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

Posted at 20:00h in Regulatory Affairs by

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 agencies.

The NAMMD recommends applicants to opt for just one route only for submission of documentation within the same procedure (either by CESP or by direct-to-agency submission).

In case of CESP submission for all procedures types (DCP, MRP, MRP-Repeat-use or purely national) concerning marketing authorisation, renewal and variation, a cover letter and corresponding filled-in payment form have to be submitted 15 days prior to the submission of documentation.

Documentation to be submitted shall also include the NAMMD registration number for the cover letter and corresponding filled-in payment form provided by the agency’s registration office on submission.

For CESP submission, national requirements for original signed documents in line with the Romanian specific requirements – published on the CMDh website, shall no longer apply.