NEW CEP 2.0: The CEP of the future

A “new look” Certification of Suitability (CEP) will be implemented from September 2023 for new CEPs and renewals.

A “new look” Certification of Suitability (CEP) will be implemented from September 2023 for new CEPs and renewals.
July 31, 2023

With the implementation of CEP 2.0, CEP becomes an electronic document with a digital signature, downloadable as a pdf or printable by CEP holders, enabling to share it with customers for its inclusion in the Marketing Authorisation Application (MAA). However, this new look brings many more important changes:

  • Regarding the information reported in a CEP: the numbering system will change, the declaration of access box will be replaced by a letter of access, and company details will be completed by the EMA SPOR/OMS. Additionally, information reported in the CEP for chemical purity, herbal drug preparations and related to the quality of the substance will be revised.
  • The assessment of CEP applications will change.
  • New features will be available in the online public certification database and the Authorities database, such as EMA SPOR/OMS Org and Loc ID.
  • CEP applicants will have to provide a commitment to share information with their customers as part of the application form for a CEP.
  • CEPs will no longer be revised if their content has not changed.
  • Specifications of the substance applied by the CEP holder will be appended to the CEP.
  • Further changes to promote/facilitate the use of CEP 2.0 in non-EU markets will be incorporated.

From Asphalion, we can help you understand how this implementation impacts your CEP or Marketing Authorisation (MA).

Do not hesitate and reach out to us  by scheduling a call or writing at info@asphalion.com and get to know all the details!

 

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CTIS is the single-entry point for the submission and assessment of clinical trial applications in the EU. It features a public, searchable database aimed at delivering a high level of transparency. The authorisation and oversight of clinical trials are managed by EU/EEA Member States, while the EMA maintains the CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation.

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