EDQM: CEP 2.0 implemented

Recommendation

17/18 September 2024

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
With updates on the CEP 2.0!

Since the beginning of September 2023, the CEP 2.0 is implemented by the EDQM (European Directorate for the Quality of Medicines & HealthCare). From now on, applicants of a new dossier or renewals will receive a CEP 2.0. This will be available as a PDF file in the so called sharing tool "DCEP" and will be signed electronically only. The document "Certificates of suitability: electronic signature features", which is available on the website of the EDQM, explains how the electronic signatures are used and how you can detect valid and invalid electronic signatures. For any cases, the CEP holder has doubts regarding the electronic signatures, the EDQM helpdesk may be contacted.

For revisions, that affected the content of the CEP, a so called "Hybrid CEP" will be issued.
In addition, a switch from a valid CEP to a CEP 2.0 is now also possible for CEP holders. The holders need to update their CEPs in accordance with the requirements of the CEP 2.0 guidelines and can then submit a minor revision mentioning the switch to CEP 2.0.

The validity of a CEP 2.0 or a Hybrid CEP can be checked in the "Certification" data base. Since September it is also new that the date for the renewal of the CEPs is no longer mentioned on the CEP itself.

The latest updates and information of the topic "CEP 2.0" can be found on the website of the EDQM in the category "What is the CEP 2.0?".