Product Registration

Workflow steps

1. Product Registration
   ANVISA product registration is required for commercial sale of cannabis-derived products in Brazil. Full pharmaceutical dossier required. Processing is long and expensive.
   • Full pharmaceutical dossier
   • ANVISA registration application
   • GMP certificate from manufacturing site
2. ANVISA Product Registration Dossier
   Full pharmaceutical dossier submission to ANVISA. Includes quality, non-clinical, and clinical data. Portuguese-language documentation required.
   • Complete pharmaceutical dossier (CTD format)
   • Quality data: specifications, analytical methods, stability
   • Non-clinical and clinical safety/efficacy data
   • GMP certificate from manufacturing country
   • Portuguese-language technical documentation
   • Processing: 12–24 months
3. ANVISA Review
   ANVISA evaluates the dossier. May request additional data or clarification. Growing number of ANVISA-registered products (Charlotte's Web and others).
   • Respond to ANVISA queries within specified timeframes
   • Additional clinical data may be requested
   • ANVISA may conduct facility audit
4. Registration approved?
   ANVISA evaluates the complete dossier. Registration is not guaranteed — ANVISA may require additional studies or data.
5. Product Registered ✓
   Product registered for commercial sale in Brazil. Available through licensed pharmacies via prescription. Growing number of registered products.