Regulatory Hierarchy

Workflow steps

1. ANVISA — Agência Nacional de Vigilância Sanitária
   Primary regulator for medicinal cannabis. RDC 327/2019 is the primary regulation governing cannabis-derived products. ANVISA oversees product registration, import authorization, and manufacturing standards.
   • Product registration (RDC 327/2019)
   • Import authorization
   • Manufacturing standards (BPF)
   • GMP oversight for domestic production
2. Ministry of Health — Ministério da Saúde
   Policy oversight of ANVISA. Sets national medicinal cannabis policy. Brazil does not yet cover cannabis medicines under SUS (public health system).
   • National drug policy
   • Oversight of ANVISA
   • SUS coverage decisions (pending)
3. ANVISA Regional Offices — State-level enforcement (VISA)
   Vigilância Sanitária (VISA) offices enforce ANVISA regulations at the state level. Conduct facility inspections and monitor compliance.
   • State-level facility inspections
   • Compliance monitoring
   • Enforcement of ANVISA standards
4. Pharmacies — Dispensing
   Dispensing of ANVISA-registered cannabis products. Growing private market as access expands. No SUS coverage — patients pay out-of-pocket.
   • Pharmacy license
   • ANVISA-registered products only
   • Prescription required
5. Patients — End recipients
   Growing patient access. No SUS (public health) coverage yet — all cannabis medicines paid privately. Brazil is the LARGEST Latin American medical cannabis market.