lääkeluvat
Lääkeluvat refers to the official authorization required for medicinal products to be marketed and sold in a specific country or region. These permits are granted by regulatory authorities, such as the Finnish Medicines Agency (Fimea) in Finland, after a thorough evaluation of the drug's quality, safety, and efficacy. The process typically involves submitting a comprehensive dossier containing preclinical and clinical trial data, manufacturing information, and proposed labeling.
The primary objective of lääkeluvat is to protect public health by ensuring that only medicines that meet
Once a medicinal product receives lääkeluvat, it is subject to ongoing post-marketing surveillance. This includes monitoring