SUB03: The Mutual Recognition Procedure (MRP)

Description

The Mutual Recognition Procedure (MRP) 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. A national authorisation is converted to harmonised authorisations issued in a number of other member states chosen by the applicant.

The MRP is similar to the Decentralised Procedure but with later involvement of the Concerned Member States in the assessment by the Reference Member State. The Coordination Group for Mutual Recognition and Decentralised Procedures 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 MRP.