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 and get to know all the details!


Search News & Events

  • Filter by category


Related news and events

CTIS applicable | Faster Access to Clinical Trial Information in Europe

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.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting