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 […]

Updated versions of variations and renewal application forms*

Updated versions of variations and renewal application forms*

In June 2014 the Notice to Applicants, volume 2B was updated with the publication of the new versions of application form for the submission of variations and application form for renewal of a marketing authorisation for drugs in human medicine. Update January 2016: Mandatory use of electronic application forms * This post has been marked […]