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).