SUB02: The European Centralised Procedure (CP)

Description

The Centralised Procedure (CP) is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA) on the basis of a single application. In the CP, one successful application leads to a marketing authorisation being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.

This module describes the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions.