Changing of Reference Member State duties to Finland

Fimea’s long-term experience and competence as a Reference Member State will give your product a solid foundation for administering the processes involved. Fimea already acts as a Reference Member State for hundreds of processes.

The change of the Reference Member State is a quick process in which the marketing authorisation holder, the current Reference Member State and the future Reference Member State will jointly agree upon the timetable of the change process. No fee will be charged for the Reference Member State change process.

Brexit

Following the UK’s exit from the EU, a number of Reference Member State duties will be transferred to other Member States. Consequently, Fimea has prepared to act as the Reference Member State for the marketing authorisation processes transferred from the UK.

Good to know before changing the Reference Member State (sub-heading)

  •  Finland must be a Concerned Member State in the process
  •  No processes may be pending during the change
  •  The CMDh template must be used for submitting a request for the change of the Reference Member State
  •  CMDh guideline and template
  •  CMDv guideline

Enquiries/Further information

Change of the Reference Member State:

 

Human medicines:

Pekka Kervinen, Coordinator for Marketing Authorisations, pekka.kervinen(a)fimea.fi, tel. +358 29 522 3014

Veterinary medicines:

Heidi Mustalammi, Procedure Manager, heidi.mustalammi(a)fimea.fi, tel. +358 29 522 3329

 

New DCP/MRP requests:

Human medicines:

Leena Pietilä, Head of Unit, leena.pietila(a)fimea.fi, tel. +358 29 522 3360

Veterinary medicines:

Heidi Mustalammi, Procedure Manager, heidi.mustalammi(a)fimea.fi, tel. +358 29 522 3329