To obtain a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP), applicants must send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM ...
Detailed information on what an application should contain is described in the documents below. Refer to the document relevant to your application.
The sister file procedure is intended to facilitate the submission of similar dossiers within the Certification Procedure, and to allow applicants to benefit from a fast-track procedure and harmonised assessments ...
Applicants should send their documentation in electronic format only to the Certification of Substances Department (DCEP) of the EDQM.
- New requirements for the content of the CEP dossier for chemical purity and for herbal drugs/herbal drug preparations according to the CEP 2.0
- How CEP holders can avoid the rejection of notifications
- Change in contact details for a certificate of suitability application (to be used from 1 April 2022)
- CEP holders responsibilities towards their customers (PA/PH/CEP (21) 57, January 2022)
Search for a list of granted CEPs, their type, the name of the substance, the full CEP number, the issue date and validity status, using the Certification Database (updated daily).
Applicants commit to provide samples of substance and/or impurities when requested by the EDQM.