Overview
- Anvisa issued four resolutions in the Diário Oficial that regulate cultivation, production, research and use exclusively for medical and scientific purposes, with entry into force on 4 August 2026.
- Cultivation is limited to legal entities holding an Autorização Especial, with lot‑level traceability, mandatory THC testing for every batch, and destruction plus notification within 48 hours if plants exceed the 0.3% limit.
- A five‑year experimental sandbox will select small‑scale and associative models under strict controls, with no broad commercialization or advertising and obligations to meet future definitive rules.
- Research cultivation, including higher‑THC varieties, is permitted for approved institutions under reinforced security and international‑treaty compliance, with special authorization required.
- Patient access expands to allow formulations with THC above 0.2% for severe, debilitating conditions and to include buccal, sublingual and dermatological forms, while exports of plants and seeds are barred and existing court‑authorized growers have until 5 August 2027 to comply.