Finland

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.

Remote and telephone appointments included in nurses' limited right to prescribe medicines

Nurses' limited prescribing authority now extends to remote and telephone appointments, effective 10 June 2026.

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.

Packaging labels for smokeless nicotine products to be harmonised – law to enter into force on 1 August 2026

Amendment to the Tobacco Act harmonises packaging labels and appearance of smokeless nicotine products, extending smoking-ban label requirements from 1 August 2026.

Employee exposure to heat must be limited

Occupational heat exposure limits for employees are established or amended.

Fimea warns against use of illegal medicines

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

Supervision of summer work: employers have improved their act, but customer behaviour burdens young employees

Finnish occupational safety inspectors report improvements in summer job conditions but note increasing customer-related stress on young workers.

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

JulkiTerhikki register: use only at julkiterhikki.lvv.fi

Finnish Supervisory Agency warns users to access the health and social care professional registers only at the official URL julkiterhikki.lvv.fi to avoid fraudulent websites.

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

Parliament approves amendments to the Alcohol Act – Finnish Supervisory Agency preparing implementation guidelines

Parliament approved amendments to the Alcohol Act on 23 June 2026, which concern, among other things, the remote sales, delivery and marketing of alcoholic beverages. The amendments will enter into force in stages, th...

Announcement from the Adoption Board: Norway's national adoption inquiry raises concerns about the risks of international adoption and recommends further development

Norway has published a national adoption report calling for stronger supervision, a reassessment of the funding structure for adoption services, and services grounded in specialised adoption expertise. The Finnish Ado...

Employee contacts about harassment and workload increased again

Finnish occupational safety authority received 3,100 contacts about harassment and workload in 2025, a 15% increase from 2024.

Finnish occupational safety and health authority reports increase in workplace discrimination contacts

The occupational safety and health authority received approximately 700 discrimination-related contacts last year, a 10% increase, resulting in 282 enforcement requests and 121 inspections.

Supervision of the use of foreign labour revealed bogus self-employment and the vulnerable position of students

05.06.2026 Supervision of the use of foreign labour revealed bogus self-employment and the vulnerable position of students

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.

Supreme Administrative Court rejects appeals on UWE Bristol psychotherapy training; Valvira decisions upheld

Finland's Supreme Administrative Court rejected appeals against Valvira's decisions that UWE Bristol Solution Focused Therapy training does not qualify for psychotherapist title use.