Access: New Anvisa rule redefines regulations for Cannabis products in Brazil
Update to RDC No. 1015/2026 brings stricter rules for Cannabis products, focusing on safety, THC control, and advertising restrictions, while reinforcing technical criteria for sanitary authorization
The publication of RDC No. 1015/2026 marks a new chapter in the regulation of Cannabis-based products in the country. The rule, which updates previous guidelines, establishes clearer criteria for the manufacturing, quality control, prescription, and commercialization of these products for medicinal use.
Among the main changes is the reinforcement of technical and scientific requirements for sanitary authorization. Companies must present data supporting the safety and therapeutic plausibility of the products, especially in cases involving higher concentrations of THC.
Another relevant point is the limitation on advertising. According to the regulation, the promotion of these products is now restricted to qualified healthcare professionals, such as doctors and pharmacists, with direct communication to the general public being prohibited.
The rule also defines strict composition criteria. Products must predominantly contain cannabidiol (CBD), with the use of plant extracts permitted provided they have a CBD concentration significantly higher than that of THC.
In addition, the regulation maintains important restrictions, such as the prohibition of free samples and stricter control over products with a THC content above 0.2%, which are limited to cases of serious or life-threatening diseases.
Experts assess that the new RDC brings greater legal certainty to the sector, while maintaining a cautious approach regarding the use of substances with psychoactive potential.
The full document with all technical rules and guidelines is now available for consultation and download.