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Law for medicinal products in human medicine (“The Drug Act“).
State Gazette No. 31/2007.
Last revised: State Gazette No. 48/2015.
Published on this site: 08.01.2016.

This document specifies all aspects of pharmaceutical legislation in Bulgaria.
The Drug Act does not cover medical devices and medicines containing narcotic substances.
Additional regulations have been issued to further specify various procedures for drug manufacture, marketing authorization, clinical trials, wholesale and retail trade in drugs, etc.
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Regulation No 1/2012 on the requirements to medicinal product advertising.
State Gazette No 10/2012.
Last revised: State Gazette No 10/2012.
Published on this site: 20.01.2016.

This Regulation provides the framework for advertising of medicinal products to health professionals and the general public. It specifies the provisions of Chapter 11 of the Drug Act and aligns the Bulgarian requirements with the EU drug advertising framework.
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Regulation No 2/2008 on the requirements to the collection, verification and presentation of information on adverse drug reactions, and the content and format of expedited adverse drug reaction reports, and the periodic safety update reports.
State Gazette No 24/2008.
Last revised: State Gazette No 24/2008.
Published on this site: 20.01.2016.

This document specifies the procedures for the full cycle of collecting, verifying and reporting adverse drug reactions (ADRs). There is specific guidance on the preparation of the periodic safety update reports (PSUR) and all other aspects of ADR reporting, including the obligations of all parties concerned to the Bulgarian competent authority, the relevant bodies of the other EU member states and EMA.


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Regulation No 3/2008 on the criteria for classification of medicinal products and the requirements to the documentation for a change in the classification.
State Gazette No 28/2008.
Last revised: State Gazette No 28/2008.
Published on this site: 20.01.2016.

This Regulation provides the framework for classification of medicinal products into prescription-only or over-the-counter. The classification criteria relate to various types of restrictions on the prescription status of a drug. The procedures for administering the prescription status are laid down in detail.


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Regulation No 4/2009 on the conditions and procedures for prescribing and dispensing medicinal products.
State Gazette No 21/2009.
Last revised: State Gazette No 95/2014.
Published on this site: 20.01.2016.

This document specifies the procedures for prescribing and dispensing medicinal products, including narcotic and psychotropic substances. Special emphasis is laid on the procedures for prescribing reimbursable medicinal products. The latest amendments implement the requirements of EU Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State.


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Regulation 5/2011 on the conditions and procedures for granting authorization for storage and sales of medicinal products to physicians and doctors of dental medicine and their supply with medicinal products.
State Gazette No 54/2011.
Published on this site: 27.01.2016.
Last revised: State Gazette No 54/2011.

This Regulation specifies the conditions for authorizing doctors and dentists in Bulgaria to store and sell medicines. This is allowed only in towns and villages where no pharmacy is open. Doctors can get products from a very broad selection of product groups but they are not allowed to sell products which are reimbursed by the Sick Fund. The list of eligible products is given in an annex.


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Regulation No. 7/2015 on the criteria for determining the diseases for whose outpatient treatment the National Health Insurance Fund reimburses completely or partially medicinal products, medical devices and diet foods for special purposes.
State Gazette No 89/2015.
Last revised: State Gazette No 89/2015.
Published on this site: 27.01.2016.

This Regulation specifies the criteria for determining the diseases eligible for reimbursement by the NHIF of medicinal products, medical devices and diet foods for special purposes applied for outpatient treatment. This regulation also covers the reimbursement of such products for outpatient treatment of rare diseases.


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Regulation No 9/2008 on the conditions and procedures for suspension and recall of medicinal products for which there is evidence of nonconformity with the requirements for quality, safety and efficacy.
State Gazette No 45/2008.
Last revised: State Gazette No 45/2008.
Published on this site: 27.01.2016.

This Regulation specifies the procedures for suspension and recall of nonconforming medicinal products, including the responsibilities of the competent government bodies and the market agents along the supply chain. The reporting requirements are also specified according to a risk classification scheme given in an Annex.


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Regulation No. 9/2015 on the conditions and procedures for conducting health technology assessment.
State Gazette No 97/2015.
Last revised: State Gazette No 97/2015.
Published on this site: 27.01.2016.

This Regulation determines the scope of mandatory health technology assessment (HTA) and the methodology for performing HTA. The approved HTA Guideline is laid down in big detail and covers all aspects of the assessment process.


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Regulation No. 10/2009 on the conditions and procedures for reimbursement of medicinal products pursuant to points 1 and 2 of Art. 262(6) of the Law for Medicinal Products in Human Medicine, of medical devices and diet foods for special medical purposes, and for medicinal products for health activities pursuant to point 3 of Art. 82(2) of the Law for Health.
State Gazette No. 24/2009.
Last revised: State Gazette No 62/2015.
Published on this site: 27.01.2016.

This Regulation specifies the procedures for reimbursement of medicines, medical devices and diet foods for medical purposes for outpatient treatment and inpatient application of medical devices by the NHIF. These procedures include the special provisions on providing discounts by the pharmaceutical manufacturers to the NHIF.


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Regulation No 10/2011 on the conditions and procedures for treatment with medicinal products without marketing authorisation for the Republic of Bulgaria, and the conditions and procedures for inclusion, changes, exclusion and supplies of medicinal products pursuant to the list in Article 266a(2) of the Law for Medicinal Products in Human Medicine.
State Gazette No. 95/2011.
Last revised: State Gazette No 24/2013.
Published on this site: 27.01.2016.

This document specifies the conditions for treatment with medicinal products which have not been granted marketing authorization for Bulgaria and provides the framework for their prescription, approval, supply and delivery.


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Regulation No. 10/2015 on the surveys of patient satisfaction with the medical activities purchased by the National Health Insurance Fund.
State Gazette No 97/2015.
Last revised: State Gazette No 97/2015.
Published on this site: 27.01.2016.

This Regulation specifies a model and a methodology to make surveys of patient satisfaction with the medical activities covered by the NHIF. It also provides a set of questionnaires to be used in the different kinds of medical facilities. This translation does not include the annexes.



Regulation No. 15/2009 on the conditions for issuing an authorization for manufacture/imports and the principles of and the requirements to Good Manufacturing Practice for all types of medicinal products, medicinal products for clinical trials and active substances.
State Gazette No 38/2009.
Last revised: State Gazette No 35/2013.
Published on this site: 27.01.2016.

This document specifies the requirements to manufacturers and importers for compliance with Good Manufacturing Practice (GMP). The text of this Regulation covers the key points for each aspect of GMP whereas the details are referred to EudraLex Volume 4 - Good manufacturing practice (GMP) Guidelines. This Regulation covers also the GMP requirements to investigational medicinal products and active substances.


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Regulation No 27/2007 on the requirements to the data and documentation for marketing authorisation and registration of medicinal products.
State Gazette No 54/2007.
Last revised: State Gazette No 47/2011.
Published on this site: 27.01.2016.

This document specifies the procedures for marketing authorisation and registration of medicinal products, including all types of medicinal products and all types of procedures as related to the EU marketing authorisation framework. This regulation lists all documents required for initial marketing authorisation, extensions, variations and renewals. The annexes to this regulation specify the particulars required in the application dossier (some annexes are not translated).


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Regulation No 28/2000 on the conditions and procedures for the destruction, recycling or using medicines for other purposes.
State Gazette No 106/2000.
Last revised: State Gazette No 106/2000.
Published on this site: 27.01.2016.

This Regulation specifies the conditions and procedures for destruction or recycling of medicines which cannot, for various reasons, be administered for their intended use. The role of the authorities and the specific procedures to prevent risk to human health are described in detail.


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Regulation 28/2008 on the structure, procedures and organization of work in the pharmacies and the medicinal product range therein.
State Gazette No 109/2008..
Last revised: State Gazette No 2/2012.
Published on this site: 27.01.2016.

This document specifies the requirements to the structure and organization of work in community and hospital pharmacies in Bulgaria. This regulation lists explictily the requirements to pharmacy furniture and equipment, the types of premises depending on the scope of work, and the groups of medicinal products which should be available at the pharmacy at all times. Special attention is paid to medicinal products prepared according to magistral and pharmacopoeic recipes. The storage conditions and the major reporting routines are also specified.  (Some annexes are not translated).


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EGULATION No. 29/2008 on the conditions and procedures for opening a health store.
State Gazette No. 109/2008.
Last revised: State Gazette No 2/2012.
Published on this site: 27.01.2016.

This Regulation provides the framework for the setting up of health stores, an outlet intended for retail trade in OTC products, medical devices, health-related products (such as food supplements, special purpose foods and cosmetics) and biocides for disinfection and pest control. Health stores may not sell prescription drugs nor general merchandise. The requirements to the facilities, the organisation of activities and the staff of health stores are laid down in this Regulation.


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Regulation No 31/2007 on establishing guidelines for Good Clinical Practice
State Gazette No 67/2007.
Last revised: State Gazette No 14/2012.
Published on this site: 27.01.2016.

This Regulation specifies the conditions for conducting clinical trials on medicinal products in Bulgaria. It supplements the provisions of the Drug Act 2007, Chapter IV, and includes the Guidelines for Good Clinical Practice as an Annex. The Annexes are not included in this translation.


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Regulation No 35/2007 on the conditions, procedures and requirements to the documentation for issuing a Batch Release Certificate for a medicinal product by the Bulgarian Drug Agency.
State Gazette No 71/2007.
Last revised: State Gazette No 71/2007.
Published on this site: 07.02.2016.

This document specifies the requirements and the procedures for issuing batch release certificates by the Bulgarian drug regulatory authority, the Bulgarian Drug Agency. The Bulgarian regulatory framework for batch release has been harmonized with the European Union guidelines for Official Control Authority Batch Release and the respective administrative procedures.


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Regulation No 36 on the conditions and procedures for taking samples for the purposes of state control over the medicinal products, for performing tests and for payment for them.
State Gazette No 71/2007.
Last revised: State Gazette No 71/2007.
Published on this site: 07.02.2016.

This Regulation specifies the conditions and procedures for sampling of medicinal products and substances used for their manufacture for the purposes of laboratory testing to ensure their quality and conformity to the requirements.


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Regulation No 38/2007 on the requirements to the data on the packaging and leaflets of medicinal products.
State Gazette No. 77/2007.
Last revised: State Gazette No 77/2007.
Published on this site: 07.02.2016.

This Regulation provides the framework for labelling and package leaflets of medicinal products in Bulgaria. It supplements the provisions of the Drug Act on labelling and package leaflets and is harmonised to a great extent with the provisions of Title V of Council Directive 2001/83/EEC and the other relevant EU requirements.


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Regulation No 39/2007 on the principles and requirements for Good Distribution Practice.
State Gazette No. 77/2007.
Last revised: State Gazette No 16/2010.
Published on this site: 07.02.2016.

This Regulation provides the framework for wholesale trade in medicinal products in Bulgaria. It covers the major requirements of Good Distribution Practice outlined in the EU guidelines for GDP (with some variations). It also sets out requirements to the storage premises and equipment, and requirements to marking on the outer packaging.


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Regulation on the conditions, rules and procedures for regulating and registering the prices of medicinal products.
State Gazette No 40/2013.
Last revised: State Gazette No 92/2015.
Published on this site: 07.02.2016.

This Regulation determines the rules for pricing of medicinal products in Bulgaria, including the mark-ups for wholesalers and retailers (restricted by a sliding scale). The prices of medicines subject to reimbursement from public funds are referenced against the prices paid by health insurance funds in 10 EU countries. OTC prices are freely made by the manufacturer but registration is still required. As a temporary measure valid to the end of 2017, OTC prices have been limited to the inflation rates.  This Regulation also lays down the framework for compiling a Positive Drug List which serves as the basis for selecting drugs subject to public funding. Specific criteria are laid down for inclusion, amendments, or exclusion from the Positive Drug List. A procedure for keeping up the reimbursement status requires submission of set of documents every three years (sort of a "mini" HTA). This translation does not include the annexes.


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Tariff of fees collected in pursuance of the Law for Medicinal Products in Human Medicine.
State Gazette No 106/2007.
Last revised: State Gazette No 9/2016.
Published on this site: 09.02.2016.

This Tariff specifies the fees payable to the Ministry of Health, the Bulgarian Drug Agency and the National Council on Drug Pricing and Reimbursement for obtaining various authorisations related to activities on the drug market in Bulgaria: authorisation for manufacturing of medicinal products, marketing authorisation and variations thereof, authorisation of imports and parallel imports, authorisation of clinical trials, authorisation for drug advertising, authorisation for wholesale and retail trade in medicinal products. Fees are also specified for conducting tests and analytical procedures and for issuing various certificates related to activities on the drug market.


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