Requesting a Certificate of Medicinal Product from the EMA – New Certificate Processing System

EMA Account Management

Do you need an EMA Certificate of Medicinal Product to support Marketing Authorisation Applications outside of the EU?  If yes then you need to be aware of a new system introduced by EMA.

From Jan 2025 requests for Certificates of Medicinal Products, should be requested through the Certificates Processing System (CPS). To be able to access CPS applicants will need to have an active EMA account in the EMA’s account management portal.:

• Accessing CPS and requesting certificates

Certificates are requested via the following link Certificates | CPS; users should log into CPS using their EMA account credentials.

Requesters should work through the system populating the required information. The information requested is aligned to the information required in the old Certificates of Medicinal Products application form.

Useful information to note

• Payment of the fee invoiced is required before a certificate will be issued.
• At the time of writing this post, when populating the CPS there is no option to save the request and go back to it to complete at a later time; users should ensure they have all required information to hand before preparing the request.

Further information including a useful flowchart of the process can be found on the EMA website:

European Medicines Agency certificates of medicinal products – instructions on how to fill the application form – Revision 15 (Draft)

If you have any questions or face challenges with the EMA CPS or EMA Account Management, transScrip regulatory and clinical experts are able to guide you on the CPS access and request process.