Import Authorization

Workflow steps

1. Import Intent
   Finland is an EEA country with no domestic commercial cannabis production. All medicinal cannabis must be imported under FIMEA ERN (Erityislupa = Special Permission) authorization. EU-GMP Part I required.
   • Specialist physician prescription
   • ERN authorization for unapproved medicine
   • EU-GMP Part I certificate mandatory
2. Specialist Physician Application
   Prescribing specialist applies to FIMEA for ERN (Erityislupa) — special permission for unapproved medicines. Must document treatment failure of conventional therapies. Conservative prescribing culture.
   • Specialist qualification documentation
   • Documented treatment failure of conventional therapies
   • Product identification (name, manufacturer, THC/CBD content)
   • Patient clinical justification
3. FIMEA ERN Authorization
   FIMEA issues per-patient, per-product ERN authorization (Erityislupa). Processing: approximately 4–6 weeks. Authorization specifies product, quantity, and duration.
   • FIMEA ERN (Erityislupa) authorization
   • Per-patient, per-product — not blanket
   • EU-GMP Part I certificate from manufacturer
4. Authorization granted?
   FIMEA reviews clinical justification. Conservative approach — may request additional documentation.
5. Import Clearance
   Product cleared for import under ERN authorization. EU customs procedures apply. Dispensed via hospital pharmacy.
   • FIMEA ERN authorization (original)
   • All shipping documentation
   • EU customs narcotic declaration
6. Import Authorized ✓
   Product may be imported for the named patient. Dispensed via hospital pharmacy.