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Brazilian health regulator issues new rules on medical cannabis production Marina Castro de Amorim. Mattos Filho Thursday 12 Feb 2026 The new regulatory framework for medical cannabis aims to both increase access to evidence-based products and treatments and to foster scientific research in the field. Key aspects of the new framework are outlined below. Anvisa Resolution No. 1,011/2026 Resolution No. 1,011/2026 has updated Annex I of the Ministry of Health’s Ordinance No. 344/1998, which lists substances subject to special controls. Consequently, companies are now permitted to cultivate Cannabis sativa for medical, pharmaceutical, and research purposes, provided they obtain a license (Autorização Especial – AE) issued by Anvisa under the terms of Resolution No. 16/2014. This license is issued for activities involving high-risk products – pharmaceutical ingredients, medicines, and substances subject to special control – and requires specific technical and administrative conditions to be met. In addition, Resolution No. 1,011/2026 introduces the following controls and restrictions: Cultivation, imports, and acquisitions of cannabis are limited to varieties with a maximum THC content of 0.3%, as established by the STJ; All propagation materials must be registered on the Brazilian Ministry of Agriculture, Livestock and Supply’s National Cultivar Registry; Issued licenses (and the activities linked to them) may be immediately suspended, and production destroyed, in the event production deviates from approved standards or in the case of any other potential irregularities. Such measures comply with international control requirements under the UN Conventions and the International Narcotics Control Board. Anvisa Resolution No. 1,011/2026 takes effect as of August 4, 2026. Anvisa Resolution No. 1,012/2026 Resolution No. 1,012/2026 sets out requirements for cultivating Cannabis sativa L. for research purposes (authorized by Article 4 of Ministry of Health Ordinance No. 344/1998). The rules introduced by the resolution apply to any forms of cultivation of Cannabis sativa L. intended exclusively for research, including in vitro formats or cases that do not involve vegetative growth of the plant species. Key requirements and controls provided for in the resolution include: Only public Science, Technology and Innovation Institutions (ICTs), higher education or technical institutions recognized by the Ministry of Education (MEC), state-level defense or drug enforcement bodies, and establishments with a license (AE) to manufacture pharmaceutical ingredients or medicines are eligible to cultivate cannabis for research; These entities must obtain an AE from Anvisa to cultivate cannabis for research under the terms of Resolution No. 16/2014; These entities must also submit specific documents and information to competent local health authorities to obtain authorization to cultivate. Examples of such information include the geographic coordinates of the area cultivated, a description with photographic records of the areas where the cannabis will be cultivated (including measurements, dimensions, and specific activities), estimates of the quantities to be cultivated per square meter and per hectare (compatible with the purpose of the research), and documentation demonstrating the origin of and access to propagation material; Prior to cultivation, a control plan containing detailed analysis of all conditions at the cultivation site must be submitted. The site must have an adequate level of security to ensure controlled cultivation, constant surveillance across the entire perimeter of the site, restricted access to authorized personnel, effective controls to avoid the risk of the plant species diverging, and there must be a contingency plan accounting for potential security incidents, among other issues; he sale of products resulting from research is prohibited. Shipments and donations to other institutions are permitted for analysis and other research-related activities if they are duly authorized by Anvisa. Anvisa Resolution No. 1,012/2026 takes effect as of August 4, 2026. Anvisa Resolution No. 1,013/2026 In line with Resolution No. 1,011/2026, Anvisa’s Resolution No. 1,013/2026 regulates the cultivation of Cannabis sativa L. with 0.3% THC content or less exclusively for medical and/or pharmaceutical purposes. The main requirements include: Entities seeking to cultivate Cannabis sativa L. for medical and/or pharmaceutical purposes must obtain a license (AE) under the terms of Resolution No. 16/2014; These entities must also submit specific documents and information to competent local health authorities to obtain authorization to cultivate. Examples of such information include the geographic coordinates of the area cultivated, a description with photographic records of the areas where the cannabis will be cultivated (including measurements, dimensions, and specific activities), estimates of the quantities to be cultivated per square meter and per hectare (compatible with the purpose of the research , and documentation demonstrating the origin of and access to propagation material. Propagation material that demonstrably produces Cannabis sativa L. with a THC content of 0.3% or less may be imported or acquired for cultivation that is intended for medical and research purposes; Establishments authorized to cultivate Cannabis sativa L. with a THC content of 0.3% or less may supply or distribute it to specific entities; Entities seeking to cultivate Cannabis sativa L. for medical and/or pharmaceutical purposes must implement robust systems for monitoring, controlling, and tracing production; The resolution exclusively provides for the cultivation of Cannabis sativa L. with a THC content of 0.3% or less. Establishments looking to carry out this activity must apply for a license (AE) that specifically covers such cultivation, and importing seeds for the sole purpose of distribution is prohibited. Anvisa Resolution No. 1,013/2026 takes effect as of August 4, 2026. Anvisa Resolution No. 1,014/2026 Anvisa has published Resolution No. 1,014/2026 to establish a regulatory sandbox to test activities related to cannabis for medical purposes. Regulatory sandboxes are temporary initiatives that allow regulatory agencies to let companies test innovative products, services, or business models in a controlled environment with more flexible rules and close oversight, to assess risks, impacts, and benefits before issuing final regulations. Through controlled tests of experimental techniques and technologies for products or services subject to health surveillance, the sandbox seeks to establish evidence in relation to Cannabis sativa L. cultivation for medical purposes, the production of plant-derived pharmaceutical ingredients, and the development, preparation, and supply of cannabis-based preparations for medical use. Anvisa will publish a public notice inviting interested parties to submit project proposals for execution in the regulatory sandbox. Although Anvisa Resolution No. 1,014/2026 takes immediate effect, Anvisa will need to publish the public notice for the sandbox to be effectively implemented. Anvisa Resolution No. 1,015/2026 Published in the wake of Public Consultation No. 1,316/2025, Anvisa Resolution No. 1,015/2026 amends Resolution No. 327/2019 to set out the conditions and procedures for applying for and receiving sanitary authorization to manufacture and import industrialized Cannabis sativa L-derived pharmaceutical products for human medical use. It also includes the sanitary requirements for activities preceding and arising from the sale of these products in Brazil. he main updates that Anvisa Resolution No. 1,015/2026 introduces include: Previously, products with THC levels above 0.2% were only permitted if intended for palliative care. This has now been extended to products intended to treat serious and debilitating diseases; The routes of administration for products derived from Cannabis sativa L., which were previously restricted to oral and nasal routes, now also include inhalation, buccal, sublingual, and dermal routes; Previously prohibited, the promotion of medicinal products derived from Cannabis sativa L. is now permitted, provided that the rules applicable to medicines subject to special control are observed. This includes only targeting promotion at professionals authorized to prescribe them; Doctors are now authorized to prescribe medicinal products derived from Cannabis sativa L. Previously, authorization was restricted to doctors. Anvisa Resolution No. 1,015/2026 takes effect as of August 4, 2026. https://www.mattosfilho.com.br/en/unico/brazilian-medical-cannabis/ For more information on this topic, please contact Mattos Filho’s Life Sciences & Healthcare practice area. https://www.mattosfilho.com.br/en/practice-areas/life-sciences-and-healthcare/ *With the collaboration of Marina Castro de Amorim.
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