{"id":4893,"date":"2026-08-17T10:35:48","date_gmt":"2026-08-17T13:35:48","guid":{"rendered":"https:\/\/feadv.com.br\/?p=4893"},"modified":"2026-08-17T10:35:48","modified_gmt":"2026-08-17T13:35:48","slug":"rdc-no-1015-2026-the-new-regulatory-framework-for-medicinal-cannabis-in-brazil","status":"publish","type":"post","link":"https:\/\/feadv.com.br\/en\/rdc-n-o-1-015-2026-o-novo-marco-regulatorio-da-cannabis-medicinal-no-brasil\/","title":{"rendered":"RDC No. 1,015\/2026: the new regulatory framework for medicinal cannabis in Brazil"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"4893\" class=\"elementor elementor-4893\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-18a470c4 e-flex e-con-boxed e-con e-parent\" data-id=\"18a470c4\" 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-4fb89604 elementor-widget elementor-widget-text-editor\" data-id=\"4fb89604\" 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;\">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.<\/span><\/p><p><span style=\"font-weight: 400;\">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.<br \/><br \/><\/span><\/p><h3><strong>The main changes in RDC No. 1,015\/2026<\/strong><\/h3><p><b>Relaxation of access to THC products<\/b><\/p><p><span style=\"font-weight: 400;\">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.<\/span><\/p><p><span style=\"font-weight: 400;\">Previously, the framework was restricted to treatments in the palliative stage or refractory to conventional medications.<\/span><\/p><p><b>Expanded routes of administration<\/b><\/p><p><span style=\"font-weight: 400;\">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.<\/span><\/p><p><b>Compounding in compounding pharmacies<\/b><\/p><p><span style=\"font-weight: 400;\">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.<br \/><br \/><\/span><\/p><h3><strong>Domestic cultivation of Cannabis Sativa L.<\/strong><\/h3><p><span style=\"font-weight: 400;\">The primary institutional innovation is the allowance of domestic cultivation by legal entities, strictly for pharmaceutical or scientific research purposes.<\/span><\/p><p><span style=\"font-weight: 400;\">To start operations, companies must obtain prior health authorization and comply with strict safety requirements, such as:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">24-hour camera monitoring and dedicated asset security;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Complete georeferencing of production facilities;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A THC concentration limit of up to 0.3% in the crop; and<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">ANVISA inspection and physical walkthrough prior to operational startup.<br \/><br \/><\/span><\/span><\/span><\/li><\/ul><h3><strong>What changes for the market and industry stakeholders<\/strong><\/h3><p><span style=\"font-weight: 400;\">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.<\/span><\/p><p><span style=\"font-weight: 400;\">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.<br \/><br \/><\/span><\/p><h3><strong>Medical cannabis in Brazil: what changed with ANVISA's new regulations<\/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-3bbd9f0 e-flex e-con-boxed e-con e-parent\" data-id=\"3bbd9f0\" 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-f69a99c elementor-widget elementor-widget-n-accordion\" data-id=\"f69a99c\" 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-2580\" 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-2580\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What physical security rules are required for companies to grow cannabis in Brazil?\u00a0 <\/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-2580\" class=\"elementor-element elementor-element-388cadc e-con-full e-flex e-con e-child\" data-id=\"388cadc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2580\" class=\"elementor-element elementor-element-4b4e72c e-flex e-con-boxed e-con e-child\" data-id=\"4b4e72c\" 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-aadc7fe elementor-widget elementor-widget-text-editor\" data-id=\"aadc7fe\" 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>Authorized companies must implement 24-hour continuous video monitoring, georeference the entire area, and undergo a prior sanitary technical inspection carried out by ANVISA.<\/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-2581\" 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-2581\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which patients are entitled to the use of products with higher THC levels?  <\/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-2581\" class=\"elementor-element elementor-element-69e932f e-con-full e-flex e-con e-child\" data-id=\"69e932f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2581\" class=\"elementor-element elementor-element-995a225 e-flex e-con-boxed e-con e-child\" data-id=\"995a225\" 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-232635e elementor-widget elementor-widget-text-editor\" data-id=\"232635e\" 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>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.<\/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-2582\" 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-2582\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Can cannabidiol already be compounded in pharmacies in the country?  <\/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-2582\" class=\"elementor-element elementor-element-19f6aad e-con-full e-flex e-con e-child\" data-id=\"19f6aad\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2582\" class=\"elementor-element elementor-element-ed48083 e-flex e-con-boxed e-con e-child\" data-id=\"ed48083\" 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-8cdcb52 elementor-widget elementor-widget-text-editor\" data-id=\"8cdcb52\" 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>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.<\/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-5b9b33f e-flex e-con-boxed e-con e-parent\" data-id=\"5b9b33f\" 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-ebb22a8 elementor-widget elementor-widget-text-editor\" data-id=\"ebb22a8\" 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><strong>Life Sciences and Healthcare<\/strong><\/h3><p>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.<\/p><h4><strong><br \/><\/strong>References<\/h4><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/abiquifi.org.br\/indice-de-noticia\/atualizacao-da-rdc-1015-2026-sobre-o-marco-regulatorio-de-fabricacao-e-importacao-de-produtos-de-cannabis\/\"><span style=\"font-weight: 400;\">ANVISA's Collegiate Board Resolution RDC No. 1,015\/2026<\/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>Em 4 de maio de 2026, entrou em vigor a Resolu\u00e7\u00e3o da Diretoria Colegiada n.\u00ba 1.015\/2026 da ANVISA, que estabelece novos requisitos para fabrica\u00e7\u00e3o, importa\u00e7\u00e3o e comercializa\u00e7\u00e3o de derivados de cannabis no pa\u00eds. O ato revoga a RDC n.\u00ba 327\/2019 e cria um ecossistema mais amplo de acesso cl\u00ednico e flexibiliza\u00e7\u00e3o controlada para pesquisa e [&hellip;]<\/p>\n","protected":false},"author":12,"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":[38,36],"ppma_author":[33,34],"class_list":["post-4893","post","type-post","status-publish","format-standard","hentry","category-life-sciences-e-healthcare","tag-direito-administrativo-e-regulatorio","tag-direito-sanitario"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>RDC n.\u00ba 1.015\/2026: o novo marco regulat\u00f3rio da cannabis medicinal no Brasil - Fialdini Einsfeld Advogados<\/title>\n<meta name=\"description\" content=\"A RDC n.\u00ba 1.015\/2026 da ANVISA entrou em vigor em maio de 2026 e amplia o acesso \u00e0 cannabis medicinal, viabiliza cultivo nacional e novas formas de administra\u00e7\u00e3o.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/feadv.com.br\/en\/rdc-no-1015-2026-the-new-regulatory-framework-for-medicinal-cannabis-in-brazil\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"RDC n.\u00ba 1.015\/2026: o novo marco regulat\u00f3rio da cannabis medicinal no Brasil - 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