Mutual Recognition Procedure (MRP) – Overview
A Marketing Authorization Holder (MAH) who already holds authorization for a medicinal product in an EU member state can leverage the Mutual Recognition Procedure (MRP) to obtain approval in multiple EU member states.
In this procedure, the member state that granted the initial authorization acts as the Reference Member State (RMS), while the other EU member states where the Marketing Authorization Application (MAA) is submitted act as the Concerned Member States (CMSs). Following the submission of the MAA to all EU member states (RMS and CMSs), the RMS assessment report forms the basis for the CMSs to grant authorization.
According to EU directives, the MRP follows a 90-day review cycle, followed by a 30-day national phase for translating product information into regional languages. After the first MRP, the Repeat Use Procedure (RUP) can be applied to obtain authorizations in additional member states, applicable only between the RMS and a new CMS.
Preparation for MRP can be challenging due to stringent regulatory requirements. Non-compliance or incomplete preparation may lead to validation issues and delays in the review process, which can impact go-to-market timelines.
X Pharma Plus, with extensive Regulatory expertise, supports manufacturers in understanding submission requirements under Article 10(1), managing pre-submission administrative activities, and providing end-to-end support in compiling, technically reviewing, finalizing, and publishing submission documents for a smooth MRP process.
Mutual Recognition Procedure (MRP) – Services
“Allows marketing authorization of a medicinal product in additional EU member states based on an existing approval in one reference member state.”