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Updated Guidance for e-Submissions for CEP applications

As the eCTD format is mandatory for the submission of all applications for Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs), except for applications for the risk of transmissible spongiform encephalopathy (TSE) (PDF format) and for substances for veterinary use (eCTD or VNeeS format), the European Directorate for the Quality of Medicines & HealthCare (EDQM) document “Guidance for electronic submissions for Certificates of Suitability (CEP) applications” (PA/PHCEP (09) 108) has been updated to reflect the current practices to facilitate submissions for applicants.

This document provides guidance for electronic submissions for Certificates of Suitability (CEP) applications submitted to the EDQM.

Information and requirements described in this document are intended to facilitate the handling and assessment of submissions for CEPs and to maintain their lifecycle even if the submission is not an eCTD.

An important update is that when switching to the eCTD format from another format, it will be mandatory to include any information already assessed and approved previously in a “baseline (full dossier)” to facilitate the lifecycle management of the dossier.

This will be implemented at the latest in January 2022.


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