Marketing authorisations

Finland as a Reference Member State in the Mutual Recognition / Repeat Use Procedure (MRP/RUP)

Finland as a Reference Member State in the Mutual Recognition Procedure

Finland can act as the Reference Member State (RMS) in the Mutual Recognition procedure when the product has first been granted a national marketing authorisation in Finland. The same instructions apply also to so-called Repeat Use procedure.

The request can be submitted by filling in CMD(h) form Request for MRP/RUP for Medicinal Products for Human and Appendix 1.

The request is submitted by email to FI-RMSREQUEST(a)fimea.fi

More information:

Please use the following as the email subject: MRP RMS request for API (the active substance in question).