The forms for the submission of Certificate of Suitability to the European Pharmacopoeia monographs (CEP) applications (new applications, revisions and sister files) have been updated in order to facilitate their handling and the transfer of the collected data in the new IT tools implemented at the European Directorate for the Quality of Medicines & HealthCare (EDQM). The implementation date for the updated forms is 1 April 2022.
Major changes are listed here.
- Information regarding company details, names and addresses has been reviewed and additional data such as ORG_ID and LOC_ID (linked to data in the SPOR - Organisation Management Services (OMS) on the European Medicines Agency website) are recommended. Localisation data (GPS co-ordinates) for manufacturing sites need to be aligned with the internationally recognised WGS 84 system using latitude and longitude (with the + and – symbols) expressed in degrees to at least five decimal places, as described in policy document PA/PH/CEP (10) 118.
- In order to better take into account a substance’s commercialisation history and quality assessments already performed, the tables to gather information on the marketed medicinal products and list of accepted Active Substance Master Files/Drug Master Files (ASMFs/DMFs) have been updated.
- The form “change of contact details” is the preferred way to inform the EDQM when the contact person for one or more CEP dossiers has changed, as described in the policy document PA/PH/CEP (10) 86.
A webinar entitled “How to communicate efficiently with the EDQM on CEP applications” will be held on 29 March 2022 to provide further details to applicants on how to complete the new application forms. Participants will be guided through the updated forms and advice will be given on how to fill in the different fields to facilitate the handling of their application. The instructions on how to fill in the forms will also be available on the EDQM website soon.
Links to the application forms:
- Certification Policy Documents & Guidelines
- New EDQM IT tool for the management of CEP activities – Impact for CEP applicants and CEP holders (EDQM news, 24 September 2021)
- How to use the EDQM DCEP sharing tool (EDQM news, 31 January 2022)