Mutual Recognition Procedure (MRP)

The Mutual Recognition Procedure (MP) allows for a single application for marketing authorization for medicinal products in multiple countries (within the European Economic Area (EEA)), selected by the applicant. Take this course to understand how the MRP intertwines with other regulatory bodies governing the EEA. The cours is primarily aimed at regulatory affairs professionals dealing with marketing authorization applications and related submissions for regulatory approval in Europe. More generally, it will also be of interest to all those involved in the development and registration of medicinal products.

The Mutual Recognition Procedure (MRP) is one of three routes available to applicants to gain multinational Marketing Authorization within the European Economic Area (EEA) on the basis of a single application. A national authorization is converted to harmonized authorizations issued in a number of other member states chosen by the applicant. The MRP is similar to the Decentralized 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 Decentralized 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.

You will:

• Get an overview of the Mutual Recognition Procedure (MRP)
• Learn what medicinal products fall under the MRP Umbrella.
• Understand the critical steps, primary documents required, and important deadlines throughout the MRP
• Learn the three ways to obtain approval to market medicinal products to member states.
• Understand the importance of the applicant, Concerned Member States, the Reference Members State, and other regulatory authorities