CASubmissionFee object

Yes

An administrative application/ notification fee is charged by Fimea according to the Decree of the Ministry of Social Affairs and Health No 346/2015 (unofficial translation).

• Processing of Clinical trial notification (silent approval): € 2200.-
• Processing of Clinical trial authorization (explicit written approval): € 2500.- (applicable to clinical trials involving medicinal products for gene therapy, somatic or xenogenic cell therapy or medicinal products containing GMOs)

A single fee is payable for multi-centre trials.

Yes

Current fees are provided on the FIMEA website in section: Supervision > Clinical Drug Trials.
Further information on payment and applicable regulation (Decree No 346/2015) available in section: About us > Fees

Decree of the Ministry of Social Affairs and Health concerning activities of the Finnish Medicines Agency subject to fees No 346/2015

ad waiver: A waiver of processing fee may be requested in respect of a notification relating to a clinical trial on a medicinal product conducted by an individual investigator, a trial team, a university institute, a university hospital clinic or the National Institute for Health and Welfare without outside financing or with financing by a non-profit corporation. In these cases, the notification concerning a trial must be accompanied by an informal statement to the effect that the investigation will not receive any outside financing.