News archive
389 results
Submitting a NIS2 entity notification via Fimea’s electronic services
Utilisation of antipsychotic drug clozapine in Finland is the second highest in the world
Report lack of efficacy of a veterinary antiparasitic medicine
Fimea published a clinical investigation plan template to support clinical investigations of medical devices
Finns consider medicine counselling important
Up-to-dateness of registration information is the responsibility of the medical device operator
Medical devices can also be handed over to patients outside the hospital
Fimea’s final accounts and annual report for 2025 have been published
Fimea.fi user survey is now open
Nordic pilot of medicine packages in English for small-scale hospital products will continue
Fimea and Tukija to speed up evaluation of national clinical trials
Fimea prepares for the expansion of non-prescription medicine sales channels
Report on joint inspections at EU level published – Fimea participates in strengthening market surveillance in the EU
More detailed instructions for the FAST-EU pilot on clinical drug trials published for sponsors
How does a professional user benefit from ensuring conformity?
Fimea has released a guideline page on using artificial intelligence in medical devices
Manufacturers of medical devices must report serious incidents using a new form starting May 2026
Number of shortages at similar level to previous years
New decree on fees chargeable by the Finnish Medicines Agency entered into force on 1 January 2026
European Commission published new proposal for the Biotech Act
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