etusivun uusi hero englanti

Fimea supervises, safeguards and develops

Finnish Medicines Agency

Medicine search Shortages

Etusivun nostokortti 1 en

Prescriptions for biological medicines are only valid for one year at a time

Etusivun nostokortti 2 en

Fimea designates the first notified body under the IVD Regulation in Finland

Etusivun nostokortti 3 en

Etusivun nostokortti 4 en

E-service for reporting shortages

Asset Publisher

News

Online reporting of adverse drug reactions to be renewed

7 December 2023
Fimea participates in an EU4Health project focusing on market surveillance of medical devices

29 November 2023
Sales of antibiotics for production animals halved in Europe over ten years

21 November 2023
Composition of Fimea’s patient advisory board for the term 2024–2025

7 November 2023

Kaikki uutiset

News archive

Kansalaisille otsikko

For public

Kansalaisille kortti 1

Article 75 of the Convention implementing the Schengen Agreement lays down provisions on a certificate which private persons wishing to travel within the Schengen Area and carry pharmaceutical preparations containing narcotic drugs and/or psychotropic substances can use to prove that these preparations are necessary for their medical treatment.

Kansalaisille kortti 2

Why is the food supplement I ordered considered to be a medicine?

The classification of products as medicines varies in different countries. A product can be sold as a food supplement in some countries and as medicine in others. In Finland, the Finnish Medicines Agency Fimea decides whether a substance or a product is a medicine or not based on the Medicines Act.

Kansalaisille kortti 3

How can I assess the reliability of drug information?

Be critical of all information found online. The DARTS checklist lists how you can assess the reliability of drug information found online. The same criteria can also be used to assess the reliability of other written information.

Kansalaisille kortti 4

Submitting a report on an adverse reaction

An adverse reaction report may be submitted electronically or using the Fimea form.

Ammattilaisille otsikko

For professionals

Ammattilaisille kortti 1

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.

Ammattilaisille kortti 2

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

Incident reports

Incident reports of medical devices may be submitted electronically.

Ammattilaisille kortti 4

Reporting adverse reactions

An adverse reaction report may be submitted electronically or using the Fimea form.

Ammattilaisille kortti 5

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.

Ammattilaisille kortti 6

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.

Kieliversion valinta

Kieliversion valinta

etusivun uusi hero englanti

Fimea supervises, safeguards and develops

Schengen certificates

Why is the food supplement I ordered considered to be a medicine?

How can I assess the reliability of drug information?