EMA – Revision of the EMA pre-authorisation procedural advice for users of the centralised procedure
The EMA published its last version of the pre-authorisation procedural advice for users of the centralised procedure.
These questions and answers (Q&As) provide an overview of the European Medicines Agency’s (EMA) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase.
More specifically, the EMA revised the three following questions:
- 6 What will be the legal basis for my application?
- 4 What is the procedure for appointment of Rapporteurs/CoRapporteurs and their assessment teams?
- 7 How should I notify a change in the contact person and/or intended submission date of my application?
This Q&A is available directly on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (22 novembre 2025). EMA – Revision of the EMA pre-authorisation procedural advice for users of the centralised procedure. ELSIBI. Consulté le 18 janvier 2026 à l’adresse https://doi.org/10.58079/156rm





