Change in fees related to mandatory reserve supply permits as of 1 January 2025

The Ministry of Social Affairs and Health has issued a Decree on fees chargeable by the Finnish Medicines Agency (1053/2024). The new Decree has entered into force on 1 January 2025, and it applies to any pending applications that are related to mandatory reserve supplies and have been submitted on or after 1 January 2025. 

In accordance with the new Decree, the fee for a permit to maintain lower mandatory reserve supplies will be 610 euro, regardless of how far in advance the application has been submitted. 

The estimated processing time of applications for permits to maintain lower mandatory reserve supplies is two weeks from the date on which the application was submitted. In the future, it will be particularly important to try to anticipate the need for a permit to maintain lower mandatory reserve supplies, as applications will be processed primarily in the order of submission. 

The estimated processing time of applications for exemption from the obligation to maintain mandatory reserve supplies and for the arrangement of mandatory reserve supplies though alternative means is one month after the application has been submitted. The tiered payment structure for these decisions is retained in the new Decree, and the fee is either  670 euro (application submitted at least two weeks before the start date of the requested exemption or alternative arrangements) or 1 340 euro (application submitted less than two weeks before the start date of the requested exemption or alternative arrangements).

More information

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

Ministry Decree STM/2024/182 (stm.fi, in Finnish)