CEPs: New IT Application of the EDQM

Recommendation

20/21 February 2024
Munich, Germany

GMP meets Regulatory Affairs
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

In October 2021, the EDQM (European Directorate for the Quality of Medicines & HealthCare) introduced a new IT application for handling and managing CEP applications. This resulted in some innovations and changes, especially in the communication between the applicant and the EDQM.

• Firstly, applicants now receive the relevant documents via the so-called "EDQM DCEP Sharing tool" and no longer by email as before.
• The "EDQM Database of Certificates of Suitability" now shows in real time the reasons for withdrawals or suspensions.
• Communication with applicants will be bundled from now on and will mainly be via e-mail or automatically generated notifications and not by letter contact as before.

The above-mentioned changes also resulted in updates to the associated documents and guidelines. These include, for example, the document "Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the 'sister files' procedure", which was revised in November 2021. This document now comprises the topics associated with the new IT application, and the resulting changes have been incorporated. One example of this is the new system for calculating time lines for evaluating CEP applications and revisions: From now on, the working days will be specified and no longer the calendar days as before.

The latest version of "Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the 'sister files' procedure" as well as further information are available on the EDQM website.