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null Fimea started its operations 10 years ago

Fimea started its operations 10 years ago


The Finnish Medicines Agency Fimea started its operations in November 2009 when its predecessor, the National Agency for Medicines, was closed down. The duties of the new medicines agency included authorisation and supervision tasks in the pharmaceutical sector, research and development, and production and dissemination of information on medicinal products to improve the effectiveness of pharmaceutical service and pharmacotherapy. The aim was to improve the pharmaceutical service for the population and the safety, appropriateness and economy of pharmacotherapy. The same duties and targets continue to guide our operations.

Birthday celebrated through work

Fimea celebrates its anniversary through intense work. Our ambition is that the effectiveness, safety, availability and sensible use of medicines is world-class in Finland. We aim to be an open, efficient, skilled and extensively networked organisation in the pharmaceutical sector.

In addition to our basic duties, we also have a number of development projects currently under way to promote the utilisation of digitalisation and medicines information, among other things. Of topical matters, especially the preparations for the changes brought about by Brexit and disruptions in the availability of medicinal products call for special effort.

During its entire operating history, Fimea has constantly grown its expertise in EU bodies and European pharmaceutical networks. Autumn 2019, in particular, has been very busy because of the additional duties involved with Finland’s presidency of the Council of the EU and the meetings we arrange during it. Our operational priorities have included biological medicines and medicines that are of significance for public health, generic medicines and individual medication. We have expanded our expertise by actively seeking international tasks related to marketing authorisation, supervision and assessment of pharmacotherapies.

The transfer of health technology duties from Valvira to Fimea will bring about new additional tasks and responsibilities. The duties to be transferred include the supervision of medical devices and supplies, guidance, supervision and registration duties related to biobanks, the licensing and supervision duties specified in the Act on the Medical Use of Human Organs and Tissues, duties related to embryo research, and the supervision duties under the Gene Technology Act.

Fimea operates in multiple locations: the head office is located in Kuopio and the other offices in Helsinki, Turku and Tampere. Our premises in Helsinki will be relocated in Tilkanmäki at the beginning of 2020, following which we will initiate the update of our strategy. We will also invite our stakeholders to present their views on which direction Fimea should develop its operations.

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Fimea monitors medicinal, blood and tissue products and is involved in pharmaceuticals sector development

Fimea’s duty is to oversee 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. We issue licenses and other permits to medicinal product manufacturers, wholesalers and pharmacies. We ensure the appropriateness of the manufacturing and distribution of the medicinal products on the market as well as their availability and user safety and promote Finnish pharmaceutical innovations and pharmaceutical research.

Fimea produces and provides healthcare professionals, medicine users and the general public with unbiased and current information on medicines and their use. We assess the therapeutic and economic value of medicines and coordinate research in the pharmaceutical sector in support of societal decision-making related to medicines.

We engage actively in international cooperation and contribute to the formulation of the pharmaceutical policy of the European Union as part of the European medicines regulatory network. We engage in cooperation with various operators in the social and healthcare sector and with authorities, universities and research institutes.