Domestic Production License

Workflow steps

1. Domestic Production Intent
   Domestic production of cannabis-derived products is now permitted in Brazil. ANVISA manufacturing license and BPF (Good Manufacturing Practices) required. Growing domestic production investment.
   • ANVISA manufacturing license
   • BPF (Good Manufacturing Practices) compliance
   • Facility requirements
2. ANVISA Manufacturing License Application
   Application to ANVISA for manufacturing license for cannabis-derived products. Must demonstrate BPF-compliant facility and qualified personnel.
   • ANVISA manufacturing license application
   • BPF-compliant facility documentation
   • Qualified personnel (pharmacist responsible)
   • Quality management system documentation
   • Security and storage requirements
3. BPF Inspection
   ANVISA conducts BPF inspection of manufacturing facility. Full GMP compliance assessment including facility, equipment, documentation, and personnel.
   • Facility walkthrough and assessment
   • Equipment qualification review
   • Documentation and SOP review
   • Personnel qualification verification
   • ANVISA inspection report
4. License granted?
   ANVISA evaluates inspection results and application. May require corrective actions before granting license.
5. Manufacturing License Granted ✓
   ANVISA manufacturing license granted. Domestic cannabis production permitted under ANVISA oversight. Growing domestic production investment in Brazil.