CRED ERP 25

Quick Reference Guide for the Centralised Procedure (CP)

Background: The CP was first introduced into the European Union (EU) in 1995. It was designed to ensure a harmonised scientific assessment and approval of new medicines across the EU; one submission which results in a single market authorisation for the EEA. (EEA defined as the 27 Member States; the European Free Trade Association or EFTA also include Iceland, Liechtenstein, and Norway.)

Strategy:

For some the applicant can choose either centralised procedure or national/ MRP/ DCP procedure ( “ optional CP scope ” )

Some products can now be authorised only via centralised procedure ( “ mandatory CP scope ” )

Some products are excluded from centralised procedure ( outside CP scope)

“Mandatory scope” CP: • Biotechnological and orphan

medicinal products and for human products containing a new active substance [authorised after 20 May 2004] and advanced therapies • CP is mandatory for products which are intended for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes

“Optional scope” CP: