{"id":5021,"date":"2026-09-10T10:00:44","date_gmt":"2026-09-10T13:00:44","guid":{"rendered":"https:\/\/feadv.com.br\/?p=5021"},"modified":"2026-09-14T17:44:54","modified_gmt":"2026-09-14T20:44:54","slug":"the-new-regulatory-framework-for-cannabis-for-medicinal-and-pharmaceutical-purposes-in-brazil","status":"publish","type":"post","link":"https:\/\/feadv.com.br\/en\/o-novo-marco-regulatorio-da-cannabis-para-fins-medicinais-e-farmaceuticos-no-brasil\/","title":{"rendered":"The new regulatory framework for cannabis for medicinal and pharmaceutical purposes in Brazil"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"5021\" class=\"elementor elementor-5021\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-23f4687 e-flex e-con-boxed e-con e-parent\" data-id=\"23f4687\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5a53f08 elementor-widget elementor-widget-text-editor\" data-id=\"5a53f08\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The entry into force of Anvisa's Collegiate Board Resolutions (RDCs) numbers 1,011 to 1,015 of 2026 represents a watershed moment in the regulation of medicinal cannabis.<\/span><\/p><p><span style=\"font-weight: 400;\">This set of regulations consolidates the guidelines established by the Superior Court of Justice (STJ) in the judgment of the Incident of Assumption of Competence (IAC) number 16, enhancing legal certainty for research, cultivation, and industrialization in the country.<\/span><\/p><p><span style=\"font-weight: 400;\">Below, we present a detailed analysis of the practical operation of the new rules and their effects on the Brazilian pharmaceutical market.<br \/><br \/><\/span><\/p><h3><b>The STJ ruling and the transition to the administrative sphere<\/b><\/h3><p><span style=\"font-weight: 400;\">In November 2024, the First Section of the STJ recognized the lawfulness of cultivating industrial hemp exclusively for medicinal and pharmaceutical industrial purposes.<\/span><\/p><p><span style=\"font-weight: 400;\">The ruling ordered Anvisa to issue detailed regulations on the sector. The result of this process was the publication of the package of RDCs in the first half of 2026.<\/span><\/p><p><span style=\"font-weight: 400;\">Subsequently, the STJ itself confirmed that the regulations issued complied with the ruling in an adequate and comprehensive manner, extending the special regulatory treatment to products with a tetrahydrocannabinol (THC) content of up to 0.3%.<br \/><br \/><\/span><\/p><h3><b>The new regulatory design of Anvisa's RDCs<\/b><\/h3><p><span style=\"font-weight: 400;\">The five new Anvisa resolutions organize the sector through a functional and operational division of activities:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><b>RDC 1.011\/2026: <\/b><span style=\"font-weight: 400;\">It promoted an amendment to Ordinance 344\/1998 to remove the species Cannabis sativa L., with a THC content of up to 0.3%, from the list of prohibited plants (List E) and include it in the list of controlled substances (Schedule C1).<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>RDC 1,012\/2026: <\/b><span style=\"font-weight: 400;\">Regulates cultivation rules for scientific and research purposes, allowing the acquisition of domestic seeds from authorized suppliers, without exclusive dependence on importation.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>RDC 1.013\/2026:<\/b><span style=\"font-weight: 400;\"> It establishes cultivation parameters for the pharmaceutical and therapeutic use of plants containing up to 0.3% of THC, covering traceability, monitoring, and the safe transport of raw materials.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>RDC 1,014\/2026: <\/b><span style=\"font-weight: 400;\">It established the Regulatory Sandbox, which allows for monitored testing of cultivation and processing focused on innovation under the direct supervision of the regulatory agency.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>RDC 1,015\/2026: <\/b><span style=\"font-weight: 400;\">It revoked the former RDC 327\/2019, regulating the process of industrialization, distribution, and trade of medicinal Cannabis products.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><h3><b>Urgent compliance deadlines for companies<\/b><\/h3><p><span style=\"font-weight: 400;\">For establishments currently operating based on preliminary or final judicial decisions, Anvisa has imposed specific transition deadlines.<\/span><\/p><p><span style=\"font-weight: 400;\">Companies in this condition must adapt their operations and obtain the respective Special Authorization (AE) by the date of<\/span><b> August 5, 2027<\/b><span style=\"font-weight: 400;\">.<\/span><\/p><p><span style=\"font-weight: 400;\">Failure to comply with this deadline will result in the loss of legal protection for the cultivation and handling of the substances, requiring prompt and preventive action by regulatory departments.<\/span><\/p><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><h3><b>Regulatory sandbox and risk governance<\/b><\/h3><p><span style=\"font-weight: 400;\">The Experimental Regulatory Environment (Sandbox) created by RDC 1.014\/2026 will have a maximum duration of five years.<\/span><\/p><p><span style=\"font-weight: 400;\">Because of its transitional and testing nature, participation in the program does not guarantee acquired rights or the automatic obtaining of definitive authorization after the expiration of the term.<\/span><\/p><p><span style=\"font-weight: 400;\">Therefore, companies that decide to participate must carefully structure the allocation of regulatory risks in their contracts with investors and partner suppliers.<\/span><\/p><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><h3><b>Industrialization, new formats, and tariff flexibility<\/b><\/h3><p><span style=\"font-weight: 400;\">RDC Resolution 1,015\/2026 brought important benefits by eliminating the mandatory import of pharmaceutical inputs, thereby stimulating domestic verticalized production.<\/span><\/p><p><span style=\"font-weight: 400;\">There was also an expansion of the permitted routes of administration, with the inclusion of buccal, sublingual, and dermatological forms of use.<\/span><\/p><p><span style=\"font-weight: 400;\">Another relevant point clarified by Anvisa is that, because they are in a transitional category, these products are not under the price control of CMED (Chamber of Regulation of the Medicine Market) until they undergo final drug registration.<\/span><\/p><p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p><h3><strong>Medical Cannabis in Brazil: Crucial Regulatory Aspects<\/strong><\/h3>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e20f84e e-flex e-con-boxed e-con e-parent\" data-id=\"e20f84e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b40b9e8 elementor-widget elementor-widget-n-accordion\" data-id=\"b40b9e8\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1880\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-1880\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is the deadline for compliance for companies that have judicial authorization for cultivation? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1880\" class=\"elementor-element elementor-element-05818e5 e-con-full e-flex e-con e-child\" data-id=\"05818e5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1880\" class=\"elementor-element elementor-element-1dfb1b4 e-flex e-con-boxed e-con e-child\" data-id=\"1dfb1b4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bfc1c6a elementor-widget elementor-widget-text-editor\" data-id=\"bfc1c6a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Establishments authorized by judicial decision must transition to the new ordinary administrative regime and obtain Anvisa's Special Authorization by August 5, 2027.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1881\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1881\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What does the Regulatory Sandbox instituted by Anvisa mean? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1881\" class=\"elementor-element elementor-element-940f897 e-con-full e-flex e-con e-child\" data-id=\"940f897\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1881\" class=\"elementor-element elementor-element-22b8de2 e-flex e-con-boxed e-con e-child\" data-id=\"22b8de2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-889fd14 elementor-widget elementor-widget-text-editor\" data-id=\"889fd14\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">It is a temporary, data-driven testing environment with a timeframe of up to 5 years, focused on gathering evidence of quality and safety in domestic production and cultivation.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1882\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1882\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Are the cannabis products sold in the country subject to CMED pricing rules? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1882\" class=\"elementor-element elementor-element-95886ea e-con-full e-flex e-con e-child\" data-id=\"95886ea\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1882\" class=\"elementor-element elementor-element-c6fa6b2 e-flex e-con-boxed e-con e-child\" data-id=\"c6fa6b2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1dfc9ed elementor-widget elementor-widget-text-editor\" data-id=\"1dfc9ed\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Temporarily no. The agency clarified that these products are part of a transitional category without mandatory pricing, but they will have to comply with price controls if they are eventually registered as medications.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-20b5813 e-flex e-con-boxed e-con e-parent\" data-id=\"20b5813\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7c070cb elementor-widget elementor-widget-text-editor\" data-id=\"7c070cb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h3><b>Life Sciences and Healthcare<\/b><\/h3><p><span style=\"font-weight: 400;\">Fialdini Einsfeld Advogados (FEADV) provides strategic regulatory advice to pharmaceutical industries, clinical research institutions, and companies interested in the medicinal cannabis market. Our team advises sector stakeholders on obtaining authorizations, drafting supply contracts, and ensuring compliance with new Anvisa regulations.<\/span><\/p><p>\u00a0<\/p><h4><b>References<\/b><\/h4><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.stj.jus.br\/sites\/portalp\/Paginas\/Comunicacao\/Noticias\/2026\/16082026-Os-precedentes-civeis-e-penais-do-STJ-sobre-o-uso-medicinal-da-cannabis.aspx\"><span style=\"font-weight: 400;\">Superior Court of Justice (STJ) \u2013 IAC 16 \/ REsp 2,024,250<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2026\/anvisa-publica-regras-para-producao-de-cannabis-medicinal\"><span style=\"font-weight: 400;\">Collegiate Board Resolutions RDCs 1,011 to 1,015\/2026 of Anvisa<\/span><\/a><\/span><\/p><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.migalhas.com.br\/depeso\/462778\/o-novo-marco-regulatorio-da-cannabis-para-fins-medicinais-no-brasil\"><span style=\"font-weight: 400;\">Reference article on the Migalhas portal<\/span><\/a><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>The new medical cannabis framework brings clear rules and a critical deadline: companies with judicial authorizations have until August 2027 to comply.<\/p>","protected":false},"author":10,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[32],"tags":[41,42,36,40],"ppma_author":[28,39],"class_list":["post-5021","post","type-post","status-publish","format-standard","hentry","category-life-sciences-e-healthcare","tag-cannabis-medicinal","tag-direito-da-saude","tag-direito-sanitario","tag-life-sciences"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - 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