New course: The Mutual Recognition Procedure (MRP)

Thu 30 May 2013 @ 10:59

Zenosis, the leading provider of specialized training solutions for the pharmaceutical industry has announced the release of a new e-course, The Mutual Recognition Procedure (MRP).

  • A fresh new interface
  • Audio support with animation
  • Immersive activities throughout

The Mutual Recognition Procedure is one of three routes available to applicants to gain multinational Marketing Authorisation within the European Economic Area (EEA). A national licence is converted to harmonised licences 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.