GMP Pathway

Workflow steps

1. GMP Assessment
   Determine which GMP pathway applies for medical cannabis in Peru. Peru has no MRA with the EU — EU-GMP or FDA GMP accepted for imports but not directly equivalent to DIGEMID GMP.
2. Import or domestic?
   Are you importing finished product into Peru, or manufacturing domestically within Peru under DIGEMID oversight?
3. EU-GMP or FDA GMP — Import pathway
   For imported medical cannabis products, DIGEMID accepts EU-GMP Part I certificates from EEA authorities or FDA GMP certificates. No Peru-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. DIGEMID GMP — Domestic production
   Domestic manufacturers must hold DIGEMID GMP certification. DIGEMID conducts inspections against national GMP (Buenas Prácticas de Manufactura) standards aligned with WHO GMP.
   • DIGEMID manufacturing license
   • DIGEMID GMP inspection and certification
   • GACP certification for cultivation sites
   • National GMP standard (WHO-aligned)
5. GMP Pathway Defined ✓
   GMP standard met for Peruvian market. Import products: EU-GMP or FDA. Domestic: DIGEMID GMP. Proceed with DIGEMID import authorization or manufacturing license.