causal relationship with a taken medicinal product;
p.(None): c) "serious" – any unfavorable effect on the health condition, which has become the reason for a lethal outcome,
p.(None): immediate threat to life, hospitalisation, or prolongation if hospitalisation, significant or durable injury,
p.(None): disability, and innate anomalies;
p.(None): d) combination of reactions according to subsections "a", "b", and "c".
p.(None): 42. "Common name" shall mean the international non-proprietary name (INN) of a medicinal substance or
p.(None): excipient recommended by the World Health Organisation; if not any, the name in the European Pharmacopoeia shall be
p.(None): used; if there is no such name there, another pharmacopoeia name shall be used; if there is no pharmacopoeia name, the
p.(None): common name shall be used.
p.(None): 42a (new – SG, 102/2012, in force from 21.12.2012) "Basic documentation of a system of pharmaco-vigilance" is a detail
p.(None): description of the pharmaco-vigilance system, used by the marketing authorisation holder in relation or one or more
p.(None): authorised for use medicinal products.
p.(None): 42b. (new - SG48/15) "Health technology assessment" shall mesn:
p.(None): a) a form of policy on research that examines the short- and long-term outcomes related to the implementation of
p.(None): health technologies and aims to provide information concerning alternative health strategies;
p.(None): b) multidisciplinary activity that systematically evaluates technical specifications, safety, clinical efficacy and
p.(None): effectiveness, cost, cost effectiveness, organizational, social, legal and ethical consequences of
p.(None): administration of medicinal products in health care and focuses on value - clinical and economic, provided
p.(None): that the analysis is comparative to existing or best alternative at the time;
p.(None):
p.(None): 43. "Batch" shall mean a definite quantity of a medicinal product manufactured according to an established reproducible
p.(None): technological scheme ensuring the required batch homogeneity with respect to the required quality characteristics.
p.(None): 43a. (new – SG, 102/2012, in force from 21.12.2012) "plan for risk management" is a detailed description of the system
p.(None): for risk management.
p.(None): 44. "Maintenance of a marketing authorisation" shall include all required activities with regard to the maintenance of
p.(None): an updated registration status of a medicinal product including pharmaco-vigilance.
p.(None): 45. "Benefit" shall mean a positive result/therapeutic efficacy of a medicinal product for a definite patient,
p.(None): patient group, or the society. Quantitative assessment of the anticipated benefit shall include approximate
p.(None): calculation of the probability of this positive result.
p.(None): 46. (amend. – SG, 102/2012, in force from 02.01.2013) "Auxiliary substance" is any component of a medicinal product,
p.(None): different for the active substance and the packing material.
p.(None): 47. "Post marketing study" shall mean any study conducted during the use of a medicinal product within the approved
p.(None): summary of product characteristics during the period after the authorisation to market.
p.(None): 47a (new - SG, 102/2012, in force from 02.01.2013) "Mediation in the area of medicinal products" are all the
p.(None): activities, which aim at signing contract for buying or selling of medicinal products with the exception of wholesale
p.(None): trade, which do not include physical keeping and which are expressed in negotiating independent and on behalf of
p.(None): another legal or natural person.
p.(None): 48. "Post marketing safety study" shall mean any study, related to an authorised for use medicinal product, conducted
p.(None): with the purpose of identification, characterisation of defining the risk level in relation of safety, to confirm the
p.(None): safety profile of the medicinal product or to assess the effectiveness of the measures for risk management.
p.(None): 49. "Potential serious risk for the population" shall exist where there is a high probability a medicinal product to
p.(None): cause irremovable, irremediable, and irreversible consequences. The assessment process shall identify the threat of
p.(None): causing damages to the health of the population and its actual exposition during wide use of the product. The serious
p.(None): risk for the health in the context of the use of a given medicinal can be assessed under the following conditions:
...
p.(None): the Republic of Bulgaria.
p.(None): 51. "Acceptable safety level" shall be in place where the submitted data shall be accepted as
p.(None): statistically reliable safety according to clinical trials conducted in compliance with the Good Clinical Practice.
p.(None): 52. "Manufacture of a medicinal product" shall mean all operations relating to the supply
p.(None):
p.(None): of materials, their processing during the manufacturing process including packaging and labeling, quality control,
p.(None): batch release, storage, shipment, and operations control relating there to.
p.(None): 53. "Clinical test protocol" shall mean a document describing the purpose(s), design, methodology, statistical
p.(None): processing, and organisation of a clinical test. The protocol shall also include all subsequent amendments thereto.
p.(None): 54. "Placing on the market" shall mean the distribution of a medicinal product in the trade network on the territory of
p.(None): the Republic of Bulgaria outside the direct control of the marketing authorisation holder.
p.(None): 55. "Immediate packaging" shall mean the packaging, which enters in immediate contact with a product.
p.(None): 56. "Radiopharmaceutical" shall mean a medicinal product, which when in a ready for use form contains one or more
p.(None): radionuclides (radioactive isotopes) included with medical purpose.
p.(None): 57. "Radionuclide generator" shall mean any system, which includes a fixed maternal radionuclide from which a filial
p.(None): radionuclide is obtained, which is separated by elusion or other methods and is used in a radiopharmaceutical.
p.(None): 58. "Radionuclide precursor" shall mean any other radionuclide manufactured for radioactive marking of another
p.(None): substance immediately before its introduction in a patient’s body.
p.(None): 59. "Herbal medicinal product" shall mean a medicinal product containing as active ingredient one or more
p.(None): herbal substances or one or more herbal preparations, or one or more herbal substances in a combination with one or
p.(None): more herbal preparations.
p.(None): 60. "Herbal substances" shall basically mean plants or parts of plants, seaweed, mushrooms, and lichens,
p.(None): which are whole, broken, or cut, usually dried or sometimes fresh. Certain exudates, which have not been subjected to
p.(None): specific processing, shall also be assigned to the herbal substances. Herbal substances shall have be accurately
p.(None): defined botanical scientific name of the plant wherefrom they originate according to the binominal system (species,
p.(None): sort, variety, and author).
p.(None): 61. "Herbal preparation" shall mean the product obtained after extraction, distillation, pressing, fractionation,
p.(None): purification, concentration, or fermentation of herbal substance. The herbal preparation can also represent
p.(None): ground or powdered herbal substances, tinctures, extracts, essential oils, and processed herbal liquids/juices.
p.(None): 62. "Rare diseases" shall mean the diseases, which are characterised with incidence of not more than 5 in 10,000 of the
p.(None): population.
p.(None): 63. "Reference medicinal product" shall mean a medicinal product authorised under the terms of Art. 23 in compliance
p.(None): with the requirements of Art. 27.
p.(None): 64. "Reference value of a defined daily dose" on an international non-proprietary name with the corresponding
p.(None): pharmaceutical for according to the anatomo-therapeutic classification of medicinal products shall mean the lowest
p.(None): value of a defined daily dose determined on the basis of the values of a defined daily dose for various medicinal
p.(None): products for the international non-proprietary with the corresponding pharmaceutical form according to the
p.(None): anatomo- therapeutic classification of medicinal products.
p.(None): 65. "Reference value of a therapeutic course" shall be the lowest value of a therapeutic course determined on the basis
p.(None): of the values of a therapeutic course of the medicinal products according to international non-proprietary name with
p.(None): the corresponding pharmaceutical form.
p.(None): 66. "Risk during the use of a medicinal product" shall mean:
p.(None): a) risk for the health of the patient or risk for the health of the population, which is associated
p.(None): with the quality, safety, or efficacy of a medicinal product;
p.(None): b) risk of undesirable effects on the environment.
...
p.(None): 69b (new – SG, 102/2012, in force from 21.12.2012) "Pharmaco-vigilance system" is a system, used by the marketing
p.(None): authorisation holder and BDA for implementation of the tasks and responsibilities under Chapter Eight, intended for
p.(None): observation of vigilance of the permitted for use medicinal products and for finding every change in the benefit/risk
p.(None): ratio.
p.(None): 70. "Urgent limitation safety measures" shall mean temporary changes in the product information with respect of one
p.(None): or more parts of the summary of product characteristics, indications, method of administration,
p.(None): contraindications, and warnings, which result from new information associated with the safe use of a medicinal product.
p.(None): 71. "Spontaneous report" shall mean a voluntarily report for a suspected adverse reaction during the use of
p.(None): a medicinal product forwarded to the marketing authorisation holder, to the bodies for supervision on the medicinal
p.(None): products, or to other organisations, which is not originating from a study or another organised system for data
p.(None): capturing.
p.(None): 72. "Expiry period of a medicinal product" shall mean the interval of time during which, if a medicinal product is
p.(None): stored under the prescribed conditions, it shall comply with the specification developed on the grounds of
p.(None): stability tests of several batches of the finished form.
p.(None): 73. (Amen. - SG 71/2008, in force from 12.08.2008) "Medicinal product equivalent to a herbal medicinal product"
p.(None): shall mean a product containing the same active substances irrespective of the composition of the excipients
p.(None): and which is intended for the same purpose, has equivalent quantity of the medicinal substance, the same dosage and the
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
...
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
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p.(None): 1. chemico-pharmaceutical examinations;
p.(None): 2. laboratory analyses and tests;
p.(None): 3. assessment of documentation and issue of authorisations, certificates, and other documents set forth in
p.(None): this Act;
p.(None): 4. evaluation by the renewal, variation and cease of marketing authorisation approval and certificate for registration
p.(None): of medicinal product;
p.(None): 5. maintenance of marketing authorisations of medicinal products;
p.(None): 6. fines and property sanctions imposed by penal ordinances issued for infringements of this Act;
p.(None): 7. consulting, publishing, and research activities in the field of the drug sector;
p.(None): 8. coordination of investment projects for the construction of new and/or refurbishing of existing sites relating to
p.(None): the manufacture of medicinal products;
p.(None): 9. conduct of inspections in connection with assessment of compliance of the manufacturing conditions with
p.(None): the requirements of Good Manufacturing Practice;
p.(None): 10 other sources.
p.(None): (2) During the execution of the activities according to para 1, points 1 – 5, points 7 – 9 the Bulgarian Drug Agency
p.(None): shall collect fees to the amounts as defined in a tariff adopted by the
p.(None):
p.(None): Council of Ministers.
p.(None): (3) (New - SG 71/2008, in force from 12.08.2008) The tariff under para 2 shall have determined lower and various in
p.(None): amount fees for realisation of the procedures on permission for usage, production and import of medicinal products for
p.(None): small and medium enterprises in the pharmaceutical sector in the meaning of the Small- and Medium-Size Enterprises Act.
p.(None):
p.(None):
p.(None): Art. 22. (1) The funds according to Art. 21 shall be spent for:
p.(None): 1. control activity of the BDA;
p.(None): 2. Payment of the activities according to Art. 21, Para. 1, p. 1 and 2, when The BDA is assigned their execution of
p.(None): another persons by contract;
p.(None): 3. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 4. establishment and maintenance and update of the registers according to Art. 19, Para.
p.(None): 1;
p.(None): 5. maintenance of systems for electronic data exchange with the regulatory bodies of
p.(None): the other Member States, with the European Commission, with and the European Medicines Agency;
p.(None): 6. (suppl. – SG, 102/2012, in force from 21.12.2012) information and publishing activities relating to the quality,
p.(None): efficacy, and safety of the medicinal products and vigilance medicinal safety;
p.(None): 7. provision of the activity of the specialised commissions according to Art. 47, Par. 1 and 2 and the council
p.(None): according to Art. 251, Para. 3;
p.(None): 8. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 9. participations in international and national inter-laboratory tests;
p.(None): 10. (amend. – SG. 60/2011, in force from 5. 8. 2011; revoked – SG 38/12, in force from 01.07.2012)
p.(None): (2) ( suppl. SG 71/2008, in force from 12.08.2008; amend. and suppl. – SG 12/11, in force from 08.02. 2011, amend. –
p.(None): SG, 60/2011, in force from 5.8.2011, amend. – SG, 102.2012, in force from 21.12.2012) The funds according to Art. 114,
p.(None): Para. 4, and Art. 259, Para. 5 shall be spent for:
p.(None): 1. (amend. – SG, 60/2011, in force from 5.8.2011).
p.(None): 2. activities of the Pharmacopoeia Committee;
p.(None): 3. (amend. – SG, 60/2011, in force from 5.8.2011, amend. – SG, 102.2012, in force from 21.12.2012) ).activities of the
p.(None): Transparency Commission, the Central Commission on Ethics and the Commission on Ethics for Multi-centre Tests;
p.(None): 4. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 5. (suppl. – SG 71/08, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011, amend. –
p.(None): SG, 60/2011, in force from 5.8.2011; revoked – SG 38/12, in force from 01.07.2012)
p.(None):
p.(None): Chapter three.
p.(None): PLACING MEDICINAL PRODUCTS ON THE MARKET
p.(None):
p.(None): Section I. General Provisions
p.(None):
p.(None): Art. 23. (1) An industrially manufactured medicinal product or a medicinal product obtained by a method
p.(None): involving an industrial process may only be placed on the market after a
p.(None):
p.(None): marketing authorisation or a registration certificate has been issued under the terms of:
p.(None): 1. this Act or
p.(None): 2. Regulation (EC) 726/2004 of the European Parliament and the Council.
p.(None): (2) A marketing authorisation within the meaning of para 1 shall also be required for a radionuclide generator,
p.(None): radionuclide precursor, or a kit.
p.(None): (3) Types of procedures according to para 1 shall be:
p.(None): 1. centralised procedure;
p.(None): 2. mutual recognition /decentralised procedure;
p.(None): 3. national procedure.
p.(None): (4) (New - SG 71/2008, in force from 12.08.2008) On the territory of the Republic of Bulgaria may be placed on the
p.(None): market only medicinal products, whose owner of permission for usage/certificate for registration has been established
p.(None): on the territory of a Member State.
p.(None):
p.(None):
p.(None): Art. 24. (1) Marketing authorisation shall not be required for radiopharmaceuticals prepared immediately
p.(None): before use from authorised radionuclide generators, radionuclide precursors, or kits in accordance with the
p.(None): manufacturer’s instructions.
p.(None): (2) The products according to para 1 shall be prepared by qualified persons I laboratories or institutes authorised for
p.(None): such activity under the terms of the Safe Use of Nuclear Energy Act.
p.(None): (3) The preparation, use, and administration of the products according to para 1 shall be performed in compliance with
p.(None): the nuclear medicine standard.
p.(None):
p.(None):
p.(None): Art. 25. (1) The criteria for the determination of a medicinal product designated for the treatment, prophylaxis, or
p.(None): diagnostics of rare diseases are laid down in Regulation (EC) N 141/2000 of the European Parliament and of
p.(None): the Council.
p.(None): (2) The conditions and order for granting of a marketing authorisation of the medicinal products according to para 1
p.(None): are laid down in (EC) N 726/2004 of the European Parliament and of the Council.
p.(None):
p.(None):
p.(None): Art. 26. (1) A marketing authorisation of a medicinal product, a registration certificate for the authorisation of a
p.(None): homeopathic medicinal product according to Art. 35, or a registration certificate for the authorisation of a
p.(None): traditional herbal medicinal product according to Art. 37 on the territory of the Republic of Bulgaria shall be issued
p.(None): by the executive director BDA to a natural or legal person established on the territory of a Member State or a state
p.(None): member of the European Economic Area.
...
p.(None): authorisation/registration certificate of medicinal product where certain data in the dossier do not comply with the
p.(None): requirements of Art. 27 - 32.
p.(None): (3) The executive director of the BDA shall refuse registration of a traditional herbal medicinal product where,
p.(None): after assessment of the documentation, it shall be established that the product does not comply with the conditions
p.(None): according to Art. 37, para 1, the data in the dossier do not comply with Art. 38, or:
p.(None): 1. the qualitative and quantitative composition does not comply with those described in the dossier;
p.(None): 2. the medicinal product can be noxious at correct use;
p.(None): 3. the data for the traditional use are insufficient, especially where the pharmacological properties or the efficacy
p.(None): are not proven on the basis long-standing use and the experience acquired;
p.(None): 4. the pharmaceutical quality of the medicinal product is insufficiently grounded.
p.(None):
p.(None): Art. 58. The marketing authorisation holder takes the responsibility for the completeness and authenticity of the data
p.(None): in the dossier.
p.(None):
p.(None):
p.(None): Art. 59. (1) The refusal of the executive director of the BDA to grant a marketing
p.(None): authorisation/registration certificate of a medicinal product may be appealed under the terms of the Administrative
p.(None): Procedure Code.
p.(None): (2) The refusal of the executive director of the BDA and the motives thereof shall be published on the internet site of
p.(None): the Agency.
p.(None):
p.(None):
p.(None): Art. 59a. (New - SG 71/2008, in force from 12.08.2008) (1) (amend. – SG, 102/2012, in force from 21.12.2012) In the
p.(None): cases under Art. 55, Para. 2 and 5 not later than 6 months before expiry of the term of the authorisation for
p.(None): usage/certificate for registration, its owner shall file to BDA application for renewal, accompanied with a summarised
p.(None): dossier in relation to the quality, safety and efficacy of the medicinal product, including data assessment, contained
p.(None): in the reports for suspected unwilling medicinal reactions and the periodical updated safety reports, submitted under
p.(None): Chapter Eight, and all the approved changes after issuing the authorisation for usage/certificate for
p.(None): registration.
p.(None): (2) The requirements for the data and the documents of the dossier under para 1 shall be determined by the ordinance
p.(None): under Art. 42.
p.(None): (3) within 120 days after filing the application and the documentation under para 1, BDA shall assess the quality,
p.(None): safety and efficacy of the medicinal product and shall prepare an assessment report, which shall be submitted
p.(None): to the executive director of BDA
p.(None): (4) In cases, where incompleteness and/or incompatibilities have been established in the presented documentation
p.(None): under para 1, BDA shall notify in writing the owner of the authorisation for usage/certificate for
p.(None): registration and shall give instructions for their removal. The owner of the authorisation for
p.(None): usage/certificate for registration shall remove the incompleteness and/or incompatibilities in the
p.(None): documentation within the term of 30 days after the date of receiving the notification.
p.(None): (5) within the term of 10 days after receiving the assessment report under para 3, the executive director of BDA
p.(None): shall issue authorisation for renewal of the authorisation for usage/certificate for registration of the
p.(None): medicinal product or a motivated refusal.
p.(None):
p.(None):
p.(None): Art. 59b. (New - SG 71/2008, in force from 12.08.2008) (1) The executive director of BDA shall refuse renewal of
p.(None): the authorisation for usage/certificate for registration of the medicinal product, in cases where after the
p.(None): assessment of the dossier under Art. 59a, para 1 it is established, that:
p.(None): 1. the medicinal product is hazardous in correct usage, or
p.(None): 2. there is not therapeutic efficacy, or
p.(None): 3. the relation between usefulness/risk is unfavourable in correct usage, or
p.(None): 4. the quantity and quality composition of the medicinal product do not comply with the one, described in the dossier,
p.(None): or
p.(None): 5. the data in the dossier under. 59a, para 1 are not true, or
p.(None): 6. the control of the medicinal product and/or of the ingredients and of the interim stages of the production process
p.(None): has not been performed or another requirement has not been fulfilled, where the authorisation for production has been
p.(None): issued, or
p.(None): 7. some of the data in the dossier do not comply with the requirements of Art. 59a, para
p.(None):
p.(None): 1 and 2.
p.(None): (2) The refusal of the executive director of BDA to renew the authorisation for the usage/certificate for
p.(None): registration of the medicinal product may be appealed, as provided by the Administrative Procedure Code.
p.(None): (3) The refusal of the executive director of BDA and the motives shall be published on the BDA website.
p.(None):
p.(None):
p.(None): Art. 59c. (New – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 01.04.2013) The BDA
p.(None): shall notify the National council of prices and reimbursement of medicinal products about the terminated and
p.(None): withdrawn authorisations for use, as well as the made refusals for renewal of issued authorisations for use of
p.(None): medicinal products within 7 day term from issuance of the relevant act.
p.(None):
p.(None): Section VI.
p.(None): Variations in Granted Marketing Authorisation
p.(None):
p.(None): Art. 60. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of a marketing authorisation of the medicinal
p.(None): product shall be obliged to notify the BDA about any change in the conditions under which the permit has been granted.
p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011)Variations may be of type IA, of type IB, of type II, extension of the
p.(None): marketing authorisation and urgent restricting measures of safety.
p.(None): (3) (amend. – SG 12/11, in force from 08.02.2011) Terms and criteria of classification of the variation shall be laid
p.(None): down in the regulation envisaged in Art. 42.
p.(None): (4) (amend. – SG 12/11, in force from 08.02.2011) Any variation, which is not an extension and whose
p.(None): classification is undetermined after application of the terms and criteria stipulated in the envisaged in Art. 42
p.(None): regulation, shall be considered a variation of type IB by default.
p.(None): (5) (new – SG 12/11, in force from 08.02.2011) As an exception from Para 4, and whose classification is undetermined
...
p.(None): (2) The patients may report adverse medicinal reactions at any time to the medical
p.(None):
p.(None): specialists or to BDA.
p.(None): (3) In the cases under Para. 1 and 2 where the report refers to biological medicinal product, prescribed, disseminated
p.(None): or sold on the territory of the Republic of Bulgaria, it must be clearly identified by the reporter with its trade name
p.(None): and lot number or this information is provided during the additional vigilance.
p.(None):
p.(None):
p.(None): Art. 185. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall maintain national internet portal for
p.(None): medicinal products, connected to the European internet portal for medicinal products under Art. 68, Para. 1, p. 4.
p.(None): (2) The BDA shall provide through the portal under Para. 1 at least the following information:
p.(None): 1. the public assessment reports under Art. 53, Para. 2 and their summaries;
p.(None): 2. the short characteristics of the products and the leaflets;
p.(None): 3. summary of the risk management plans of the medicinal products, permitted for use on the territory of the Republic
p.(None): of Bulgaria;
p.(None): 4. standard forms for reporting of suspected adverse reactions by medical specialists and patients, drawn up with
p.(None): compliance with the requirements of Art. 25 of Regulation (EC) N 726/2004 of the European Parliament and of the
p.(None): Council;
p.(None): 5. updated list of the medicinal products under Art. 23 of Regulation (EC) N 726/2004 of the European Parliament and of
p.(None): the Council;
p.(None): 6. announcements, providing information of the wide public about suspicions about safety of usage of a
p.(None): certain medicinal product;
p.(None): 7. instructions for all ways and forms for announcements of suspected adverse medicinal reactions by medical
p.(None): specialists and patients.
p.(None):
p.(None):
p.(None): Art. 186. (1) (amend. – SG, 102/2012, in force from 21.12.2012) The BDA shall carry out the following actions for the
p.(None): medicinal products, placed on the market of the Republic of Bulgaria:
p.(None): 1. monitoring of the result of the measures for decreasing the risk for a medical products, contained in the risk
p.(None): management plan;
p.(None): 2. monitoring of the result of implementation of conditions, indicated in Art. 55a, 56, or
p.(None):
p.(None): 56a;
p.(None):
p.(None): 3. assessment of the updating of the risk management system;
p.(None): 4. monitoring of the data base of Eudra Vigilance", created in compliance with Art. 24 of
p.(None): Regulation (EC) N 726/2004 of the European Parliament and of the Council for new risks or for change of already
p.(None): established and for change of the correlation benefit/risk.
p.(None):
p.(None):
p.(None): Art. 187. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall inform the European Medicines Agency
p.(None): and the marketing authorisation holder at identification of signals for new risks or change of found risks or in
p.(None): case of change of the correlation benefit/risk of a medicinal products.
p.(None): (2) The committee under Art. 56a, Para. 1, p. 1 shall analyze and prioritize the valid signals for new risks or for
...
Health / Mentally Disabled
Searching for indicator disability:
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p.(None): controlled throughout the clinical test;
p.(None): 9. the study has been planned and shall be conducted in compliance with the guidelines of the European Medicines
p.(None): Agency;
p.(None): 10. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 101. (1) Clinical trials in the persons according to Art. 96, para 4 and 5, who are not capable of giving informed
p.(None): consent, shall be conducted in compliance with the requirements of Art. 90.
p.(None): (2) Except for the requirements of para 1, inclusion of major persons who are not capable of giving informed consent in
p.(None): clinical trials is permitted provided that:
p.(None): 1. the respective ethics committee with the participation of a specialist competent in the respective disease or in the
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
p.(None): consent or of data obtained through other research methods;
p.(None): 4. the study is directly associated with a disease, which is life-threatening or resulting in disability, from which
p.(None): the major person who is not capable of giving informed consent is suffering;
p.(None): 5. the clinical trials are planned in such manner that pain, inconvenience, fear, and the other foreseeable risks
p.(None): associated with the disease are minimised and the risk threshold and physical pain degree have been determined in
p.(None): advance and shall be incessantly controlled throughout the clinical test;
p.(None): 6. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 102. No clinical test with a medicinal product can be conducted in pregnant women or breastfeeding mothers except
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
...
p.(None): 26. "Coordinating researcher" shall mean a researcher appointed for the purpose of coordinating the researchers or
p.(None): various sites participating in a multicentre test.
p.(None): 27. "Patient information leaflet" shall mean a leaflet accompanying a medicinal product and containing information for
p.(None): the customer.
p.(None): 27a. (New - SG 71/2008 in force from 12.08.2008, amend. – SG, 102/2012, in force from 21.12.2012) "Medicinal product
p.(None): for modern therapy" is a medicinal product, determined in Art. 2 of Regulation (EC) N 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on the medicinal products for modern therapy and amending Directive
p.(None): 2001/83/EC and Regulation (EC) № 726/2004.
p.(None): 28. "Medicinal product obtained from human plasma or human blood" shall mean a medicinal product produced
p.(None): from human blood constituents and by a method involving industrial process. The following shall be ascribed to this
p.(None): group: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, and other plasma
p.(None): fractions and combinations thereof.
p.(None): 29. "Medicinal product intended for treatment, prophylaxis, and diagnostics of rare
p.(None):
p.(None): diseases" shall mean a product, which:
p.(None): a) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases or chronic diseases taking
p.(None): progressive course, which affect not more than 5 of 10,000 people on the territory of a state or
p.(None): b) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases and severely health damaging
p.(None): chronic disease (diseases with high percentage of disease-related incapacity of work or disability) and are there is
p.(None): evidence appended that the sale of the product does ensure satisfactory return, which can justify the required
p.(None): investment for scientific research and development without having stimuli for the creator of the product, and
p.(None): c) where the is no satisfactory method of diagnostics, prophylaxis, or treatment of a given condition or where there is
p.(None): such method the proposed medicinal product has significantly more advantages and benefits for the people affected by
p.(None): this condition.
p.(None): 30. "Pharmaceutical form" shall mean an adequate for intake structure containing active substance(s), which can
p.(None): include or cannot include excipients and which is obtained through application of certain technological operations
p.(None): ensuring the desired healing effect and stability at storage within the expiry term.
p.(None): 31.. (Amen. - SG 71/2008 in force from 12.08.2008) "Any person, established on the territory of a Member State shall
p.(None): mean a legal subject registered according to the civil or trade legislation of a Member State or established pursuant
p.(None): to a normative act and having place of business in a Member State or a state - party of the European Economic Area.
p.(None): 32. "Magisterial formula" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): prescription of a medical specialist or according to an established recipe and intended for a definite patient.
p.(None): 33. "International non-proprietary name" shall mean a recommended name of an active substance approved and published by
p.(None): the World Health Organisation.
...
p.(None): of a medicinal product in a patient or a clinical test subject and which has not necessarily a causal relationship with
p.(None): this treatment.
p.(None): 41. (amend. – SG, 102/2012, in force from 21.12.2012) "Adverse drug reaction" shall mean any untoward and unpredicted
p.(None): response to a medicinal product. In case of a clinical test
p.(None): – any untoward and unpredicted response to a study medicinal product irrespective of the administered
p.(None): dose. The types of adverse reactions shall be:
p.(None): a) "unexpected" – an adverse drug reaction, which has not been mentioned in the summary of product
p.(None): characteristics of the character, severity, and outcome of which do not comply with those mentioned in the
p.(None): summary of product characteristics. In case of a clinical test
p.(None): – an adverse drug reaction the character, severity, and outcome of which do not comply with the information for the
p.(None): study medicinal product mentioned in the researcher’s brochure;
p.(None): b) "suspected" – and adverse drug reaction fore which the reporter or the marketing authorisation holder supposes that
p.(None): there is a possible causal relationship with a taken medicinal product;
p.(None): c) "serious" – any unfavorable effect on the health condition, which has become the reason for a lethal outcome,
p.(None): immediate threat to life, hospitalisation, or prolongation if hospitalisation, significant or durable injury,
p.(None): disability, and innate anomalies;
p.(None): d) combination of reactions according to subsections "a", "b", and "c".
p.(None): 42. "Common name" shall mean the international non-proprietary name (INN) of a medicinal substance or
p.(None): excipient recommended by the World Health Organisation; if not any, the name in the European Pharmacopoeia shall be
p.(None): used; if there is no such name there, another pharmacopoeia name shall be used; if there is no pharmacopoeia name, the
p.(None): common name shall be used.
p.(None): 42a (new – SG, 102/2012, in force from 21.12.2012) "Basic documentation of a system of pharmaco-vigilance" is a detail
p.(None): description of the pharmaco-vigilance system, used by the marketing authorisation holder in relation or one or more
p.(None): authorised for use medicinal products.
p.(None): 42b. (new - SG48/15) "Health technology assessment" shall mesn:
p.(None): a) a form of policy on research that examines the short- and long-term outcomes related to the implementation of
p.(None): health technologies and aims to provide information concerning alternative health strategies;
p.(None): b) multidisciplinary activity that systematically evaluates technical specifications, safety, clinical efficacy and
p.(None): effectiveness, cost, cost effectiveness, organizational, social, legal and ethical consequences of
p.(None): administration of medicinal products in health care and focuses on value - clinical and economic, provided
p.(None): that the analysis is comparative to existing or best alternative at the time;
p.(None):
p.(None): 43. "Batch" shall mean a definite quantity of a medicinal product manufactured according to an established reproducible
p.(None): technological scheme ensuring the required batch homogeneity with respect to the required quality characteristics.
...
p.(None): with the requirements of Art. 27.
p.(None): 64. "Reference value of a defined daily dose" on an international non-proprietary name with the corresponding
p.(None): pharmaceutical for according to the anatomo-therapeutic classification of medicinal products shall mean the lowest
p.(None): value of a defined daily dose determined on the basis of the values of a defined daily dose for various medicinal
p.(None): products for the international non-proprietary with the corresponding pharmaceutical form according to the
p.(None): anatomo- therapeutic classification of medicinal products.
p.(None): 65. "Reference value of a therapeutic course" shall be the lowest value of a therapeutic course determined on the basis
p.(None): of the values of a therapeutic course of the medicinal products according to international non-proprietary name with
p.(None): the corresponding pharmaceutical form.
p.(None): 66. "Risk during the use of a medicinal product" shall mean:
p.(None): a) risk for the health of the patient or risk for the health of the population, which is associated
p.(None): with the quality, safety, or efficacy of a medicinal product;
p.(None): b) risk of undesirable effects on the environment.
p.(None): 67. "Serious adverse event" shall mean any unfavorable change in the health condition,
p.(None):
p.(None): which has become the cause of lethal outcome, immediate threat to life, hospitalisation or extension of
p.(None): hospitalisation, significant or durable injury, disability, and innate anomalies.
p.(None): 68. "Batch release certificate" shall mean a document issued for each batch by the qualified person of the
p.(None): manufacturer or importer and shall include the requirements according to the specification, as well as all results from
p.(None): the tests for the release of the batch.
p.(None): 69. "Additional protection certificate" shall mean a document, which shall provide additional patent
p.(None): protection for a medicinal product of maximum 5 years after the lapse date of the main patent.
p.(None): 69a (new – SG, 102/2012, in force from 21.12.2012) "Risk management system" is a system of measures and
p.(None): activities for pharmaco-vigilance, intended for identification, characteristics, prevention or setting to
p.(None): minimum risks, related to the medicinal product, including effectiveness assessment of these activities and measures.
p.(None): 69b (new – SG, 102/2012, in force from 21.12.2012) "Pharmaco-vigilance system" is a system, used by the marketing
p.(None): authorisation holder and BDA for implementation of the tasks and responsibilities under Chapter Eight, intended for
p.(None): observation of vigilance of the permitted for use medicinal products and for finding every change in the benefit/risk
p.(None): ratio.
p.(None): 70. "Urgent limitation safety measures" shall mean temporary changes in the product information with respect of one
p.(None): or more parts of the summary of product characteristics, indications, method of administration,
p.(None): contraindications, and warnings, which result from new information associated with the safe use of a medicinal product.
...
Health / Mentally Incapacitated
Searching for indicator incapable:
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p.(None): determined by the regulation according to Art. 170.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): has:
p.(None): Art. 96. (1) A clinical test with medicinal products shall only be allowed in a person who
p.(None):
p.(None): 1. been informed in a preliminary conversation with a physician member of the study
p.(None): team about the purposes, risks and inconveniences of the study and about the conditions in which it is to be conducted;
p.(None): 2. been informed about his/her right to withdraw from the study at any time without this having any negative
p.(None): consequences for him/her;
p.(None): 3. personally given written informed consent to participate having been familiarised of the essence, importance,
p.(None): consequences, and eventual risks of the clinical test.
p.(None): (2) Where the person cannot write, the informed consent to participate in the clinical test shall be given by word of
p.(None): mouth in the presence of at least one independent witness who shall certify in writing that this subject has expressed
p.(None): informed consent to participate in the clinical test in person.
p.(None): (3) The informed consent according to para 1, point 3, and para 2 can only be given by a capable person who
p.(None): understands the essence, importance, scope, consequences, and eventual risks of the clinical test. Informed
p.(None): consent to participate in a clinical test can be withdrawn at any time.
p.(None): (4) The informed consent according to para 1, point 3, of an incapable major person shall be given by his/her
p.(None): legal representative. The consent of the legal representative must represent the supposed will of the subject
p.(None): and can be withdrawn at any time without negative consequences for the subject.
p.(None): (5) In the cases according to Art. 162, para 3 of the Health Act, informed consent shall be given by the person
p.(None): appointed by the court.
p.(None): (6) An incapable person shall be given information about the clinical test, eventual risks, and benefits in accordance
p.(None): with his/her capability to understand.
p.(None): (7) The explicit will of an incapable major person to refuse to participate in or to withdraw from the clinical test at
p.(None): any time must be taken into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None):
p.(None): Art. 97. (1) A clinical test in a minor person shall be conducted after obtaining written informed consent by both
p.(None): subject’s parents or guardians with observation of Art. 96, para 1 and 3.
p.(None): (2) Parents’ or guardians’ consent must represent the supposed will of the minor person and can be withdrawn at any
p.(None): time without negative consequences for the minor person.
p.(None): (3) The express will of the minor person to participate or to at any time withdraw from the clinical test must be taken
p.(None): into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (4) A clinical test in a minor person shall be conducted after obtaining written informed consent by both parents and
p.(None): the guardian in compliance of Art. 96, para 1 and 3. Where one of the parents is unknown, deceased, or deprived of
...
p.(None): the respective ethics committee according to Art. 103 the following documentation:
p.(None): 1. administrative documentation;
p.(None): 2. subject information;
p.(None): 3. documentation about the study protocol;
p.(None): 4. documentation about the study medicinal product(s);
p.(None): 5. documentation about the technical requirements and about the staff;
p.(None): 6. data about the financing and administrative organisation of the clinical test.
p.(None): (2) The content, form, and requirements to the documentation according to para 1 shall be determined in the regulation
p.(None): according to Art. 82, para 3.
p.(None):
p.(None): Art. 111. (1) The ethics committee shall establish an opinion taking into consideration the following:
p.(None): 1. importance of the clinical test;
p.(None): 2. positive assessment of the ratio between the anticipated benefits and risks according to Art. 90, para 1, and the
p.(None): motivation of the conclusions;
p.(None): 3. protocol of the clinical test;
p.(None): 4. to what extent the principal researcher and the study team are adequate for the conduct of the
p.(None): clinical test;
p.(None): 5. researcher’s brochure;
p.(None): 6. availability of the required equipment and its adequate quality;
p.(None): 7. compliance and completeness of the written information, which is to be given, as well as the procedure for obtaining
p.(None): informed consent and the validity of the clinical test in human subjects incapable of giving informed consent in the
p.(None): cases according to Art. 100 and 101;
p.(None): 8. provided indemnity or recovery in case of injury or death, which could result from the clinical test;
p.(None): 9. insurance covering researcher or contracting authority liability;
p.(None): 10. where necessary, the conditions and order for remuneration or indemnification of study researchers and subjects
p.(None): and the elements of the contract between the contracting authority and the healthcare establishment;
p.(None): 11. conditions and order for subject recruitment.
p.(None): (2) The ethics committee shall:
p.(None): 1. give positive opinion;
p.(None): 2.. refuse in a motivated manner, or
p.(None): 3. request amendment of a part of the documentation as a condition for obtaining a positive opinion.
p.(None):
p.(None):
p.(None): Art. 112. (1) Within 60 days from the submission of an application, the ethics committee shall pass resolution with an
p.(None): opinion, which shall be sent to the applicant and the BDA.
p.(None): (2) Where the clinical test involves a medicinal product for gene therapy or somato- cellular therapy or a medicinal
p.(None): product containing genetically modified organisms, the time limit according to para 1 shall be extended by 30 days.
p.(None): (3) Where for the review of a clinical test involving a medicinal product for gene therapy or somato-0-cellular therapy
...
p.(None): shall be punished by the fine under para 1, and in repeated perpetration of the infringement the issued
p.(None): registration of the drug store will be deprived of.
p.(None): (4) In the cases according to para 1 and 2, the bodies of the state control on the medicinal products
p.(None): shall stop the operation of the site by an order.
p.(None): (5) The order according to para 4 shall be subject to appeal under the terms of the Administrative Procedure Code;
p.(None): however, the appeal shall not stop its execution.
p.(None): (6) (Repealed - SG 71/2008 in force from 12.08.2008).
p.(None):
p.(None):
p.(None): Art. 287a. (New - SG 71/2008 in force from 12.08.2008). (1) Medical specialist, who works with persons,
p.(None): performing retail trade with medicinal products, without having authorisation/certificate for this, shall
p.(None): be punished by a fine of BGN 2500 to 5000
p.(None): (2) The punishment under para 1 shall be imposed on a person under para 1, who works in a pharmacy or a drugstore after
p.(None): termination of the action of the authorisation/certificate.
p.(None): (3)In case of established more than 2 violations under para 1 and 2, the Minister of Health may deprive the medical
p.(None): specialist of the right to exercise his/her profession for the term of up to 2 years.
p.(None):
p.(None):
p.(None): Art. 287b. (new – SG, 102/2012, in force from 02.01.2013) Anyone, who carries out trade with medicinal products on
p.(None): internet in violation of this act and the ordinance under Art. 234, Para. 5 shall be punished by a fine of BGN 5000 to
p.(None): 10 000.
p.(None):
p.(None):
p.(None): Art. 288. (1) A retailer in medicinal products who has permitted an incapable person to exercise activities, pointed
p.(None): out in Art. 219, shall be penalised with a property sanction from BGN 5,000 to BGN 10,000 and in case of repeated
p.(None): perpetration of the infringement the issued retail trade authorisation shall be bereaved.
p.(None): (2) In the cases according to para 1 the bodies of the state control shall stop the operation of the
p.(None): site by an order.
p.(None):
p.(None):
p.(None): Art. 289. (1) (prev. text of Art. 289 – SG 60.12, in force from 07.08.2012) Whoever sells medicinal products on prices
p.(None): different from those formed under the terms of this law shall be penalised with a fine from BGN 5,000 to BGN 10,000 and
p.(None): in case of repeated perpetration of the same infringement – with a fine from BGN 6,000 to BGN 12,000.
p.(None): (2) (new – SG 60.12, in force from 07.08.2012, amend. – SG, 102/2012, in force from 21.12.2012) A marketing
p.(None): authorisation holder who fails to fulfill an obligation set out by the Ordinance under Art. 261a, Para. 5,
p.(None): shall be punishable by property sanction amounting from BGN 5000 to BGN 10 000, and in case of repeated offence – by a
p.(None): property sanction amounting from BGN 10 000 to BGN 20 000.
p.(None): (3) (new - SG, 102/2012, in force from 21.12.2012). The violations under Para. 1 and 2 shall be found out by acts,
p.(None): drawn up by officials, determined by the Council chairperson under Art. 258, Para. 1, and the penal decrees shall be
p.(None): issued by the Council chairperson under Art. 258, Para. 1 or a council member, authorised by him/her.
p.(None):
p.(None): Art. 289a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG, 102/2012, in force from 21.12.2012) whoever
...
p.(None): substance or a therapeutically significant part of a studied medicinal product reach from the pharmaceutical form to
p.(None): the systemic circulation of the blood.
p.(None): 20. "Study medicinal product" shall mean a pharmaceutical form of an active substance or placebo, which are
p.(None): investigated or used as comparators in a clinical test including products with granted marketing authorisation but are
p.(None): used in an unauthorised indication or with a view of obtaining additional information for an authorised form, or are
p.(None): made up (in a pharmaceutical form or packaged) in a manner, which is different from the authorised form.
p.(None): 21. "Researcher" shall mean an appointed by the contracting authority and the principal researcher medical doctor or
p.(None): doctor in dental medicine who practically conducts a clinical test under the management of a principal researcher in
p.(None): compliance with an approved protocol and the guidelines for Good Clinical Practice in an investigational site for the
p.(None): conduct of a clinical test. If a clinical test is not conducted by a team, the researcher shall be the manager
p.(None): responsible for the team and shall be called principal researcher.
p.(None): 22. "Informed consent" shall mean a decision to participate in a clinical test, which must be in writing, dated and
p.(None): signed and taken freely by any person capable of giving his consent or
p.(None): – where a person is incapable of giving his consent by his legal representative after being duly informed about the
p.(None): essence, importance, consequences and risks of a clinical test and documented in an adequate manner.
p.(None): 23. "Kit" shall mean any substance, which – usually before use – shall be dissolved, suspended, diluted, or combined
p.(None): with radionuclides as a result of which procedure the finished radioactive medicinal product is obtained.
p.(None): 24. "Clinical test of a medicinal product" shall mean any study in man intended for discovering or
p.(None): confirming clinical, pharmacological, and/or other pharmacodynamic effects of one or more study medicinal products, and
p.(None): /or for determination of the adverse reactions to one or more study medicinal products, and/or for studying the
p.(None): absorption, distribution, metabolism, and excretion of one or more study medicinal products with the purpose of
p.(None): establishing their safety and/or efficacy.
p.(None): 25. "Clinical advantage" shall mean a significant therapeutic or diagnostic advantage of a medicinal product compared
p.(None): to a medicinal product, which has already received marketing authorisation.
p.(None): 26. "Coordinating researcher" shall mean a researcher appointed for the purpose of coordinating the researchers or
p.(None): various sites participating in a multicentre test.
p.(None): 27. "Patient information leaflet" shall mean a leaflet accompanying a medicinal product and containing information for
p.(None): the customer.
p.(None): 27a. (New - SG 71/2008 in force from 12.08.2008, amend. – SG, 102/2012, in force from 21.12.2012) "Medicinal product
p.(None): for modern therapy" is a medicinal product, determined in Art. 2 of Regulation (EC) N 1394/2007 of the European
...
Health / Physically Disabled
Searching for indicator illness:
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p.(None): only under strict doctor’s control in a medical establishment for medicinal help and in case of
p.(None): radiopharmaceutical specialist – only under the control of an authorised person;
p.(None): 3. the leaflet, as well as in any medical information, attached to the medicinal product should contain a text, which
p.(None): pays attention to the medicinal specialists, that some of the available data for the medicinal product are subject to
p.(None): further researches.
p.(None): (3) The marketing authorisation/registration certificate under Para. 1 shall be issued for the term of 1 year and for
p.(None): each following year may be extended on the basis of an assessment of the fulfillment of the conditions under Para. 2.
p.(None):
p.(None):
p.(None): Art. 56a (new – SG, 102/2012, in force from 21.12.2012) (1) After issuing the marketing authorisation/registration
p.(None): certificate, BDA may olige the holder of the marketing authorisation/registration certificate
p.(None): to conduct:
p.(None): 1. post-marketing safety research, if there are concerns for identified or potential risks or lack of information,
p.(None): related to vigilance the medicinal safety for the relevant medicinal product, where the same risks refer to other
p.(None): medicinal products, after consultations with the Committee for risk assessment in the area of the pharmacologic
p.(None): awareness, established under Art. 56, Para. 1, letter "aa" of Regulation (EC) N 726/2004 of the European Parliament and
p.(None): of the Council, BDA recommends to the relevant holder of marketing authorisation to conduct a mutual safety
p.(None): research with the other concerned holders of authorisation;
p.(None): 2. post-marketing efficiency research, where the knowledge about the illness or the used clinic methodology gives
p.(None): ground for revision of the efficiency assessment, the conclusions about which have been made on the date of issuance of
p.(None): the authorisation.
p.(None): (2) The BDA shall notify in writing the owner of the marketing authorisation/registration certificate for the
p.(None): obligation under Para. 1, by grounding the reasons and indicating the objectives of the research and the terms for its
p.(None): conducting.
p.(None): (3) Within 30-day term after receiving the notification under Para. 2, the owner of the marketing
p.(None): authorisation/registration certificate may request from BDA granting a possibility for providing information about the
p.(None): obligations under Para. 1.
p.(None):
p.(None): (4) After receiving the request under Para. 3, the BDA shall set a term for provision of the information by the
p.(None): authorisation/registration certificate holder.
p.(None): (5) The BDA after information analysis under Para. 3, may:
p.(None): 1. confirm the obligation under Para. 1, or
p.(None): 2. repeal it.
p.(None): (6) The BDA shall notify the holder about the decision, taken under Para. 5.
p.(None): (7) In the cases under Para. 5, p. 1, the BDA executive director shall officially amend the issued marketing
p.(None): authorisation/registration certificate of the medicinal product by including in it the obligation under Para. 1 as a
p.(None): condition.
p.(None): (8) The grounds for imposing the obligations under Para. 1, p. 2 shall be determined by a delegated instrument under
p.(None): Art. 22b of Directive 2001/83/EC.
p.(None):
p.(None):
p.(None): Art. 56b (new – SG 102/2012, in force from 21.12.2012) (1) The holder of the marketing authorisation/registration
p.(None): certificate shall include in his/her risk management system all the conditions under Art. 551,56 and 56a.
...
p.(None): (2) The BDA internet site under Para. 1 shall be connected with the internet site of the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 234b (new – SG, 102/2012, in force from 02.01.2013) The BDA shall participate in information campaigns, organised
p.(None): by the European Commission and the European Medicines Agency about the danger of falsified medicinal products.
p.(None):
p.(None): Art. 235. (1) The authorisation to carry out retail trade with medicinal products shall be cancelled with the
p.(None): termination of the activity of the persons according to Art. 222.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The executive director of BDA shall cancel the authorisation for
p.(None): retail trade with medicinal products:
p.(None): 1. according to an application by the person who has received authorisation for carrying out retail trade with
p.(None): medicinal products:
p.(None): 2. wherever it has been established that the manager of the pharmacy does not comply with the requirements laid down in
p.(None): Art. 224 and 225.
p.(None): (3) (Amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 222 and 225 shall notify the BDA in
p.(None): writing within 14 days of the termination of the activity according to para 1.
p.(None):
p.(None):
p.(None): Art. 236. (1) The pharmacy cannot be closed for more than 30 days within a calendar year due to the absence of the
p.(None): manager.
p.(None): (2) (suppl. – SG 71/2008, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011, amend. – SG,
p.(None): 60/2011, in force from 5. 8. 2011) Where the manager of the pharmacy is not in a position to fulfil his
p.(None): obligations due to a leave for temporary incapacity of work due to an illness, pregnancy and birth, or adoption and
p.(None): leave for breeding of a little child, as per Labour Code, the pharmacy can operate under the management of another
p.(None): master of pharmacy, respectively another assistant pharmacist, in the cases to Art. 225 complying with the requirements
p.(None): of Art. 224 for not more than two years. In all these cases a permission of the executive director of BDA shall be
p.(None): issued.
p.(None): (3) The permission according to 2 shall be issued within 30 days.
p.(None):
p.(None):
p.(None): Art. 237. Upon termination of the activity of the person who received authorisation to retail trade with medicinal
p.(None): products, the medicinal products can be sold by persons who have received authorisation for wholesale trade in
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
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Health / Pregnant
Searching for indicator pregnant:
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p.(None): clinical trials is permitted provided that:
p.(None): 1. the respective ethics committee with the participation of a specialist competent in the respective disease or in the
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
p.(None): consent or of data obtained through other research methods;
p.(None): 4. the study is directly associated with a disease, which is life-threatening or resulting in disability, from which
p.(None): the major person who is not capable of giving informed consent is suffering;
p.(None): 5. the clinical trials are planned in such manner that pain, inconvenience, fear, and the other foreseeable risks
p.(None): associated with the disease are minimised and the risk threshold and physical pain degree have been determined in
p.(None): advance and shall be incessantly controlled throughout the clinical test;
p.(None): 6. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 102. No clinical test with a medicinal product can be conducted in pregnant women or breastfeeding mothers except
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
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Health / Unconscious People
Searching for indicator unconscious:
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p.(None): 5. Committee for radiopharmaceuticals.
p.(None): 6. (new – SG, 71/2008, in force from 12.08.200) Commission for medicinal products with application in podiatry;
p.(None): 7. (amend. – SG, 71/2008, in force from 12.08.200) Commission for medicinal products for modern therapies;
p.(None): 8. (new - SG, 71/2008, in force from 12.08.200) commission for risk assessment at
p.(None):
p.(None): pharmaco-vigilance medicinal safety.
p.(None): (2) In case of necessity, the executive director of the BDA may also establish specialised committees other than those
p.(None): mentioned in para 1.
p.(None): (3) The specialised committees shall involve medical and other specialists with scientific achievements and practical
p.(None): experience in the respective fields of application of the medicinal products.
p.(None): (4) External specialists with scientific achievements and practical experience in the field of a specific group of
p.(None): medicinal products may be involved in the standing staff of the committees.
p.(None): (5) The executive director of the BDA shall appoint by an order the composition of the committees for a period of three
p.(None): years, the amount of their remuneration and shall approve a regulation on the conditions and order of their work.
p.(None): (6) Not later than 30 January of each year, the executive director of the BDA shall approve lists of the
p.(None): experts outside the composition of the committees according to para 1 after receiving the approval of the Minister of
p.(None): Health.
p.(None): (7) The executive director of the BDA may ahead of term dismiss a member of a specialised committee on
p.(None): his own request, in case of failure to fulfil his obligations for a period of more than three months, or in case of
p.(None): unconscious conduct of his functions.
p.(None): (8) The composition of the committees and the list of experts according to para 6 shall be published on the internet
p.(None): site of the BDA.
p.(None):
p.(None):
p.(None): Art. 48. (1) The members of the specialised committees according to Art. 47, para 1, and the experts according to Art.
p.(None): 47, para 4, shall sign a declaration to the effect of their obligation:
p.(None): 1. not to disclose data and circumstances, which have become known to them during or on the occasion of the conduct of
p.(None): their activities;
p.(None): 2. not to be involved in activities associated with the manufacture of or wholesale or retail trade in medicinal
p.(None): products.
p.(None): (2) In case the persons according to para 1 have been involved in the stages or preparation of the
p.(None): documentation necessary for the marketing authorisation of a medicinal product, they shall not participate
p.(None): in the sessions of the respective specialised committee according to Art. 47.
p.(None): (3) The persons according to para 1 shall not vote during making of a decision on issues in which they or members of
p.(None): their families have commercial, financial, or other interests.
p.(None):
p.(None):
p.(None): Art. 49. (1) (amend. – SG, 102/2012, in force from 21.12.2012) Within 200 days from the receipt of a valid
p.(None): documentation, the BDA, jointly with the respective committee according to Art. 47, Para. 1, shall assess the quality,
p.(None): safety, and efficacy of the medicinal product and shall establish an assessment report, with comments of the result of
p.(None): the pharmaceutical an pre-clinic tests, clinic studies of the system for risk management and of the system for safety
p.(None): vigilance of the relevant medicinal product.
...
Health / breastfeeding
Searching for indicator breastfeeding:
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p.(None): 1. the respective ethics committee with the participation of a specialist competent in the respective disease or in the
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
p.(None): consent or of data obtained through other research methods;
p.(None): 4. the study is directly associated with a disease, which is life-threatening or resulting in disability, from which
p.(None): the major person who is not capable of giving informed consent is suffering;
p.(None): 5. the clinical trials are planned in such manner that pain, inconvenience, fear, and the other foreseeable risks
p.(None): associated with the disease are minimised and the risk threshold and physical pain degree have been determined in
p.(None): advance and shall be incessantly controlled throughout the clinical test;
p.(None): 6. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 102. No clinical test with a medicinal product can be conducted in pregnant women or breastfeeding mothers except
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
...
Health / ill
Searching for indicator ill:
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p.(None): Medicine Act;
p.(None): 4. a verified copy of the employment contract with the manager of the pharmacy – where such is required;
p.(None): 5. a declaration by the persons as per Art. 222, para 1 that the requirements under which is granted the authorisation
p.(None): for retail trade in medicinal products to persons under para 1, have been met;
p.(None): 6. a document issued by the mayor of the respective municipality verifying the number of citizens in the respective
p.(None): populated area;
p.(None): 7. a document for paid fee amounting to 100 BGN.
p.(None):
p.(None):
p.(None): § 5. Within three months from the entry into force of this Act the Minister of Health shall make the respective
p.(None): amendments in the ordinance as per Art. 219, para 2.
p.(None):
p.(None):
p.(None): § 6. The Act shall enter into force from the date of its promulgation in the State Gazette.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE MEDICAL ESTABLISHMENTS ACT
p.(None):
p.(None): (PROM. – SG 59/10, IN FORCE FROM 31.07.2010)
p.(None):
p.(None): § 77. The Act shall enter into force from the day of its promulgation in the State Gazette, except for:
p.(None): 1. paragraphs 9 (regarding Art. 19, para. 4), 53, 60 and 66 (regarding Art. 98, para 5 and 6), which shall enter into
p.(None): force from 1 January 2011;
p.(None): 2. paragraph 75, which shall enter into force from 30 September 2011.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT ON THE BUDGET OF THE NATIONAL HEALT HINSURANCE FUND FOR YEAR 2011
p.(None):
p.(None): (PROM. – SG 98/2010, IN FORCE FROM 01.01.2011)
p.(None):
p.(None): § 5. (1) In year 2011 activities on diagnosing and treatments of malignant illnesses and of ill of renal insufficiency
p.(None): treated with dialysis, including provision of the medical products and articles, as well as the other medical
p.(None): activities, which in 2010 has been funded through the budget of the Ministry of Health and through the
p.(None): assigned by the state activities to the
p.(None):
p.(None): municipalities, shall be paid with the funds envisaged in Art. 1, Para 2, line 5.
p.(None): (2) Activities, medical products and articles envisaged in Para 1 shall be paid under a procedure and method,
p.(None): determined by the Minister of Health.
p.(None): (3) Funds envisaged in Art.1, Para 2, line 5 shall be transferred monthly the end of the current month.
p.(None):
p.(None):
p.(None): § 7. Supervising Board of the National Health Insurance Fund shall be entitled to execute internal compensated changes
p.(None): of the credits between the elements of the expenses and of the transfers envisaged in Art.1, Para 2, which shall be
p.(None): within the frames of the approved budged.
p.(None):
p.(None):
p.(None): § 8. Supervising Board of the National Health Insurance Fund, on the grounds of Art. 26, Para 2 of the Health
p.(None): Insurance Act, shall be entitled to spend the funds of the reserve for unexpected and urgent expenditures
p.(None): envisaged in Art.1, Para 2, line 3.
p.(None): ………….
p.(None):
p.(None):
p.(None): § 15. This Act shall enter into force from 1st of January 2011, except for § 10, which shall enter into force from the
p.(None): day of its promulgation in the State Gazette.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE HEALTH ACT
p.(None):
p.(None): (PROM. - SG 98/2010, IN FORCE FROM 01.01.2011)
p.(None):
p.(None): § 106. In the Medicinal Products in Human Medicine Act (prom. – SG 31/2007; amend.
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): the Regional health inspectorates (RHI) in the field of the control on the medicinal products.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The implementation of this act measures, related to
p.(None): prevention of entering and dissemination of falsified medicinal products shall be carried out in cooperation
p.(None): between the Bulgarian Drug Agency and the customs authorities.
p.(None):
p.(None): Art. 17a (New – SG, 60/2011, in force from 05.08. 2011) The Regional health inspectorates shall issue
p.(None): authorisations for registration of drug stores.
p.(None):
p.(None):
p.(None): Art. 17b. (new – SG 18/14) (1) Expert drug retail trade council shall be set up subordinated to the
p.(None): Managing Director of the BDA including three representatives of Bulgarian Pharmaceutical Association, one
p.(None): representative of every Pharmaceutical department of Higher Medicinal Schools and four representatives of the BDA. The
p.(None): members of the council shall be appointed by an order of the Managing Director of BDA agreed by the Minister of Health.
p.(None): (2) The council referred to in par. 1 is a consultancy unit, which shall:
p.(None): 1. issue opinions on the submitted to the BDA applications and documents under Art. 228, par. 1 and 5 which they are
p.(None): submitting to the Managing Director of BDA;
p.(None): 2. make justified proposals to the Minister of Health through the Managing Director of BDA for improvement of the
p.(None): access of individuals to drugs.
p.(None): (3) The organization and the activity of the expert council under par. 1 shall be regulated by regulations issued by
p.(None): the Managing Director of BDA upon council’s proposal.
p.(None): (4) The members of the expert council referred to in par. 1 shall not get paid for the participation in council
p.(None): meetings.
p.(None): (5) The expert council referred to in par. 1 shall report on their activity on an annual basis to the Minister of
p.(None): Health.
p.(None):
p.(None):
p.(None): Art. 17c. (new – SG 18/14) Cannot be members of the expert council referred to in Art.
p.(None): 17b, par.1 persons who are:
p.(None): 1. owners, members of managing and supervisory bodies of business companies or sole traders with a scope of business
p.(None): production, import, wholesale or retail trade with drugs;
p.(None): 2. partners or shareholders holding more than 5 per cent of the equity of business companies with a scope
p.(None): of business production, import, wholesale or retail trade with drugs or working under a full time employment agreement
p.(None): in such companies.
p.(None):
p.(None): Section II. Registers
p.(None):
p.(None): Art. 18. (Repealed - SG, 60/2011, in force from 05.08. 2011)
p.(None):
p.(None):
p.(None): Art. 19. (1) The Bulgarian Drug Agency shall keep registers of:
p.(None): 1. (amend. – SG, 102/2012, in force from 21.12.2012) manufacturers and importers of medicinal products on the territory
p.(None): of the Republic of Bulgaria and qualified persons according to Art. 148, point 2,and Art. 161, Para. 2, p. 1;
p.(None): 2. (amend. – SG, 102/2012, in force from 21.12.2012) the manufacturers, importers and the wholesale traders of active
p.(None): substances;
p.(None): 3. authorised/registered medicinal products on the territory of the Republic of Bulgaria;
...
p.(None): the procedure shall be terminated and the clinical test shall no be conducted.
p.(None):
p.(None):
p.(None): Art. 119. (1) Within 60 days of the date of submission of an application for a clinical test with the medicinal
p.(None): products according to Art. 109, point 2,, the executive director of the BDA shall:
p.(None): 1. issue authorisation for the conduct of the clinical test, or
p.(None): 2. issue a motivated refusal.
p.(None): (2) The refusal according to para 1, point 2, shall be subject to appeal under the terms of the Administrative
p.(None): Procedure Code.
p.(None):
p.(None):
p.(None): Art. 120. (1) In case of medicinal products according to Art. 109, point 2, letters "a" - "c" the time limit according
p.(None): to Art. 119, para 1, for the issue of authorisation by the BDA for the conduct of a clinical test can be extended by 30
p.(None): days.
p.(None): (2) Provided that the BDA should consult the expert commission according to Art. 112, para 3, which is to assess the
p.(None): safety of the medicinal products according to para 1, the extended time limit according to para 1 can be extended by
p.(None): another 90 days.
p.(None):
p.(None):
p.(None): Art. 121. The executive director of the BDA shall refuse to issue authorisation for the conduct of a clinical test of
p.(None): medicinal products for gene therapy where there is a risk of modifying the genome of the reproductive cells of a study
p.(None): subject.
p.(None):
p.(None):
p.(None): Art. 122. (1) In case of a multicentre clinical test in the Republic of Bulgaria and in a third
p.(None):
p.(None): state, the BDA shall request the contracting authority to submit a declaration that he shall provide access to
p.(None): representatives of the BDA for inspection aimed at the establishment of compliance with the requirements and principles
p.(None): of Good Clinical Practice and Good Manufacturing Practice.
p.(None): (2) Provided that the contracting authority should not submit the declaration according to para 1, the BDA shall not
p.(None): review the submitted application.
p.(None):
p.(None):
p.(None): Art. 123. The contracting authority shall declare that the documentation submitted to the BDA and the ethics committee
p.(None): contains the same information.
p.(None):
p.(None):
p.(None): Art. 124. (1) The procedures in the ethics committee and in the BDA can be carried out simultaneously or consecutively
p.(None): at the discretion of the contracting authority.
p.(None): (2) The time limit for documentation review according to Art. 118, para 1, shall not cease to run in case of lack of
p.(None): decision of the ethics committee.
p.(None):
p.(None):
p.(None): Art. 125. The clinical test shall be conducted in compliance with the study protocol, which has received positive
p.(None): opinion of the respective ethics committee according to Art. 103 and under the conditions set out in the submitted
p.(None): documentation.
p.(None):
p.(None): Section V. Amendments
p.(None):
p.(None): Art. 126. (1) The contracting authority can at any time make amendments in the study protocol different from the
...
p.(None): 1. ensure the performance of the manufacturing operations in compliance with the requirements of the Good
p.(None): Manufacturing Practice and in compliance with the information according to Art. 27, Para. 1, points 7
p.(None): and 8 approved from the BDA, and in the cases of medicinal products for clinical trials – in compliance with
p.(None): the information according to Art. 110, Para. 1, point 4 submitted to the agency by the contracting authority.
p.(None): 2. (amend. – SG, 102/2012, in force from 02.01.2013) use only active substances, which have been manufactured in
p.(None): compliance with the requirements of the Good Manufacturing Practice for active substances;
p.(None): 2a. (new – SG, 102/2012, in force from 02.01.2013) be certain that the assisting substances, put in the
p.(None): medicinal products are manufactured in compliance with the appropriate Good manufacturing practices for assisting
p.(None): substances, determined on the basis of an official risk assessment in compliance with the applicable directives,
p.(None): adopted by the European Commission;
p.(None): 3. ensure on a permanent basis qualified personnel for the production and control according to the
p.(None): requirements the regulation according to Art. 152;
p.(None): 4. (amend. – SG 12/11, in force from 08.02.2011) only dispose of medicinal products, which have marketing authorisation
p.(None): fulfilling the requirements of this Act;
p.(None): 5. (revoked – SG 12/11, in force from 08.02.2011);
p.(None): 6. immediately notify the control bodies in case of substitution of the qualified person according to Art. 148, point
p.(None): 2;
p.(None): 7. ensure access of the control bodies to the premises and the documentation at any
p.(None): time;
p.(None): 8. ensures to the qualified person according to Art. 148, point 2 the required condition
p.(None): to fulfill his obligations.
p.(None): 9. (new – SG, 102/2012, in force from 02.01.2013) inform immediately the BDA and the use authorisation holder, if
p.(None): information is received that the medicinal products, which fall in the scope of hi/her manufacture automation, are
p.(None): falsified or there are suspects for falsification, notwithstanding of the fact whether these medicinal products
p.(None): have been disseminated within the
p.(None):
p.(None): frames of the legal supply or an illegal way, including through illegal sale through the services of the information
p.(None): society;
p.(None): 10 (new – SG, 102/2012, in force from 02.01.2013) check if the manufacturers, importers or traders, from whom he/she
p.(None): receives active substances have been register by the competent body of the Member state in which they are established;
p.(None): 11. (new – SG, 102/2012, in force from 02.01.2013) check up the authenticity and quality of the active and assisting
p.(None): substances.
p.(None): (2) (new – SG, 102/2012, in force from 02.01.2013) The manufacturing authorisation holder shall perform audits in
p.(None): the production sites and trade with active substances for observation of the Good manufacturing practice
p.(None): and the Good distribution practice. The manufacture authorisation holder may sign a contract with a third person
p.(None): to carry out the audit on his/her behalf and on his/her account.
p.(None): (3) (new – SG, 102/2012, in force from 02.01.2013) The manufacturing authorisation holder shall document the undertaken
...
p.(None): which shall contain:
p.(None): 1. certificate number and date;
p.(None): 2. number of the authorisation for wholesale of medicinal products and the issuing body;
p.(None): 3. name, place of business and address of management of the person who has received the certificate;
p.(None): 4. data for the person according to Art. 199, para 2, p. 2;
p.(None): 5. date of deletion of the certificate from the register and reason therefore;
p.(None): 6. remarks relating to the inscribed circumstances.
p.(None): (3) Data from the register shall be published on the internet site of the BDA.
p.(None): (4) (new – SG, 102/2012, in force from 02.01.2013) The BDA shall introduce to the data base under Art. 147
p.(None): information about the issued authorisations for wholesale trade with medicinal products.
p.(None): (5) (new – SG, 102/2012, in force from 02.01.2013) Upon request by the European Commission or by a Member State,
p.(None): BDA shall provide information about an issued authorisation for wholesale trade with medicinal products.
p.(None):
p.(None):
p.(None): Art. 206. (1) In case of change of the circumstances associated with the issued wholesale authorisation,
p.(None): its holder shall summit to the BDA an application under the terms of Art. 199 and append the documentation associated
p.(None): with the change.
p.(None): (2) The change authorisation shall be issued under the conditions and under the terms of Art. 200-202. In case of
p.(None): change of the premises for storage, the term according to Art. 202 shall apply and for the other cases the term shall
p.(None): be 14 days.
p.(None):
p.(None): Art. 207. (1) The wholesale authorisation holder who conducts his activity on the territory of the Republic of Bulgaria
p.(None): shall be obliged to:
p.(None): 1. at any time ensure access of the control bodies to the premises for storage of the medicinal products;
p.(None): 2. only trade in medicinal products authorised to the order of this Act;
p.(None): 3. trade in medicinal products, whose packaging and leaflets of which are in compliance with the issued marketing
p.(None): authorisation and under the terms of this Act and the expiry term of which has not elapsed;
p.(None): 4. only supply medicinal products from manufacturers, importers, and wholesalers of medicinal products who have
p.(None): received authorisation to perform such activity under the terms of this Act;
p.(None): 4a (new – SG, 102/2012, in force from 02.01.2013) check whether the received medicinal products from the
p.(None): persons under p. 4 have been falsified by a checkup of the safety indicators on the secondary packing;
p.(None): 5. supply medicinal products to other wholesale authorisation holders, pharmacies, and drugstores, opened under the
p.(None): terms of this Act;
p.(None): 6. supply medicinal products to physicians and physicians in dental medicine where a settlement has no pharmacy under
p.(None): the conditions and order laid down in a regulation of the Minister of Health;
p.(None): 6a (new – SG, 102/2012, in force from 02.01.2013) enter in the documents for supply the lot number of the supplied
p.(None): medicinal products;
p.(None): 6b (new – SG, 102/2012, in force from 02.01.2013) have an action plan in extraordinary situations, which shall contain
p.(None): effective measures for drawing out a medicinal product from the market upon an order of BDA or upon initiative of the
p.(None): manufacturer or the marketing authorisation holder of the relevant medicinal product;
p.(None): 6c (new – SG 18/14) provide for the supply of sufficient quantities of medicinal products for satisfying of health care
p.(None): needs of the individuals of the Republic of Bulgaria;
...
p.(None): Art. 269b. (new – SG, 102/2012, in force from 21.12.2012) (1) Where as a result of carried out inspections under Art.
p.(None): 269, Para. 3 compliance with the Good manufacturing practice is found, or the Good distribution practices where
p.(None): applicable, BDA shall issue to the manufacturer, importer or wholesale trader a certificate for Good
p.(None): manufacturing practice or certificate for Good distribution practice within the term of 90 days from the inspection.
p.(None): (2) Where as a result of a carried out inspection under Art. 269, Para. 3 it is found that the manufacturer, importer
p.(None): or wholesale trader of medicinal products or active substances fails to observe the requirements of the act and/or
p.(None): principles and directives of Good manufacturing practice and/or Good distribution practice, BDA shall issue an
p.(None): incompliance opinion.
p.(None): (3) The BDA shall introduce to the data base under Art. 147 the issued certificates under Para. 1 and information under
p.(None): Para. 2.
p.(None):
p.(None):
p.(None): Art. 269c. (new – SG, 102/2012, in force from 21.12.2012) (1) Where as a result of an inspection under Art. 270, Para.
p.(None): 1, p. 5 it is found that the marketing authorisation holder fails to observe the requirements of Chapter Eight,
p.(None): BDA shall give prescriptions for removal of the incompliance.
p.(None): (2) In the cases under Para. 1, BDA shall notify the Member States, the European
p.(None):
p.(None): medicines Agency and the European Commission.
p.(None):
p.(None):
p.(None): Art. 270. (1) Within the framework of their competence, the officials according to Art. 267, Para. 3, shall be entitled
p.(None): to:
p.(None): 1. (amend. - SG, 102/2012, in force from 21.12.2012) Access to all documents, connected to the subject
p.(None): of the inspection, as well as documents, connected directly and indirectly with violation of this Act or
p.(None): of legislation of the Member States, implementing requirements of Directive 2001/83/EC of the European
p.(None): Parliament and the Council for approval of the Community code concerning medicinal products for human use, as
p.(None): last amended by Directive 2004/27/EC of the European Parliament and the Council, independently from the form of the
p.(None): document;
p.(None): 2. order of each person to present information for violations according to point 1, which are familiar to him;
p.(None): 2a (new - SG, 102/2012, in force from 21.12.2012) inspect the manufacture and trade sites of manufacturers of
p.(None): medicinal products, active or auxiliary substances, as well as the laboratories, used by manufacture or import
p.(None): authorisation holders;
p.(None): 3. at any time inspect the sites subject to control and require, check, or make copies of all documents relating to the
p.(None): overall activity of the controlled site;
p.(None): 4. take samples of medicinal products, active substances, and percipients for laboratory
p.(None): tests;
p.(None): 5. (amend. - SG, 102/2012, in force from 21.12.2012) inspect the premises, archives,
p.(None): records, and documents and the basic documentation of the pharmaco-vigilance of the marketing authorisation
p.(None): holder or persons, who have been assigned to carry out the activities under Chapter Eight;
p.(None): 6. (new - SG, 102/2012, in force from 21.12.2012) carry out inspection about the observation of
p.(None): confirmed prices, limit prices or registered prices during sale of medicinal products;
...
p.(None):
p.(None):
p.(None): § 75. Within the term of up to 3 months from the enforcement of this Act the Council of Ministers shall select a staff
p.(None): of the Commission on prices and reimbursement.
p.(None):
p.(None): § 76. Within the term of up to 3 months from the enforcement of this Act:
p.(None): 1. The Minister of Health shall amend and supplement the ordinances under Art. 82, Para. 3, Art. 219, Para. 2 and Art.
p.(None): 243 in compliance with this Act.
p.(None): 2. The Council of Ministers shall adopt the Ordinance under Art. 258, Para. 5 and shall amend the tariff under Art. 21,
p.(None): Para. 2 and the Rules of procedure of the Ministry of Health in compliance with this Act.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 84. This Act shall come into force from the day of its publication in the State Gazette, with the exception of § 65,
p.(None): which shall come into force from 30 September 2011.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.(None):
p.(None): (PROM. - SG 38/12, IN FORCE FROM 01.07.2012)
p.(None):
p.(None): § 84. (In force from 18.05.2012) Within one month after the promulgation of this Act in the State Gazette:
p.(None): 1. The Council of Ministers shall adjust the Classified of positions in administration to the provision of this Act;
p.(None): 2. the competent bodies shall adjust the structural acts of the respective administration to the provisions of this
p.(None): Act.
p.(None):
p.(None):
p.(None): § 85. (1) The legal relationships with the persons from administrations under the Radio and Television Act, Independent
p.(None): Financial Audit Act, Electronic Communications Act, Financial Supervision Commission Act, Act on Access to and
p.(None): Disclosure of the Documents and Announcing Affiliation of Bulgarian Citizens with the State Security Service and
p.(None): the Intelligence Services of the Bulgarian Popular Army, Act on Seizure in Favour of the State of
p.(None): Property, Acquired through Criminal Activity Act on Prevention and Findings of Conflict of Interests, Code of Social
p.(None): Insurance, Health Insurance Act, Agricultural Producers Assistance Act, Roads Act shall be regulated subject to
p.(None): compliance with the provisions and following the procedure of § 36 of the Transitional and Conclusive Provisions of the
p.(None): Act amending and supplementing the Civil Servants Act (SG 24/06).
p.(None): (2) By the act of appointment of a civil servant:
p.(None): 1. the minimum rank for the occupied position shall be conferred, as determined in the Classified of positions in the
p.(None): administration, unless the servant hold a higher rank;
p.(None): 2. individual monthly salary shall be fixed.
p.(None): (3) Additionally required funds for insurance contributions of the persons under par. 2 shall be provided within the
p.(None): cost of salaries, remunerations and insurance contributions within the budgets of the respective administrators of
p.(None): budget credits.
p.(None): (4) Council of Ministers must make necessary adjustments in the out-of-budget account of State Fund "Agriculture",
p.(None): arising out of this Act.
p.(None): (5) Managing bodies of National Social Insurance Institute and of National Health Insurance Fund must make
p.(None): necessary adjustments in the respective budgets, arising out of this
p.(None):
p.(None): Act.
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p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
p.(None): contain contact details of an independent person for additional information.
p.(None):
p.(None): Section .
p.(None): Clinical Trials in Vulnerable Patient Groups
p.(None):
p.(None): Art. 100. A clinical test in minor or underage persons can be undertaken provided that:
p.(None): 1. the study protocol has been approved by the respective ethics committee after discussion of the
p.(None): clinical, moral, and psycho-social aspects of childhood age in which at least two paediatricians have participated;
p.(None): 2. there is an anticipated direct benefit of the clinical test for the patient group, which is to be included;
p.(None): 3. the study is directly associated with the clinical condition from which the minor or underage person is suffering;
p.(None): 4. the study medicinal product is designated for the diagnosis, treatment, or prophylaxis of diseases, which are
p.(None): specific for minor or underage persons;
p.(None): 5. the study is designated to be conducted in minor or underage persons;
p.(None):
p.(None): 6. the study purpose is to check data obtained in clinical trials in persons who are capable of giving
p.(None): informed consent or of data obtained by other research methods;
p.(None): 7. the results obtained from clinical trials in adults and the interpretation thereof cannot be considered also valid
p.(None): for minor or underage persons;
p.(None): 8. the study is planned in a manner that pain, inconvenience, fear, and other disease- associated foreseeable risks are
p.(None): minimised and the risk threshold and physical pain degree have been determined in advance and shall be incessantly
p.(None): controlled throughout the clinical test;
p.(None): 9. the study has been planned and shall be conducted in compliance with the guidelines of the European Medicines
p.(None): Agency;
p.(None): 10. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
...
p.(None): contraindications, and warnings, which result from new information associated with the safe use of a medicinal product.
p.(None): 71. "Spontaneous report" shall mean a voluntarily report for a suspected adverse reaction during the use of
p.(None): a medicinal product forwarded to the marketing authorisation holder, to the bodies for supervision on the medicinal
p.(None): products, or to other organisations, which is not originating from a study or another organised system for data
p.(None): capturing.
p.(None): 72. "Expiry period of a medicinal product" shall mean the interval of time during which, if a medicinal product is
p.(None): stored under the prescribed conditions, it shall comply with the specification developed on the grounds of
p.(None): stability tests of several batches of the finished form.
p.(None): 73. (Amen. - SG 71/2008, in force from 12.08.2008) "Medicinal product equivalent to a herbal medicinal product"
p.(None): shall mean a product containing the same active substances irrespective of the composition of the excipients
p.(None): and which is intended for the same purpose, has equivalent quantity of the medicinal substance, the same dosage and the
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
...
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
p.(None): 91 (new – SG, 102/2012, in force from 21.12.2012) "Delegated act" is an act in the meaning of Art. 290 of the Treaty on
p.(None): the European Union.
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
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p.(None):
p.(None):
p.(None): Art. 234b (new – SG, 102/2012, in force from 02.01.2013) The BDA shall participate in information campaigns, organised
p.(None): by the European Commission and the European Medicines Agency about the danger of falsified medicinal products.
p.(None):
p.(None): Art. 235. (1) The authorisation to carry out retail trade with medicinal products shall be cancelled with the
p.(None): termination of the activity of the persons according to Art. 222.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The executive director of BDA shall cancel the authorisation for
p.(None): retail trade with medicinal products:
p.(None): 1. according to an application by the person who has received authorisation for carrying out retail trade with
p.(None): medicinal products:
p.(None): 2. wherever it has been established that the manager of the pharmacy does not comply with the requirements laid down in
p.(None): Art. 224 and 225.
p.(None): (3) (Amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 222 and 225 shall notify the BDA in
p.(None): writing within 14 days of the termination of the activity according to para 1.
p.(None):
p.(None):
p.(None): Art. 236. (1) The pharmacy cannot be closed for more than 30 days within a calendar year due to the absence of the
p.(None): manager.
p.(None): (2) (suppl. – SG 71/2008, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011, amend. – SG,
p.(None): 60/2011, in force from 5. 8. 2011) Where the manager of the pharmacy is not in a position to fulfil his
p.(None): obligations due to a leave for temporary incapacity of work due to an illness, pregnancy and birth, or adoption and
p.(None): leave for breeding of a little child, as per Labour Code, the pharmacy can operate under the management of another
p.(None): master of pharmacy, respectively another assistant pharmacist, in the cases to Art. 225 complying with the requirements
p.(None): of Art. 224 for not more than two years. In all these cases a permission of the executive director of BDA shall be
p.(None): issued.
p.(None): (3) The permission according to 2 shall be issued within 30 days.
p.(None):
p.(None):
p.(None): Art. 237. Upon termination of the activity of the person who received authorisation to retail trade with medicinal
p.(None): products, the medicinal products can be sold by persons who have received authorisation for wholesale trade in
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
p.(None): 3. has at least 1 year of professional experience in this field.
p.(None):
p.(None):
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Searching for indicator children:
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p.(None): substance.
p.(None):
p.(None):
p.(None): Art. 32. The marketing authorisation holder of a medicinal product may authorise the use of the pharmaceutical,
p.(None): preclinical and clinical documentation contained in the dossier of the medicinal product for the assessment of
p.(None): subsequent applications for medicinal products with the same qualitative and quantitative composition with respect to
p.(None): the active substances and with the same pharmaceutical form.
p.(None):
p.(None):
p.(None): Art. 33. Conducting the necessary studies and tests for the purpose of preparing the documentation for marketing
p.(None): authorisation and the subsequent practical requirements in connection with the authorisation to market of
p.(None): medicinal products according to Art. 28 and Art. 29 shall not be regarded as breach of patent rights or to
p.(None): supplementary protection certificates of medicinal products.
p.(None):
p.(None):
p.(None): Art. 34. (1) The summary of product characteristics shall contain the following information:
p.(None):
p.(None): 1. name of the medicinal product, quantity of the active substance in a dose unit, and pharmaceutical form;
p.(None): 2. qualitative and quantitative composition in terms of the active substances and constituents of the
p.(None): excipient, the information of which is essential for proper administration of the medicinal product. The usual common
p.(None): name or chemical description shall be used;
p.(None): 3. pharmaceutical form;
p.(None): 4. clinical particulars:
p.(None): a) therapeutic indications,
p.(None): b) posology and method of administration for adults and, where necessary, for children,
p.(None): c) contra-indications,
p.(None): d) special warnings and precautions for use and, in the case of immunological medicinal products, any special
p.(None): precautions to be taken by persons handling such products and administering them to patients, together with
p.(None): any precautions to be taken by the patient,
p.(None): e) interaction with other medicinal products and other forms of interactions,
p.(None): f) use during pregnancy and lactation,
p.(None): g) effects on ability to drive and to use machines,
p.(None): h) undesirable effects,
p.(None): i) overdose (symptoms, antidotes, emergency measures).
p.(None): 5. pharmacological properties:
p.(None): a) pharmacodynamic properties,
p.(None): b) pharmacokinetic properties,
p.(None): c) preclinical safety data.
p.(None): 6. pharmaceutical particulars:
p.(None): a) list of excipients,
p.(None): b) major incompatibilities,
p.(None): c) shelf life, where necessary after reconstitution of the medicinal product or where the immediate packaging is opened
p.(None): for the first time,
p.(None): d) special precautions for storage,
p.(None): e) nature and contents of container,
p.(None): f) special precautions for disposal of unused medicinal product or waste materials from such medicinal product.
p.(None): 7. marketing authorisation holder.
p.(None): 8. registration number.
p.(None): 9. date of the first marketing authorisation or renewal of the marketing authorisation.
p.(None): 10. date of a variation in the summary of product characteristics.
p.(None): 11. for radiopharmaceuticals, full details of internal radiation dosimetry.
p.(None): 12. for radiopharmaceuticals, detailed instructions for extemporaneous preparation and quality control and, where
p.(None): appropriate, maximum storage time during which any intermediate preparation such as an eluate or the
...
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
p.(None): 91 (new – SG, 102/2012, in force from 21.12.2012) "Delegated act" is an act in the meaning of Art. 290 of the Treaty on
p.(None): the European Union.
p.(None):
p.(None):
...
Social / Incarcerated
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p.(None): (2) (new - SG, 102/2012, in force from 01.03.2012; suppl. – SG 18/14) Where a medicinal product,
p.(None): permitted for use under this act, is not intended for direct supply to the patient or is not available on the market in
p.(None): the Republic of Bulgaria, BDA may permit its use, where some of the data, determined by the ordinance under
p.(None): Para. 1 has not been placed on the package or in the leaflet.
p.(None): (3) (new - SG, 102/2012, in force from 01.03.2012) In the cases under Para. 2, the information on the packing and in
p.(None): the leaflets may not be provided in the Bulgarian language.
p.(None): (4) (new - SG, 102/2012, in force from 01.03.2012) The conditions and procedure for supply of medicinal products under
p.(None): Para. 2 shall be determined by the ordinance under Art. 198.
p.(None):
p.(None): Chapter seven.
p.(None): CLASSIFICATION OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 171. (1) Depending on the method of dispensing, the medicinal products shall be classified as follows:
p.(None): 1. medicinal products dispensed on medical prescription;
p.(None): 2. medicinal products dispensed without medical prescription.
p.(None): (2) The dispensing regime of a medicinal product shall be determined by the BDA in the marketing
p.(None): authorisation/registration certificate.
p.(None): (3) The person according to Art. 26, para 1, shall indicate the dispensing regime of a medicinal product in the
p.(None): application for marketing authorisation/registration certificate, variation of the marketing authorisation or its
p.(None): renewal.
p.(None):
p.(None):
p.(None): Art. 172. The medicinal products according to Art. 171, para 1, point 1, shall be divided in the following categories:
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
p.(None): 2. medicinal products, which are frequently and very widely administered in a wrong manner and as a result of that can
p.(None): represent a threat for the people’s health;
p.(None): 3. medicinal products containing substances the activity and/or adverse drug reactions of which require subsequent
p.(None): additional study;
p.(None): 4. medicinal products, which are usually prescribed by a physician for potential administration.
p.(None):
p.(None):
p.(None): Art. 174. Medicinal products shall be subject to special medical prescription wherever
p.(None):
p.(None): these meet one of the following conditions:
p.(None): 1. contain narcotic substances within the meaning of the Control on Drugs and Precursors Act in admissible
p.(None): for use quantities;
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
...
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p.(None): authorisation or refusal shall be delivered to the person who has submitted the application.
p.(None): (3) (Amend. - SG, 60/2011, in force from 5. 8. 2011) Where discrepancies with or omissions in the
p.(None): submitted documentation have been established, within 15 day term from filing the documentation under Art. 228, Para.
p.(None): 6, the BDA shall perform a check up of the produced documents and shall notify the candidate in writing about the found
p.(None): discrepancies and omissions. In these cases the term according to para 2 shall cease to run as from the date of the
p.(None): notification till the elimination of the defects.
p.(None): (4) (New SG. 71/2008, in force from 12. 08. 2008) In case that within 60 day term after the notification date, under
p.(None): para 3, the applicant fails to remove the established irregularities or incompleteness, the procedure for issuing
p.(None): authorisation for retail trade in medicinal products or for change of an issued authorisation shall be terminated.
p.(None): (5) (Former para 4 – SG 71/2008, in force from 12, 08 2008, amend. – SG, 60/2011, in force from 5. 8. 2011). The
p.(None): refusal of the executive director of the BDA to issue an authorisation shall be subject to appeal under the terms of
p.(None): the Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 229a. (New – SG. 23/2009, in force from 30. 03. 2009) (1) (amend. and suppl. - SG.
p.(None):
p.(None): 41/2009, in force from 02.06.2009; amend. – SG 98/10, in force from 01.01.2011, amend. – SG, 60/2011, in force from 5.
p.(None): 8. 2011) The BDA shall officially submit to RHI on the location of the relevant pharmacy with an authorisation, issued
p.(None): under Art. 229, para 2, including retail trade with food supplements, dietetic foods for special medical purposes,
p.(None): Infant formulas and transitional foods, copy of the authorisation for registering into the register under Art.
p.(None): 14, para 1 of the Foodstuffs Act.
p.(None): (2) (Amen. And suppl. – SG. 41/2009, in force from 02.06.2009) The pharmacies which perform retail trade with food
p.(None): supplements, dietetic foods for special medical purposes, Infant formulas and reansitional foods shall be subject to
p.(None): control according to the Foodstuffs Act;
p.(None):
p.(None):
p.(None): Art. 230. (1) (Amend. – SG, 60/2011, in force from 5. 8. 2011) The BDA shall keep a register of the issued
p.(None): authorisations for retail trade with medicinal products under Art. 229, para 2, which shall contain:
p.(None): 1. authorisation number and date;
p.(None): 2. name, place of business and address of management of the person who has received the authorisation;
p.(None): 3.(amend. – SG 12/11, in force from 08.02.2011) name and UCN of the manager of the pharmacy;
p.(None): 4. address of the pharmacy;
p.(None): 5. activities, which will be conducted in the pharmacy;
p.(None): 6. date of cancelling the authorisation and its deletion from the register and reason therefore;
p.(None): 7. remarks relating to the inscribed circumstances.
p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011) Data from the register shall be published on the
p.(None): internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 231. (1) In case of change of the circumstances inscribed in the register according to Art. 230, para 1, points
p.(None): 2-5, the person who has received authorisation to carry out retail trade with medicinal products shall submit an
p.(None): application under the terms of Art. 228, para 1, and shall append the documents associated with the change.
p.(None): (2) (New – SG, 60/2011, in force from 5. 8. 2011) In case of a change of the name and type of the trader, address of
p.(None): the pharmacy and manager of the pharmacy, a new application shall be submitted under Art. 228, Para. 1 and the charge
p.(None): for issuance a new authorisation for retail trade with medicinal products in a pharmacy shall be paid, determined by
p.(None): the tariff under Art. 21, Para. 2.
...
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
p.(None): 91 (new – SG, 102/2012, in force from 21.12.2012) "Delegated act" is an act in the meaning of Art. 290 of the Treaty on
p.(None): the European Union.
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
p.(None):
...
p.(None): and 43, which shall come into force from 26 July 2008.
p.(None):
p.(None): Concluding provisions
p.(None): TO THE ACT AMENDING THE MEDICINAL PRODUCTS IN HUMAN MEDICINE ACT
p.(None): (PUBL. - SG 10/2009, IN FORCE FROM 29.01.2009)
p.(None):
p.(None): § 2. The Act shall come into force from 29 January 2009.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE MEDICINAL PRODUCTS IN HUMAN MEDICINE ACT
p.(None):
p.(None): (PUBL. - SG 23/2009, IN FORCE FROM 30.03.2009)
p.(None):
p.(None): § 4. Persons, who have received by the time this Act comes into force authorisation under Art. 229, para 2, including
p.(None): performing trade with food supplements, may perform retail trade with dietetic foods for special medical purposes.
p.(None):
p.(None):
p.(None): § 5. Within 2 months after this Act comes into force, the Ministry of Health shall officially sent to the relevant
p.(None): RIPCPH of the locality of the pharmacies for listing into the register under
p.(None):
p.(None): Art. 14, para 1 of the Foodstuffs Act, a copy of the authorisations under Art. 229, para 2, issued by this Act comes
p.(None): into force.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 7. This Act shall come into force from 30 March 2009.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE HEALTH ACT
p.(None):
p.(None): (PUBL. - SG 41/2009, IN FORCE FROM 02.06.2009)
p.(None):
p.(None): § 92. (1) Persons, who have received by the time this Act comes into force authorisation under Art. 229, para 2 of the
p.(None): Medicinal Products in Human Medicine Act, including performing trade with food supplements, may perform retail trade
p.(None): also with Infant formulas and transitional foods.
p.(None): (2) Within the term of 2 months after this Act comes into force, the Ministry of Health shall officially submit in the
p.(None): relevant RIPCPH on the locality of the pharmacies, which perform retail trade with Infant formulas and transitional
p.(None): foods under Art. 1 for listing into the register under Art. 14, para 1 of the Foodstuffs Act copy of the authorisations
p.(None): under Art. 229, para 2 of the Medicinal Products in Human Medicine Act issued by the time this Act comes into force.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 96. This Act shall come into force from the day of its publication in the State Gazette, with the exception of:
p.(None): 1. para 3, 5, 6 and 9, which shall come into force from 1 January 2009;
p.(None): 2. para 26, 36, 38, 39, 40, 41, 42, 43, 44, 65, 66, 69, 70, 73, 77, 78, 79, 80, 81, 82, 83,
p.(None): 88, 89 and 90, which shall come into force from 1 July 2009;
p.(None): 3. para 21, which shall come into force from 1 June 2009.
p.(None):
p.(None): Concluding provisions
p.(None): TO THE ACT SUPPLEMENTING THE MEDICINAL PRODUCTS IN THE HUMANE MEDICINE ACT
p.(None): (PUBL. - SG 88/2009 IN FORCE FROM 06.11.2009)
p.(None):
p.(None): § 2. The Act shall enter into force from the day of its promulgation in the State Gazette.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE MEDICINAL PRODUCTS IN HUMAN MEDICINE ACT
p.(None):
p.(None): (PROM. - SG 102/09, IN FORCE FROM 22.12.2009)
p.(None):
p.(None): § 4. (1) Master-pharmacists and assistant pharmacists who, prior to the entry into force of this Act, have been granted
p.(None): permissions to open a pharmacy in populated areas referred to in Art. 228, para 4 according to the revoked Act on
p.(None): Medicines and Pharmacies for the Human Medicine, and who have not submitted an application for re-registration within
p.(None): the term fixed in
p.(None):
p.(None): § 66, para 3 of the Act on Amendment and Supplementation of the Medicinal Products in Human Medicine Act (SG 71/08),
...
Social / Linguistic Proficiency
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p.(None):
p.(None):
p.(None): Art. 11. (1) The Minister of Health may, due to reasons relating to the protection of the health of the population,
p.(None): instruct by way of order the Executive Director of the BDA to authorise the use of a medicinal product, which has not
p.(None): been authorised for use on the territory of the Republic of Bulgaria and for which no application for issuing
p.(None): of an authorisation has been submitted but which has been authorised in another Member State.
p.(None): (2) In the cases under para 1, the director of BDA, or his authorised representative shall:
p.(None): 1. inform the holder of the marketing authorisation for the medicinal product on the
p.(None):
p.(None): initiation of a procedure for the authorisation of the medicinal product for use;
p.(None): 2. register the person referred to in point 1 as a holder of the issued authorisation;
p.(None): 3. demand from the regulatory body of the Member State that has issued the marketing authorisation a copy of the
p.(None): assessment report and a copy of the marketing authorisation.
p.(None): (3) (suppl. – SG, 102/2012, in force from 21.12.2012) The Bulgarian Drug Agency shall be obliged to ensure
p.(None): compliance of the label, patient information leaflet, classification, advertising, and follow-up of the
p.(None): safety of the medicinal product released on the market according to Para. 1 with the requirements of this Act.
p.(None): The information on the packing and in the leaflet of the medicinal product under Para. 1 shall not be obligatorily in
p.(None): the Bulgarian language.
p.(None): (4) The Executive Director of BDA shall inform the European Commission about the authorisation issued according to para
p.(None): 1, the name and address of the authorisation holder, as well as about the date of termination of the validity thereof.
p.(None):
p.(None):
p.(None): Art. 12. (1) The official pharmacopoeia of the Republic of Bulgaria shall be the European Pharmacopoeia
p.(None): (2) The official pharmacopoeia may be supplemented with the requirements of the Bulgarian pharmacopoeia.
p.(None): (3) The Minister of Health shall determine by way of order the dates of entry into effect of the current edition of the
p.(None): official pharmacopoeia and the annexes thereof.
p.(None): (4) The order according to para 3 shall be promulgated in the State Gazette and published on the internet
p.(None): site of BDA.
p.(None):
p.(None):
p.(None): Art. 13. (1) The monographs of the European Pharmacopoeia shall be obligatory for all substances, preparations, and
p.(None): pharmaceutical forms contained therein. In the cases where there is no monographs in the European Pharmacopoeia, the
p.(None): requirements of the current editions of the pharmacopoeias of the Member States, the U.S.A, and Japan provided that
p.(None): these are in compliance with the general rules of the European Pharmacopoeia.
p.(None): (2) Where the specification contained in a monograph of the European Pharmacopoeia or other national pharmacopoeia
p.(None): is insufficient to ensure the quality of the substance or pharmaceutical form, the Bulgarian Drug
p.(None): Agency can require supplementation of the specification by the applicant/marketing authorisation holder.
p.(None):
p.(None): Chapter two.
p.(None): MANAGING AND FINANCING BODIES
p.(None):
...
p.(None): 21. copy of a refusal for a marketing authorisation in a Member State or a third state accompanied by motives;
p.(None): information for temporary suspension or termination of the effect of the marketing authorisation;
p.(None): 22. copy of the proposed package leaflet accompanied by a summary of the results of the assessment of the level of
p.(None): comprehensibility of the contents of the package leaflet by a target patient group selected by the applicant or a copy
p.(None): of a leaflet approved by a regulatory authority in a Member State, which has already issued a marketing authorisation;
p.(None): 23. document of paid fee in amounts up in the tariff according to Art. 21, para 2.
p.(None): (2) (suppl. – SG 18/14) The documents according to para 1, item 18 and 18a, relating to the Member States, and point
p.(None): 19, respectively, shall only be submitted in the procedures according to section VII.
p.(None): (3) To radionuclide generators, the following documents shall be added to the data according to para 1:
p.(None): 1. description of the system together with a detailed description of its components, which may affect the composition
p.(None): or quality of the daughter radionuclides;
p.(None): 2. qualitative and quantitative particulars of the eluate or the sublimate.
p.(None): (4) The documents and data from pharmaceutical tests, preclinical and clinical trials shall be accompanied by
p.(None): summarised reports prepared by experts with the required technical and professional qualification. To the reports a
p.(None): curricula vitae report of the experts shall be applied.
p.(None): (5) The dossier of the medicinal product shall be submitted in the Bulgarian and/or English language.
p.(None): (6) (new – SG, 102/2012, in force from 21.12.2012) The risk management system under Para. 1, p. 13 should be
p.(None): proportional to the identified and to the potential risks of the medicinal product and to the need of collecting safety
p.(None): data of post-marketing researches.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The holder of the authorisation for use shall update the data of the
p.(None): file under Para. 1. For each change in the file the provisions of Chapter Three Section VI shall apply, where
p.(None): applicable.
p.(None):
p.(None):
p.(None): Art. 28. (1) The person according to Art. 26, para 1, insofar as he does not infringe industrial and commercial
p.(None): property rights, shall not submit to the BDA the data according to Art.
p.(None):
p.(None): 27, para 1, point 10, letters "b" and "c" provided that he can prove that the medicinal product indicated in the
p.(None): application is generic of a reference medicinal product, which is or has been authorised to market for not less than 8
p.(None): years in a Member State or in a state member of the European Economic Area.
p.(None): (2) The marketing authorisation holder of a generic product according to para 1 may not place it to market until 10
p.(None): years from the initial marketing authorisation of the reference medicinal product have elapsed.
p.(None): (3) Under observance of the conditions of para 1 and 2, the person according to Art. 26, para 1, may submit to the BDA
p.(None): an application for marketing authorisation of a medicinal product, which is generic of a reference medicinal product,
p.(None): even where the reference product has never had marketing authorisation on the territory of the Republic of Bulgaria.
...
p.(None): following data for the certificate:
p.(None): 1. registration number;
p.(None): 2. number and date of the marketing authorisation/registration certificate of the medicinal product;
p.(None): 3. name of the medicinal product;
p.(None): 4. international non-proprietary name of any active substance;
p.(None): 5. name and address of the holder of the marketing authorisation/registration certificate; 5a (new - SG, 102/2012, in
p.(None): force from 21.12.2012) the conditions of Art. 55a, 56 and
p.(None): 56a, entered in the authorisation for use/registration certificate;
p.(None): 6. date of variation of the marketing authorisation/registration certificate;
p.(None): 7. date of termination of the marketing authorisation/registration certificate;
p.(None): 8. other data.
p.(None): (2) The marketing authorisation/registration certificate of the medicinal product shall be delivered to the person
p.(None): according to Art. 26, Para. 1, and shall enter into effect as from the date
p.(None):
p.(None): of its inscription in the register according to Art. 19, Para. 1, point 3.
p.(None):
p.(None):
p.(None): Art. 53. (1) (amend. – SG, 102/2012, in force from 21.12.2012) The BDA shall publish on its internet site data
p.(None): according to Art. 52, Para.1 for the marketing authorisation of the medicinal product granted and the
p.(None): approved summary of product characteristics and the datas of the leaflet.
p.(None): (2) The BDA shall publish o its internet site the assessment report under art. 49, Para. 1 with the motives of the
p.(None): decision taken while deleting the data, representing commercial secret.
p.(None): (3) The report under Para. 2 shall be accompanied by a summary in understandable by the public language. The summary
p.(None): shall contain a section, related to the conditions for use of the medicinal product.
p.(None):
p.(None):
p.(None): Art. 54. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of a marketing authorisation/registration
p.(None): certificate of a medicinal product shall notify the BDA in writing about the date of actual placing on the market of
p.(None): the medicinal product in the Republic of Bulgaria.
p.(None): (2) (amend. – SG 18/14) The holder of a marketing authorisation/registration certificate of a medicinal product shall
p.(None): notify the BDA in writing within minimum two months prior to any discontinuation of the sales of a medicinal product
p.(None): irrespective temporary or permanent.
p.(None): (3) (amend. – SG 18/14) The holder of a marketing authorisation/registration certificate of a medicinal product shall
p.(None): indicate the reasons for the discontinuation of the sales subject to compliance with the provision of Art. 68, par. 1,
p.(None): item 6 and shall declare whether the measures under par. 2 undertaken by them are because of any of the grounds
p.(None): referred to in Art. 276 and Art. 277.
p.(None): (4) (amend. – SG 18/14) In case of discontinuation of the sales of a medicinal product as a result of unforeseen
p.(None): circumstances, the holder of a marketing authorisation/registration certificate of a medicinal product shall notify the
p.(None): BDA in writing within 7 days of the establishment of the circumstances.
p.(None):
p.(None):
p.(None): Art. 54a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG 18/14) With receiving a signal at the
p.(None): Executive Agency on Medicines (EAM) for termination of sales of a medicinal product, with the exception of the cases
p.(None): under Art. 54, Para. 2 and 4, the Agency shall perform a check within the term of 30 days after receiving the signal.
...
p.(None): been fulfilled:
p.(None): 1. the manufacturing authorisation holder, before partially or thoroughly removes or closes the safety
p.(None): indicators, shall check whether the relevant medicinal product is authentic or it has been faked;
p.(None): 2. the manufacturing authorisation holder while observing the requirements of Art. 168, Para. 8 may replace the safety
p.(None): indicators with ones, equal to them in relation to the possibility for guaranteeing the authenticity,
p.(None): identification and provision of evidences for faking the medicinal product.
p.(None): (3) The safety indicators shall be considered as equal, if:
p.(None): 1. they meet the requirements, determined by the delegated acts under Art. 54a, Para. 2 of Directive 2001/83/EC and
p.(None): 2. they are so effected that they allow the check of authenticity and identification of the medicinal products and
p.(None): provide evidences for their being faked.
p.(None): (4) The replacement under Para. 2, p. 2 shall be made without opening the initial packing of the medicinal product and
p.(None): in compliance with the Good manufacturing practice for medicinal products.
p.(None): (5) The BDA shall carry out supervision on the replacement of the safety indicators.
p.(None):
p.(None):
p.(None): Art. 169. (1) The information of the packaging and the medicinal product leaflet must be in full compliance with the
p.(None): data in the summary of product characteristics approved by the BDA upon the issue of the marketing authorisation and
p.(None): must comply with the requirements set out in the regulation according to Art. 170.
p.(None): (2) The information on the packaging and leaflet can be in several languages but one of these must obligatorily be
p.(None): Bulgarian language. The content of the information in various languages must be identical.
p.(None): (3) The name of the medicinal product shall obligatorily be written in the Bulgarian language and the
p.(None): international non-proprietary name of the medicinal substance shall be written according to the
p.(None): Anatomic-Chemical-Therapeutic Classification of the WHO. The name
p.(None): and address of the marketing authorisation holder can be written in Latin.
p.(None): (4) The information of the packaging and leaflet must be in a language comprehensible for the patient and must be
p.(None): readable and indelible.
p.(None): (5) (new – SG 18/14) The leaflet must be produced so that to be clear and understandable, and to allow
p.(None): the patient to undertake adequate actions, where required, with the assistance of the health care specialists.
p.(None):
p.(None): Art.170. (1) (former text of Art. 170 – SG, 102/2012, in force from 01.03.2012) The requirements relating
p.(None): to the packaging and leaflets of medicinal products shall be determined by an ordinance of the Minister of Health.
p.(None): (2) (new - SG, 102/2012, in force from 01.03.2012; suppl. – SG 18/14) Where a medicinal product,
p.(None): permitted for use under this act, is not intended for direct supply to the patient or is not available on the market in
p.(None): the Republic of Bulgaria, BDA may permit its use, where some of the data, determined by the ordinance under
p.(None): Para. 1 has not been placed on the package or in the leaflet.
p.(None): (3) (new - SG, 102/2012, in force from 01.03.2012) In the cases under Para. 2, the information on the packing and in
p.(None): the leaflets may not be provided in the Bulgarian language.
p.(None): (4) (new - SG, 102/2012, in force from 01.03.2012) The conditions and procedure for supply of medicinal products under
p.(None): Para. 2 shall be determined by the ordinance under Art. 198.
p.(None):
p.(None): Chapter seven.
p.(None): CLASSIFICATION OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 171. (1) Depending on the method of dispensing, the medicinal products shall be classified as follows:
p.(None): 1. medicinal products dispensed on medical prescription;
p.(None): 2. medicinal products dispensed without medical prescription.
p.(None): (2) The dispensing regime of a medicinal product shall be determined by the BDA in the marketing
p.(None): authorisation/registration certificate.
p.(None): (3) The person according to Art. 26, para 1, shall indicate the dispensing regime of a medicinal product in the
p.(None): application for marketing authorisation/registration certificate, variation of the marketing authorisation or its
p.(None): renewal.
p.(None):
p.(None):
p.(None): Art. 172. The medicinal products according to Art. 171, para 1, point 1, shall be divided in the following categories:
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
...
p.(None):
p.(None):
p.(None): Art. 215. (1) (Amen. And suppl. - SG 71/2008, in force from 12.08.2008) To obtain authorisation to
p.(None): perform parallel import on the territory of the Republic of Bulgaria, the person according to Art. 213, para 1 shall
p.(None): submit to the executive director of BDA an application stating the Member State from which the parallel import of the
p.(None): medicinal product is to be effected from.
p.(None): (2) The following data and documents shall be appended to the application:
p.(None): 1. name, pharmaceutical form, quantity of the active substance in a dose unit of the medicinal product authorised for
p.(None): use in the Republic of Bulgaria;
p.(None): 2. name, pharmaceutical form, quantity of the active substance in a dose unit of the medicinal product intended for
p.(None): parallel import;
p.(None): 3. (suppl. – SG 12/11, in force from 08.02.2011) name of the marketing authorisation holder and the manufacturer if a
p.(None): person different from the marketing authorisation holder, name of the medicinal product intended for parallel import;
p.(None): 4. number of the marketing authorisation of the medicinal product in the Republic of Bulgaria and number of the
p.(None): marketing authorisation of the medicinal product in the Member State where the parallel import is to be effected from;
p.(None): 5. declaration for establishment of circumstances pursuant 217, issue 1;
p.(None): 6. copy of the patient information leaflet and a sample of the medicinal product in the form in which it is sold in the
p.(None): Member State where the parallel import is to be effected from,
p.(None):
p.(None): translation of the patient information leaflet in the Bulgarian language accompanied by a declaration that
p.(None): the translation is in compliance with the original of the leaflet;
p.(None): 7. proposal for patient information leaflet of the parallel imported medicinal product accompanied by a
p.(None): declaration that the content of the leaflet is identical with the content of the medicinal product authorised in the
p.(None): Republic of Bulgaria except for the following data:
p.(None): a) name and address of management of the person effecting the parallel import;
p.(None): b) name of manufacturer where it is different for both products;
p.(None): c) stability period where it is different for both products;
p.(None): d) excipients where these are different in both products;
p.(None): 8. in case of repackaging:
p.(None): a) sample of the parallel import product;
p.(None): b) copy of the contract between the person carrying out parallel import and the persons performing partial
p.(None): manufacturing activity – packaging, labelling;
p.(None): c) certificate of Good Manufacturing Practice where the repackaging processes are performed outside the
p.(None): territory of the Republic of Bulgaria;
p.(None): d) where repackaging is performed by the person according to Art. 213, para 1, copy of the manufacturing
p.(None): authorisation issued by the regulatory body of the Member State where repackaging is to be performed;
p.(None): 9. document for paid fee, in the amount as laid down in the tariff according to Art. 21,
p.(None): para 2.
p.(None): (3) (Amen. - SG 71/2008, in force from 12.08.2008) Where there are differences (in the
p.(None): composition of the excipients or other) between the parallel imported medicinal product and the product authorised for
p.(None): use on the territory of the Republic of Bulgaria, the person according to para 1 shall submit evidence that these do
p.(None): not affect the therapeutic qualities of the parallel imported medicinal product.
p.(None): (4) In the cases according to para 3 the person according to para 1 shall point out the differences on the packaging
p.(None): and in the patient information leaflet of the parallel imported medicinal product.
p.(None): (5) Where the person according to Art. 213, para 1, is repackaging and/or labelling the medicinal product in the
p.(None): Bulgarian language on the territory of the Republic of Bulgaria, it must possess a manufacturing authorisation issued
p.(None): by the executive director of the BDA.
p.(None): (6) The parallel imported product shall be used according to the conditions of the issued marketing authorisation for
p.(None): the use of the medicinal product on the territory of the Republic of Bulgaria.
p.(None):
p.(None):
p.(None): Art. 216. (1) The authorisation for parallel import on the territory of the Republic of Bulgaria shall be
p.(None): issued within 45 days of the date of submission of the documentation to the BDA.
p.(None): (2) Where the BDA shall request additional documentation from the applicant, the term according to para 1 shall cease
p.(None): to run until receipt of the requested information.
p.(None): (3) Where the BDA shall require information relating to the issue of the marketing authorisation of the
p.(None): imported medicinal product from the regulatory body of the Member State where the parallel import is to be effected
p.(None): from, the term according to para 1 shall be extended by 45 days.
p.(None): (4) If the BDA does not receive the requested documentation within the term according to para 3, the procedure for the
p.(None): issue of a parallel import authorisation for the territory of the Republic of Bulgaria shall be terminated.
p.(None): (5) The issued parallel import authorisations for the territory of the Republic of Bulgaria
p.(None):
p.(None): shall be published on the internet site of the BDA.
p.(None): (6) The parallel import authorisation shall be valid for 5 years. New authorisation shall be issued under the terms of
p.(None): Art. 215.
p.(None): (7) The parallel import authorisation shall not be automatically cancelled where the marketing authorisation
...
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p.(None): characteristics, labelling and package leaflet;
p.(None): e) all variations in the group are changes to the Active Substance Master File, Vaccine Antigen Master File or Plasma
p.(None): Master File;
p.(None): f) all variations in the group relate to a project intended to improve the manufacturing process and the quality of the
p.(None): medicinal product concerned or its active substance(s);
p.(None): g) all variations in the group are changes affecting the quality of a human pandemic influenza vaccine;
p.(None): h) all variations in the group are changes to the pharmaco-vigilance system referred to in Chapter Eight;
p.(None): i) all variations in the group are consequential to a given urgent safety restriction and are submitted in accordance
p.(None): with Art. 66;
p.(None): k) all variations in the group relate to the implementation of a given class labelling;
p.(None): l) all variations of the group are consequential to the assessment of a given periodic update report on the safety;
p.(None): m) all variations in the group are consequential to a given post-authorisation study conducted under the
p.(None): supervision of the holder of the marketing authorisation;
p.(None): n) all variations in the group are consequential to a specific obligation carried out pursuant to Art. 56;
p.(None): 3. the declared variations to the terms of the same marketing authorisation do not fall within one of the cases
p.(None): specified in item 2, provided that the BDS agrees to subject those variations to the same procedure.
p.(None): (4) Where variations as per Para 3, items 2 and 3 are grouped, holder of the marketing authorisation shall submit to
p.(None): the BDA:
p.(None): 1. a single notification, where at least one of the variations is a variation of type IB and all variations are of type
p.(None): IA or of type IB;
p.(None): 2. a single application, if the main variation is of type II and none of the rest of variations is an extension of the
p.(None): marketing authorisation;
p.(None): 3. a single application, where the main variation is extension of the marketing authorisation.
p.(None): (5) Attached to the application, respectively to the notification, the holder of the marketing
p.(None): authorisation shall submit:
p.(None): 1. documentation, related to the variations, as determined by the regulation envisaged in Art. 42;
p.(None): 2. a document, certifying that the fee, in an amount as per Tariff under Art. 21, Para 2,
p.(None): is paid.
p.(None): (6) The Executive Director of the BDA shall approve form of the application, respectively
p.(None): of notification, envisaged in Para 1 and 4, which shall be published on the Internet site of the BDA.
p.(None):
p.(None): Art. 62. (amend. – SG 12/11, in force from 08.02.2011) (1) The holder of marketing authorisation shall submit a
p.(None): notification of variations of type IA within 12 months following the implementation of the variation, except for
p.(None): the cases where variations require immediate notification.
p.(None): (2) Variations of type IA requiring immediate notification shall be specified in the regulation envisaged
p.(None): in Art. 42.
p.(None): (3) In the cases of Para 2, holder of marketing authorisation shall submit notification for the variation of type IA
p.(None): immediately after its implementation.
p.(None): (4) Within 30 days following receipt of the notification per Para 1, respectively per Para 3, the BDA shall notify the
p.(None): marketing authorisation holder:
p.(None): 1. if the variation(s) is/are accepted or not; in the cases where the variation(s) concerned is/are not accepted,
p.(None): reasons for that shall be stated; and
p.(None): 2. if variation(s) concerned lead(s) to amendment of the data in the issued marketing authorisation; where amendment of
p.(None): the issued marketing authorisation is needed, Art. 64a shall be applied.
...
p.(None): (2) The BDA shall pass a judgment regarding the measures within 24 hours of the notification.
p.(None): (3) Where the BDA has not passed a judgment within the term according to para 2, it shall be presumed that the measures
p.(None): have been approved.
p.(None): (4) Where the BDA has established that there is a risk for the health of the population from the use of medicinal
p.(None): product, it shall order the marketing authorisation holder to immediately undertake limiting measures.
p.(None): (5) In the cases according to para 1 and 4, the marketing authorisation holder of the medicinal product shall
p.(None): coordinate the method and term of implementation of the undertaken measures with the BDA.
p.(None): (6) Marketing authorisation holder of the medicinal product shall submit to the executive director of The BDA a
p.(None): variation application under the terms Art. 64 not later than 15 from the date undertaking the measures.
p.(None):
p.(None):
p.(None): Art. 66. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of the marketing authorisation of a medicinal
p.(None): product shall submit an application for enlargement of the scope of the granted marketing authorisation in case of:
p.(None): 1. change of the active substance(s):
p.(None): a. replacement of a chemical active substance by a different by a different salt/ester, complex/derivative, including
p.(None): the same therapeutic moiety, where the efficacy/safety characteristics are not significantly different.
p.(None): b. replacement by a different isomer, mixture of isomers, of a mixture by an isolated isomer (e.g. racemate with single
p.(None): enantiomer), where the efficacy/safety characteristics are not significantly different;
p.(None): c. replacement of a biological active substance with one of a slightly different molecular structure where the
p.(None): efficacy/safety characteristics are not significantly different, with the exception of changes to the active
p.(None): substance of a seasonal, pre-pandemic or pandemic vaccine against human influenza;
p.(None):
p.(None): d. modification of the vector used to produce the antigen of the source material, including a new master cell bank from
p.(None): a different source, where the efficacy/safety characteristics are not significantly different;
p.(None): e. a new ligand or coupling mechanism for a radiopharmaceutical, where the efficacy/safety
p.(None): characteristics are not significantly different
p.(None): f. change to the extraction solvent of the ration of herbal drug to herbal drug preparation where the efficacy/safety
p.(None): characteristics are not significantly different.
p.(None): 2. Changes to strength, pharmaceutical form and route of administration:
p.(None): a. change of bioavailability;
p.(None): b. change of pharmacokinetics e.g. change in rate of release;
p.(None): c. change or addition of a new strength/potency;
p.(None): d. change or addition of a new pharmaceutical form; e.g. change or addition of a new route of administration– for
p.(None): parenteral application to differentiate between intraarterial, intravenous, intramuscular, subcutaneous and
p.(None): other routs of administration.
...
p.(None): equipment and control laboratories.
p.(None):
p.(None):
p.(None): Art. 149. The managers of manufacture and quality control of medicinal products in the manufacturing enterprises shall
p.(None): be:
p.(None): 1. persons with educational qualification master’s degree in pharmacy, chemistry, or biology and at least two-year
p.(None): practical experience in the pharmaceutical manufacture;
p.(None): 2. for the manufacture of radiopharmaceuticals or medicinal products subjected to ionizing radiation –
p.(None): persons who comply with the requirements according to point 1 and have an additionally recognised specialty in
p.(None): radiobiology or radiochemistry.
p.(None): 3. for the manufacture of immunological medicinal products including vaccines, toxins, sera, biotechnological products,
p.(None): and medicinal products obtained from human plasma or human blood – persons with recognised speciality in medical
p.(None): haematology, medical microbiology, virology, or immunology.
p.(None):
p.(None):
p.(None): Art. 150. (1) The person according to Art. 146 shall submit to the BDA a formal application as approved
p.(None): by the director of the Agency.
p.(None): (2) Together with the application according to para 1 the applicant shall also submit:
p.(None): 1. diploma, document for acquired speciality, document for length of service, certificate of clean court record, and
p.(None): employment contract for the persons according to Art. 148, point 2, and Art. 149;
p.(None): 2. copies of contracts of assignment of the manufacture and/or control of the products ordered for manufacture – in the
p.(None): cases according to Art. 151;
p.(None): 3.(amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code
p.(None):
p.(None): of the trader or cooperation from the Trade register, and for the companies, registered in a EU Member State or in a
p.(None): state – party on the Agreement for the EEA – a document for updated registration under the national legislation, issued
p.(None): by a competent body of the relevant state;
p.(None): 4. (amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 02.01.2013)) a list of
p.(None): the production activities and the medicinal forms, which will be manufactured;
p.(None): 5. schemes of the premises for the manufacture, control, and storage and a dossier of the manufacturing capacity;
p.(None): 6. assessment of the environmental impact during the manufacture of the medicinal products for the cases
p.(None): stipulated in the Environmental Protection Act;
p.(None): 7. authorisation by the Nuclear Regulatory Agency where the application concerns manufacture of
p.(None): radiopharmaceuticals or medicinal products subjected to ionised radiation during their manufacture;
p.(None): 8. authorisation for the use of the premises for manufacture, control, and storage issued according to order of the
p.(None): Spatial Development Act or another substituting document;
p.(None): 9. (amend., - SG 98/10, in force from 01.01.2011, repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 10. document for paid fee, in amount determined in the tariff to Art. 21, para 2.
p.(None): (3) For the manufacturing of narcotic substances and pharmaceutical forms containing such substances, the
p.(None): requirements of the Control on Drugs and Precursors Act shall be observed.
p.(None):
p.(None):
...
p.(None): 3. address of the premises for the control and storage of the medicinal products;
p.(None): 4. (amend. – SG, 102/2012, in force from 02.01.2013) the medicinal products, and forms for which the authorisation has
p.(None): been obtained;
p.(None): 5. name of the person according to Art. 161, para 2, point 1;
p.(None): 6. date of deletion of the import authorisation from the register and reason thereof.
p.(None): (2) Data from the register shall be published on the internet site of the BDA.
p.(None):
p.(None): Section III.
p.(None): PRODUCTION, IMPORT AND WHOLESALE TRADE WITH ACTIVE SUBSTANCES (NEW – SG, 102/2012, IN FORCE FROM 02.01.2013)
p.(None):
p.(None): Art. 167a. (new – SG, 102/2012, in force from 02.01.2013) Manufacture, import or wholesale trade with
p.(None): active substance may be carried out by natural or legal persons, registered as traders under the legislation of an EU
p.(None): Member State and entered in to the register under Art. 167.
p.(None):
p.(None):
p.(None): Art. 167b. (new – SG, 102/2012, in force from 02.01.2013) (1) For entering into the register under Art. 167d, the
p.(None): applicant shall submit to BDA an application according to a form, confirmed by the BDA executive director, which shall
p.(None): contain:
p.(None): 1. name, management central office of the person under Art. 167a;
p.(None): 2. a list of the active substances, which will be imported, manufactured or traded;
p.(None): 3. the activities, which the person under Art. 167a will carry out;
p.(None):
p.(None): 4. Premise addresses for the technical equipment for realizing the activity of the persons under Art. 167a;
p.(None): (2) The application under Para. 1 shall have attached:
p.(None): 1. data about the single identification code (SIC) of the trader and for the companies, registered in an EU Member
p.(None): State p a document for current registration under the national legislation, issued by a competent body of the
p.(None): relevant state;
p.(None): 2. document for a paid fee under Art. 21, Para. 2.
p.(None): (3) Within the term of 60 days after the application and the documents under Para. 1 and 2 are received, BDA, on the
p.(None): basis of the risk assessment shall:
p.(None): 1. enter the person under Art. 167a in the register under Art. 167d, for which shall notify,
p.(None): or
p.(None): 2. notify about the date of the inspection, carried out for establishing the compliance of
p.(None): the conditions for the activities under Art. 167a with the requirements of the Good manufacturing practice under Art.
p.(None): 152, Para. 1 and of the Good distribution practices of active substances under Art. 198.
p.(None): (4) Where as a result of the inspection under Para. 3, p. 2, BDA finds out compliance with the Good manufacturing
p.(None): practice under Art. 152, Para. 1 and of the Good distribution practices of active substances under Art. 198,
p.(None): it shall enter the applicant in the register under art. 167d, for which it shall notify him/her.
p.(None): (5) The expenses for performing the inspection under Para. 3, p. 2 shall be on the account of the
p.(None): applicant.
p.(None): (6) For the inspection under Para. 3, p. 2 the applicant shall pay a fee in the amount, determined by the tariff under
p.(None): Art. 21, Para. 2.
p.(None): (7) In the cases under Para. 3, p. 1 and Para. 4 the applicant may start to carry out his/her activity after
p.(None): registering in the register under Art. 167d.
p.(None):
p.(None):
...
p.(None): containing substances specified in the list under Art. 3, para 2, item 2 of the Control on Drugs and Precursors Act –
p.(None): with two blue strips. The packaging shall obligatorily contain a notice that the medicinal product shall only be
p.(None): dispensed by special medical prescription.
p.(None): (3) (amend. – SG, 102/2012, in force from 21.12.2012) The leaflet of the medical products, included in
p.(None): the list under Art. 23 of Regulation (EC) N 7262004 of the European Parliament and of the Council
p.(None): contains information with the following text: "This medicinal product is subject to additional observation".
p.(None): Before the text a sign is placed in black cooler under Art. 23, Para. 5 of Regulation (EC) N 7262004 of the European
p.(None): Parliament and of the Council, accompanied by an explanatory note.
p.(None): (4) (amend. – SG, 102/2012, in force from 21,12,2012) The leaflet of the medicinal products shall included
p.(None): a standard text, by which the patients are invited to report to the medical specialists or directly to BDA about every
p.(None): suspected unwilling medicinal reaction according to the samples in Art. 185, Para. 2, p. 4.
p.(None): (5) Where a medicinal product is to be authorised for use on the territory of the Republic of Bulgaria, a marking for
p.(None): separate collection and recycling according to the Waste Management Act and the acts for the application thereof shall
p.(None): be placed in its secondary packaging.
p.(None): (6) Where a medicinal product is to be authorised for use, its name on the secondary packaging, pharmaceutical form,
p.(None): and content of active substance in a single dose shall also be printed in the Braille’s alphabet.
p.(None): (7) The requirements of para 6 are not applied for vaccines and medicinal products in hospital’s packages.
p.(None): (8) (new – SG, 102/2012, in force from 21.12.2012) On the secondary package (if there is no such) on the initial
p.(None): package of the medicinal products, with the exception of radio- pharmaceutics, the following shall be placed:
p.(None): 1. individual identification sign for indicators of safety, which gives opportunity for the wholesale and retail
p.(None): traders to:
p.(None): a) check up the authenticity of the medicinal product;
p.(None): b) to identify separate packages.
p.(None): 2. a means, which may check up the package of the medicinal product if it has been
p.(None): faked.
p.(None):
p.(None):
p.(None): Art. 168a. (new – SG, 102/2012, in force from 21.12.2012) (1). On the package of the medicinal product, which is
p.(None): prescribed by a doctor’s prescription, safety indicators shall be placed under Art. 168, Para. 8 with the
p.(None): exception of the cases, in which the medicinal product has been included in the list, determined by the European
p.(None): Commission by a delegated act under Art. 168b.
p.(None): (2) On the package of a medicinal product, which does not need doctor’s prescription, no safety indicators shall be
p.(None): placed under Art. 168, Para. 8, with the exception of the cases, in which the medicinal product is included in the
p.(None): list, determined by the European Commission by a delegated act under Art. 168b, after it has been assessed, that it may
p.(None): be put to a risk to be faked.
p.(None): (3) The BDA shall notify the European Commission:
...
p.(None): the Republic of Bulgaria, BDA may permit its use, where some of the data, determined by the ordinance under
p.(None): Para. 1 has not been placed on the package or in the leaflet.
p.(None): (3) (new - SG, 102/2012, in force from 01.03.2012) In the cases under Para. 2, the information on the packing and in
p.(None): the leaflets may not be provided in the Bulgarian language.
p.(None): (4) (new - SG, 102/2012, in force from 01.03.2012) The conditions and procedure for supply of medicinal products under
p.(None): Para. 2 shall be determined by the ordinance under Art. 198.
p.(None):
p.(None): Chapter seven.
p.(None): CLASSIFICATION OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 171. (1) Depending on the method of dispensing, the medicinal products shall be classified as follows:
p.(None): 1. medicinal products dispensed on medical prescription;
p.(None): 2. medicinal products dispensed without medical prescription.
p.(None): (2) The dispensing regime of a medicinal product shall be determined by the BDA in the marketing
p.(None): authorisation/registration certificate.
p.(None): (3) The person according to Art. 26, para 1, shall indicate the dispensing regime of a medicinal product in the
p.(None): application for marketing authorisation/registration certificate, variation of the marketing authorisation or its
p.(None): renewal.
p.(None):
p.(None):
p.(None): Art. 172. The medicinal products according to Art. 171, para 1, point 1, shall be divided in the following categories:
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
p.(None): 2. medicinal products, which are frequently and very widely administered in a wrong manner and as a result of that can
p.(None): represent a threat for the people’s health;
p.(None): 3. medicinal products containing substances the activity and/or adverse drug reactions of which require subsequent
p.(None): additional study;
p.(None): 4. medicinal products, which are usually prescribed by a physician for potential administration.
p.(None):
p.(None):
p.(None): Art. 174. Medicinal products shall be subject to special medical prescription wherever
p.(None):
p.(None): these meet one of the following conditions:
p.(None): 1. contain narcotic substances within the meaning of the Control on Drugs and Precursors Act in admissible
p.(None): for use quantities;
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
p.(None): 3. contain new medicinal substances the characteristics of which are not sufficiently known and therefore these
p.(None): can be assigned to the group of medicinal products according to point 2.
p.(None):
p.(None):
p.(None): Art. 175. Medicinal products shall be subject to limited medical prescription wherever these meet one of the following
p.(None): conditions:
p.(None): 1. are limited to administration in hospital conditions only due to limited experience with their use or in the
p.(None): interest of public health;
p.(None): 2. are intended for treatment of pathological conditions, which can only be diagnosed in therapeutic establishments,
p.(None): irrespective that their administration and follow-up in the course of treatment can be carried out in other healthcare
p.(None): establishments;
p.(None): 3. are intended for treatment of out-patients but their use can cause serious adverse drug reactions, which can require
p.(None): specialist prescribing and monitoring in the course of treatment.
p.(None):
p.(None):
p.(None): Art. 176. (1) The BDA can refuse to approve the dispensing regime of a medicinal product requested by the
p.(None): applicant according to Art. 26, para 1, on the grounds of assessment of:
p.(None): 1. the maximum single dose, maximum daily dose, quantity of the active substance in one dose unit, pharmaceutical
p.(None): form, specific appearance of the primary product packaging, and/or
p.(None): 2. other specific conditions of use.
p.(None): (2) The BDA can refuse to indicate the exact category of a medicinal product according to Art. 172 but pursuant to the
p.(None): criteria according to Art. 174 and Art. 175 shall determine whether a medicinal product shall be classified as a
p.(None): product dispensed only on medical prescription.
p.(None):
p.(None):
p.(None): Art. 177. Medicinal products, which do not meet the requirements according to Art. 173, 174, and 175 and the criteria
p.(None): laid down in the regulation according to Art. 178, shall be dispensed without medical prescription.
p.(None):
p.(None):
p.(None): Art. 178. The criteria for classification of medicinal products and the requirements to the documentation for changing
p.(None): the classification shall be determines by a regulation of the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 179. (1) The BDA shall draw and publish on its internet site a list of the medicinal products, which shall be
p.(None): dispensed on the territory of the Republic of Bulgaria on medical prescription.
p.(None): (2) The list according to para 1 shall be updated annually.
p.(None):
p.(None): Art. 180. Should new data of a medicinal product, which has a marketing
p.(None): authorisation/registration certificate issued, become available, the BDA shall reconsider and if necessary change the
p.(None): classification in accordance with the requirements of Art. 173 and the criteria laid down in the regulation according
p.(None): to Art. 178.
p.(None):
p.(None):
...
p.(None): under Art. 56a, Para. 1. P. 1 by:
p.(None): 1.The Committee on Medicinal Products for human use – where at least on of the marketing authorisations
p.(None): for medicinal products, containing the relevant active substance has been provided in compliance with the centralised
p.(None): procedure, provided in Title II, Chapter 1 of Regulation (EC) N 726/2004 of the European Parliament and of the Council,
p.(None): or
p.(None): 2. the coordination group under Art. 77, Para. 2 – for cases, different from the ones, indicated in p. 1.
p.(None): (4) The list with the reference dates of the EU of the medicinal products under Art. 194l and the harmonised frequency
p.(None): for submitting their periodic updated vigilance reports shall be published on the European internet portal under Art.
p.(None): 68, Para. 1, p. 4.
p.(None): (5) The marketing authorisation holder after publication of the data under Para. 4 shall produce to BDA an
p.(None): application for change of the marketing authorisation of the relevant medicinal product. Each change of the
p.(None): dates of submitting the frequency of submission of the periodic updated safety reports, defined in the marketing
p.(None): authorisation, shall come into force 6 months after the date of their publication.
p.(None):
p.(None):
p.(None): Art. 194o. (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall assess the periodic updated safety reports
p.(None): fpr the medicinal products, in order to define whether there are new risks or change of the established risks or change
p.(None): of the correlation benefit/risk.
p.(None): (2) The BDA shall carry out single assessment of the periodic updated safety reports of the medicinal products for
p.(None): which the Republic of Bulgaria has fulfilled the functions of a reference state in the meaning of Art. 76 and has been
p.(None): defined by the coordination group under art. 77, Para. 2.
p.(None): (3) A reporter from the Republic of Bulgaria shall participate in the single assessment of the periodic updated safety
p.(None): reports of medicinal products, where one of the products has been permitted for use under Regulation (EC) N 726/2004 of
p.(None): the European Parliament and of the Council and has been defined as such by the committee under Art. 56a, Para. 1, p. 1.
p.(None):
p.(None): Art. 194p. (new – SG, 102/2012, in force from 21.12.2012) (1) In the cases under Art. 194o, Para. 2 and 3, BDA or the
p.(None): reporter from the Republic of Bulgaria within the term of 60 days from the date of receiving the periodic updated
p.(None): safety report shall draw up n assessment report and shall submit it electronically to the European Medicines Agency and
p.(None): to the regulatory bodies of the Member States. The marketing authorisation holder shall receive the assessment report
p.(None): from the European Medicines Agency.
p.(None): (2) Within the term of up to 30 days from receiving the report under Para. 1, the marketing
p.(None): authorisation holder or the regulatory bodies of the Member States may produce their comments to the European medicines
p.(None): Agency and to BDA.
p.(None): (3) Within the term of up to 15 days from the date of receiving the comments under Para. 2, BDA shall update the
p.(None): assessment report y taking into consideration all produced objections and shall submit it to the committee under
p.(None): Art. 56a, Para. 1, p. 1 for approval and recommendation.
p.(None): (4) The European Medicines agency shall include the adopted assessment report and the recommendation of the committee
p.(None): under Art. 56a, Para. 1, p. 1 to the register under Art. 194h, Para. 3 and shall submit it to the marketing
p.(None): authorisation holder.
p.(None):
p.(None):
p.(None): Art. 194q. (new – SG, 102/2012, in force from 21.12.2012). Where the Republic of Bulgaria is not a
p.(None): reporter in the procedure under Art. 194o, Para. 2, BDA may produce comments within the term under Art. 194p, Para. 2
p.(None): to the European Medicines Agency and to the regulatory body of the Member State, which has drawn up the report.
p.(None):
p.(None):
p.(None): Art. 194r. (new – SG, 102/2012, in force from 21.12.2012). (1) In case of a single assessment of
p.(None): periodic updated safety reports of medicinal product under Art. 194l and where neither of the marketing authorisations
p.(None): of these products has been issued under Regulation (EC) 726/2004 of the European Parliament and of the Council, the
p.(None): coordination group under Art. 77, Para. 2 within the term of up to 30 days from the date of receiving the
p.(None): recommendation of the committee under Art. 56a, Para. 1, p. 1 shall issue an opinion about keeping, change, termination
p.(None): of the relevant marketing authorisations, including a schedule for implementation of the opinion.
p.(None): (2) Where the represented Member States in the coordination group under Art. 77, Para. 2 reach agreement about the
p.(None): action to be undertaken, BDA shall fulfill the adopted decision.
p.(None): (3) Where the opinion under Para. 1 is for interruption or termination of the marketing authorisation, the BDA
p.(None): executive director shall issue the order.
p.(None): (4) Where the opinion under Para. 1 recommends changes in the issued marketing authorisation, the marketing
p.(None): authorisation holder shall submit to BDA an application for change, including an updated short characteristics of the
p.(None): product and a leaflet, within the frames of the defined implementation schedule.
p.(None): (5) Where no agreement can be reached in the coordination group under Art. 77, Para. 2, the position of the majority
p.(None): Member States shall be produced to the European Commission, which shall adopt a decision for change, interruption or
p.(None): termination of the marketing authorisation, issued by the relevant regulatory bodies of the Member States.
p.(None): (6) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 5.
p.(None):
p.(None):
p.(None): Art. 194s. (new – SG, 102/2012, in force from 21.12.2012).(1) In case of single assessment of periodic
p.(None): updated safety reports of medicinal products under Art. 194l and where
p.(None):
p.(None): at least one of the marketing authorisations has been issued under Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council, the Committee of the medicinal products for human use within the term of 30 days from
p.(None): receiving the recommendation of the committee under Art. 56a, Para. 1, p. 1 shall issue an opinion about keeping,
p.(None): changing, termination or interruption of the validity of the relevant marketing authorisations, including a schedule
p.(None): for the opinion implementation.
p.(None): (2) Where the opinion under Para. 1 expresses a position for undertaking regulatory actions in relation to the
p.(None): marketing authorisations, the European Commission shall:
p.(None): 1. adopt as decision for change, termination or interruption of the marketing authorisations,
p.(None): issue under Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 2. adopt decision with a recommendation for change, termination or interruption of the marketing authorisations, issued
p.(None): by the relevant Member States regulatory bodies.
p.(None): (3) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 2, p. 2.
p.(None):
p.(None): Section IV.
p.(None): Urgent Procedure at European Union Level. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 194t. (new – SG, 102/2012, in force from 21.12.2012) (1) Urgent procedure at the level of the European Union may
...
p.(None): the BDA.
p.(None):
p.(None):
p.(None): Art. 196. (1) Manufacturer of medicinal products within the meaning of this Act can only perform wholesale of the
p.(None): medicinal products, which he has an issued manufacturing authorisation for.
p.(None): (2) Importer of medicinal products within the meaning of this Act can only perform wholesale of the
p.(None): medicinal products, which he has an issued import authorisation for.
p.(None):
p.(None):
p.(None): Art. 197. The persons according to Art. 195 shall dispose of:
p.(None): 1. suitable premises, equipment and outfits, and transport vehicles ensuring correct storage, distribution,
p.(None): and transportation of the medicinal products in compliance with the requirements of the Good Distribution
p.(None): Practice;
p.(None): 2. personnel and responsible master-pharmacist with at least two years length of service in his speciality and whose
p.(None): obligations shall be laid down in the regulation according to Art. 198.
p.(None):
p.(None):
p.(None): Art. 198. (amend. – SG, 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.(None): Distribution Practice of medicinal products and of active substances shall be adopted by an ordinance of the Minister
p.(None): of Health and by directives, adopted by the European Commission.
p.(None):
p.(None):
p.(None): Art. 199. (1) The persons according to Art. 195, para 2, shall submit to the BDA:
p.(None): 1. application containing name, place of business and address of management of the trader; address and description of
p.(None): the premises and equipment for the storage of the medicinal products;
p.(None): 2. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification
p.(None):
p.(None): code of the trader of cooperation from the Trade Register and for the companies, registered in a EU Member State or
p.(None): a state – party on the EEA Agreement – a document for updated registration according to the national
p.(None): legislation, issued by a competent body of the relevant state;
p.(None): 3. name, certificate of clean court record, diploma for higher education and length of service for the responsible
p.(None): master - pharmacist according to Art. 197, point 2, and a copy of his/her employment contract;
p.(None): 4. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 5. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 6. document certifying the legal grounds for the use of the premises;
p.(None): 7. (amend., - SG 98/10, in force from 01.01.2011) conclusion of the Regional Health Inspectorates after inspection on
p.(None): the spot evidencing that the health requirements in the whole sale premises according to the regulation according to
p.(None): Art. 198.
p.(None): 8. document for paid fee as laid down in the tariff Art. 21, para 2.
p.(None): (2) The persons according to Art. 195, para 1, shall submit to the BDA an application accompanied by the following
p.(None): documents:
p.(None): 1. copy of the wholesale authorisation issued by a regulatory body of a Member State;
p.(None): 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.(None): 3. address of the premises for the storage of the medicinal products on the territory of the Member State.
p.(None): (3) In case of wholesale of narcotic substances, as well as pharmaceutical forms containing such
p.(None): substances, the requirements of the Control on Drugs and Precursors Act shall also be applied.
...
p.(None): perform the following activities : storage and selling without doctor’s prescription permitted for use in the Republic
p.(None): of Bulgaria medicinal products, medical items, diet food for special medical purposes and food for babies and
p.(None): transitional food, as well as food supplements, cosmetic and sanitary-hygienic articles.
p.(None):
p.(None):
p.(None): Art. 226. (1) Pharmacies for selling medicinal products to citizens can be opened on the territory of healthcare
p.(None): establishments for outpatient care.
p.(None): (2) Pharmacies for selling medicinal products to citizens cannot be opened on the territory of healthcare
p.(None): establishments to Art. 21, para 2 of the Health Act, therapeutic establishments for hospital care, and
p.(None): healthcare establishments according to Art. 10 of the Medical Establishments Act.
p.(None):
p.(None):
p.(None): Art. 227. (1) (Prev. text of Art. 227 – SG 102/09, in force from 22.12.2009) The requirements relating
p.(None): to the location and to the premises of the pharmacy shall be laid down in the regulation according to Art. 219, para 2.
p.(None): (2) (New – SG 102/09, in force from 22.12.2009, amend. – SG, 60/2011, in force from
p.(None): 5. 8. 2011) The requirements to the structure and the premises of pharmacies as per Art. 228, para. 5 shall be set
p.(None): forth in an ordinance mentioned in para. 1.
p.(None):
p.(None):
p.(None): Art. 228. (Amen. - SG 71/2008, in force from 26.07.2008) (1) (amend. – SG, 60/2011, in force from 5. 8. 2011)
p.(None): Authorisation for retail trade with medicinal product shall be issued by the executive director of BDA, on the grounds
p.(None): of a formal application accompanied with the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 222, Para. 1;
p.(None): 2. labour contract or a contract for managing a pharmacy, signed with a Master of Pharmacy or assistant
p.(None): Pharmacist;
p.(None): 3. copy of the act for establishing the persons under Art. 222, para 4;
p.(None): 4. documents, evidencing that the requirements of Art. 224 have been observed;
p.(None): 5. certificate of court record of the Master of Pharmacy, respectively of the assistant pharmacist indicated as manager
p.(None): of the pharmacy;
p.(None): 6. medical certificate of the Master of Pharmacy or the assistant pharmacist, manager of the pharmacy;
p.(None): 7. (suppl. – SG, 60/2011, in force from 5. 8. 2011; revoked - SG 48/15)
p.(None): 7a. (new - SG, 60/2011, in force from 5. 8. 2011) hygiene conclusion, issued by the relevant RHI;
p.(None): 8. document for paid state fee in the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (2) (New - SG, 60/2011, in force from 5. 8. 2011) While issuing an authorisation for retail trade with medicinal
p.(None): products a check up shall be performed if the produced diploma of the Master Pharmacist /Assistant Pharmacist has been
p.(None): issued by the relevant competent institution.
p.(None): (3) (Former Para. 2, amend. - SG, 60/2011, in force from 5. 8. 2011) The pharmacies of
p.(None):
p.(None): the therapeutic establishments according to Art. 222, para 4 and 6 shall be opened and closed according to the request
p.(None): of the person representing the healthcare establishment;
...
p.(None): products, the medicinal products can be sold by persons who have received authorisation for wholesale trade in
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
p.(None): 3. has at least 1 year of professional experience in this field.
p.(None):
p.(None):
p.(None): Art. 239. (1) (amend. – SG, 60/2011, in force from 5. 8. 2011) Drugstores shall be opened after
p.(None): registration at the relevant RHI.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 238,
p.(None):
p.(None): para 2, shall submit to the RHI a registration application accompanied by the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 238, Para. 1;
p.(None): 2. education document and certificate of clean court record or the person appointed as manager of the drugstore;
p.(None): 3. medical certificate of the person according to point 2;
p.(None): 4. (repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 5. (amend., - SG 98/10, in force from 01.01.2011, repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 6. document for paid state fee to the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011).Within 14 day term from receiving the application under Para. 2,
p.(None): RHI shall perform an inspection on the observation of the requirements of the Ordinance under Art. 243.
p.(None): In the cases, where it is found that the requirements of the Ordinance under Art. 243 have not been observed,
p.(None): within 7 day term after the inspection the RHI shall give instructions and shall determine term for removing them.
p.(None): (4) (New – SG, 60/2011, in force from 5. 8. 2011). Within 14 day term from receiving the application and the
p.(None): documents under Para. 2, the director of RHI shall notify in writing the persons for finding irregularities
p.(None): in them and shall determine a term for their removal.
...
p.(None): (3) Investment projects for construction of new and/or refurbishment of existing sites associated with the manufacture
p.(None): of medicinal products in compliance with the rules for Good Manufacturing Practice of medicinal products shall be
p.(None): coordinated with the BDA.
p.(None):
p.(None):
p.(None): Art. 268a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) Donations of medicinal products from holders authorisation
p.(None): for use, producers, wholesale and retail traders and from the Bulgarian red cross may be done only after coordination
p.(None): of the donator with the BDA through producing an application according to a form, confirmed by the Minister of Health
p.(None): upon proposal of the executive director of BDA.
p.(None): (2) The donations shall be done while observing the rules for Good donation practice of the World Health Organisation.
p.(None): (3) Where within 10 day term from receiving the application under Para. 1, BDA fails to respond in writing to the
p.(None): donator, it shall be accepted, that there is a silent agreement for the donation.
p.(None): (4) The medical establishments and the Bulgarian red cross shall inform BDA for the received donations of medicinal
p.(None): products within 7 day term from their receiving.
p.(None): (5) At the end of each quarterly, the BDA shall send information to the Ministry of Health about the donations under
p.(None): Para, 4.
p.(None): (6) For a performed donation of a medicinal product upon request of a medical establishment, intended for
p.(None): treatment of a concrete patient in a lifesaving situation, the donator shall inform the BDA within 7 day term from the
p.(None): donation.
p.(None): (7) The donations under Para. 6 shall not exceed the quantity, needed for a single course of treatment.
p.(None):
p.(None):
p.(None): Art. 269. (1) The control according to Art. 267 shall be exercised through inspections and laboratory tests.
p.(None): (2) The inspections and laboratory tests according to Para. 1 shall be conducted:
p.(None): 1. in connection with issuing marketing, manufacture, and import authorisations and certificates under the
p.(None): terms of this Act;
p.(None): 2. in connection with exercising surveillance on the medicinal products market;
p.(None): 3. in case of application on the part of the European Commission, the European Medicines Agency, or on the
p.(None): part of a competent body of another Member State;
p.(None): 4. in case of application on the part of a manufacturer, importer, or marketing authorisation holder
p.(None): outside the cases according to point 1.
p.(None): (3) (amend. – SG, 102/2012, in force from 21.12.2012) The BDA shall conduct inspections:
p.(None): 1. of manufacturers of medicinal products, placed on the territory of the Republic of Bulgaria of a Member
p.(None): State or in third states;
p.(None): 2. of importers and wholesale traders of medicinal products;
p.(None): 3. of the manufacturers, importers and wholesale traders of active substances premises, placed on the territory of the
p.(None): Republic of Bulgaria;
p.(None): 4. of premises of manufacturers or wholesale traders of active substances, placed in third states, as well as of
p.(None): manufacturers or importers of auxiliary substances;
p.(None):
p.(None): 5. of premises of marketing authorisation holders of medicinal products and of intermediaries in the area of
p.(None): medicinal products, registered under Art. 212a;
p.(None): 6. as a part of the certification procedure, which in connection with European Pharmacopoeia monographs.
...
p.(None): mean a legal subject registered according to the civil or trade legislation of a Member State or established pursuant
p.(None): to a normative act and having place of business in a Member State or a state - party of the European Economic Area.
p.(None): 32. "Magisterial formula" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): prescription of a medical specialist or according to an established recipe and intended for a definite patient.
p.(None): 33. "International non-proprietary name" shall mean a recommended name of an active substance approved and published by
p.(None): the World Health Organisation.
p.(None): 34. "Medical specialists" shall mean medical doctors, doctors in dental medicine, masters of pharmacy,
p.(None): nurses, midwives, medical laboratory assistants, medical auxiliaries and pharmacy assistants.
p.(None): 35. "Medical trade representative" shall mean a person who has passed special training and possessing scientific
p.(None): knowledge for the presentation of accurate and comprehensive information about the medicinal product he is
p.(None): advertising.
p.(None): 35a. (new – SG 1/14, in force from 03.01.2014)”Medical prescription” shall mean a prescription of a
p.(None): medicinal product, issued by a person who exercises a regulated medical profession within the meaning of § 1,
p.(None): item 1 of the Additional Provisions of the Recognition of Professional Qualifications Act and who is legally entitled
p.(None): to do so in the Member State in which the medical prescription is issued.
p.(None): 36. "Multicentre clinical test" shall mean a clinical test, which is conducted according to a single protocol but in
p.(None): more than one site and by more than one researcher. Researcher sites can be situated in the territory of one Member
p.(None): State, more than one Member State, and/or in Member States and third states.
p.(None): 37. "Name of a medicinal product" shall mean the name given to a medicinal product, which can be:
p.(None): a) a freely selected name (trade name);
p.(None): b) (amend. – SG 12/11, in force from 08.02.2011) a common name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation;
p.(None): c) (amend. – SG 12/11, in force from 08.02.2011) scientific name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation.
p.(None): 38. "Scientific literature" shall mean publication(s) of results from scientific research in specialised international
p.(None): scientific editions.
p.(None):
p.(None): 39. "New active substance" shall mean:
p.(None): a) chemical, biological, or radiopharmaceutical substance, which has not been authorised to market in
p.(None): the European Union as a medicinal product;
p.(None): b) isomer, mixture of isomers, complex or derivative or salt of a chemical substance, which has been authorised to
p.(None): market in the European Union as a medicinal product but is different with respect to safety and efficacy from
p.(None): a formerly authorised substance;
...
p.(None): provided by the Act on the Medicines and Pharmacies in the Human Medicine shall perform their activity as
p.(None): provided by their issued authorisations.
p.(None): (2) By this Act comes into force, the filed applications for issuing authorisation for retail
p.(None):
p.(None): trade with medicinal products shall be examined under the terms and conditions, provided by it.
p.(None): (3) Apart from the cases under para 1, the persons, status quo at the time of this Act comes into force, who have
p.(None): received authorisation for opening a pharmacy, shall comply their activity with its requirements within 1 year after
p.(None): its coming into force.
p.(None): (4) The persons under para 3 shall file in the Ministry of Health an application for re- registration, which shall
p.(None): contain:
p.(None): 1. application for issuing authorisation for retail trade with medicinal products by the persons under Art. 222, para
p.(None): 1, according to a form, approved by the Minister of Health;
p.(None): 2. updated certificate for listing into the trade register, correspondingly a document for updated registration of the
p.(None): person under Art. 222, para 1;
p.(None): 3. copy of the issued authorisation for opening a pharmacy, as provided by the Act on the Medicines and Pharmacies in
p.(None): the Human Medicine
p.(None): 4. certified copy of the employment contract or a contract for assignment of management of the head of the pharmacy –
p.(None): in the cases, where such is required;
p.(None): 5. declaration of the persons under Art. 222, para 1, that the conditions have been met for issuing the authorisation
p.(None): for retail trade with medicinal products of the persons under para 2;
p.(None): 6. document for a single paid fee in the amount of BGN 100.
p.(None):
p.(None):
p.(None): § 67. The persons, who have filed by this Act comes into force application for re- registration as
p.(None): provided by the repealed § 16 of the Transitional and Final Provisions, who will perform their activity as provided by
p.(None): the requirements of this Act, shall file in the Ministry of Health within 3 months after its coming into force, the
p.(None): following documents:
p.(None): 1. application, according to a form, approved by the Minister of Health;
p.(None): 2.updated certificate for listing in the trade register, or a document for updated registration or a
p.(None): certified copy of a similar document according to the national legislation of an EU Member State or the legislation of
p.(None): another Member- State – party of the EEA, under Art. 222, para 1;
p.(None): 3. employment contract or a contract for management of the pharmacy, signed with a Master of Pharmacy of Assistant
p.(None): Pharmacist.
p.(None):
p.(None):
p.(None): § 68. (1) Master of Pharmacy of Assistant Pharmacist, who has received authorisation for opening a pharmacy, as
p.(None): provided by the repealed § 16 of the Transitional and Final Provisions may transfer the issued authorisation
p.(None): to a person under Art. 222, para 1.
p.(None): (2) For performing the transfer, the persons under para 1 shall file in the Ministry of Health an application, which
p.(None): shall contain:
p.(None): 1. an application for issuing authorisation for retail trade with medicinal products by the persons under Art. 222,
p.(None): para 1, according to a form, approved by the Minister of Health;
p.(None): 2. an updated certificate for listing in the trade register, or a document for updated registration of
p.(None): the persons under Art. 22, para 1;
...
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p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
p.(None): consent or of data obtained through other research methods;
p.(None): 4. the study is directly associated with a disease, which is life-threatening or resulting in disability, from which
p.(None): the major person who is not capable of giving informed consent is suffering;
p.(None): 5. the clinical trials are planned in such manner that pain, inconvenience, fear, and the other foreseeable risks
p.(None): associated with the disease are minimised and the risk threshold and physical pain degree have been determined in
p.(None): advance and shall be incessantly controlled throughout the clinical test;
p.(None): 6. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 102. No clinical test with a medicinal product can be conducted in pregnant women or breastfeeding mothers except
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
p.(None): (2) The committees according to para 1 shall include at least two persons of non-medical education, representatives of
...
Social / Property Ownership
Searching for indicator property:
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p.(None): keep and maintain public registers for the issued by them authorisations for registration of drug
p.(None): stores.
p.(None): (2) Within 7-day term from the issuance of an authorisation for registration of a drug store, the relevant RHI shall
p.(None): submit information to the Ministry of Health about the issued act.
p.(None): (3) The Ministry of Health shall keep and maintain on its internet site a public national register of the issued
p.(None): authorisations for registration of a drug store.
p.(None):
p.(None): Section III. Financing
p.(None):
p.(None): Art. 20. (1) The activity of the Bulgarian Drug Agency is financed from the budget funds and its own activity.
p.(None): (2) (amend. SG 15/13, in force from 01.01.2014) Budget funds shall be ensured by a subsidy from the state budget
p.(None): through the budget of the Ministry of Health.
p.(None):
p.(None):
p.(None): Art. 21. (1) The Bulgarian Drug Agency shall be the administrator of the revenues of its own activity, namely:
p.(None): 1. chemico-pharmaceutical examinations;
p.(None): 2. laboratory analyses and tests;
p.(None): 3. assessment of documentation and issue of authorisations, certificates, and other documents set forth in
p.(None): this Act;
p.(None): 4. evaluation by the renewal, variation and cease of marketing authorisation approval and certificate for registration
p.(None): of medicinal product;
p.(None): 5. maintenance of marketing authorisations of medicinal products;
p.(None): 6. fines and property sanctions imposed by penal ordinances issued for infringements of this Act;
p.(None): 7. consulting, publishing, and research activities in the field of the drug sector;
p.(None): 8. coordination of investment projects for the construction of new and/or refurbishing of existing sites relating to
p.(None): the manufacture of medicinal products;
p.(None): 9. conduct of inspections in connection with assessment of compliance of the manufacturing conditions with
p.(None): the requirements of Good Manufacturing Practice;
p.(None): 10 other sources.
p.(None): (2) During the execution of the activities according to para 1, points 1 – 5, points 7 – 9 the Bulgarian Drug Agency
p.(None): shall collect fees to the amounts as defined in a tariff adopted by the
p.(None):
p.(None): Council of Ministers.
p.(None): (3) (New - SG 71/2008, in force from 12.08.2008) The tariff under para 2 shall have determined lower and various in
p.(None): amount fees for realisation of the procedures on permission for usage, production and import of medicinal products for
p.(None): small and medium enterprises in the pharmaceutical sector in the meaning of the Small- and Medium-Size Enterprises Act.
p.(None):
p.(None):
p.(None): Art. 22. (1) The funds according to Art. 21 shall be spent for:
p.(None): 1. control activity of the BDA;
p.(None): 2. Payment of the activities according to Art. 21, Para. 1, p. 1 and 2, when The BDA is assigned their execution of
p.(None): another persons by contract;
p.(None): 3. (revoked – SG 38/12, in force from 01.07.2012)
p.(None): 4. establishment and maintenance and update of the registers according to Art. 19, Para.
p.(None): 1;
p.(None): 5. maintenance of systems for electronic data exchange with the regulatory bodies of
...
p.(None): (2) (suppl. – SG 18/14) The documents according to para 1, item 18 and 18a, relating to the Member States, and point
p.(None): 19, respectively, shall only be submitted in the procedures according to section VII.
p.(None): (3) To radionuclide generators, the following documents shall be added to the data according to para 1:
p.(None): 1. description of the system together with a detailed description of its components, which may affect the composition
p.(None): or quality of the daughter radionuclides;
p.(None): 2. qualitative and quantitative particulars of the eluate or the sublimate.
p.(None): (4) The documents and data from pharmaceutical tests, preclinical and clinical trials shall be accompanied by
p.(None): summarised reports prepared by experts with the required technical and professional qualification. To the reports a
p.(None): curricula vitae report of the experts shall be applied.
p.(None): (5) The dossier of the medicinal product shall be submitted in the Bulgarian and/or English language.
p.(None): (6) (new – SG, 102/2012, in force from 21.12.2012) The risk management system under Para. 1, p. 13 should be
p.(None): proportional to the identified and to the potential risks of the medicinal product and to the need of collecting safety
p.(None): data of post-marketing researches.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The holder of the authorisation for use shall update the data of the
p.(None): file under Para. 1. For each change in the file the provisions of Chapter Three Section VI shall apply, where
p.(None): applicable.
p.(None):
p.(None):
p.(None): Art. 28. (1) The person according to Art. 26, para 1, insofar as he does not infringe industrial and commercial
p.(None): property rights, shall not submit to the BDA the data according to Art.
p.(None):
p.(None): 27, para 1, point 10, letters "b" and "c" provided that he can prove that the medicinal product indicated in the
p.(None): application is generic of a reference medicinal product, which is or has been authorised to market for not less than 8
p.(None): years in a Member State or in a state member of the European Economic Area.
p.(None): (2) The marketing authorisation holder of a generic product according to para 1 may not place it to market until 10
p.(None): years from the initial marketing authorisation of the reference medicinal product have elapsed.
p.(None): (3) Under observance of the conditions of para 1 and 2, the person according to Art. 26, para 1, may submit to the BDA
p.(None): an application for marketing authorisation of a medicinal product, which is generic of a reference medicinal product,
p.(None): even where the reference product has never had marketing authorisation on the territory of the Republic of Bulgaria.
p.(None): (4) In the cases according to para 3, the person according to Art. 26, para 1, shall indicate in the
p.(None): application according to Art. 27, para 1, the Member State where the reference product is or has been authorised to
p.(None): market.
p.(None): (5) In the cases according to para 3, the BDA shall request from the regulatory authority of the Member State indicated
p.(None): in the application according to Art. 27, para 1, a confirmation of the information according to para 4, the qualitative
p.(None): and quantitative composition of the reference product and, if necessary, additional documentation.
p.(None): (6) At the request of a regulatory authority of a Member State where the application for a medicinal product generic to
...
p.(None): supplemented. All these authorisations shall be considered belonging to a general marketing authorisation of the
p.(None): medicinal product for the purposes of application of this Article.
p.(None):
p.(None):
p.(None): Art. 29. (1) The person according to Art. 26, para 1, shall submit to the BDA the results of the required preclinical
p.(None): and/or clinical trials in the cases where the medicinal product indicated in the application:
p.(None): 1. cannot be defined as generic or
p.(None): 2. the bioavailability tests do not prove bioequivalence, or
p.(None): 3. there is a change in the active substance(s), therapeutic indications, pharmaceutical form, and/or posology compared
p.(None): with the reference medicinal product, or
p.(None): 4. is offered in dosage units, which are different compared with the reference medicinal product.
p.(None): (2) Where a biological medicinal product indicated in the application as similar to a reference biological
p.(None): medicinal product does not comply with the conditions to be determined as
p.(None):
p.(None): a generic medicinal product due to different method of manufacture or different starting materials compared with the
p.(None): reference product, or for other reasons, the applicant shall submit to the BDA the results of the required preclinical
p.(None): and/or clinical trials associated with these conditions.
p.(None): (3) In the cases according to para 1 and 2 the documentation as laid down in the regulation according
p.(None): to Art. 42 shall also be submitted.
p.(None):
p.(None):
p.(None): Art. 30. (1) The person according to Art. 26, para 1, insofar as he does not infringe the industrial and commercial
p.(None): property, shall not submit to the BDA the data according to Art. 27, para 1, point 10, letters "b" and "c" provided
p.(None): that he can prove that the conditions laid down in the regulation according to Art. 42 to the effect that the
p.(None): active substance included in the composition of the medicinal product applied for marketing authorisation has a
p.(None): well-established use in the medical practice and possesses acknowledged efficacy and acceptable safety level. In these
p.(None): cases, the results from the tests and tests may be replaced by the relevant scientific publications.
p.(None): (2) The person according to para 1 shall submit the results from the required preclinical and clinical trials in
p.(None): case that the medicinal product containing active substances with well- established use, which have not been
p.(None): used for therapeutic use in the proposed combination. In this case, the documentation relating to each active substance
p.(None): shall not be submitted.
p.(None): (3) Where an active substance within the meaning of para 1 has a proven new therapeutic indication on the
p.(None): basis of significant preclinical or clinical data associated with the new indication, the next applicant may not refer
p.(None): to the data for the new indication of the active substance more than once in a year.
p.(None):
p.(None):
p.(None): Art. 31. In case, when medicinal product containing active substances used in the composition of
p.(None): authorised medicinal products but which are not used in the proposed combination for therapeutic purposes,
...
p.(None): of Regulation N 726/2004 (EC) of the European Parliament and of the Council.
p.(None):
p.(None):
p.(None): Art. 89. (1) A clinical test in human subjects shall be conducted with medicinal products, which are manufactured,
p.(None): maintained, and stored in compliance with the rules for Good Manufacturing Practice for medicinal products
p.(None): under development and research.
p.(None): (2) The rules for Good Manufacturing Practice for medicinal products under development and research
p.(None): shall be laid down in the regulation according to Art. 152.
p.(None): (3) A medicinal product can be proposed for a clinical test where pharmacological and toxicological studies have
p.(None): been conducted in accordance with the requirements for Good Laboratory Practice.
p.(None):
p.(None):
p.(None): Art. 90. The clinical test can be started and conducted provided that:
p.(None): 1. the anticipated therapeutic benefits for the study subjects, for current and future patients and the
p.(None): benefits for the healthcare justify the foreseen risks;
p.(None): 2. the physical and mental immunity of the study subjects, their right of immunity of their private life and the
p.(None): right of personal data protection have been guaranteed pursuant to the Protection of Personal Data Act;
p.(None): 3. insurance or indemnity for covering researcher or contracting authority liability has been provided.
p.(None):
p.(None):
p.(None): Art. 91. The contracting authority and the principal researcher shall make insurance covering their liability
p.(None): for property or non-property damages to the study subjects caused in or on the occasion of the conduct of the clinical
p.(None): test.
p.(None):
p.(None):
p.(None): Art. 92. (1) The contracting authority shall be responsible in case of injury of the health or death caused by or in
p.(None): the occasion of the conduct of the clinical test where the clinical test has been conducted in compliance with the
p.(None): requirements and procedures of the study protocol as approved by the ethics committee.
p.(None): (2) The principal researcher shall be responsible in case of injury of the health or death caused by or in the occasion
p.(None): of the conduct of the clinical test where the clinical test has not
p.(None):
p.(None): been conducted in compliance with the requirements and procedures of the study protocol as approved by the ethics
p.(None): committee.
p.(None):
p.(None):
p.(None): Art. 93. (1) Contracting authority of a clinical test shall be a person established on the territory of a Member State.
p.(None): (2) Contracting authority and researcher can be the same person.
p.(None):
p.(None):
p.(None): Art. 94. The contracting authority shall gratuitously provide the study medicinal product(s) and any device
p.(None): required for the administration thereof.
p.(None):
p.(None):
p.(None): Art. 95. (1) The contracting authority shall develop the labelling of the study medicinal product in compliance with
p.(None): the rules for Good Manufacturing Practice for medicinal products under development and research.
...
p.(None): which has received an authorisation for retail trade with medicinal products under terms and conditions,
p.(None): determined by the Ordinance under Art. 219, Para. 2.
p.(None): (6) (Repealed., former para 4, amen. - SG 71/2008, in force from26.07.2008, former Para. 5, amend. – SG, 60/2011,
p.(None): in force from 5. 8. 2011) Pharmacies of therapeutic establishments for outpatient care at the Ministry of
p.(None): Defence and Ministry of Interior can be managed from assistant pharmacist after proposal by the corresponding
p.(None): administration and after issued approval from the executive director of BDA.
p.(None):
p.(None):
p.(None): Art. 223. (1) Master - pharmacist and assistant pharmacist can be manager of only one pharmacy and shall obligatorily
p.(None): work in it.
p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011) Master of pharmacy or assistant pharmacist who is the manager of a
p.(None): pharmacy cannot be hired to work upon agreement with sole trader or trade company having as its objectives manufacture,
p.(None): import, wholesale or retail trade in medicinal products.
p.(None): (3) The person, envisaged in Para 1, who have received authorisation to retail trade with medicinal products cannot be
p.(None): an owner or participate in trade companies that have as their objectives manufacture, import, or wholesale trade in
p.(None): medicinal products including companies of related persons within the meaning of the Commerce Act.
p.(None):
p.(None):
p.(None): Art. 224. The manager of a pharmacy must:
p.(None): 1. be a Master in Pharmacy, respectively assistant pharmacist in the cases stipulated by the law;
p.(None): 2. not be deprived of the right to practice the profession;
p.(None): 3. not to be convicted for crimes associated with practicing his profession, for crimes against property and economy,
p.(None): or for intentional crimes against personality;
p.(None): 4. have at least one year practice like the person obtaining a master in pharmacy.
p.(None):
p.(None):
p.(None): Art. 225. (1). (Amen. - SG 71/2008, in force from 26.07.2008) In settlement on the territory, which does
p.(None): not have another pharmacy, right for retail trade with medicinal products, shall have a person under Art. 222, para 1,
p.(None): who has signed an employment contract or contract for managing of the pharmacy with an Assistant Pharmacist or Master
p.(None): of Pharmacy with less than a year of work experience.
p.(None): (2) The assistant pharmacist who has authorisation for retail trade with medicinal products according to
p.(None): para 1 is the manager of the pharmacy and he/she shall obligatory work in it.
p.(None):
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011) Assistant – pharmacist – manager of the pharmacy under Para. 1 may
p.(None): perform the following activities : storage and selling without doctor’s prescription permitted for use in the Republic
p.(None): of Bulgaria medicinal products, medical items, diet food for special medical purposes and food for babies and
p.(None): transitional food, as well as food supplements, cosmetic and sanitary-hygienic articles.
p.(None):
p.(None):
p.(None): Art. 226. (1) Pharmacies for selling medicinal products to citizens can be opened on the territory of healthcare
p.(None): establishments for outpatient care.
p.(None): (2) Pharmacies for selling medicinal products to citizens cannot be opened on the territory of healthcare
p.(None): establishments to Art. 21, para 2 of the Health Act, therapeutic establishments for hospital care, and
p.(None): healthcare establishments according to Art. 10 of the Medical Establishments Act.
p.(None):
p.(None):
...
p.(None): leave for breeding of a little child, as per Labour Code, the pharmacy can operate under the management of another
p.(None): master of pharmacy, respectively another assistant pharmacist, in the cases to Art. 225 complying with the requirements
p.(None): of Art. 224 for not more than two years. In all these cases a permission of the executive director of BDA shall be
p.(None): issued.
p.(None): (3) The permission according to 2 shall be issued within 30 days.
p.(None):
p.(None):
p.(None): Art. 237. Upon termination of the activity of the person who received authorisation to retail trade with medicinal
p.(None): products, the medicinal products can be sold by persons who have received authorisation for wholesale trade in
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
p.(None): 3. has at least 1 year of professional experience in this field.
p.(None):
p.(None):
p.(None): Art. 239. (1) (amend. – SG, 60/2011, in force from 5. 8. 2011) Drugstores shall be opened after
p.(None): registration at the relevant RHI.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 238,
p.(None):
p.(None): para 2, shall submit to the RHI a registration application accompanied by the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 238, Para. 1;
p.(None): 2. education document and certificate of clean court record or the person appointed as manager of the drugstore;
p.(None): 3. medical certificate of the person according to point 2;
p.(None): 4. (repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 5. (amend., - SG 98/10, in force from 01.01.2011, repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 6. document for paid state fee to the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011).Within 14 day term from receiving the application under Para. 2,
p.(None): RHI shall perform an inspection on the observation of the requirements of the Ordinance under Art. 243.
...
p.(None): including information about the groups, which the advertising is intended for, about the method of its realisation, as
p.(None): well as the starting date of the advertising campaign;
p.(None): 3. guarantee the training of the medical trade representatives;
p.(None): 4. accurately and timely fulfil the instructions of the persons responsible for the control of advertising.
p.(None): (3) The medical trade representatives must report to the scientific units according to para 1 any information about the
p.(None): use of the advertised medicinal products, particularly with respect of the information of adverse drug reactions
p.(None): communicated to them by the medical specialists.
p.(None):
p.(None):
p.(None): Art. 245a. (New – SG. 71/2008, in force from 12. 08. 2008) Advertisement shall be admitted only of
p.(None): medicinal products, for which an authorisation has been issued under this Act.
p.(None):
p.(None):
p.(None): Art. 246. (1) The content of the advertising must comply with the data of the approved during the marketing
p.(None): authorisation procedure summary of product characteristics and only present the indications approved therein.
p.(None): (2) Advertising of a medicinal product must only bear on its correct use by objectively presenting the therapeutic
p.(None): indications of the medicinal product without exaggerating its therapeutic, prophylactic, and diagnostic
p.(None): capacities.
p.(None): (3) The advertising must not contain misleading information.
p.(None):
p.(None): (4) (New – SG. 71/2008, in force from 12.08.2008) The advertisement shall not contain proposal and/or promise for a
p.(None): gift and/or another property or non-property benefit.
p.(None): (5) (New – SG. 71/2008, in force from 12.08.2008) A medical specialist or a person, representing himself/herself as
p.(None): a medical specialist shall not perform direct or indirect advertisement of medicinal products in the printed
p.(None): and/or electronic media, as well as in internet.
p.(None):
p.(None):
p.(None): Art. 247. Advertising to the population shall only be allowed for medicinal products dispensed without
p.(None): medical prescription.
p.(None):
p.(None):
p.(None): Art. 248. Besides the cases according to Art. 247, advertising campaigns carried out by marketing authorisation
p.(None): holders in connection with vaccination shall be permitted provided observation of the requirements of Art. 251,
p.(None): and under terms and procedure, provided for in the Ordinance under Art. 249.
p.(None):
p.(None):
p.(None): Art. 248a. (New – SG. 71/2008, in force from 12.08.2008) Advertising in internet shall be prohibited of medicinal
p.(None): products, which are prescribed by doctor’s prescription, with the e exception of advertisement campaigns of
p.(None): vaccination, performed as provided by Art. 248, and approved by the competent authorities.
p.(None):
p.(None):
p.(None): Art. 249. The requirements to the advertising of medicinal products shall be paid down in a regulation of the Minister
p.(None): of Health.
p.(None):
p.(None):
p.(None): Art. 250. Application for authorisation of advertising of medicinal product shall be submitted by the
p.(None): marketing authorisation holder of the medicinal product or a duly empowered person.
p.(None):
p.(None):
p.(None): Art. 251. (1) For advertising authorisation the person according to Art. 250 shall submit to the BDA a formal
p.(None): application as approved by the executive director of the agency accompanied by:
p.(None): 1. design of the advertising;
...
p.(None): (2) Whoever breaks the primary/secondary packaging or sells/provides medicinal products with broken
p.(None): primary/secondary packaging shall be penalised with a fine from BGN 750 to BGN 1500 and in case of a repeated
p.(None): infringement with a fine from BGN 1,500 to BGN 3,000.
p.(None):
p.(None):
p.(None): Art. 284. (1) Whoever manufactures, imports, or conducts wholesale with medicinal products, or sells without
p.(None): respective authorisation or in infringement of an issued authorisation shall be penalised with a fine from BGN 50,000.
p.(None): (2) amend. – SG, 102/2012, in force from 02.01.2013) Whoever manufactures, imports, or conducts wholesale with
p.(None): medicinal products, or sells without respective authorisation or in infringement, or sell, storage or provides
p.(None): medicinal products, which of uncertain origin, shall be penalised with a fine from BGN 25,000 to BGN 50,000.
p.(None): (3) In the cases according to Para. 1 the bodies of the state control shall stop the operation of the
p.(None): site by an order.
p.(None): (4) The order according to Para. 3 shall be subject to appeal under the terms of the Administrative Procedure Code;
p.(None): however, the appeal shall not stop its execution.
p.(None):
p.(None):
p.(None): Art. 284a (new – SG, 102/2012, in force from 02.01.2013) Anyone, who manufactures, imports, exports, keeps, sells or
p.(None): provides false medicinal products, as well as intermediates in selling and buying falsified medicinal products, shall
p.(None): be punished by a fine of BGN 25 000 to BGN 50 000.
p.(None):
p.(None):
p.(None): Art. 284b (new – SG, 102/2012, in force from 02.01.2013) Any marketing authorisation holder, who fails to fulfill
p.(None): his/her obligation under Art. 160, shall be punished by a property sanctions of BGN 5000 to 10 000 and in a
p.(None): repeated violation – by a property sanction of BGN 10 000 to 20 000.
p.(None):
p.(None):
p.(None): Art. 284c (new – SG, 102/2012, in force from 02.01.2013) Any wholesale authorisation holder of medicinal products, who
p.(None): fails to fulfill his/her obligation under Art. 207 shall be punished by a property sanction of BGN 2000 to 5000 and in
p.(None): a repeated deed of the same violation 0 by
p.(None):
p.(None): a property sanction of BGN 5000 to 10000.
p.(None):
p.(None):
p.(None): Art. 285. (1) Whoever trades in medicinal products without certificate of batch release shall be penalised with a
p.(None): fine from BGN 5,000 to BGN 10,000 and in case of repeated perpetration of the same infringement – with a
p.(None): fine from BGN 10,000 to BGN 20,000.
p.(None): (2) (Amend. – SG, 60/2011, in force from 5. 8. 2011) A wholesaler who supplies drugstores with medicinal
p.(None): products upon doctor's prescription, outside the lists approved by the Minister of Health shall be penalised with a
p.(None): property sanction from BGN 2500 to 5000 and in case of repeated infringement with a fine from BGN 5,000 to BGN 10,000.
p.(None): (3) A qualified person who has permitted sale of batches of medicinal products without certificate of batch release of
p.(None): any separate batch shall be penalised with a fine from BGN 2,500 to BGN 5,000.
p.(None):
p.(None):
p.(None): Art. 285a. (New – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012) Holder of an authorisation for use, who
p.(None): fails to notify the Minister of health for termination of the sales under Art. 264 shall be punished by a property
p.(None): sanction of BGN 25 000 to 50 000.
p.(None):
p.(None):
p.(None): Art. 285b. (new – SG, 102/2012, in force from 21.12.2012) Anyone, who manufactures, imports, exports, sells or keeps
p.(None): active substances in violation of this act, shall be punished by a fine BGN 10 000 to 20 000.
p.(None):
p.(None):
p.(None): Art. 285c. (new – SG 18/14) A holder of a permit for wholesale of medicinal products failing to notify BDA of carrying
p.(None): out export of medicinal products under Art. 217a, par. 4 shall be punished with a fine, respectively with a proprietary
p.(None): sanction from BGN50 000 to BGN100 000, and in case of repeated the same violation – from BGN100 000 to BGN200 000.
p.(None):
p.(None):
p.(None): Art. 286. (1) In case of clinical trials conducted in infringement of this Act, provided no crime has been committed,
p.(None): the guilty persons shall be penalised with a fine from BGN 5,000 to BGN 10000 and in case of repeated permission or
p.(None): commitment of the same infringement – with a fine from BGN 10000 to BGN 20000.
p.(None): (2) Medial specialists who have permitted or committed infringements according to para 1 can be imposed the penalty of
p.(None): "deprived of the right to exercise the profession" for a term from 6 months to two years.
p.(None): (3) The measure according to para 2 shall be imposed by the Minister of Health according to a proposal by
p.(None): the executive director of the BDA.
p.(None):
p.(None):
p.(None): Art. 287. (1) (Supl.. - SG 71/2008 in force from 12.08.2008, amend. – SG, 60/2011, in force from 5. 8. 2011)
p.(None): Whoever conducts retail trade in medicinal products without having respective authorisation/certificate, or
p.(None): works in violation of his/her issued authorisation/certificate, shall be penalised by a fine from BGN 5,000 to BGN
p.(None): 10,000.
...
p.(None): registration of the drug store will be deprived of.
p.(None): (4) In the cases according to para 1 and 2, the bodies of the state control on the medicinal products
p.(None): shall stop the operation of the site by an order.
p.(None): (5) The order according to para 4 shall be subject to appeal under the terms of the Administrative Procedure Code;
p.(None): however, the appeal shall not stop its execution.
p.(None): (6) (Repealed - SG 71/2008 in force from 12.08.2008).
p.(None):
p.(None):
p.(None): Art. 287a. (New - SG 71/2008 in force from 12.08.2008). (1) Medical specialist, who works with persons,
p.(None): performing retail trade with medicinal products, without having authorisation/certificate for this, shall
p.(None): be punished by a fine of BGN 2500 to 5000
p.(None): (2) The punishment under para 1 shall be imposed on a person under para 1, who works in a pharmacy or a drugstore after
p.(None): termination of the action of the authorisation/certificate.
p.(None): (3)In case of established more than 2 violations under para 1 and 2, the Minister of Health may deprive the medical
p.(None): specialist of the right to exercise his/her profession for the term of up to 2 years.
p.(None):
p.(None):
p.(None): Art. 287b. (new – SG, 102/2012, in force from 02.01.2013) Anyone, who carries out trade with medicinal products on
p.(None): internet in violation of this act and the ordinance under Art. 234, Para. 5 shall be punished by a fine of BGN 5000 to
p.(None): 10 000.
p.(None):
p.(None):
p.(None): Art. 288. (1) A retailer in medicinal products who has permitted an incapable person to exercise activities, pointed
p.(None): out in Art. 219, shall be penalised with a property sanction from BGN 5,000 to BGN 10,000 and in case of repeated
p.(None): perpetration of the infringement the issued retail trade authorisation shall be bereaved.
p.(None): (2) In the cases according to para 1 the bodies of the state control shall stop the operation of the
p.(None): site by an order.
p.(None):
p.(None):
p.(None): Art. 289. (1) (prev. text of Art. 289 – SG 60.12, in force from 07.08.2012) Whoever sells medicinal products on prices
p.(None): different from those formed under the terms of this law shall be penalised with a fine from BGN 5,000 to BGN 10,000 and
p.(None): in case of repeated perpetration of the same infringement – with a fine from BGN 6,000 to BGN 12,000.
p.(None): (2) (new – SG 60.12, in force from 07.08.2012, amend. – SG, 102/2012, in force from 21.12.2012) A marketing
p.(None): authorisation holder who fails to fulfill an obligation set out by the Ordinance under Art. 261a, Para. 5,
p.(None): shall be punishable by property sanction amounting from BGN 5000 to BGN 10 000, and in case of repeated offence – by a
p.(None): property sanction amounting from BGN 10 000 to BGN 20 000.
p.(None): (3) (new - SG, 102/2012, in force from 21.12.2012). The violations under Para. 1 and 2 shall be found out by acts,
p.(None): drawn up by officials, determined by the Council chairperson under Art. 258, Para. 1, and the penal decrees shall be
p.(None): issued by the Council chairperson under Art. 258, Para. 1 or a council member, authorised by him/her.
p.(None):
p.(None): Art. 289a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG, 102/2012, in force from 21.12.2012) whoever
p.(None): works in violation of the confirmed pharmaco-therapeutic guides or performs assessment of the efficiency of the
p.(None): therapy not in the criteria under Art. 259, Para. 1, p. 4, shall be punished by a fine of BGN 1000 to 2000, and in a
p.(None): repeated violation – by a fine of BGN 2000 to 3000.
p.(None): (2) The violations under Para. 1 shall be established by acts, drawn out by officials, determined by the executive
p.(None): director of the Executive agency Medical Audit, and the penal orders shall be issued by the executive director
p.(None): of the Executive agency Medical Audit
p.(None):
p.(None):
p.(None): Art. 290. (1) (Amend. - SG 71/2008 in force from 12.08.2008) Whoever advertises medicinal products, which
p.(None): are not authorised under the terms of this Act, shall be penalised by a fine from BGN 10000 to BGN 20000.
p.(None): (2) (New - SG 71/2008 in force from 12.08.2008) Whoever advertises medicinal products describing and/or directing to
p.(None): properties, related to prophylactics, diagnosis or treatment of human illnesses, shall be penalised by a fine
p.(None): from BGN 10000 to BGN 20000.
p.(None): (3) (Former para 2 - SG 71/2008 in force from 12.08.2008) Whoever advertises medicinal products in
p.(None): violation of this Act shall be punished by a fine from BGN 10 000 to 20 000.
p.(None): (4) (Former para 3, amen. - SG 71/2008 in force from 12.08.2008) The penalties according to para 1-3
p.(None): shall also be imposed on persons who have permitted the emission, publication, and proliferation of the
p.(None): advertisement.
p.(None):
p.(None):
p.(None): Art. 290a. (New - SG 71/2008 in force from 12.08.2008) Any medical specialist or person representing himself/herself
p.(None): for a medical specialist, who performs direct or indirect advertisement of medicinal products in the
p.(None): printed and/or in electronic media, as well as in the internet, shall be punished by a fine from BGN 1000 to 5000, and
p.(None): in a repeated violation – from BGN 3000 to 10 000.
p.(None):
p.(None):
p.(None): Art. 290b. (New – SG, 60/2011, in force from 5. 8. 2011) Whoever performs a donation of medicinal products in violation
p.(None): of Art. 268a, Para. 1 shall be punished by a fine of BGN 1000 to 3000, and in repeated violation – by a fine of BGN
p.(None): 3000 to 5000.
p.(None):
p.(None):
p.(None): Art. 290c. (new – SG, 102/2012, in force from 21.12.2012) Any marketing authorisation holder, who holds
p.(None): non-interventional studies in violation of this act shall be punished by a property sanction of BGN 5000 to
p.(None): 10 000 and in a repeated deed of the same violation – by a property sanction of BGN 10 000 to 20 000.
p.(None):
p.(None):
p.(None): Art. 290d. (new – SG, 102/2012, in force from 21.12.2012) Any marketing authorisation holder, who fails to fulfill the
p.(None): provision of Art. 55a, 56a and 56b shall be punished by a property sanction of BGN 5000 to 10 000 and in a repeated
p.(None): deed of the same violation – by a property sanction of BGN 10000 to 20000.
p.(None):
p.(None):
p.(None): Art. 290e. (new – SG, 102/2012, in force from 21.12.2012) Any marketing authorisation holder, who fails to fulfill the
p.(None): obligations under Art. 190 – 192, 194b, 194c, 194h and 194i shall
p.(None):
p.(None): be punished by a property sanction of BGN 5 000 to 10 000 and in a repeated deed of the same violation 0 by a property
p.(None): sanction of BGN 10 000 to 20 000.
p.(None):
p.(None):
p.(None): Art. 290f. (new – SG, 102/2012, in force from 21.12.2012) Any marketing authorisation holder, who fails to fulfill the
p.(None): obligation under Art. 193 and 194 shall be punished by a property sanction of BGN 2000 to 5000 and in a repeated deed
p.(None): of the same violation – by a property sanction of BGN 5000 to 10 000.
p.(None):
p.(None):
p.(None): Art. 291. (1) (Suppl. SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012 in force from 21.12.2012) Property
p.(None): sanctions shall be imposed in case the infringements according to Art. 281-284a, 285, 285b, Art. 286, Para. 1 and 287b,
p.(None): Art. 289, Para. 1, Art. 289a, Art. 290, 290b, 292 and 294 have been committed by legal persons or sole traders in
p.(None): amount of the property sanction cannot be less than the triple amount of the respective fines and cannot be more than
p.(None): the triple amount of the stipulated maximum amounts of the respective fines.
p.(None): (2) (suppl. – SG 60.12, in force from 07.08.2012) For infringements according to Art. 289, para 1 the property
p.(None): sanction shall be the nine-fold amount of the overdrawn amount provided that it exceeds the maximum amount of
p.(None): the sanction according to para 1.
p.(None): (3) The imposing of a property sanction shall not exclude fining of the guilty officials.
p.(None): (4) The imposing of property sanctions shall not exclude the imposing of the stipulated measures regarding the right of
p.(None): the medical specialists and qualified persons.
p.(None):
p.(None):
p.(None): Art. 292. (1) Whoever shall not execute an order, directions, or instruction of the bodies of the state control, except
p.(None): in the cases pursuant to Art. 270, para 1, issue 2 and para 3 shall be penalised with a fine from BGN 1,500 to BGN
p.(None): 3,000.
p.(None): (2) For failure to execute an order, pursuant Art. 270, para 1, issue 2 and 3, the blamed persons shall be penalised
p.(None): with a fine of from BGN 500 to BGN1000.
p.(None):
p.(None):
p.(None): Art. 293. (1) (amend. – SG, 102/2012, in force from 02.01.2013)In cases according Art. 281, Para. 1-3, Art. 283, Para.
p.(None): 1, as and of non-observance of the condition under which the authorisations to retail trade with medicinal products in
p.(None): a pharmacy, the BDA executive director shall issue an order for the bereavement thereof.
p.(None): (2) In case of non-observance of the conditions under which the
p.(None): authorisations/certificates for registration of a drug store as well as in the cases under 287, Para. 3, the director
p.(None): of the BDA shall issue an order for the bereavement thereof.
p.(None): (3) In case of non-observance of the obligation to notify according to Art. 204, Para. 3, for the termination of the
p.(None): activity on the part of a wholesaler of medicinal products, the executive director of the BDA shall issue an order for
p.(None): the bereavement the issued authorisation.
p.(None): (4) (amend. – SG, 102/2012, in force from 02.01. 2013) In case of non-observance of the obligation to notify according
p.(None): to Art. 235, Para. 3, for the termination of the activity on the part of a holder of an authorisation to retail trade
...
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
...
p.(None): 243 in compliance with this Act.
p.(None): 2. The Council of Ministers shall adopt the Ordinance under Art. 258, Para. 5 and shall amend the tariff under Art. 21,
p.(None): Para. 2 and the Rules of procedure of the Ministry of Health in compliance with this Act.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 84. This Act shall come into force from the day of its publication in the State Gazette, with the exception of § 65,
p.(None): which shall come into force from 30 September 2011.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.(None):
p.(None): (PROM. - SG 38/12, IN FORCE FROM 01.07.2012)
p.(None):
p.(None): § 84. (In force from 18.05.2012) Within one month after the promulgation of this Act in the State Gazette:
p.(None): 1. The Council of Ministers shall adjust the Classified of positions in administration to the provision of this Act;
p.(None): 2. the competent bodies shall adjust the structural acts of the respective administration to the provisions of this
p.(None): Act.
p.(None):
p.(None):
p.(None): § 85. (1) The legal relationships with the persons from administrations under the Radio and Television Act, Independent
p.(None): Financial Audit Act, Electronic Communications Act, Financial Supervision Commission Act, Act on Access to and
p.(None): Disclosure of the Documents and Announcing Affiliation of Bulgarian Citizens with the State Security Service and
p.(None): the Intelligence Services of the Bulgarian Popular Army, Act on Seizure in Favour of the State of
p.(None): Property, Acquired through Criminal Activity Act on Prevention and Findings of Conflict of Interests, Code of Social
p.(None): Insurance, Health Insurance Act, Agricultural Producers Assistance Act, Roads Act shall be regulated subject to
p.(None): compliance with the provisions and following the procedure of § 36 of the Transitional and Conclusive Provisions of the
p.(None): Act amending and supplementing the Civil Servants Act (SG 24/06).
p.(None): (2) By the act of appointment of a civil servant:
p.(None): 1. the minimum rank for the occupied position shall be conferred, as determined in the Classified of positions in the
p.(None): administration, unless the servant hold a higher rank;
p.(None): 2. individual monthly salary shall be fixed.
p.(None): (3) Additionally required funds for insurance contributions of the persons under par. 2 shall be provided within the
p.(None): cost of salaries, remunerations and insurance contributions within the budgets of the respective administrators of
p.(None): budget credits.
p.(None): (4) Council of Ministers must make necessary adjustments in the out-of-budget account of State Fund "Agriculture",
p.(None): arising out of this Act.
p.(None): (5) Managing bodies of National Social Insurance Institute and of National Health Insurance Fund must make
p.(None): necessary adjustments in the respective budgets, arising out of this
p.(None):
p.(None): Act.
p.(None): (6) The non-used leaves regulated in the employment agreement shall be kept and shall
p.(None): not be compensated with a financial benefit.
p.(None):
p.(None):
p.(None): § 86. (1) Within one month after entering of this Act into force the individual basic monthly salary of the employee
p.(None): shall be determined in such a way that the salary after the due tax and the obligatory insurance contributions
...
Social / Soldier
Searching for indicator armed forces:
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p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
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Searching for indicator army:
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p.(None): 1. The Minister of Health shall amend and supplement the ordinances under Art. 82, Para. 3, Art. 219, Para. 2 and Art.
p.(None): 243 in compliance with this Act.
p.(None): 2. The Council of Ministers shall adopt the Ordinance under Art. 258, Para. 5 and shall amend the tariff under Art. 21,
p.(None): Para. 2 and the Rules of procedure of the Ministry of Health in compliance with this Act.
p.(None): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
p.(None):
p.(None):
p.(None): § 84. This Act shall come into force from the day of its publication in the State Gazette, with the exception of § 65,
p.(None): which shall come into force from 30 September 2011.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE CIVIL SERVANTS ACT
p.(None):
p.(None): (PROM. - SG 38/12, IN FORCE FROM 01.07.2012)
p.(None):
p.(None): § 84. (In force from 18.05.2012) Within one month after the promulgation of this Act in the State Gazette:
p.(None): 1. The Council of Ministers shall adjust the Classified of positions in administration to the provision of this Act;
p.(None): 2. the competent bodies shall adjust the structural acts of the respective administration to the provisions of this
p.(None): Act.
p.(None):
p.(None):
p.(None): § 85. (1) The legal relationships with the persons from administrations under the Radio and Television Act, Independent
p.(None): Financial Audit Act, Electronic Communications Act, Financial Supervision Commission Act, Act on Access to and
p.(None): Disclosure of the Documents and Announcing Affiliation of Bulgarian Citizens with the State Security Service and
p.(None): the Intelligence Services of the Bulgarian Popular Army, Act on Seizure in Favour of the State of
p.(None): Property, Acquired through Criminal Activity Act on Prevention and Findings of Conflict of Interests, Code of Social
p.(None): Insurance, Health Insurance Act, Agricultural Producers Assistance Act, Roads Act shall be regulated subject to
p.(None): compliance with the provisions and following the procedure of § 36 of the Transitional and Conclusive Provisions of the
p.(None): Act amending and supplementing the Civil Servants Act (SG 24/06).
p.(None): (2) By the act of appointment of a civil servant:
p.(None): 1. the minimum rank for the occupied position shall be conferred, as determined in the Classified of positions in the
p.(None): administration, unless the servant hold a higher rank;
p.(None): 2. individual monthly salary shall be fixed.
p.(None): (3) Additionally required funds for insurance contributions of the persons under par. 2 shall be provided within the
p.(None): cost of salaries, remunerations and insurance contributions within the budgets of the respective administrators of
p.(None): budget credits.
p.(None): (4) Council of Ministers must make necessary adjustments in the out-of-budget account of State Fund "Agriculture",
p.(None): arising out of this Act.
p.(None): (5) Managing bodies of National Social Insurance Institute and of National Health Insurance Fund must make
p.(None): necessary adjustments in the respective budgets, arising out of this
p.(None):
p.(None): Act.
p.(None): (6) The non-used leaves regulated in the employment agreement shall be kept and shall
p.(None): not be compensated with a financial benefit.
p.(None):
p.(None):
p.(None): § 86. (1) Within one month after entering of this Act into force the individual basic monthly salary of the employee
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Searching for indicator military:
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p.(None): Art. 198, as well as if he has authorisation for wholesale trade;
p.(None): 13. (new – SG, 102/2012, in force from 02.01.2013) check up whether the manufacturer or importer, from whom the
p.(None): medicinal product is received, has authorisation for manufacture/import;
p.(None): 14. (new – SG, 102/2012, in force from 02.01.2013) check up whether the intermediary, through whom the medicinal
p.(None): product is received, meets the requirements of this Chapter.
p.(None): (2) The documentation according to Para. 1, points 7 and 8 shall be kept for at least 5 years and shall be provided to
p.(None): the control bodies upon request.
p.(None):
p.(None):
p.(None): Art. 208. (amend. – SG, 102/2012, in force from 02.01.2013) The obligations according to Art. 207, Para. 1, point 2,
p.(None): and Art. 209a shall also apply to the wholesalers according to Art. 203, as well as to the importers and manufacturers
p.(None): trading in medicinal products manufactured by them.
p.(None):
p.(None):
p.(None): Art. 209. The requirements of the special provisions of other laws shall also apply to the wholesale of medicinal
p.(None): products containing narcotic substances or obtained from blood, or immunological products, or
p.(None): radiopharmaceuticals.
p.(None):
p.(None):
p.(None): Art. 209a. (New - SG 71/2008, in force from 12.08.2008) (1) The wholesale traders with medicinal products may deliver
p.(None): medicinal products to:
p.(None): 1. other wholesale traders with medicinal products;
p.(None): 2. pharmacies and drugstores;
p.(None): 3. the Ministry of Defence and the Ministry of Interior for own needs, with the exception of their medical
p.(None): institutions, as well as the State Reserve and Military time Reserve State Agency;
p.(None): 4. the Ministry of Health with:
p.(None): a) vaccines, tocsins and serums, needed for implementation of the Immunisation calendar of the Republic of
p.(None): Bulgaria, as well as during emergency epidemical situations;
p.(None): b) medicinal products, intended for treatment of illnesses, which are paid as provided by the Health Act, as well as
p.(None): for providing the implementation of national programmes in the area of healthcare;
p.(None): 5. (new – SG 60/12, in force from 07.08.2012) outpatient health care institutions which have signed an agreement with
p.(None): the National Health Insurance Fund, with medicinal products required for performance of health activities under Art.
p.(None): 82, para 2, item 3 of the Health Act.
p.(None): (2) Doctors and Dental doctors in the populated areas, where there are no pharmacies may be supplied with medicinal
p.(None): products by wholesale traders, as provided by the ordinance under Art. 207, para 1, p. 6.
p.(None):
p.(None):
p.(None): Art. 209b. (new – SG, 102/2012, in force from 02.01.2013) (1) In wholesale trade of medicinal products in third states
p.(None): the requirements of Art. 207, Para. 1, p. 2, 5 and 6 shall not apply, as well as the requirements of Chapter Nine "a".
p.(None):
p.(None): (2) Where the medicinal product is received directly from a third state, but jas not been imported on the territory of
p.(None): the Republic of Bulgaria, the requirements of Art. 207, Para. 1, p. 4 and 4a shall not apply.
p.(None): (3) (new – SG 18/14) In cases referred to in par. 1 the wholesalers shall certify by relevant documents
p.(None): that the medicinal products are received from persons holding a permit or have got the right to supply medicinal
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Social / Threat of Stigma
Searching for indicator threat:
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p.(None): the safety of the subjects, the scientific value of the clinical test, and/or the observation of the rules for Good
p.(None): Clinical Practice.
p.(None): (2) Essential amendment in the conduct of the clinical test shall be any amendment in the study protocol and/or in the
p.(None): information and the documentation according to Art. 110 and 116, which can affect:
p.(None): 1. the safety or the physical and mental immunity of the study subjects;
p.(None): 2. the scientific value of the clinical test;
p.(None): 3. the conduct or the organisation of the clinical test;
p.(None): 4. the quality or the safety of any study medicinal products.
p.(None):
p.(None):
p.(None): Art. 128. (1) The contracting authority can also implement planned study essential protocol and
p.(None): documentation amendments according to Art. 110 and 116 wherever:
p.(None): 1. the ethics committee has given a written positive opinion;
p.(None): 2. the executive director of the BDA has issued a written authorisation as to clinical trials with medicinal products
p.(None): according to Art. 109, point 2, or
p.(None):
p.(None): 3. the contracting authority has not been notified by the BDA about refusal of the proposed amendment in
p.(None): the clinical test with medicinal products according to Art. 109, point 3.
p.(None): (2) The provision of para 1 shall not apply to changes in an approved protocol, which are imperative to protect the
p.(None): subjects from immediate threat in case of occurrence or new information associated with the conduct of
p.(None): the clinical test or the development of the study medicinal product.
p.(None): (3) In the cases according to para 2, the contracting authority shall immediately notify the ethics committee
p.(None): according to para 1, point 1, and the BDA about the available new information, the measures taken, and the
p.(None): applied changes in the protocol.
p.(None):
p.(None):
p.(None): Art. 129. (1) While planning essential amendments to the clinical test and the documentation according to
p.(None): Art. 110 and 116, the applicant shall submit a formal written application to the BDA and the respective
p.(None): ethics committee.
p.(None): (2) The application shall be accompanied by documentation, which is necessary for grounding the amendments
p.(None): and certifies that after the implementation of the amendment the assessment of the benefit/risk ratio according to Art.
p.(None): 90, para 1, shall remain unchanged.
p.(None): (3) The requirements relating to the application and the documentation for the amendment shall be determined
p.(None): in the regulation according to Art. 82, para 3.
p.(None):
p.(None):
p.(None): Art. 130. (1) Within 35 days of receipt of an application for amendment, the ethics committee shall
p.(None): notify the contracting authority of its decision by issuing:
p.(None): 1. positive opinion on the requested amendment or
...
p.(None):
p.(None): to protect the study subjects from suddenly occurred risks for their safety and health.
p.(None): (2) In the cases according to para 1 the contracting authority shall immediately notify the BDA and the respective
p.(None): ethics committee about the undertaken actions and the reasons, which have raised these.
p.(None):
p.(None):
p.(None): Art. 133. (1) Where the clinical test is to be conducted under conditions different from those determined at the issue
p.(None): of the authorisation or there is information vitiating the scientific validity of the clinical test or the safety of
p.(None): the study subjects, the BDA can temporarily stop the conduct of the test or put a ban on it.
p.(None): (2) The ban can be imposed for a specific centre or for all centres in a multicentre clinical test on the territory of
p.(None): the Republic of Bulgaria.
p.(None): (3) In case of termination of the clinical test in all centres on the territory of the Republic of Bulgaria, the BDA
p.(None): shall, prior to undertaking actions according to para 1, notify the contracting authority and the principal researcher
p.(None): or the coordinating researcher in writing.
p.(None): (4) Within 7 days of the receipt of the notification the contracting authority and/or the principal researcher can
p.(None): express an opinion on the undertaken measures by the BDA.
p.(None): (5) The provision of para 3 shall not apply provided that there is an immediate threat for the health and safety of the
p.(None): study subjects.
p.(None):
p.(None):
p.(None): Art. 134. In the cases according to Art. 133, para 1, the BDA shall immediately notify the respective ethics
p.(None): committee, the regulatory bodies of the Member States, the European Medicines Agency, and the European
p.(None): Commission about the undertaken measures and the reasons therefore.
p.(None):
p.(None): Section V. Pharmaco-vigilance
p.(None):
p.(None): Art. 135. (1) The principal researcher shall immediately report in writing or by word of mouth any serious adverse
p.(None): event that has occurred in the course of the clinical test in a study subject at the centre he is responsible for.
p.(None): (2) A detailed written report shall be submitted after the report according to para 1.
p.(None): (3) At the notification according to para 1 and in the report according to para 2 the study subject shall be identified
p.(None): by a unique code number as defined in the study protocol.
p.(None): (4) The provisions of para 1 and 2 shall not apply provided that the protocol of the clinical test or the researcher’s
p.(None): brochure explicitly states that there is no requirement for an urgent report of a specific serious adverse event.
p.(None): (5) The researcher shall report to the contracting authority any adverse events or laboratory aberrations,
p.(None): which are defined in the study protocol as critical with respect to safety, within the timelines and format as required
p.(None): by the protocol.
p.(None):
p.(None):
p.(None): Art. 136. Where the outcome of an adverse event during the conduct of a clinical test is death, the researcher shall
...
p.(None): Para. 2 shall be determined by the ordinance under Art. 198.
p.(None):
p.(None): Chapter seven.
p.(None): CLASSIFICATION OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 171. (1) Depending on the method of dispensing, the medicinal products shall be classified as follows:
p.(None): 1. medicinal products dispensed on medical prescription;
p.(None): 2. medicinal products dispensed without medical prescription.
p.(None): (2) The dispensing regime of a medicinal product shall be determined by the BDA in the marketing
p.(None): authorisation/registration certificate.
p.(None): (3) The person according to Art. 26, para 1, shall indicate the dispensing regime of a medicinal product in the
p.(None): application for marketing authorisation/registration certificate, variation of the marketing authorisation or its
p.(None): renewal.
p.(None):
p.(None):
p.(None): Art. 172. The medicinal products according to Art. 171, para 1, point 1, shall be divided in the following categories:
p.(None): 1. medicinal products with restricted medical prescription intended only for use in certain specialised fields;
p.(None): 2. medicinal products subject to special medical prescription;
p.(None): 3. medicinal products for multiple or single dispensing on the same medical prescription.
p.(None): Art.173. Medicinal products, which meet the following requirements, shall be dispensed on medical prescription:
p.(None): 1. medicinal products, which can represent a direct or indirect danger for human health even at correct use if
p.(None): administered without medical observation;
p.(None): 2. medicinal products, which are frequently and very widely administered in a wrong manner and as a result of that can
p.(None): represent a threat for the people’s health;
p.(None): 3. medicinal products containing substances the activity and/or adverse drug reactions of which require subsequent
p.(None): additional study;
p.(None): 4. medicinal products, which are usually prescribed by a physician for potential administration.
p.(None):
p.(None):
p.(None): Art. 174. Medicinal products shall be subject to special medical prescription wherever
p.(None):
p.(None): these meet one of the following conditions:
p.(None): 1. contain narcotic substances within the meaning of the Control on Drugs and Precursors Act in admissible
p.(None): for use quantities;
p.(None): 2. in case of incorrect use can cause significant risk of misuse, lead to drug addiction, or be used for illegal
p.(None): purposes;
p.(None): 3. contain new medicinal substances the characteristics of which are not sufficiently known and therefore these
p.(None): can be assigned to the group of medicinal products according to point 2.
p.(None):
p.(None):
p.(None): Art. 175. Medicinal products shall be subject to limited medical prescription wherever these meet one of the following
p.(None): conditions:
p.(None): 1. are limited to administration in hospital conditions only due to limited experience with their use or in the
p.(None): interest of public health;
p.(None): 2. are intended for treatment of pathological conditions, which can only be diagnosed in therapeutic establishments,
p.(None): irrespective that their administration and follow-up in the course of treatment can be carried out in other healthcare
p.(None): establishments;
...
p.(None): (6) The parallel imported product shall be used according to the conditions of the issued marketing authorisation for
p.(None): the use of the medicinal product on the territory of the Republic of Bulgaria.
p.(None):
p.(None):
p.(None): Art. 216. (1) The authorisation for parallel import on the territory of the Republic of Bulgaria shall be
p.(None): issued within 45 days of the date of submission of the documentation to the BDA.
p.(None): (2) Where the BDA shall request additional documentation from the applicant, the term according to para 1 shall cease
p.(None): to run until receipt of the requested information.
p.(None): (3) Where the BDA shall require information relating to the issue of the marketing authorisation of the
p.(None): imported medicinal product from the regulatory body of the Member State where the parallel import is to be effected
p.(None): from, the term according to para 1 shall be extended by 45 days.
p.(None): (4) If the BDA does not receive the requested documentation within the term according to para 3, the procedure for the
p.(None): issue of a parallel import authorisation for the territory of the Republic of Bulgaria shall be terminated.
p.(None): (5) The issued parallel import authorisations for the territory of the Republic of Bulgaria
p.(None):
p.(None): shall be published on the internet site of the BDA.
p.(None): (6) The parallel import authorisation shall be valid for 5 years. New authorisation shall be issued under the terms of
p.(None): Art. 215.
p.(None): (7) The parallel import authorisation shall not be automatically cancelled where the marketing authorisation
p.(None): holder of the medicinal product launched on the market on the territory of the Republic of Bulgaria would withdraw it
p.(None): for reasons, which are not associated with a threat for the health of the population.
p.(None):
p.(None):
p.(None): Art. 217. The parallel import authorisation holder shall be obliged to:
p.(None): 1. notify the marketing authorisation holder of the medicinal product launched on the territory of the Republic of
p.(None): Bulgaria of his intention to effect parallel import and provide a sample of the parallel imported medicinal product
p.(None): upon request;
p.(None): 2. keep the following information for 5 years: name and address of the person whom the parallel imported medicinal
p.(None): product is to be delivered to, date of delivery, delivered quantity, and batch number;
p.(None): 3. submit in BDA:
p.(None): a) actualised patient’s leaflet of parallel imported product according with the variations in issued marketing
p.(None): authorisation of the approved medicinal product in Republic of Bulgaria;
p.(None): b)(Amen. - SG 71/2008, in force from 12.08.2008) declaration that the content of the leaflet according to letter "a"
p.(None): shall be identical with the content of the product leaflet, approved in Republic of Bulgaria except of the data
p.(None): according to Art. 215, para 2, point 7, letters "a" – "d";
p.(None): 4. document and report to the marketing authorisation holder and the BDA all reports of adverse drug reactions of the
p.(None): imported medicinal product.
p.(None):
p.(None): Chapter nine.
p.(None): "B" EXPORT OF MEDICINAL PRODUCTS (NEW – SG 18/14)
p.(None):
p.(None): Art. 217a. (new – SG 18/14) (1) Export of medicinal products from the territory of the Republic of Bulgaria may be done
p.(None): by a natural person or a legal entity holding a permit for wholesale with medicinal products or by a holder of a
p.(None): production license.
p.(None): (2) Holders of a production license may carry out export only of the medicinal products manufactured by them.
...
p.(None): 40. "Adverse event" shall mean any untoward unfavorable change the health condition observed during the administration
p.(None): of a medicinal product in a patient or a clinical test subject and which has not necessarily a causal relationship with
p.(None): this treatment.
p.(None): 41. (amend. – SG, 102/2012, in force from 21.12.2012) "Adverse drug reaction" shall mean any untoward and unpredicted
p.(None): response to a medicinal product. In case of a clinical test
p.(None): – any untoward and unpredicted response to a study medicinal product irrespective of the administered
p.(None): dose. The types of adverse reactions shall be:
p.(None): a) "unexpected" – an adverse drug reaction, which has not been mentioned in the summary of product
p.(None): characteristics of the character, severity, and outcome of which do not comply with those mentioned in the
p.(None): summary of product characteristics. In case of a clinical test
p.(None): – an adverse drug reaction the character, severity, and outcome of which do not comply with the information for the
p.(None): study medicinal product mentioned in the researcher’s brochure;
p.(None): b) "suspected" – and adverse drug reaction fore which the reporter or the marketing authorisation holder supposes that
p.(None): there is a possible causal relationship with a taken medicinal product;
p.(None): c) "serious" – any unfavorable effect on the health condition, which has become the reason for a lethal outcome,
p.(None): immediate threat to life, hospitalisation, or prolongation if hospitalisation, significant or durable injury,
p.(None): disability, and innate anomalies;
p.(None): d) combination of reactions according to subsections "a", "b", and "c".
p.(None): 42. "Common name" shall mean the international non-proprietary name (INN) of a medicinal substance or
p.(None): excipient recommended by the World Health Organisation; if not any, the name in the European Pharmacopoeia shall be
p.(None): used; if there is no such name there, another pharmacopoeia name shall be used; if there is no pharmacopoeia name, the
p.(None): common name shall be used.
p.(None): 42a (new – SG, 102/2012, in force from 21.12.2012) "Basic documentation of a system of pharmaco-vigilance" is a detail
p.(None): description of the pharmaco-vigilance system, used by the marketing authorisation holder in relation or one or more
p.(None): authorised for use medicinal products.
p.(None): 42b. (new - SG48/15) "Health technology assessment" shall mesn:
p.(None): a) a form of policy on research that examines the short- and long-term outcomes related to the implementation of
p.(None): health technologies and aims to provide information concerning alternative health strategies;
p.(None): b) multidisciplinary activity that systematically evaluates technical specifications, safety, clinical efficacy and
p.(None): effectiveness, cost, cost effectiveness, organizational, social, legal and ethical consequences of
p.(None): administration of medicinal products in health care and focuses on value - clinical and economic, provided
p.(None): that the analysis is comparative to existing or best alternative at the time;
p.(None):
...
p.(None): calculation of the probability of this positive result.
p.(None): 46. (amend. – SG, 102/2012, in force from 02.01.2013) "Auxiliary substance" is any component of a medicinal product,
p.(None): different for the active substance and the packing material.
p.(None): 47. "Post marketing study" shall mean any study conducted during the use of a medicinal product within the approved
p.(None): summary of product characteristics during the period after the authorisation to market.
p.(None): 47a (new - SG, 102/2012, in force from 02.01.2013) "Mediation in the area of medicinal products" are all the
p.(None): activities, which aim at signing contract for buying or selling of medicinal products with the exception of wholesale
p.(None): trade, which do not include physical keeping and which are expressed in negotiating independent and on behalf of
p.(None): another legal or natural person.
p.(None): 48. "Post marketing safety study" shall mean any study, related to an authorised for use medicinal product, conducted
p.(None): with the purpose of identification, characterisation of defining the risk level in relation of safety, to confirm the
p.(None): safety profile of the medicinal product or to assess the effectiveness of the measures for risk management.
p.(None): 49. "Potential serious risk for the population" shall exist where there is a high probability a medicinal product to
p.(None): cause irremovable, irremediable, and irreversible consequences. The assessment process shall identify the threat of
p.(None): causing damages to the health of the population and its actual exposition during wide use of the product. The serious
p.(None): risk for the health in the context of the use of a given medicinal can be assessed under the following conditions:
p.(None): a) efficacy – the submitted therapeutic efficacy data with regard to the proposed indication(s), the
p.(None): proposed target group, and the proposed dosage mentioned in the proposed patient information leaflet do not
p.(None): scientifically defend to the full extent the efficacy claims;
p.(None): b) safety – the assessment of the data for preclinical toxicity/pharmacological safety and clinical safety cannot
p.(None): convincingly defend the conclusion that all potential safety aspects with regard to the target patient group(s) have
p.(None): been accurately and comprehensively reflected in the proposed patient information leaflet or the absolute risk degree
p.(None): is unacceptable;
p.(None): c) quality – the proposed method of manufacture and control methods cannot guarantee the lack of an essential defect in
p.(None): the quality of the product, which can affect the product safety and/or efficacy;
p.(None): d) benefit/risk ratio: the assessment of the benefit/risk ratio and the potential benefit for the proposed
p.(None): indication(s) and the patient group(s).
p.(None): 50. "Representative of the person according to Art. 26, Para. 1, or of a marketing authorisation holder"
p.(None): shall mean a person residing on the territory of the Republic of Bulgaria appointed by the person according to Art. 26,
...
p.(None): population.
p.(None): 63. "Reference medicinal product" shall mean a medicinal product authorised under the terms of Art. 23 in compliance
p.(None): with the requirements of Art. 27.
p.(None): 64. "Reference value of a defined daily dose" on an international non-proprietary name with the corresponding
p.(None): pharmaceutical for according to the anatomo-therapeutic classification of medicinal products shall mean the lowest
p.(None): value of a defined daily dose determined on the basis of the values of a defined daily dose for various medicinal
p.(None): products for the international non-proprietary with the corresponding pharmaceutical form according to the
p.(None): anatomo- therapeutic classification of medicinal products.
p.(None): 65. "Reference value of a therapeutic course" shall be the lowest value of a therapeutic course determined on the basis
p.(None): of the values of a therapeutic course of the medicinal products according to international non-proprietary name with
p.(None): the corresponding pharmaceutical form.
p.(None): 66. "Risk during the use of a medicinal product" shall mean:
p.(None): a) risk for the health of the patient or risk for the health of the population, which is associated
p.(None): with the quality, safety, or efficacy of a medicinal product;
p.(None): b) risk of undesirable effects on the environment.
p.(None): 67. "Serious adverse event" shall mean any unfavorable change in the health condition,
p.(None):
p.(None): which has become the cause of lethal outcome, immediate threat to life, hospitalisation or extension of
p.(None): hospitalisation, significant or durable injury, disability, and innate anomalies.
p.(None): 68. "Batch release certificate" shall mean a document issued for each batch by the qualified person of the
p.(None): manufacturer or importer and shall include the requirements according to the specification, as well as all results from
p.(None): the tests for the release of the batch.
p.(None): 69. "Additional protection certificate" shall mean a document, which shall provide additional patent
p.(None): protection for a medicinal product of maximum 5 years after the lapse date of the main patent.
p.(None): 69a (new – SG, 102/2012, in force from 21.12.2012) "Risk management system" is a system of measures and
p.(None): activities for pharmaco-vigilance, intended for identification, characteristics, prevention or setting to
p.(None): minimum risks, related to the medicinal product, including effectiveness assessment of these activities and measures.
p.(None): 69b (new – SG, 102/2012, in force from 21.12.2012) "Pharmaco-vigilance system" is a system, used by the marketing
p.(None): authorisation holder and BDA for implementation of the tasks and responsibilities under Chapter Eight, intended for
p.(None): observation of vigilance of the permitted for use medicinal products and for finding every change in the benefit/risk
p.(None): ratio.
p.(None): 70. "Urgent limitation safety measures" shall mean temporary changes in the product information with respect of one
...
Social / Threat of Violence
Searching for indicator violence:
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p.(None): last amended by Directive 2004/27/EC of the European Parliament and the Council, independently from the form of the
p.(None): document;
p.(None): 2. order of each person to present information for violations according to point 1, which are familiar to him;
p.(None): 2a (new - SG, 102/2012, in force from 21.12.2012) inspect the manufacture and trade sites of manufacturers of
p.(None): medicinal products, active or auxiliary substances, as well as the laboratories, used by manufacture or import
p.(None): authorisation holders;
p.(None): 3. at any time inspect the sites subject to control and require, check, or make copies of all documents relating to the
p.(None): overall activity of the controlled site;
p.(None): 4. take samples of medicinal products, active substances, and percipients for laboratory
p.(None): tests;
p.(None): 5. (amend. - SG, 102/2012, in force from 21.12.2012) inspect the premises, archives,
p.(None): records, and documents and the basic documentation of the pharmaco-vigilance of the marketing authorisation
p.(None): holder or persons, who have been assigned to carry out the activities under Chapter Eight;
p.(None): 6. (new - SG, 102/2012, in force from 21.12.2012) carry out inspection about the observation of
p.(None): confirmed prices, limit prices or registered prices during sale of medicinal products;
p.(None): 7. (former Art. 6 - SG, 102/2012, in force from 21.12.2012) draw up statements of administrative
p.(None): infringements.
p.(None): (2) (repealed - SG, 102/2012, in force from 21.12.2012).
p.(None): (3) (amend., - SG 98/10, in force from 01.01.2011) The Executive Director of BDA of the corresponding director of
p.(None): RHI, depending of the administrative person, who determined the violence, has right to:
p.(None): 1. order in written form to the violator to cease the violation according to Para. 1, point
p.(None): 1;
p.(None): 2. requires from the violator to declare that it will cease the violation according to Para.
p.(None): 1, point 1 and when it is necessary to makes the declaration matter publicly available.
p.(None): 3. to order cease or prohibition of each violation according to Para. 1, point 1 and when it is necessary to order for
p.(None): cease or prohibition of violation matter publicly available.
p.(None): (4) (new - SG, 102/2012, in force from 21.12.2012). The Council chairperson under Art. 258, Para. 1 shall have the
p.(None): right to order in writing to the violator to stop the violation, found during the inspection under Para. 1, p. 6.
p.(None):
p.(None):
p.(None): Art. 271. (1) (amend., - SG 98/10, in force from 01.01.2011) The regional health inspectorates shall be
p.(None): entitled to:
p.(None): 1. stop construction and issue directions where violations of hygienic norms and requirements have been
p.(None): established in the course of construction; notify the Directorate for
p.(None):
p.(None): National Construction Control or the municipal technical office in case of illegal construction of sites and
p.(None): equipment for manufacture, storage, and sale of medicinal products shall be established;
p.(None): 2. prohibit the commissioning and stop the operation of sites and equipment in case of violation of the hygienic norms
p.(None): for the manufacture, storage, and sale of medicinal products – until the elimination of the violations;
p.(None): 3. block medicinal products in case of available documented information of discrepancies with the
...
Social / Trade Union Membership
Searching for indicator union:
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p.(None): implemented by the Minister of Health.
p.(None): (2) The Minister of Health shall:
p.(None): 1. be the national coordinator for the problems of medicinal product;
p.(None): 2. take part in international bodies and organisations carrying out activities in the domain of the medicinal products;
p.(None): 3. (repealed – SG, 60/2011, in force from 05.08.2011 new – SG, 102/2012, in force from 21.12.2012) organize provision
p.(None): of public information to the patient organisations and to the
p.(None):
p.(None): consumers organisations about the actions, undertaken against falsification of medicinal products.
p.(None): 4. Carry out other activities set out by a law.
p.(None): When activities according para 2, point 3 carried out, the Ministry of Health collect taxes in amount, determined in
p.(None): tariff according to Art. 21, para 2.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None):
p.(None):
p.(None): Art. 15. (1) Pharmacopoeia Committee shall be established with the Minister of Health as a consulting body on issues
p.(None): relating to the current pharmacopoeia.
p.(None): (2) The Minister of Health shall, on the grounds of a proposal of the Executive Director of the BDA determine by an
p.(None): order the composition of the Pharmacopoeia Committee and the expert groups thereto and shall approve the regulation
p.(None): relating to their activity.
p.(None): (3) The activity of the Pharmacopoeia Committee shall be financed by the budget of the Ministry of Health.
p.(None):
p.(None):
p.(None): Art. 16. (1) Higher Council of Pharmacy shall be established to the Minister of Health as a consulting body on issues
p.(None): relating to pharmacy. It shall be composed by five representatives appointed by the Minister of Health, five
p.(None): representatives from Bulgarian Pharmaceutical Union, two representatives from National Health Insurance Fund (NHIF) and
p.(None): one representative from Faculty of pharmacy of the high medicinal schools. The Minister of Health is a chairman of the
p.(None): council without right of vote.
p.(None): (2) The Higher Council of Pharmacy is consultative body, which discuss and provide statements for:
p.(None): 1. Basic approaches and priorities in the pharmaceutical area;
p.(None): 2. Ethical problems of the pharmacy;
p.(None): 3. Projects for normative acts, related with the pharmacy;
p.(None): 4. The scientific priorities in the area of pharmacy;
p.(None): 5. Programs for organisation of social educational campaign in the area of medicinal products.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None): (4) The organisation and the activity of the Higher Council of Pharmacy are settled with ordinance issued by the
p.(None): Minister of Health, after proposal of Higher Council of Pharmacy.
p.(None):
p.(None):
p.(None): Art. 17. (1) The Bulgarian Drug Agency shall be a specialised body at the Minister of Health for the surveillance on
p.(None): the quality, safety, and efficacy of the medicinal products.
p.(None): (2) (amend. SG 15/13, in force from 01.01.2014) The Bulgarian Drug Agency shall be a legal entity budget financed with
p.(None): registered office in the city of Sofia with the Minister of Health.
p.(None): (3) The Bulgarian Drug Agency shall be managed and represented by an Executive Director who shall be appointed under
p.(None): the terms of the Administration Act.
...
p.(None): types of medicinal products and medicinal products intended for clinical trials can only be performed on the
p.(None): territory of the Republic of Bulgaria by natural or legal persons registered as traders on the territory of a
p.(None): Member State which have received manufacturing authorisation issued by the director of the BDA.
p.(None): (2) Manufacturing authorisation shall also be required in the cases where the products according to para 1 are intended
p.(None): for export only.
p.(None):
p.(None): (3) Manufacturing authorisation shall also be required for persons who perform simultaneously of separately
p.(None): one of the following activities: packaging, retail packaging, repackaging, labelling of medicinal products, and
p.(None): medicinal products intended for clinical trials.
p.(None): (4) Manufacturing authorisation shall also be required for persons who perform simultaneously or separately
p.(None): one of the following activities: complete or partial manufacture of active substances intended for the manufacture of
p.(None): medicinal products and various processes of packaging, retail packaging, repackaging, and re-labelling of active
p.(None): substances.
p.(None): (5) No manufacturing authorisation shall be required where the processes of retail packaging, mixing, or
p.(None): packaging are performed according to magisterial or pharmacopoeia recipe in a pharmacy.
p.(None):
p.(None):
p.(None): Art. 147. (amend. – SG, 102/2012, in force from 02.01.2013) The BDA shall introduce information about the issued
p.(None): manufacturing authorisations of medicinal products and certificates for good production practice to be entered in the
p.(None): European Union database.
p.(None):
p.(None):
p.(None): Art. 148. To obtain manufacturing authorisation the person according to Art. 146 must possess:
p.(None): 1. personnel with adequate qualification depending on the specificity of the manufactured types of
p.(None): medicinal products and pharmaceutical forms;
p.(None): 2. always at least one qualified person, who correspond to the condition of Art. 159 at any time;
p.(None): 3. manufacturing, control, and storage facilities for the medicinal products equipped with the required technical
p.(None): equipment and control laboratories.
p.(None):
p.(None):
p.(None): Art. 149. The managers of manufacture and quality control of medicinal products in the manufacturing enterprises shall
p.(None): be:
p.(None): 1. persons with educational qualification master’s degree in pharmacy, chemistry, or biology and at least two-year
p.(None): practical experience in the pharmaceutical manufacture;
p.(None): 2. for the manufacture of radiopharmaceuticals or medicinal products subjected to ionizing radiation –
p.(None): persons who comply with the requirements according to point 1 and have an additionally recognised specialty in
p.(None): radiobiology or radiochemistry.
p.(None): 3. for the manufacture of immunological medicinal products including vaccines, toxins, sera, biotechnological products,
p.(None): and medicinal products obtained from human plasma or human blood – persons with recognised speciality in medical
p.(None): haematology, medical microbiology, virology, or immunology.
p.(None):
p.(None):
p.(None): Art. 150. (1) The person according to Art. 146 shall submit to the BDA a formal application as approved
p.(None): by the director of the Agency.
p.(None): (2) Together with the application according to para 1 the applicant shall also submit:
...
p.(None): 1. name management address of the person under Art. 167a;
p.(None): 2. list of the active substances to be imported, manufactured or traded;
p.(None): 3. the activities, which the person under Art. 167a will carry out;
p.(None): 4. 4. Premise address in which the activities will be carried out;
p.(None): 5. 5. Notes on the entered circumstances.
p.(None): (2) The BDA shall enter in the data base under Art. 147 the information about the registered importers,
p.(None): manufacturers and wholesale traders of active substances.
p.(None):
p.(None):
p.(None): Art. 167e. (new – SG, 102/2012, in force from 02.01.2013) (1) The person under Art. 167a shall submit to BDA yearly by
p.(None): 31 January a notification about changes in the information, entered in the register under Art. 167d.
p.(None): (2) In case of changes, which may influence the quality or safety of the active substances, which are manufactured,
p.(None): imported or disseminated, the person under Art. 167a shall notify the
p.(None):
p.(None): BDA immediately
p.(None):
p.(None):
p.(None): Art. 167f. (1) (new – SG, 102/2012, in force from 02.01.2013) The manufacture, import and wholesale trade of active
p.(None): substances on the territory of the Republic of Bulgaria, including active substances, intended for export, shall
p.(None): be carried out in compliance with the Good manufacturing practice and the Good dissemination practices for
p.(None): active substances.
p.(None): (2) The importers may import active substances only if the following conditions have been observed:
p.(None): 1. the active substances are manufactured in compliance with standards for Good manufacturing practice,
p.(None): which are at least equivalent to the ones, established in the European Union and
p.(None): 2. (in force from 02.07.2013) the active substances are accompanied by a written confirmation by the
p.(None): competent body of the state-importer, that:
p.(None): a) the standards for good manufacturing practice, applicable to the object for manufacture of the
p.(None): exported active substances are at least equivalent to the ones, established by the European Union;
p.(None): b) The relevant object for manufacture shall be subject to a regular control and in it effectively is applied the
p.(None): Good manufacturing practice, where this includes multiple and immediate inspections in view to guaranteeing
p.(None): protection of the public health, at least equal to the one in the European Union, and
p.(None): c) in case of a found failure to observe the requirements, the state exporter shall inform immediately the BDA.
p.(None): (3) (in force from 02.07.2013) The requirement of Para. 2, p. 2 shall not apply if the state exporter is included in
p.(None): the list under Art. 111b of Directive 2001/83/EC
p.(None):
p.(None):
p.(None): Art. 167g. (new – SG, 102/2012, in force from 02.07.2013) (1) As an exception, where it is needed to be provided
p.(None): availability of medicinal products, the importer may import the active substance without a written confirmation under
p.(None): Art. 167f, Para. 2, p. 2 for the term, not longer than the validity term of the certificate for Good manufacturing
p.(None): practice, where the object for manufacture of an active substance in the state exporter has been inspected by a regular
p.(None): body of a Member State and it has been found, that it observes the principle and directives for Good manufacturing
p.(None): practice.
p.(None): (2) In the cases of Para. 1, BDA shall notify the European Commission.
p.(None):
p.(None):
p.(None): Art. 167h. (new – SG, 102/2012, in force from 02.01.2013) manufacturing authorisation holders, including those, who
p.(None): fulfill the activities under Art. 168b, Para. 2 shall be considered as manufacturers in the meaning of § 13, p. 3 of
p.(None): the Additional Provisions of the Act on Consumer Protection and shall bare responsibility for harms, caused by goods
p.(None): defects, provided in it.
p.(None):
p.(None): Chapter six.
p.(None): PACKAGING AND LEAFLETS OF MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 168 (1) Medicinal product packaging consists of primary and/or secondary packaging and patient
p.(None): information leaflet.
...
p.(None): traders to:
p.(None): a) check up the authenticity of the medicinal product;
p.(None): b) to identify separate packages.
p.(None): 2. a means, which may check up the package of the medicinal product if it has been
p.(None): faked.
p.(None):
p.(None):
p.(None): Art. 168a. (new – SG, 102/2012, in force from 21.12.2012) (1). On the package of the medicinal product, which is
p.(None): prescribed by a doctor’s prescription, safety indicators shall be placed under Art. 168, Para. 8 with the
p.(None): exception of the cases, in which the medicinal product has been included in the list, determined by the European
p.(None): Commission by a delegated act under Art. 168b.
p.(None): (2) On the package of a medicinal product, which does not need doctor’s prescription, no safety indicators shall be
p.(None): placed under Art. 168, Para. 8, with the exception of the cases, in which the medicinal product is included in the
p.(None): list, determined by the European Commission by a delegated act under Art. 168b, after it has been assessed, that it may
p.(None): be put to a risk to be faked.
p.(None): (3) The BDA shall notify the European Commission:
p.(None): 1. about medicinal products, which do not need doctor’s prescription, for which it has found that there is a risk to be
p.(None): faked;
p.(None): 2. about medicinal products, for which it has found that there is not risk to be fakes, while
p.(None):
p.(None): accounting the following criteria:
p.(None): a) price and volume of the sales of the medicinal product;
p.(None): b) number and frequency of cases of faked medicinal products, registered in the frames of the European Union and in
p.(None): third states and change in the number and frequency of similar cases in historical plan;
p.(None): c) specific characteristics of the relevant medicinal products;
p.(None): d) stage of the sicknesses, whose treatment is aimed;
p.(None): e) other potential risks for public health.
p.(None):
p.(None):
p.(None): Art. 168b. (new – SG, 102/2012, in force from 21.12.2012) (1) The rules about the safety indicators under Art. 168,
p.(None): Para. 8 shall be determined by the European Commission with the delegated acts under Art. 54a, Para. 2 of Directive
p.(None): 2001/83/EC.
p.(None): (2) The safety indicators shall not be removed nor closed partially or thoroughly, unless the following conditions have
p.(None): been fulfilled:
p.(None): 1. the manufacturing authorisation holder, before partially or thoroughly removes or closes the safety
p.(None): indicators, shall check whether the relevant medicinal product is authentic or it has been faked;
p.(None): 2. the manufacturing authorisation holder while observing the requirements of Art. 168, Para. 8 may replace the safety
p.(None): indicators with ones, equal to them in relation to the possibility for guaranteeing the authenticity,
p.(None): identification and provision of evidences for faking the medicinal product.
p.(None): (3) The safety indicators shall be considered as equal, if:
p.(None): 1. they meet the requirements, determined by the delegated acts under Art. 54a, Para. 2 of Directive 2001/83/EC and
p.(None): 2. they are so effected that they allow the check of authenticity and identification of the medicinal products and
p.(None): provide evidences for their being faked.
p.(None): (4) The replacement under Para. 2, p. 2 shall be made without opening the initial packing of the medicinal product and
p.(None): in compliance with the Good manufacturing practice for medicinal products.
...
p.(None):
p.(None):
p.(None): Art. 194. (amend. – SG, 102/2012, in force from 21,12,2012) (1) The marketing authorisation holder shall
p.(None): simultaneously or before providing for the public new information about concerns, related to pharmaco-vigilance of a
p.(None): certain medicinal product, permitted for use on the territory of the Republic of Bulgaria, shall notify the BDA, the
p.(None): European Medicines Agency and the European Commission.
p.(None): (2) The information under Para. 1 shall be objective and not misleading.
p.(None): (3) before disseminating information, related to pharmaco-vigilance, the marketing authorisation holder shall
p.(None): coordinate it in advance with BDA with the exception of the cases under Para. 1.
p.(None): (4) For carrying out assessment of the information under Para. 3, a fee shall be paid in the amount, determined by the
p.(None): tariff under Art. 21, Para. 2.
p.(None):
p.(None): Art. 194a. (new – SG, 102/2012, in force from 21.12.2012) (1) The principles and requirements of the Good
p.(None): pahrmaco-vigilance practice shall be defined by a manual, issued by the European Medicines Agency.
p.(None): (2) While carrying out the pharmaco-vigilance activities, the marketing authorisation holder shall observe the
p.(None): good practice under Para. 1.
p.(None):
p.(None): Section II.
p.(None): Collecting and Announcing Information about Suspected Adverse Reactions. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 194b. (new – SG, 102/2012, in force from 21.12.2012) The marketing authorisation holder in fulfilling his/her
p.(None): duties under Art. 190, shall be obliged to document all reports for suspected adverse medicinal reactions,
p.(None): observed on the territory of the European Union or in third states, reported spontaneously by medical specialists or
p.(None): patients or occurred in the process of conducting post-marketing studies.
p.(None):
p.(None):
p.(None): Art. 194c. (new – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder shall
p.(None): submit electronically to the data base "Eudra Vigilance" under Art. 24 of Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council reports about suspected adverse medicinal reactions, occurred on the territory of the EU
p.(None): and in third states within the term of 15 days from the date of receiving the report.
p.(None): (2) The marketing authorisation holder shall submit electronically to the database "Eudra Vigilance" reports, about
p.(None): all suspected adverse medicinal reactions, different form the ones, indicated in Para. 1, occurred on the territory
p.(None): of the EU within the term of 90 days from the date of receiving the report.
p.(None): (3) The marketing authorisation holder shall follow the publications in the specialised medicinal literature and
p.(None): shall report in the database "Eudra Vigilance" every described in it suspected adverse medicinal reaction
p.(None): with the exception of suspected adverse medicinal reactions of medicinal products, containing active substances,
p.(None): indicated in the list of Art. 27 of Regulation (EC) N 726/2004 of the European Parliament and of the Council and
p.(None): described in the literature sources of pharmaco-vigilance of the European Medicines Agency.
p.(None): (5) The form and contents of the reports under Para. 1 – 3 shall be provided by Implementation
p.(None): Regulation (EU) 520/2012.
p.(None):
p.(None):
p.(None): Art. 194d. (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall register in the system under Art. 183 all
...
p.(None): request by BDA.
p.(None):
p.(None):
p.(None): Art. 194e. (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall submit electronically to the Eudra
p.(None): Vigilance database reports about all serious suspected adverse
p.(None):
p.(None): medicinal reactions, occurred on the territory of the Republic of Bulgaria within the term of up to 15 days from the
p.(None): date of their receiving;
p.(None): (2) The BDA shall submit electronically to the Eudra Vigilance database reports about all serious suspected adverse
p.(None): medicinal reactions, different from the ones, indicated in Para. 1, occurred on the territory of the Republic of
p.(None): Bulgaria within the term of 90 days from the date of receiving the report.
p.(None): (3) The BDA shall submit electronically to the Eudra Vigilance database reports about suspected adverse medicinal
p.(None): reactions, occurred on the territory of the Republic of Bulgaria as a result of incorrect use of the medicinal
p.(None): product. The BDA shall inform about this fact the Ministry of Health and the professional organisations of the
p.(None): medical specialists.
p.(None): (4) Each body or institution, to which information has been received about suspected medicinal adverse reaction on the
p.(None): territory of the Republic of Bulgaria, shall inform the BDA about this fact.
p.(None): (5) The contents and form of the announcements and reports under Para. 1 – 3 shall be provided by the Implementation
p.(None): Regulation (EU) N 520/2012.
p.(None):
p.(None):
p.(None): Art. 194f. (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall receive the submitted information by the
p.(None): marketing authorisation holder about serious suspected adverse medicinal reactions, occurred on the territory of the
p.(None): European Union, or in a third state through the Eudra Vigilance database.
p.(None): (2) The requirements for monitoring of the information in the Eudra Vigilance database shall be provided by the
p.(None): Implementation Regulation (EU) N 520/2012.
p.(None):
p.(None):
p.(None): Art. 194g. (new – SG, 102/2012, in force from 21.12.2012). In the process of the information exchange,
p.(None): BDA, the marketing authorisations holders and the European Medicines Agency shall cooperate about finding duplicated
p.(None): reports about suspected adverse medicinal reactions.
p.(None):
p.(None): Section III.
p.(None): Periodic updated reports for vigilance. (new – SG, 102/2012, in force from 21.12.2012).
p.(None):
p.(None): Art. 194h. (new – SG, 102/2012, in force from 21.12.2012). (1) The marketing authorisation holder shall be
p.(None): obliged to provide electronically to the European Medicines agency periodic updated safety reports, which shall
p.(None): contain:
p.(None): 1. summarised data about the relation benefit/risk of the medicinal product, including the results from all studies in
p.(None): view to their potential reflection on the marketing authorisation;
p.(None): 2. scientific assessment of the correlation benefit/risk of the medicinal product; the assessment shall be
p.(None): based on all available data, including data from clinical tests for non- permitted indications and for
p.(None): target groups, which have not been included in the product short characteristics;
p.(None): 3. all the data about the volume of the sales of the medicinal product and any other information, which the marketing
p.(None): authorisation holder has about the volume of the prescriptions, including the approximate number of the persons, having
...
p.(None): where the frequency of submission of the reports is a condition for issuance of the marketing
p.(None): authorisation/registration certificate or it has been determined in compliance with Art. 194l, 194m and 194n:
p.(None): 1. every 6 months from the date of issuance of the marketing authorisation/registration certificate of a medicinal
p.(None): product till the date of its placement on the market;
p.(None): 2. every 6 months during the first 2 years from the date of placement on the market of the medicinal product;
p.(None): 3. once a year during the following 2 years;
p.(None): 4. once every 3 years after the 4th year from the date of placement on the market of the medicinal product;
p.(None): (4) Apart from the cases under Para. 3, the periodic updated safety reports shall be submitted immediately upon request
p.(None): of BDA or a regulatory body of a Member State.
p.(None):
p.(None):
p.(None): Art. 194l. (new – SG, 102/2012, in force from 21.12.2012) Where the medicinal products, which contain one and the same
p.(None): active substance, or combination lf one and the same active substances, have received separate marketing
p.(None): authorisations/ registration certificates, the frequency and the date of submitting of the periodic updated safety
p.(None): reports may be changed and harmonised in view to performing one assessment of these reports.
p.(None):
p.(None):
p.(None): Art. 194m. (new – SG, 102/2012, in force from 21.12.2012) (1) The dates of submission of the periodic updated
p.(None): safety reports for the medicinal products under art. 194l shall be calculated according to the reference date
p.(None): of the European Union.
p.(None): (2) The reference date of the EU under Para. 1 is:
p.(None): 1. the ate of the first marketing authorisation in the European Union of the medicinal
p.(None):
p.(None): product, containing the relevant active substance or the relevant combination of the active substances, or
p.(None): 2.the earliest of the known dates of the marketing authorisations of the medicinal product, containing the relevant
p.(None): active substance or the relevant combination of active substances, if the date, indicated in p. 1 cannot be found.
p.(None):
p.(None):
p.(None): Art. 194n. (new – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder of
p.(None): medicinal products under Art. 194l may submit a motivated request to the Committee of Medicinal Products for human use
p.(None): or to the coordination group under Art. 77, Para. 2 for defining the reference date of the EU or for change of the
p.(None): frequency of submitting periodic updated vigilance reports on one of the following grounds:
p.(None): 1. reasons, related to public health;
p.(None): 2. in order to be avoided duplicating of an assessment;
p.(None): 3. in order to be reached international harmonisation.
p.(None): (2) The Committee on Medicinal Products for human use, or the coordination group under Art. 77, Para. 2 after
p.(None): consultations with the committee under Art. 56a, Para. 1, p. 1 shall approve the request or shall make a motivated
p.(None): refusal.
p.(None): (3) The frequency of submitting and the reference ate of the EU shall be defined after consultation with the committee
p.(None): under Art. 56a, Para. 1. P. 1 by:
p.(None): 1.The Committee on Medicinal Products for human use – where at least on of the marketing authorisations
...
p.(None): 5.
p.(None):
p.(None):
p.(None): Art. 194s. (new – SG, 102/2012, in force from 21.12.2012).(1) In case of single assessment of periodic
p.(None): updated safety reports of medicinal products under Art. 194l and where
p.(None):
p.(None): at least one of the marketing authorisations has been issued under Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council, the Committee of the medicinal products for human use within the term of 30 days from
p.(None): receiving the recommendation of the committee under Art. 56a, Para. 1, p. 1 shall issue an opinion about keeping,
p.(None): changing, termination or interruption of the validity of the relevant marketing authorisations, including a schedule
p.(None): for the opinion implementation.
p.(None): (2) Where the opinion under Para. 1 expresses a position for undertaking regulatory actions in relation to the
p.(None): marketing authorisations, the European Commission shall:
p.(None): 1. adopt as decision for change, termination or interruption of the marketing authorisations,
p.(None): issue under Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 2. adopt decision with a recommendation for change, termination or interruption of the marketing authorisations, issued
p.(None): by the relevant Member States regulatory bodies.
p.(None): (3) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 2, p. 2.
p.(None):
p.(None): Section IV.
p.(None): Urgent Procedure at European Union Level. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 194t. (new – SG, 102/2012, in force from 21.12.2012) (1) Urgent procedure at the level of the European Union may
p.(None): be initiated by the European Commission, by the European Medicines Agency or by a Member State.
p.(None): (2) (amend. – SG 18/14) The BDA shall initiate an urgent procedure under this section by notification of the regulatory
p.(None): bodies of the other Member States, the European Medicines Agency and the European Commission where upon
p.(None): considerations, related with pharmaco- vigilance considers, that for a certain medicinal product, placed on the
p.(None): Bulgarian market, one of the following measures are needed to be undertaken:
p.(None): 1. termination or interruption of the marketing authorisation;
p.(None): 2. prohibition of distribution of the medicinal product;
p.(None): 3. issuing a refusal for renewing the marketing authorisation.
p.(None): (3) (amend. – SG 18/14) The BDA shall initiate the procedure under Para. 2 where they are advised by the marketing
p.(None): authorisation holder that, for reasons related to tracing of drug safety, they terminate the distribution of the
p.(None): medicinal product or they have undertaken or they intend to undertake actions for its withdrawal from the market, or
p.(None): will not undertake actions for the renewal of the issued marketing authorisation.
p.(None): (4) (amend. – SG 18/14) The BDA may initiate the procedure under par. 2 in the cases where they consider that for
p.(None): reasons, related to tracing of drug safety, regarding a particular medicinal product new counter-indications may be
p.(None): added or the recommended dose should be reduced, or the indications shall be limited.
p.(None): (5) (amend. – SG 18/14) The BDA shall submit to the European Medicines Agency and to the regulatory authorities of the
...
p.(None): Bulgaria of his intention to effect parallel import and provide a sample of the parallel imported medicinal product
p.(None): upon request;
p.(None): 2. keep the following information for 5 years: name and address of the person whom the parallel imported medicinal
p.(None): product is to be delivered to, date of delivery, delivered quantity, and batch number;
p.(None): 3. submit in BDA:
p.(None): a) actualised patient’s leaflet of parallel imported product according with the variations in issued marketing
p.(None): authorisation of the approved medicinal product in Republic of Bulgaria;
p.(None): b)(Amen. - SG 71/2008, in force from 12.08.2008) declaration that the content of the leaflet according to letter "a"
p.(None): shall be identical with the content of the product leaflet, approved in Republic of Bulgaria except of the data
p.(None): according to Art. 215, para 2, point 7, letters "a" – "d";
p.(None): 4. document and report to the marketing authorisation holder and the BDA all reports of adverse drug reactions of the
p.(None): imported medicinal product.
p.(None):
p.(None): Chapter nine.
p.(None): "B" EXPORT OF MEDICINAL PRODUCTS (NEW – SG 18/14)
p.(None):
p.(None): Art. 217a. (new – SG 18/14) (1) Export of medicinal products from the territory of the Republic of Bulgaria may be done
p.(None): by a natural person or a legal entity holding a permit for wholesale with medicinal products or by a holder of a
p.(None): production license.
p.(None): (2) Holders of a production license may carry out export only of the medicinal products manufactured by them.
p.(None): (3) Within the meaning of this Chapter, export shall also be an intra-Community supply within the European Union.
p.(None): (4) Export of medicinal products included in the Positive Medicines List referred to in Art. 262, par. 1 from the
p.(None): territory of the Republic of Bulgaria shall take place upon notification of BDA in every individual case, where the
p.(None): export is being carried out by the holder of a permit for wholesale of drugs.
p.(None):
p.(None):
p.(None): Art. 217b. (new – SG 18/14) The notification referred to in Art. 217a, par. 4 shall be send to the Managing Director of
p.(None): BDA and shall contain the following information:
p.(None): 1. name and registered address of the person under Art. 217a, par. 1;
p.(None): 2. name, pharmaceutical form and active substance quantity in a dose unit of the medicinal product
p.(None): intended for export;
p.(None): 3. reference number of the permit for wholesale of medicinal products;
p.(None): 4. number of packages of the medicinal product intended for export;
p.(None):
p.(None): 5. the state of destination of the export.
p.(None):
p.(None):
p.(None): Art. 217c. (new – SG 18/14; declared anti-constitutional CCD No 1 of 2015 - SG 12/2015) (1) Upon receipt
p.(None): of a notification under Art. 217b, BDA shall request information about the medicinal product intended for export for a
p.(None): period of the last 6 months as from the day of the notification:
p.(None): 1. about the consumption of the respective medicinal product from the National Health Insurance Fund and/or from the
p.(None): Ministry of Health;
p.(None): 2. about the supplied quantities of the respective medicinal product to the Republic of Bulgaria by the holder of the
p.(None): marketing authorisation.
p.(None): (2) The persons referred to in par. 1 shall provide the information requested by BDA within 15 days after the request.
...
p.(None): vaccination, performed as provided by Art. 248, and approved by the competent authorities.
p.(None):
p.(None):
p.(None): Art. 249. The requirements to the advertising of medicinal products shall be paid down in a regulation of the Minister
p.(None): of Health.
p.(None):
p.(None):
p.(None): Art. 250. Application for authorisation of advertising of medicinal product shall be submitted by the
p.(None): marketing authorisation holder of the medicinal product or a duly empowered person.
p.(None):
p.(None):
p.(None): Art. 251. (1) For advertising authorisation the person according to Art. 250 shall submit to the BDA a formal
p.(None): application as approved by the executive director of the agency accompanied by:
p.(None): 1. design of the advertising;
p.(None): 2. notarised power of attorney issued by the marketing authorisation holder where the application shall be submitted by
p.(None): another person;
p.(None): 3. bibliographical references of the used quotations, tables, or other materials, if any;
p.(None): 4. document for paid fee to the amount as paid down in the tariff according to Art. 21,
p.(None): para 2.
p.(None): (2) The presented advertising drafts - designs to Art. 1 issue 1 must be clear and if there
p.(None): is text, it must be understandable providing possibility to assess all of its elements - text and illustrations.
p.(None): (3) Expert Council of Advertising shall be established to the BDA. It shall involve physicians and
p.(None): specialists with practical experience in the field of advertising. The executive director of the BDA shall appoint
p.(None): by an order the composition of the council, where a representatives of the Professional Ethic Commission
p.(None): of the Bulgarian Medical Association, Bulgarian Dental Association and Bulgarian Pharmacists Union, the amount of
p.(None): the remuneration
p.(None):
p.(None): of its members, and shall approve rules for the condition and order for its work. In the Council representatives of
p.(None): patients organisations may be included.
p.(None): (4) The council according to para 3 shall prepare examination to the advertising design and shall establish an opinion
p.(None): for the executive director of the BDA.
p.(None): (5) In case of establishment of discrepancies between the advertising and the requirements of this Act,
p.(None): the BDA shall, within 7 days of the submission of the application according to para 1, give written
p.(None): instructions for their elimination by the applicant within one month of the notification date. This decision term shall
p.(None): cease to run as from the notification date till the elimination of the discrepancies.
p.(None): (6) If the applicant shall not fulfil the instructions within one month of the notification date according to para 5,
p.(None): the authorisation procedure shall be terminated.
p.(None):
p.(None):
p.(None): Art. 252. (1) The executive director of the BDA shall authorise or issue a motivated refusal of the
p.(None): advertising by an order within one month of the submission of the documentation according to Art. 251, para 1, on the
p.(None): grounds of the opinion according to Art. 251, para 4, and shall notify the marketing authorisation holder.
p.(None): (2) (New – SG, 60/2011, in force from 5. 8. 2011) Where within the term under Para. 1 the executive director of BDA
p.(None): does not permit by an order the advertisement or fails to make a grounded refusal, it shall be accepted, that there is
...
p.(None): (4) The marketing authorisation holder shall have the obligation to effect the notification under par. 1 not later than
p.(None): 18 months prior to the date of discontinuation of the sales, and in the cases under par. 2 - not later than three
p.(None): months prior to the date of discontinuation of the sales.
p.(None): (5) (suppl. - SG No. 18/14) Prior to the discontinuation of the sales under Paragraphs 1 and 2, the marketing
p.(None): authorisation holder shall be obliged to secure sufficient quantities of the respective medicinal product for
p.(None): satisfying the health needs, except for in cases where
p.(None):
p.(None): discontinuation is based on any of the grounds referred to in Art. 276, or Art. 277 of this Act.
p.(None): (6) Upon expiration of the terms under par. 4, the marketing authorisation holder shall file an application with the
p.(None): relevant document for deletion of the medicinal product from the Positive Medicines List.
p.(None): (7) Where after the discontinuation of the sales of the medicinal product the marketing authorisation holder has failed
p.(None): to fulfil his obligation under par. 6, the Council under Art. 258, par. 1 shall delete it ex officio from the Positive
p.(None): Medicines List.
p.(None):
p.(None):
p.(None): Art. 265. (1) (Suppl. – SG, 60/2011, in force from 5. 8. 2011) The Council of Ministers shall establish a Transparency
p.(None): Commission.
p.(None): (2) The composition of the Transparency Commission shall be determined by the Council of Ministers according
p.(None): to a proposal by the Minister of Health. In it representatives of the Ministry of Health, the Ministry of Labour and
p.(None): Social Policy, the BDA, the NHIF, the Bulgarian Medical Association, Bulgarian Dental Association, Bulgarian
p.(None): Pharmacists Union, the professional organisation of the pharmacists, and organisations of the patients
p.(None): and the pharmaceutical industry are obligatory included.
p.(None): (3) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) A person, who is
p.(None): a member of the Transparency Commission shall not be a member of the Council.
p.(None): (4) The Council of Ministers determines with Rules the condition and the order for work of the Transparency Commission.
p.(None):
p.(None):
p.(None): Art. 266. (1) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) The
p.(None): Transparency Commission shall be a body before which decisions of the Council may be appealed.
p.(None): (2) The decisions of the Transparency Commission shall be taken by a majority of two thirds of its members.
p.(None): (3) The decisions of Para. 2 could be appealed under the terms of the Administrative Procedure Code and the appeal has
p.(None): no suspense effect.
p.(None):
p.(None):
p.(None): Art. 266a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) Where the treatment of a relevant sickness is without
p.(None): alternative in the country, for a concrete patient may be applied a medicinal products, which is authorised for use in
p.(None): an EU Member State, authorised for use under this Act, but is not sold on the Bulgarian market.
p.(None): (2) Annually, upon proposal of the medical establishments for hospital assistance after an opinion of the relevant
p.(None): national consultant on the profile of the sickness, the Minister of Health shall confirm a list of the medicinal
p.(None): products under Para. 1, which shall contain the following information:
p.(None): 1. code on the anatomy-therapeutic – chemical classification;
...
p.(None): that their effects with respect to efficacy and safety are essentially similar.
p.(None): 3. "Bioavailability" shall mean the rate and degree at which an active substance or its therapeutically active part is
p.(None): absorbed from the pharmaceutical form and it becomes available at its site of action. Where the medicinal substance is
p.(None): intended to exert a systemic therapeutic effect, bioavailability shall mean the rate and degree at which the medicinal
p.(None): substance or its therapeutically active part is released from the pharmaceutical form and passes into the total
p.(None): circulation.
p.(None): 4. "Researcher’s brochure" shall mean the aggregate of clinical and non clinical data of tests of medicinal product(s),
p.(None): which are relevant to the clinical test of the product(s) in man.
p.(None): 5. "Valid documentation" shall mean any documentation which is compliant with the requirements laid down in
p.(None): a give procedure pursuant to this Act both with respect to content and
p.(None):
p.(None): completeness.
p.(None): 6. "Substance with well established use in medical practice" shall mean a substance to which the following criteria can
p.(None): be applied:
p.(None): a) the period for proving the well established use in medical practice is not less than 10 years from the date of
p.(None): the first systematised and documented use of the substance as a medicinal product in the European Union or in
p.(None): the European Economic Area;
p.(None): b) quantitative aspects of the use of the substance, taking into consideration the degree of use in medical practice,
p.(None): the degree of use on geographical principle, and the degree of follow- up through the pharmaco-vigilance system
p.(None): including pre- and post marketing studies and published scientific literature for epidemiological studies
p.(None): and comparative epidemiological studies in particular;
p.(None): c) high degree of scientific interest in the use of the substance (number of scientific publications) and coherence
p.(None): in scientific assessments.
p.(None): 7. "Outer packaging" shall mean the packaging, which does not come in immediate contact with the medicinal
p.(None): product.
p.(None): 8. "Contracting authority" shall mean a natural or legal person, institution, or organisation responsible for the
p.(None): start-up, management, and/or financing of a clinical test.
p.(None): 9. "Generic medicinal product" shall mean a medicinal product, which has the same qualitative and quantitative
p.(None): composition as regards the active substances and the same pharmaceutical form as the reference medicinal
p.(None): product and its bioequivalence compared to the reference medicinal product has been proven in adequate
p.(None): bioavailability studies. Various immediate release oral pharmaceutical forms shall be regarded as the same
p.(None): pharmaceutical form. Various salts, esters, ethers, isomers, mixtures of isomers, complexes, or derivatives of an
p.(None): active substance shall be regarded as the same active substance except if these are significantly
p.(None): different in respect of safety and/or efficacy.
p.(None): 10. "Principal researcher" shall mean an appointed by the contracting authority medical doctor or doctor in dental
p.(None): medicine who is managing the overall conduct of a clinical test in compliance with an approved protocol and the rules
p.(None): for Good Clinical Practice and is responsible for the work of the researchers.
p.(None): 11. "Defined daily dose" shall be the mean daily maintenance dose of a given medicinal product, which administered to
p.(None): adults according to the main indication of a medicinal product.
p.(None): 12. "Good clinical practice" shall mean the aggregate of internationally recognised ethical and scientific
p.(None): quality requirement, which shall be observed during the planning, conduct, accounting, and reporting of clinical
p.(None): trials.
p.(None): 13. "Good laboratory practice" shall mean a system of rules in respect if the conditions for planning, processes of
p.(None): organizing, conduct, follow up, and documenting of laboratory tests.
p.(None): 14. "Good manufacturing practice" shall mean a system of rules encompassing all aspects of manufacture:
p.(None): personnel, premises, equipment, materials, documentation, and quality control and has the purpose of ensuring safety,
p.(None): efficacy, and compliance with a specification.
p.(None): 15.. (Suppl. - SG 71/2008 in force from 12.08.2008) "Member State" shall mean a State Member of the European Union, or
p.(None): a State, party of the Agreement of the EEA.
p.(None): 16. "Labeling" shall mean information on the immediate or outer packaging of a medicinal product.
p.(None): 17. "Immunological medicinal product" shall mean a medicinal product, which contains vaccines, toxins, sera, or
p.(None): allergens. Agents used to create active immunity or establish a condition of immunity or invoke passive
p.(None): immunity shall be involved in the scope of vaccines, toxins, and sera. Allergens shall mean medicinal products,
p.(None): which are intended to identify or stimulate specific purposeful change in the immunological response to an allergens
p.(None): agent.
p.(None): 18. "Bioequivalence study" shall mean a clinical test aimed at proving that two medicinal
p.(None):
p.(None): products are bioequivalent provided that they are pharmaceutically equivalent or pharmaceutical alternatives and
p.(None): provided that their bioavailability after administration of the same molar dose are similar to a degree, which is a
p.(None): condition for equivalence in respect of efficacy and safety.
p.(None): 19. "Bioavailability study" shall mean a clinical test aimed at showing what is the rate and degree which an active
p.(None): substance or a therapeutically significant part of a studied medicinal product reach from the pharmaceutical form to
p.(None): the systemic circulation of the blood.
p.(None): 20. "Study medicinal product" shall mean a pharmaceutical form of an active substance or placebo, which are
p.(None): investigated or used as comparators in a clinical test including products with granted marketing authorisation but are
...
p.(None): advertising.
p.(None): 35a. (new – SG 1/14, in force from 03.01.2014)”Medical prescription” shall mean a prescription of a
p.(None): medicinal product, issued by a person who exercises a regulated medical profession within the meaning of § 1,
p.(None): item 1 of the Additional Provisions of the Recognition of Professional Qualifications Act and who is legally entitled
p.(None): to do so in the Member State in which the medical prescription is issued.
p.(None): 36. "Multicentre clinical test" shall mean a clinical test, which is conducted according to a single protocol but in
p.(None): more than one site and by more than one researcher. Researcher sites can be situated in the territory of one Member
p.(None): State, more than one Member State, and/or in Member States and third states.
p.(None): 37. "Name of a medicinal product" shall mean the name given to a medicinal product, which can be:
p.(None): a) a freely selected name (trade name);
p.(None): b) (amend. – SG 12/11, in force from 08.02.2011) a common name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation;
p.(None): c) (amend. – SG 12/11, in force from 08.02.2011) scientific name together with the trade mark or the name of the holder
p.(None): of the marketing authorisation.
p.(None): 38. "Scientific literature" shall mean publication(s) of results from scientific research in specialised international
p.(None): scientific editions.
p.(None):
p.(None): 39. "New active substance" shall mean:
p.(None): a) chemical, biological, or radiopharmaceutical substance, which has not been authorised to market in
p.(None): the European Union as a medicinal product;
p.(None): b) isomer, mixture of isomers, complex or derivative or salt of a chemical substance, which has been authorised to
p.(None): market in the European Union as a medicinal product but is different with respect to safety and efficacy from
p.(None): a formerly authorised substance;
p.(None): c) biological substance, which has been authorised to market in the European Union as a medicinal product but has
p.(None): different molecular structure, different origin with respect to the starting material, or has been obtained
p.(None): through a different manufacturing process;
p.(None): d) radiopharmaceutical substance the radionuclides or molecular bonds (ligands) of which have not been
p.(None): authorised in the European Union as a medicinal product or the mechanism of bonding in a couple of the molecules
p.(None): and radionuclides has not been authorised in the European Union.
p.(None): 40. "Adverse event" shall mean any untoward unfavorable change the health condition observed during the administration
p.(None): of a medicinal product in a patient or a clinical test subject and which has not necessarily a causal relationship with
p.(None): this treatment.
p.(None): 41. (amend. – SG, 102/2012, in force from 21.12.2012) "Adverse drug reaction" shall mean any untoward and unpredicted
p.(None): response to a medicinal product. In case of a clinical test
p.(None): – any untoward and unpredicted response to a study medicinal product irrespective of the administered
p.(None): dose. The types of adverse reactions shall be:
p.(None): a) "unexpected" – an adverse drug reaction, which has not been mentioned in the summary of product
p.(None): characteristics of the character, severity, and outcome of which do not comply with those mentioned in the
p.(None): summary of product characteristics. In case of a clinical test
p.(None): – an adverse drug reaction the character, severity, and outcome of which do not comply with the information for the
p.(None): study medicinal product mentioned in the researcher’s brochure;
p.(None): b) "suspected" – and adverse drug reaction fore which the reporter or the marketing authorisation holder supposes that
p.(None): there is a possible causal relationship with a taken medicinal product;
p.(None): c) "serious" – any unfavorable effect on the health condition, which has become the reason for a lethal outcome,
p.(None): immediate threat to life, hospitalisation, or prolongation if hospitalisation, significant or durable injury,
...
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
...
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
p.(None): 91 (new – SG, 102/2012, in force from 21.12.2012) "Delegated act" is an act in the meaning of Art. 290 of the Treaty on
p.(None): the European Union.
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
p.(None):
p.(None): § 2. The name of the Executive Drug Agency shall be written in Latin as "Bulgarian Drug Agency".
p.(None):
p.(None):
p.(None): § 3. The Council of Ministers shall determine the conditions and order for the supply, storage and renewal of the
p.(None): medicinal products kept in the State Agency "State Reserve and War-time Reserves".
p.(None):
p.(None):
p.(None): § 4. (suppl. – SG 18/14) This Act shall implement the provisions of Directive 2001/83/EC of the European Parliament
p.(None): and the Council on the Community code relating to medicinal products for human use subsequently amended
p.(None): by Directive 2004/27/EC of the European Parliament and the Council and of Directive 2012/26/EU of the European
p.(None): Parliament and of the Council of 25 October 2012.
p.(None):
p.(None):
p.(None): § 5. The data protection periods for reference medicinal products shall be applied according to the
p.(None): provisions of Art. 89 of Regulation (EC) № 726/2004 of the European Parliament and the Council and Art. 2 of Directive
p.(None): 2004/27/EC of the European Parliament and the Council
p.(None):
p.(None):
p.(None): § 5a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG, 102/2012, in force from 21.12.2012) The Ministry
p.(None): of Health, the National Council on prices and reimbursement of medicinal products, the BDA and the Regional health
...
p.(None): No 10 of the Constitutional Court from 1996; amended, State Gazette No 38 from 1998, No 30 from 1999, No 10 from 2000,
p.(None): No 37 from 2000 - Decision No 3 of the Constitutional Court from 2000; amended, State Gazette No 59 from 2000, No 78
p.(None): from 2000 - Decision № 7 of the Constitutional Court from 2000; amended, State Gazette No 41 from 2001, No 107 and 120
p.(None): from 2002; amended, State Gazette No 2 from
p.(None): 2003; amended, State Gazette No 56, 71 and 112 from 2003, No 70 and 111 from 2004,
p.(None): No 37, 76, 85, 87, 99 and 105 from 2005, No 30, 31, 34, 75 and 105 from 2006) is repealed, with exception of the
p.(None): Regulation of Art. 10, para 2, which is applied for term to one year since the day of the coming in the force of this
p.(None): Act.
p.(None):
p.(None):
p.(None): § 7. (1) The marketing authorisations for medicinal products published before the entering into force of
p.(None): this Act under national procedure, which are authorised also in a Member States under centralised procedure shall cease
p.(None): to be valid as from 1 January 2007.
p.(None): (2) The marketing authorisations for medicinal products issued up to the entering into force of this Act under national
p.(None): procedure shall be brought into line with the requirements at the date of their renewal.
p.(None): (3) The marketing authorisations for medicinal products falling within the scope of Regulation (EC) 726/2004
p.(None): of the European Parliament and the Council and which have issued marketing authorisation under the terms of the
p.(None): repealed Medicines and Pharmacies in Human Medicine Act as materially similar products, but which have no
p.(None): marketing authorisation in European Union under the centralised procedure shall cease to be valid.
p.(None): (4) The medicinal products which have been issued marketing authorisation in the European Union under the
p.(None): centralised procedure, which national marketing authorisation is ceased under the terms of para 1, can be sold
p.(None): on the territory of Republic of Bulgaria in packages and with leaflets according to the ceased national marketing
p.(None): authorisation for a time limit not longer than one year since the date of its cessation.
p.(None):
p.(None):
p.(None): § 8. (1) The setting up of ceiling prices and the registered prices under the terms of the repealed Medicines and
p.(None): Pharmacies in Human Medicine Act of the medicinal product, which have marketing authorisation in the European Union
p.(None): according to the centralised procedure, which national marketing authorisation is suspended under the terms of
p.(None):
p.(None):
p.(None): § 7, para 1, remain in force for a time limit of one year from the date of its cessation.
p.(None): (2) The setting up of ceiling prices and registered prices under the terms of the repealed Medicines and Pharmacies in
p.(None): Human Medicine Act of the medicinal products, other than those according to para 1 remain in force for a time limit
p.(None): expiring on 31 December 2007.
p.(None):
p.(None): § 9. (1) The applications for marketing authorisation, renewal, modification of the published authorisation,
p.(None): which are submitted up to the entering into force of this Act are reviewed and closed according to the terms and the
p.(None): conditions provided for herein.
p.(None): (2) The submitted applications and documentations for marketing authorisation for medicinal products falling
p.(None): within the scope of the procedure provided for in Art. 74 and also according to Art. 75 shall be brought into
p.(None): line with the requirements of this Act within three months from its entering into force.
p.(None): (3) When in the case provided for in para 2, the application and the documentation under para 2 have not been brought
p.(None): into line with the requirements of this Act, the procedure of their review shall be terminated.
p.(None):
p.(None):
p.(None): § 10. (1) The clinical trials which were approved before this Act comes in force shall be finished according to under
p.(None): the conditions prevailing hitherto.
p.(None): (2) The applications for conduction of the clinical trial on the territory of Republic of Bulgaria are
p.(None): submitted, reviewed and closed according to the terms and conditions of this Act after the regulation according Art.
p.(None): 82, para 3 comes in force.
...
Social / Unemployment
Searching for indicator unemployed:
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p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
p.(None): c) chronology, including records and documents, related to the used delivery chain. Medicinal product shall
p.(None): not be considered as falsified with not intentionally admitted diverse in quality, as well as such, placed on the
p.(None): market in violation of the intellectual property rights.
p.(None): 82. "Homeopathic medicinal product" shall mean a medicinal product prepared from substances called
p.(None): homeopathic source according to the manufacturing procedures of the European Pharmacopoeia and – in the
p.(None): absence of such – according to the national pharmacopoeia of a Member State.
p.(None): 83. "Price calculated on the basis of a referent value" shall be the price formed for any medicinal product included
p.(None): in the Positive Medicines Listcalculated on the basis of the determined reference value for a defined daily
p.(None): dose or therapeutic course.
p.(None): 84. "Site" shall mean a structure in a healthcare establishment where a clinical test is conducted.
p.(None): 85. "Abuse of medicinal products" shall mean permanent or incidental intentional excessive use of medicinal
p.(None): products accompanied by noxious physical or mental effects.
p.(None): 86. (New - SG 41/2009, in force from 02.06.2009) "Sucklings" are children under 12 months of age.
p.(None): 87. (New - SG 41/2009, in force from 02.06.2009) "Infant formulas" are foods, intended for specific feeding use by
p.(None): sucklings in the period of their first months, which are sufficient to satisfy the feeding needs of those sucklings by
p.(None): the moment of introducing appropriate additional food.
p.(None):
p.(None): 88. (New - SG 41/2009, in force from 02.06.2009) "Transitional foods" are foods, intended for specific
p.(None): feeding use by sucklings in introducing of appropriate additional food and which represent the basic liquid of
p.(None): progressively increasing varieties of the foods of these sucklings.
p.(None): 89. (new – SG 12/11, in force from 08.02.2011) "Variation of type IA" means a variation which has only a minimal
p.(None): impact, or no impact at all, on the quality, safety or efficacy of the medicinal product concerned;
p.(None): 90. (new – SG 12/11, in force from 08.02.2011) "Variation of type IB" means a variation which is neither variation
p.(None): of type IA nor variation of type II nor extension a marketing authorisation.
p.(None): 91. (new – SG 12/11, in force from 08.02.2011) "Variation of type II" means a variation, which is not a extension of a
p.(None): marketing authorisation and which may have a significant impact on the quality, safety or on the efficacy of the
p.(None): medicinal product concerned.
...
Social / Women
Searching for indicator women:
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p.(None): clinical trials is permitted provided that:
p.(None): 1. the respective ethics committee with the participation of a specialist competent in the respective disease or in the
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
p.(None): consent or of data obtained through other research methods;
p.(None): 4. the study is directly associated with a disease, which is life-threatening or resulting in disability, from which
p.(None): the major person who is not capable of giving informed consent is suffering;
p.(None): 5. the clinical trials are planned in such manner that pain, inconvenience, fear, and the other foreseeable risks
p.(None): associated with the disease are minimised and the risk threshold and physical pain degree have been determined in
p.(None): advance and shall be incessantly controlled throughout the clinical test;
p.(None): 6. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 102. No clinical test with a medicinal product can be conducted in pregnant women or breastfeeding mothers except
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): (3) The informed consent according to para 1, point 3, and para 2 can only be given by a capable person who
p.(None): understands the essence, importance, scope, consequences, and eventual risks of the clinical test. Informed
p.(None): consent to participate in a clinical test can be withdrawn at any time.
p.(None): (4) The informed consent according to para 1, point 3, of an incapable major person shall be given by his/her
p.(None): legal representative. The consent of the legal representative must represent the supposed will of the subject
p.(None): and can be withdrawn at any time without negative consequences for the subject.
p.(None): (5) In the cases according to Art. 162, para 3 of the Health Act, informed consent shall be given by the person
p.(None): appointed by the court.
p.(None): (6) An incapable person shall be given information about the clinical test, eventual risks, and benefits in accordance
p.(None): with his/her capability to understand.
p.(None): (7) The explicit will of an incapable major person to refuse to participate in or to withdraw from the clinical test at
p.(None): any time must be taken into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None):
p.(None): Art. 97. (1) A clinical test in a minor person shall be conducted after obtaining written informed consent by both
p.(None): subject’s parents or guardians with observation of Art. 96, para 1 and 3.
p.(None): (2) Parents’ or guardians’ consent must represent the supposed will of the minor person and can be withdrawn at any
p.(None): time without negative consequences for the minor person.
p.(None): (3) The express will of the minor person to participate or to at any time withdraw from the clinical test must be taken
p.(None): into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (4) A clinical test in a minor person shall be conducted after obtaining written informed consent by both parents and
p.(None): the guardian in compliance of Art. 96, para 1 and 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, the written informed consent shall be given
p.(None): by the parent who is exercising the parental rights.
p.(None): (5) Minor’s, parents’ and guardian’s’ consent can be withdrawn at any time without negative consequences
p.(None): for the minor person.
p.(None): (6) The express will of the minor person to at any time withdraw from the clinical test must be taken into
p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
p.(None): contain contact details of an independent person for additional information.
p.(None):
p.(None): Section .
p.(None): Clinical Trials in Vulnerable Patient Groups
p.(None):
p.(None): Art. 100. A clinical test in minor or underage persons can be undertaken provided that:
p.(None): 1. the study protocol has been approved by the respective ethics committee after discussion of the
p.(None): clinical, moral, and psycho-social aspects of childhood age in which at least two paediatricians have participated;
p.(None): 2. there is an anticipated direct benefit of the clinical test for the patient group, which is to be included;
p.(None): 3. the study is directly associated with the clinical condition from which the minor or underage person is suffering;
p.(None): 4. the study medicinal product is designated for the diagnosis, treatment, or prophylaxis of diseases, which are
p.(None): specific for minor or underage persons;
p.(None): 5. the study is designated to be conducted in minor or underage persons;
p.(None):
p.(None): 6. the study purpose is to check data obtained in clinical trials in persons who are capable of giving
p.(None): informed consent or of data obtained by other research methods;
p.(None): 7. the results obtained from clinical trials in adults and the interpretation thereof cannot be considered also valid
p.(None): for minor or underage persons;
p.(None): 8. the study is planned in a manner that pain, inconvenience, fear, and other disease- associated foreseeable risks are
p.(None): minimised and the risk threshold and physical pain degree have been determined in advance and shall be incessantly
p.(None): controlled throughout the clinical test;
p.(None): 9. the study has been planned and shall be conducted in compliance with the guidelines of the European Medicines
p.(None): Agency;
p.(None): 10. no financial or other incentives shall be given except compensations.
p.(None):
p.(None):
p.(None): Art. 101. (1) Clinical trials in the persons according to Art. 96, para 4 and 5, who are not capable of giving informed
p.(None): consent, shall be conducted in compliance with the requirements of Art. 90.
p.(None): (2) Except for the requirements of para 1, inclusion of major persons who are not capable of giving informed consent in
p.(None): clinical trials is permitted provided that:
p.(None): 1. the respective ethics committee with the participation of a specialist competent in the respective disease or in the
p.(None): patient group has approved the study protocol after discussion of the clinical, moral, and psycho-social aspects
p.(None): relating to the respective disease and patient group;
p.(None): 2. it can be anticipated that taking the medicinal product subject to research would result in benefits, which
p.(None): overweigh the risks or the risks are fully eliminated;
p.(None): 3. the study purpose is to check data obtained from clinical trials in persons who are capable of giving informed
...
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
p.(None): (2) The committees according to para 1 shall include at least two persons of non-medical education, representatives of
p.(None): both genders, who are financially and administratively independent of the healthcare establishment where the clinical
p.(None): test is to be conducted.
p.(None): (3) The committees according to para 1 can involve external specialists for the needs of their work.
p.(None): (4) In clinical trials in minor or underage persons the respective ethics committee at the healthcare establishment can
p.(None): involve external experts in order to facilitate its work.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): years.
p.(None): Art. 105. (1) The mandate of the ethics committee members shall have duration of 4
p.(None):
p.(None): (2) One half of the composition of the ethics committees shall be renewed every 2 years.
p.(None): (3) A member of an ethics committee cannot be appointed in the same committee for
p.(None): more than two consecutive mandates.
p.(None):
p.(None):
p.(None): Art. 106. (1) The ethics committees according to Art. 103, para 1 and 2, shall draw written standard operating
p.(None): procedures in compliance with the rules for Good Clinical
p.(None): Practice, which shall determine the conditions and order for their work within one month from its establishment.
p.(None): (2) The standard operating procedures of the ethics committees shall be approved by the executive director of the BDA.
p.(None): (3) The sessions of the ethics committees shall be held in camera. In case of necessity, the chairman of the ethics
p.(None): committee can invite the contracting authority or the principal researcher to participate.
...
Social / education
Searching for indicator education:
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p.(None): 6. precautions and safety measures during storage of the medicinal product, its administration to patients
p.(None): and for the disposal of waste products together with an indication of potential risks for the environment;
p.(None): 7. description of the method of manufacture;
p.(None): 8. description of the control methods employed by the manufacturer;
p.(None): 8a (new – SG, 102/2012, in force from 02.01.2013) declaration, that the audit results under Art. 160, Para. 2,
p.(None): conducted by the manufacturer of the medicinal product confirm that the active substance has been produced in
p.(None): compliance with the principles and directives for good production practice; the declaration shall indicate the date on
p.(None): which the audit is conducted;
p.(None): 9. assessment of the potential risks presented by the medicinal product for the environment for every
p.(None): individual case and measures for the limitation thereof;
p.(None): 10. results of:
p.(None): a) pharmaceutical (physico-chemical, biological or microbiological) tests;
p.(None): b) preclinical (toxicological and pharmacological) tests;
p.(None): c) clinical trials;
p.(None): 11. declaration that the ethic principles of the Good Manufacturing Practice have been complied with in the clinical
p.(None): trials conducted outside the territory of the Member States;
p.(None): 12. (amend. – SG, 102/2012, in force from 21.12.2012) a summary of the system
p.(None): a) for vigilance the medicinal safety, which shall include the following elements:
p.(None): b) which is to be implemented and, where appropriate, description of the risk management system;
p.(None): c) name of the qualified person under Art. 191, a CV – education, acquired professional experience in the area of
p.(None): vigilance the medicinal safety and qualification for performing his/her duties under Chapter Eight;
p.(None): d) each Member state in which the qualified person fulfils his/her duties;
p.(None): e) address, tel. fax, e-amil address of the person under letter "a";
p.(None): f) address, at which the basic document is kept of the system for vigilance medicinal
p.(None): safety;
p.(None): 12a. (new - SG, 102/2012, in force from 21.12.2012) declaration by the applicant that
p.(None): he/she has the needed means for fulfilling the obligations under Chapter Eight;
p.(None): 13. (amend. -SG, 102/2012, in force from 21.12.2012) plan for risk management with a description of the system for risk
p.(None): management, which the applicant will introduce for the relevant medicinal product with the plan summary;
p.(None): 14. summary of product characteristics according to Art. 34;
p.(None): 15. mock-up of the immediate and outer packaging of the product and a proposed package leaflet in
p.(None): compliance with the requirements of chapter six;
p.(None): 16. copy of the manufacturing authorisation issued by the regulatory authority of the
p.(None):
p.(None): country where manufacture is performed accompanied by a Good Manufacturing Practice certificate or a
p.(None): certificate evidencing that the manufacture of the medicinal product and the active substances contained in its
p.(None): composition has been performed in compliance with standards, which are at least equivalent to the standards of
p.(None): the Good Manufacturing Practice;
p.(None): 17. copy of a document evidencing that the medicinal product is designated for treatment, prophylaxis, or diagnostics
...
p.(None): if the medicinal product is required for their treatment or cannot be tested in other patient groups.
p.(None):
p.(None): Section .
p.(None): Ethics Committee
p.(None):
p.(None): Art. 103. (1) (amend. – SG, 6/2011, in force from 5. 8. 2011) Ethics Commission for multicentre clinical trials shall
p.(None): be established to the Minister of Health the composition of which shall be determined by an order of the Minister and
p.(None): shall include regular and reserve members. The reserve members shall participate in the Commission meetings and shall
p.(None): have the right to vote in the event of absence of the regular members.
p.(None): (2) Ethics committees shall be established at the healthcare establishments where clinical trials are to be
p.(None): conducted the composition of which shall be determined by an order of
p.(None):
p.(None): the manager of the healthcare establishment.
p.(None): (3) The BDA shall maintain and keep a register of ethics committees.
p.(None): (4) The register of healthcare establishments where ethics committees have been established shall be
p.(None): published on the internet site of the BDA.
p.(None):
p.(None):
p.(None): Art. 104. (1) The committees according to Art. 103 para 1 and 2 shall be composed of 7 to 12 persons with qualification
p.(None): and experience to review and assess the scientific, medical, and ethic aspects of the proposed clinical test.
p.(None): (2) The committees according to para 1 shall include at least two persons of non-medical education, representatives of
p.(None): both genders, who are financially and administratively independent of the healthcare establishment where the clinical
p.(None): test is to be conducted.
p.(None): (3) The committees according to para 1 can involve external specialists for the needs of their work.
p.(None): (4) In clinical trials in minor or underage persons the respective ethics committee at the healthcare establishment can
p.(None): involve external experts in order to facilitate its work.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): years.
p.(None): Art. 105. (1) The mandate of the ethics committee members shall have duration of 4
p.(None):
p.(None): (2) One half of the composition of the ethics committees shall be renewed every 2 years.
p.(None): (3) A member of an ethics committee cannot be appointed in the same committee for
p.(None): more than two consecutive mandates.
p.(None):
p.(None):
p.(None): Art. 106. (1) The ethics committees according to Art. 103, para 1 and 2, shall draw written standard operating
p.(None): procedures in compliance with the rules for Good Clinical
p.(None): Practice, which shall determine the conditions and order for their work within one month from its establishment.
p.(None): (2) The standard operating procedures of the ethics committees shall be approved by the executive director of the BDA.
...
p.(None):
p.(None):
p.(None): Art. 197. The persons according to Art. 195 shall dispose of:
p.(None): 1. suitable premises, equipment and outfits, and transport vehicles ensuring correct storage, distribution,
p.(None): and transportation of the medicinal products in compliance with the requirements of the Good Distribution
p.(None): Practice;
p.(None): 2. personnel and responsible master-pharmacist with at least two years length of service in his speciality and whose
p.(None): obligations shall be laid down in the regulation according to Art. 198.
p.(None):
p.(None):
p.(None): Art. 198. (amend. – SG, 102/2012, in force from 02.01.2013) The principles and requirements for the Good
p.(None): Distribution Practice of medicinal products and of active substances shall be adopted by an ordinance of the Minister
p.(None): of Health and by directives, adopted by the European Commission.
p.(None):
p.(None):
p.(None): Art. 199. (1) The persons according to Art. 195, para 2, shall submit to the BDA:
p.(None): 1. application containing name, place of business and address of management of the trader; address and description of
p.(None): the premises and equipment for the storage of the medicinal products;
p.(None): 2. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification
p.(None):
p.(None): code of the trader of cooperation from the Trade Register and for the companies, registered in a EU Member State or
p.(None): a state – party on the EEA Agreement – a document for updated registration according to the national
p.(None): legislation, issued by a competent body of the relevant state;
p.(None): 3. name, certificate of clean court record, diploma for higher education and length of service for the responsible
p.(None): master - pharmacist according to Art. 197, point 2, and a copy of his/her employment contract;
p.(None): 4. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 5. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 6. document certifying the legal grounds for the use of the premises;
p.(None): 7. (amend., - SG 98/10, in force from 01.01.2011) conclusion of the Regional Health Inspectorates after inspection on
p.(None): the spot evidencing that the health requirements in the whole sale premises according to the regulation according to
p.(None): Art. 198.
p.(None): 8. document for paid fee as laid down in the tariff Art. 21, para 2.
p.(None): (2) The persons according to Art. 195, para 1, shall submit to the BDA an application accompanied by the following
p.(None): documents:
p.(None): 1. copy of the wholesale authorisation issued by a regulatory body of a Member State;
p.(None): 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.(None): 3. address of the premises for the storage of the medicinal products on the territory of the Member State.
p.(None): (3) In case of wholesale of narcotic substances, as well as pharmaceutical forms containing such
p.(None): substances, the requirements of the Control on Drugs and Precursors Act shall also be applied.
p.(None): (4) In case of wholesale of radiopharmaceuticals, an opinion of the Nuclear Regulatory Agency shall also be submitted.
p.(None):
p.(None):
p.(None): Art. 200. The BDA shall assess the documentation the documentation and conduct an inspection on the spot of the sites
p.(None): mentioned in the application to certify their compliance with the requirements of the Good Distribution Practice.
p.(None):
p.(None):
...
p.(None): (4) (new – SG 18/14) Where the wholesalers supply medicinal products to persons in third countries, they certify by
p.(None): relevant documents that the supplies are solely for persons, holding a permit or having got the right to
p.(None): receive medicinal products intended for wholesaling or for supplying to individuals subject to compliance with the
p.(None): applicable national laws of the third country.
p.(None): (5) (prev. par. 3 – SG 18/14) A wholesale trader, who delivers medicinal products to persons from third states, which
p.(None): have the right under the relevant national legislation to deliver medicinal products to the consumers, shall issue a
p.(None): document ,which shall certify:
p.(None): 1. date of delivery;
p.(None): 2. name and form of the medicinal product;
p.(None): 3. delivered quantity;
p.(None): 4. name and address of the person, to whom the medicinal product has been delivered;
p.(None): 5. lot number.
p.(None):
p.(None):
p.(None): Art. 210. (Amend. – SG, 60/2011, in force from 5. 8. 2011) (1) The holder of the authorisation for use
p.(None): and the person under Art. 26, Para. 2 may provide samples of authorised medicinal products to:
p.(None): 1. physicians and physicians in dental medicine;
p.(None): 2. higher medical schools and medical colleges;
p.(None): (2) In the cases according to para 1, the packaging of the medicinal products shall bear an inscription "Sample".
p.(None): (3) The persons according to para 1, point 1, maid be supplied not more than two pieces of the same pharmaceutical form
p.(None): of a medicinal product in one calendar year in the smallest existing pack of a manufacturer, and the higher medical
p.(None): schools and medical colleges – only in quantities required for the purposes of the education.
p.(None): (4) The holder of the authorisation for use and the person under Art. 26, Para. 2 shall keep record of all persons whom
p.(None): they have delivered samples to, about the type, quantity, and time of delivery and shall provide this data to the
p.(None): control bodies upon request.
p.(None):
p.(None):
p.(None): Art. 211. (1) The wholesalers must have a system for blocking and recall of medicinal products, which have shown
p.(None): discrepancies with the requirements relating to quality, safety, and efficacy.
p.(None): (2) The holder of approval for wholesale is duty to freeze and draw out medicinal product, which showed discrepancies
p.(None): with the requirement for quality, safety and efficacy based on the order, determined in the regulation according Art
p.(None): 274, para 1.
p.(None):
p.(None):
p.(None): Art. 212. (1) The executive director of the BDA shall notify the European Commission, the regulatory bodies of the
p.(None): other Member States, and the European Medicines Agency for the issued wholesale authorisations, temporarily
p.(None): stopped, or bereaved authorisations and the
p.(None):
p.(None): reasons therefore.
p.(None): (2) (amend. – SG, 102/2012, in force from 02.01.2013) Where the executive director of the BDA has established that
p.(None): the person according to Art. 195, Para. 1, does not fulfill its obligations according to Art. 207, Para. 1,
p.(None): points 2-14, he shall notify the regulatory body of the Member State, which has issued the wholesale
p.(None): authorisation, as well as the European Commission.
p.(None): (3) Where the regulatory body according to para 2 has temporarily stopped or bereaved the wholesale authorisation of
p.(None): the person according to Art. 195, para 1, it shall notify the executive director of the BDA and the
p.(None): European Commission.
p.(None):
p.(None):
...
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
p.(None): for premeditated crimes against the personality;
p.(None): 3. has at least 1 year of professional experience in this field.
p.(None):
p.(None):
p.(None): Art. 239. (1) (amend. – SG, 60/2011, in force from 5. 8. 2011) Drugstores shall be opened after
p.(None): registration at the relevant RHI.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 238,
p.(None):
p.(None): para 2, shall submit to the RHI a registration application accompanied by the following documents:
p.(None): 1. (amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code of the trader or
p.(None): cooperation from the Trade register and for the companies, registered in EU Member State or in a state – party
p.(None): of the EEA Agreement – a document for updated registration according to the national legislation, issued by a
p.(None): competent body of the relevant state of the persons under Art. 238, Para. 1;
p.(None): 2. education document and certificate of clean court record or the person appointed as manager of the drugstore;
p.(None): 3. medical certificate of the person according to point 2;
p.(None): 4. (repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 5. (amend., - SG 98/10, in force from 01.01.2011, repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): 6. document for paid state fee to the amount as laid down in the tariff according to Art. 21, para 2.
p.(None): (3) (New – SG, 60/2011, in force from 5. 8. 2011).Within 14 day term from receiving the application under Para. 2,
p.(None): RHI shall perform an inspection on the observation of the requirements of the Ordinance under Art. 243.
p.(None): In the cases, where it is found that the requirements of the Ordinance under Art. 243 have not been observed,
p.(None): within 7 day term after the inspection the RHI shall give instructions and shall determine term for removing them.
p.(None): (4) (New – SG, 60/2011, in force from 5. 8. 2011). Within 14 day term from receiving the application and the
p.(None): documents under Para. 2, the director of RHI shall notify in writing the persons for finding irregularities
p.(None): in them and shall determine a term for their removal.
p.(None): (5) (New – SG, 60/2011, in force from 5. 8. 2011). For submitting a registration application for a drug
p.(None): store or for performing a change under Art. 242, the relevant RHI shall collect charges in the amount, determined by
p.(None): the tariff under Art. 21, Para. 2.
p.(None):
p.(None):
p.(None): Art. 240 (Amend. - SG, 60/2011, in force from 5. 8. 2011). Within 14 day term after the inspection under Art. 239,
p.(None): Para. 3 or after removing the irregularities under Art. 239, Para. 4, the director of the RDA shall issue a
...
p.(None): within the validity of its marketing authorisation.
p.(None): (2) Where there have been variations in the marketing authorisation of a medicinal product resulting in
p.(None): changes of an authorised advertising of this product, the marketing authorisation holder shall submit to the
p.(None): BDA an application for change.
p.(None):
p.(None):
p.(None): Art. 254. In case of change in the authorised advertising, the person according to Art.
p.(None): 250 shall submit an application under the terms of Art. 251.
p.(None):
p.(None):
p.(None): Art. 254a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) The advertisement, intended for the medical specialists
p.(None): shall not be permitted under Art. 250 – 252.
p.(None): (2) The advertisement under Para. 1 shall be disseminated after submitting a notification to BDA, which shall contain
p.(None): an advertisement draft, while observing the requirements of this Chapter and the Ordinance under Art. 249.
p.(None):
p.(None):
p.(None): Art. 255. (1) The proliferation of samples of medicinal products containing narcotic substances within the
p.(None): meaning of the Control on Drugs and Precursors Act shall be prohibited.
p.(None): (2) The direct provision of samples of medicinal products to the population by medical trade representatives according
p.(None): to Art. 244, para 1, point 3 shall be prohibited.
p.(None):
p.(None): Art. 256. Samples of medicinal products shall be provided to medical specialists under the conditions and order laid
p.(None): down in the regulation according to Art. 249.
p.(None):
p.(None):
p.(None): Art. 257. (1) The medical trade representatives according to Art. 245, para 2, point 3, must have passed special
p.(None): education organised by the marketing authorisation holder who has employed them and must possess scientific knowledge
p.(None): about the presented medicinal product.
p.(None): (2) During any visit, the medical trade representatives must dispose of the summary of the product characteristics and
p.(None): price data of the medicinal product and about the conditions of its payment and shall provide these upon request.
p.(None): (3) While presenting medicinal products before medical specialists, the medical trade representatives cannot offer
p.(None): gifts and other material and immaterial benefits.
p.(None):
p.(None): Chapter twelve.
p.(None): REGULATION OF PRICES OF MEDICINAL PRODUCTS (TITLE, AMEND. – SG 102/2012)
p.(None):
p.(None): Section I.
p.(None): National Council on Prices and Reimbursement of Medicinal Products (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 258. (1) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) (1)
p.(None): (amend. – SG 43/16) Under the Minister of Health shall be established National Council on Prices and
p.(None): Reimbursement of medicinal products, called hereinafter "The Council". The Council shall be a legal
p.(None): persons, a second level budget administrator. Its status is of a state commission with a central office in Sofia.
p.(None): (2) The Council activity shall be funded by the state budget through the budget of the Ministry of Health.
p.(None): (3) The Council shall be a college body and shall consist of a Chairperson and 6 members of whom 3 shall
p.(None): be medical doctors or Master-Pharmacists, 2 layers and 2 economists, all with at least 5 years professional
p.(None): practical experience. The chairperson and the Council members shall be elected and discharged by a decision of
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p.(None): When activities according para 2, point 3 carried out, the Ministry of Health collect taxes in amount, determined in
p.(None): tariff according to Art. 21, para 2.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None):
p.(None):
p.(None): Art. 15. (1) Pharmacopoeia Committee shall be established with the Minister of Health as a consulting body on issues
p.(None): relating to the current pharmacopoeia.
p.(None): (2) The Minister of Health shall, on the grounds of a proposal of the Executive Director of the BDA determine by an
p.(None): order the composition of the Pharmacopoeia Committee and the expert groups thereto and shall approve the regulation
p.(None): relating to their activity.
p.(None): (3) The activity of the Pharmacopoeia Committee shall be financed by the budget of the Ministry of Health.
p.(None):
p.(None):
p.(None): Art. 16. (1) Higher Council of Pharmacy shall be established to the Minister of Health as a consulting body on issues
p.(None): relating to pharmacy. It shall be composed by five representatives appointed by the Minister of Health, five
p.(None): representatives from Bulgarian Pharmaceutical Union, two representatives from National Health Insurance Fund (NHIF) and
p.(None): one representative from Faculty of pharmacy of the high medicinal schools. The Minister of Health is a chairman of the
p.(None): council without right of vote.
p.(None): (2) The Higher Council of Pharmacy is consultative body, which discuss and provide statements for:
p.(None): 1. Basic approaches and priorities in the pharmaceutical area;
p.(None): 2. Ethical problems of the pharmacy;
p.(None): 3. Projects for normative acts, related with the pharmacy;
p.(None): 4. The scientific priorities in the area of pharmacy;
p.(None): 5. Programs for organisation of social educational campaign in the area of medicinal products.
p.(None): (3) (repealed – SG, 60/2011, in force from 05.08.2011)
p.(None): (4) The organisation and the activity of the Higher Council of Pharmacy are settled with ordinance issued by the
p.(None): Minister of Health, after proposal of Higher Council of Pharmacy.
p.(None):
p.(None):
p.(None): Art. 17. (1) The Bulgarian Drug Agency shall be a specialised body at the Minister of Health for the surveillance on
p.(None): the quality, safety, and efficacy of the medicinal products.
p.(None): (2) (amend. SG 15/13, in force from 01.01.2014) The Bulgarian Drug Agency shall be a legal entity budget financed with
p.(None): registered office in the city of Sofia with the Minister of Health.
p.(None): (3) The Bulgarian Drug Agency shall be managed and represented by an Executive Director who shall be appointed under
p.(None): the terms of the Administration Act.
p.(None): (4) The structure, functions, and work organisation of the Bulgarian Drug Agency shall be regulated by statutes adopted
p.(None): by the Council of Ministers.
p.(None): (5) The Bulgarian Drug Agency shall:
p.(None): 1. issue manufacture authorisation for medicinal products;
p.(None): 2. issue marketing authorisations and registration certificated for medicinal products;
p.(None): 3. issue authorisations for wholesale of medicinal products;
p.(None): 4. issue authorisations for parallel import of medicinal products;
p.(None):
p.(None): 5. (amend. – SG, 60/2011, in force from 05.08.2011), issue, refuse or terminate authorisations for retail
p.(None): trade with medicinal products;
...
p.(None): medicinal products intended for clinical trials.
p.(None): (4) Manufacturing authorisation shall also be required for persons who perform simultaneously or separately
p.(None): one of the following activities: complete or partial manufacture of active substances intended for the manufacture of
p.(None): medicinal products and various processes of packaging, retail packaging, repackaging, and re-labelling of active
p.(None): substances.
p.(None): (5) No manufacturing authorisation shall be required where the processes of retail packaging, mixing, or
p.(None): packaging are performed according to magisterial or pharmacopoeia recipe in a pharmacy.
p.(None):
p.(None):
p.(None): Art. 147. (amend. – SG, 102/2012, in force from 02.01.2013) The BDA shall introduce information about the issued
p.(None): manufacturing authorisations of medicinal products and certificates for good production practice to be entered in the
p.(None): European Union database.
p.(None):
p.(None):
p.(None): Art. 148. To obtain manufacturing authorisation the person according to Art. 146 must possess:
p.(None): 1. personnel with adequate qualification depending on the specificity of the manufactured types of
p.(None): medicinal products and pharmaceutical forms;
p.(None): 2. always at least one qualified person, who correspond to the condition of Art. 159 at any time;
p.(None): 3. manufacturing, control, and storage facilities for the medicinal products equipped with the required technical
p.(None): equipment and control laboratories.
p.(None):
p.(None):
p.(None): Art. 149. The managers of manufacture and quality control of medicinal products in the manufacturing enterprises shall
p.(None): be:
p.(None): 1. persons with educational qualification master’s degree in pharmacy, chemistry, or biology and at least two-year
p.(None): practical experience in the pharmaceutical manufacture;
p.(None): 2. for the manufacture of radiopharmaceuticals or medicinal products subjected to ionizing radiation –
p.(None): persons who comply with the requirements according to point 1 and have an additionally recognised specialty in
p.(None): radiobiology or radiochemistry.
p.(None): 3. for the manufacture of immunological medicinal products including vaccines, toxins, sera, biotechnological products,
p.(None): and medicinal products obtained from human plasma or human blood – persons with recognised speciality in medical
p.(None): haematology, medical microbiology, virology, or immunology.
p.(None):
p.(None):
p.(None): Art. 150. (1) The person according to Art. 146 shall submit to the BDA a formal application as approved
p.(None): by the director of the Agency.
p.(None): (2) Together with the application according to para 1 the applicant shall also submit:
p.(None): 1. diploma, document for acquired speciality, document for length of service, certificate of clean court record, and
p.(None): employment contract for the persons according to Art. 148, point 2, and Art. 149;
p.(None): 2. copies of contracts of assignment of the manufacture and/or control of the products ordered for manufacture – in the
p.(None): cases according to Art. 151;
p.(None): 3.(amend. – SG, 60/2011, in force from 5. 8. 2011) data for the Single identification code
p.(None):
p.(None): of the trader or cooperation from the Trade register, and for the companies, registered in a EU Member State or in a
p.(None): state – party on the Agreement for the EEA – a document for updated registration under the national legislation, issued
...
Social / employees
Searching for indicator employees:
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p.(None): 3. 30 days where an application has been submitted for confirmation, change or deletion of a price under Art. 261a,
p.(None): Para. 2;
p.(None): 4. 30 days, where an application has been submitted for registration, change or deletion of a price under Art. 161a,
p.(None): Para. 3;
p.(None):
p.(None): 5. 30 days for confirmation/registration of a price of medicinal products, for which authorisation for
p.(None): parallel import has been received;
p.(None): 6. (new - SG 48/15) ninety days where an application is filed for inclusion in the Positive Medicine List of a
p.(None): medicinal product with a new international non-proprietary name;
p.(None): 7. (new - SG 48/15) sixty days where an application is filed for maintaining the the reimbursement
p.(None): status of a medicinal products included in the Positive Medicine List.
p.(None): (2) For the medicinal products under Art. 262, Para. 5, the Council shall pronounce within the term of up to 30 days
p.(None): where an application has been submitted for confirmation of a price under Art. 261a, Para. 1 and including the product
p.(None): in the Positive medicine list.
p.(None): (3) The terms under Para. 1 and 2 start to run from the date of submitting an application under the ordinance under
p.(None): Art. 261a, Para. 5.
p.(None):
p.(None):
p.(None): Art. 259c. (New – SG, 60/2011, in force from 5. 8. 2011, repealed – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None):
p.(None): Art. 259d. (New – SG, 60/2011, in force from 5. 8. 2011, repealed – SG, 102/2012, in force from 21.12.2012).
p.(None):
p.(None):
p.(None): Art. 260. (Amend. - SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) The state
p.(None): bodies, officials and applicants on this Chapter shall be obliged to give assistance to the Council and the employees
p.(None): in it while fulfilling their assigned obligations.
p.(None):
p.(None):
p.(None): Art. 261. (Amend. - SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) (1) The
p.(None): Council members and its employees shall be obliged not to announce circumstances and facts, known to them during
p.(None): fulfilling their official duties under this act, unless upon a written request by a state body, where this is provided
p.(None): by an act.
p.(None): (2) In relation to their duties under Para. 1 the persons shall sign a declaration according to a form, confirmed by
p.(None): the Council chairperson.
p.(None):
p.(None): Section II.
p.(None): Regulation and registration of prices of medicinal products. Algorithms for treatment with medicinal products (new –
p.(None): SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 261a (New – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) (1) The
p.(None): council shall regulate the prices of medicinal products, included in the Positive Medicines List under Art. 262, Para.
p.(None): 1 and paid by public means in compliance with the lowest reference prices in the Member States.
p.(None): (2) The Council shall regulate the limit prices of the medicinal products, which are sold after doctor’s prescription
p.(None): apart from those under Para. 1 in compliance with the lowest reference prices of the Member States.
p.(None): (3) The Council shall register maximum selling prices for retail trade of the medicinal products, which are sold
p.(None): without doctor’s prescription.
p.(None): (4) The price, defined under Para. 1 shall also be the limit price of the medicinal products at their retail trade.
p.(None):
p.(None): (5) The Council of Ministers upon proposal of the Minister of Health shall determine by an ordinance the conditions and
p.(None): rules for regulation of prices of medicinal products under Para. 1 for regulation of the limit prices of medicines,
p.(None): sold after doctor’s prescription under Para. 2 at their retail trade, as well as the conditions and procedure for
...
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
p.(None): associated with the person’s participation or refusal to participate in the clinical test. Examples of such group in
p.(None): the hierarchical structures shall be students in medicine, pharmacy, dental medicine or nursing, laboratory personnel,
p.(None): employees in the pharmaceutical industry, members of the armed forces or persons deprived of freedom. Other vulnerable
p.(None): groups shall be patients with incurable diseases, persons in hospices, unemployed and beggars, patients
p.(None): in critical conditions, waifs and strays, under-aged and minors and persons who are unable to give consent.
p.(None): 80. "Pharmacopoeia" shall mean a collection of approved specifications and respective requirements in connection with
p.(None): the manufacture, investigation, storage, and marking of active substances, excipients, pharmaceutical forms,
p.(None): packaging materials, and components of the medicinal products.
p.(None): 81. "Pharmacopoeia recipe" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): recipe from an acting pharmacopoeia and intended for provision to the patients in the same pharmacy.
p.(None): 81a. (New - SG 71/2008, in force from 12.08.2008, amend. – SG, 102/2012, in force from 02.01.2013) "False medicinal
p.(None): product" is any medicinal product, in which untrue have been presented:
p.(None): a) its identity, including the data on the initial or secondary packing, its name or contents in relation to any of its
p.(None): compounds, including the auxiliary substances and the quantity of active substance in a dose unit;
p.(None): b) its source, including the manufacturer, state, in which it is manufactured, the state in which it is placed on the
p.(None): market or the marketing authorisation holder, or
...
Social / gender
Searching for indicator gender:
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p.(None): 71. "Spontaneous report" shall mean a voluntarily report for a suspected adverse reaction during the use of
p.(None): a medicinal product forwarded to the marketing authorisation holder, to the bodies for supervision on the medicinal
p.(None): products, or to other organisations, which is not originating from a study or another organised system for data
p.(None): capturing.
p.(None): 72. "Expiry period of a medicinal product" shall mean the interval of time during which, if a medicinal product is
p.(None): stored under the prescribed conditions, it shall comply with the specification developed on the grounds of
p.(None): stability tests of several batches of the finished form.
p.(None): 73. (Amen. - SG 71/2008, in force from 12.08.2008) "Medicinal product equivalent to a herbal medicinal product"
p.(None): shall mean a product containing the same active substances irrespective of the composition of the excipients
p.(None): and which is intended for the same purpose, has equivalent quantity of the medicinal substance, the same dosage and the
p.(None): same or similar method of administration as the product for which an application has been submitted.
p.(None): 74. "Adverse drug reaction reports" shall mean documented information for one or more suspected adverse reactions
p.(None): associated with the use of one or more medicinal products by one patient. Required to recognize the validity of an
p.(None): adverse drug reaction report shall be minimum data for the identification of the reporter (initials or age, or date of
p.(None): birth, or gender) and data about the adverse reaction/event and the suspected medicinal product.
p.(None): 75. "Essential amendment in a clinical test protocol" shall mean any amendment in the protocol and/or in the
p.(None): information of the accompanying documentation, which can affect:
p.(None): a) the safety or physical and mental validity of the participants;
p.(None): b) the scientific value of the study;
p.(None): c) the conduct or the organisation of the study;
p.(None): d) the quality or the safety of any study medicinal product.
p.(None): 75a (new – SG, 102/2012, in forcefrom 21.12.2012) "Substantial changes in the protocol for non-intervention
p.(None): postmarketing study" are changes. Which influence safety, physical or mental inviolability of patients or the
p.(None): study results and their interpretation.
p.(None): 76. (Amen. - SG 71/2008, in force from 12.08.2008) "Third country" shall mean a state outside the Member States of the
p.(None): European Union, or a state – party of the European Economic Area.
p.(None):
p.(None): 77. "Wholesale distribution" shall mean all activities for the acquisition, storage, supply, import, or export of
p.(None): medicinal products except for the cases of provision of medicinal products directly to the population.
p.(None): 78. "Subject" shall mean a person taking part in a clinical test irrespective whether taking the study medicinal
p.(None): product or a medicinal product used for comparison.
p.(None): 79. "Vulnerable patient groups" shall mean persons whose wish to participate in s clinical test can be affected by the
p.(None): anticipation of benefits or affected by eventual penalty on the part of higher officials in the hierarchical structure
...
Social / orphan
Searching for indicator orphan:
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p.(None): plasma
p.(None): COUNCIL DIRECTIVE 87/18/EEC OF 18 DECEMBER 1986 on the harmonisation of laws, regulations and administrative provisions
p.(None): relating to the application of the principles of good laboratory practice and the verification of their
p.(None): applications for trials on chemical substances.
p.(None): COUNCIL DIRECTIVE 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates
p.(None): and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the
p.(None): right of establishment relating to certain activities in the field of pharmacy
p.(None): SECOND COUNCIL DIRECTIVE 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or
p.(None): Administrative Action relating to proprietary medicinal products
p.(None): DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.(None): of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
p.(None): REGULATION (EC) NO 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE
p.(None): COUNCIL of 31 March 2004 laying down Community procedures for the authorisation and supervision of
p.(None): medicinal products for human and veterinary use and establishing a European Medicines Agency.
p.(None): COMMISSION REGULATION (EC) NO 1084/2003 of 3 June 2003 concerning the examination of variations to the terms
p.(None): of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a
p.(None): competent authority of a Member State.
p.(None): REGULATION (EC) NO 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE
p.(None): COUNCIL of 16 December 1999 on orphan medicinal products.
p.(None): COMMISSION REGULATION (EC) NO 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of
p.(None): marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ, L 334/7 of
...
Social / parents
Searching for indicator parent:
(return to top)
p.(None): subject’s parents or guardians with observation of Art. 96, para 1 and 3.
p.(None): (2) Parents’ or guardians’ consent must represent the supposed will of the minor person and can be withdrawn at any
p.(None): time without negative consequences for the minor person.
p.(None): (3) The express will of the minor person to participate or to at any time withdraw from the clinical test must be taken
p.(None): into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (4) A clinical test in a minor person shall be conducted after obtaining written informed consent by both parents and
p.(None): the guardian in compliance of Art. 96, para 1 and 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, the written informed consent shall be given
p.(None): by the parent who is exercising the parental rights.
p.(None): (5) Minor’s, parents’ and guardian’s’ consent can be withdrawn at any time without negative consequences
p.(None): for the minor person.
p.(None): (6) The express will of the minor person to at any time withdraw from the clinical test must be taken into
p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
...
Searching for indicator parents:
(return to top)
p.(None): understands the essence, importance, scope, consequences, and eventual risks of the clinical test. Informed
p.(None): consent to participate in a clinical test can be withdrawn at any time.
p.(None): (4) The informed consent according to para 1, point 3, of an incapable major person shall be given by his/her
p.(None): legal representative. The consent of the legal representative must represent the supposed will of the subject
p.(None): and can be withdrawn at any time without negative consequences for the subject.
p.(None): (5) In the cases according to Art. 162, para 3 of the Health Act, informed consent shall be given by the person
p.(None): appointed by the court.
p.(None): (6) An incapable person shall be given information about the clinical test, eventual risks, and benefits in accordance
p.(None): with his/her capability to understand.
p.(None): (7) The explicit will of an incapable major person to refuse to participate in or to withdraw from the clinical test at
p.(None): any time must be taken into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None):
p.(None): Art. 97. (1) A clinical test in a minor person shall be conducted after obtaining written informed consent by both
p.(None): subject’s parents or guardians with observation of Art. 96, para 1 and 3.
p.(None): (2) Parents’ or guardians’ consent must represent the supposed will of the minor person and can be withdrawn at any
p.(None): time without negative consequences for the minor person.
p.(None): (3) The express will of the minor person to participate or to at any time withdraw from the clinical test must be taken
p.(None): into consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (4) A clinical test in a minor person shall be conducted after obtaining written informed consent by both parents and
p.(None): the guardian in compliance of Art. 96, para 1 and 3. Where one of the parents is unknown, deceased, or deprived of
p.(None): parental rights or such rights have not been delegated in case of divorce, the written informed consent shall be given
p.(None): by the parent who is exercising the parental rights.
p.(None): (5) Minor’s, parents’ and guardian’s’ consent can be withdrawn at any time without negative consequences
p.(None): for the minor person.
p.(None): (6) The express will of the minor person to at any time withdraw from the clinical test must be taken into
p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
p.(None): contain contact details of an independent person for additional information.
p.(None):
p.(None): Section .
p.(None): Clinical Trials in Vulnerable Patient Groups
p.(None):
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): d) each Member state in which the qualified person fulfils his/her duties;
p.(None): e) address, tel. fax, e-amil address of the person under letter "a";
p.(None): f) address, at which the basic document is kept of the system for vigilance medicinal
p.(None): safety;
p.(None): 12a. (new - SG, 102/2012, in force from 21.12.2012) declaration by the applicant that
p.(None): he/she has the needed means for fulfilling the obligations under Chapter Eight;
p.(None): 13. (amend. -SG, 102/2012, in force from 21.12.2012) plan for risk management with a description of the system for risk
p.(None): management, which the applicant will introduce for the relevant medicinal product with the plan summary;
p.(None): 14. summary of product characteristics according to Art. 34;
p.(None): 15. mock-up of the immediate and outer packaging of the product and a proposed package leaflet in
p.(None): compliance with the requirements of chapter six;
p.(None): 16. copy of the manufacturing authorisation issued by the regulatory authority of the
p.(None):
p.(None): country where manufacture is performed accompanied by a Good Manufacturing Practice certificate or a
p.(None): certificate evidencing that the manufacture of the medicinal product and the active substances contained in its
p.(None): composition has been performed in compliance with standards, which are at least equivalent to the standards of
p.(None): the Good Manufacturing Practice;
p.(None): 17. copy of a document evidencing that the medicinal product is designated for treatment, prophylaxis, or diagnostics
p.(None): of rare diseases accompanied by a copy of the opinion of the European Medicines Agency;
p.(None): 18. copies of all marketing authorisations issued in other Member States or in a third state of the medicinal product
p.(None): applied for marketing authorisation;
p.(None): 18a. (new -SG, 102/2012, in force from 21.12.2012) a copy of summary of the safety data, including the data,
p.(None): contained in the periodical updated safety reports and if any – the signals for suspected unacceptable
p.(None): medicinal reactions;
p.(None): 19. list of the Member States where an application for marketing authorisation the medicinal product has
p.(None): been submitted;
p.(None): 20. copy of the summary of product characteristics proposed by the person according to Art. 26, para 1, or a copy of
p.(None): the summary of product characteristics approved by a regulatory authority of a Member State/ states members of
p.(None): the European Economic Area, which has already issued a marketing authorisation;
p.(None): 21. copy of a refusal for a marketing authorisation in a Member State or a third state accompanied by motives;
p.(None): information for temporary suspension or termination of the effect of the marketing authorisation;
p.(None): 22. copy of the proposed package leaflet accompanied by a summary of the results of the assessment of the level of
p.(None): comprehensibility of the contents of the package leaflet by a target patient group selected by the applicant or a copy
p.(None): of a leaflet approved by a regulatory authority in a Member State, which has already issued a marketing authorisation;
p.(None): 23. document of paid fee in amounts up in the tariff according to Art. 21, para 2.
p.(None): (2) (suppl. – SG 18/14) The documents according to para 1, item 18 and 18a, relating to the Member States, and point
...
p.(None): 1. the data according to Art. 27, para 1, points 1 – 9 and point 10, letter "a";
p.(None): 2. summary of product characteristics without the data according to Art. 34, para 1, point
p.(None): 4;
p.(None): 3. in case of a herbal medicinal product according to Art. 37, para 2, or of a combined
p.(None): herbal medicinal product – the information according to Art. 37, para 1, point 5 for the combination;
p.(None): where the individual active substances of the combined product are not sufficiently known, data on the traditional use
p.(None): of each shall be provided;
p.(None):
p.(None): 4. a copy of the marketing authorisation or registration certificate of the herbal medicinal product granted by a
p.(None): Member State or a third country and/or a copy of a refusal accompanied by the motives of the decision;
p.(None): 5. bibliographical or expert evidence to the effect that the medicinal product in question or a corresponding product
p.(None): has been in medicinal use throughout a period of at least 30 years preceding the date of the application including at
p.(None): least 15 years within a Member State or country of the European Economic Area preceding the date the application;
p.(None): 6. bibliographical evidence of the safety the product accompanied by an expert report for the product accompanied by an
p.(None): expert report;
p.(None): 7. a copy of the manufacturing authorisation accompanied by a Good Manufacturing Practice certificate or by a
p.(None): certificate evidencing that the product is manufactured under conditions equivalent to the requirements of the
p.(None): Good Manufacturing Practice.
p.(None): (2) The BDA may request additional information from the applicant for the assessment of the safety of the medicinal
p.(None): product according to para 1.
p.(None): (3) The BDA may request an opinion of the Committee for Herbal Medicinal Products at the European Medicines Agency
p.(None): relating to the adequacy of the data according to para 1, point 5, by submitting the necessary parts of the dossier of
p.(None): medicinal product.
p.(None): (4) The data submitted according to para 1, point 5 shall also be valid in the cases where throughout the period of 30
p.(None): years of use in the medical practice:
p.(None): 1. the medicinal product, which is similar to the product which is applied for registration, has been marketed without
p.(None): authorisation or registration or
p.(None): 2. where the number of the components or the strength of the medicinal product, which is applied for registration, is
p.(None): decreased.
p.(None):
p.(None):
p.(None): Art. 39. (1) Where the product has been used in the Community for less than 15 years, but is otherwise eligible for
p.(None): simplified registration Art. 37, para 1, the BDA shall submit the documentation according to Art. 38, para
p.(None): 1, to the Committee on Herbal Medicinal Products for opinion.
p.(None): (2) The BDA shall make the final decision following the establishment of the monograph of the Committee according to
p.(None): para 1 on the compliance or the product with the criteria for registration for traditional use.
p.(None): (3) In the cases according to para 1 the term according to Art. 44 shall cease to run.
p.(None):
p.(None):
p.(None): Art. 40. The BDA may request from the applicant for herbal medicinal product to submit the documentation according to
p.(None): Art. 27 - 32 or according to Art. 35.
p.(None):
p.(None):
p.(None): Art. 41. (1) The BDA shall publish on its internet site a list of the herbal substances, preparations, or
p.(None): combinations thereof used in the traditional herbal medicinal products established by the Committee on Herbal
p.(None): Medicinal Products of the European Evaluation Agency. The list shall contain therapeutic indications, strength,
p.(None): posology and method of administration as well as other information, which is necessary for the safe use of the herbal
p.(None): substance as a traditional medicinal product.
p.(None): (2) Where the product proposed in the application for registration for traditional use contains herbal
p.(None): substance, preparation, or combination of products included in the list according to para 1, the applicant shall not
p.(None): submit the data according to Art. 38, para 1, points 4 - 6.
p.(None): (3) Where the herbal substance, preparation, or combination thereof are excluded from
p.(None):
p.(None): the list according to para 1, the holder of the registration certificate of a herbal medicinal product must submit to
p.(None): the BDA the full documentation according to Art. 38 within three months from the amendment.
...
p.(None): in the sessions of the respective specialised committee according to Art. 47.
p.(None): (3) The persons according to para 1 shall not vote during making of a decision on issues in which they or members of
p.(None): their families have commercial, financial, or other interests.
p.(None):
p.(None):
p.(None): Art. 49. (1) (amend. – SG, 102/2012, in force from 21.12.2012) Within 200 days from the receipt of a valid
p.(None): documentation, the BDA, jointly with the respective committee according to Art. 47, Para. 1, shall assess the quality,
p.(None): safety, and efficacy of the medicinal product and shall establish an assessment report, with comments of the result of
p.(None): the pharmaceutical an pre-clinic tests, clinic studies of the system for risk management and of the system for safety
p.(None): vigilance of the relevant medicinal product.
p.(None): which shall be submitted to the of the. The assessment report shall be updated upon receipt of new information relating
p.(None): to the quality, safety and efficacy of the product. The drawn up assessment report shall be produced to the BDA
p.(None): executive director.
p.(None): (2)(new – SG, 102/2012, in force from 21.12.2012) The report under Para. 1 shall be updated in case that new
p.(None): information appears, important for the quality assessment, safety and efficiency of the medicinal product.
p.(None): (3) (former Para. (2) – SG, 102/2012, in force from 21.12.2012) Where a medicinal product contains
p.(None): genetically modified organisms, the BDA shall submit to the Ministry of
p.(None):
p.(None): Environment and Waters the necessary documentation of the dossier of the medicinal product and request an opinion with
p.(None): respect to the potential risk to the environment established within 60 days. The sixty-day period shall be within the
p.(None): frames of the period according to Para. 1.
p.(None): (4) (former Para. (3) – SG, 102/2012, in force from 21.12.2012) In the cases of radiopharmaceuticals, the
p.(None): BDA shall submit the necessary documentation of the dossier of the medicinal product to the Nuclear Regulatory
p.(None): Agency request an opinion with respect to the quality and safety of the product established within 60 days. The
p.(None): sixty-day period shall be within the frames of the period according to Para. 1.
p.(None): (5) (former Para. (4) – SG, 102/2012, in fore rom 21.12.2012) Where the Ministry of Environment and the Nuclear
p.(None): Regulatory Agency do not pass a judgment within the terms according to Para. 3 and 4, it shall be presumed
p.(None): that their opinion is positive.
p.(None):
p.(None):
p.(None): Art. 50. (1) Where the BDA establishes incompliance of the dossier with the requirements for
p.(None): granting marketing authorisation or registration certificate according to this Act, it shall notify the applicant
p.(None): in writing to submit additional information associated with the documentation according to Art. 27-32 or
p.(None): according to Art. 35, para 3, or according to Art. 38, and or to present an oral or written explanation of
p.(None): the established incompleteness and discrepancies within 180 days of the notification date.
p.(None): (2) In the cases according to para 1, the term according to Art. 44 shall cease to run as from the notification date
p.(None): until the presentation of the requested information.
p.(None): (3) The executive director of the BDA shall terminate the procedure for granting a marketing authorisation
p.(None): or authorisation for registration of a medicinal product where:
p.(None): 1. the applicant has not submitted the information according to para 1 within the required time limit;
p.(None): 2. the persons according to Art. 26, para 1, request its termination in writing.
p.(None):
p.(None):
p.(None): Art. 51. Within 10 days of the establishment of the assessment report according to Art. 49, para 1, the executive
p.(None): director of the BDA shall issue a marketing authorisation/registration certificate of the medicinal product or make a
p.(None): motivated refusal.
p.(None):
p.(None):
p.(None): Art. 52. (1) (amend. – SG, 102/2012, in force from 21.12.2012) Within 5 days of granting, the marketing
p.(None): authorisation/registration certificate in the register according to Art. 19, Para. 1, point 3, which shall contain the
p.(None): following data for the certificate:
p.(None): 1. registration number;
...
p.(None): withdrawn authorisations for use, as well as the made refusals for renewal of issued authorisations for use of
p.(None): medicinal products within 7 day term from issuance of the relevant act.
p.(None):
p.(None): Section VI.
p.(None): Variations in Granted Marketing Authorisation
p.(None):
p.(None): Art. 60. (1) (amend. – SG 12/11, in force from 08.02.2011) The holder of a marketing authorisation of the medicinal
p.(None): product shall be obliged to notify the BDA about any change in the conditions under which the permit has been granted.
p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011)Variations may be of type IA, of type IB, of type II, extension of the
p.(None): marketing authorisation and urgent restricting measures of safety.
p.(None): (3) (amend. – SG 12/11, in force from 08.02.2011) Terms and criteria of classification of the variation shall be laid
p.(None): down in the regulation envisaged in Art. 42.
p.(None): (4) (amend. – SG 12/11, in force from 08.02.2011) Any variation, which is not an extension and whose
p.(None): classification is undetermined after application of the terms and criteria stipulated in the envisaged in Art. 42
p.(None): regulation, shall be considered a variation of type IB by default.
p.(None): (5) (new – SG 12/11, in force from 08.02.2011) As an exception from Para 4, and whose classification is undetermined
p.(None): after application of the terms and criteria stipulated in the envisaged in Art. 42 regulation, shall be
p.(None): considered, shall be considered a variation of type II in the following cases:
p.(None): 1. upon a request of the holder of the marketing authorisation, entered in the application for variation;
p.(None): 2. where the BDA, after an assessment of the validity of the notification under Art. 63, comes to the opinion that the
p.(None): change could have significant impact on the quality, safety or on the efficacy of the medicinal product.
p.(None):
p.(None):
p.(None): Art. 61. (amend. – SG 12/11, in force from 08.02.2011) (1) Holder of the marketing authorisation of
p.(None): the medicinal product shall submit separate notifications, respectively applications to the BDA for each
p.(None): variation of type IA, type IB or type II or for extension of the range.
p.(None): (2) If a concrete variation leads to a change in the data of the summary characteristic of the product, of the
p.(None): labelling or of the leaflet, these changes shall be assumed as a part of the declared variation and about them separate
p.(None): application shall not be submitted.
p.(None): (3) Holder of the marketing authorisation may arrange the variations in groups, where:
p.(None): 1. notifies simultaneously of one and the same variations of type IA in the conditions of
p.(None):
p.(None): one or several marketing authorisations;
p.(None): 2. declares simultaneously several variations in the conditions of the marketing authorisations, belonging to
p.(None): a global marketing authorisation for the medicinal products as per Art. 28, Para 8, provided that the envisaged
p.(None): variations fall under one of the following cases:
p.(None): a) one of the variations in the group constitutes extension of the marketing authorisation;
p.(None): b) one of the variations in the group constitutes a variation of type II, and all the other variations appear as a
p.(None): consequence of the variation of type II;
p.(None): c) one of the variations in the group constitutes variation of type IB, and all the other variations appear as a
p.(None): consequence of the variation of IB
p.(None): d) all variations in the group relate solely to changes of administrative nature to the summary product
...
p.(None): authorisation shall submit:
p.(None): 1. documentation, related to the variations, as determined by the regulation envisaged in Art. 42;
p.(None): 2. a document, certifying that the fee, in an amount as per Tariff under Art. 21, Para 2,
p.(None): is paid.
p.(None): (6) The Executive Director of the BDA shall approve form of the application, respectively
p.(None): of notification, envisaged in Para 1 and 4, which shall be published on the Internet site of the BDA.
p.(None):
p.(None): Art. 62. (amend. – SG 12/11, in force from 08.02.2011) (1) The holder of marketing authorisation shall submit a
p.(None): notification of variations of type IA within 12 months following the implementation of the variation, except for
p.(None): the cases where variations require immediate notification.
p.(None): (2) Variations of type IA requiring immediate notification shall be specified in the regulation envisaged
p.(None): in Art. 42.
p.(None): (3) In the cases of Para 2, holder of marketing authorisation shall submit notification for the variation of type IA
p.(None): immediately after its implementation.
p.(None): (4) Within 30 days following receipt of the notification per Para 1, respectively per Para 3, the BDA shall notify the
p.(None): marketing authorisation holder:
p.(None): 1. if the variation(s) is/are accepted or not; in the cases where the variation(s) concerned is/are not accepted,
p.(None): reasons for that shall be stated; and
p.(None): 2. if variation(s) concerned lead(s) to amendment of the data in the issued marketing authorisation; where amendment of
p.(None): the issued marketing authorisation is needed, Art. 64a shall be applied.
p.(None): (5) Marketing authorisation holder shall stop implementation of the respective variation(s) of type
p.(None): IA, immediately after a notification of unfavourable opinion under Para 4, item 1 is received.
p.(None):
p.(None):
p.(None): Art. 63. (amend. – SG 12/11, in force from 08.02.2011)(1) In event that the notification for variation of type IB meets
p.(None): the requirements of Art. 61, the BDA shall inform the holder of marketing authorisation that the notification is valid,
p.(None): and shall state the date from which the term as per Para 2 starts running.
p.(None): (2) Within 30 days following the receipt of a valid notification, the BDA shall assess the submitted documentation and
p.(None): shall notify the holder of marketing authorisation:
p.(None): 1. whether it accepts or rejects the variation concerned; in the cases where the notification cannot be
p.(None): accepted, the grounds on which its unfavourable opinion is based shall be stated, and
p.(None): 2. if variation concerned leads to change in the data of the issued marketing authorisation; where
p.(None): amendment of the issued marketing authorisation is needed, Art. 64a shall be applied.
p.(None): (3) Where, within the term laid down in Para 2, the BDA finds that the submitted documentation does not
p.(None): fulfil the requirements of the Law and of the regulation envisaged in Art. 42, it shall notify of this the holder of
p.(None): the marketing authorisation.
p.(None): (4) Within 30 days, following the receipt of the notification per Para 3, the holder of the marketing authorisation may
p.(None): amend or supplement the notification.
p.(None): (5) Where, within the term per Para 4, the holder of the marketing authorisation does not submit amended or
p.(None): supplemented documentation, the BDA shall terminate the procedure and notify of this the holder of the marketing
p.(None): authorisation.
p.(None): (6) Within 30 days from the receipt of the amended documentation envisaged in Para 4, the BDA shall notify the holder
p.(None): of the marketing authorisation:
p.(None): 1. whether it accepts or rejects the variation concerned; in the cases where the notification cannot be
p.(None): accepted, the grounds on which its unfavourable opinion is based shall be stated, and
p.(None): 2. if variation concerned leads to change in the data of the issued marketing authorisation; where
p.(None): amendment of the issued marketing authorisation is needed, Art. 64a shall be applied.
p.(None):
p.(None): (7) The holder of the marketing authorisation shall apply the approved variation of type IB only after a notification
p.(None): of approval as per Para 2, item 1, respectively notification as per Para 6, item 1 is received.
p.(None):
p.(None):
p.(None): Art. 64. (amend. – SG 12/11, in force from 08.02.2011)(1) Where the application for variation of type II fulfils
p.(None): the requirements of Art. 61, the BDA shall notify the holder of the marketing authorisation about receipt
p.(None): of a valid application and by stating the date from which the period envisaged in Para 2 starts.
p.(None): (2) Within 60 days from the receipt of a valid application, BDA shall prepare an assessment report.
p.(None): (3) The period referred to in Para 2 may be:
p.(None): 1. reduced, having regard to the urgency of the matter of safe use of the medicinal product, or
p.(None): 2. extended to 90 days for variations concerning a change to or addition of therapeutic indications.
p.(None): (4) In event that the BDA finds that the submitted documentation does not fulfil the requirements of the
p.(None): Law and of the regulation envisaged in Art. 42, it shall notify the holder of the marketing authorisation of this
p.(None): and shall set a time limit within which supplementary information and documentation shall be provided.
p.(None): (5) In the cases under Para 4, the time period envisaged in Para 2 shall be suspended until the requested supplementary
p.(None): information and documentation has been provided.
...
p.(None): Art. 103, para 1 and 2, the BDA, or by contracting authorities.
p.(None): (5) The Central Ethics Committee shall carry out the methodical guidance with respect to the ethics committees
p.(None): according to Art. 103, para 1 and 2.
p.(None): (6) The sessions of the Central Ethics Committee shall be held in camera. In case of necessity, the chairman of the
p.(None): Central Ethics Committee can invite the contracting authority or the principal researcher to participate.
p.(None): (7) The Council of Ministers, according to a proposal of the Minister of Health, shall determine the conditions and
p.(None): order for the work of the Central Ethics Committee by a regulation.
p.(None):
p.(None):
p.(None): Art. 108. (1) A member of the Central Ethics Committee cannot be appointed in the same committee for more than two
p.(None): consecutive mandates. The duration of a mandate shall be 4 years.
p.(None): (2) Half of the composition of the Central Ethics Committee shall be renewed every 2
p.(None): years.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): met:
p.(None): Section V.
p.(None): Authorisation to Conduct a Clinical Test
p.(None):
p.(None): Art. 109. A clinical test can be started provided that the following conditions have been
p.(None):
p.(None): 1. the respective ethics committee has given a positive opinion and
p.(None): 2. the executive director of BDA has issued a written authorisation for the conduct
p.(None): thereof where one of the study medicinal products is either:
p.(None): a) a medicinal product for gene therapy;
p.(None): b) a medicinal product for somato-cellular therapy;
p.(None): c) a medicinal product, which contains genetically modified organisms;
p.(None): d) a high technology medicinal product described in the Annex to Regulation (EC) 726/2004 of the European
p.(None): Parliament and the Council;
p.(None): e) a medicinal product, which contains biological substance(s) of human or animal origin or contains biological
p.(None): components of human or animal origin or the manufacturing process of which involves such components, or
p.(None): 3. the contracting authority has not been notified by the BDA in writing that the clinical test cannot be conducted
p.(None): within the time limit as set out by the law; for medicinal products outside those according to 2.
p.(None):
p.(None):
p.(None): Art. 110. (1) For obtaining opinion, the principal researcher or the coordinating researcher shall submit to
p.(None): the respective ethics committee according to Art. 103 the following documentation:
p.(None): 1. administrative documentation;
p.(None): 2. subject information;
p.(None): 3. documentation about the study protocol;
p.(None): 4. documentation about the study medicinal product(s);
p.(None): 5. documentation about the technical requirements and about the staff;
p.(None): 6. data about the financing and administrative organisation of the clinical test.
p.(None): (2) The content, form, and requirements to the documentation according to para 1 shall be determined in the regulation
p.(None): according to Art. 82, para 3.
p.(None):
p.(None): Art. 111. (1) The ethics committee shall establish an opinion taking into consideration the following:
p.(None): 1. importance of the clinical test;
p.(None): 2. positive assessment of the ratio between the anticipated benefits and risks according to Art. 90, para 1, and the
p.(None): motivation of the conclusions;
p.(None): 3. protocol of the clinical test;
p.(None): 4. to what extent the principal researcher and the study team are adequate for the conduct of the
p.(None): clinical test;
p.(None): 5. researcher’s brochure;
p.(None): 6. availability of the required equipment and its adequate quality;
p.(None): 7. compliance and completeness of the written information, which is to be given, as well as the procedure for obtaining
p.(None): informed consent and the validity of the clinical test in human subjects incapable of giving informed consent in the
p.(None): cases according to Art. 100 and 101;
p.(None): 8. provided indemnity or recovery in case of injury or death, which could result from the clinical test;
p.(None): 9. insurance covering researcher or contracting authority liability;
p.(None): 10. where necessary, the conditions and order for remuneration or indemnification of study researchers and subjects
p.(None): and the elements of the contract between the contracting authority and the healthcare establishment;
p.(None): 11. conditions and order for subject recruitment.
p.(None): (2) The ethics committee shall:
p.(None): 1. give positive opinion;
p.(None): 2.. refuse in a motivated manner, or
p.(None): 3. request amendment of a part of the documentation as a condition for obtaining a positive opinion.
p.(None):
p.(None):
p.(None): Art. 112. (1) Within 60 days from the submission of an application, the ethics committee shall pass resolution with an
p.(None): opinion, which shall be sent to the applicant and the BDA.
p.(None): (2) Where the clinical test involves a medicinal product for gene therapy or somato- cellular therapy or a medicinal
p.(None): product containing genetically modified organisms, the time limit according to para 1 shall be extended by 30 days.
p.(None): (3) Where for the review of a clinical test involving a medicinal product for gene therapy or somato-0-cellular therapy
p.(None): or a medicinal product containing genetically modified organisms it shall be imperative to consult a specially
p.(None): established for the purpose expert committee by an order to the director of the BDA, the time limit for drawing an
p.(None): opinion shall be 180 days.
p.(None):
p.(None):
p.(None): Art. 113. (1) During assessment of the documentation, the ethics committee can once request additional written
p.(None): documentation from the applicant. The time limits according to Art. 112 shall cease to run until submission of the
p.(None): requested documentation.
p.(None): (2) The review procedure of the study shall be terminated if the applicant should not submit the additional
p.(None): documentation required by the committee within 30 days of the receipt of the request for additional information.
p.(None):
p.(None):
p.(None): Art. 114. (1) Where the clinical test is to be conducted in more than one centre on the territory of the Republic of
p.(None): Bulgaria, the application shall be submitted to the ethics committee
p.(None):
p.(None): for multicentre tests according to Art. 103, para 1.
p.(None): (2) Where the clinical test is to be conducted in only one centre on the territory of the Republic of Bulgaria, the
p.(None): application can be submitted to the ethics committee according to Art. 103, para 1 or 2 at applicant’s discretion.
p.(None): (3) The opinion of the ethics committee according to Art. 103, para 1, shall be valid for all centres on the territory
p.(None): of the Republic of Bulgaria.
p.(None): (4) (new – SG 12/11, in force from 08.02.2011) For submission of applications to obtain opinion by the Ethics
p.(None): Committee, the Ministry of Health shall collect a fee in amount as determined by the Tariff envisaged in
p.(None): Art. 21. Para 2.
p.(None):
p.(None):
p.(None): Art. 115. (1) Where the opinion of the respective ethics committee according to Art. 103 is negative, the applicant can
p.(None): appeal before the Central Ethics Committee within 90 days of the date of notification.
p.(None): (2) Where the negative opinion of the respective ethics committee according to Art. 103 is established without taking
p.(None): into consideration the opinion of the expert commission according to Art. 112, para 3, the contracting authority can,
p.(None): within 14 days of the date of notification, request in writing that the committee revise its opinion.
p.(None): (3) The expert committee according to Art. 112, para 3, shall, within 60 days of the date of receipt of a written
p.(None): application of the applicant, pass a resolution on the negative opinion of the respective committee and can either
p.(None): challenge or support it, wherefore it shall notify the ethics committee in writing. The ethics committee shall take
p.(None): final decision and send it to the applicant.
p.(None): (4) Where the expert commission according to Art. 112, para 3, supports the negative opinion, the contracting authority
p.(None): can, within 14 days of the date of notification, appeal against the decision before the Central Ethics Committee.
p.(None): (5) The opinion of the Central Ethics Committee shall be final and binding on the respective ethics
p.(None): committee.
p.(None):
p.(None):
p.(None): Art. 116. (1) The applicant shall submit to the BDA an application after the pattern for the conduct of the clinical
p.(None): test.
p.(None): (2) Where the applicant for the clinical test is not the contracting authority, the application shall be accompanied by
p.(None): documentation certifying that the person has been empowered by the contracting authority.
p.(None): (3) Where the contracting authority has not been registered as a natural person or legal entity on the territory of
p.(None): Bulgaria, the application shall be accompanied by a document evidencing the data of his empowered
p.(None): representative on the territory of the Republic of Bulgaria.
p.(None): (4) The following documents shall be appended to the application:
p.(None): 1. administrative documentation;
p.(None): 2. subject information;
p.(None): 3. documentation about the study protocol;
p.(None): 4. documentation about the study medicinal product(s);
p.(None): 5. documentation about the technical requirements and about the staff;
p.(None): 6. data about the financing and administrative organisation of the clinical test.
p.(None): (5) The content, form, and requirements to the documentation according to para 1 shall be determined in the regulation
p.(None): according to Art. 82, para 3.
p.(None):
p.(None): Art. 117. (1) During assessment of the documentation, the BDA can once request additional written
p.(None): documentation from the applicant.
...
p.(None): subject.
p.(None):
p.(None):
p.(None): Art. 122. (1) In case of a multicentre clinical test in the Republic of Bulgaria and in a third
p.(None):
p.(None): state, the BDA shall request the contracting authority to submit a declaration that he shall provide access to
p.(None): representatives of the BDA for inspection aimed at the establishment of compliance with the requirements and principles
p.(None): of Good Clinical Practice and Good Manufacturing Practice.
p.(None): (2) Provided that the contracting authority should not submit the declaration according to para 1, the BDA shall not
p.(None): review the submitted application.
p.(None):
p.(None):
p.(None): Art. 123. The contracting authority shall declare that the documentation submitted to the BDA and the ethics committee
p.(None): contains the same information.
p.(None):
p.(None):
p.(None): Art. 124. (1) The procedures in the ethics committee and in the BDA can be carried out simultaneously or consecutively
p.(None): at the discretion of the contracting authority.
p.(None): (2) The time limit for documentation review according to Art. 118, para 1, shall not cease to run in case of lack of
p.(None): decision of the ethics committee.
p.(None):
p.(None):
p.(None): Art. 125. The clinical test shall be conducted in compliance with the study protocol, which has received positive
p.(None): opinion of the respective ethics committee according to Art. 103 and under the conditions set out in the submitted
p.(None): documentation.
p.(None):
p.(None): Section V. Amendments
p.(None):
p.(None): Art. 126. (1) The contracting authority can at any time make amendments in the study protocol different from the
p.(None): essential amendments according to Art. 127, para 2.
p.(None): (2) In the cases according to para 1 the contracting authority shall keep the documentation relating to
p.(None): the amendments and shall provide it to the BDA and the ethics committee upon request.
p.(None):
p.(None):
p.(None): Art. 127. (1) Amendment in the conduct of a clinical test can be required by the BDA wherever necessary to guarantee
p.(None): the safety of the subjects, the scientific value of the clinical test, and/or the observation of the rules for Good
p.(None): Clinical Practice.
p.(None): (2) Essential amendment in the conduct of the clinical test shall be any amendment in the study protocol and/or in the
p.(None): information and the documentation according to Art. 110 and 116, which can affect:
p.(None): 1. the safety or the physical and mental immunity of the study subjects;
p.(None): 2. the scientific value of the clinical test;
p.(None): 3. the conduct or the organisation of the clinical test;
p.(None): 4. the quality or the safety of any study medicinal products.
p.(None):
p.(None):
p.(None): Art. 128. (1) The contracting authority can also implement planned study essential protocol and
p.(None): documentation amendments according to Art. 110 and 116 wherever:
p.(None): 1. the ethics committee has given a written positive opinion;
p.(None): 2. the executive director of the BDA has issued a written authorisation as to clinical trials with medicinal products
p.(None): according to Art. 109, point 2, or
p.(None):
p.(None): 3. the contracting authority has not been notified by the BDA about refusal of the proposed amendment in
p.(None): the clinical test with medicinal products according to Art. 109, point 3.
p.(None): (2) The provision of para 1 shall not apply to changes in an approved protocol, which are imperative to protect the
p.(None): subjects from immediate threat in case of occurrence or new information associated with the conduct of
p.(None): the clinical test or the development of the study medicinal product.
p.(None): (3) In the cases according to para 2, the contracting authority shall immediately notify the ethics committee
p.(None): according to para 1, point 1, and the BDA about the available new information, the measures taken, and the
p.(None): applied changes in the protocol.
p.(None):
p.(None):
p.(None): Art. 129. (1) While planning essential amendments to the clinical test and the documentation according to
p.(None): Art. 110 and 116, the applicant shall submit a formal written application to the BDA and the respective
p.(None): ethics committee.
p.(None): (2) The application shall be accompanied by documentation, which is necessary for grounding the amendments
p.(None): and certifies that after the implementation of the amendment the assessment of the benefit/risk ratio according to Art.
p.(None): 90, para 1, shall remain unchanged.
p.(None): (3) The requirements relating to the application and the documentation for the amendment shall be determined
p.(None): in the regulation according to Art. 82, para 3.
p.(None):
p.(None):
p.(None): Art. 130. (1) Within 35 days of receipt of an application for amendment, the ethics committee shall
p.(None): notify the contracting authority of its decision by issuing:
p.(None): 1. positive opinion on the requested amendment or
p.(None): 2. motivated refusal of the amendments in the clinical test.
p.(None): (2) Within 35 days of the date of receipt of an application with positive opinion of the ethics committee, the BDA
p.(None): shall:
p.(None): 1 approve the amendments in a clinical test of medicinal products according to Art. 109, point 2, or
p.(None): 2. disapprove the amendments with explicit motivation.
p.(None): (3) Provided that within 35 days of the submission of the documentation for amendments in clinical trials of medicinal
p.(None): products according to Art. 109, point 3, the applicant does not receive notification for disapproval of the amendment,
p.(None): the proposed amendments can be implemented.
p.(None):
p.(None):
p.(None): Art. 131. (1) In the cases according to Art. 130, para 2, point 2, the contracting authority can submit alteration of
p.(None): the proposed amendments consistent with the motives not later than 14 days prior to the implementation of the
p.(None): amendments.
p.(None): (2) Within 14 days of the date of receipt of the amended documentation according to para 1, the BDA shall issue and
p.(None): amendment of its authorisation for the clinical test of medicinal products according to Art. 109, point 2, or shall
p.(None): issue a refusal, which shall not be subject to appeal.
p.(None): (3) The refusal according to para 2 shall not be subject to appeal.
p.(None):
p.(None): Section V. Cessation of the Clinical Test
p.(None):
p.(None): Art. 132. (1) The contracting authority or the researcher can undertake urgent measures
p.(None):
p.(None): to protect the study subjects from suddenly occurred risks for their safety and health.
p.(None): (2) In the cases according to para 1 the contracting authority shall immediately notify the BDA and the respective
p.(None): ethics committee about the undertaken actions and the reasons, which have raised these.
p.(None):
p.(None):
p.(None): Art. 133. (1) Where the clinical test is to be conducted under conditions different from those determined at the issue
p.(None): of the authorisation or there is information vitiating the scientific validity of the clinical test or the safety of
p.(None): the study subjects, the BDA can temporarily stop the conduct of the test or put a ban on it.
p.(None): (2) The ban can be imposed for a specific centre or for all centres in a multicentre clinical test on the territory of
p.(None): the Republic of Bulgaria.
p.(None): (3) In case of termination of the clinical test in all centres on the territory of the Republic of Bulgaria, the BDA
p.(None): shall, prior to undertaking actions according to para 1, notify the contracting authority and the principal researcher
p.(None): or the coordinating researcher in writing.
p.(None): (4) Within 7 days of the receipt of the notification the contracting authority and/or the principal researcher can
p.(None): express an opinion on the undertaken measures by the BDA.
p.(None): (5) The provision of para 3 shall not apply provided that there is an immediate threat for the health and safety of the
p.(None): study subjects.
p.(None):
p.(None):
p.(None): Art. 134. In the cases according to Art. 133, para 1, the BDA shall immediately notify the respective ethics
p.(None): committee, the regulatory bodies of the Member States, the European Medicines Agency, and the European
p.(None): Commission about the undertaken measures and the reasons therefore.
p.(None):
p.(None): Section V. Pharmaco-vigilance
p.(None):
p.(None): Art. 135. (1) The principal researcher shall immediately report in writing or by word of mouth any serious adverse
p.(None): event that has occurred in the course of the clinical test in a study subject at the centre he is responsible for.
p.(None): (2) A detailed written report shall be submitted after the report according to para 1.
p.(None): (3) At the notification according to para 1 and in the report according to para 2 the study subject shall be identified
p.(None): by a unique code number as defined in the study protocol.
p.(None): (4) The provisions of para 1 and 2 shall not apply provided that the protocol of the clinical test or the researcher’s
p.(None): brochure explicitly states that there is no requirement for an urgent report of a specific serious adverse event.
p.(None): (5) The researcher shall report to the contracting authority any adverse events or laboratory aberrations,
p.(None): which are defined in the study protocol as critical with respect to safety, within the timelines and format as required
p.(None): by the protocol.
p.(None):
p.(None):
...
p.(None): (2) The marketing authorisation holder shall announce to BDA about each new information, which could
p.(None): influence the correlation benefit-risk for the medicinal product.
p.(None): (3) The obligation under Para. 2 shall not liberate the marketing authorisation holder from the requirements of Art.
p.(None): 194h for providing the information under Para. 2 and through the periodic updated safety reports.
p.(None):
p.(None):
p.(None): Art. 145c. (new – SG, 102/2012, in force from 21.12.2012) (1) Where the study is conducted only on the
p.(None): territory of the Republic of Bulgaria in implementation of the obligation under Art. 56a, the holder of the marketing
p.(None): authorisation shall produce a draft protocol of the study to BDA. The draft protocol, with a written consent
p.(None): under Art. 145a, Para. 2 shall be produced also to the commissions under Art. 103, Para. 1 or 2, where
p.(None): applicable.
p.(None): (2) The BDA executive director, within the term of up to 60 days from the date of receiving the
p.(None): documentation under Para. 1, the marketing authorisation holder shall submit a notification of the study or shall give
p.(None): a grounded refusal.
p.(None): (3) The BDA executive director shall refuse conducting of the study with one or more of the grounds under Art. 145f,
p.(None): Para. 2, p. 2.
p.(None): (4) The commission under Art. 103, Para. 1 or the commissions under Art. 103, Para. 2 within the term of up to 60 days
p.(None): from the date of receiving the documentation under Para. 1 shall submit to the marketing authorisation holder a
p.(None): positive or negative opinion.
p.(None): (5) Conducting of the study may start after receiving approval by BDA and a positive opinion by the commission under
p.(None): Art. 103, Para. 1 or by the commissions under Art. 103, Para. 2.
p.(None): (6) For assessment of the documentation under Para. 1, BDA shall collect a fee in the amount, determined by the tariff
p.(None): under Art. 21,Para. 2.
p.(None):
p.(None):
p.(None): Art. 145d. (new – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder shall
p.(None): apply planned substantial changes in the protocol in the cases under Art. 145c, Para. 1 after their prior approval by
p.(None): BDA and by the commission under art. 103, Para. 1, or the commissions under Art. 103, Para. 2.
p.(None): (2) The marketing authorisation holder shall produce to BDA and to the commission under Art. 103, Para. 1 or the
p.(None): commissions under Art. 103, Para. 2 the documentation, related to the changes and thee motives for that.
p.(None): (3) The BDA executive director within the term of 30 days after receiving the documentation under Para. 2
p.(None): shall approve the changed protocol or shall issue a motivated refusal and shall notify the marketing authorisation
p.(None): holder.
p.(None): (4) The commission under Art. 103, Para. 1 or the commissions under Art. 103, Para. 2
p.(None):
p.(None): within the term of 30 days from the date of receiving the documentation under Para. 2 shall submit to the marketing
p.(None): authorisation holder a positive or negative opinion.
p.(None): (5) The BDA executive director shall refuse the changes under Para. 1 with one or more of the grounds, indicated in
p.(None): Art. 145f, Para. 2, p. 2.
p.(None): (6) The marketing authorisation holder may apply the changes under Para. 1 after receiving an approval by
p.(None): BDA and a positive opinion by the commission under Art. 103, Para. 1 or by the commissions under Art. 103, Para. 2.
p.(None): (7) BDA shall collect fee in the amount, defined by the tariff under Art. 21, Para. 2 for assessment of the
p.(None): documentation under Para. 1.
p.(None):
p.(None):
p.(None): Art. 145e. (New – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder shall
p.(None): produce to BDA a final report of the study within the term of up to 12 months after finalisation of the data
p.(None): collecting. The report shall have attached a study result summary.
p.(None): (2) The marketing authorisation holder may submit a grounded request to BDA for postponing the term under
p.(None): Para. 1 at least 3 months before the date for producing the final report, indicated in the protocol.
p.(None): (3) The BDA shall approve or refuse grounded the request under Para. 2 and shall notify the marketing authorisation
p.(None): holder.
p.(None): (4) Where the marketing authorisation holder, based on the report of Para. 1, considers that a change in the
p.(None): marketing authorisation is needed, he/she shall submit to BDA an application for a change under Chapter Three,
p.(None): Section VI.
p.(None): (5) The BDA executive director by an order shall interrupt the action or shall terminate the marketing authorisation,
p.(None): where BDA on the basis of the report under Para. 1 after consultation with the marketing authorisation
p.(None): holder considers that interruption or termination of marketing authorisation is needed.
p.(None):
p.(None):
p.(None): Art. 145f. (new – SG, 102/2012, in force from 21.12.2012) (1) Where the study is conducted on the
p.(None): territory of the Republic of Bulgaria, also on the territory of other EU Member States, for medicinal products,
p.(None): permitted under Regulation (EC) N 726.2004 of the European Parliament and of the Council or under Chapter Three,
p.(None): Section VII in implementation of the obligations under Art. 55a or Art. 56a, the marketing authorisation holder shall
p.(None): submit the draft protocol to the committee under Art. 56a, Para. 1, p. 1.
p.(None): (2) Within the term of up to 60 days from the date of receiving the documentation under Para. 1, the committee under
p.(None): Art. 56a, Para. 1, p. 1. Shall draw up an opinion and shall submit to the marketing authorisation holder:
p.(None): 1. a approval notification, or
p.(None): 2. grounded refusal, where:
p.(None): a) it finds, that the study conducting encourages the use of the medicinal product, and/or
p.(None): b) considers, that the design of the study will not achieve the objectives, laid down in the protocol, and/or
p.(None): c) the study has nature of a clinic study.
p.(None): (3) In the cases under Para. 2, p. 1 the marketing authorisation holder shall produce the notification to BDA and to
p.(None): the commissions under Art. 103, Para. 1 or 2, where applicable.
p.(None): (4) The commission under Art. 103, Para. 1 or the commissions under Art. 103, Para. 2, within the term of up to 15 days
p.(None): from the date of receiving the notification under Pra. 3 shall submit to the marketing authorisation holder a positive
p.(None): or negative opinion.
p.(None):
p.(None): (5) The study conducting may start after receiving a positive opinion by the commission under Art. 103, Para. 1 or a
p.(None): commission under art. 103, Para. 2.
p.(None): (6) The contents and the form of the protocol under Para. 1 shall be determined by Commission Implementing Regulation
p.(None): (EU) No 520/2012 of 19 June 2012 on the performance of pharmaco-vigilance activities provided for in Regulation (EC) No
p.(None): 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the
p.(None): Council (OJ, L 159/5 of 20 June 2012), called hereinafter "Implementing Regulation (EU) N 520/2012".
p.(None):
p.(None):
p.(None): Art. 145g. (new – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder in the
p.(None): cases under art. 154f, Para. 1 shall apply planned substantial changes in the study protocol after their prior approval
p.(None): by the committee under Art. 56a, Para. 1, p. 1.
p.(None): (2) The marketing authorisation holder shall produce to the committee under Art. 56a, Para. 1, p. 1 the documentation,
p.(None): related to the changes and grounds for that.
p.(None): (3) Where the committee under Art. 56a, Para. 1 approves the protocol changes, the marketing authorisation holder shall
p.(None): notify the BDA and the commission under Art. 103, Para. 1 or the commissions under Art. 103. Para. 2.
p.(None): (4) The marketing authorisation holder may apply the changes under Para. 1 after receiving a positive
p.(None): opinion by the commission under Art. 103, Para. 1 or the commissions under Art. 103, Para. 2.
p.(None):
p.(None):
p.(None): Art. 145h. (new – SG, 102/2012, in force from 21.12.2012) The marketing authorisation holder shall submit in electronic
p.(None): way to the committee under Art. 56a, Para. 1, p. 1 a final report, with a study result summary within the term of up to
p.(None): 12 months after finalisation of data collecting.
p.(None): (2) The marketing authorisation holder may submit a grounded request to the committee under Art. 56.a, Para. 1, p. 1
p.(None): for postponing the term under Para. 1 at least 3 months before the date for producing the final report, indicated in
p.(None): the protocol.
p.(None): (3) The committee under Art. 56a, Para. 1, p. 1 shall approve or refuse groundedly the request under Para. 2 and shall
p.(None): notify the marketing authorisation holder.
p.(None): (4) The contents and form of the report under Para. 1 shall be determined by Implementing Regulation (EU)
p.(None): N 520/2012.
p.(None):
p.(None):
p.(None): Art. 145i. (new – SG, 102/2012, in force from 21.12.2012) (1) The committee under Art. 56a, Para. 1, p. 1 based on the
p.(None): report under Art. 145h, Para. 1 and after consultation with the marketing authorisation holder shall issue a grounded
p.(None): recommendation about the marketing authorisation of the medicinal product and shall submit it to:
p.(None): 1. The committee of the medicinal product for human use under Art. 5 of Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council or
p.(None): 2. The coordination group under art. 77, Para. 2.
p.(None): (2) In the cases under Para. 1. P. 2 where the committee under Art. 56a, Para. 1, p. 1 has recommended a change,
p.(None): interruption or termination of the marketing authorisation, the coordination group, represented by the Member
p.(None): States, in which the study has been conducted, shall issue an opinion about the needed actions, to be undertaken in
p.(None): relation to the marketing authorisation, including a schedule for its implementation.
p.(None): (3) Where the represented member States in the coordination group reach consensus about the opinion under Para. 2,
p.(None): it shall be published on the European internet portal for
p.(None):
p.(None): medicinal products under Art. 68, Para. 1, p. 4 and shall be submitted to the marketing authorisation
p.(None): holder.
p.(None): (4) The BDA executive director in compliance with the opinion under Para. 2 shall interrupt or terminate
p.(None): the action of the marketing authorisation.
p.(None): (5) Where in the opinion under Para. 2 changes have been recommended in the issued marketing authorisation, the
p.(None): marketing authorisation holder within the frames of the determined implementation schedule shall submit to BDA an
p.(None): application for change under Chapter Three, Section VI, including an updated short characteristic of the product and a
p.(None): leaflet.
p.(None): (6) Where it is impossible an agreement to be reached within the frames of the coordination group, the
p.(None): position of the majority Member States shall be produced to the European Commission, which shall adopt a
p.(None): decision for change, interruption or termination of the marketing authorisation, issued by the relevant regulatory
p.(None): bodies of the Member States.
p.(None): (7) The decision under Para. 6 shall be published on the European internet portal for medicinal products under Art.
p.(None): 68, Para. 1, p. 4 and shall be submitted to the marketing authorisation holder.
p.(None): (8) The BDA shall apply the temporary and/or final measures of the decision under Para. 6 and shall inform the European
p.(None): Medicines Agency and the European Commission.
p.(None): (9) In the cases under Para. 1, the Committee on medicinal products for human use in compliance with the
p.(None): recommendations of the committee under art. 56a, Para. 1, p. 1 shall issue an opinion about storage, change,
p.(None): termination or interruption of the validity of the marketing authorisation, including a schedule for
p.(None): implementation of the opinion. The opinion shall be published on the European internet portal for medicinal
p.(None): products under Art. 68, Para. 1, p. 4 and shall be submitted to the marketing authorisation holder.
p.(None): (10) Where in the opinion under Para. 9 a position is expressed for undertaking regulatory actions in
p.(None): relation to the marketing authorisations, the European Commission shall undertake a decision for a change, termination
p.(None): or interruption of the marketing authorisation, issued under Regulation (EC) N 726/2004 of the European Parliament and
p.(None): of the Council.
p.(None):
p.(None):
p.(None): Art. 145j. (new – SG, 102/2012, in force from 21.12.2012) (1) Non-interventional studies on the territory of the
p.(None): Republic of Bulgaria shall be conducted under Art. 145c – 145e.
p.(None): (2) During conducting non-interventional studies under Para. 1 the financing source shall ne indicated
p.(None):
p.(None): Chapter five.
p.(None): MANUFACTURING AND IMPORT OF MEDICINAL PRODUCTS AND ACTIVE SUBSTANCES (TITLE. AMEND. – SG, 102/2012, IN FORCE FROM
p.(None): 02.01.2013)
p.(None):
p.(None): Section .
p.(None): Manufacture
p.(None):
p.(None): Art. 146. (1) (amend. – SG, 102/2012, in force from 02.01.2013)Within the meaning of this Act manufacture of all
p.(None): types of medicinal products and medicinal products intended for clinical trials can only be performed on the
p.(None): territory of the Republic of Bulgaria by natural or legal persons registered as traders on the territory of a
p.(None): Member State which have received manufacturing authorisation issued by the director of the BDA.
p.(None): (2) Manufacturing authorisation shall also be required in the cases where the products according to para 1 are intended
p.(None): for export only.
p.(None):
p.(None): (3) Manufacturing authorisation shall also be required for persons who perform simultaneously of separately
p.(None): one of the following activities: packaging, retail packaging, repackaging, labelling of medicinal products, and
p.(None): medicinal products intended for clinical trials.
...
p.(None): medicinal products, placed on the market of the Republic of Bulgaria:
p.(None): 1. monitoring of the result of the measures for decreasing the risk for a medical products, contained in the risk
p.(None): management plan;
p.(None): 2. monitoring of the result of implementation of conditions, indicated in Art. 55a, 56, or
p.(None):
p.(None): 56a;
p.(None):
p.(None): 3. assessment of the updating of the risk management system;
p.(None): 4. monitoring of the data base of Eudra Vigilance", created in compliance with Art. 24 of
p.(None): Regulation (EC) N 726/2004 of the European Parliament and of the Council for new risks or for change of already
p.(None): established and for change of the correlation benefit/risk.
p.(None):
p.(None):
p.(None): Art. 187. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall inform the European Medicines Agency
p.(None): and the marketing authorisation holder at identification of signals for new risks or change of found risks or in
p.(None): case of change of the correlation benefit/risk of a medicinal products.
p.(None): (2) The committee under Art. 56a, Para. 1, p. 1 shall analyze and prioritize the valid signals for new risks or for
p.(None): change of already found and for change of the correlation benefit/risk.
p.(None): (3) Where the Committee under Art. 56a, Para. 1, p. 1 recommends follow up actions, the coordination group under Art.
p.(None): 77, Para. 2 or the Committee on Medicinal Products for Human Use shall draw up an opinion for regulatory actions
p.(None): related to the authorisation for use within the
p.(None):
p.(None): frames of a schedule, drawn up in compliance with the seriousness and level of danger.
p.(None): (4) The BDA shall apply the recommended in the opinion of the coordination group under Art. 77, Para. 2 or in the
p.(None): decision of the European Commission temporary and/or final measures.
p.(None):
p.(None):
p.(None): Art. 188. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA shall inform the European Medicines Agency, the
p.(None): regulatory bodies of the other EU Member States and the European Commission at least 24 hours before the public
p.(None): announcement of the information about suspects, related to vigilance of safety of the medicinal product, unless in the
p.(None): cases, where protection of public health required immediate announcement of the information.
p.(None): (2) The BDA shall publish information, related to active substances, contained in medicinal products,
p.(None): permitted for use and in other Member States by using harmonised draft announcement and schedule of the publication,
p.(None): proposed by the European Medicines Agency.
p.(None): (3) In the cases under Para. 1 and 2 the information, containing personal data or trade secret, shall be deleted,
p.(None): unless the publication of this data is needed for protection of public health.
p.(None):
p.(None):
p.(None): Art. 189. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA may delegate some of the rights and duties
p.(None): under this Chapter to a regulatory body of another Member State by signing an agreement.
p.(None): (2) In the cases under Para. 1, BDA shall inform the European Commission, the European Medicines Agency
p.(None): and the regulatory bodies of the other Member States for the delegation of the authorisations and shall
p.(None): publish and announcement on the internet portal under Art. 185, Para. 1 or on its internet site.
p.(None):
p.(None):
...
p.(None): authorisation holder or the regulatory bodies of the Member States may produce their comments to the European medicines
p.(None): Agency and to BDA.
p.(None): (3) Within the term of up to 15 days from the date of receiving the comments under Para. 2, BDA shall update the
p.(None): assessment report y taking into consideration all produced objections and shall submit it to the committee under
p.(None): Art. 56a, Para. 1, p. 1 for approval and recommendation.
p.(None): (4) The European Medicines agency shall include the adopted assessment report and the recommendation of the committee
p.(None): under Art. 56a, Para. 1, p. 1 to the register under Art. 194h, Para. 3 and shall submit it to the marketing
p.(None): authorisation holder.
p.(None):
p.(None):
p.(None): Art. 194q. (new – SG, 102/2012, in force from 21.12.2012). Where the Republic of Bulgaria is not a
p.(None): reporter in the procedure under Art. 194o, Para. 2, BDA may produce comments within the term under Art. 194p, Para. 2
p.(None): to the European Medicines Agency and to the regulatory body of the Member State, which has drawn up the report.
p.(None):
p.(None):
p.(None): Art. 194r. (new – SG, 102/2012, in force from 21.12.2012). (1) In case of a single assessment of
p.(None): periodic updated safety reports of medicinal product under Art. 194l and where neither of the marketing authorisations
p.(None): of these products has been issued under Regulation (EC) 726/2004 of the European Parliament and of the Council, the
p.(None): coordination group under Art. 77, Para. 2 within the term of up to 30 days from the date of receiving the
p.(None): recommendation of the committee under Art. 56a, Para. 1, p. 1 shall issue an opinion about keeping, change, termination
p.(None): of the relevant marketing authorisations, including a schedule for implementation of the opinion.
p.(None): (2) Where the represented Member States in the coordination group under Art. 77, Para. 2 reach agreement about the
p.(None): action to be undertaken, BDA shall fulfill the adopted decision.
p.(None): (3) Where the opinion under Para. 1 is for interruption or termination of the marketing authorisation, the BDA
p.(None): executive director shall issue the order.
p.(None): (4) Where the opinion under Para. 1 recommends changes in the issued marketing authorisation, the marketing
p.(None): authorisation holder shall submit to BDA an application for change, including an updated short characteristics of the
p.(None): product and a leaflet, within the frames of the defined implementation schedule.
p.(None): (5) Where no agreement can be reached in the coordination group under Art. 77, Para. 2, the position of the majority
p.(None): Member States shall be produced to the European Commission, which shall adopt a decision for change, interruption or
p.(None): termination of the marketing authorisation, issued by the relevant regulatory bodies of the Member States.
p.(None): (6) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 5.
p.(None):
p.(None):
p.(None): Art. 194s. (new – SG, 102/2012, in force from 21.12.2012).(1) In case of single assessment of periodic
p.(None): updated safety reports of medicinal products under Art. 194l and where
p.(None):
p.(None): at least one of the marketing authorisations has been issued under Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council, the Committee of the medicinal products for human use within the term of 30 days from
p.(None): receiving the recommendation of the committee under Art. 56a, Para. 1, p. 1 shall issue an opinion about keeping,
p.(None): changing, termination or interruption of the validity of the relevant marketing authorisations, including a schedule
p.(None): for the opinion implementation.
p.(None): (2) Where the opinion under Para. 1 expresses a position for undertaking regulatory actions in relation to the
p.(None): marketing authorisations, the European Commission shall:
p.(None): 1. adopt as decision for change, termination or interruption of the marketing authorisations,
p.(None): issue under Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 2. adopt decision with a recommendation for change, termination or interruption of the marketing authorisations, issued
p.(None): by the relevant Member States regulatory bodies.
p.(None): (3) The BDA shall apply the temporary and/or final measures of the decision under Para.
p.(None): 2, p. 2.
p.(None):
p.(None): Section IV.
p.(None): Urgent Procedure at European Union Level. (new – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None): Art. 194t. (new – SG, 102/2012, in force from 21.12.2012) (1) Urgent procedure at the level of the European Union may
p.(None): be initiated by the European Commission, by the European Medicines Agency or by a Member State.
p.(None): (2) (amend. – SG 18/14) The BDA shall initiate an urgent procedure under this section by notification of the regulatory
p.(None): bodies of the other Member States, the European Medicines Agency and the European Commission where upon
p.(None): considerations, related with pharmaco- vigilance considers, that for a certain medicinal product, placed on the
p.(None): Bulgarian market, one of the following measures are needed to be undertaken:
p.(None): 1. termination or interruption of the marketing authorisation;
p.(None): 2. prohibition of distribution of the medicinal product;
p.(None): 3. issuing a refusal for renewing the marketing authorisation.
...
p.(None): and shall contain one or more of the following conclusions:
p.(None): 1.it is not needed additional study or undertaking actions at Community level;
p.(None): 2. the marketing authorisation holder shall have to carry out an additional study and data analysis;
p.(None): 3. the marketing authorisation holder shall have to conduct safety post-marketing study with a follow up assessment of
p.(None): the results from it;
p.(None): 4. the Member State or the marketing authorisation holder shall apply measures for decreasing the risk;
p.(None): 5. the marketing authorisation shall have to be terminated, interrupted or a refusal for its renewal has to be issued;
p.(None): 6 the marketing authorisation shall have to be changed.
p.(None): (4) The concrete measures under Para. 3, p. 4, as well as the conditions and restrictions, which are to be included in
p.(None): the marketing authorisation, shall be indicated in the recommendation.
p.(None):
p.(None): (5) In the cases under Para. 3, p. 6, where the changes are related to change or addition of information in the short
p.(None): characteristics, on the packing or leaflet of the medicinal product, the recommendation shall contain the formulation
p.(None): of the changes or added information and the place, where it has to be put.
p.(None):
p.(None):
p.(None): Art. 194x. (new – SG, 102/2012, in force from 21.12.2012) (1) Where in the scope of the procedure under Art. 194t no
p.(None): medicinal product has been included, permitted for use under Regulation (EC) N 726/2004 of the European Parliament
p.(None): and of the Council, the coordination group under Art. 77, Para. 2 on the basis of the recommendation under Art. 194v
p.(None): within the term of up to 30 days from the date of its receiving shall issue an opinion about the keeping, change,
p.(None): termination, interruption of the validity of the relevant decisions for use or refusal of their renewal, including a
p.(None): schedule for implementation of the opinion.
p.(None): (2) Where the opinion recommends undertaking measures under Art. 194v, Para. 3, p. 5, the BDA executive director
p.(None): shall interrupt by an order the action or shall terminate the marketing authorisation or shall refuse its
p.(None): renewal.
p.(None): (3) Where the opinion under Para. 1 recommends changes in the issuance of a marketing authorisation, the
p.(None): marketing authorisation holder shall submit an application and a leaflet to BDA for a change, including an updated
p.(None): short characteristics of the product and a leaflet, within the frames of the schedule for implementation.
p.(None): (4) Where the opinion under Para. 1 recommends undertaking measures under Art. 194v, Para. 3, p. 2 – 4, the
p.(None): marketing authorisation holder shall undertake the needed actions and shall inform BDA and the regulatory bodies of the
p.(None): other Member States.
p.(None): (5) Where within the frames of the coordination group under Art. 77, Para. 2 no agreement can be reached,
p.(None): the position of the majority of the Member States shall be given to the European Commission, which shall adopt a
p.(None): decision with a recommendation for a change, termination or interruption of the marketing authorisation, issued
p.(None): by the relevant regulatory bodies of the Member States.
p.(None): (6) The BDA shall apply the temporary or final measures, recommended in the decision.
p.(None):
p.(None):
p.(None): Art. 194y. (new – SG, 102/2012, in force from 21.12.2012) (1) Where in the scope of the procedure under Art. 194t a
p.(None): medicinal products has been included, permitted for use under Regulation (EC) N 726/2004 of the European
p.(None): Parliament and of the Council, the Committee of the medicinal products for human medicine on the basis of the
p.(None): recommendation under Art. 194v, Para. 3 within the term of 30 days from the date of its receiving, shall issue an
p.(None): opinion about keeping, change, termination, interruption of the validity of the relevant marketing authorisations or
p.(None): refusal for their renewal, including a schedule for implementation of the opinion.
p.(None): (2) Where the opinion under Para. 1 expresses a position for undertaking regulatory action in relation to the marketing
p.(None): authorisations, the European Commission shall:
p.(None): 1. adopt a decision for change, termination or interruption the validity of the marketing authorisations, issued under
p.(None): Regulation (EC) N 726/2004 of the European Parliament and of the Council;
p.(None): 2. adopt a decision with a recommendation for a change, termination or interruption of the validity of the
p.(None): marketing authorisations, issued by the relevant regulatory bodies of the Member States.
p.(None): (3) The BDA shall apply the recommended temporary and/or final measures in the decision of the European
p.(None): Commission under Para. 2, p. 2.
p.(None):
p.(None): Art. 194z. (new – SG, 102/2012, in force from 21.12.2012) The recommendation under Art. 194v, Para. 1, the opinion
p.(None): under Art. 194x, Para. 1 and the decision of the European Commission under Art. 194w, Para. 5 and Art. 194x,
p.(None): Para. 2 shall be published on the European internet portal under Art. 68, Para. 1, p. 4.
p.(None):
p.(None): Chapter nine.
p.(None): WHOLESALE TRADE OF MEDICINAL PRODUCTS AND intermediation IN THE AREA OF THE MEDICINAL PRODUCTS (TITLE, AMEND. – SG,
p.(None): 71/2008, IN FORCE FROM 12.08.2008, TITLE, AMEND. – SG, 102/2012, IN FORCE FROM 02.01.2013)
p.(None):
p.(None): Section .
p.(None): Wholesale Trade of Medicinal Products
p.(None):
p.(None): Art. 195. (1) Wholesale of medicinal products can perform natural and legal persons registered as traders pursuant to
p.(None): the national legislation of a Member State and possessing authorisation for such activity issued by a regulatory body
p.(None): of the respective Member State.
p.(None): (2) Where the person according to para 1 is in possession of warehouse premises on the territory of the Republic of
p.(None): Bulgaria, he can perform wholesale of medicinal products after receipt of authorisation from the executive director of
p.(None): the BDA.
p.(None):
p.(None):
p.(None): Art. 196. (1) Manufacturer of medicinal products within the meaning of this Act can only perform wholesale of the
p.(None): medicinal products, which he has an issued manufacturing authorisation for.
p.(None): (2) Importer of medicinal products within the meaning of this Act can only perform wholesale of the
p.(None): medicinal products, which he has an issued import authorisation for.
p.(None):
p.(None):
p.(None): Art. 197. The persons according to Art. 195 shall dispose of:
p.(None): 1. suitable premises, equipment and outfits, and transport vehicles ensuring correct storage, distribution,
...
p.(None): a state – party on the EEA Agreement – a document for updated registration according to the national
p.(None): legislation, issued by a competent body of the relevant state;
p.(None): 3. name, certificate of clean court record, diploma for higher education and length of service for the responsible
p.(None): master - pharmacist according to Art. 197, point 2, and a copy of his/her employment contract;
p.(None): 4. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 5. (repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 6. document certifying the legal grounds for the use of the premises;
p.(None): 7. (amend., - SG 98/10, in force from 01.01.2011) conclusion of the Regional Health Inspectorates after inspection on
p.(None): the spot evidencing that the health requirements in the whole sale premises according to the regulation according to
p.(None): Art. 198.
p.(None): 8. document for paid fee as laid down in the tariff Art. 21, para 2.
p.(None): (2) The persons according to Art. 195, para 1, shall submit to the BDA an application accompanied by the following
p.(None): documents:
p.(None): 1. copy of the wholesale authorisation issued by a regulatory body of a Member State;
p.(None): 2. name and address of the contact person on the territory of the Republic of Bulgaria;
p.(None): 3. address of the premises for the storage of the medicinal products on the territory of the Member State.
p.(None): (3) In case of wholesale of narcotic substances, as well as pharmaceutical forms containing such
p.(None): substances, the requirements of the Control on Drugs and Precursors Act shall also be applied.
p.(None): (4) In case of wholesale of radiopharmaceuticals, an opinion of the Nuclear Regulatory Agency shall also be submitted.
p.(None):
p.(None):
p.(None): Art. 200. The BDA shall assess the documentation the documentation and conduct an inspection on the spot of the sites
p.(None): mentioned in the application to certify their compliance with the requirements of the Good Distribution Practice.
p.(None):
p.(None):
p.(None): Art. 201. (1) Provided that the BDA establishes omissions in the submitted documentation, it
p.(None): shall notify the applicant in writing.
p.(None): (2) In the cases according to para 1 the term according to Art. 202, para 1, shall cease
p.(None): to run.
p.(None):
p.(None):
p.(None): Art. 202. (1) In a period of 90 days of the date of submission of the application according to Art. 199, para 1, the
p.(None): executive director of the BDA shall issue a wholesale authorisation or make a motivated refusal.
p.(None): (2) The refusal according to para 1 shall be subject to appeal under the terms of the Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 203. In a period of 15 days of the date of submission of the documentation according to Art. 199, para 2, the
p.(None): executive director of the BDA shall issue a registration certificate for wholesale on the territory of the Republic of
p.(None): Bulgaria to the person according to Art. 195, para 1.
p.(None):
p.(None): Art. 204. (1) The wholesale authorisation for medicinal products shall be timeless.
p.(None): (2) The authorisation according to Art. 202 or the certificate according to Art. 203 shall be cancelled provided that
p.(None): its holder requests so from the executive director of the BDA in writing.
p.(None): (3) The person according to Art. 195 shall be obliged to notify the BDA in writing within 7 days of the termination of
p.(None): its activities relating the wholesale of medicinal products. In such cases, the executive director of the BDA shall
...
p.(None): for retail trade in medicinal products at a pharmacy, opened in a populated area with not more than 10 000 citizens,
p.(None): shall be issued on the grounds of a submitted request in a form, to which shall be attached the following documents:
p.(None): 1. (amend. - SG, 60/2011, in force from 5. 8. 2011) the documents referred to in para 1, items 1, - 7a and a document
p.(None): issued by the mayor of the respective municipality, certifying the number of citizens in the respective populated area;
p.(None): 2. (amend. – SG, 102/2012, in force from 02.01.20120 document for paid fee amounting to 50% of the fee, defined by the
p.(None): tariff under Art. 21, Para. 2 for issuance of a permit for retail sale with medicinal products under Art. 222, Para. 1.
p.(None): (6) (prev. text of para 4, suppl. – SG 102/09, in force from 22.12.2009; amend., - SG 98/10, in force from 01.01.2011,
p.(None): former Para. 5, amend. – SG, 60/2011, in force from 5. 8. 2011) The application and the documents under para 1 and 5
p.(None): shall be filed to the BDA.
p.(None): (7) (prev. text of para 5, amend. – SG 102/09, in force from 22.12.2009; amend., - SG 98/10, in force from 01.01.2011,
p.(None): former Para. 6, amend. – SG, 60/2011, in force from 5. 8. 2011) The RHI shall issue hygiene resolution up to 14 days
p.(None): from the date of filing the application about this.
p.(None): submit the documents under para 5 to the Ministry of Health within 3 days from issuing
p.(None): the
p.(None):
p.(None):
p.(None): Art. 229. (1) (Repealed – SG, 60/2011, in force from 5. 8. 2011).
p.(None): (2) (amend. – SG 102/09, in force from 22.12.2009, amend. – SG, 60/2011, in force from
p.(None): 5. 8. 2011; suppl. – SG 18/14) Within the term of 1 month after receiving the documentation under Art. 228, Para. 6,
p.(None): the executive director of BDA upon an issued opinion by the Expert Council for Retail Sale of Medicinal Products shall
p.(None): issue authorisation for retail with medicinal products or make a motivated refusal to issue an authorisation. The
p.(None): authorisation or refusal shall be delivered to the person who has submitted the application.
p.(None): (3) (Amend. - SG, 60/2011, in force from 5. 8. 2011) Where discrepancies with or omissions in the
p.(None): submitted documentation have been established, within 15 day term from filing the documentation under Art. 228, Para.
p.(None): 6, the BDA shall perform a check up of the produced documents and shall notify the candidate in writing about the found
p.(None): discrepancies and omissions. In these cases the term according to para 2 shall cease to run as from the date of the
p.(None): notification till the elimination of the defects.
p.(None): (4) (New SG. 71/2008, in force from 12. 08. 2008) In case that within 60 day term after the notification date, under
p.(None): para 3, the applicant fails to remove the established irregularities or incompleteness, the procedure for issuing
p.(None): authorisation for retail trade in medicinal products or for change of an issued authorisation shall be terminated.
p.(None): (5) (Former para 4 – SG 71/2008, in force from 12, 08 2008, amend. – SG, 60/2011, in force from 5. 8. 2011). The
p.(None): refusal of the executive director of the BDA to issue an authorisation shall be subject to appeal under the terms of
p.(None): the Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 229a. (New – SG. 23/2009, in force from 30. 03. 2009) (1) (amend. and suppl. - SG.
p.(None):
p.(None): 41/2009, in force from 02.06.2009; amend. – SG 98/10, in force from 01.01.2011, amend. – SG, 60/2011, in force from 5.
p.(None): 8. 2011) The BDA shall officially submit to RHI on the location of the relevant pharmacy with an authorisation, issued
...
p.(None): marketing authorisation holder of the medicinal product or a duly empowered person.
p.(None):
p.(None):
p.(None): Art. 251. (1) For advertising authorisation the person according to Art. 250 shall submit to the BDA a formal
p.(None): application as approved by the executive director of the agency accompanied by:
p.(None): 1. design of the advertising;
p.(None): 2. notarised power of attorney issued by the marketing authorisation holder where the application shall be submitted by
p.(None): another person;
p.(None): 3. bibliographical references of the used quotations, tables, or other materials, if any;
p.(None): 4. document for paid fee to the amount as paid down in the tariff according to Art. 21,
p.(None): para 2.
p.(None): (2) The presented advertising drafts - designs to Art. 1 issue 1 must be clear and if there
p.(None): is text, it must be understandable providing possibility to assess all of its elements - text and illustrations.
p.(None): (3) Expert Council of Advertising shall be established to the BDA. It shall involve physicians and
p.(None): specialists with practical experience in the field of advertising. The executive director of the BDA shall appoint
p.(None): by an order the composition of the council, where a representatives of the Professional Ethic Commission
p.(None): of the Bulgarian Medical Association, Bulgarian Dental Association and Bulgarian Pharmacists Union, the amount of
p.(None): the remuneration
p.(None):
p.(None): of its members, and shall approve rules for the condition and order for its work. In the Council representatives of
p.(None): patients organisations may be included.
p.(None): (4) The council according to para 3 shall prepare examination to the advertising design and shall establish an opinion
p.(None): for the executive director of the BDA.
p.(None): (5) In case of establishment of discrepancies between the advertising and the requirements of this Act,
p.(None): the BDA shall, within 7 days of the submission of the application according to para 1, give written
p.(None): instructions for their elimination by the applicant within one month of the notification date. This decision term shall
p.(None): cease to run as from the notification date till the elimination of the discrepancies.
p.(None): (6) If the applicant shall not fulfil the instructions within one month of the notification date according to para 5,
p.(None): the authorisation procedure shall be terminated.
p.(None):
p.(None):
p.(None): Art. 252. (1) The executive director of the BDA shall authorise or issue a motivated refusal of the
p.(None): advertising by an order within one month of the submission of the documentation according to Art. 251, para 1, on the
p.(None): grounds of the opinion according to Art. 251, para 4, and shall notify the marketing authorisation holder.
p.(None): (2) (New – SG, 60/2011, in force from 5. 8. 2011) Where within the term under Para. 1 the executive director of BDA
p.(None): does not permit by an order the advertisement or fails to make a grounded refusal, it shall be accepted, that there is
p.(None): a silent agreement with the project of the advertisement under Art. 251, Para. 1, p. 1 and it may be disseminated.
p.(None): (3) (Former, Para. 2 – SG, 60/2011, in force from 5. 8. 2011) The refusal of the executive director of the BDA shall be
p.(None): subject to appeal under the terms of the Administrative Procedure Code.
p.(None):
p.(None):
p.(None): Art. 253. (1) The issued advertising authorisation to Art. 252, para 1 shall refer to a concrete medicinal product
p.(None): within the validity of its marketing authorisation.
p.(None): (2) Where there have been variations in the marketing authorisation of a medicinal product resulting in
p.(None): changes of an authorised advertising of this product, the marketing authorisation holder shall submit to the
p.(None): BDA an application for change.
p.(None):
p.(None):
p.(None): Art. 254. In case of change in the authorised advertising, the person according to Art.
p.(None): 250 shall submit an application under the terms of Art. 251.
p.(None):
p.(None):
p.(None): Art. 254a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) The advertisement, intended for the medical specialists
p.(None): shall not be permitted under Art. 250 – 252.
p.(None): (2) The advertisement under Para. 1 shall be disseminated after submitting a notification to BDA, which shall contain
p.(None): an advertisement draft, while observing the requirements of this Chapter and the Ordinance under Art. 249.
p.(None):
p.(None):
...
p.(None): to a proposal by the Minister of Health. In it representatives of the Ministry of Health, the Ministry of Labour and
p.(None): Social Policy, the BDA, the NHIF, the Bulgarian Medical Association, Bulgarian Dental Association, Bulgarian
p.(None): Pharmacists Union, the professional organisation of the pharmacists, and organisations of the patients
p.(None): and the pharmaceutical industry are obligatory included.
p.(None): (3) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) A person, who is
p.(None): a member of the Transparency Commission shall not be a member of the Council.
p.(None): (4) The Council of Ministers determines with Rules the condition and the order for work of the Transparency Commission.
p.(None):
p.(None):
p.(None): Art. 266. (1) (Amend. – SG, 60/2011, in force from 5. 8. 2011, amend. – SG, 102/2012, in force from 21.12.2012) The
p.(None): Transparency Commission shall be a body before which decisions of the Council may be appealed.
p.(None): (2) The decisions of the Transparency Commission shall be taken by a majority of two thirds of its members.
p.(None): (3) The decisions of Para. 2 could be appealed under the terms of the Administrative Procedure Code and the appeal has
p.(None): no suspense effect.
p.(None):
p.(None):
p.(None): Art. 266a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) Where the treatment of a relevant sickness is without
p.(None): alternative in the country, for a concrete patient may be applied a medicinal products, which is authorised for use in
p.(None): an EU Member State, authorised for use under this Act, but is not sold on the Bulgarian market.
p.(None): (2) Annually, upon proposal of the medical establishments for hospital assistance after an opinion of the relevant
p.(None): national consultant on the profile of the sickness, the Minister of Health shall confirm a list of the medicinal
p.(None): products under Para. 1, which shall contain the following information:
p.(None): 1. code on the anatomy-therapeutic – chemical classification;
p.(None): 2. international non-patent name, to which the product belongs; 3.sickness according to international code of
p.(None): sicknesses; 4.medicinal form and quantity active substance;
p.(None): 5. additional information.
p.(None): (3) The list under Para. 2 shall be published on the internet site of the Ministry of Health.
p.(None): (4) The terms and conditions for inclusion, changes or exclusion of medicinal products in the list under Para. 2 shall
p.(None): be determined by the Ordinance under Art. 9, Para. 1.
p.(None):
p.(None): (5) The medicinal product under Para. 1 shall be supplied upon a special order of a medical establishment for hospital
p.(None): assistance under terms and conditions, determined by the Ordinance under Art. 9, Para. 1.
p.(None): (6) The head of the medical establishment under Para. 5 shall bear responsibility for applying the treatment under
p.(None): Para. 1.
p.(None):
p.(None): Chapter thirteen.
p.(None): STATE CONTROL ON THE MEDICINAL PRODUCTS
p.(None):
p.(None): Art. 267. (1) (amend., - SG 98/10, in force from 01.01.2011, suppl. – SG 102/2012, in force from 21.12.2012) The
p.(None): Ministry of Health shall exercise the state control on the medicinal products. The immediate management shall be
p.(None): executed by the chief state health inspector, the Council chairperson under Art. 258, Para. 1, the executive director
p.(None): of the BDA, and the directors of the regional health inspectorates (RHI) who shall be state inspectors for the control
p.(None): of the medicinal products.
...
p.(None): (8) (new – SG, 102/2012, in force from 21.12.2012) The BDA shall cooperation with the European Medicines Agency in
p.(None): coordination of inspections in third states.
p.(None):
p.(None):
p.(None): Art. 269a. (new - SG, 102/2012, in force from 21.12.2012) (1) The officials under Art. 267, Para. 3 shall draw up a
p.(None): report for each carried out inspection under Art. 269, Para. 3 and 4 for observing the principles and directions
p.(None): for Good manufacturing practice or for Good distribution practices or for observation of the requirements of
p.(None): Chapter Eight, as well as the requirements of this act.
p.(None): (2) The report under Para. 1 shall be given to the checked person, who can provide notes on it.
p.(None): (3) with receiving a grounded request, BDA shall submit electronically the reports under Para. 1 to the competent body
p.(None): of another Member State or to the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 269b. (new – SG, 102/2012, in force from 21.12.2012) (1) Where as a result of carried out inspections under Art.
p.(None): 269, Para. 3 compliance with the Good manufacturing practice is found, or the Good distribution practices where
p.(None): applicable, BDA shall issue to the manufacturer, importer or wholesale trader a certificate for Good
p.(None): manufacturing practice or certificate for Good distribution practice within the term of 90 days from the inspection.
p.(None): (2) Where as a result of a carried out inspection under Art. 269, Para. 3 it is found that the manufacturer, importer
p.(None): or wholesale trader of medicinal products or active substances fails to observe the requirements of the act and/or
p.(None): principles and directives of Good manufacturing practice and/or Good distribution practice, BDA shall issue an
p.(None): incompliance opinion.
p.(None): (3) The BDA shall introduce to the data base under Art. 147 the issued certificates under Para. 1 and information under
p.(None): Para. 2.
p.(None):
p.(None):
p.(None): Art. 269c. (new – SG, 102/2012, in force from 21.12.2012) (1) Where as a result of an inspection under Art. 270, Para.
p.(None): 1, p. 5 it is found that the marketing authorisation holder fails to observe the requirements of Chapter Eight,
p.(None): BDA shall give prescriptions for removal of the incompliance.
p.(None): (2) In the cases under Para. 1, BDA shall notify the Member States, the European
p.(None):
p.(None): medicines Agency and the European Commission.
p.(None):
p.(None):
p.(None): Art. 270. (1) Within the framework of their competence, the officials according to Art. 267, Para. 3, shall be entitled
p.(None): to:
p.(None): 1. (amend. - SG, 102/2012, in force from 21.12.2012) Access to all documents, connected to the subject
p.(None): of the inspection, as well as documents, connected directly and indirectly with violation of this Act or
p.(None): of legislation of the Member States, implementing requirements of Directive 2001/83/EC of the European
p.(None): Parliament and the Council for approval of the Community code concerning medicinal products for human use, as
p.(None): last amended by Directive 2004/27/EC of the European Parliament and the Council, independently from the form of the
p.(None): document;
p.(None): 2. order of each person to present information for violations according to point 1, which are familiar to him;
p.(None): 2a (new - SG, 102/2012, in force from 21.12.2012) inspect the manufacture and trade sites of manufacturers of
p.(None): medicinal products, active or auxiliary substances, as well as the laboratories, used by manufacture or import
...
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p.(None): violation of the ordinance under Art. 234, Para. 5.
p.(None): (2) The BDA internet site under Para. 1 shall be connected with the internet site of the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 234b (new – SG, 102/2012, in force from 02.01.2013) The BDA shall participate in information campaigns, organised
p.(None): by the European Commission and the European Medicines Agency about the danger of falsified medicinal products.
p.(None):
p.(None): Art. 235. (1) The authorisation to carry out retail trade with medicinal products shall be cancelled with the
p.(None): termination of the activity of the persons according to Art. 222.
p.(None): (2) (amend. – SG, 60/2011, in force from 5. 8. 2011) The executive director of BDA shall cancel the authorisation for
p.(None): retail trade with medicinal products:
p.(None): 1. according to an application by the person who has received authorisation for carrying out retail trade with
p.(None): medicinal products:
p.(None): 2. wherever it has been established that the manager of the pharmacy does not comply with the requirements laid down in
p.(None): Art. 224 and 225.
p.(None): (3) (Amend. – SG, 60/2011, in force from 5. 8. 2011) The persons according to Art. 222 and 225 shall notify the BDA in
p.(None): writing within 14 days of the termination of the activity according to para 1.
p.(None):
p.(None):
p.(None): Art. 236. (1) The pharmacy cannot be closed for more than 30 days within a calendar year due to the absence of the
p.(None): manager.
p.(None): (2) (suppl. – SG 71/2008, in force from 12.08.2008; amend. – SG 12/11, in force from 08.02.2011, amend. – SG,
p.(None): 60/2011, in force from 5. 8. 2011) Where the manager of the pharmacy is not in a position to fulfil his
p.(None): obligations due to a leave for temporary incapacity of work due to an illness, pregnancy and birth, or adoption and
p.(None): leave for breeding of a little child, as per Labour Code, the pharmacy can operate under the management of another
p.(None): master of pharmacy, respectively another assistant pharmacist, in the cases to Art. 225 complying with the requirements
p.(None): of Art. 224 for not more than two years. In all these cases a permission of the executive director of BDA shall be
p.(None): issued.
p.(None): (3) The permission according to 2 shall be issued within 30 days.
p.(None):
p.(None):
p.(None): Art. 237. Upon termination of the activity of the person who received authorisation to retail trade with medicinal
p.(None): products, the medicinal products can be sold by persons who have received authorisation for wholesale trade in
p.(None): medicinal products.
p.(None):
p.(None):
p.(None): Art. 238. (1) Products of importance for human health and medicinal products, which are dispensed without medical
p.(None): prescription as laid down in lists of the Minister of Health, can be sold in a drugstore. Also, products and
p.(None): goods of importance for human health may be sold in drugstores, as laid down in the Ordinance under Art. 243,
p.(None): and medical products.
p.(None): (2) Entitled for carry out retail trade with medicinal products, as opening drugstores shall have all natural or legal
p.(None): person registered according to the Commerce Act or the legislation of a Member State;
p.(None): (3) The manager of a drugstore must be a medical specialist, who: 1.has not been deprived of the right to exercise
p.(None): his/her profession;
p.(None): 2.has not been convicted for crimes in relation to his/her profession, for crimes against property and undertaking, or
...
p.(None): to a medicinal product, which has already received marketing authorisation.
p.(None): 26. "Coordinating researcher" shall mean a researcher appointed for the purpose of coordinating the researchers or
p.(None): various sites participating in a multicentre test.
p.(None): 27. "Patient information leaflet" shall mean a leaflet accompanying a medicinal product and containing information for
p.(None): the customer.
p.(None): 27a. (New - SG 71/2008 in force from 12.08.2008, amend. – SG, 102/2012, in force from 21.12.2012) "Medicinal product
p.(None): for modern therapy" is a medicinal product, determined in Art. 2 of Regulation (EC) N 1394/2007 of the European
p.(None): Parliament and of the Council of 13 November 2007 on the medicinal products for modern therapy and amending Directive
p.(None): 2001/83/EC and Regulation (EC) № 726/2004.
p.(None): 28. "Medicinal product obtained from human plasma or human blood" shall mean a medicinal product produced
p.(None): from human blood constituents and by a method involving industrial process. The following shall be ascribed to this
p.(None): group: immunoglobulins, coagulating factors and antiproteases, solutions of plasma proteins, and other plasma
p.(None): fractions and combinations thereof.
p.(None): 29. "Medicinal product intended for treatment, prophylaxis, and diagnostics of rare
p.(None):
p.(None): diseases" shall mean a product, which:
p.(None): a) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases or chronic diseases taking
p.(None): progressive course, which affect not more than 5 of 10,000 people on the territory of a state or
p.(None): b) is intended for diagnostics, prophylaxis, or treatment of life-threatening diseases and severely health damaging
p.(None): chronic disease (diseases with high percentage of disease-related incapacity of work or disability) and are there is
p.(None): evidence appended that the sale of the product does ensure satisfactory return, which can justify the required
p.(None): investment for scientific research and development without having stimuli for the creator of the product, and
p.(None): c) where the is no satisfactory method of diagnostics, prophylaxis, or treatment of a given condition or where there is
p.(None): such method the proposed medicinal product has significantly more advantages and benefits for the people affected by
p.(None): this condition.
p.(None): 30. "Pharmaceutical form" shall mean an adequate for intake structure containing active substance(s), which can
p.(None): include or cannot include excipients and which is obtained through application of certain technological operations
p.(None): ensuring the desired healing effect and stability at storage within the expiry term.
p.(None): 31.. (Amen. - SG 71/2008 in force from 12.08.2008) "Any person, established on the territory of a Member State shall
p.(None): mean a legal subject registered according to the civil or trade legislation of a Member State or established pursuant
p.(None): to a normative act and having place of business in a Member State or a state - party of the European Economic Area.
p.(None): 32. "Magisterial formula" shall mean a prescription for a medicinal product prepared in a pharmacy according to a
p.(None): prescription of a medical specialist or according to an established recipe and intended for a definite patient.
p.(None): 33. "International non-proprietary name" shall mean a recommended name of an active substance approved and published by
p.(None): the World Health Organisation.
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p.(None): authorisation and the subsequent practical requirements in connection with the authorisation to market of
p.(None): medicinal products according to Art. 28 and Art. 29 shall not be regarded as breach of patent rights or to
p.(None): supplementary protection certificates of medicinal products.
p.(None):
p.(None):
p.(None): Art. 34. (1) The summary of product characteristics shall contain the following information:
p.(None):
p.(None): 1. name of the medicinal product, quantity of the active substance in a dose unit, and pharmaceutical form;
p.(None): 2. qualitative and quantitative composition in terms of the active substances and constituents of the
p.(None): excipient, the information of which is essential for proper administration of the medicinal product. The usual common
p.(None): name or chemical description shall be used;
p.(None): 3. pharmaceutical form;
p.(None): 4. clinical particulars:
p.(None): a) therapeutic indications,
p.(None): b) posology and method of administration for adults and, where necessary, for children,
p.(None): c) contra-indications,
p.(None): d) special warnings and precautions for use and, in the case of immunological medicinal products, any special
p.(None): precautions to be taken by persons handling such products and administering them to patients, together with
p.(None): any precautions to be taken by the patient,
p.(None): e) interaction with other medicinal products and other forms of interactions,
p.(None): f) use during pregnancy and lactation,
p.(None): g) effects on ability to drive and to use machines,
p.(None): h) undesirable effects,
p.(None): i) overdose (symptoms, antidotes, emergency measures).
p.(None): 5. pharmacological properties:
p.(None): a) pharmacodynamic properties,
p.(None): b) pharmacokinetic properties,
p.(None): c) preclinical safety data.
p.(None): 6. pharmaceutical particulars:
p.(None): a) list of excipients,
p.(None): b) major incompatibilities,
p.(None): c) shelf life, where necessary after reconstitution of the medicinal product or where the immediate packaging is opened
p.(None): for the first time,
p.(None): d) special precautions for storage,
p.(None): e) nature and contents of container,
p.(None): f) special precautions for disposal of unused medicinal product or waste materials from such medicinal product.
p.(None): 7. marketing authorisation holder.
p.(None): 8. registration number.
p.(None): 9. date of the first marketing authorisation or renewal of the marketing authorisation.
p.(None): 10. date of a variation in the summary of product characteristics.
p.(None): 11. for radiopharmaceuticals, full details of internal radiation dosimetry.
p.(None): 12. for radiopharmaceuticals, detailed instructions for extemporaneous preparation and quality control and, where
p.(None): appropriate, maximum storage time during which any intermediate preparation such as an eluate or the
p.(None): ready-to-use pharmaceutical will conform to its specifications.
p.(None): (2) The summary of product characteristics of medicinal products according to Art. 28- 33, those parts of the summary
p.(None): of product characteristics of the reference medicinal product referring to indications or dosage forms which were still
p.(None): covered by patent law at the time when a generic medicine was marketed shall not be included.
p.(None): (3) The requirements relating to the form and content of the summary of product characteristics shall be
p.(None): laid down in the regulation according to Art. 42.
...
p.(None): medicinal product is received, has authorisation for manufacture/import;
p.(None): 14. (new – SG, 102/2012, in force from 02.01.2013) check up whether the intermediary, through whom the medicinal
p.(None): product is received, meets the requirements of this Chapter.
p.(None): (2) The documentation according to Para. 1, points 7 and 8 shall be kept for at least 5 years and shall be provided to
p.(None): the control bodies upon request.
p.(None):
p.(None):
p.(None): Art. 208. (amend. – SG, 102/2012, in force from 02.01.2013) The obligations according to Art. 207, Para. 1, point 2,
p.(None): and Art. 209a shall also apply to the wholesalers according to Art. 203, as well as to the importers and manufacturers
p.(None): trading in medicinal products manufactured by them.
p.(None):
p.(None):
p.(None): Art. 209. The requirements of the special provisions of other laws shall also apply to the wholesale of medicinal
p.(None): products containing narcotic substances or obtained from blood, or immunological products, or
p.(None): radiopharmaceuticals.
p.(None):
p.(None):
p.(None): Art. 209a. (New - SG 71/2008, in force from 12.08.2008) (1) The wholesale traders with medicinal products may deliver
p.(None): medicinal products to:
p.(None): 1. other wholesale traders with medicinal products;
p.(None): 2. pharmacies and drugstores;
p.(None): 3. the Ministry of Defence and the Ministry of Interior for own needs, with the exception of their medical
p.(None): institutions, as well as the State Reserve and Military time Reserve State Agency;
p.(None): 4. the Ministry of Health with:
p.(None): a) vaccines, tocsins and serums, needed for implementation of the Immunisation calendar of the Republic of
p.(None): Bulgaria, as well as during emergency epidemical situations;
p.(None): b) medicinal products, intended for treatment of illnesses, which are paid as provided by the Health Act, as well as
p.(None): for providing the implementation of national programmes in the area of healthcare;
p.(None): 5. (new – SG 60/12, in force from 07.08.2012) outpatient health care institutions which have signed an agreement with
p.(None): the National Health Insurance Fund, with medicinal products required for performance of health activities under Art.
p.(None): 82, para 2, item 3 of the Health Act.
p.(None): (2) Doctors and Dental doctors in the populated areas, where there are no pharmacies may be supplied with medicinal
p.(None): products by wholesale traders, as provided by the ordinance under Art. 207, para 1, p. 6.
p.(None):
p.(None):
p.(None): Art. 209b. (new – SG, 102/2012, in force from 02.01.2013) (1) In wholesale trade of medicinal products in third states
p.(None): the requirements of Art. 207, Para. 1, p. 2, 5 and 6 shall not apply, as well as the requirements of Chapter Nine "a".
p.(None):
p.(None): (2) Where the medicinal product is received directly from a third state, but jas not been imported on the territory of
p.(None): the Republic of Bulgaria, the requirements of Art. 207, Para. 1, p. 4 and 4a shall not apply.
p.(None): (3) (new – SG 18/14) In cases referred to in par. 1 the wholesalers shall certify by relevant documents
p.(None): that the medicinal products are received from persons holding a permit or have got the right to supply medicinal
p.(None): products subject to compliance with the applicable national laws of the third country.
p.(None): (4) (new – SG 18/14) Where the wholesalers supply medicinal products to persons in third countries, they certify by
p.(None): relevant documents that the supplies are solely for persons, holding a permit or having got the right to
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): trials conducted outside the territory of the Member States;
p.(None): 12. (amend. – SG, 102/2012, in force from 21.12.2012) a summary of the system
p.(None): a) for vigilance the medicinal safety, which shall include the following elements:
p.(None): b) which is to be implemented and, where appropriate, description of the risk management system;
p.(None): c) name of the qualified person under Art. 191, a CV – education, acquired professional experience in the area of
p.(None): vigilance the medicinal safety and qualification for performing his/her duties under Chapter Eight;
p.(None): d) each Member state in which the qualified person fulfils his/her duties;
p.(None): e) address, tel. fax, e-amil address of the person under letter "a";
p.(None): f) address, at which the basic document is kept of the system for vigilance medicinal
p.(None): safety;
p.(None): 12a. (new - SG, 102/2012, in force from 21.12.2012) declaration by the applicant that
p.(None): he/she has the needed means for fulfilling the obligations under Chapter Eight;
p.(None): 13. (amend. -SG, 102/2012, in force from 21.12.2012) plan for risk management with a description of the system for risk
p.(None): management, which the applicant will introduce for the relevant medicinal product with the plan summary;
p.(None): 14. summary of product characteristics according to Art. 34;
p.(None): 15. mock-up of the immediate and outer packaging of the product and a proposed package leaflet in
p.(None): compliance with the requirements of chapter six;
p.(None): 16. copy of the manufacturing authorisation issued by the regulatory authority of the
p.(None):
p.(None): country where manufacture is performed accompanied by a Good Manufacturing Practice certificate or a
p.(None): certificate evidencing that the manufacture of the medicinal product and the active substances contained in its
p.(None): composition has been performed in compliance with standards, which are at least equivalent to the standards of
p.(None): the Good Manufacturing Practice;
p.(None): 17. copy of a document evidencing that the medicinal product is designated for treatment, prophylaxis, or diagnostics
p.(None): of rare diseases accompanied by a copy of the opinion of the European Medicines Agency;
p.(None): 18. copies of all marketing authorisations issued in other Member States or in a third state of the medicinal product
p.(None): applied for marketing authorisation;
p.(None): 18a. (new -SG, 102/2012, in force from 21.12.2012) a copy of summary of the safety data, including the data,
p.(None): contained in the periodical updated safety reports and if any – the signals for suspected unacceptable
p.(None): medicinal reactions;
p.(None): 19. list of the Member States where an application for marketing authorisation the medicinal product has
p.(None): been submitted;
p.(None): 20. copy of the summary of product characteristics proposed by the person according to Art. 26, para 1, or a copy of
p.(None): the summary of product characteristics approved by a regulatory authority of a Member State/ states members of
p.(None): the European Economic Area, which has already issued a marketing authorisation;
p.(None): 21. copy of a refusal for a marketing authorisation in a Member State or a third state accompanied by motives;
p.(None): information for temporary suspension or termination of the effect of the marketing authorisation;
p.(None): 22. copy of the proposed package leaflet accompanied by a summary of the results of the assessment of the level of
p.(None): comprehensibility of the contents of the package leaflet by a target patient group selected by the applicant or a copy
p.(None): of a leaflet approved by a regulatory authority in a Member State, which has already issued a marketing authorisation;
p.(None): 23. document of paid fee in amounts up in the tariff according to Art. 21, para 2.
p.(None): (2) (suppl. – SG 18/14) The documents according to para 1, item 18 and 18a, relating to the Member States, and point
p.(None): 19, respectively, shall only be submitted in the procedures according to section VII.
p.(None): (3) To radionuclide generators, the following documents shall be added to the data according to para 1:
p.(None): 1. description of the system together with a detailed description of its components, which may affect the composition
p.(None): or quality of the daughter radionuclides;
p.(None): 2. qualitative and quantitative particulars of the eluate or the sublimate.
p.(None): (4) The documents and data from pharmaceutical tests, preclinical and clinical trials shall be accompanied by
p.(None): summarised reports prepared by experts with the required technical and professional qualification. To the reports a
p.(None): curricula vitae report of the experts shall be applied.
p.(None): (5) The dossier of the medicinal product shall be submitted in the Bulgarian and/or English language.
p.(None): (6) (new – SG, 102/2012, in force from 21.12.2012) The risk management system under Para. 1, p. 13 should be
p.(None): proportional to the identified and to the potential risks of the medicinal product and to the need of collecting safety
p.(None): data of post-marketing researches.
p.(None): (7) (new – SG, 102/2012, in force from 21.12.2012) The holder of the authorisation for use shall update the data of the
p.(None): file under Para. 1. For each change in the file the provisions of Chapter Three Section VI shall apply, where
p.(None): applicable.
p.(None):
p.(None):
p.(None): Art. 28. (1) The person according to Art. 26, para 1, insofar as he does not infringe industrial and commercial
p.(None): property rights, shall not submit to the BDA the data according to Art.
p.(None):
p.(None): 27, para 1, point 10, letters "b" and "c" provided that he can prove that the medicinal product indicated in the
p.(None): application is generic of a reference medicinal product, which is or has been authorised to market for not less than 8
p.(None): years in a Member State or in a state member of the European Economic Area.
p.(None): (2) The marketing authorisation holder of a generic product according to para 1 may not place it to market until 10
p.(None): years from the initial marketing authorisation of the reference medicinal product have elapsed.
p.(None): (3) Under observance of the conditions of para 1 and 2, the person according to Art. 26, para 1, may submit to the BDA
p.(None): an application for marketing authorisation of a medicinal product, which is generic of a reference medicinal product,
p.(None): even where the reference product has never had marketing authorisation on the territory of the Republic of Bulgaria.
p.(None): (4) In the cases according to para 3, the person according to Art. 26, para 1, shall indicate in the
p.(None): application according to Art. 27, para 1, the Member State where the reference product is or has been authorised to
p.(None): market.
p.(None): (5) In the cases according to para 3, the BDA shall request from the regulatory authority of the Member State indicated
p.(None): in the application according to Art. 27, para 1, a confirmation of the information according to para 4, the qualitative
p.(None): and quantitative composition of the reference product and, if necessary, additional documentation.
p.(None): (6) At the request of a regulatory authority of a Member State where the application for a medicinal product generic to
p.(None): a referent medicinal product, which is or has been authorised to market on the territory of the Republic of
p.(None): Bulgaria, is submitted, the BDA shall submit the requested information according to para 5 within one month from
p.(None): the request date.
p.(None): (7) The ten-year period according to para 2 may be extended by maximum one year at the request of the marketing
p.(None): authorisation holder of the reference medicinal product provided that during the first 8 years from the issue
p.(None): of the marketing authorisation of the reference medicinal product its marketing authorisation holder has
p.(None): received authorisation for a new therapeutic indication the significant clinical advantages of which versus the
p.(None): existing therapeutic opportunities are scientifically well-grounded.
p.(None): (8) (new – SG 12/11, in force from 08.02.2011) Where for a medicinal product an initial marketing authorisation has
p.(None): been issued according to Art. 23, regarding each change of the strength of the active substance, in the pharmaceutical
p.(None): form, of the quantity per package, of the administrative route of the medicinal product, as well as regarding
p.(None): all other changes or extensions of the range of the marketing authorisation, an authorisation according
p.(None): to the requirements of this Act shall be also issued or the initial marketing authorisation shall be
p.(None): supplemented. All these authorisations shall be considered belonging to a general marketing authorisation of the
p.(None): medicinal product for the purposes of application of this Article.
p.(None):
p.(None):
...
p.(None):
p.(None):
p.(None): Art. 70. (1) Prior to the placement on the market of each batch of the product the marketing
p.(None): authorisation of a medicinal product obtained from human blood or human plasma shall submit to the BDA the following:
p.(None): 1. a sample of the finished product and/or a sample of the bulk/ unfinished product;
p.(None): 2. manufacturing and quality control protocols;
p.(None): 3. document for paid fee as laid down in the tariff according to Art. 21, para 2.
p.(None): (2) Within 60 days of the submission of the full set of documents, the BDA shall perform an assessment of the
p.(None): manufacturing and control protocols of the medicinal product obtained from human blood or human plasma and tests
p.(None): of the submitted samples in an accredited laboratory in order to establish whether the medicinal product
p.(None): according to para 1 is manufactured in compliance with the approved specifications.
p.(None): (3) In case of a positive result from the tests, the BDA shall issue a batch release certificate.
p.(None): (4) The conditions and order, as well as the requirements to the documentation for granting a batch
p.(None): release certificate for the products according to para 1 shall be laid down in the regulation according to Art. 69,
p.(None): para 5.
p.(None): (5) Where the assessment and tests according to para 2 of the respective batch of medicinal products
p.(None): have been conducted in an official laboratory for control of medicinal products in another Member State, the
p.(None): marketing authorisation holder shall submit to the BDA the medicinal products batch release certificate issued by the
p.(None): regulatory authority of the Member State for the respective batch of the medicinal product.
p.(None): (6) In the cases according to para 6 the BDA shall not conduct the activities according to para 2 and 3.
p.(None):
p.(None):
p.(None): Art. 71. (1) The marketing authorisation holder shall be obliged to maintain a system for blocking and recall of
p.(None): medicinal products, which do not comply with the requirements relating to quality, safety, and efficacy.
p.(None):
p.(None): (2) The marketing authorisation holder shall be obliged to block and recall of medicinal products, which do not
p.(None): comply with the requirements relating to quality, safety, and efficacy under the terms in the regulation pursuant
p.(None): to Art. 274, para 1.
p.(None):
p.(None):
p.(None): Art. 72. (repealed – SG, 102/2012, in force from 21.12.2012)
p.(None):
p.(None):
p.(None): Art. 73. (1) The marketing authorisation holder may assign the rights over the marketing authorisation of a medicinal
p.(None): product to another legal person or to unions, which are not legal persons established on the territory of the Member
p.(None): States.
p.(None): (2) The marketing authorisation holder shall submit to the BDA an application appending the documentation laid down in
p.(None): the regulation according to Art. 42 indicating a proposal for the date of assignment.
p.(None): (3) In case of establishing incompleteness in the documentation according to para 2, the BDA shall notify the
p.(None): marketing authorisation holder in writing to, within 30 days, submit the necessary additional information.
p.(None): The term according to para 5 shall cease to run as from the notification date until submission of the requested
p.(None): information.
p.(None): (4) if the marketing authorisation holder does not supplement the documentation within the term according to para 3,
p.(None): the procedure of assignment of the marketing authorisation of the medicinal product shall be terminated.
p.(None): (5) Within 30 days from the date of submission of the application according to para 2, the executive director of the
p.(None): BDA shall issue an authorisation for variation for the transfer. In the variation approval of the assignment stating
p.(None): explicitly the date of assignment of the marketing authorisation is pointed out.
p.(None): (6) The holder of the marketing authorisation shall wholly assume the rights and obligations of the former
p.(None): marketing authorisation holder.
p.(None): (7) By the transfer of the marketing authorisation of the medicinal product pursuant to the order of para 1-6 the time
p.(None): limit shall remain unchanged.
p.(None):
p.(None): Section VII.
p.(None): Mutual Recognition Procedure and Decentralised Procedure
p.(None):
p.(None): Art. 74. (1) Where the person according to Art. 26, para 1, has a granted marketing authorisation in another Member
p.(None): State for the same product within the meaning of Art. 45, para 3, for which this person has submitted an application
p.(None): for marketing authorisation to the BDA, this person shall submit a request to the regulatory authority of the state
p.(None): indicated in the application, hereinafter referred to as "Reference Member State", to establish an assessment
p.(None): report or update the existing one.
p.(None): (2) Together with the application, the person according to para 1 shall submit to the BDA a dossier identical to the
p.(None): one submitted in the reference Member State and in the other Member States indicated in the application, hereinafter
p.(None): referred to as "Concerned Member States".
p.(None): (3) The BDA and the applicant shall officially receive the assessment report together by the approved summary of
p.(None): product characteristics and the approved packaging mock-up and package leaflet from the regulatory authority of the
p.(None): Reference Member State according to para 1.
p.(None): (4) The BDA shall review the documents according to para 3 and inform the reference Member State for the decision taken
p.(None): in writing within 90 days from the date of receipt thereof.
p.(None):
p.(None): (5) Within 30 days of the receipt of a notification for the accomplishment of the procedure from the part of the
p.(None): Reference Member State, the executive director of the BDA shall issue a marketing authorisation of the medicinal
p.(None): product for the territory of the Republic of Bulgaria with the approved summary of product characteristics, packaging
p.(None): mock-up, and package leaflet.
p.(None):
p.(None):
p.(None): Art. 75. (1) Where the person according to Art. 26, para 1 submits simultaneously to the BDA and in other Member
p.(None): States an application for marketing authorisation of a medicinal product for which there is a granted marketing
p.(None): authorisation on the territory of a Member State, this person shall indicate in the application the regulatory
p.(None): authority of the Member State, hereinafter referred to as "reference member state", which shall establish a draft
p.(None): assessment report, a draft summary of product characteristics and packaging mock-up and package leaflet.
p.(None): (2) Together with the application the person according to para 1 shall submit to the BDA a dossier identical to the one
p.(None): submitted in all other Member States indicated in the application, hereinafter referred to as "states concerned".
p.(None): (3) The BDA and the applicant shall officially receive from the regulatory authority of the Reference Member State the
p.(None): draft assessment report, draft summary of product characteristics and draft packaging mock-up and packaging leaflet.
p.(None): (4) The BDA shall review the documents according to para 3 and inform the Reference Member State for the decision taken
p.(None): in writing within 90 days from the date of receipt thereof.
p.(None): (5) Within 30 days of the receipt of a notification for the accomplishment of the procedure from the part of the
p.(None): Reference Member State, the executive director of the BDA shall issue a marketing authorisation of the medicinal
p.(None): product for the territory of the Republic of Bulgaria with the approved summary of product characteristics, packaging
p.(None): mock-up, and patient leaflet.
p.(None):
p.(None):
p.(None): Art. 76. (1) Where the Republic of Bulgaria is a Reference Member State according to Art. 74, the BDA shall:
p.(None): 1. forward the assessment report accompanied by the approved summary of product characteristics and the approved
p.(None): packaging mock-up and package leaflet within 90 days from the submission of a valid documentation;
p.(None): 2. close the procedure and notify the applicant and the Concerned Member States provided that all Concerned
p.(None): Member States have approved it.
p.(None): (2) Within 30 days of the closure of the procedure according to para 1, point 2, the executive director of the
p.(None): BDA shall issue a marketing authorisation of the medicinal product for the territory of the Republic of Bulgaria with
p.(None): the approved summary of product characteristics, packaging mock-up, and package leaflet.
p.(None): (3) Where The Republic of Bulgaria is a reference Member State according to Art. 75, the BDA shall:
p.(None): 1. submit to the regulatory authorities of the Concerned Member States and the applicant the draft assessment
...
p.(None): 1. to reveal and confirm clinical, pharmacological, or pharmacodynamic effects of one or more study medicinal products;
p.(None): 2. to determine the adverse reactions to one or more study medicinal products;
p.(None): 3. to investigate the absorption, distribution, metabolism, and excretion of one or more study medicinal products
p.(None): and/or to establish their safety and/or efficacy.
p.(None):
p.(None):
p.(None): Art. 82. (1) Clinical trials in human subjects shall be conducted with observation of the
p.(None):
p.(None): basic principles for the protection of human rights and human dignity in any medico-biological study according to the
p.(None): Helsinki Declaration.
p.(None): (2) Any clinical test of medicinal products in human subjects including bioavailability and bioequivalence shall be
p.(None): planned, conducted, and reported in compliance with the principles of Good Clinical Practice and in accordance with the
p.(None): requirements of this Act.
p.(None): (3) The rules of Good Clinical Practice shall be laid down in a regulation issued by the Minister of Health.
p.(None):
p.(None):
p.(None): Art. 83. (1) The rights, safety, and health of the subjects in the clinical test shall be placed above the interests of
p.(None): science and society.
p.(None): (2) The available preclinical and/or clinical data about the study medicinal product shall be sufficient to
p.(None): substantiate the conduct of a clinical test.
p.(None):
p.(None):
p.(None): Art. 84. (1) The clinical test shall be scientifically substantiated and clearly described in detail in the study
p.(None): protocol.
p.(None): (2) During the development of the documentation and the conduct of the clinical test of a medicinal product, the
p.(None): contracting authority and the researcher shall take into account any available guidelines published by the
p.(None): European Commission and the European Medicine Agency, and the scientific committees thereto.
p.(None):
p.(None):
p.(None): Art. 85. (1) Any clinical test of a medicinal product in human subjects shall be conducted with observation of the
p.(None): required quality assurance procedures in any aspect of the clinical test.
p.(None): (2) The whole information from a clinical test shall be recorded and kept in a manner ensuring its accurate reporting,
p.(None): interpretation, and confirmation with protection of the personal data of the subjects.
p.(None):
p.(None):
p.(None): Art. 86. (1) All persons conducting clinical trials shall possess the respective qualification, training, and
p.(None): experience to perform the study related tasks in compliance with rules for Good Clinical Practice.
p.(None): (2) A clinical test of a medicinal product shall be conducted under the leadership of a medical doctor or a doctor
p.(None): of dental medicine with acknowledged medical specialty in the respective field and shall be familiar with the
p.(None): available preclinical and/or clinical data about the product and the study risks and procedures.
p.(None): (3) During a clinical test, responsible for the medical care delivered to a study subject and for the medical decisions
p.(None): taken shall be a medical doctor or a doctor of dental medicine with adequate qualification.
p.(None):
p.(None):
p.(None): Art. 87. (1) (amend. – SG 59/10, in force from 31.07.2010, amend. – SG, 60/2011, in force from 5. 8. 2011) A clinical
p.(None): test may only be conducted in hospital healthcare establishments, mental health centres, skin and venereal diseases
...
p.(None): obtaining additional data.
p.(None): (2) Medicinal products authorised for use in the Republic of Bulgaria within the meaning of para 1 above shall be
p.(None): medicinal products that have received marketing authorisation under the terms of this Act or under the terms
p.(None): of Regulation N 726/2004 (EC) of the European Parliament and of the Council.
p.(None):
p.(None):
p.(None): Art. 89. (1) A clinical test in human subjects shall be conducted with medicinal products, which are manufactured,
p.(None): maintained, and stored in compliance with the rules for Good Manufacturing Practice for medicinal products
p.(None): under development and research.
p.(None): (2) The rules for Good Manufacturing Practice for medicinal products under development and research
p.(None): shall be laid down in the regulation according to Art. 152.
p.(None): (3) A medicinal product can be proposed for a clinical test where pharmacological and toxicological studies have
p.(None): been conducted in accordance with the requirements for Good Laboratory Practice.
p.(None):
p.(None):
p.(None): Art. 90. The clinical test can be started and conducted provided that:
p.(None): 1. the anticipated therapeutic benefits for the study subjects, for current and future patients and the
p.(None): benefits for the healthcare justify the foreseen risks;
p.(None): 2. the physical and mental immunity of the study subjects, their right of immunity of their private life and the
p.(None): right of personal data protection have been guaranteed pursuant to the Protection of Personal Data Act;
p.(None): 3. insurance or indemnity for covering researcher or contracting authority liability has been provided.
p.(None):
p.(None):
p.(None): Art. 91. The contracting authority and the principal researcher shall make insurance covering their liability
p.(None): for property or non-property damages to the study subjects caused in or on the occasion of the conduct of the clinical
p.(None): test.
p.(None):
p.(None):
p.(None): Art. 92. (1) The contracting authority shall be responsible in case of injury of the health or death caused by or in
p.(None): the occasion of the conduct of the clinical test where the clinical test has been conducted in compliance with the
p.(None): requirements and procedures of the study protocol as approved by the ethics committee.
p.(None): (2) The principal researcher shall be responsible in case of injury of the health or death caused by or in the occasion
p.(None): of the conduct of the clinical test where the clinical test has not
p.(None):
p.(None): been conducted in compliance with the requirements and procedures of the study protocol as approved by the ethics
p.(None): committee.
p.(None):
p.(None):
p.(None): Art. 93. (1) Contracting authority of a clinical test shall be a person established on the territory of a Member State.
p.(None): (2) Contracting authority and researcher can be the same person.
p.(None):
p.(None):
p.(None): Art. 94. The contracting authority shall gratuitously provide the study medicinal product(s) and any device
p.(None): required for the administration thereof.
p.(None):
p.(None):
p.(None): Art. 95. (1) The contracting authority shall develop the labelling of the study medicinal product in compliance with
p.(None): the rules for Good Manufacturing Practice for medicinal products under development and research.
p.(None): (2) The requirements relating to the data on the packaging of medicinal products for a clinical test shall be
p.(None): determined by the regulation according to Art. 170.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): has:
p.(None): Art. 96. (1) A clinical test with medicinal products shall only be allowed in a person who
p.(None):
p.(None): 1. been informed in a preliminary conversation with a physician member of the study
p.(None): team about the purposes, risks and inconveniences of the study and about the conditions in which it is to be conducted;
p.(None): 2. been informed about his/her right to withdraw from the study at any time without this having any negative
p.(None): consequences for him/her;
p.(None): 3. personally given written informed consent to participate having been familiarised of the essence, importance,
p.(None): consequences, and eventual risks of the clinical test.
p.(None): (2) Where the person cannot write, the informed consent to participate in the clinical test shall be given by word of
p.(None): mouth in the presence of at least one independent witness who shall certify in writing that this subject has expressed
p.(None): informed consent to participate in the clinical test in person.
p.(None): (3) The informed consent according to para 1, point 3, and para 2 can only be given by a capable person who
p.(None): understands the essence, importance, scope, consequences, and eventual risks of the clinical test. Informed
...
p.(None): by the parent who is exercising the parental rights.
p.(None): (5) Minor’s, parents’ and guardian’s’ consent can be withdrawn at any time without negative consequences
p.(None): for the minor person.
p.(None): (6) The express will of the minor person to at any time withdraw from the clinical test must be taken into
p.(None): consideration by the researcher or, in case of necessity, by the principal researcher.
p.(None): (7) The minor or underage person shall be provided information about the clinical test and for the eventual risks and
p.(None): benefits in a manner understandable for that person by a physician with experience with minor or underage persons.
p.(None):
p.(None):
p.(None): Art. 98. Informed consent to participate in a clinical test shall not be required if immediate decision is imperative
p.(None): to save the patient’s life or if at that moment it cannot be obtained. Decision shall be taken by at least two
p.(None): physicians who are not part of the study team.
p.(None):
p.(None):
p.(None): Art. 99. (1) In the course of the clinical test the study subject shall receive additional information by a person
p.(None): independent from the contracting authority upon request.
p.(None): (2) The written information provided to the subjects in a clinical test of a medicinal product shall
p.(None): contain contact details of an independent person for additional information.
p.(None):
p.(None): Section .
p.(None): Clinical Trials in Vulnerable Patient Groups
p.(None):
p.(None): Art. 100. A clinical test in minor or underage persons can be undertaken provided that:
p.(None): 1. the study protocol has been approved by the respective ethics committee after discussion of the
p.(None): clinical, moral, and psycho-social aspects of childhood age in which at least two paediatricians have participated;
p.(None): 2. there is an anticipated direct benefit of the clinical test for the patient group, which is to be included;
p.(None): 3. the study is directly associated with the clinical condition from which the minor or underage person is suffering;
p.(None): 4. the study medicinal product is designated for the diagnosis, treatment, or prophylaxis of diseases, which are
p.(None): specific for minor or underage persons;
p.(None): 5. the study is designated to be conducted in minor or underage persons;
p.(None):
p.(None): 6. the study purpose is to check data obtained in clinical trials in persons who are capable of giving
p.(None): informed consent or of data obtained by other research methods;
...
p.(None): (3) The committees according to para 1 can involve external specialists for the needs of their work.
p.(None): (4) In clinical trials in minor or underage persons the respective ethics committee at the healthcare establishment can
p.(None): involve external experts in order to facilitate its work.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): years.
p.(None): Art. 105. (1) The mandate of the ethics committee members shall have duration of 4
p.(None):
p.(None): (2) One half of the composition of the ethics committees shall be renewed every 2 years.
p.(None): (3) A member of an ethics committee cannot be appointed in the same committee for
p.(None): more than two consecutive mandates.
p.(None):
p.(None):
p.(None): Art. 106. (1) The ethics committees according to Art. 103, para 1 and 2, shall draw written standard operating
p.(None): procedures in compliance with the rules for Good Clinical
p.(None): Practice, which shall determine the conditions and order for their work within one month from its establishment.
p.(None): (2) The standard operating procedures of the ethics committees shall be approved by the executive director of the BDA.
p.(None): (3) The sessions of the ethics committees shall be held in camera. In case of necessity, the chairman of the ethics
p.(None): committee can invite the contracting authority or the principal researcher to participate.
p.(None): (4) only members of ethics committees who do not participate in a particular clinical test and are administratively and
p.(None): financially independent of the contracting authority and the principal researcher can vote and participate in the
p.(None): discussion.
p.(None): (5) To certify the circumstances according to para 4, the members of the ethics committees shall sign
p.(None): declarations for conflict of interests.
p.(None):
p.(None):
p.(None): Art. 107. (1) Central Ethics Committee shall be established to the Council of Ministers.
p.(None): (2) The Central Ethics Committee shall consist of 9 members, representatives of both genders and shall obligatorily
p.(None): include medical doctors, doctors of dental medicine, a psychologist, a theologian, and a lawyer.
p.(None): (3) The composition of the committee shall be determined by a decision of the Council of Ministers according to a
p.(None): proposal of the Minister of Health for a period of 4 years.
p.(None): (4) The Central Ethics Committee shall provide opinions on deontological and ethics issues in the field of clinical
p.(None): trials where it is approached by the ethics committees according to
p.(None):
p.(None): Art. 103, para 1 and 2, the BDA, or by contracting authorities.
p.(None): (5) The Central Ethics Committee shall carry out the methodical guidance with respect to the ethics committees
p.(None): according to Art. 103, para 1 and 2.
p.(None): (6) The sessions of the Central Ethics Committee shall be held in camera. In case of necessity, the chairman of the
p.(None): Central Ethics Committee can invite the contracting authority or the principal researcher to participate.
p.(None): (7) The Council of Ministers, according to a proposal of the Minister of Health, shall determine the conditions and
p.(None): order for the work of the Central Ethics Committee by a regulation.
p.(None):
p.(None):
p.(None): Art. 108. (1) A member of the Central Ethics Committee cannot be appointed in the same committee for more than two
p.(None): consecutive mandates. The duration of a mandate shall be 4 years.
p.(None): (2) Half of the composition of the Central Ethics Committee shall be renewed every 2
p.(None): years.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): met:
p.(None): Section V.
p.(None): Authorisation to Conduct a Clinical Test
p.(None):
p.(None): Art. 109. A clinical test can be started provided that the following conditions have been
p.(None):
p.(None): 1. the respective ethics committee has given a positive opinion and
p.(None): 2. the executive director of BDA has issued a written authorisation for the conduct
p.(None): thereof where one of the study medicinal products is either:
p.(None): a) a medicinal product for gene therapy;
p.(None): b) a medicinal product for somato-cellular therapy;
p.(None): c) a medicinal product, which contains genetically modified organisms;
p.(None): d) a high technology medicinal product described in the Annex to Regulation (EC) 726/2004 of the European
p.(None): Parliament and the Council;
p.(None): e) a medicinal product, which contains biological substance(s) of human or animal origin or contains biological
p.(None): components of human or animal origin or the manufacturing process of which involves such components, or
p.(None): 3. the contracting authority has not been notified by the BDA in writing that the clinical test cannot be conducted
p.(None): within the time limit as set out by the law; for medicinal products outside those according to 2.
p.(None):
p.(None):
p.(None): Art. 110. (1) For obtaining opinion, the principal researcher or the coordinating researcher shall submit to
p.(None): the respective ethics committee according to Art. 103 the following documentation:
p.(None): 1. administrative documentation;
p.(None): 2. subject information;
p.(None): 3. documentation about the study protocol;
p.(None): 4. documentation about the study medicinal product(s);
p.(None): 5. documentation about the technical requirements and about the staff;
p.(None): 6. data about the financing and administrative organisation of the clinical test.
p.(None): (2) The content, form, and requirements to the documentation according to para 1 shall be determined in the regulation
p.(None): according to Art. 82, para 3.
p.(None):
p.(None): Art. 111. (1) The ethics committee shall establish an opinion taking into consideration the following:
p.(None): 1. importance of the clinical test;
p.(None): 2. positive assessment of the ratio between the anticipated benefits and risks according to Art. 90, para 1, and the
p.(None): motivation of the conclusions;
p.(None): 3. protocol of the clinical test;
p.(None): 4. to what extent the principal researcher and the study team are adequate for the conduct of the
p.(None): clinical test;
p.(None): 5. researcher’s brochure;
p.(None): 6. availability of the required equipment and its adequate quality;
p.(None): 7. compliance and completeness of the written information, which is to be given, as well as the procedure for obtaining
p.(None): informed consent and the validity of the clinical test in human subjects incapable of giving informed consent in the
p.(None): cases according to Art. 100 and 101;
p.(None): 8. provided indemnity or recovery in case of injury or death, which could result from the clinical test;
p.(None): 9. insurance covering researcher or contracting authority liability;
p.(None): 10. where necessary, the conditions and order for remuneration or indemnification of study researchers and subjects
p.(None): and the elements of the contract between the contracting authority and the healthcare establishment;
p.(None): 11. conditions and order for subject recruitment.
p.(None): (2) The ethics committee shall:
p.(None): 1. give positive opinion;
p.(None): 2.. refuse in a motivated manner, or
p.(None): 3. request amendment of a part of the documentation as a condition for obtaining a positive opinion.
p.(None):
p.(None):
p.(None): Art. 112. (1) Within 60 days from the submission of an application, the ethics committee shall pass resolution with an
p.(None): opinion, which shall be sent to the applicant and the BDA.
p.(None): (2) Where the clinical test involves a medicinal product for gene therapy or somato- cellular therapy or a medicinal
p.(None): product containing genetically modified organisms, the time limit according to para 1 shall be extended by 30 days.
p.(None): (3) Where for the review of a clinical test involving a medicinal product for gene therapy or somato-0-cellular therapy
p.(None): or a medicinal product containing genetically modified organisms it shall be imperative to consult a specially
p.(None): established for the purpose expert committee by an order to the director of the BDA, the time limit for drawing an
p.(None): opinion shall be 180 days.
p.(None):
p.(None):
p.(None): Art. 113. (1) During assessment of the documentation, the ethics committee can once request additional written
p.(None): documentation from the applicant. The time limits according to Art. 112 shall cease to run until submission of the
p.(None): requested documentation.
...
p.(None):
p.(None): for multicentre tests according to Art. 103, para 1.
p.(None): (2) Where the clinical test is to be conducted in only one centre on the territory of the Republic of Bulgaria, the
p.(None): application can be submitted to the ethics committee according to Art. 103, para 1 or 2 at applicant’s discretion.
p.(None): (3) The opinion of the ethics committee according to Art. 103, para 1, shall be valid for all centres on the territory
p.(None): of the Republic of Bulgaria.
p.(None): (4) (new – SG 12/11, in force from 08.02.2011) For submission of applications to obtain opinion by the Ethics
p.(None): Committee, the Ministry of Health shall collect a fee in amount as determined by the Tariff envisaged in
p.(None): Art. 21. Para 2.
p.(None):
p.(None):
p.(None): Art. 115. (1) Where the opinion of the respective ethics committee according to Art. 103 is negative, the applicant can
p.(None): appeal before the Central Ethics Committee within 90 days of the date of notification.
p.(None): (2) Where the negative opinion of the respective ethics committee according to Art. 103 is established without taking
p.(None): into consideration the opinion of the expert commission according to Art. 112, para 3, the contracting authority can,
p.(None): within 14 days of the date of notification, request in writing that the committee revise its opinion.
p.(None): (3) The expert committee according to Art. 112, para 3, shall, within 60 days of the date of receipt of a written
p.(None): application of the applicant, pass a resolution on the negative opinion of the respective committee and can either
p.(None): challenge or support it, wherefore it shall notify the ethics committee in writing. The ethics committee shall take
p.(None): final decision and send it to the applicant.
p.(None): (4) Where the expert commission according to Art. 112, para 3, supports the negative opinion, the contracting authority
p.(None): can, within 14 days of the date of notification, appeal against the decision before the Central Ethics Committee.
p.(None): (5) The opinion of the Central Ethics Committee shall be final and binding on the respective ethics
p.(None): committee.
p.(None):
p.(None):
p.(None): Art. 116. (1) The applicant shall submit to the BDA an application after the pattern for the conduct of the clinical
p.(None): test.
p.(None): (2) Where the applicant for the clinical test is not the contracting authority, the application shall be accompanied by
p.(None): documentation certifying that the person has been empowered by the contracting authority.
p.(None): (3) Where the contracting authority has not been registered as a natural person or legal entity on the territory of
p.(None): Bulgaria, the application shall be accompanied by a document evidencing the data of his empowered
p.(None): representative on the territory of the Republic of Bulgaria.
p.(None): (4) The following documents shall be appended to the application:
p.(None): 1. administrative documentation;
p.(None): 2. subject information;
p.(None): 3. documentation about the study protocol;
p.(None): 4. documentation about the study medicinal product(s);
p.(None): 5. documentation about the technical requirements and about the staff;
p.(None): 6. data about the financing and administrative organisation of the clinical test.
p.(None): (5) The content, form, and requirements to the documentation according to para 1 shall be determined in the regulation
p.(None): according to Art. 82, para 3.
p.(None):
p.(None): Art. 117. (1) During assessment of the documentation, the BDA can once request additional written
p.(None): documentation from the applicant.
p.(None): (2) The time limits according to Art. 118, 119, and 120 shall cease to run until submission of the requested
p.(None): documentation.
p.(None):
p.(None):
p.(None): Art. 118. (1) Within 60 days of the date of submission of an application for a clinical test of medicinal products
p.(None): according to Art. 109, point 3, the BDA shall notify the applicant that:
p.(None): 1. the clinical test can be conducted on the territory of the Republic of Bulgaria or
p.(None): 2. the clinical test cannot be conducted indicating the reasons therefore.
p.(None): (2) In the cases according to para 1, point 2, the contracting authority can submit to the BDA an application amended
p.(None): in accordance with the motives set out or submit the required information in accordance with the requirements of the
p.(None): BDA within 30 days.
p.(None): (3) Within 30 days of the submission of the amended application according to para 2 or the additional information, the
p.(None): BDA shall notify the applicant in writing that:
p.(None): 1. the clinical test can be conducted on the territory of the Republic of Bulgaria or
p.(None): 2. that it refuses the conduct of the clinical test stating the reasons therefore.
p.(None): (4) The refusal according to para 3, point 2, shall be subject to appeal under the terms of the Administrative
p.(None): Procedure Code.
p.(None): (5) The clinical test can be started provided that within the time limit according to para 1 the BDA has not issued a
p.(None): notification with motives of disapproval of the clinical test.
p.(None): (6) Provided that the applicant does not submit an application according to para 2 within the stipulated time limit,
p.(None): the procedure shall be terminated and the clinical test shall no be conducted.
p.(None):
p.(None):
p.(None): Art. 119. (1) Within 60 days of the date of submission of an application for a clinical test with the medicinal
p.(None): products according to Art. 109, point 2,, the executive director of the BDA shall:
p.(None): 1. issue authorisation for the conduct of the clinical test, or
p.(None): 2. issue a motivated refusal.
p.(None): (2) The refusal according to para 1, point 2, shall be subject to appeal under the terms of the Administrative
p.(None): Procedure Code.
p.(None):
p.(None):
p.(None): Art. 120. (1) In case of medicinal products according to Art. 109, point 2, letters "a" - "c" the time limit according
p.(None): to Art. 119, para 1, for the issue of authorisation by the BDA for the conduct of a clinical test can be extended by 30
p.(None): days.
p.(None): (2) Provided that the BDA should consult the expert commission according to Art. 112, para 3, which is to assess the
p.(None): safety of the medicinal products according to para 1, the extended time limit according to para 1 can be extended by
p.(None): another 90 days.
p.(None):
p.(None):
p.(None): Art. 121. The executive director of the BDA shall refuse to issue authorisation for the conduct of a clinical test of
p.(None): medicinal products for gene therapy where there is a risk of modifying the genome of the reproductive cells of a study
p.(None): subject.
p.(None):
p.(None):
p.(None): Art. 122. (1) In case of a multicentre clinical test in the Republic of Bulgaria and in a third
p.(None):
p.(None): state, the BDA shall request the contracting authority to submit a declaration that he shall provide access to
p.(None): representatives of the BDA for inspection aimed at the establishment of compliance with the requirements and principles
p.(None): of Good Clinical Practice and Good Manufacturing Practice.
p.(None): (2) Provided that the contracting authority should not submit the declaration according to para 1, the BDA shall not
p.(None): review the submitted application.
p.(None):
p.(None):
p.(None): Art. 123. The contracting authority shall declare that the documentation submitted to the BDA and the ethics committee
p.(None): contains the same information.
p.(None):
p.(None):
p.(None): Art. 124. (1) The procedures in the ethics committee and in the BDA can be carried out simultaneously or consecutively
p.(None): at the discretion of the contracting authority.
p.(None): (2) The time limit for documentation review according to Art. 118, para 1, shall not cease to run in case of lack of
p.(None): decision of the ethics committee.
p.(None):
p.(None):
p.(None): Art. 125. The clinical test shall be conducted in compliance with the study protocol, which has received positive
p.(None): opinion of the respective ethics committee according to Art. 103 and under the conditions set out in the submitted
p.(None): documentation.
p.(None):
p.(None): Section V. Amendments
p.(None):
p.(None): Art. 126. (1) The contracting authority can at any time make amendments in the study protocol different from the
p.(None): essential amendments according to Art. 127, para 2.
p.(None): (2) In the cases according to para 1 the contracting authority shall keep the documentation relating to
p.(None): the amendments and shall provide it to the BDA and the ethics committee upon request.
p.(None):
p.(None):
p.(None): Art. 127. (1) Amendment in the conduct of a clinical test can be required by the BDA wherever necessary to guarantee
p.(None): the safety of the subjects, the scientific value of the clinical test, and/or the observation of the rules for Good
p.(None): Clinical Practice.
p.(None): (2) Essential amendment in the conduct of the clinical test shall be any amendment in the study protocol and/or in the
p.(None): information and the documentation according to Art. 110 and 116, which can affect:
p.(None): 1. the safety or the physical and mental immunity of the study subjects;
p.(None): 2. the scientific value of the clinical test;
p.(None): 3. the conduct or the organisation of the clinical test;
p.(None): 4. the quality or the safety of any study medicinal products.
p.(None):
p.(None):
p.(None): Art. 128. (1) The contracting authority can also implement planned study essential protocol and
p.(None): documentation amendments according to Art. 110 and 116 wherever:
p.(None): 1. the ethics committee has given a written positive opinion;
p.(None): 2. the executive director of the BDA has issued a written authorisation as to clinical trials with medicinal products
p.(None): according to Art. 109, point 2, or
p.(None):
p.(None): 3. the contracting authority has not been notified by the BDA about refusal of the proposed amendment in
p.(None): the clinical test with medicinal products according to Art. 109, point 3.
p.(None): (2) The provision of para 1 shall not apply to changes in an approved protocol, which are imperative to protect the
p.(None): subjects from immediate threat in case of occurrence or new information associated with the conduct of
p.(None): the clinical test or the development of the study medicinal product.
p.(None): (3) In the cases according to para 2, the contracting authority shall immediately notify the ethics committee
p.(None): according to para 1, point 1, and the BDA about the available new information, the measures taken, and the
p.(None): applied changes in the protocol.
p.(None):
p.(None):
p.(None): Art. 129. (1) While planning essential amendments to the clinical test and the documentation according to
p.(None): Art. 110 and 116, the applicant shall submit a formal written application to the BDA and the respective
p.(None): ethics committee.
p.(None): (2) The application shall be accompanied by documentation, which is necessary for grounding the amendments
p.(None): and certifies that after the implementation of the amendment the assessment of the benefit/risk ratio according to Art.
p.(None): 90, para 1, shall remain unchanged.
p.(None): (3) The requirements relating to the application and the documentation for the amendment shall be determined
p.(None): in the regulation according to Art. 82, para 3.
p.(None):
p.(None):
p.(None): Art. 130. (1) Within 35 days of receipt of an application for amendment, the ethics committee shall
p.(None): notify the contracting authority of its decision by issuing:
p.(None): 1. positive opinion on the requested amendment or
p.(None): 2. motivated refusal of the amendments in the clinical test.
p.(None): (2) Within 35 days of the date of receipt of an application with positive opinion of the ethics committee, the BDA
p.(None): shall:
p.(None): 1 approve the amendments in a clinical test of medicinal products according to Art. 109, point 2, or
p.(None): 2. disapprove the amendments with explicit motivation.
p.(None): (3) Provided that within 35 days of the submission of the documentation for amendments in clinical trials of medicinal
p.(None): products according to Art. 109, point 3, the applicant does not receive notification for disapproval of the amendment,
p.(None): the proposed amendments can be implemented.
p.(None):
p.(None):
p.(None): Art. 131. (1) In the cases according to Art. 130, para 2, point 2, the contracting authority can submit alteration of
p.(None): the proposed amendments consistent with the motives not later than 14 days prior to the implementation of the
p.(None): amendments.
p.(None): (2) Within 14 days of the date of receipt of the amended documentation according to para 1, the BDA shall issue and
p.(None): amendment of its authorisation for the clinical test of medicinal products according to Art. 109, point 2, or shall
p.(None): issue a refusal, which shall not be subject to appeal.
p.(None): (3) The refusal according to para 2 shall not be subject to appeal.
p.(None):
p.(None): Section V. Cessation of the Clinical Test
p.(None):
p.(None): Art. 132. (1) The contracting authority or the researcher can undertake urgent measures
p.(None):
p.(None): to protect the study subjects from suddenly occurred risks for their safety and health.
p.(None): (2) In the cases according to para 1 the contracting authority shall immediately notify the BDA and the respective
p.(None): ethics committee about the undertaken actions and the reasons, which have raised these.
p.(None):
p.(None):
p.(None): Art. 133. (1) Where the clinical test is to be conducted under conditions different from those determined at the issue
p.(None): of the authorisation or there is information vitiating the scientific validity of the clinical test or the safety of
p.(None): the study subjects, the BDA can temporarily stop the conduct of the test or put a ban on it.
p.(None): (2) The ban can be imposed for a specific centre or for all centres in a multicentre clinical test on the territory of
p.(None): the Republic of Bulgaria.
p.(None): (3) In case of termination of the clinical test in all centres on the territory of the Republic of Bulgaria, the BDA
p.(None): shall, prior to undertaking actions according to para 1, notify the contracting authority and the principal researcher
p.(None): or the coordinating researcher in writing.
p.(None): (4) Within 7 days of the receipt of the notification the contracting authority and/or the principal researcher can
p.(None): express an opinion on the undertaken measures by the BDA.
p.(None): (5) The provision of para 3 shall not apply provided that there is an immediate threat for the health and safety of the
p.(None): study subjects.
p.(None):
p.(None):
p.(None): Art. 134. In the cases according to Art. 133, para 1, the BDA shall immediately notify the respective ethics
p.(None): committee, the regulatory bodies of the Member States, the European Medicines Agency, and the European
p.(None): Commission about the undertaken measures and the reasons therefore.
p.(None):
p.(None): Section V. Pharmaco-vigilance
p.(None):
p.(None): Art. 135. (1) The principal researcher shall immediately report in writing or by word of mouth any serious adverse
p.(None): event that has occurred in the course of the clinical test in a study subject at the centre he is responsible for.
p.(None): (2) A detailed written report shall be submitted after the report according to para 1.
p.(None): (3) At the notification according to para 1 and in the report according to para 2 the study subject shall be identified
p.(None): by a unique code number as defined in the study protocol.
p.(None): (4) The provisions of para 1 and 2 shall not apply provided that the protocol of the clinical test or the researcher’s
p.(None): brochure explicitly states that there is no requirement for an urgent report of a specific serious adverse event.
p.(None): (5) The researcher shall report to the contracting authority any adverse events or laboratory aberrations,
p.(None): which are defined in the study protocol as critical with respect to safety, within the timelines and format as required
p.(None): by the protocol.
p.(None):
p.(None):
p.(None): Art. 136. Where the outcome of an adverse event during the conduct of a clinical test is death, the researcher shall
p.(None): be obliged to submit to the contracting authority and the ethics committees any information requested
p.(None): additionally.
p.(None):
p.(None): Art. 137. The contracting authority shall keep detailed records of any serious adverse events provided to him by the
p.(None): researchers and shall present these upon request to the BDA or the regulatory bodies of the Member States where
p.(None): the clinical test is conducted in case of multicentre clinical test.
p.(None):
p.(None):
p.(None): Art. 138. (1) The contracting authority shall notify the BDA, the regulatory bodies of all Member States where the
p.(None): clinical test is conducted in case of a multicentre test, and the respective ethics committee of any
p.(None): suspected serious adverse drug reaction occurring in the course of the clinical test, which has resulted in death or
p.(None): has been life-threatening not later than 7 days of receipt of information thereof.
p.(None): (2) The contracting authority shall provide the bodies according to para 1 with additional information on the case
p.(None): within 8 days of the date of the notification sent.
p.(None): (3) The contracting authority shall notify the bodies according to para 1 of any other suspected unexpected serious
p.(None): drug reactions occurring in the course of the clinical test, which are different from those set out in para 1, not
p.(None): later than 15 days from the date of receipt of the information for their occurrence.
p.(None):
p.(None):
p.(None): Art. 139. (1) The contracting authority can fulfil his obligations according to Art. 138, para 1 and 3, by entering his
p.(None): reports in the European adverse drug reactions database.
p.(None): (2) Where the clinical test is also conducted in countries outside the Member States and the European Economic Area,
p.(None): the contracting authority shall enter his reports of suspected unexpected serious adverse drug reactions in
p.(None): the European adverse drug reactions database.
p.(None): (3) (amend. – SG, 102/2012, in force from 21.12.2012) The format and content of the reports for adverse drug reactions
p.(None): shall be determined by the regulation according to Art. 82, Para. 3.
p.(None): (4) The contracting authority shall inform the researchers conducting a clinical test with medicinal product about any
p.(None): suspected unexpected serious adverse drug reaction associated with the study medicinal product irrespective of its
p.(None): origin.
p.(None):
p.(None):
p.(None): Art. 140. (1) The contracting authority shall submit to the BDA and the respective ethics committee a list of all
p.(None): suspected serious adverse drug reactions occurring during the past period and a report about the safety of the study
p.(None): subjects once yearly.
p.(None): (2) (amend. – SG, 102/2012, in force from 21.12.2012) The format and content of the reports for adverse drug reactions
p.(None): shall be determined by the regulation according to Art. 82, Para. 3.
p.(None):
p.(None):
p.(None): Art. 141. (1) The BDA shall document any information about suspected unexpected serious adverse drug
p.(None): reactions of the study medicinal products provided under the terms of Art. 138, para 1 and 3.
p.(None): (2) The BDA shall immediately enter the information according to para 1 in the European adverse drug reactions
p.(None): database.
p.(None):
p.(None): Section V.
p.(None): Notification of Clinical Test Closure
p.(None):
p.(None): Art. 142. (1) The contracting authority shall notify in writing the BDA and the respective ethics committee of the
p.(None): closure of the clinical test on the territory of the Republic of Bulgaria.
p.(None): (2) The notification shall be submitted within 90 days of the closure of the clinical test in a format as defined by
p.(None): the regulation according to Art. 82, para 3.
p.(None): (3) Provided that nothing is otherwise stipulated in the protocol as approved by the respective ethics
p.(None): committee, the last subject visit shall be considered as end of study.
p.(None): (4) Where the study is prematurely terminated, the contracting authority shall notify the BDA and the respective ethics
p.(None): committee within 15 days of taking such decision providing the reasons thereof.
p.(None):
p.(None):
p.(None): Art. 143. The contracting authority shall submit a final report of the clinical test to the BDA and the respective
p.(None): ethics committee.
p.(None):
p.(None):
p.(None): Art. 144. (1) The BDA shall enter data of any clinical test conducted on the territory of the Republic of Bulgaria in
p.(None): the European clinical trials database: application submitted, ethics committee decision, authorisation, essential
p.(None): amendments, end of study, and data of any audit conducted.
p.(None): (2) Upon request by another Member State, the European Medicines Agency or the European Commission, the BDA shall
p.(None): provide additional information besides that entered in the European clinical trials database.
p.(None): (3) During the fulfilment of its obligations according to para 1, the BDA shall observe the published guidelines of the
p.(None): European Commission.
p.(None):
p.(None): Chapter four.
p.(None): NON-INTERVENTIONAL STUDY (NEW, PREVIOUS SECTION IX,"NON-INTERVENTIONAL STUDY" – SG 12/11, IN FORCE FROM 08.02.2011)
p.(None):
p.(None): Art. 145. (1) (suppl. – SG 12/11, in force from 08.02.2011) A non-interventional study shall be conducted with
p.(None): medicinal products authorised for use in the Republic of Bulgaria where these are studied in order to obtain additional
p.(None): information about the product prescribed in the usual manner in compliance with the conditions determined in the
p.(None): marketing authorisation. No additional diagnostic or monitoring procedures, different from the usual practices shall be
p.(None): applied to the patients in non-interventional studies, and epidemiological methods should be used for the analysis of
p.(None): the collected data.
p.(None): (2) (amend. – SG 12/11, in force from 08.02.2011, repealed – SG, 102/2012, in force from 21.12.2012)
...
p.(None): manufacturing dossier of the product, and the information submitted according to Art. 110, Para. 1, point 4.
p.(None): (7) (former Para. 6 - SG, 102/2012, in force from 21.02.2012) The qualified person shall keep a register of the issued
p.(None): release certificates for each batch of a medicinal product.
p.(None): (8) (former Para. 7 - SG, 102/2012, in force from 21.02.2012) The data from the register according to Para. 6 shall be
p.(None): kept at least 5 years after the last entry and shall be provided to the control bodies upon request.
p.(None): (9) (former Para, 8, - SG, 102/2012, in force from 21.02.2012) In case of constitution of an administrative-penal
p.(None): procedure for violations committed during the execution of the obligations of the qualified person, the BDA
p.(None): shall order the manufacturing authorisation holder to temporarily dismiss the qualified person from the position.
p.(None): (10) (former Para. 9, - SG, 102/2012, in force from 21.02.2012) The criteria and requirements relating to
p.(None): the qualification and training of the persons according to Art. 148, point 2, shall be laid down in the regulation
p.(None): according to Art. 152.
p.(None):
p.(None):
p.(None): Art. 160. (1) The manufacturing authorisation holder shall:
p.(None): 1. ensure the performance of the manufacturing operations in compliance with the requirements of the Good
p.(None): Manufacturing Practice and in compliance with the information according to Art. 27, Para. 1, points 7
p.(None): and 8 approved from the BDA, and in the cases of medicinal products for clinical trials – in compliance with
p.(None): the information according to Art. 110, Para. 1, point 4 submitted to the agency by the contracting authority.
p.(None): 2. (amend. – SG, 102/2012, in force from 02.01.2013) use only active substances, which have been manufactured in
p.(None): compliance with the requirements of the Good Manufacturing Practice for active substances;
p.(None): 2a. (new – SG, 102/2012, in force from 02.01.2013) be certain that the assisting substances, put in the
p.(None): medicinal products are manufactured in compliance with the appropriate Good manufacturing practices for assisting
p.(None): substances, determined on the basis of an official risk assessment in compliance with the applicable directives,
p.(None): adopted by the European Commission;
p.(None): 3. ensure on a permanent basis qualified personnel for the production and control according to the
p.(None): requirements the regulation according to Art. 152;
p.(None): 4. (amend. – SG 12/11, in force from 08.02.2011) only dispose of medicinal products, which have marketing authorisation
p.(None): fulfilling the requirements of this Act;
p.(None): 5. (revoked – SG 12/11, in force from 08.02.2011);
p.(None): 6. immediately notify the control bodies in case of substitution of the qualified person according to Art. 148, point
p.(None): 2;
p.(None): 7. ensure access of the control bodies to the premises and the documentation at any
p.(None): time;
p.(None): 8. ensures to the qualified person according to Art. 148, point 2 the required condition
p.(None): to fulfill his obligations.
p.(None): 9. (new – SG, 102/2012, in force from 02.01.2013) inform immediately the BDA and the use authorisation holder, if
p.(None): information is received that the medicinal products, which fall in the scope of hi/her manufacture automation, are
...
p.(None): society;
p.(None): 10 (new – SG, 102/2012, in force from 02.01.2013) check if the manufacturers, importers or traders, from whom he/she
p.(None): receives active substances have been register by the competent body of the Member state in which they are established;
p.(None): 11. (new – SG, 102/2012, in force from 02.01.2013) check up the authenticity and quality of the active and assisting
p.(None): substances.
p.(None): (2) (new – SG, 102/2012, in force from 02.01.2013) The manufacturing authorisation holder shall perform audits in
p.(None): the production sites and trade with active substances for observation of the Good manufacturing practice
p.(None): and the Good distribution practice. The manufacture authorisation holder may sign a contract with a third person
p.(None): to carry out the audit on his/her behalf and on his/her account.
p.(None): (3) (new – SG, 102/2012, in force from 02.01.2013) The manufacturing authorisation holder shall document the undertaken
p.(None): under Para.. 1, p. 2 and 2a measures.
p.(None): (4) (former Para. 2 – SG, 102/2012, in force from 01.01.2013)The manufacturing authorisation holder shall
p.(None): keep the samples of and the documentation for the manufactured medicinal products, active substances, and
p.(None): medicinal products intended for clinical trials under the conditions and under the terms laid down in the regulation
p.(None): according to Art. 152.
p.(None): (5) (former Para. 3 – SG, 102/2012, in force from 01.01.2013)The In case of a medicinal product intended for clinical
p.(None): trials, the manufacturing authorisation holder shall guarantee that all manufacturing operations shall be carried out
p.(None): in compliance with the information submitted by the contracting authority to the BDA in accordance with the regulation
p.(None): according to Art. 82, Para. 3.
p.(None): (6) (former Para. 4 – SG, 102/2012, in force from 01.01.2013)The documentation for any deal made shall be kept for 5
p.(None): years and shall contain the date, description of the medicinal product, quantity delivered, consignee’s name and
p.(None): address, and batch number.
p.(None): (7) (former Para. 5 – SG, 102/2012, in force from 01.01.2013)The manufacturing authorisation holder shall
p.(None): ensure and maintain a system for blocking and recall of medicinal products, which have shown discrepancies with the
p.(None): requirements relating to quality.
p.(None): (8) (former Para. 6 – SG, 102/2012, in force from 01.01.2013)The manufacturing authorisation holder shall be
p.(None): obliged to block and recall the medicinal products, which have shown discrepancies with the requirements relating to
p.(None): quality, efficacy, and safety under the terms of the regulation according to Art. 274, Para. 1.
p.(None): (9) (former Para. 7 – SG, 102/2012, in force from 01.01.2013)The manufacturing authorisation holder shall be
p.(None): obliged to update the manufacturing methods in compliance with the development of new technologies and the development
p.(None): of medicinal products for tests.
p.(None): (10) (new – SG 12/11, in force from 08.02.2011,former Para. 8, amend. – SG, 102/2012, in force from 01.01.2013)) On the
p.(None): base of the manufacturing authorisation, issued under the procedure of this Section, its holder may perform import of
p.(None): auxiliary substances, needed for the manufacturing of medicinal products, enlisted in the manufacturing authorisation.
p.(None):
p.(None):
p.(None): Art. 160a. (New – SG, 60/2011, in force from 5. 8. 2011) The executive director of BDA by an order shall withdraw an
...
p.(None): complete quantitative and qualitative analysis, at least of the active substances, and all required tests and checks
p.(None): for compliance with the requirements for issuing a marketing authorisation under the terms of this Act have been
p.(None): performed prior to the introduction to the market on the territory of, irrespective whether the product
p.(None): has been manufactured in another Member State or not.
p.(None): (2) Where the batch of a medicinal product imported from a third country has been subjected to the
p.(None): analyses according to para 1 in another Member State and is accompanied y a certificate of batch release signed by
p.(None): another qualified person, no conduct of control tests on the territory of the Republic of Bulgaria shall be required.
p.(None): (3) Where the batch of a medicinal product imported from a third country with which the European Community has signed
p.(None): an agreement for mutual recognition of Good Manufacturing Practice certificates, the qualified person shall issue a
p.(None): certificate of batch release based in the documents accompanying the batch without obligation to perform control tests
p.(None): on the territory of the Republic of Bulgaria.
p.(None): (4) The qualified person according to para 1, shall issue a certificate of release for each imported batch certifying
p.(None): that the batch of the medicinal product on the territory of the Republic of Bulgaria intended for a clinical test has
p.(None): been manufactured and controlled in compliance with standards, which are equivalent to the Good Manufacturing Practice
p.(None): and with the manufacturing dossier of the product and that all required quality analyses and tests in accordance with
p.(None): the information submitted by the contracting authority to the BDA according to the regulation Art. 82, para 3, have
p.(None): been performed.
p.(None): (5) The qualified person according to Art. 161, para 2, point 1, shall issue a certificate of
p.(None):
p.(None): release for each batch of a medicinal product used as a comparator in a clinical test conducted on the territory of the
p.(None): Republic of Bulgaria, which is to be imported from a third country and is not accompanied by a document evidencing
p.(None): that the product has been manufactured and controlled in compliance with standards equivalent to the Good
p.(None): Manufacturing Practice including where this medicinal product has an issued marketing authorisation.
p.(None): (6) No conduct of control tests on the territory of the Republic of Bulgaria shall be required where the
p.(None): requirements according to para 4 or 5 have been fulfilled in another Member State or a country of the European Economic
p.(None): Area and a medicinal product intended for clinical trials is accompanied by a certificate of batch release signed by
p.(None): another qualified person.
p.(None): (7) The qualified person according to para 1 shall keep the documentation for any imported batch of a
p.(None): medicinal product at least 5 years and shall provide it to the control bodies upon request.
p.(None): (8) The import authorisation holder shall ensure and maintain a system for blocking and recall of medicinal products,
p.(None): which have shown discrepancies with the quality requirements.
p.(None): (9) The import authorisation holder shall be obliged to block and recall medicinal products, which have
p.(None): shown discrepancies with the requirements of safety, and efficacy according to the regulation according to Art.
p.(None): 274, para 1.
p.(None): (10) (amend. – SG 12/11, in force from 08.02.2011) Provisions of Art. 160, Para 1, points 4 and 7, shall also be
...
p.(None): 5. "Valid documentation" shall mean any documentation which is compliant with the requirements laid down in
p.(None): a give procedure pursuant to this Act both with respect to content and
p.(None):
p.(None): completeness.
p.(None): 6. "Substance with well established use in medical practice" shall mean a substance to which the following criteria can
p.(None): be applied:
p.(None): a) the period for proving the well established use in medical practice is not less than 10 years from the date of
p.(None): the first systematised and documented use of the substance as a medicinal product in the European Union or in
p.(None): the European Economic Area;
p.(None): b) quantitative aspects of the use of the substance, taking into consideration the degree of use in medical practice,
p.(None): the degree of use on geographical principle, and the degree of follow- up through the pharmaco-vigilance system
p.(None): including pre- and post marketing studies and published scientific literature for epidemiological studies
p.(None): and comparative epidemiological studies in particular;
p.(None): c) high degree of scientific interest in the use of the substance (number of scientific publications) and coherence
p.(None): in scientific assessments.
p.(None): 7. "Outer packaging" shall mean the packaging, which does not come in immediate contact with the medicinal
p.(None): product.
p.(None): 8. "Contracting authority" shall mean a natural or legal person, institution, or organisation responsible for the
p.(None): start-up, management, and/or financing of a clinical test.
p.(None): 9. "Generic medicinal product" shall mean a medicinal product, which has the same qualitative and quantitative
p.(None): composition as regards the active substances and the same pharmaceutical form as the reference medicinal
p.(None): product and its bioequivalence compared to the reference medicinal product has been proven in adequate
p.(None): bioavailability studies. Various immediate release oral pharmaceutical forms shall be regarded as the same
p.(None): pharmaceutical form. Various salts, esters, ethers, isomers, mixtures of isomers, complexes, or derivatives of an
p.(None): active substance shall be regarded as the same active substance except if these are significantly
p.(None): different in respect of safety and/or efficacy.
p.(None): 10. "Principal researcher" shall mean an appointed by the contracting authority medical doctor or doctor in dental
p.(None): medicine who is managing the overall conduct of a clinical test in compliance with an approved protocol and the rules
p.(None): for Good Clinical Practice and is responsible for the work of the researchers.
p.(None): 11. "Defined daily dose" shall be the mean daily maintenance dose of a given medicinal product, which administered to
p.(None): adults according to the main indication of a medicinal product.
p.(None): 12. "Good clinical practice" shall mean the aggregate of internationally recognised ethical and scientific
p.(None): quality requirement, which shall be observed during the planning, conduct, accounting, and reporting of clinical
p.(None): trials.
p.(None): 13. "Good laboratory practice" shall mean a system of rules in respect if the conditions for planning, processes of
p.(None): organizing, conduct, follow up, and documenting of laboratory tests.
p.(None): 14. "Good manufacturing practice" shall mean a system of rules encompassing all aspects of manufacture:
p.(None): personnel, premises, equipment, materials, documentation, and quality control and has the purpose of ensuring safety,
p.(None): efficacy, and compliance with a specification.
p.(None): 15.. (Suppl. - SG 71/2008 in force from 12.08.2008) "Member State" shall mean a State Member of the European Union, or
p.(None): a State, party of the Agreement of the EEA.
p.(None): 16. "Labeling" shall mean information on the immediate or outer packaging of a medicinal product.
p.(None): 17. "Immunological medicinal product" shall mean a medicinal product, which contains vaccines, toxins, sera, or
p.(None): allergens. Agents used to create active immunity or establish a condition of immunity or invoke passive
p.(None): immunity shall be involved in the scope of vaccines, toxins, and sera. Allergens shall mean medicinal products,
p.(None): which are intended to identify or stimulate specific purposeful change in the immunological response to an allergens
p.(None): agent.
p.(None): 18. "Bioequivalence study" shall mean a clinical test aimed at proving that two medicinal
p.(None):
p.(None): products are bioequivalent provided that they are pharmaceutically equivalent or pharmaceutical alternatives and
p.(None): provided that their bioavailability after administration of the same molar dose are similar to a degree, which is a
p.(None): condition for equivalence in respect of efficacy and safety.
p.(None): 19. "Bioavailability study" shall mean a clinical test aimed at showing what is the rate and degree which an active
p.(None): substance or a therapeutically significant part of a studied medicinal product reach from the pharmaceutical form to
p.(None): the systemic circulation of the blood.
p.(None): 20. "Study medicinal product" shall mean a pharmaceutical form of an active substance or placebo, which are
p.(None): investigated or used as comparators in a clinical test including products with granted marketing authorisation but are
p.(None): used in an unauthorised indication or with a view of obtaining additional information for an authorised form, or are
p.(None): made up (in a pharmaceutical form or packaged) in a manner, which is different from the authorised form.
p.(None): 21. "Researcher" shall mean an appointed by the contracting authority and the principal researcher medical doctor or
p.(None): doctor in dental medicine who practically conducts a clinical test under the management of a principal researcher in
p.(None): compliance with an approved protocol and the guidelines for Good Clinical Practice in an investigational site for the
p.(None): conduct of a clinical test. If a clinical test is not conducted by a team, the researcher shall be the manager
p.(None): responsible for the team and shall be called principal researcher.
p.(None): 22. "Informed consent" shall mean a decision to participate in a clinical test, which must be in writing, dated and
p.(None): signed and taken freely by any person capable of giving his consent or
p.(None): – where a person is incapable of giving his consent by his legal representative after being duly informed about the
p.(None): essence, importance, consequences and risks of a clinical test and documented in an adequate manner.
p.(None): 23. "Kit" shall mean any substance, which – usually before use – shall be dissolved, suspended, diluted, or combined
p.(None): with radionuclides as a result of which procedure the finished radioactive medicinal product is obtained.
p.(None): 24. "Clinical test of a medicinal product" shall mean any study in man intended for discovering or
p.(None): confirming clinical, pharmacological, and/or other pharmacodynamic effects of one or more study medicinal products, and
p.(None): /or for determination of the adverse reactions to one or more study medicinal products, and/or for studying the
...
p.(None): medicinal products and establishing specific provisions for the medicinal products derived from human blood and
p.(None): plasma
p.(None): COUNCIL DIRECTIVE 87/18/EEC OF 18 DECEMBER 1986 on the harmonisation of laws, regulations and administrative provisions
p.(None): relating to the application of the principles of good laboratory practice and the verification of their
p.(None): applications for trials on chemical substances.
p.(None): COUNCIL DIRECTIVE 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates
p.(None): and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the
p.(None): right of establishment relating to certain activities in the field of pharmacy
p.(None): SECOND COUNCIL DIRECTIVE 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or
p.(None): Administrative Action relating to proprietary medicinal products
p.(None): DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
p.(None): of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
p.(None): REGULATION (EC) NO 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE
p.(None): COUNCIL of 31 March 2004 laying down Community procedures for the authorisation and supervision of
p.(None): medicinal products for human and veterinary use and establishing a European Medicines Agency.
p.(None): COMMISSION REGULATION (EC) NO 1084/2003 of 3 June 2003 concerning the examination of variations to the terms
p.(None): of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a
p.(None): competent authority of a Member State.
p.(None): REGULATION (EC) NO 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE
p.(None): COUNCIL of 16 December 1999 on orphan medicinal products.
p.(None): COMMISSION REGULATION (EC) NO 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of
p.(None): marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ, L 334/7 of
...
General/Other / participants in a control group
Searching for indicator placebo:
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p.(None): 15.. (Suppl. - SG 71/2008 in force from 12.08.2008) "Member State" shall mean a State Member of the European Union, or
p.(None): a State, party of the Agreement of the EEA.
p.(None): 16. "Labeling" shall mean information on the immediate or outer packaging of a medicinal product.
p.(None): 17. "Immunological medicinal product" shall mean a medicinal product, which contains vaccines, toxins, sera, or
p.(None): allergens. Agents used to create active immunity or establish a condition of immunity or invoke passive
p.(None): immunity shall be involved in the scope of vaccines, toxins, and sera. Allergens shall mean medicinal products,
p.(None): which are intended to identify or stimulate specific purposeful change in the immunological response to an allergens
p.(None): agent.
p.(None): 18. "Bioequivalence study" shall mean a clinical test aimed at proving that two medicinal
p.(None):
p.(None): products are bioequivalent provided that they are pharmaceutically equivalent or pharmaceutical alternatives and
p.(None): provided that their bioavailability after administration of the same molar dose are similar to a degree, which is a
p.(None): condition for equivalence in respect of efficacy and safety.
p.(None): 19. "Bioavailability study" shall mean a clinical test aimed at showing what is the rate and degree which an active
p.(None): substance or a therapeutically significant part of a studied medicinal product reach from the pharmaceutical form to
p.(None): the systemic circulation of the blood.
p.(None): 20. "Study medicinal product" shall mean a pharmaceutical form of an active substance or placebo, which are
p.(None): investigated or used as comparators in a clinical test including products with granted marketing authorisation but are
p.(None): used in an unauthorised indication or with a view of obtaining additional information for an authorised form, or are
p.(None): made up (in a pharmaceutical form or packaged) in a manner, which is different from the authorised form.
p.(None): 21. "Researcher" shall mean an appointed by the contracting authority and the principal researcher medical doctor or
p.(None): doctor in dental medicine who practically conducts a clinical test under the management of a principal researcher in
p.(None): compliance with an approved protocol and the guidelines for Good Clinical Practice in an investigational site for the
p.(None): conduct of a clinical test. If a clinical test is not conducted by a team, the researcher shall be the manager
p.(None): responsible for the team and shall be called principal researcher.
p.(None): 22. "Informed consent" shall mean a decision to participate in a clinical test, which must be in writing, dated and
p.(None): signed and taken freely by any person capable of giving his consent or
p.(None): – where a person is incapable of giving his consent by his legal representative after being duly informed about the
p.(None): essence, importance, consequences and risks of a clinical test and documented in an adequate manner.
p.(None): 23. "Kit" shall mean any substance, which – usually before use – shall be dissolved, suspended, diluted, or combined
...
Orphaned Trigger Words
p.(None): item 6 and shall declare whether the measures under par. 2 undertaken by them are because of any of the grounds
p.(None): referred to in Art. 276 and Art. 277.
p.(None): (4) (amend. – SG 18/14) In case of discontinuation of the sales of a medicinal product as a result of unforeseen
p.(None): circumstances, the holder of a marketing authorisation/registration certificate of a medicinal product shall notify the
p.(None): BDA in writing within 7 days of the establishment of the circumstances.
p.(None):
p.(None):
p.(None): Art. 54a. (New – SG, 60/2011, in force from 5. 8. 2011) (1) (amend. – SG 18/14) With receiving a signal at the
p.(None): Executive Agency on Medicines (EAM) for termination of sales of a medicinal product, with the exception of the cases
p.(None): under Art. 54, Para. 2 and 4, the Agency shall perform a check within the term of 30 days after receiving the signal.
p.(None): (2) While performing the check under Para. 1, the BDA may request information from the holder of the authorisation
p.(None): for use and/or from the person under Art. 26, Para. 2 on termination of the sales of the concrete medicinal
p.(None): product, as well as from the wholesale traders with medicinal products about the available quantities of the products.
p.(None): (3) The BDA shall publish on its internet site the results from the performed check.
p.(None):
p.(None):
p.(None): Art. 55. (1) The marketing authorisation/registration certificate of a medicinal product shall be issued by the
p.(None): executive director of the BDA for a period of 5 years.
p.(None): (2) Upon expiration of the period according to para 1, the marketing
p.(None): authorisation/registration certificate of the medicinal product may be renewed by the BDA on the basis of an assessment
p.(None): of the benefit/risk ratio.
p.(None): (3) In the case according to para 2, the holder of a marketing authorisation/registration certificate shall submit to
p.(None): the BDA renewal application accompanied by a summarised dossier
p.(None):
p.(None): relating to the quality, safety, and efficacy the medicinal product including the variations thereof effected during
p.(None): the validity period according to para 1 within 6 months prior to the expiration of the period.
p.(None): (4) The marketing authorisation/registration certificate shall become timeless upon its renewal.
p.(None): (5) (amend. – SG, 102/2012, in force from 21.12.2012) In the presence of well-grounded reasons vigilance of the
p.(None): medicinal safety, including because of exposition of the medicinal product on not sufficient number of
p.(None): patients, the BDA may request the holder of a marketing authorisation to submit a renewal application for another 5
p.(None): years under Art. 59a.
p.(None): (6) Upon expiration of the term of the marketing authorisation, the medicinal product may be sold until the quantities
p.(None): available in this country are exhausted but for not more than one year of the expiration of the marketing
p.(None): authorisation.
p.(None): (7) The executive director of The BDA shall revoke by an order the marketing authorisation of a medicinal
p.(None): product provided that:
p.(None): 1. the holder has not placed the medicinal product on the market within three years from the date of granting the
p.(None): marketing authorisation or
p.(None): 2. the sales of the medicinal product have been discontinued for a period of 3 consecutive years after
p.(None): its placing on the Bulgarian market.
p.(None): (8) The order according to para 7 shall be subject to appeal under the terms of the Administrative Procedure Code.
p.(None): (9) By way of exception and in the interest of the public health, the provision of para 7 may not be applied provided
p.(None): that the marketing authorisation holder of the medicinal product shall indicate well-grounded reasons. In these cases
p.(None): the executive director of the BDA shall motivate his decision.
p.(None): (10) The holder of a marketing authorisation shall annually pay a fee as laid down in the tariff according to Art. 21,
p.(None): para 2, for the maintenance of the granted marketing authorisation.
p.(None):
p.(None):
p.(None): Art. 55a (new – SG, 102/2012, in force from 21.12.2012) (1) The BDA executive director may issue a marketing
p.(None): authorisation/registration certificate of a medicinal product, which shall contain one or more of the following
p.(None): conditions:
p.(None): 1. to be undertaken certain measures for guaranteeing safe use of the medicinal product, which shall be included in the
p.(None): risk management system;
p.(None): 2. to be observed stricter obligations than the ones, indicated in Chapter Eight for registration or
p.(None): reporting of suspected not willing medicinal reactions;
p.(None): 3. to be observed stricter obligations, than the ones, indicated in Chapter Eight for registration or
p.(None): reporting of suspected not willing medicinal reactions;
p.(None): 4. to be observed any other conditions or restrictions in view to safe and efficient use of the medicinal product;
p.(None): 5. existence of an adequate vigilance system of the medicinal safety;
p.(None): 6. to be conucted postmarketing researches for efficiency, where there are doubts, related to efficiency of
p.(None): the medicinal product, which may be permitted only after the medicinal product is placed on the market.
p.(None): (2) The marketing authorisation/registration certificate shall indicate the terms for fulfillment of the
p.(None): conditions uner Para. 1, where applicable.
p.(None): (3) The reasons for imposing the condition under Para. 1, p. 6 shall be determined by a delegated act uder Art. 22b
p.(None): of Directive 2001/93/EC, by accounting the scientific irectives, developed in the Manual under Art. 194a.
p.(None): (4) The requirement for conducting post-marketing researches for efficiency shall be
p.(None):
p.(None): determined by a Manual, issued by the European Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 56 (Amend. – SG, 102/2012, in force from 21.12.2012) (1) exceptionally, after conulation with the
p.(None): applicant, the BDA excutive director may issue a marketing authorisation/registration certificate
p.(None): under the condition, where the applicant may prove that he/she has not produced sufficient data about the
p.(None): efficiency and safety of the medicinal product under normal conditions of use because of one of the following reasons:
p.(None): 1. the indications, for which the medicinal prodict is intended, are so rare, that the applicant cannot
p.(None): produce complete evidence material, or
p.(None): 2. the condition of the scientific knowledge at the moment is such, that no complete data may be produced, or
p.(None): 3. collecting similar ata contradicts the commonly adopted principles of the medical
p.(None): ethics.
p.(None): (2) The marketing authorisation/registration certificate under Para. 1 shall be issued
p.(None): under one of the following conditions:
p.(None): 1. the applicant/holder should fulfill a programme of researches for the term under Para. 3 where the results serve for
p.(None): re-assessment of the correlation benefit – risk;
p.(None): 2. the medicinal product has regime of prescribing only by a doctor’s prescription, where in certain cases may be used
p.(None): only under strict doctor’s control in a medical establishment for medicinal help and in case of
p.(None): radiopharmaceutical specialist – only under the control of an authorised person;
p.(None): 3. the leaflet, as well as in any medical information, attached to the medicinal product should contain a text, which
p.(None): pays attention to the medicinal specialists, that some of the available data for the medicinal product are subject to
p.(None): further researches.
p.(None): (3) The marketing authorisation/registration certificate under Para. 1 shall be issued for the term of 1 year and for
p.(None): each following year may be extended on the basis of an assessment of the fulfillment of the conditions under Para. 2.
p.(None):
p.(None):
p.(None): Art. 56a (new – SG, 102/2012, in force from 21.12.2012) (1) After issuing the marketing authorisation/registration
p.(None): certificate, BDA may olige the holder of the marketing authorisation/registration certificate
p.(None): to conduct:
p.(None): 1. post-marketing safety research, if there are concerns for identified or potential risks or lack of information,
p.(None): related to vigilance the medicinal safety for the relevant medicinal product, where the same risks refer to other
p.(None): medicinal products, after consultations with the Committee for risk assessment in the area of the pharmacologic
p.(None): awareness, established under Art. 56, Para. 1, letter "aa" of Regulation (EC) N 726/2004 of the European Parliament and
p.(None): of the Council, BDA recommends to the relevant holder of marketing authorisation to conduct a mutual safety
p.(None): research with the other concerned holders of authorisation;
...
p.(None): (2) The BDA shall notify in writing the owner of the marketing authorisation/registration certificate for the
p.(None): obligation under Para. 1, by grounding the reasons and indicating the objectives of the research and the terms for its
p.(None): conducting.
p.(None): (3) Within 30-day term after receiving the notification under Para. 2, the owner of the marketing
p.(None): authorisation/registration certificate may request from BDA granting a possibility for providing information about the
p.(None): obligations under Para. 1.
p.(None):
p.(None): (4) After receiving the request under Para. 3, the BDA shall set a term for provision of the information by the
p.(None): authorisation/registration certificate holder.
p.(None): (5) The BDA after information analysis under Para. 3, may:
p.(None): 1. confirm the obligation under Para. 1, or
p.(None): 2. repeal it.
p.(None): (6) The BDA shall notify the holder about the decision, taken under Para. 5.
p.(None): (7) In the cases under Para. 5, p. 1, the BDA executive director shall officially amend the issued marketing
p.(None): authorisation/registration certificate of the medicinal product by including in it the obligation under Para. 1 as a
p.(None): condition.
p.(None): (8) The grounds for imposing the obligations under Para. 1, p. 2 shall be determined by a delegated instrument under
p.(None): Art. 22b of Directive 2001/83/EC.
p.(None):
p.(None):
p.(None): Art. 56b (new – SG 102/2012, in force from 21.12.2012) (1) The holder of the marketing authorisation/registration
p.(None): certificate shall include in his/her risk management system all the conditions under Art. 551,56 and 56a.
p.(None): (2) In the cases under Para. 1 the holder of the marketing authorisation/registration certificate shall
p.(None): submit to BDA a notification about any change in the risk management system.
p.(None):
p.(None):
p.(None): Art. 56c (new – SG 102/2012, in force from 21.12.2012) The BDA shall submit information to the European
p.(None): Medicines Agency about the issued authorisations under Art. 551, 56 and 56a.
p.(None):
p.(None):
p.(None): Art. 57. (1) The executive director of The BDA shall refuse to grant a marketing authorisation or
p.(None): registration certificate of a medicinal product where, after assessment of the dossier according to Art. 27 – 32, it
p.(None): shall be established that:
p.(None): 1. the benefit/risk ratio is unfavourable or
p.(None): 2. the efficacy of the medicinal product has not been convincingly defended by he applicant, or
p.(None): 3. the qualitative and quantitative composition of the medicinal product does not comply with those described in the
p.(None): dossier.
p.(None): (2) The executive director of The BDA shall refuse to grant a marketing
p.(None): authorisation/registration certificate of medicinal product where certain data in the dossier do not comply with the
p.(None): requirements of Art. 27 - 32.
p.(None): (3) The executive director of the BDA shall refuse registration of a traditional herbal medicinal product where,
p.(None): after assessment of the documentation, it shall be established that the product does not comply with the conditions
p.(None): according to Art. 37, para 1, the data in the dossier do not comply with Art. 38, or:
p.(None): 1. the qualitative and quantitative composition does not comply with those described in the dossier;
p.(None): 2. the medicinal product can be noxious at correct use;
p.(None): 3. the data for the traditional use are insufficient, especially where the pharmacological properties or the efficacy
p.(None): are not proven on the basis long-standing use and the experience acquired;
p.(None): 4. the pharmaceutical quality of the medicinal product is insufficiently grounded.
p.(None):
p.(None): Art. 58. The marketing authorisation holder takes the responsibility for the completeness and authenticity of the data
p.(None): in the dossier.
p.(None):
p.(None):
p.(None): Art. 59. (1) The refusal of the executive director of the BDA to grant a marketing
p.(None): authorisation/registration certificate of a medicinal product may be appealed under the terms of the Administrative
p.(None): Procedure Code.
...
p.(None): 1. forward the assessment report accompanied by the approved summary of product characteristics and the approved
p.(None): packaging mock-up and package leaflet within 90 days from the submission of a valid documentation;
p.(None): 2. close the procedure and notify the applicant and the Concerned Member States provided that all Concerned
p.(None): Member States have approved it.
p.(None): (2) Within 30 days of the closure of the procedure according to para 1, point 2, the executive director of the
p.(None): BDA shall issue a marketing authorisation of the medicinal product for the territory of the Republic of Bulgaria with
p.(None): the approved summary of product characteristics, packaging mock-up, and package leaflet.
p.(None): (3) Where The Republic of Bulgaria is a reference Member State according to Art. 75, the BDA shall:
p.(None): 1. submit to the regulatory authorities of the Concerned Member States and the applicant the draft assessment
p.(None): report, draft summary of product characteristics, and draft packaging mock-up and packaging leaflet
p.(None): within 120 days from the submission date of a valid documentation;
p.(None): 2. close the procedure and notify the applicant and the Concerned Member States provided that all Concerned
p.(None): Member States have approved it.
p.(None): (4) Within 30 days of the closure of the procedure according to para 3, point 2, the executive director of the
p.(None): BDA shall issue a marketing authorisation of the medicinal product for the territory of the Republic of Bulgaria with
p.(None): the approved summary of product characteristics, packaging mock-up, and package leaflet.
p.(None):
p.(None): Art. 77. (1) Where the BDA disapproves the submitted documentation according to Art. 74, para 4 or according to Art.
p.(None): 75, para 4, due to considerations of potential serious risk for the population health, it shall establish a detailed
p.(None): report with motives to the Referent Member State, the other Concerned Member States, and the applicant.
p.(None): (2) Disputable issues according to para 1 shall be considered by the Coordination Group to the European Medicines
p.(None): Agency. The applicant may present his position for consideration in writing or by word of mouth.
p.(None): (3) The BDA shall participate in the sessions of the Coordination Group according to para 2 until the closure of the
p.(None): procedure by the Reference Member State.
p.(None): (4) The executive director of the BDA shall issue a marketing authorisation of the medicinal product with
p.(None): the approved summary of product characteristics, packaging mock-up, and package leaflet within 30 days from the
p.(None): receipt of a notification for the closure of the procedure by the Reference Member State.
p.(None):
p.(None):
p.(None): Art. 78. (1) Where the Member States do not reach agreement before the Coordination Group, pursuant to Art. 22, para 2,
p.(None): the disputable issues shall be considered by the Committee for Medicinal Products for Human Medicine to the European
p.(None): Medicines Agency according to an arbitrage procedure. A copy of the documentation shall be forwarded to the applicant.
p.(None): (2) The applicant shall submit to the European Medicines Agency the dossier of the medicinal product and the summary of
p.(None): product characteristics.
p.(None): (3) In the cases according to para 1, provided that the BDA has approved the assessment report, draft
p.(None): summary of product characteristics and packaging mock-up and package leaflet submitted by the Reference Member
p.(None): State, the executive director of the BDA may, upon a request of the applicant, grant a marketing authorisation of the
...
p.(None): required quality assurance procedures in any aspect of the clinical test.
p.(None): (2) The whole information from a clinical test shall be recorded and kept in a manner ensuring its accurate reporting,
p.(None): interpretation, and confirmation with protection of the personal data of the subjects.
p.(None):
p.(None):
p.(None): Art. 86. (1) All persons conducting clinical trials shall possess the respective qualification, training, and
p.(None): experience to perform the study related tasks in compliance with rules for Good Clinical Practice.
p.(None): (2) A clinical test of a medicinal product shall be conducted under the leadership of a medical doctor or a doctor
p.(None): of dental medicine with acknowledged medical specialty in the respective field and shall be familiar with the
p.(None): available preclinical and/or clinical data about the product and the study risks and procedures.
p.(None): (3) During a clinical test, responsible for the medical care delivered to a study subject and for the medical decisions
p.(None): taken shall be a medical doctor or a doctor of dental medicine with adequate qualification.
p.(None):
p.(None):
p.(None): Art. 87. (1) (amend. – SG 59/10, in force from 31.07.2010, amend. – SG, 60/2011, in force from 5. 8. 2011) A clinical
p.(None): test may only be conducted in hospital healthcare establishments, mental health centres, skin and venereal diseases
p.(None): health centre, complex oncologic centres and diagnostic-consulting centres, medical centres, dental centres and
p.(None): medical-dental centres, which have received authorisation for activity/certificate for registration in accordance with
p.(None): the Medical Establishments Act.
p.(None): (2) A clinical test can only be conducted in healthcare establishments which shall have
p.(None):
p.(None): an ethics Commission established and inscribed in the register of the BDA in accordance with Art. 103.
p.(None): (3) The manager of the healthcare establishment, in which a clinical test of a medicinal product is to be conducted,
p.(None): shall give his/her consent as to the participation of the principal researcher in the study, as well as to the conduct
p.(None): of the study.
p.(None):
p.(None):
p.(None): Art. 88. (1) A clinical test in human subjects shall be conducted with:
p.(None): 1. medicinal products unauthorised for use in the Republic of Bulgaria;
p.(None): 2. medicinal products authorised for use in the Republic of Bulgaria where these are studied for an unauthorised
p.(None): indication, pharmaceutical form different from the authorised one, in a so far unstudied patient group, or for
p.(None): obtaining additional data.
p.(None): (2) Medicinal products authorised for use in the Republic of Bulgaria within the meaning of para 1 above shall be
p.(None): medicinal products that have received marketing authorisation under the terms of this Act or under the terms
p.(None): of Regulation N 726/2004 (EC) of the European Parliament and of the Council.
p.(None):
p.(None):
p.(None): Art. 89. (1) A clinical test in human subjects shall be conducted with medicinal products, which are manufactured,
p.(None): maintained, and stored in compliance with the rules for Good Manufacturing Practice for medicinal products
p.(None): under development and research.
p.(None): (2) The rules for Good Manufacturing Practice for medicinal products under development and research
p.(None): shall be laid down in the regulation according to Art. 152.
p.(None): (3) A medicinal product can be proposed for a clinical test where pharmacological and toxicological studies have
p.(None): been conducted in accordance with the requirements for Good Laboratory Practice.
p.(None):
p.(None):
p.(None): Art. 90. The clinical test can be started and conducted provided that:
p.(None): 1. the anticipated therapeutic benefits for the study subjects, for current and future patients and the
...
p.(None): radiopharmaceuticals or medicinal products subjected to ionised radiation during their manufacture;
p.(None): 8. authorisation for the use of the premises for manufacture, control, and storage issued according to order of the
p.(None): Spatial Development Act or another substituting document;
p.(None): 9. (amend., - SG 98/10, in force from 01.01.2011, repealed - SG, 60/2011, in force from 5. 8. 2011)
p.(None): 10. document for paid fee, in amount determined in the tariff to Art. 21, para 2.
p.(None): (3) For the manufacturing of narcotic substances and pharmaceutical forms containing such substances, the
p.(None): requirements of the Control on Drugs and Precursors Act shall be observed.
p.(None):
p.(None):
p.(None): Art. 151. Where some aspects of the stages of manufacture or control tests within the manufacturing process shall be
p.(None): carried in another site of the territory of Bulgaria or abroad under contract, the persons according to Art. 146 shall
p.(None): be obliged to indicate the location of that site and a copy of the contract determining the responsibilities of the
p.(None): parties thereto with respect to the observation of the requirements of the Good Manufacturing Practice for medicinal
p.(None): products the obligations of the qualified person according to Art. 148, point 2.
p.(None):
p.(None):
p.(None): Art. 152. (amend. – SG, 102/2012, in force fro 02.01.2013) (1) The principles and requirements for Good
p.(None): Manufacturing Practice for all types of medicinal products, medicinal products for clinical trials, and active
p.(None): substances shall be arranged by a regulation of the Minister of Health and by acts and directives, adopted by the
p.(None): European Commission.
p.(None): (2) The principles and requirements for official risk assessment in view to establishing Good manufacturing practice
p.(None): for assisting substances shall be determined by the ordinance under Para. 1 and by directives, adopted by the
p.(None): European Commission.
p.(None):
p.(None):
p.(None): Art. 153. (1) Upon receipt of an application according to Art. 150, the BDA shall assess the submitted documentation
p.(None): and shall conduct inspection on the spot of the location of the sites for manufacture, control, and storage including
p.(None): the cases according to Art. 151 to determine the compliance between the submitted documentation and the conditions for
p.(None): manufacture, control, and storage of the starting manufacturing materials and the finished medicinal products and their
p.(None): compliance with the requirements of the Good Manufacturing Practice.
p.(None): (2) The expenses for the conduct of an on the spot inspection according to para 1 shall be carried out at the expenses
p.(None): of the applicant.
p.(None): (3) For conducting of on the spot inspection according to para 1 the applicant shall pay
p.(None):
p.(None): a fee of the amount as laid down in the tariff under Art. 21, para 2.
p.(None):
p.(None):
p.(None): Art. 154. (1) Where the BDA finds omissions in the documentation submitted and/or inconsistencies between the content
p.(None): of the submitted documentation and the condition of
p.(None): the site or the requirements for the qualification of the personnel, it shall notify the applicant in
p.(None): writing and give written instructions.
p.(None): (2) In the cases according to para 1 the time limit under Art. 155, para 1 shall cease to run until rendering the site
p.(None): or documentation in compliance with the requirements.
p.(None):
p.(None):
p.(None): Art. 155. (1) Within 90 days of the date of submission of the application according to Art.
p.(None): 150, the executive director of the BDA shall:
...
p.(None): cases, where protection of public health required immediate announcement of the information.
p.(None): (2) The BDA shall publish information, related to active substances, contained in medicinal products,
p.(None): permitted for use and in other Member States by using harmonised draft announcement and schedule of the publication,
p.(None): proposed by the European Medicines Agency.
p.(None): (3) In the cases under Para. 1 and 2 the information, containing personal data or trade secret, shall be deleted,
p.(None): unless the publication of this data is needed for protection of public health.
p.(None):
p.(None):
p.(None): Art. 189. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The BDA may delegate some of the rights and duties
p.(None): under this Chapter to a regulatory body of another Member State by signing an agreement.
p.(None): (2) In the cases under Para. 1, BDA shall inform the European Commission, the European Medicines Agency
p.(None): and the regulatory bodies of the other Member States for the delegation of the authorisations and shall
p.(None): publish and announcement on the internet portal under Art. 185, Para. 1 or on its internet site.
p.(None):
p.(None):
p.(None): Art. 190. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder shall be
p.(None): obliged to dispose with a vigilance system of the medicinal safety for fulfilling his/her duty under this Chapter
p.(None): (2) The marketing authorisation holder by the system of Para. 1 shall make a scientific assessment of the collected
p.(None): information about the safety of the medicinal products, estimate the possibilities for minimizing or preventing the
p.(None): risk and shall undertake the needed actions.
p.(None): (3) The marketing authorisation holder shall apply adequate and effective system of quality in order to provide
p.(None): compliance of the system under Para. 1 with the requirements of this act. The minimal requirements for the quality
p.(None): system shall be determined by Implementation Regulation (EU) N 520/2012.
p.(None): (4) The marketing authorisation holder shall carry out a regular audit of the system under Para. 1. Information for the
p.(None): basic findings of the audit shall be entered in the basic documentation of the system and shall serve for preparing a
p.(None): plan for applying appropriate correcting actions. This information may be deleted after the thorough implementation of
p.(None): the correcting actions.
p.(None):
p.(None):
p.(None): Art. 191. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder shall
p.(None): select a qualified person with an appropriate qualification, responsible for vigilance of the medicinal safety.
p.(None): (2) The person under Para. 1 shall be established on the territory of a Member State and shall be permanently at
p.(None): disposal of the marketing authorisation holder.
p.(None): (3) In order to assist the activity of the qualified person, the marketing authorisation
p.(None):
p.(None): holder shall select a person, established on the territory of the Republic of Bulgaria. The appointment
p.(None): of such a person shall not liberate the qualified person under Para. 1 from his/her responsibilities under this
p.(None): Chapter.
p.(None): (4) The marketing authorisation holder shall produce to BDA the data under Art. 27, Para. 1, p. 12, letters "a" – "c"
p.(None): for the persons under Para. 1 and 3.
p.(None): (5) The marketing authorisation holder shall notify BDA in case of every change in the data under Para. 4.
p.(None): (6) The marketing authorisation holder shall give the data under Para. 4 to the qualified person of the European
p.(None): Medicines Agency.
p.(None):
p.(None):
p.(None): Art. 192. (amend. – SG, 102/2012, in force from 21.12.2012) (1) The marketing authorisation holder shall be
p.(None): obliged to:
p.(None): 1. maintain and produce upon request by the BDA the basic system document for vigilance of the medicinal
p.(None): safety;
p.(None): 2. apply the risk management system for each medicinal product;
p.(None): 3. carry out monitoring of the result from the measures, contained in the risk management plan, or
p.(None): 4. carry out monitoring of the result from fulfillment of the conditions under Art. 551, 56
p.(None):
p.(None): or 56a;
p.(None):
p.(None): 5.update the risk management system;
p.(None): 6. carry out monitoring of the system data under Art. 190, Para. 1 in order to identify new
p.(None): risks or change of the found risks, as well as define, whether changes have occurred in the correlation benefit/risk
p.(None): for the observed medicinal product.
p.(None): 6. carry out monitoring of the system data under Art. 190, Para. 1 in order to identify new risks or change of the
p.(None): found risks, as well as define whether changes have occurred in the correlation benefit/risk for the observed medicinal
p.(None): product.
p.(None): (2) The contents and the procedure for maintaining the basic documentation of the pharmaco-vigilance system
p.(None): shall be provided by Implementation Regulation (EU) n 520/2012.
p.(None):
p.(None):
p.(None): Art. 193. (amend. – SG, 102/2012, in force from 21.12.2012) The marketing authorisation holder
p.(None): shall inform the BDA and the European Medicines Agency in case of identified signals about new risks or
p.(None): change if the found risks, or in case of change of the correlation benefit/risk of the medicinal product.
p.(None):
p.(None):
p.(None): Art. 194. (amend. – SG, 102/2012, in force from 21,12,2012) (1) The marketing authorisation holder shall
p.(None): simultaneously or before providing for the public new information about concerns, related to pharmaco-vigilance of a
p.(None): certain medicinal product, permitted for use on the territory of the Republic of Bulgaria, shall notify the BDA, the
p.(None): European Medicines Agency and the European Commission.
p.(None): (2) The information under Para. 1 shall be objective and not misleading.
p.(None): (3) before disseminating information, related to pharmaco-vigilance, the marketing authorisation holder shall
p.(None): coordinate it in advance with BDA with the exception of the cases under Para. 1.
p.(None): (4) For carrying out assessment of the information under Para. 3, a fee shall be paid in the amount, determined by the
p.(None): tariff under Art. 21, Para. 2.
p.(None):
p.(None): Art. 194a. (new – SG, 102/2012, in force from 21.12.2012) (1) The principles and requirements of the Good
p.(None): pahrmaco-vigilance practice shall be defined by a manual, issued by the European Medicines Agency.
...
p.(None): effective measures for drawing out a medicinal product from the market upon an order of BDA or upon initiative of the
p.(None): manufacturer or the marketing authorisation holder of the relevant medicinal product;
p.(None): 6c (new – SG 18/14) provide for the supply of sufficient quantities of medicinal products for satisfying of health care
p.(None): needs of the individuals of the Republic of Bulgaria;
p.(None): 7. (amend. – SG, 102/2012, in force from 02.01.2013) keep data for each deal with received, supplied or realised by
p.(None): intermediation medicinal products under the form of invoices for buying and selling or in electronic mode or under any
p.(None): other form, as follows:
p.(None): a) date of receipt and delivery;
p.(None): b) name of the medicinal product;
p.(None): c) received, delivered or realised quantity by intermediary;
p.(None): d) name and address of the person from whom the medicinal product has been received or to whom it has been delivered;
p.(None): e) batch number and number of the batch release certificate issued by the qualified person according to Art. 148,
p.(None): point 2 or by the qualified person according to Art. 161, Para. 2, point 1, respectively, and number of the batch
p.(None): release certificate issued by the BDA - in the cases according to Art. 69 and 70;
p.(None): d) received or delivered quantity;
p.(None): e) name and address of the person whom the medicinal product has been received from or delivered to;
p.(None): 8. keep purchase/sale documentation for all medicinal products;
p.(None): 9. observe the requirements of the Good Distribution Practice laid down in the regulation according to Art. 198.
p.(None): 10. (new – SG, 102/2012, in force from 02.01.2013) maintain a quality system, defining the responsibilities, processes
p.(None): and risk management measures, elated to his/her activity;
p.(None): 11. (new – SG, 102/2012, in force from 02.01.2013) inform immediately BDA and the marketing authorisation holder, where
p.(None): he/she has found or suspects that the medicinal product,
p.(None):
p.(None): which has been received or offered is falsified;
p.(None): 12. (new – SG, 102/2012, in force from 02.01.2013) check up whether the whole sale trader, from whom has been
p.(None): received the medicinal product, observes the principles and directives for Good distribution practices under
p.(None): Art. 198, as well as if he has authorisation for wholesale trade;
p.(None): 13. (new – SG, 102/2012, in force from 02.01.2013) check up whether the manufacturer or importer, from whom the
p.(None): medicinal product is received, has authorisation for manufacture/import;
p.(None): 14. (new – SG, 102/2012, in force from 02.01.2013) check up whether the intermediary, through whom the medicinal
p.(None): product is received, meets the requirements of this Chapter.
p.(None): (2) The documentation according to Para. 1, points 7 and 8 shall be kept for at least 5 years and shall be provided to
p.(None): the control bodies upon request.
p.(None):
p.(None):
p.(None): Art. 208. (amend. – SG, 102/2012, in force from 02.01.2013) The obligations according to Art. 207, Para. 1, point 2,
p.(None): and Art. 209a shall also apply to the wholesalers according to Art. 203, as well as to the importers and manufacturers
p.(None): trading in medicinal products manufactured by them.
p.(None):
p.(None):
p.(None): Art. 209. The requirements of the special provisions of other laws shall also apply to the wholesale of medicinal
p.(None): products containing narcotic substances or obtained from blood, or immunological products, or
p.(None): radiopharmaceuticals.
p.(None):
p.(None):
...
p.(None): (4) State fees for modification in the registration under para 1 and 2 shall not be required.
p.(None):
p.(None):
p.(None): § 25. In the Act on Patents and Registration of Utility Models (promulgated SG 27 from 1993; amended, 83 from 1996, 11
p.(None): from 1998, 81 from 1999, 45 and 66 from 2002,17, 30 and 64 from 2006 ) in Art. 20, issue 7 is repealed.
p.(None):
p.(None):
p.(None): § 26. In the Act on the society organisation of master of pharmacists SG 75 from 2006, amended 105 from 2006, Art. 5,
p.(None): point 9 shall be amended as follow:
p.(None): "9. Provides statements for opening of pharmacies, pursuant Art. 228, para 1, issue 9 from the Medicinal Products in
p.(None): Human Medicine Act.
p.(None):
p.(None):
p.(None): § 27 In § 1, point 5 of the Additional provisions of the Integration of People with Disabilities Act
p.(None): (promulgated SG N81 from 2004, amended., N. 28, 88, 94, 103 and 105 from
p.(None): 2005, N 18, 30, 33, 37, 63, 95, 97 and 108 from 2006) the second sentence shall be amended as follow "Medical devices
p.(None): are not auxiliary devices, installations and equipment ".
p.(None):
p.(None):
p.(None): § 28. In the Excises and Tax Warehouses Act (promulgated, SG No 91 of 2005; amended and supplemented, No
p.(None): 105 of 2005. and No 30 and 34, 63, 81, 105 and 108 from 2006 of 2006) the words "Medicinal Products in Human Medicine
p.(None): Act" shall be replaced by "Medicinal Products in Human Medicine Act".
p.(None):
p.(None):
p.(None): § 29. In the Genetically Modified Organisms Act (promulgated, SG 27 of 2005; amended and supplemented, 88 and 99 of
p.(None): 2005 and 30 of 2006) the para 2 in Art. 2, issue 3 the words "Medicinal Products in Human Medicine Act" shall be
p.(None): replaced by "Medicinal Products in Human Medicine Act".
p.(None):
p.(None): § 30. In Protection of Customers Act (promulgated, SG No 99 of 2005; amended and supplemented, No 30 and 51, 53, 59,
p.(None): 105 and 108 of 2006) in Art. 186, para 2, issue 4 the words "Medicinal Products in Human Medicine Act" shall be
p.(None): replaced by "Medicinal Products in Human Medicine Act".
p.(None):
p.(None):
p.(None): § 31. The following amendments shall be introduced in the Health Act (promulgated, SG 70 of 2004; amended and
p.(None): supplemented, 46, 76, 85, 88, 94 and 103 of 2005 and 18, 30, and
p.(None): 34, 59, 71, 75, 81,95 and 102 of 2006):
p.(None): 1. In Art. 4 the words "Medicinal Products in Human Medicine Act" shall be replaced by "Medicinal Products in Human
p.(None): Medicine Act".
p.(None): 2. In Art. 21, para 3, the words "Medicinal Products in Human Medicine Act" shall be replaced by "Medicinal Products in
p.(None): Human Medicine Act".
p.(None):
p.(None):
p.(None): § 32. The following amendments shall be introduced in the Control on Drugs and Precursors Act
p.(None): (promulgated, SG 30 of 1999; amended and supplemented, 63 of 2000, 74, 75,
p.(None): and 120 of 2002, 56 of 2003, 76, 79, and 103 of 2005, and 30,75 and 82 of 2006):
p.(None): 1. In Art. 32, para 3 the words "Medicinal Products in Human Medicine Act" shall be replaced by "Medicinal Products in
p.(None): Human Medicine Act".
p.(None): 2. In Art. 33, para 1, item 1 the words "Medicinal Products in Human Medicine Act" shall be replaced by "Medicinal
p.(None): Products in Human Medicine Act".
p.(None): 3. In Art. 34 after the word "issued" the words "on master of pharmacy" are deleted.
p.(None): 4. In Art. 39, para 2 the words "Art. 55, item 2 of Medicinal Products in Human Medicine Act" shall be replaced by
p.(None): "Art. 197, para 2 of Medicinal Products in Human Medicine Act".
p.(None): 5. In Art. 44 a, para 3 is deleted.
p.(None): 6. In Art. 44b the words master of pharmacy are deleted.
p.(None): 7. In § 1, item 14 of the Additional provision the words "Medicinal Products in Human Medicine Act" shall be replaced
p.(None): by "Medicinal Products in Human Medicine Act".
p.(None):
p.(None):
p.(None): § 33. In the Act on Blood, Blood Donation, and Blood Transfusion (promulgated, SG 102 of 2003; amended and
p.(None): supplemented, 70 of 2004 and 30 and 65 of 2006) in Art. 8, para 4, the words "Medicinal Products in Human Medicine Act"
p.(None): shall be replaced by "Medicinal Products in Human Medicine Act".
p.(None):
p.(None):
p.(None): § 34. In Art. 140 of Environmental Protection Act (promulgated, SG 91 of 2002; correction, 98 of 2002;
p.(None): amended and supplemented, 86 of 2003, 70 of 2004, 74, 77, 88, 95, and
p.(None): 105 of 2005, and 30,65, 82, 99, 102 and 105 of 2006.) in the Art. 140 after the words "pharmaceutical
p.(None): products and medical devices" the expression "within the meaning of the Medicinal Products in Human Medicine
p.(None): Act" shall be added and the words "within the meaning of § 1, item 40 of the additional provisions of the Medicinal
p.(None): Products in Human Medicine Act and medical devices " shall be deleted.
p.(None):
p.(None):
p.(None): § 35. In Foodstuffs Act (promulgated, SG 90 of 1999; amended and supplemented, 102 of 2003, 70 of 2004, 87, 99, and 105
p.(None): of 2005 and 30, 31, 34, and 51,55 and 96 of 2006) in Art.2,
p.(None):
p.(None): para 3, issue 4 shall be amended:
p.(None): "4. medicinal product within the meaning of the "Medicinal Products in Human Medicine
p.(None): Act".
p.(None):
p.(None):
p.(None): § 36 Until coming into force of the provisions pursuant to § 19 the issued normative acts for applying the repealed
p.(None): "Medicinal Products in Human Medicine Act" shall be applied, until they shall not contradict to that Act.
p.(None):
p.(None):
p.(None): § 37. This Act shall take effect as from the date of is promulgation in State Gazette, except § 22, which shall take
p.(None): effect after one year from the date of the promulgation of this Act.
p.(None): This Act has been adopted by the 40 National Assembly on 30 of March 2007 and has been sealed with the official seal of
p.(None): the National Assembly.
p.(None): This Act was adopted by the 40th National Assembly on 30 March 2007 and has been sealed by the official stamp of the
p.(None): National Assembly.
p.(None):
p.(None): Transitional and concluding provisions
...
p.(None): assigned by the state activities to the
p.(None):
p.(None): municipalities, shall be paid with the funds envisaged in Art. 1, Para 2, line 5.
p.(None): (2) Activities, medical products and articles envisaged in Para 1 shall be paid under a procedure and method,
p.(None): determined by the Minister of Health.
p.(None): (3) Funds envisaged in Art.1, Para 2, line 5 shall be transferred monthly the end of the current month.
p.(None):
p.(None):
p.(None): § 7. Supervising Board of the National Health Insurance Fund shall be entitled to execute internal compensated changes
p.(None): of the credits between the elements of the expenses and of the transfers envisaged in Art.1, Para 2, which shall be
p.(None): within the frames of the approved budged.
p.(None):
p.(None):
p.(None): § 8. Supervising Board of the National Health Insurance Fund, on the grounds of Art. 26, Para 2 of the Health
p.(None): Insurance Act, shall be entitled to spend the funds of the reserve for unexpected and urgent expenditures
p.(None): envisaged in Art.1, Para 2, line 3.
p.(None): ………….
p.(None):
p.(None):
p.(None): § 15. This Act shall enter into force from 1st of January 2011, except for § 10, which shall enter into force from the
p.(None): day of its promulgation in the State Gazette.
p.(None):
p.(None): Transitional and concluding provisions
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE HEALTH ACT
p.(None):
p.(None): (PROM. - SG 98/2010, IN FORCE FROM 01.01.2011)
p.(None):
p.(None): § 106. In the Medicinal Products in Human Medicine Act (prom. – SG 31/2007; amend.
p.(None): – SG 19/08; decision No. 5 of the Constitutional Court of 2008- SG 65/08; amend. – SG 71/08, 10,23, 41, 88 and 102 of
p.(None): 2009 and SG 59/10), everywhere words "regional inspectorate(s) on/for protection and control of the public health", and
p.(None): "RIPCPH" shall be replaced respectively by "regional health inspectorate(s)" and "RHI".
p.(None): ……..
p.(None):
p.(None):
p.(None): § 121. This Act shall enter into force from 1st of January 2011, except for:
p.(None): 1.paragraphs 1, 16, 20, 29, 30, 33, 34, 35, 42, 44, § 56, items 1 and 2, § 65, 68, 70, 76,
p.(None): 80, 81, 90, 92, 96, § 102, items 3,4,7 and 8; § 105, items 1,3, and 5; § 107, items 1,2,3,4,6, letter
p.(None): "a", items 7, 10, 11, 13, and 15, letter "a"; § 109, 110, 112, 113; § 116, items 4 and 6; § 117, items 5 and 7 and §
p.(None): 118, item 1, which shall enter into force from the day of promulgation of the Law in the State Gazette;
p.(None): 2. paragraph 102, items 1,2 and 6, which shall enter into force from 1st of March 2011;
p.(None): 3. paragraphs 22, item1 (regarding Art. 36, Para 1, Sentence Two), § 37, § 48, item2, § 51 and 59, which shall enter
p.(None): into force from 1st of July 2011;
p.(None): 4. paragraph 107, item 15, letter ‘b", which shall enter into force from 30 September
p.(None): 2011.
p.(None):
p.(None):
p.(None): Transitional and concluding provisions
p.(None):
p.(None): TO THE ACT AMENDING AND SUPPLEMENTING THE MEDICINAL PRODUCTS IN HUMAN MEDICINE ACT
p.(None):
p.(None): (PROM. – SG 12/2011, IN FROCE FROM 08.02.2011)
p.(None):
p.(None): § 24. Lodged before the entering into force of this Act valid applications and notifications for variations to
p.(None): marketing authorisations shall be decided under the existing procedure.
p.(None):
p.(None):
p.(None): § 25. Minister of Health shall bring the ordinance envisaged in Art. 42 in accordance with this Act within three-months
p.(None): term from the moment it enters into force.
p.(None):
p.(None):
p.(None): § 27. This Act shall enter into force from the day of its promulgation in the State Gazette.
p.(None):
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| armed forces | Soldier |
| army | Soldier |
| authority | Relationship to Authority |
| breastfeeding | breastfeeding |
| child | Child |
| children | Child |
| crime | Illegal Activity |
| criminal | criminal |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergency | Public Emergency |
| employees | employees |
| gender | gender |
| ill | ill |
| illegal | Illegal Activity |
| illness | Physically Disabled |
| incapable | Mentally Incapacitated |
| incapacity | Incapacitated |
| infant | Infant |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| military | Soldier |
| minor | Youth/Minors |
| mothers | Mothers |
| opinion | philosophical differences/differences of opinion |
| orphan | orphan |
| parent | parents |
| parents | parents |
| party | political affiliation |
| placebo | participants in a control group |
| pregnant | Pregnant |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| unconscious | Unconscious People |
| unemployed | Unemployment |
| union | Trade Union Membership |
| usage | Drug Usage |
| violence | Threat of Violence |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| armed forces | ['army', 'military'] |
| army | ['armedXforces', 'military'] |
| child | ['children'] |
| children | ['child'] |
| crime | ['illegal'] |
| drug | ['influence', 'substance', 'usage'] |
| education | ['educational'] |
| educational | ['education'] |
| illegal | ['crime'] |
| influence | ['drug', 'substance', 'usage'] |
| military | ['armedXforces', 'army'] |
| parent | ['parents'] |
| parents | ['parent'] |
| substance | ['drug', 'influence', 'usage'] |
| usage | ['drug', 'influence', 'substance'] |
Trigger Words
capacity
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input