Legemiddelverket

Legemiddelverket, officially the Norwegian Medicines Agency, is a government agency in Norway responsible for regulation and supervision of medicines and other health products. It operates under the Ministry of Health and Care Services and is headquartered in Oslo. The agency’s core mission is to protect public health by ensuring that medicines and related products are safe, effective, and of high quality.

Key responsibilities include assessing and granting marketing authorization for pharmaceutical products; monitoring safety through pharmacovigilance and adverse reaction reporting; inspecting manufacturing facilities, distribution systems, and wholesale licenses; and enforcing rules on advertising and information to professionals and patients. The agency also regulates the supply chain to prevent shortages and manages post-market surveillance, risk management, and recalls when needed. In addition, it oversees regulation of certain health-related products within its statutory remit, including cosmetics and medical devices.

Legemiddelverket coordinates with international and European bodies, implementing EU/EEA medicines legislation in Norway and contributing to pan-European pharmacovigilance systems. It participates in collaboration with the European Medicines Agency and other national authorities and reviews clinical trials conducted in Norway under applicable rules.

Organization and governance: The agency is headed by a director and works with regulatory departments, inspectors, and scientific staff. It maintains contact with healthcare professionals, pharmaceutical companies, and the general public to provide guidance and information on medicines and their proper use.

See also: European Medicines Agency, Ministry of Health and Care Services (Norway), Norwegian Directorate of Health.