Bulgarian Drug Agency: reduced timelines for manufacturing authorisations and wholesale distribution licenses

Bulgarian Drug Agency: reduced timelines for manufacturing authorisations and wholesale distribution licenses

The Bulgarian Drug Law amendments were published on 12-Oct-2018 affecting the timelines which are legally set for the Bulgarian Drug Agency (BDA) to issue/refuse national manufacturing authorisations or wholesale distribution licenses. The previously provided 90 days are now reduced to 60 days. According to the Drug Law, in this timeframe the BDA should complete the procedure in a best-case scenario, provided that there are no deficiencies found. In practice, it takes longer mainly due to the agency’s GMP/GDP inspections schedule and due to deficiencies.