Back Revised Policy document PA/PH/CEP (04) 1, 7R on Content of the CEP dossier released for public consultation

EDQM Strasbourg, France 19/06/2023
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The European Directorate for the Quality of Medicines & HealthCare (EDQM) is revising the policy document PA/PH/CEP (04) 1, 6R ‘Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use’.

The draft document for public consultation is now available in the consultation space. The consultation deadline for this document is 15 September 2023. After the consultation phase the final policy document will be made available on the EDQM website.

Information related to the consultation phase and the dedicated consultation form are accessible from the consultation space.