On 1 October 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) commenced the use of a new IT tool to manage CEP applications. The implementation of this tool requires that timelines for evaluation of all CEP applications and their revisions/renewal be specified in working days instead of calendar days, which will also provide greater clarity on deadlines for applicants, particularly when the EDQM offices are closed.
Please note, however, that in order to avoid disrupting applicants’ internal procedures, the timelines for response to requests for additional information, clarification, etc., for ongoing procedures will continue to be counted in calendar days/months.
For more detailed information on changes to the EDQM timelines for CEP applications, please consult 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”.
As always, the EDQM wishes to thank applicants for their continued support and understanding during this time of change. More detailed information will soon be communicated on the impact of the new IT tool for customers.