20/21 November 2019
On January 25, 2010 the European Directorate for the Quality of Medcines and Health Care (EDQM) announced a new system for the revision and renewal of CEP certificates. The following is taken from the press release:
"To be in line with the revision of the EU Regulation on Variations to marketing applications, the system for revision/renewal of CEPs will change for all requests for revision received from 1st March 2010. As a consequence, the following documents have been revised:
- Guideline on revision/renewal of certificates of suitability to the monographs of the European Pharmacopoeia (PA/PH/CEP (04) 2, 4R, December 2009)
- Procedures for management of revisions/renewals of certificates of suitability to the monographs of the European Pharmacopoeia (PA/PH/Exp. CEP/T (04) 18, 2R, December 2009)
- Application form for revision/renewal (a revised version of the form will be available soon).
The changes are related to procedural aspects as well as to the classification of changes. As previously, changes are categorised as notifications, minor changes or major changes, with the following modifications:
The possibility of grouping variations affecting several CEP applications has been introduced and the concept of consolidated revision has been deleted. The deadlines and fees have been modified."