Lyfjastofnun

Lyfjastofnun is the Icelandic Medicines Agency, a government authority responsible for the regulation of medicines and medical devices in Iceland. It operates within the health sector and advises the Ministry of Health on pharmaceutical policy, safety, and public health matters.

The agency’s core responsibilities include licensing and marketing authorization for medicines used in Iceland, registration of pharmaceutical products, and oversight of clinical trials conducted in the country. It regulates advertising of medicines to healthcare professionals and to the public, aiming to ensure that information is accurate, balanced, and not misleading. Lyfjastofnun also oversees the import, distribution, and retailing of medicines to ensure compliance with quality standards.

A key function is pharmacovigilance and post-marketing surveillance. The agency collects and analyzes adverse drug reaction reports, monitors safety signals, and communicates risk information and safety updates to healthcare professionals and the public. It can impose corrective actions, safety warnings, or recalls when necessary. Inspections of manufacturers, wholesalers, and distributors are performed to enforce good manufacturing practice (GMP) and good distribution practice (GDP).

Lyfjastofnun operates within the European Economic Area framework, applying EU/EEA medicines and medical devices legislation as transposed into Icelandic law. It collaborates with European regulators and participates in information sharing and joint activities where appropriate. The agency also provides guidance to industry and healthcare professionals and maintains public information resources on approved products and safety notices.