backBrazil’s National Health Surveillance Agency (Anvisa) has published new resolutions in the Official Gazette establishing rules for the production of cannabis exclusively for medical and pharmaceutical purposes in Brazil, while also updating existing regulations governing the manufacture and importation of cannabis-based products. The measures, approved by Anvisa’s Board of Directors in January, implement a ruling by the Superior Court of Justice recognizing the legality of cannabis production as a means of safeguarding the constitutional right to health. Although the resolutions have been formally published, they will only take effect after a six-month transition period.
Among the key provisions is the requirement that legal entities obtain a Special Authorization, subject to prior sanitary inspection and strict compliance with control, traceability, and security standards. The framework also introduces specific rules for research institutions and nonprofit patient associations, which may operate under defined conditions but are not permitted to engage in commercial sales. In addition, Anvisa has revised the regulatory framework originally introduced in 2019. The updates expand access to products containing higher concentrations of THC for patients suffering from serious and debilitating conditions, such as fibromyalgia and lupus. The new rules also authorize additional routes of administration, including dermatological, sublingual, buccal, and inhalation use. While the agency acknowledged the possibility of compounding cannabis-based formulations by licensed pharmacies, Anvisa’s Board determined that this matter will be addressed in future, specific regulation to ensure that appropriate technical and public health safeguards are established.
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