What is the Mutual Recognition Procedure?

What Is the Mutual Recognition Procedure (MRP)?

The Mutual Recognition Procedure (MRP) is a process within the European Union (EU) that facilitates the authorization of products. It simplifies the approval process by enabling a product that has been authorised in one EU member state (known as the Reference Member State or RMS) to be acknowledged and accepted by member states (known as the Concerned Member States or CMS). It must be used for marketing authorization holders (MAHs) that are submitting applications for medicinal products in more than 1 Member States.

General Overview of the Mutual Recognition Procedure

1. National validation by RMS
2. Preparation/update of assessment report by RMS (90 days)
3. Validation by CMS
4. Approval by CMS (90 days)
5. Discussion at coordination group level (if required)
6. National Marketing Authorization step

Once the first MA has been granted, a MAH may request on or more Member States to acknowledge this application that has been granted by the RMS. This is done by submitting an application after which the RMS has 90 days to provide an assessment report with the approved summary of product characteristics (SmPC), labelling, and package leaflet (PL) to the CMS and MAH.

After 90 days of the receipt of these crucial documentation, the CMS may recognise the RMS’ decision as well as the approved SmPC, PL, and labelling, by granting an MA with a harmonized SmPC, PL, and labelling. If there are differences between the documents of the RMS and CMS for a given product, if does impact the MRP provided the differences have no therapeutic implications.

DDReg’s Capabilities

Extensive experience of the EU regulatory guidelines and procedures

Support in the pre-submission activities

Development of regulatory submission strategy via MRP

QPPV support for EEA region

Regulatory gap analysis and remediation

Drafting, compilation, review of the MAA to EU Member State authorities

Support in submission of filings to competent authorities

Query response to competent authorities of EU Member States

Extensive support for variations, renewals, well-established use for MAs under the MRP