As part of our continuous commitment to improving processes and to better support applicants in preparing compliant, complete and properly documented CEP submissions, the EDQM has published a new FAQ entitled “How to present the specification for a substance in a CEP application?”

This new FAQ can be found here: https://faq.edqm.eu/pages/viewpage.action?pageId=142868482

This resource provides clear, consolidated guidance for the preparation of section 3.2.S.4.1 of CEP dossiers and should be used for all future submissions.

The FAQ should be read in conjunction with the EDQM guideline “Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use” PA/PH/CEP (04) 1, 7R.