MRP: mutual recognition procedure
The mutual recognition procedure (MRP) extends a national marketing authorisation from one EU/EEA Member State to others, which recognise it.
Under Article 28(2) of Directive 2001/83/EC, the Member State that already authorised the product acts as reference member state (RMS) and prepares or updates its assessment report, which the concerned member states (CMS) then recognise. The same route is used for later waves, called repeat-use procedures, after a first MRP or DCP has closed.
What goes wrong: an old national dossier that no longer meets current standards, RMS product information that has drifted from the dossier, and divergent national texts that must be harmonised before the CMS will agree. A CMS can withhold recognition only on grounds of potential serious risk to public health.
Timing
The RMS has 90 days from a valid application to prepare or update the assessment report. Once the procedure starts (Day 0), CMS send comments by Day 50 and the applicant responds. If all CMS agree, the procedure closes by Day 90; if not, the disagreement goes to the CMDh for 60 days under Article 29 of Directive 2001/83/EC. National authorisations then follow within 30 days.
Used in
Before starting an MRP or a repeat-use wave, compare candidate markets and registration routes in the market expansion workflow.
Related terms
- DCP: decentralised procedureThe decentralised procedure (DCP) authorises a medicine in several EU/EEA Member States at once when it is not yet authorised in any of them.
- Referral: EU-level assessment of a disputed or safety issueA referral is an EU procedure that resolves a scientific or regulatory issue about a medicine, or a class of medicines, in a single EU-level assessment.
- RUP: repeat-use procedureA repeat-use procedure (RUP) is a further mutual recognition wave that adds new concerned member states to a product already authorised by DCP or MRP.
- CMDh: Co-ordination Group for Mutual Recognition and Decentralised ProceduresThe CMDh is the group of national authority representatives that resolves disagreements in MRP and DCP and coordinates nationally authorised medicines.
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