Schedule for generic substitution and the reference price system
Abbreviations used in the table
- Fimea = Finnish Medicines Agency
- Hila = Pharmaceuticals Pricing Board
- Kela = Social Insurance Institution of Finland
| Timetable | 2nd quarter 2024 | 3rd quarter 2024 | 4th quarter 2024 | 1st quarter 2025 |
|---|---|---|---|---|
| Fimea publishes a list of substitutable products at the latest by | 15.2.2024 | 16.5.2024 | 16.8.2024 | 15.11.2024 |
| The pharmaceutical companies report corrections and additions to Fimea at the latest by | 22.2.2024 | 23.5.2024 | 23.8.2024 | 22.11.2024 |
| Fimea publishes the updated list | 23.2.2024 | 24.5.2024 | 26.8.2024 | 25.11.2024 |
| Hila publishes a list of products subject to the price notification procedure at the latest by | 1.3.2024 | 31.5.2024 | 30.8.2024 | 29.11.2024 |
| Price notifications of the pharmaceutical companies to Kela at the latest by | 8.3.2024 at 16:15 | 7.6.2024 at 16:15 | 9.9.2024 at 16:15 | 10.12.2024 at 16:15 |
| E-service for pharmaceutical companies open* | 1.3– 8.3.2024 | 31.5– 7.6.2024 | 30.8– 9.9.2024 | 29.11– 10.12.2024 |
| Hila publishes a decision on the reference prices and Kela publishes the price bands at the latest by | 22.3.2024 | 20.6.2024 | 23.9.2024 | 23.12.2024 |
* 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).