GMP Pathway

Workflow steps

1. GMP Assessment
   Determine which GMP pathway applies for the Argentine market. No Argentina-EU GMP MRA exists. EU-GMP or FDA GMP accepted for imports; domestic production requires ANMAT BPF.
   • Import: EU-GMP or FDA GMP accepted
   • Domestic: ANMAT BPF required
   • No Argentina-EU GMP MRA
2. Import or domestic?
   Import products require recognized foreign GMP. Domestic production requires ANMAT manufacturing compliance and BPF.
3. Import GMP Pathway — EU-GMP or FDA GMP accepted
   For imported cannabis products, ANMAT accepts EU-GMP or FDA GMP certificates. No Argentina-EU MRA exists, but ANMAT recognizes these standards for import authorization.
   • EU-GMP Part I certificate (EEA-issued)
   • OR FDA GMP certificate
   • No Argentina-EU MRA — but standards accepted
   • Certificate must be current and cannabis-scoped
4. Domestic BPF Pathway — ANMAT BPF required
   Domestic production requires ANMAT BPF (Buenas Prácticas de Fabricación) compliance — Argentina's Good Manufacturing Practices standard.
   • ANMAT BPF (Buenas Prácticas de Fabricación) compliance
   • ANMAT facility inspection
   • Ongoing ANMAT GMP oversight
5. GMP Pathway Defined ✓
   GMP pathway identified for Argentine market access. Proceed with import authorization or domestic production.