Back CEP 2.0: The CEP letter of access is ready for use!

EDQM Strasbourg, France 24/07/2023
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The replacement of the declaration of access box on the CEP document by a separate letter of access is one of the changes introduced with the implementation of the CEP 2.0.

The template for this letter is now finalised taking into account comments received during the public consultation. The CEP holder should use this template or an equivalent one for any CEP without box of access. For marketing authorisation applications outside EU countries, it is recommended to use the template (if available) suggested by the local regulatory agency.