Import Authorization

Workflow steps

1. Import Intent
   You wish to import cannabis-based medicine into South Korea. ONLY pharmaceutical-grade products (Epidiolex, Sativex) are authorized. No botanical cannabis, flower, or non-pharmaceutical forms are permitted under any circumstances.
   • MFDS-approved product ONLY (Epidiolex, Sativex)
   • No botanical/flower pathway exists
   • Pharmaceutical-grade manufacturing mandatory
2. MFDS Import Authorization — Product-specific
   Apply to MFDS for product-specific import authorization. Only products with MFDS approval or KODC rare disease designation are eligible. Authorization is per-shipment and product-specific.
   • MFDS product approval or KODC designation
   • EU-GMP or FDA GMP certificate for manufacturer
   • Certificate of Analysis per batch
   • Specialist physician prescription for named patient
3. Authorization granted?
   MFDS reviews against extremely strict criteria. Only approved pharmaceutical products qualify. Any deviation from approved product form, manufacturer, or indication results in denial.
4. Application Denied
   South Korea does not offer an appeal pathway for cannabis import denials that fall outside the approved product list. Re-apply only if product gains MFDS approval or KODC designation.
   • No appeal for non-approved products
   • Re-application requires new MFDS product approval
5. Authorization Issued
   Per-shipment authorization for the specific approved product only. Valid for the specified quantity and patient.
   • Original document required at customs
   • Product must exactly match authorization
6. Customs Clearance
   Korean Customs Service processes narcotic import under the Narcotics Control Act. Extremely thorough documentation review.
   • Original MFDS import authorization
   • All shipping documents + COA
   • Narcotic import declaration
   • Pharmaceutical import license
7. Shipment Cleared ✓
   Released to designated hospital pharmacy. Product dispensed only against specialist physician prescription.