Finland Fimea
Learning from medical device incidents is possible when they are reported
Guidance on the importance of reporting medical device incidents to enable learning and safety improvements.
Finland Fimea · FinlandApplication 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.
Finland Fimea · FinlandFimea updates pharmacy online service regulation – call for comments on changes needed
Fimea invites stakeholder input on amendments to regulations governing pharmacy online services.
Finland Fimea · FinlandFimea 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.
Finland Fimea · FinlandFimea updates regulation on financial data collection from pharmacies and quality control fees
Fimea updates its regulation on financial data collection from pharmacies and quality control fee requirements.
Finland Fimea · FinlandFinnish translation of Good Clinical Practice (GCP) guidance published
Fimea has published a Finnish-language translation of Good Clinical Practice guidance.
Finland Fimea · FinlandCareful completion of special licence applications accelerates processing
Fimea provides guidance on proper completion of special licence applications to expedite review.
Finland Fimea · FinlandExpansion of over-the-counter medicine sales begins – first phase starts in October
Finland's Fimea announces the first phase of expanded over-the-counter medicine sales beginning in October.
Finland Fimea · FinlandTemporary special authorisations for human medicines extended
Finland's Fimea has extended temporary special authorisations for human medicines.
Finland Fimea · FinlandChanges 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.
Finland Fimea · FinlandFimea 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.
Finland Fimea · FinlandAuthorities 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.
Finland Fimea · FinlandExceptional veterinary medicine supply disruptions – disruptions expected to continue through winter
Finland's medicines agency reports exceptional supply disruptions in veterinary medicines expected to persist through winter.
Finland Fimea · FinlandNovoRapid PumpCart insulin preparation: supply disruption
Supply disruption reported for NovoRapid PumpCart insulin preparation.
Finland Fimea · FinlandFimea 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.
Finland Fimea · FinlandCustoms and Fimea cooperation led to discovery of illegal pharmaceutical factory in Greece
Finnish and Greek authorities discovered an illegal pharmaceutical manufacturing facility through cooperation between Customs and Fimea.
Finland Fimea · FinlandEMA 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.
Finland Fimea · FinlandFimea initiates HTA assessment of new hospital medicine tarlatamab
Fimea has initiated a health technology assessment for the hospital medicine tarlatamab.
Finland Fimea · Finland