CMS: concerned member state
A 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.
CMS review the RMS assessment report and draft product information, raise comments and must approve them before granting national authorisations. Each CMS charges its own fee and has national requirements for translations, mock-ups and local details in the product information.
A CMS can refuse to agree only on grounds of potential serious risk to public health, which leads to a CMDh referral. Applicants sometimes withdraw from a CMS to avoid that referral, which keeps the procedure on time but loses the market. Further CMS can be added later through a repeat-use procedure.
Used in
When scoping a procedure, calculate the national fee in each concerned member state with the Regunaut fee calculator.
Related terms
- RMS: reference member stateThe reference member state (RMS) is the EU/EEA Member State that leads the assessment in a decentralised or mutual recognition procedure.
- MRP: mutual recognition procedureThe mutual recognition procedure (MRP) extends a national marketing authorisation from one EU/EEA Member State to others, which recognise it.
- Blue Box: national information on packaging in MRP and DCPThe Blue Box is the blue-bordered area on EU packaging and leaflets that carries national particulars such as price, reimbursement and legal status.
- 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.
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