EMA – Revision of the EMA post-authorisation procedural advice for users of the centralised procedure
The EMA published its last version of the post-authorisation procedural advice for users of the centralised procedure.
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.
More information on post-authorisation on the EMA Website.
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vroby (19 octobre 2024). EMA – Revision of the EMA post-authorisation procedural advice for users of the centralised procedure. ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/12j9o