Starting on 1 July 2019, the Bulgarian Drug Agency (BDA) announced they will accept submissions via CESP, the Common European Submission Portal. During the pilot phase CESP submissions were limited. From 1 July 2020 BDA resumes accepting all types of applications and documents via CESP, except...
After February 9th 2019 the EU drug verification system (established by the Falsified Medicines Directive (Directive 2011/62/EU) and further detailed by Commission Delegated Regulation (EU) 2016/161) became applicable. The Bulgarian Drug Agency (BDA) and the Bulgarian Medicines Verification Organisation (BGMVO) published the first Guidelines for managing...
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 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...