GMP Pathway

Workflow steps

1. GMP Assessment
   Determine which GMP pathway applies for medical cannabis in Chile. Chile has no MRA with the EU — EU-GMP or FDA accepted for imports. Domestic production requires ISP/Chilean GMP certification.
2. Import or domestic?
   Are you importing finished product into Chile, or manufacturing domestically within Chile under ISP oversight?
3. EU-GMP or FDA GMP — Import pathway
   For imported medical cannabis products, ISP accepts EU-GMP Part I certificates from EEA authorities or FDA GMP certificates. No Chile-EU GMP MRA exists — these are accepted on a standards-equivalence basis.
   • EU-GMP Part I from EEA authority — accepted
   • FDA GMP (US) — accepted
   • Certificate must cover cannabis manufacturing scope
   • COA per batch required at import
4. ISP / Chilean GMP — Domestic production
   Domestic manufacturers must hold ISP GMP certification. ISP conducts inspections against national GMP standards aligned with WHO GMP. Chilean GMP is accepted domestically and in some LATAM markets.
   • ISP manufacturing license
   • ISP GMP inspection and certification
   • GACP certification for cultivation sites
   • National GMP standard (WHO-aligned)
5. GMP Pathway Defined ✓
   GMP standard met for Chilean market. Import products: EU-GMP or FDA. Domestic: ISP/Chilean GMP. Proceed with ISP import authorization or manufacturing license.