Regulatory Affairs
-1
archive,paged,category,category-regulatory-affairs,category-7,paged-2,category-paged-2,bridge-core-3.1.8,cookies-not-set,qode-page-transition-enabled,ajax_fade,page_not_loaded,,qode-title-hidden,qode_grid_1300,footer_responsive_adv,qode-child-theme-ver-1.0.0,qode-theme-ver-30.5,qode-theme-bridge,wpb-js-composer js-comp-ver-7.6,vc_responsive

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 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...