The statutory function of the Icelandic Medicinal Agency is as follows:

• To evaluate medicinal products and other products falling under this act in accordance with the rules in force in the European Economic Area and under the EFTA Convention of the European Free Trade Association.

• Issuing, amending, and suspending marketing authorisations for medicinal products in accordance with the rules in force in the European Economic Area.

• To process applications for using Medicinal Products that do not have a valid Marketing Authorisation in Iceland.

• Issuing licenses for clinical trials and monitoring the implementation of such trials.

• To ensure registration of adverse effects of medicinal products and the provision of information on medicinal products in cooperation with the Directorate of Health.

• Monitoring import of medicinal products, active substances and raw materials for the preparation of medicinal products.

• To ensure professional monitoring of industry, pharmacies, pharmaceutical wholesalers, holders of marketing authorisations for medicinal products and their agents.

• To monitor advertisements of medicinal products in accordance with current law and regulations.

• Cooperation with foreign institutions in the field pharmaceutical affairs, as cooperation with the European Agency for the Evaluation of Medicinal Products (EMEA), cooperation with other regulatory authorities in EEA, European Pharmacopoeia Committee and Pharmaceutical Inspection Convention/Scheme, PIC/S.
  

Mission Statement

The mission of the Icelandic Medicines Agency is to promote the health of humans and animals by:

Evaluating the quality and safety of medicinal products to ensure that good and robust medicinal products are on the market, scientific monitoring so that medicinal products and the activities of companies distributing medicinal products meet the requirements of public health authorities, provision of information so that health professionals and the general public have up-to-date, unbiased information about medicinal products, with consumer protection as a guideline, efficient service for stakeholders in cooperation with the best qualified experts in the field of pharmaceutical affairs.

Core Values

• Quality: The Icelandic Medicines Control Agency aims at always having qualified and informed employees along with experts in the field of pharmaceutical affairs, evaluating the quality and safety of medicinal products, providing professional monitoring of production and distribution of medicinal products and of disseminating information. The Icelandic Medicines Control Agency offers a creative work environment, good work facilities and opportunities for continuing education and professional development.

• Trust: Reliability and disciplined working procedures ensure safety and engender trust amongst stakeholders. The Icelandic Medicines Control Agency wants to inspire stakeholders' trust, e.g.  through dynamic dissemination of information, consistency and reliability, respect and open relations and cooperation

• Service: The Icelandic Medicines Control Agency aims at providing stakeholders with the best professional service available in issuing marketing authorisations for medicinal products, disseminating information on medicinal products and instructions on current law and regulations, in order to ensure that good and robust medicinal products are on the market. This is accomplished by good accessibility to information and instructions at the Icelandic Medicines Control Agency, access to the most capable experts and highly trained employees in dynamic collaboration with regulatory authorities in the EEA and the European Agency for the Evaluation of Medicinal Products.