The Law on Pharmaceutical Products in Human Medicine governs large scope of relations in the pharma industry including the manufacturing, wholesale trade and import of pharmaceutical products, conduct of clinical trials, advertisement and product pricing.  In addition, extensive subsidiary legislation and codes of conduct have been enacted by various state bodies and professional organizations. In general Bulgarian legislation in the field of pharmacy is in compliance with the legislation of the European Union (EU).

1. Market Authorization of Pharmaceutical Products

The manufacturing, import, wholesale trade and advertising as well as treatment, prevention and diagnosis could be performed only with pharmaceutical products (including homeopathic pharmaceutical products and traditional herbal pharmaceutical products) that have been granted market authorization or certificate for registration. Such authorization/certificate for registration might be issued by the executive director of the Bulgarian Drugs Agency (BDA) for a 5 years validity period to an individual or legal entity established on the territory of an EU member state or a state party to the Agreement on the European Economic Area (EEA). The market authorization and the certificate for registration are subject to further renewals. The law sets forth some specific requirements regarding the homeopathic pharmaceutical products and traditional herbal pharmaceutical products.

2. Manufacturing of Pharmaceutical Products

The manufacturing of all types of pharmaceutical products on the territory of the Republic of Bulgaria, including those intended only for export might be carried out only by merchants registered on the territory of an EU member state or a state party to the Agreement on the EEA, who have obtained an authorization for manufacturing, issued by the BDA’s executive director. Some of the prerequisites for issuance of such authorization are: (i) availability of suitable qualified staff and (ii) premises for manufacturing, controlling and storage of pharmaceutical products equipped with the required technical equipment and control laboratories.

The BDA keeps a register of the manufacturers and sends a copy of each authorization to the European Medicines Agency for entering into the EU database.

3. Wholesale trade with Pharmaceutical Products

Wholesale trade with pharmaceuticals requires a wholesale trade authorization or certificate for registration.  Such authorization/certificate might be obtained by merchants registered on the territory of an EU member state or a state party to the Agreement on the EEA. If the respective merchant has storage premises on the territory of Bulgaria the wholesale trade activity requires authorization issued by the executive director of the BDA. If the merchant has authorization for wholesale trade issued by EU member state or a state party to the Agreement on the EEA, or if it does not have storage premises in Bulgaria, the legislation in force requires certificate for registration again issued by the executive director of the BDA.

As Bulgaria recognizes the wholesale trade authorizations issued by EU/EEA member states, in the absence of storage premises in Bulgaria the requirements and the procedure for issuance of certificate for registration is more simplified. In order to obtain wholesale trade authorization a wholesaler having storage premises in Bulgaria should have: (i) qualified staff and in particular qualified person holding master degree in pharmacy; (ii) suitable premises, equipment and installations; as well as (iii) suitable transportation vehicles ensuring the right storage, distribution and transportation of medicinal products in compliance with the requirements of Good Distribution Practices.

4. Import of Pharmaceutical Products

Any import of pharmaceuticals requires a permit for import issued by BDA, where the product subject to import should have a market authorization as well. Import of pharmaceutical products is considered to be any import to the customs territory of Bulgaria from a country which is not an EU member state or a state party to the Agreement on the EEA. In order to obtain authorization for importation, the merchant must have: (i) quality control laboratory; (ii) premises for storage of the products, having the necessary technical equipment; and (iii) at least one person qualified to perform the activities related to the batch release. The qualified person issues a certificate for the release of each batch, evidencing that the batch of a product imported, was subject to a complete qualitative and quantitative analysis in compliance with the requirements for issuance of manufacturing authorization.

The validity of the authorizations for manufacturing, for wholesale trade and for import issued by BDA is not limited by term, however their scope is limited to the pharmaceutical products and the forms of their active substances indicated in the application, as well as with respect to the premises in which control and storage is reported to take place.

If the pharmaceutical products manufactured, distributed on wholesale trade basis or imported contain narcotic drugs, precursors or radiopharmaceuticals, the requirements of the respective legislation concerning the control over narcotic drugs, precursors and ionic radiation should be observed.

5. Clinical Trials

Clinical trials might be carried out provided that: (i) a positive opinion of the Ethics Committee of the medical treatment facility in which the trial will be conducted has been obtained; (ii) written notification from BDA has been received that the clinical trial might be conducted on the territory of Bulgaria. Where the clinical trial shall be conducted with pharmaceuticals for gene therapy, for somatic sell therapy, high technology products, products containing genetically modified organism or biologically active substances an authorization to conduct the trial issued by the Executive Director of Bulgarian Drug Agency is required.

Clinical trials might be conducted in hospitals, dispensaries and diagnostic consultative centers that have obtained a positive accreditation evaluation of overall operations and have established an Ethics Commissions that has been registered into the BDA register. Clinical trials on humans may be conducted to prove the clinical efficacy and safety of two types of pharmaceuticals: (i) products not covered by a market authorization in Bulgaria and (ii) products covered by such an authorization to the extent that it is necessary to confirm their clinical efficacy and safety. Clinical trials must be conducted in compliance with Good Clinical Practices.

Clinical trials may be undertaken only if the trial subject has given his/her written consent after being informed by the principal investigator of the nature, significance, implications and risks of the clinical trial.

6. Advertising of Pharmaceutical Products

Only products that have been issued market authorization in Bulgaria might be subject to advertisements. Pharmaceuticals available on prescription may be advertised in publications designated only for the medical professionals, where the advertising to the general public is admissible only for non-prescription products, provided that the pharmaceutical product has market authorization. An advertisement should not offer or promise gifts and/or another tangible or intangible benefit. The content of any advertisement requires the prior approval of BDA, where in approving the advertisement the BDA takes into account different criteria depending on whether the advertisement is intended for the general public or medical specialists. 

7. Product Pricing

Pharmaceutical products for retail sale are subject to maximum prices that retailers may not exceed. The formation of such maximum prices follows different methodologies depending on whether a particular product is available on prescription or without prescription. The maximum price of a prescription product (referred to as “approved marginal price”) is subject to approval by the Ministry of Healthcare, failing which the product may not be sold on the territory of Bulgaria. To obtain approval the manufacturer or holder of the market authorization must submit to the Commission on Medicinal Products Prices an application detailing the elements included in the maximum price. No specific restrictions apply to the formation of the maximum price of medicinal products available without prescription. The manufacturer or holder of the marketing authorization must submit to the Commission on Medicinal Products Prices an application detailing the manufacturer’s price as well as the final selling price (VAT included). The final selling price is subject to registration by the Ministry of Healthcare, failing which the product may not be sold on the territory of Bulgaria.

8. Reimbursement

Reimbursement is effected for pharmaceutical products included into the Positive Drugs List.  Said list includes pharmaceutical products dispensed by medical prescription, required to cover the health needs of the population and reimbursed by public means in accordance with the lowest reference prices from certain EU member states.   

There are several types of sources for reimbursement of pharmaceutical products in the public sphere in Bulgaria: (i) the National Health Insurance Fund budget; (ii) the national budget, outside the scope of mandatory health insurance; (iii) the budget of the centers for emergency medical care, the centers for transfusion hematology, the medical treatment facilities for inpatient psychiatric care, as well as the medical treatment facilities with the Council of Ministers, the Ministry of Defense, the Ministry of Interior, the Ministry of Justice and the Ministry of Transport; (iv) the budget of hospitals for active treatment, hospitals for further treatment and prolonged treatment, rehabilitation hospitals state and/or municipal interest in the capital.

The authority responsible for the inclusion and exclusion from the Positive Drugs List as well as for its amendments is the Commission for the Positive Drugs List established by the Council of Ministers.