EDQM: CEP Application Templates redesigned

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

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:

• In addition to the postal address data of the companies, the information according to the SPOR- OMS data is now also required. This includes, for example, the "ORG_ID" and the "LOC_ID".
  Likewise, the information on GPS data of the manufacturing sites must be provided according to the internationally recognised system "WGS 84".
• The lists of already accepted ASMFs/DMFs and commercialised medicinal products are now available in their updated versions.
• The "Change of contact details" form is to be used preferentially to inform the EDQM of changes in the contact details of the official contact person.

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.