- FIMEA — Finnish Medicines Agency (Lääkealan turvallisuus- ja kehittämiskeskus)
Primary regulator for all medicines including cannabis. Issues import authorizations, manages ERN (Erityislupa = Special Permission) for unapproved medicines. Conservative approach — Finland has one of the most restrictive cannabis access regimes in the EEA.
- ERN special permission per patient/product
- Import authorizations
- GMP recognition — EEA network
- Pharmacovigilance
- Ministry of Social Affairs and Health — Policy oversight
Sets national medicinal cannabis policy. Finland maintains a conservative, specialist-led approach. No broad cannabis access program.
- National drug policy
- Oversight of FIMEA
- EEA treaty obligations
- Hospital Pharmacies — Primary dispensing
Cannabis medicines primarily dispensed through hospital pharmacies in Finland. Conservative, specialist-led system — community pharmacy access is extremely limited.
- Hospital pharmacy license
- Specialist prescription required
- Controlled substance register
- Specialist Physicians — Prescribers
Only specialist physicians (neurology, oncology, pain medicine) may prescribe cannabis medicines. Conservative prescribing culture.
- Specialist qualification
- ERN authorization for unapproved products
- Documented treatment failure of conventional therapies
- Patients — End recipients
Very limited patient access. Conservative regulatory culture. Sativex is the only licensed product; all other cannabis via ERN named-patient authorization.