Finland Fimea

Application of the AI Act transparency obligation in medical devices

Guidance on how the AI Act's transparency requirements apply to artificial intelligence used in medical devices.

Finnish translation of Good Clinical Practice (GCP) guidance published

Fimea has published a Finnish-language translation of Good Clinical Practice guidance.

Fimea continues to provide CTIS guidance to clinical trial researchers on an as-needed basis

Fimea will continue to offer targeted guidance to clinical trial researchers on CTIS (Clinical Trials Information System) use as needs arise.

Temporary special authorisations for human medicines extended

Finland's Fimea has extended temporary special authorisations for human medicines.

Changes to pharmacy medicine preparation require planning but do not cause immediate changes to drug treatments

Fimea advises that regulatory changes to pharmacy medicine preparation require advance planning but will not immediately alter patient drug treatments.

Fimea publishes guidance on applying for expanded sales channels for over-the-counter medicines

Fimea has published guidance on the application process for expanding sales channels for self-care medicines.

Authorities urge aesthetic treatment clinics to ensure compliance with legal obligations

Finnish health authorities advise aesthetic treatment clinics to verify their compliance with applicable legislation and regulatory requirements.

Children and young people seek information online – medicine education materials help identify reliable drug information

Decline in pharmacy medicine manufacturing highlights need for medicines legislation reform

Guide to Safe Medication Therapy published in Easy Swedish

List of interchangeable medicinal products, 1 October – 31 December 2026

Continuation of the joint Nordic pilot for English-language medicine packages

EU4Health project for GMP/GDP inspection activities completed (EU4H 11)

NovoRapid PumpCart insulin preparation: supply disruption

Supply disruption reported for NovoRapid PumpCart insulin preparation.

Fimea assessment report on datopotamab deruxtecan for advanced hormone receptor-positive HER2-negative breast cancer

Fimea published an assessment report on the efficacy and safety of datopotamab deruxtecan for advanced hormone receptor-positive HER2-negative breast cancer.

Insulin Lispro Sanofi – update on insulin product supply disruption

EMA recommends withdrawal of marketing authorisation for Tavneos in the EU

The EMA recommends the withdrawal of the marketing authorisation for Tavneos in the European Union.

Fimea initiates HTA assessment of new hospital medicine tarlatamab

Fimea has initiated a health technology assessment for the hospital medicine tarlatamab.