Notifications, Revisions, Renewals and Sister Files
Holders of a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) must inform the EDQM of any change(s) to the information provided in the initial application.
In addition, a CEP must be renewed once, 5 years after the issue date of the original CEP for it to remain valid (regardless of revisions in the interim period).
The themed topics below help companies to understand how to notify EDQM of changes, get them approved and how to renew their CEP.
In accordance with the current European Regulation on variations to marketing applications, changes are classified into three categories:
- notifications (for changes not expected to impact quality),
- minor changes (for changes which may impact quality)
- and major changes (for changes which are likely to impact quality) ...
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 ...
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 ...
- Application form request for sister file
- 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.