26/27 October 2021
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" and published it on the corresponding website on 01 September 2021. This document provides some explanatory guidance and information on the electronic submission of "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia).
Electronic submission is performed using the eCTD (Electronic Common Technical Document) format and is mandatory for CEPs, except for TSE (transmissible spongiform encephalopathy) applications and submissions for substances for veterinary use, which have their own formats. The updated guideline, which is to be implemented in its new version on 01 October 2021, provides explanatory information on the procedures for the so-called "grouped revisions" and gives guidance on the requirements regarding the content and structure of the dossiers. Furthermore, the annexes of the guideline were used to list clarifications on these special topics and needs from applicants.
Here you can find the latest version of the "Guidance for electronic submissions for Certificates of Suitability (CEP) applications" and the related further information on the EDQM website.