New decree on fees chargeable by the Finnish Medicines Agency entered into force on 1 June 2021

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 (437/2021) replaces the old decree (1499/2019). The new decree entered into force on 1 June 2021 and will remain in force until 31 August 2022.

Fimea's expenditure is mainly covered by fees available from supervision and service activities. The fees charged for the activities and services correspond to the costs incurred to the government for producing them. New performances have also been added and price adjustments have been made to the revised decree.

In the new decree on fees chargeable by the Finnish Medicines Agency, the processing of shortage notifications of medicines is subject to a fee. The fee is applied to new notifications starting from 1.6.2021. The shortage notifications have increased, and in 2020 a mere three per cent of the notifications reached Fimea within the timetable set in the Medicines Act, i.e. two months before the shortage began. The handling fee is higher if the marketing authorisation holder of the medicinal product only reports the shortage just before the shortage begins. Delivering shortage notifications to Fimea well in advance, is of primary importance in order to investigate the criticality of the medicinal product and, if necessary, to find means of securing its availability.

With the new EU regulations, the statutory supervision tasks of operators and devices related to medical devices will increase. Alterations have been made in the decree on fees chargeable, due to the entry into force of the MD decree. New fees include the audit fee for economic operators, the first registration and inspection fees for distributors subject to the registration obligation, and the inspection fee for clinical equipment examinations.

During the coronavirus pandemic, a part of the operators' inspections have been carried out remotely, and the proven practice will continue even after the pandemic. The decree on fees chargeable does consider real-time inspections over remote connections. Inspections of operators carried out entirely as remote inspections in Finland, have a lower price than on-the-spot inspections. Fees are also reduced in certain accelerated marketing authorisation processes, which do not require Fimea's assessment report.

Decree of the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency No 437/2021 (pdf, unofficial translation)

Notification of shortage (pdf)

Notification of shortage and appendix (xls)

Appendix for notification of shortage (pdf)

Instructions for giving a shortage notification (doc)

Frequently asked questions: Shortage notification (doc)