Fimea is Finland's national competent authority for medicines and pharmacovigilance and participates in the EU medicines-safety network.
Core official resources
- Fimea pharmacovigilance — national hub for industry pharmacovigilance requirements.
- Adverse reaction reporting (EudraVigilance) — MAH reporting arrangements.
- Pharmacovigilance inspections — oversight of MAH pharmacovigilance systems.
- Additional risk-minimisation material — Finnish requirements and implementation information for aRMMs.
- Report an adverse reaction — national reporting information for healthcare professionals and consumers.
Practical use
Fimea's industry pages are particularly useful because they separate several operational areas—EudraVigilance reporting, inspections, RMP summaries and additional risk-minimisation materials—while remaining anchored to the EU pharmacovigilance framework.