20/21 February 2024
Munich, Germany
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.
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.