CRED Getting the CMC Dossier Right 2024

28/08/2024

Variations (cont …)

III CEP/TSE/Monograph

• Submission of a new CEP for an active or an update to an already approved CEP • Changes to comply with Ph. Eur. or national pharmacopeia of a member state

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Variations to the CEP

• Holders of a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEPs) must inform the EDQM of any change(s) to the information provided in the initial application.

• GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS - European Directorate for the Quality of Medicines & HealthCare (edqm.eu)

• Applicants should send the following documentation to the Certification of Substances Division (DCEP) of the EDQM:

• a completed application form, which includes your invoicing details

• data supporting the request for revision

• update of the relevant section(s) of the dossier.

• If the change impact information on the CEP a new CEP will be issued, otherwise EDQM will simply assess without any update required

The Organisation for Professionals in Regulatory Affairs

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