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:
- Human medicines:
Sektionschef, Koordinator för försäljningstillstånd Johanna Tervo, johanna.tervo(a)fimea.fi
Sektionschef, Koordinator för försäljningstillstånd Veera Torkko-Huuskonen, veera.torkko-huuskonen(a)fimea.fi
- Veterinary medicines:
Coordinator for Marketing Authorisations Matias Huhtala, matias.huhtala(a)fimea.fi
Please use the following as the email subject: MRP RMS request for API (the active substance in question).