backOn February 3, 2026, Anvisa issued five new Board of Directors Resolutions that comprehensively regulate the cultivation, research, production, and commercialization of cannabis for medicinal, pharmaceutical, and scientific purposes. These measures comply with a Superior Court of Justice (STJ) decision that assigned the Agency authority to regulate the entire production chain.
Below we summarize the key points of each regulatory act.
RDC 1,011/2026. Update to the list of controlled substances and authorization for cultivation by legal entities
RDC 1,011/2026 amends Annex I of Ministry of Health Ordinance No. 344/1998 and authorizes cannabis cultivation by legal entities for medicinal, pharmaceutical, and research purposes, subject to a Special Authorization issued by Anvisa, pursuant to RDC No. 16/2014. Key aspects include:
• THC content limited to a maximum of 0.3%, in line with the parameter set by the STJ
• Requirement that all inputs be previously registered in the Ministry of Agriculture’s National Register of Cultivars
• Possibility of immediate suspension of the Special Authorization and destruction of production in the event of irregularities
• Adoption of controls aligned with UN Conventions and the guidelines of the International Narcotics Control Board
Effective as of August 4, 2026.
RDC 1,013/2026. Cultivation for medicinal and pharmaceutical purposes with THC up to 0.3%
RDC 1,013/2026 regulates the cultivation of Cannabis sativa L. with THC content less than or equal to 0.3% for medicinal and pharmaceutical purposes. Main requirements include:
• A Special Authorization specifically covering cultivation
• Submission of technical documentation to the competent local health authority
• Exclusive use of propagation material that demonstrably yields Cannabis sativa L. with THC limited to 0.3%
• Implementation of robust monitoring, control, and traceability mechanisms
• Prohibition on importing seeds solely for distribution purposes
Supply and distribution of the plant are restricted to entities expressly authorized.
Effective as of August 4, 2026.
RDC 1,015/2026. Update to the rules on manufacturing, importing, and commercializing cannabis derived products
RDC 1,015/2026 amends RDC No. 327/2019 and establishes new conditions for Health Authorization of industrialized products obtained from Cannabis sativa L. for human use. Key changes include:
• Expansion of the use of products with THC content above 0.2% to patients with severe and debilitating diseases, in addition to palliative care
• Expansion of routes of administration to include inhalation, buccal, sublingual, and dermatological routes
• Permission for product promotion directed to qualified prescribing professionals, subject to rules applicable to controlled medicines
• Extension of prescribing authority to dental surgeons
Effective as of August 4, 2026.
RDC 1,014/2026. Establishment of a regulatory sandbox for medicinal cannabis
RDC 1,014/2026 creates an Experimental Regulatory Environment to test, under controlled conditions, techniques, technologies, and models related to medicinal cannabis. The sandbox may cover:
• Cultivation for medicinal purposes
• Production of plant based pharmaceutical inputs
• Development and supply of cannabis based preparations
Participation will depend on a public call and an official notice to be issued by Anvisa, as set out in a supplementary regulation to be published.
RDC 1,012/2026. Specific rules for cultivation exclusively for research purposes
RDC 1,012/2026 governs the cultivation of Cannabis sativa L. exclusively for research, including in vitro modalities or situations with no vegetative growth. Core requirements include:
• Obtaining a Special Authorization
• Notification to and approval by the competent local health authority
• Submission of detailed technical documentation, including geographic coordinates, cultivation estimates, and the origin of propagation material
• A robust control and security plan, with surveillance mechanisms, restricted access, and diversion risk mitigation
Commercialization of products resulting from research is prohibited, while shipments or donations to authorized institutions are permitted.
Effective as of August 4, 2026.
General Remarks
The new regulatory framework consolidates Anvisa’s authority over the entire medicinal cannabis production chain in Brazil, introducing stringent controls, detailed technical criteria, and traceability mechanisms. At the same time, it expands access to treatments and creates tools to foster research and innovation. Life Sciences and HealthTech companies, research institutions, and investors should review their operating models, regulatory strategies, and compliance frameworks in light of the new requirements, especially those relating to Special Authorization, security controls, and production traceability.
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