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Revised guidance for electronic submissions for CEP applications

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Certification of suitability (CEP)
News
01 September 2021
Strasbourg, France

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.

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. Applicants are invited to do so as soon as possible, however.

In addition, based on applicants’ feedback, a number of clarifications are given for specific topics such as the submission of grouped revisions and examples of format issues hindering the receipt of applications.

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