Lääkelain

Lääkelain is a Finnish term that translates to "Medicines Act" in English. It is the primary legislation governing the sale, marketing, and use of medicinal products in Finland. The Lääkelain establishes a comprehensive framework for ensuring the quality, safety, and efficacy of medicines available to the public. It outlines the responsibilities of pharmaceutical companies, distributors, pharmacies, and healthcare professionals in relation to medicinal products.

Key aspects covered by the Lääkelain include the authorization process for placing medicines on the market, which involves rigorous evaluation by the Finnish Medicines Agency (Fimea). It also details regulations concerning the prescription and dispensing of medicines, including requirements for pharmacies and the roles of pharmacists. Furthermore, the act addresses the advertising and promotion of medicines, aiming to prevent misleading information and ensure that marketing practices are responsible. The Lääkelain also touches upon pharmacovigilance, the ongoing monitoring of medicine safety after they have been approved and are in use.

The legislation is designed to protect public health by ensuring that only safe and effective medicines are available and that they are used appropriately. It is regularly updated to align with European Union directives and international best practices in pharmaceutical regulation. Compliance with the Lääkelain is mandatory for all entities involved in the pharmaceutical sector in Finland.