European experts criticize the Drugs Act; focus on Bulgarian drug shortages

European experts have claimed as unlawful the measures introduced by the amendments to the Act for Medicinal Products in Human Medicine which applies a new licensing regime for export.

The new amendments will require each dealer to wait 30 days for an opinion from the Bulgarian Drug Agency (BDA) on any medication on the positive list, which includes nearly 3,000 products.

Heinz Kobelt, director European affairs of the European Association of Euro-Pharmaceutical (EAEPC) companies and Thilo Baurot, board member of the German Association of the parallel importers expressed concern that the amendments were not synchronized with the European Union and, if law changes enter into force, Bulgaria is threatened to sentence penalties procedure due to the restrictions that the Law imposes on the free movement of goods within the EU. Estonia, Spain, Greece and Portugal have already faced such issues and after the intervention of the Commission they have given more freedom to parallel trade. In Slovakia the adoption of the final decision is yet to come.