EDQM updates Guidance for electronic submissions for Certificates of Suitability (CEP) applications

In July 2021, the EDQM (European Directorate for the Quality of Medicines & HealthCare) renewed the document “Guidance for electronic submissions for Certificates of Suitability (CEP) applications“. The guidance provides explanatory guidance on the electronic submission of CEPs (Certificates of Suitability of Monographs of the European Pharmacopoeia).

The new version of the updated guideline will be implemented on October 01, 2021. The information and requirements described in this document are intended to facilitate the management and evaluation of CEP submissions and to maintain their lifecycle even if the submission is not an eCTD.

This guidance should be applied to all electronic submissions submitted to EDQM as part of CEP applications.

EDQM no longer accepts paper submissions; in fact, the eCTD format is mandatory for all submissions, with the exception of applications for TSE risk (PDF format) and for veterinary substances use only (eCTD format)

EDQM no longer accepts paper submissions; in fact, the eCTD format is mandatory for all submissions, with the exception of applications for TSE risk (PDF format) and for substances for veterinary use only (eCTD format).

Guidance for electronic submissions for Certificates of Suitability (CEP) applications