On May 4, 2026, ANVISA Collegiate Board Resolution No. 1,015/2026 entered into force, establishing new requirements for the manufacture, importation, and commercialization of cannabis derivatives in the country.
The act revokes RDC No. 327/2019 and creates a broader ecosystem of clinical access and controlled flexibility for research and development in the health industry.
The main changes in RDC No. 1,015/2026
Relaxation of access to THC products
ANVISA has expanded the scope of use for products with a THC concentration exceeding 0.2%. The clinical indication now includes patients diagnosed with chronic, severe, or debilitating conditions or those at imminent risk of death.
Previously, the framework was restricted to treatments in the palliative stage or refractory to conventional medications.
Expanded routes of administration
The regulation now allows the inhalation, sublingual, and buccal routes, joining the oral and nasal options already in effect. The change facilitates administration for sensitive patient profiles, such as children and the elderly with dysphagia.
Compounding in compounding pharmacies
The compounding of cannabidiol (CBD) was authorized by the rule, opening the way for individualized formulations. The detailed operation of this segment will be regulated in a complementary technical regulation.
Domestic cultivation of Cannabis Sativa L.
The primary institutional innovation is the allowance of domestic cultivation by legal entities, strictly for pharmaceutical or scientific research purposes.
To start operations, companies must obtain prior health authorization and comply with strict safety requirements, such as:
- 24-hour camera monitoring and dedicated asset security;
- Complete georeferencing of production facilities;
- A THC concentration limit of up to 0.3% in the crop; and
- ANVISA inspection and physical walkthrough prior to operational startup.
What changes for the market and industry stakeholders
RDC No. 1,015/2026 fosters the attractiveness of the Brazilian market, reducing logistical costs by allowing the domestic production of inputs that were previously exclusively imported.
On the other hand, the strictness of the physical security conditions and raw material traceability requires structured planning and technical investment from companies wishing to enter the sector.
Medical cannabis in Brazil: what changed with ANVISA's new regulations
What physical security rules are required for companies to grow cannabis in Brazil?
Authorized companies must implement 24-hour continuous video monitoring, georeference the entire area, and undergo a prior sanitary technical inspection carried out by ANVISA.
Which patients are entitled to the use of products with higher THC levels?
The new rule allows for the prescription of THC concentrations above 0.2% for patients with severe or life-threatening debilitating conditions, simplifying the previous criteria for treatment-resistant conditions.
Can cannabidiol already be compounded in pharmacies in the country?
The compounding of CBD is permitted in the main text of RDC No. 1,015/2026, but its practical operation depends on the publication of complementary operational standards by the regulatory body.
Life Sciences and Healthcare
Fialdini Einsfeld Advogados advises companies in the pharmaceutical and healthcare sectors in navigating the regulatory framework for medicinal cannabis in Brazil, including sanitary authorization processes with ANVISA, regulatory compliance, and conformity strategies. Our team continuously monitors regulatory updates in this rapidly evolving area.
