The Icelandic Medicines Agency ensures the safety of the public by providing ready access to medicinal products and medical devices, professional services, and objective information based on the latest knowledge.

Before medicinal products are placed on the market, the manufacturer carries out extensive toxicological, quality and clinical studies. Medicines authorities assess the results in order to confirm the quality and safety of the medicinal product. Specific requirements also apply to veterinary medicinal products regarding maximum residue limits in animals intended for human consumption.

Approximately 70 people work at the Agency, most of whom are university educated and have specialist expertise in the field of medicinal products. The Agency is responsible for granting marketing authorisations and for supervising the manufacture, distribution and sale of medicinal products. In addition, it handles reports of adverse reactions related to the use of medicinal products, authorises clinical trials of medicinal products, classifies herbs and substances with regard to the definition of a medicinal product, supervises advertising of medicinal products and publishes the Register of Medicinal Products.

Valid from 1 April 2026
Last updated in March 2026

A link in the chain of medicines agencies

To ensure a high level of public health protection and the free movement of medicinal products between European countries, the European Union has harmonised requirements for studies and testing among Member States. The European Medicines Agency, EMA, based in Amsterdam, is at the centre of a network of medicines agencies in the EEA that work closely together on the authorisation and supervision of medicinal products.

The Agency is responsible for authorisations that apply throughout the entire area, i.e. centralised marketing authorisations, while the individual medicines agencies of the EEA states are responsible for assessing applications for national marketing authorisations and marketing authorisations granted through mutual recognition.

The Icelandic Medicines Agency is part of the EMRN, the European Medicines Regulatory Network, which has received quality recognition from the World Health Organization.

• Read more about the Icelandic Medicines Agency’s international cooperation.

Role

The role of the Icelandic Medicines Agency is to ensure the safety of the public by providing ready access to medicinal products and medical devices, professional services, and impartial information based on the latest knowledge.

The statutory functions of the Icelandic Medicines Agency include, among other things, the following:

• To assess medicinal products and other products covered by the Medicinal Products Act No. 100/2020 in accordance with the rules applicable in the European Economic Area.

• To handle the granting, variation, suspension and revocation of marketing authorisations for medicinal products in accordance with the rules applicable in the European Economic Area.

• To process applications for authorisation to import and sell, on prescription, medicinal products that do not have a marketing authorisation in Iceland.

• To grant authorisations for studies involving medicinal products, including clinical trials of medicinal products and bioavailability studies, and to supervise the conduct of such studies.

• To handle the recording of adverse reactions to medicinal products and provide information on medicinal products.

• To carry out professional supervision of the importation of medicinal products, active substances and raw materials for the manufacture of medicinal products, or other products falling within the Agency’s remit.

• To carry out professional supervision of the activities of pharmacies, pharmaceutical wholesalers, pharmaceutical manufacturers and blood establishments, as well as supervision of marketing authorisation holders, their representatives and other companies, institutions and individuals that sell, manufacture, import or package medicinal products and related products.

• To conduct, in Iceland and abroad, quality audits and certification of companies’ manufacturing processes at their request and in accordance with the Medicinal Products Act, the rules applicable in the European Economic Area and the Convention establishing the European Free Trade Association.

• To supervise advertising of medicinal products and ensure that the promotion and distribution of medicinal products comply with applicable laws and regulations, and that proprietary medicinal products on the market meet the applicable requirements.

• To carry out specific supervision of narcotic and psychotropic substances in relation to the dispensing, preparation and endorsement of prescriptions and the dispensing of narcotic and psychotropic substances from pharmacies.

• To supervise the activities of blood banks, including the processing, storage and handling of blood and blood components.

• To review applications and issue pharmacy licences, importation and wholesale distribution licences, manufacturing authorisations, and importation and manufacturing authorisations for medicated feed, in accordance with the provisions of the Medicinal Products Act.

• To cooperate with foreign medicines agencies in the field of medicinal products, such as the European Medicines Agency (EMA), other EEA medicines agencies and others.

• To supervise medical devices in accordance with the provisions of the Medical Devices Act No. 16/2001, as subsequently amended.

• To make decisions on medicinal product prices, guided by the objective of the Medicinal Products Act that the use of medicinal products in Iceland should be based on a rational and cost-effective foundation, and to determine reimbursement, as applicable, in accordance with the Medicinal Products Act and regulations issued on the basis of that Act.