Bridging your regulatory needs to pharma solutions

  • Regulatory affairs

    For companies in the healthcare and pharmaceutical sector
  • Pharmacovigilance

    Monitoring of your products’ safety profile as well as medical literature for identifying potential adverse reactions
  • Information

    Timely information on all new requirements and updates in medicinal products legislation and pharmacovigilance amendments
  • 1
  • 2
  • 3

National Council on prices and reimbursement of medicinal products has a new Chairman

With decision No. 660 of 18 September 2014 adopted by the Council of Ministers in Republic of Bulgaria, a new Chairman of the National Council of prices and reimbursement of medicinal products was elected. The highly acclaimed pharmacologist prof. Nikolay Dantchev, who is a leading expert in the field, has been selected to take the role of a Chairman of the National Council. He is also a Vice Dean in the Pharmaceutical Faculty at Medical University in Sofia and has over 120 scientific publications in the sphere of pharmacy.

Publishing of QR-codes and 2D barcodes on packaging

Bulgarian Drug Agency has published on its website more information about acceptability of QR-codes and 2D barcodes which aim to facilitate stock availabilities, manufacturing control or to curb falsified medicines’ use.

These codes however should not provide any additional information and should not lead to any confusion in consumers and patients.

Any addition of pictograms or symbols is subject to prior approval by the Bulgarian Drug Agency as set out in art. 18 from local regulation 27 on requirements for medicinal products registration and regulatory documentation.

As of 02.01.2014 it is no longer required to provide a stamped Proof of Payment to BDA

As of 02.01.2014 when submitting a new administrative procedure for assessment at Bulgarian Drug Agency it is no longer required to submit a stamped proof of payment.

This waiver will significantly facilitate the submission procedure as it will no longer be needed to visit the agency's financial departmen prior to submission in order to obtain such verification.