Quick guide for the price notification procedure
The pharmaceutical companies submit price notifications on the products that are included in generic substitution and the reference price system to Kela 4 times a year. The quick guide proceeds towards the first day of the quarter when the reported prices, price bands and reference prices take effect. The dates in brackets are the binding dates by which the procedure in question must be carried out at the latest.
Actors in the procedure
Fimea = Finnish Medicines Agency
Hila = Pharmaceuticals Pricing Board
Kela = The Social Insurance Institution of Finland
Pharmaceutical company = marketing authorisation holder, importer, manufacturer or authorised agent
Topics
45–38 days
List of substitutable products
Fimea publishes a list of substitutable medicinal products (45 days).
Read more on Fimea’s websiteVerification of data
The pharmaceutical company reports any corrections and additions to Fimea within one week (45–39 days).
Read more on Fimea’s websiteUpdated list
Fimea publishes the updated list (38 days).
Substitution group codes
Kela defines the substitution group codes for substitutable packages together with Hila.
Read more30–21 days
Products subject to the notification procedure
Hila publishes a list of medicinal products that are subject to the price notification procedure (30 days).
Read more on Hila’s website (in Finnish)Price notifications
The pharmaceutical company submits the price notifications to Kela (21 days).
Read more20–8 days
Forwarding of price notifications
Kela forwards the price notifications to Hila for determination of the reference prices.
Reference prices
Hila determines the reference price groups and the reference prices.
Read more on Hila’s websitePrice bands
On the basis of the prices notified, Kela determines the price bands and the products included in the price bands.
Read moreThe Pharmaceutical Database and pharmacy price lists
Kela forwards the data on generic substitution to the administrators of the Pharmaceutical Database and the pharmacy price lists. The data to be forwarded also include the reference prices determined by Hila.
7–0 days
Decision on reference prices
Hila publishes a decision on the reference price groups and the reference prices (7 days).
Read more on Hila’s website (in Finnish)List of prices and price bands
Kela publishes a list of prices and price bands for substitutable products (7 days).
Read moreEntry into force
The notified prices, price bands and reference prices enter into force on the first day of the quarter. The Pharmaceutical Database and the pharmacy price lists contain up-to-date information.