As part of the implementation of CEP 2.0 and as of 1 June 2023, the changes to the content of CEP applications listed below will be implemented AND the use of updated application forms will be mandatory.
- Changes to the CEP dossier content:
The CEP dossier, the assessment performed and the approved specification will be fully aligned. Therefore, the requirements for the content of the CEP dossier for chemical purity and for Herbal Drugs/Herbal Drug preparations have been revised. Amongst others, special attention will be needed with regard to drafting the Specification section (3.2.S.4.1), as it will be appended to the CEP. A guidance document to support applicants with the revised requirements for the impacted sections of the CEP dossier is now available.
This document should be used alongside the other Certification Policy Documents & Guidelines available on the EDQM website for the topics that have not been impacted or updated with the implementation of CEP 2.0.
These revised requirements apply to applications for new dossiers, sister files and renewals submitted as of 1 June 2023. CEP holders and applicants are encouraged to follow the requirements described in this document as soon as possible and to contact the Certification Department via the EDQM HelpDesk for assistance or to request more information.
- Revised application forms are now available for new dossier, sister file and revision/renewal applications.
CEP holders and applicants must provide the EMA SPOR/OMS ORG_ID and LOC_ID for all companies involved in CEP dossiers. More information on the SPOR/OMS database and how to register your organisation in the database is available on the EMA website: https://spor.ema.europa.eu/sporwi/.
The Holder’s Commitment has been updated to reflect the content of policy document “CEP holders responsibilities towards their customers” (PA/PH/CEP (21) 57) and to anticipate potential confidential sharing of reports for the dossier with the Competent Authorities of those countries with which the EDQM has a Memorandum of Understanding and/or Confidentiality Agreement in place.
For the Sister File Application Form, a template for comparative table has been added, in line with the policy document “Guidance on applications for sister files” (PA/PH/CEP (09) 141, 2R). The comparative table included in the application form is a key document for the acceptability of a sister file.
More information concerning these changes will be addressed in the CEP 2.0 webinars on 11 and 16 May 2023.