EMA – Guidance update: Update of the pre-authorisation procedural advice for users of the centralised procedure (Q&A)
The following sections of the Questions and Answers on the pre-authorisation procedure have been revised in December 2022:
3.5.5. How shall I present my RMP?
3.5.7. When and how will the RMP summary or the full RMP be published?
4.1. How and to whom should I submit my dossier?
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (19 avril 2023). EMA – Guidance update: Update of the pre-authorisation procedural advice for users of the centralised procedure (Q&A). ELSIBI. Consulté le 5 mars 2026 à l’adresse https://doi.org/10.58079/o690





