Finland as a Reference Member State in the Mutual Recognition / Repeat Use Procedure (MRP/RUP)
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:
- Head of unit Leena Pietilä, leena.pietila(a)fimea.fi
- VET: Head of Section, Coordinator for Marketing Authorisations Virve Aromaa, virve.aromaa(a)fimea.fi
Please use the following as the email subject: MRP RMS request for API (the active substance in question).