20/21 February 2024
Due to the introduction of new IT systems, the EDQM (European Directorate for the Quality of Medicines & HealthCare) has now also adapted the templates for applying for new CEPs, changes to CEPs and so-called "sister files". The implementation is planned to take place on 01 April 2022.
The EDQM describes the three most important changes on its website as follows:
Practical approaches on how to fill in the new forms will be available on the EDQM website in the near future. The EDQM will also provide information on the new features and updates in the so-called webinar "How to communicate efficiently with the EDQM on CEP applications".
Here you can find the information on the new forms and the recently published documents.