Changes to the rules of procedure for medicinal product authorisations, deviation from the reference price
31st January 2025
Iceland Health wants to inform you about the changed work procedure regarding the issue of medicinal product licences for certain medicinal products (R-labelled medicinal product licences).
From 15 February 2025, the licenses will be approved for certain medicines in cases where the most efficient medicines have been tried and the use of these medicines must be stopped for urgent medical reasons.
The payment of health insurance for medicine purchases is generally based on the reference price, according to the medicine price list. If a person cannot, for urgent medical reasons, such as because of serious side effects, use the medicine to which the payment of health insurance is based, a doctor may apply for a medical certificate for a specific medicine. The payment of health insurance is then based on the retail price of the medicinal product in question. A definition of serious side effects can be found on the website of the Icelandic Medicines Agency ().
This is in accordance with Article 12 of the Regulation on health insurance contributions to pharmaceutical costs (1143/2019). The updated work rules can be seen below.