EDQM Revises Guidance on Electronic Submissions for CEP Applications

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated its guidance on the electronic submission of applications for a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP).The revised document, PA/PH/CEP (09) 108, 7R, reflects the current requirements concerning the submission of an eCTD validation report, as previously communicated by the EDQM.

What does the guidance cover?

The document provides practical instructions for preparing and structuring electronic CEP application packages. It is intended to help applicants ensure that their submissions meet the EDQM’s technical and formal requirements.

The updated version now provides further clarification on the following points:

• the required naming convention for the eCTD validation report;
• the location of the validation report within the CEP application package;
• the format in which the report must be provided;
• the way in which changes to the content of Module 3 should be described.

Changes to Module 3 to be documented in Module 1

A key clarification concerns the presentation of changes to the content of Module 3. According to the updated guidance, such changes should be described in Module 1 of the CEP application.Applicants should therefore not highlight changes directly within Module 3. Instead, the relevant information should be provided in Module 1 in accordance with the applicable submission requirements.

Recommendation for CEP applicants

Companies preparing new CEP applications or updating existing submission procedures should review the revised guidance carefully. Particular attention should be paid to the requirements for the eCTD validation report and to the correct documentation of changes relating to Module 3.

Consulting the updated document before submission can help applicants:

• avoid formal deficiencies in the application package;
• ensure that the validation report is correctly prepared and positioned;
• maintain consistency with the EDQM’s current electronic submission requirements;
• reduce the risk of queries or delays during the assessment process.

The revised guidance PA/PH/CEP (09) 108, 7R should therefore be used as the current reference when preparing electronic CEP applications.