New decree on fees chargeable by the Finnish Medicines Agency entered into force on 1 January 2020
The Ministry of Social Affairs and Health has issued a decree on the fees chargeable under public law by the Finnish Medicines Agency. The new decree (1499/2019) supersedes the old decree (543/2019). The new decree entered into force on 1 January 2020 and will be effective until 31 May 2021.
Performances related to the duties transferred from Valvira to Fimea that were previously charged by Valvira have been added to the new decree. Certain new performances have also been added and price adjustments have been made to the revised decree.
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 new decree marks an increase in certain authorisation and inspection fees payable by operators in the pharmaceutical sector. Additionally, the costs incurred from an inspection cancelled by the object of the inspection will become subject to a charge.
Price adjustments concerning authorisations, notifications and inspections in the pharmaceutical sector have been made in the following performances: application-specific basic fee in national marketing authorisations and in the registration procedure, export certificates and inspections related to clinical trials.
The performances concerning the duties transferred from Valvira have been added to the Decree on fees chargeable by Fimea, and price adjustments have been made for some of them. There are six new performances related to the supervision of medical devices, one of which pertains to the first registration of operators in the sector (€500), one to the performance evaluation notifications of IVD devices (€500), and four to the applications and periodic assessments of notified bodies (€1,000–30,000). The fees pertaining to the duties transferred from Valvira are included in sections 11: Authorisations and notifications concerning medical devices, 12: Naming and assessment fees concerning notified bodies, 13: Authorisations and notifications related to biobank activities, 14: Authorisations pursuant to the Act on the Medical Use of Human Organs and Tissues, and 15: Licences issued under the Medical Research Act.
The processing of substantial amendments to clinical trials will be subject to a charge (processing fee €900). The number of notifications of substantial amendments have constantly increased during the past few years. Trials have also become more complex than before, for which reason substantial amendments to the trial protocols are made increasingly more frequently in individual trials. Exemption from the processing fee of a substantial amendment to a clinical trial can be requested from Fimea if the trial is carried out without outside financing or with financing from a non-profit organisation.
- Esko Kiiski, Finance Director, tel. +358 29 522 3630