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Fimea supervises, safeguards and develops

Finnish Medicines Agency

Medicine search Shortages

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Plenty of scam advertisements now spreading online

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The national medicines data repository will be named Farmasto

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Medicines are not sweets: read the package leaflet and follow the instructions

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A new online tool helps operators assess whether the obligations of the NIS2 Directive apply to them

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The national medicines data repository will be named Farmasto, ushering in a new era of how authorities manage medicines data

17 December 2025
EU Council and Parliament reach an agreement on the pharma package

11 December 2025
New study examined development needs of the regulatory competence of European medicines agencies

11 December 2025
Maintenance break in the publication archive on 9 December 2025

8 December 2025

Kaikki uutiset

News archive

Kansalaisille otsikko

For public

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Schengen certificates

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.

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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.

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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.

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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.

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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.

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

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?

Submitting a report on an adverse reaction

Special permits

Assessment of pharmacotherapies (HTA)

Incident reports

Reporting adverse reactions

Electronic marketing authorisation submissions

European Pharmacopoeia

Ajankohtaista

Etusivun nostokortti en 1

Etusivun nostokortti en 2

Etusivun nostokortti en 3

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Asset Publisher

News

Kaikki uutiset

Kansalaisille otsikko

For public

Kansalaisille kortti 1

Schengen certificates

Kansalaisille kortti 2

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

Kansalaisille kortti 3

How can I assess the reliability of drug information?

Kansalaisille kortti 4

Submitting a report on an adverse reaction

Ammattilaisille otsikko

For professionals

Ammattilaisille kortti 1

Special permits

Ammattilaisille kortti 2

Assessment of pharmacotherapies (HTA)

Ammattilaisille kortti 3

Incident reports

Ammattilaisille kortti 4

Reporting adverse reactions

Ammattilaisille kortti 5

Electronic marketing authorisation submissions

Ammattilaisille kortti 6

European Pharmacopoeia

Julkaisut ja ohjeet

Publications and decrees

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