New decree on fees chargeable by the Finnish Medicines Agency entered into force on 1 January 2026

The Ministry of Social Affairs and Health has issued a decree on the fees chargeable under public law by the Finnish Medicines Agency Fimea. The new decree (1344/2025) will replace the old decree (1053/2024). The new decree will take effect on 1 January 2026 and it is expected to remain in force until 31 December 2026. 

Fimea is a net budgeted agency that is funded mainly by the customer fees of pharmaceutical operators. Most of the fees remain unchanged in 2026. 

The decree contains some new performances based on the Cybersecurity Act, the Act on the Protection of Infrastructure Critical to Society and on the Improvement of Resilience, and the EU AI Act.

Decree of the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency (finlex.fi)