Legemiddelkontrollen

Legemiddelkontrollen refers to the set of policies, procedures, and activities that govern the development, production, distribution, and use of medicines to protect public health. It covers assessment of quality, safety, and efficacy, as well as licensing, monitoring, and enforcement throughout a medicine’s life cycle.

Pre-market assessment and authorization: before a medicine can be marketed, sponsors submit a detailed dossier with clinical data, quality information, and labeling proposals. The national medicines authority evaluates the dossier and decides whether to grant marketing authorization, request additional studies, or reject the product.

Manufacturing quality and supply chain: legemiddelkontrollen includes controls to ensure medicines are produced according to good manufacturing practice (GMP) and distributed under proper conditions. This involves inspections of manufacturing sites, warehouses, and the integrity of the supply chain to prevent counterfeit or substandard products.

Labeling, information, and promotion: medicines must have accurate labeling, patient information leaflets, and clear instructions for use. Advertising and promotion are regulated to avoid misleading claims and to protect patients and health professionals.

Pharmacovigilance and post-market surveillance: authorities monitor medicine safety after authorization through adverse event reporting, signal detection, and risk management plans. This ongoing surveillance helps identify rare or long-term risks and informs safety advisories or actions.

Regulatory cooperation and framework: legemiddelkontrollen operates within national and international frameworks, aligning with European and global guidelines. In many regions, cooperation with bodies like the EMA and adherence to EU/EEA rules shape assessment procedures, pharmacovigilance requirements, and post-authorization activities.

Enforcement and public health outcomes: authorities can suspend or revoke licenses, issue recalls or safety warnings, and publish updates to healthcare professionals and the public. The overarching aim is to ensure medicines are safe, effective, high quality, and accessible for responsible use.