Markedstillatelse

Markedstillatelse is the official permission to place a product on the market in a given country or region, issued by a competent regulatory authority. The authorization indicates that the product has been assessed as safe, effective for its intended use, and manufactured to stipulated quality standards. In Norway, medicines are regulated by the national authority responsible for pharmaceuticals, while other product categories are governed by relevant agencies within the regulatory framework. In many parts of the European Economic Area, marketing authorization for medicines may follow centralized, decentralized, mutual recognition, or national procedures.

The scope of markedstillatelse varies by jurisdiction. It mainly applies to medicines, but the exact rules can also cover certain medical devices, cosmetics, and other regulated products. The decision to grant authorization is based on a comprehensive evaluation of the product’s quality, safety, and efficacy, using data supplied by the applicant, including manufacturing information, preclinical and clinical studies, and proposed labeling and packaging.

The application process typically requires a detailed dossier with chemistry, manufacturing and controls information, safety data, and a pharmacovigilance plan. The authority may request clarifications or additional studies. An authorization may be granted with conditions or restrictions, and can be conditional or provisional in some cases, with post-authorization commitments.

After approval, ongoing obligations include post-market surveillance, periodic safety reporting, and possible variations if changes are made to the product or its manufacturing. The status of markedstillatelse is essential for market access, pricing, and reimbursement, and it can be suspended or withdrawn if safety concerns arise.