The new framework
Brazil's health regulator ANVISA published regulations allowing Cannabis Sativa cultivation in Brazil for:
- Medicinal purposes — production of raw material for medications based on cannabidiol (CBD) and tetrahydrocannabinol (THC) at therapeutic concentrations
- Scientific research — universities, research institutes and pharmaceutical companies with approved projects
The measure closes a regulatory cycle that began in 2019 with RDC 327 (use of Cannabis-based products) and evolved via RDC 660/2022 (cultivation for research) — now reaching controlled industrial-scale production.
Who can cultivate
- Pharmaceutical companies with health license and CBPF (Good Manufacturing Practices Certificate)
- Teaching and research institutions with approved projects
- Rural producers authorized under contract with licensed pharmaceutical industries
Cultivation is rigorously controlled: requires ANVISA authorization, oversight by Federal Police, seed-to-harvest traceability, and patrimonial security protocols.
Market impact
Estimates suggest the Brazilian Cannabis-based products market could move tens of billions of reais in coming years. Today, raw material imports represent significant cost — local production changes that equation.
The authorization:
- Reduces drug prices for patients (today often economically unfeasible)
- Opens industrial opportunity for Brazilian manufacturers
- Creates a new regulatory frontier that demands specialists in registration, GMP and pharmacovigilance
- Accelerates clinical research with locally available raw material
Requirements to enter the sector
- Specific health license for the activity
- Updated CBPF (Good Manufacturing Practices Certificate)
- Cultivation, processing and storage plan approved by ANVISA
- Auditable patrimonial security — access control, monitoring, prevention of diversion
- Product registration (medication, herbal medicine or active raw material)
- Structured pharmacovigilance
Next steps for interested companies
Entering the sector requires long-term planning (12-24 months between feasibility study and first commercial harvest). Those who prepare early gain competitive advantage — the regulatory bottleneck is still significant, and time-to-market depends on the quality of the protocol filed.
For international Cannabis companies
International cannabis companies looking at Brazil as a market should approach via partnership with a licensed Brazilian holder — Brazilian rules are strict about who can hold cannabis registrations, and the local presence requirement is substantial. Engagement should start at strategy phase, not at product-launch phase.