IPEC e-newsletter - Excipients Insight June 2018 - 19-06-18

 

Inside this issue

     

New EDQM guideline "How to read a CEP"

The European Directorate for the Quality of Medicines & Healthcare (EDQM) has drawn up a new guideline entitled “How to read a CEP” or Certificate of Suitability.

The aim is "clarifying the information to be concluded from a Certificate of suitability to the Monographs of the European Pharmacopoeia (CEP) for industry and the competent authorities," it says. Marketing Authorisation (MA) applicants are advised to read existing guidance published by the competent authorities in their countries, or to contact them directly for advice, when using a CEP to replace the respective quality part of the CTD dossier related to that given source, or in any variation.
 

 

 

 

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