28th August 2025
28th August 2025
6,000 fewer applications for a drug licence per year
The amendment to the Regulation will take effect on 1 September.
On 1 September, the change on health insurance’s participation in the cost of medicine will take effect, see collection of regulations.
The main change is that Article 8 of the Regulation, which dealt with payment participation with price limits, is deleted. This means that a number of medicines will receive general payment participation and no longer will be necessary to apply for a medicinal product licence for them. Therefore, payment participation will be in accordance with the general rules that apply to payment participation for medicines.
These include proton pump inhibitors, lipid-lowering drugs, drugs that affect bone structure and bone formation, antipsychotics, specialized serotonin reuptake inhibitors and other antidepressants.
The change has increased expenditure for the Icelandic Health Insurance, but will also significantly reduce the administrative burden on doctors in relation to these medicines. To date, the Icelandic Health Insurance has had to process about 6,000 applications annually because of this provision. Only in case of expensive medicines will an application for a medicinal product licence continue to be required when there is a more cost-effective treatment option.
On the website and in the Directorate of Medicine you can see which medicines have received general payment participation (G-labelling).
For further information, please visit the website of the Icelandic Medicines Agency.