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The Bulgarian Drug Agency is administration to the Minister of Health, whose competences, functions and activities are set out in three laws:

  • According to the Law on Medicinal Products in Humane Medicine (LMPHM) BDA is a specialized body to the Minister of Health to supervise the quality, effectiveness and safety of medicines.
  • According to the Law on Medicinal Products (LMP) BDA has supervisory authority over the quality, efficiency and safety of medicines.
  • According to the Law on Blood, Blood Donation and Blood Transfusion (LBBDBT) the executive director of the BDA acts as competent authority for the operation of medical institutions in sampling, diagnosis, processing, storage, use, distribution, quality assurance and safety of blood and blood components and for transfusion supervision for compliance with the law, the standard under Art. 1, para. 4 and Rules for Good Laboratory and Good Manufacturing Practice.

The overall activity of the Agency in achieving the goals of these three laws includes activities in implementing the goals of the National Health Strategy of the Ministry of Health and participation in activities related to the work of the European Medicines Agency, the European Directorate for the Quality of Medicines and Health, international bodies and organizations, as well as the implementation of international treaties to which Bulgaria is a party.

Contact and information

Visit the website of the Bulgarian Drug Agency