Updated Procedure for the Renewal and Revision of CEPs!

After the latest updates in the categorisation of variations in authorisation procedures (see our GMP News from 3 July 2013), the EDQM has now published the revised version of the document entitled "Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs". This Guideline is addressed to CEP holders and describes the approaches regarding variations leading to the revision or renewal of an existing CEP.

The Guideline provides a list of changes for the sections administration, quality and TSE. Moreover, the respective category is indicated together with the documentation to be submitted for the variation application in question. Purely editorial changes should not be submitted as separate variations but a declaration should be provided that the content of the concerned part of the dossier has not been changed by the editorial changes. Changes which require a new CEP application are expressly mentioned. These changes concern:

• "Addition of a new route of synthesis and/or a new manufacturing site where the specification of the final substance is different from the one already approved, and
• Transfer to a new holder, where the transfer does not occur because of a merger or because the company is sold, and where the manufacturer does not take out the CEP in their own name".

Still, the holder of a CEP is obliged to ask for its renewal six months prior to expiry date (5 year validity) by providing an update of the Certification dossier regardless of any revisions treated in the meantime.

Together with the update of this guideline, the respective application forms "Request for new Certificate of Suitability" and "Request for Revision or Renewal of Certificate of Suitability" have been updated too. The most important change in both forms can be found respectively in Annex 7 ("Declaration of Holder's commitments, to be filled in for each submission"). There, the CEP holder has to confirm that he accepts "that the Certification of Substances Division of the European Directorate for the Quality of Medicines & Healthcare may share the assessment reports for this application with EU/EEA National Competent Authorities of the Ph. Eur. member states, and the EMA including all CHMP and CVMP Members and their experts".

The Guideline entitled "Procedures for management of revisions/renewals of certificates of suitability to the European Pharmacopoeia monographs" has also been updated and released. The document describes the timelines for renewals and revisions of CEP with regard to the various variation categories. An approach is also presented in the case when a pharmacopoeia monograph has been revised.

All the documents named above are coming into force as of 1st September 2013. They can be downloaded from the EDQM's News page.