Finland as a Reference Member State in the decentralised procedure (DCP)
Finland as a Reference Member State in the decentralised procedure
Fimea can continuously be asked to act as a Reference Member State (RMS) in applications submitted via the decentralised procedure (DCP). The applicants should be ready to submit their application in approximately 3–9 months.
Making the request
A request is submitted by completing the RMS request form of CMD(h): Request for RMS in a Decentralised Procedure, medicinal products for human use.
The reservation request should be sent by email to FI-RMSREQUEST(a)fimea.fi
- 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
On the subject line, please write DCP RMS request for API (the active substance in question).
Processing of requests
Fimea will process the RMS requests in approximately two weeks after the reception of the request. The applicant must adhere to the agreed schedule.