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EDQM Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation (Catapult’s regulatory round-up – May 2024)

EDQM has drafted a guideline ‘Content of the dossier for sterile substances’ (PA/PH/CEP (23) 54) which is now available for public consultation until 15 August 2024. It is intended for applicants as a guide for compiling a dossier in order to obtain a Certificate of Suitability (CEP) for a sterile substance. This guidance document can be downloaded here.

Published on the 5th of June in Catapult’s regulatory round-up for May 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (4 novembre 2024). EDQM Draft guideline on ‘Content of the dossier for sterile substances’ released for public consultation (Catapult’s regulatory round-up – May 2024). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/12m73


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