- Submit a Revision Application
- Submit a Renewal Application
- Sister files
- Content of an Application
- Submission Format
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.
Applicants should send in electronic format the following documentation to the Certification of Substances Department (DCEP) of the EDQM:
- a completed application form, which includes invoicing details
- a comparative table of the changes, highlighting approved and proposed text,
- data supporting the request for revision,
- update of the relevant section(s) of the dossier.
The policy applied to the management of applications for revision and renewal of CEPs is now described in document PA/PH/CEP (13) 110. This document describes the policy relative to three rounds of assessment and provides clarification on the potential outcomes of assessment and subsequent activities. Applications lacking sufficient information after evaluation of the applicant's response to a maximum of 2 EDQM deficiency letter(s) are 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.
Once renewed, CEPs are valid for an unlimited period unless decided by the EDQM upon justified grounds to request an additional renewal , and provided that the dossier is in compliance with current regulatory requirements. For CEPs which were renewed prior to 1 January 2006, a second renewal may have taken place.
CEP holders should check that their manufacturing methods are in compliance with current regulatory requirements, and, if necessary, they should update the information provided in their application.
CEP holders do not have the possibility to include major changes to the content of the dossier. Only minor changes are accepted and assessed. If there are major changes, the CEP holder should submit a separate revision prior to or after the renewal application.
The sister files procedure is intended to facilitate the submission of similar dossiers within the Certification Procedure, and to allow applicants benefit from a fast-track procedure and harmonised assessments.
A company which has been granted a certificate of suitability (CEP) may wish to apply for another CEP for the same substance, either when it is not possible to apply for a revision of the initial CEP or when the company wishes to have separate CEPs for different conditions of preparation or qualities (for example, to cover an alternative manufacturing process, manufacturing site or an alternative grade).
This new application can be submitted as a “sister file”, provided that the conditions listed in the guideline are fulfilled.
A specific application form should be used for the submission of a sister file.
These applications are managed as described in the document Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure, December 2018.
In accordance with the current European regulation on variations to marketing applications, changes are classified into three categories: notifications, minor changes and major changes.
The classification of changes, the conditions to be met and the documentation to be provided for each type of variation are described in detail in the: Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs, PA/PH/CEP (04) 2, current version. A revised version of the guideline will be in force on 1st January 2019.
Applicants should send their documentation in electronic format only to the Certification of Substances Department (DCEP) of the EDQM.
Submissions should be sent via the “Common European Submission Platform (CESP)”. Users should first register with the CESP (cespportal.hma.eu) before sending submissions to the EDQM.
Instructions for submitting electronic documents using the CESP platform are available here: User guide (PA/PH/CEP (13) 67, 2R)
The "Guidance for electronic submissions for Certificates of Suitability (CEP) applications" should be used.