To the attention of Marketing Authorisation Holders
Please be advised that, as of 15.06.2014, in addition to the usual procedure (direct submission at the NAMMD headquarters), submission of documentation to the NAMMD Registration office may also be performed via the Common European Submission Platform (CESP).
The NAMMD recommends applicants to opt for one route only for submission of documentation within the same procedure.
ASMFs shall not be sent via the CESP.
It should be noted that, in case of CESP submission for all procedures types (DCP, MRP, MRP-Repeat-use, National) concerning authorisation, renewal and variation, a cover letter and corresponding filled-in payment form have to be submitted 15 days prior to 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 on submission.
For CESP submission, national requirements for original signed documents in line with Romania specific NtA and published on the CMDh website, shall no longer apply.
Applicants are required to fill in the administrative details accurately.
The schedule for documentation receipt is available on the NAMMD website, under “CONTACT“.