The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated the guidance PA/PH/CEP (09) 108, 7R for electronic submissions of applications for a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) in order to reflect current requirements regarding the need to provide an eCTD validation report, as communicated previously.

The updated guidance:

• describes how the eCTD validation report should be named, where in the CEP application package it should be located, and the format in which it should be presented;
• indicates that changes to the content of module 3 of a CEP application should be described in module 1 and not highlighted in module 3 itself.

CEP applicants are encouraged to consult the updated guidance to ensure compliance with these revised requirements when preparing their CEP submissions.