About Icelandic Medicines Agency

The Icelandic Medicines Agency (IMA) is an independent regulatory authority, which appertains to the Ministry of Welfare. One of its main functions is to issue marketing authorisations for medicines in Iceland in collaboration with regulatory authorities in the European Economic Area (EEA), ensure control and surveillance of the pharmaceutical industry in Iceland and to contribute to making available to health professionals and consumers professional and unbiased information on medicines.

Safety and health issues are the main reasons why medicines are assessed by the authorities before they are placed on the market. Before a new Medicinal Product can be placed on the market, the applicant must perform extensive toxicological, quality and clinical studies. The regulatory authorities consequently assess the results of these studies in order to confirm the quality and safety of the medicine. Only then can the medicine be released on the market to the consumers. Further requirements are made to veterinary medicines on maximum residue limits in animals intended for human consumption.

In order to ensure health protection and free movements of medicines across the EEA, the European Union (EU) has harmonised requirements for research and testing among the Member States. The European Medicines Agency (EMA) located in London plays a central role in the network of close collaboration among the medicines authorities, concerning marketing authorisations and surveillance of medicines. EMA is responsible for the centrally authorised medicines but the individual Member States perform the assessments of application for National and Mutual recognition Mas.

Most of IMAs staff has a University degree and/or an expertise in medicines. In addition to the main functions mentioned before of marketing authorisations and surveillance, the Agency is also responsible for receiving reports on adverse reactions of medicines occurring in Iceland. The Agency also issues permissions for clinical trials, classifies natural products and food supplements into medicines and regular commodities, controls ads on medicines and publishes the catalogue of Medicinal Product.