What RDC 1.015 establishes
The regulation disciplines manufacturing, importation, distribution, sale, prescription and dispensation of industrialized cannabis-based products for human use.
Main changes
- New administration routes authorized: inhalation, oral, sublingual, nasal and dermal
- Expanded access criteria: serious debilitating diseases replaces previous terminal or palliative conditions
- Products with THC above 0.2% can now be prescribed for more clinical situations
- Permanent framework: moves from exceptional/transitory to definitive regulation
Complete RDC package
- RDC 1.012/2026: cultivation for scientific research
- RDC 1.013/2026: cultivation of low-THC plants
- RDC 1.014/2026: regulatory sandbox
- RDC 1.015/2026: industrialized products
For international cannabis companies
International cannabis companies looking at Brazil should approach via partnership with a licensed Brazilian holder. Brazilian rules are strict about who can hold cannabis registrations.