Back CEPs for sterile substances – Guideline for preparing your dossier now available

EDQM Strasbourg, France 26/11/2024
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CEPs for sterile substances – Guideline for preparing your dossier now available

The European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes to provide further guidance to applicants for the preparation of their dossiers to obtain a Certificate of Suitability (CEP) for a sterile substance.

This document clarifies the conditions for acceptability of this type of dossiers and describes the documentation to be provided. 

 Content of the dossier for sterile substances, PA/PH/CEP (23) 54, November 2024