Finland as a Reference Member State in the decentralised procedure (DCP)
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:
- ATC: A, J, N, P, R, S, V: Procedure Manager Leena Pietilä, leena.pietila(a)fimea.fi
- ATC: B, C, D, G, H, L, M: Procedure Manager Tommi Koskela, tommi.koskela(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. If the applicant’s RMS request is approved, they must pay the advance fee stated in the Decree issued by the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency within 14 days. The applicant must adhere to the agreed schedule.