GMP Pathway

Workflow steps

1. GMP Assessment
   Finland is an EEA country. FIMEA recognizes all EEA-issued GMP certificates. EU-GMP Part I required for all finished medicinal cannabis. Sativex is the only licensed product; other products via ERN named-patient.
2. EU-GMP Part I Required
   All finished medicinal cannabis must be manufactured under EU-GMP Part I. Certificate from any EEA competent authority is accepted by FIMEA.
   • EEA authority EU-GMP Part I certificate
   • Cannabis manufacturing scope explicitly stated
   • Certificate must be current (valid at time of import)
3. FIMEA Accepts EEA + PIC/S Certificates
   FIMEA recognizes all EEA-issued GMP certificates. PIC/S member certificates (TGA Australia, Health Canada, MHRA UK) also accepted as equivalent.
   • EEA or PIC/S member GMP certificate
   • Cannabis manufacturing scope stated
   • FIMEA evaluates on case-by-case basis
4. QP Batch Release
   EU QP certifies batch for Finnish market release under ERN authorization.
   • QP named on Finnish wholesale authorization
   • Full batch record reviewed
5. GMP Pathway Cleared ✓
   GMP requirements satisfied. Proceed with FIMEA ERN import authorization application.