EDQM announces new System for Revision/Renewal of CEP Certificates

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:

  • Notifications are split in immediate notifications and "annual" notifications. 
  • Unclassified changes are now minor by default. Some minor changes of the former guideline have also been downgraded to notifications. For unclassified variations, an applicant will also have the possibility to request for confirmation of the type of revision through the EDQM HelpDesk. 
  • Major changes are now listed.

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."

Source: www.edqm.eu


 

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