Brazilian Medical Cannabis Decree Takes Effect
Brazilian Medical Cannabis Decree Takes Effect
Starting earlier this month, new regulations for dispensing various medical cannabis products in Brazil’s pharmacies and other outlets took effect. The recently implemented measure, RDC No. 1.015/2026, from Brazil’s National Health Surveillance Agency (Anvisa), replaced RDC No. 327/2019.
“Among the key points, the resolution establishes that products must be industrially manufactured and contain exclusively cannabidiol (CBD) or extracts of Cannabis sativa L. with a predominance of CBD. The presence of THC above 0.2% is only permitted in specific cases, such as in patients with serious or life-threatening illnesses, subject to medical evaluation.” reported Sechat in its local coverage.
“The regulation also details stringent requirements for obtaining Sanitary Authorization, including proof of good manufacturing practices, quality control, stability studies, technical data on formulation, and scientific evidence supporting the therapeutic plausibility of the products.” the outlet also reported.
Other notable provisions of the decree include:
- Definitions for permitted consumption methods (oral, sublingual, buccal, dermatological, and inhalation)
- Requirements for ‘Sanitary Authorization’ approval
- Expanded list of approved conditions for access to higher-THC therapies
Brazilian researchers estimate that there are roughly 10 million “recent users” of cannabis in the country. The Federal University of São Paulo researchers found that 15.8% of adults report having consumed cannabis at least once in their lives.
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