EMA – Publication of the Revision 111 of the Q&A on the European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
EMA’s post-authorisation procedural advice document provides a printable overview in Q&A format of EMA’s position on issues typically addressed with marketing authorisation holders.
EMA regularly updates the Q&A to reflect new developments, additional guidance and the implementation of new European legislation.
More information on the post-authorisation guidance and procedure on the EMA Website.
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vroby (25 mars 2025). EMA – Publication of the Revision 111 of the Q&A on the European Medicines Agency post-authorisation procedural advice for users of the centralised procedure. ELSIBI. Consulté le 5 mars 2026 à l’adresse https://doi.org/10.58079/13kgu





