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Fimea supervises, safeguards and develops

Finnish Medicines Agency

Medicine search Shortages

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Twitter portlet

Kansalaisille otsikko

For public

Ammattilaisille otsikko

For professionals

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Pharmacist helping a customer

Special permits

Fimea may grant a special permit for a medicinal product that has no marketing authorisation in Finland to be released for consumption in individual cases for special therapeutic reasons.

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A doctor inspecting liquid medicine

Assessment of pharmacotherapies (HTA)

Fimea produces and compiles assessments of the therapeutic and economic value of medicines and coordinates the related collaboration. The operations focus on the assessment of new hospital-only medicinal products.

Ammattilaisille kortti 3

Inspector inside a medicine factory

Mandatory reserve supplies

The purpose of legislation concerning mandatory reserve medical supplies is to ensure the availability of medicines in circumstances in which such availability is restricted or prevented as a result of suspension of deliveries, a serious crisis or other equivalent reason.

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Older woman using a computer

Fees

Fimea invoices its customers for marketing authorisation and variation applications, and for the permit and notification fees of clinical trials. The invoice will be sent as soon as the application has been accepted for processing.

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Experts discussing in an EU function

Electronic marketing authorisation submissions

Fimea requests that any submissions related to marketing authorisation applications be conducted electronically whenever possible. Electronic submissions covers almost all applications related to human and veterinary medicines and herbal remedies.

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Inspector in a medical factory

European Pharmacopoeia

The European Pharmacopoeia is published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe in Strasbourg. The publication contains standardised specifications defining the quality of pharmaceutical preparations, their constituents and containers.