Schedule for generic substitution and the reference price system in 2020

Abbreviations used in the table

  • Fimea = Finnish Medicines Agency
  • Hila = Pharmaceuticals Pricing Board
  • Kela = Social Insurance Institution of Finland
  2nd quarter 2020 3rd quarter 2020 4th quarter 2020 1st quarter 2021
Fimea publishes a list of substitutable products at the latest by 14.2.2020 15.5.2020 14.8.2020 16.11.2020
The pharmaceutical companies report corrections and additions to Fimea at the latest by 21.2.2020 22.5.2020 21.8.2020 23.11.2020
Fimea publishes the updated list 24.2.2020 25.5.2020 24.8.2020 24.11.2020
Hila publishes a list of products subject to the price notification procedure at the latest by 28.2.2020 29.5.2020 31.8.2020 1.12.2020
Price notifications of the pharmaceutical companies to Kela at the latest by 10.3.2020
at 16:15
9.6.2020
at 16:15
9.9.2020
at 16:15
10.12.2020
at 16:15
E-service for pharmaceutical companies open* 28.2.–10.3.2020 29.5.–9.6.2020 31.8.–9.9.2020 1.12.–10.12.2020 
Hila publishes a decision on the reference prices and Kela publishes the price bands at the latest by 24.3.2020 23.6.2020 23.9.2020 23.12.2020

* The service can only be used by pharmaceutical companies that have a Finnish business ID (Y-tunnus). The service is only available in Finnish and Swedish.

The schedule is based on the following legal provisions:

  • Fimea must publish a list of interchangeable products at the latest 45 days before the beginning of each quarter (Medicines Act, chapter 6, section 57c, subsection 2).
  • Hila must publish a list of the products subject to the price notification procedure at the latest 30 days before the start of the reference price period (Health Insurance Act, chapter 6, section 20, subsection 1).
  • Prices for interchangeable medicines must be notified to Kela at least 21 days before the first day of each quarter. Kela forwards the price notifications to Hila for determination of the reference prices (Decree of the Ministry of Social Affairs and Health concerning generic substitution, section 1, subsection 1).
  • The marketing authorisation holder must notify the wholesale price of a product subject to the price notification procedure to Hila at the latest 21 days before the start of the reference price period (Health Insurance Act, chapter 6, section 20, subsection 2).
  • Hila must make a decision on the reference price groups, the reference prices and the inclusion of a product in the reference price group at the latest seven days before the start of the reference price period (Health Insurance Act, chapter 6, section 21, subsection 2).
  • Kela must publish a list of the interchangeable products notified to Kela and their prices at the latest seven days before the first day of each quarter (Decree of the Ministry of Social Affairs and Health concerning generic substitution, section 1, subsection 2).

Read more