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The Bulgarian Drug Agency (BDA) announced that on May 10th, 2016 they completed the first decentralised procedure for authorising medicinal product where the reference member state (RMS) is Bulgaria. The procedure has been accepted by all six concerned member states. Gaining experience to act as RMS...

The Bulgarian Drug Agency (BDA) announced that starting from January 1st, 2016 the use of the EU Electronic Application Forms (eAF) for initial marketing authorisations, renewals and variations concerning medicinal products for human use is mandatory for national procedures, as well as mutual recognition and...

After the amendments made to the Bulgarian regulation on pricing and reimbursement in December 2014, it is now hard to say if the government is regulating or registering OTC prices in Bulgaria. According to the Bulgarian Law on Medicinal Products in Human Medicine (the Drug Law),...

Following the developments of the pharmacovigilance legislations at EU level Bulgaria imposed the requirement for the appointment by the marketing authorisation holders (MAHs) of a local contact person for pharmacovigilance issues (LPPV) for medicinal products for human use. The national legislation does not contain detailed requirements...

After Romania joined the CESP system for e-submissions in June 2014, in September 2014 the Bulgarian Drug Agency announced that by September 2015 it is expected that the Agency’s platform for e-submissions will be operational and the next step will be joining the CESP. The...

In January 2014 the Bulgarian Parliament passed amendments to the Medicinal Products in Human Medicine Act (the Drug Law) aiming restriction of the parallel trade with pharmaceutical products exported from Bulgaria. The justification given for this action was to avoid shortages of medicinal products on...

  The prices of RX medicinal products are regulated by the National Council on Pricing and Reimbursement in Bulgaria. Before placing any RX medicinal product (whether reimbursed or non-reimbursed) on the Bulgarian market the concerned marketing authorisation holders (MAH) have to initiate administrative procedure for price...