Läkemedelsverket (Swedish Medical Products Agency)

Läkemedelsverket is the Swedish competent authority for medicinal products (for human and veterinary use), medical devices and IVDs, cosmetics, tattoo inks and certain narcotics. The agency authorises clinical trials and clinical investigations, grants national marketing authorisations and participates in EU procedures (centralised, decentralised and mutual recognition) for medicinal products, conducts market surveillance of medical devices and IVDs placed on the Swedish market under the EU MDR and IVDR, supervises national medical information systems under national regulation, supervises pharmacies, and operates the Swedish Poisons Information Centre and the Medicines Information service. Läkemedelsverket also has a designated preparedness role for medicinal products and medical devices, and a government remit to support research and innovation within its areas of responsibility. The agency has no office in Skåne, but interacts with regional life science actors as part of the innovation ecosystem.