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    CEP 2.0 as new certification form issued by EDQM for demonstrating substance used in the preparation of medicinal products compliance with the European Pharmacopoeia

    The CEP, as you know, is a “Certificate of suitability to the monographs of the European Pharmacopoeia“. As we can read on the EDQM (European Directorate for the Quality of Medicines and HealthCare) website it is not mandatory, but the preferred option for demonstrating that a substance used in the preparation of medicinal products complies with the European Pharmacopoeia specifications according to the Note for Guidance on summary requirements for active substances in the quality part of the dossier (CPMP /QWP/297/97 Rev 1 corr; EMEA/CVMP/1069/02).

    The above-mentioned project is currently being implemented. Why?

    • To meet the most recent needs of CEP holders/API manufacturers, drug product manufacturers, regulatory agencies
    • To make the registration activities easier
    • To increase the acceptance of CEPs by EDQM

    What are the objectives?


    • To make it easier to use the CEP – the electronic document with a digital signature, downloadable as a pdf or printed by CEP holders to share with their customers for inclusion in MAA (Marketing Authorisation Application), no paper copy, a new numbering system
    • To specify the requirements for CEP dossier content and structure so that it contains only the correctly presented required quality data to be reflected on the certificate
    • To improve information sharing between CEP holders & MAH (Marketing Authorization Holder) – no declaration of access box in the CEP document anymore, provision the customers by holders with the letter of access according to the template available on the EDQM website
    • To reduce revisions of CEPs – CEPs are no longer revised for changes not impacting their content, no renewed CEPs issued
    • To improve on-line databases – EMA SPOR/OMS Organisation (Org) and Location (Loc) ID of a holder, access to short history of finalised procedures, extension of access to some regulatory authorities beyond Ph. Eur.

    The changes are being implemented successively starting in 2023.

    • “Old look”, “hybrid look” and “new look” CEPs will coexist for some time.
    • The “new look” CEP is issued for any new CEP granted and after the renewal procedure.
    • “Hybrid look” is used after revision of existing dossiers when there is no impact on the information reported on the CEP.
    • The “old look” CEPs granted before the implementation of CEP 2.0 will still be valid until they get revised.

    Are you interested in the CEP2.0? Please, use the dedicated website: https://www.edqm.eu/en/what-is-the-cep-2.

    If you are the API manufacturer, drug product manufacturer or MAH planning the activities related to the product registration or the CEP application, please contact SciencePharma, we will be happy to help you.