GMP Pathway

Workflow steps

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