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Pharma Boardroom goes deep into key country markets, conducting hundreds of exclusive interviews with the movers and shakers of the industry in order to outline the pharmaceutical industry trends and to provide news and reports intended for senior professionals who want to understand local and...

The Announcement of the EMA Management Board earlier in May 2017 confirmed the full functionality of the EudraVigilance database. Hence, the transitional period in pharmacovigilance reporting in the EEA is about to expire. The simplified electronic reporting of suspected adverse reactions related to medicines by...

In May 2016 the Bulgarian Drug Agency (BDA) completed the first DCP with RMS Bulgaria. They now announced that in August 2016 the first mutual recognition procedure (MRP) will start with reference member state (RMS) Bulgaria and the concerned member state is Romania. Both procedures...

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),...