Fimea’s regulation and supervision cover the entire life cycle of medicinal products, from classification and preclinical studies to distribution, pharmacovigilance and marketing promotion.
25.2.2019 Changes in clinical trials due to Brexit
Fimea regulates human clinical trials on medicinal products
Fimea is the national competent supervisory authority for pharmaceutical manufacturers and wholesalers. Fimea is also in charge of supervising blood service and tissue establishments. In addition, Fimea is the competent authority in narcotics control according to Finnish narcotics legislation and in charge of supervising the obligatory stockpiling of medicinal products.
The supervision of pharmaceutical manufacturers consists of licensing procedures and regular inspections. Normative regulation and guidance provision are natural parts of official supervision.
The Official Medicines Control Laboratory is in charge of the quality control of medicinal products marketed in Finland. The Laboratory also participates in the development of the European Pharmacopoeia.