- GMP Assessment
Determine GMP pathway for cannabis-based pharmaceutical products for the South Korean market. Only pharmaceutical-grade products are accepted — no botanical or herbal GMP pathways exist.
- MFDS Product Approval Required — Pharmaceutical grade only
MFDS requires full pharmaceutical product approval before any import authorization. Only approved products (Epidiolex, Sativex) with established pharmaceutical dossiers qualify.
- MFDS product approval (or KODC designation)
- Full pharmaceutical dossier
- Clinical evidence for approved indications
- MFDS-accepted GMP?
Does the manufacturer hold a GMP certificate from an authority that MFDS recognizes? MFDS accepts EU-GMP and FDA GMP. Other standards reviewed case-by-case.
- EU-GMP or FDA GMP — Accepted by MFDS
MFDS accepts EU-GMP Part I certificates from EEA authorities and FDA GMP certificates. These are the primary GMP standards recognized for pharmaceutical cannabis imports.
- EU-GMP Part I from EEA authority — accepted
- FDA GMP (US) — accepted
- Certificate must cover pharmaceutical cannabis scope
- QP batch certification for EU-GMP products
- Other GMP Standards — Case-by-case review
GMP certificates from other jurisdictions (TGA, Health Canada, etc.) reviewed by MFDS on a case-by-case basis. No guaranteed acceptance.
- Submit GMP certificate for MFDS review
- MFDS may request additional documentation or inspection
- Processing times vary significantly
- GMP Pathway Defined ✓
MFDS-accepted GMP standard met. Product eligible for MFDS import authorization process. Only pharmaceutical-grade products proceed.