RMS: reference member state
The reference member state (RMS) is the EU/EEA Member State that leads the assessment in a decentralised or mutual recognition procedure.
In an MRP the RMS is the country that already granted the national authorisation; in a DCP the applicant chooses it. The RMS validates the application, writes the assessment reports, coordinates questions from the concerned member states and closes the procedure. It normally also leads later variations and renewals for the product.
Choosing an RMS means weighing assessment experience in the therapeutic area, slot availability, fees, timelines and language requirements. The RMS can be changed later, but only with the agreement of the authorities involved.
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When choosing an RMS, compare registration routes and target markets in the market expansion workflow.
Related terms
- CMS: concerned member stateA concerned member state (CMS) is any EU/EEA Member State, other than the reference member state, where an applicant seeks authorisation via a DCP or MRP.
- 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.
- 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.
- MRP: mutual recognition procedureThe mutual recognition procedure (MRP) extends a national marketing authorisation from one EU/EEA Member State to others, which recognise it.
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