Council for europe portal
Language : en Search
Choose language

Revisions & Renewals

Submit a Revision Application

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 Division (DCEP) of the EDQM:

  • 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.

Management of applications for new CEPs and applications for revision/renewal of CEPs (PA/PH/CEP (13) 110 1R, January 2017)

 

Submit a Renewal Application

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. Provisional certificates may be granted if a request has been submitted in time and has not been approved at the time of expiry.

Once renewed, CEPs are valid for an unlimited period unless decided by the EDQM upon justified grounds to request one additional renewal (as foreseen by Directives 2004/27/EC and 2004/28/EC of the European Council and of the Parliament) and provided that the dossier is in compliance with current legal 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 legal requirements, and, if necessary, they should update the information provided in their application.

Applicants should send in electronic format the following documentation to the Certification of Substances Division (DCEP) of the EDQM:

  • a completed application form (including its annexes and the invoicing details),
  • updated technical documentation in CTD format OR a declaration that no changes have been made since the last request for revision sent to EDQM,
  • certificates of analysis of 2 recent production batches.

If an application is submitted, which includes changes, it should include an exhaustive list in the format of a comparative table  of those changes as well as supportive data.

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, CEP holders should submit a revision rather than a renewal application. In any case, the type of request should take into account the expiry date of the certificate.

 

Content of an Application

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.

 

Submission Format

From June 2016 the EDQM does not accept paper applications anymore. All submissions should be in electronic format (PDF, NeeS, VNeeS and eCTD).

From 1 January 2017 submissions should be sent via the “Common European Submission Platform (CESP)”. Users should first register with the CESP (https://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)

Please read the "Guidance for electronic submissions for Certificates of Suitability (CEP) applications"

"Guidance for electronic submissions for Certificates of Suitability (CEP) applications", PA/PH/CEP (09) 108, 4R

twitter facebook googleplus pinterest linkedin email
twitter facebook googleplus pinterest linkedin email