Fimea has three core roles based on its duties prescribed by law.
1. A public service agency providing services to the business community
Fimea’s marketing authorisation system is designed to ensure that all medicinal products available in the Finnish pharmaceuticals markets for human and veterinary use meet the requirements set for them in terms of safety, efficacy and quality.
Fimea issues licenses and other permits to medicinal product manufacturers, wholesalers and pharmacies. We conduct inspections to ensure that the medicinal products available in the Finnish markets are correctly manufactured and distributed, readily available, and safe to use.
2. A regulatory and supervisory agency
Fimea fosters novel drug development and drug research in Finland through regulation and supervision.
3. A development agency
Fimea produces and provides healthcare professionals, medicine users and the general public with unbiased and current information on medicines and their use. We study and assess the therapeutic and economic value of medicines and coordinate drug research in the pharmaceutical sector in order to contribute to decision-making in society.
Fimea’s organisation is structured around three core processes: enforcement and inspections in the pharmaceuticals sector, regulating medicinal products, and the evaluation of pharmacotherapies. The organisation is supported by a process of internal services.
Supervision and licenses department divides into four units: supervision control and development unit, quality surveillance unit, inspectorate and medical devices unit. Assessment of medicinal products department divides into five units: regulatory procedures unit, clinico-pharmacological unit, pharmacobiological unit, pharmacovigilance unit and veterinary medicines unit. Internal services divides into four units: administrative services, financial administration, information resources management and legal services.