SUB11: The Decentralised Procedure (DCP)

Description

The Decentralised Procedure 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. It can be used only for a product which has no existing marketing authorisation in any member state. It is similar to the Mutual Recognition Procedure (MRP) but with earlier involvement of the Concerned Member States in the assessment by the Reference Member State. The Coordination Group for Mutual Recognition and Decentralised Procedures (CMD) provides guidance and acts to facilitate agreement among the participating states.

This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.