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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:

1.11. What should I do if I want to submit multiple/duplicate applications for the same medicinal product?

3.4.3. What should I submit if my medicinal product contains or consists of genetically modified organisms (GMOs)?

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


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