News & General Information

NEWS
A summary of the main deficiencies found in the dossiers for Certificates of Suitability (CEP)

(25/09/08) A summary of the main deficiencies found in the dossiers for Certificates of Suitability (CEP) assessed from October to December 2007 is now available. By including the recommandations described in this summary together with the requirements listed in the guideline « Content of the dossier for chemical purity » (PA/PH//CEP (04) 1 4R) in the submission, the applicant for a CEP can improve the quality of their dossiers and therefore limit the time taken to receive the CEP. More information, click here.

EDQM continues to optimise the evaluation process of CEP applications

(11/07/08) In order to optimise the process of CEP evaluation and to ensure that the official timelines are met, EDQM has decided to apply the procedure for managing the Certification scheme described in the Resolution AP CSP (07) 1 more strictly. This means that the evaluation of new dossiers will be handled in two phases: the evaluation of the original dossier and, if necessary, a single request for additional information. Based on this information, a final decision whether a CEP can be granted will be taken, following a risk-based assessment. A second request for further additional information will only be issued in exceptional cases.

Any application that does not include sufficient information after evaluation of the applicant’s response to the deficiency letter will be definitively closed. This procedure will be implemented on 1st of September 2008. More information, click HERE.

Providing samples

(18/06/08) The Certification Division wishes to announce that its policy concerning Certification samples will change from 1st July 2008. Instead of providing samples for every new ‘chemical’ or ‘herbal drug/herbal drug preparation’ application for a Certificate of Suitability, a commitment to provide samples of the substance and/or its impurities when requested by the EDQM should be provided.

The application form has been updated accordingly and in particular Annex 6 has been added. 

New system for revision/renewal of CEPs

(18/06/08) The system for revision/renewal of CEPs will change for all requests for revision received from 1st July 2008. The main change to the system is that minor revisions to the Certification dossier, which do not cover a change in the specification of the final substance and which do not affect the content of the CEP, will not lead to the revision of the CEP after approval. To allow this modification, the minor change coded R3 has been split into two separate variations.
The following documents have been revised accordingly, and several other clarifications have been introduced:

• Guideline on revision/renewal of certificates of suitability to the monographs of the European Pharmacopoeia (PA/PH/CEP (04) 2 3R)
• Procedures for management of revisions/renewals of certificates of suitability to the monographs of the European Pharmacopoeia (PA/PH/Exp. CEP/T (04) 18)
  
• Application form for revision/renewal.

Note for the applicants: Procedure for validation of new applications

(16/6/08) This document presents the measures taken for the validation of new applications for a CEP that were put in place in 2007 and how to avoid the blockage of an application at receipt.  More information ...

Notice to holders of CEPs for heparin or enoxaparin

(20/05/08) Following the adverse events observed recently in the United States of America and in Europe, and following the measures taken by European Authorities, the EDQM has published a notice to the attention of holders of CEPs for heparin or enoxaparin. More information...

As failure to commitments of willingness to be inspected (refusal of inspection, reconstruction/restoration of sites to achieve GMP level, temporary closure of a site...) and/or to operate according to EU GMP :