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EMA – Publication of the European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications

This document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission interactions/meetings.

It will be updated regularly to reflect new developments, to include guidance on further pre- authorisation procedures and to reflect the implementation of the new European legislation. Revised topics will be marked by “New” or “Rev” upon publication.

More guidance and information on Biosimilars marketing authorisation on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (26 mars 2025). EMA – Publication of the European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/13kna


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