Full List of Pharmaceutical Legislation in Bulgaria

      The pharmaceutical sector in Bulgaria has been developing dramatically in every respect since 1991. The market has changed completely from local generics to full integration with the world supply chains. Market growth has been tremendous even if it is still one of the small markets. Legislation has been continuously changing since 1995 when the first Drug Act was issued.

      Following the accession of Bulgaria to the European Union in 2007, the pharmaceutical legislation has also been undated and almost fully harmonized with EU requirements through the Drug Act 2007 and the related regulations. Some key documents have been continuously changing (e.g., the Positive Drug List Regulation has changed 3 times in 2009).

      A full updated List of Pharmaceutical Legislation in Bulgaria is available at our web site: - HERE.