The new decree on fees chargeable by the Finnish Medicines Agency entering into force on 1 September 2022

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 (798/2022) replaces the old decree (437/2021). The new decree will take effect on 1 September 2022 and it is expected to remain in force until 31 December 2023. New performances have been added to the revised decree and it also contains price adjustments.

The expenses arising from statutory tasks are covered by fees on a cost-equivalent basis

Fimea’s expenditure is mainly covered by fees generated by supervisory and service activities. Fimea allocates resources to the performances with function-based calculation in accordance with the cost causation principle to make the proceeds obtained from the performances match with the costs incurred from them. The calculations comprise real-time monitoring of working hours, accounting material and the number of performances.

New EU legislation making changes in performances and adjustments to fees necessary

Three new EU regulations entered into force in early 2022 and as a result, Fimea was given new tasks, and there were also significant changes to a number of chargeable performances.

The EU regulation on veterinary medical products (2019/6) adds the registration of the manufacturers of active substances used in veterinary medical products, and parties importing them to and distributing them in the European Economic Area, and changing of the register data to the list of chargeable performances.

The EU regulation on clinical trials (536/2014) entered into force on 31 January 2022. However, clinical trials can still be launched and continued during the transition period in accordance with the previous directive, and provisions on fees for them are also contained in the new decree on fees chargeable by Fimea.

With the entry into force of the EU regulation on in vitro diagnostic medical devices (2017/746), the performance fees applicable to medical devices will also start applying to IVD equipment.

Changes to licence and inspection fees

With the new decree on fees chargeable by Fimea, there will also be changes to the handling fees for biobank licences and notifications and the inspection fee.

The fee charged for shortage notifications will change so that the same fee will always be charged for the first notification.

Decree of the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency 798/2022 (pdf, in Finnish)