Determination of maximum price
All registered, prescription-only medicines (POM) for humans must have a maximum price, set by the Norwegian Medicines Agency (NoMA), before they can be marketed in Norway. The market authorization-holder must apply for a maximum price.
Price application/information form.
The maximum pharmacy purchase price (PPP) and the pharmacy mark-up is determined by NOMA. The maximum PPP and mark-up add up to the maximum pharmacy retail price (PRP).
The maximum PPP is set as the mean of the three lowest market prices of the product in a selection of European countries. The price comparison group includes Sweden, Finland, Denmark, Germany, Great Britain, The Netherlands, Austria, Belgium and Ireland. For more information regarding price setting see the following link:
NOMA aims to process 80 % of the price applications within 50 days. In the 4th quarter of 2018, 44% of the price applications were processed within 50 days. In the preceeding quarter the result was 87%. The average processing time in the 4th quarter of 2018 was 47 days.
Prices from the reference countries are submitted in local currency. To convert prices into Norwegian kroner (NOK), NOMA uses the mean exchange rate of the last six months, as presented by the Central Bank of Norway (www.norges-bank.no).
List of products with maximum prices
The list contains price- and reimbursement information on all POM for humans with a maximum price in Norway. The list shows the maximum PPP (exclusive VAT) and the maximum PRP (inclusive VAT). Please note that actual prices may be lower than maximum prices stated. This is for example relevant for pharmaceuticals with market entry agreements (Repatha and Praluent).
There is no price regulation for over the counter medicines, products without marketing authorization and veterinary medicines.
Reevaluation of maximum prices
The marketing authorization holder and NOMA may initiate a reevaluation of the maximum prices. However, adjustments should normally not occur more frequently than once per year. NoMA reevaluates the maximum price for the active ingredients with the highest turnover. The purpose is to ensure that the maximum prices reflect the developments in European prices.
In the end of August/early September each year, NoMA publishes the reevaluation order for the upcoming year. NOMA determines the active ingredients that will be reconsidered, and in what order.