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

45–38 days

 

List of substitutable products

Fimea publishes a list of substitutable medicinal products (45 days).

Read more on Fimea’s website
 

Verification of data

The pharmaceutical company reports any corrections and additions to Fimea within one week (45–39 days).

Read more on Fimea’s website
 

Updated list

Fimea publishes the updated list (38 days).

 

Substitution group codes

Kela defines the substitution group codes for substitutable packages together with Hila.

Read more

30–21 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 more

20–8 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 website
 

Price bands

On the basis of the prices notified, Kela determines the price bands and the products included in the price bands.

Read more
 

The 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 more
 

Entry 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.