The marketing authorisation holder shall, in accordance with Annex I to Tariff no. 1454/2020, pay an annual fee pursuant to Article 89 of the Medicinal Products Act No. 100/2020 for each pharmaceutical form and strength of a proprietary medicinal product, a parallel-imported medicinal product, a herbal medicinal product and a medicinal product pursuant to Article 17 of the Medicinal Products Act, which has a marketing authorisation on 1 January each year.
The annual fees are inter alia intended to cover the maintenance of the drug catalogues, the registration of adverse reactions and the information service in respect of medicinal products which have a marketing authorisation in Iceland, as well as expenses resulting from necessary co-operation with foreign agencies in respect of medicinal products that have already been granted marketing authorisations in Iceland.
If the marketing authorisation holder does not reside in Iceland, his national representative is responsible for paying the annual fee.
(09.11.2017)