The Icelandic Medicines Agency has for several years worked to increase the number of marketed medicinal products in Iceland, for both human and veterinary use. The primary objective has been to fill gaps in the medicinal products market and reduce the risk of supply problems, but also to increase competition.
The following measures can be applied for from the Icelandic Medicines Agency and support the above:
0-day procedure
A request may be submitted for a medicinal product to undergo a simpler application procedure. Each request is assessed individually with regard to whether the medicinal product concerned may be approved for a simpler application procedure and may possibly rec
eive a reduction in fees on that basis. Requests shall be sent to lyfjastofnun@lyfjastofnun.is.
Fee for a marketing authorisation for a medicinal product under the 0-day procedure
If the medicinal product applied for is on the price list as a product used on exemption grounds, or a comparable medicinal product, i.e. with the same active substance, pharmaceutical form and strength, and has been approved for a marketing authorisation through the 0-day procedure, a 30% discount is granted on tariff item 2.17, which applies to the zero-day procedure in the tariff.
Fee for a variation of a medicinal product that has received a marketing authorisation under the 0-day procedure
Fees for variations for medicinal products that receive a marketing authorisation through the 0-day procedure and have been used in the exemption system will be independent of the number of strengths under the marketing authorisation, i.e. only one fee will be charged for the variation even if it affects more than one strength under the marketing authorisation. This applies while the medicinal product is the only one on the market. If another comparable medicinal product enters the market, this will cease to apply. The fee for the zero-day procedure applies only to the strengths of the medicinal product that are marketed.
Administrative/shortened renewal: Generic medicinal products
In cases where an application is submitted for a shortened renewal procedure and all conditions for such a procedure are met, a 20% discount on fees may be requested. The request is submitted by writing “For this administrative renewal we apply for 20% discount” in the free text field of the cover letter accompanying the application.
Annual fees
An application may be submitted for a medicinal product to be exempted from the annual fee if the medicinal product meets the following conditions:
Information on the medicinal product must have been included in medicinal product databases on 31 December of the previous year.
No medicinal product that can replace the medicinal product in question is marketed in Iceland.
The combined annual turnover, based on wholesale price excluding VAT, of all pharmaceutical forms/strengths of the medicinal product in the previous year is less than ISK 1,800,000.
The pharmaceutical form/strength for which a reduction of the annual fee is being applied for was on the market, i.e. available, in Iceland throughout the previous year.
To apply for the above measure, the following form must be completed:
The completed form, together with the applicant’s cover letter, shall be submitted to the Icelandic Medicines Agency after 1 January and no later than 20 January each year. No exemption from the annual fee will be granted for applications received by the Icelandic Medicines Agency after that deadline.
Each cover letter may be accompanied by application forms for medicinal products from the same marketing authorisation holder. Each form may cover all strengths of one pharmaceutical form. The application must include information on the turnover of the medicinal product for the previous two years. Turnover means the combined wholesale value of all packs under the marketing authorisation number of the medicinal product concerned, excluding value-added tax.
