Holders of a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) should send, in electronic format, the following documentation to the Certification of Substances Department (DCEP) of the EDQM:
- a completed application form, which includes classification of the changes, invoicing details and a comparative table of the changes, highlighting approved and proposed text;
- data supporting the changes;
- an update of the relevant section(s) of the dossier if the dossier is already in eCTD format, or a baseline dossier in eCTD format (including all sections and not just those impacted by the change) if the dossier is not yet in eCTD format.
The EDQM Guideline PA/PH/CEP (13) 110 details the policy applied to the management of notifications, revisions and renewals and makes clear:
- that if a notification is not accepted, there is no possibility to submit additional information regarding the notification and the holder will be advised of the rejection;
- that a revision application lacking sufficient information after evaluation of the applicant's response to a maximum of two EDQM deficiency letter(s) will be rejected.
Requests for renewal should be submitted about 6 months before a certificate's expiry date. Requests sent later may lead to a gap between the expiry date and the approval of the renewal request. CEPs are only renewed once. Requests for renewal should not include major changes, if needed, these should be submitted as a separate revision before or after the renewal.
- Application form "Request for Revision or renewal of Certificate of Suitability"
- 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.