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EMA – Update of the Post-authorisation procedural advice for users of the centralised procedure

The EMA updated its 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 and guidance on the EMA website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (12 mars 2024). EMA – Update of the Post-authorisation procedural advice for users of the centralised procedure. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/w0a6


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