Electronic submission via the Common European Submission Platform (CESP) should be preferred. The Common European Submission Platform (CESP) is a mechanism for the secure electronic transmission of files to the Medicines Agencies of the Member States of the European Union.
This device allows the transmission of files in a secure manner, without size limits, to several recipients simultaneously (several health agencies). It works on a one-way basis: transmission takes place only to the Agencies.
As part of a generalised process of digitalised exchanges, the ANMV offers applicants the opportunity to submit their MA dossiers to it using the CESP system: new MA applications, applications for MA variations, renewals, transfers...
Applicants are strongly encouraged to submit files under this framework.
All information about the CEPA is available on its website: cesp.hma.eu
- specifies the agencies authorising the transmission of files via the CEPA;
- details the procedure for registering applicants wishing to use the CEPA;
- describes the process for forwarding files;
- provides user tutorials as well as a question/answer set.
Contact: administrative Decisions Unit: firstname.lastname@example.org