PARTICIPATION of BfArM at the COMMON EU SUBMISSION PLATFORM (CESP) PROJECT
BfArM joins the ‘extended Proof of Concept’ for the CESP Project aiming to establish a single portal for electronic submissions to multiple competent authorities in the context of European registration and post-approval procedures in the EEA. Please do notice that for the time being CESP submissions need to be made in addition to the current submission way. This means that until further notice a legally valid submission needs to be made on CD/DVD and includes certain paper documents signed by hand (here) in addition to the identical eSubmission uploaded via the CESP.
Deviating from the principle of general acceptance of all types of submissions as expressed on the CESP web pages, BfArM only accepts submissions via CESP in line with the BfArM strategy for the acceptance of electronic-only submissions (here). The below conditions for CESP submissions apply:
eSubmissions via CESP will be accepted for
- Marketing Authorisation Applications (MAA) via decentralized procedure (DCP), Mutual recognition procedure (MRP) or purely national procedure.
- Variations for which the complete licensing documentation has already been submitted electronically as a consequence of the rule of 31 March 2010 (so called eOnly submissions)
- submissions structured according to eCTD or NeeS specification and tested for technical validity
BfArM will not accept via CESP:
- electronic submissions for other regulatory post-authorisation activities or other procedures as e.g. Renewals, PSURs.
No notice to the applicant/Marketing Authorisation Holder will be given, that a submission not acceptable via CESP will be ignored, but that only the conventional submission will be further processed by BfArM.
Apart from the above we recommend using our national Portal for online variation submissions (here) for the generation of the application and structured data.