Lääkevalmisteasetuksen

Lääkevalmisteasetus, also known as the Medicines Decree in English, is a Finnish statutory instrument that governs the marketing, sale, and use of medicinal products. It provides detailed regulations on various aspects of pharmaceuticals, supplementing the overarching Medicines Act. This decree outlines the requirements for medicinal products to be placed on the market, including their quality, safety, and efficacy. It also specifies conditions for their packaging, labeling, and advertising to ensure that consumers receive accurate and understandable information.

Furthermore, the Lääkevalmisteasetus addresses the responsibilities of pharmaceutical companies, wholesalers, and retailers. It defines the procedures for obtaining marketing authorizations, the rules for the storage and distribution of medicines, and the obligations related to pharmacovigilance, which is the monitoring of adverse drug reactions. The decree also covers aspects related to the prescription and dispensing of medicines, including the classification of medicines as prescription-only or over-the-counter products. Its purpose is to safeguard public health by ensuring that medicinal products available in Finland meet high standards and are used appropriately.