markedsføringstillatelse
Markedsføringstillatelse refers to the official authorization granted by a regulatory authority allowing a medicinal product to be sold or marketed within a specific jurisdiction. This permit signifies that the product has undergone rigorous evaluation and meets established standards for quality, safety, and efficacy. The process of obtaining a markedsføringstillatelse typically involves submitting a comprehensive dossier containing detailed information about the drug's manufacturing, preclinical and clinical trial data, labeling, and proposed packaging.
Regulatory bodies, such as the European Medicines Agency (EMA) for the European Union or the Food and