Mandatory use of electronic application forms

Mandatory use of electronic application forms

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 decentralised procedures. Along with the eAF the applicants have to […]

Bulgaria: first steps to e-submissions

Bulgaria: first steps to e-submissions

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 project is currently under development and it is planned that […]

Romanian Drug Agency have now joined the CESP system for e-submissions

Romanian Drug Agency have now joined the CESP system for e-submissions

In June 2014 the Romanian National Agency for Medicines and Medical Devices (NAMMD) announced that in addition to the usual submission procedure – direct submission at the NAMMD headquarters, e-submission of documentation to the NAMMD may also be performed via the Common European Submission Platform (CESP) for electronic exchange of information between applicants and regulatory […]