{"id":8245,"date":"2025-04-28T11:19:30","date_gmt":"2025-04-28T10:19:30","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8245"},"modified":"2025-04-28T11:53:14","modified_gmt":"2025-04-28T10:53:14","slug":"produtos-base-cannabis-fins-medicinais-brasil","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/pt-pt\/produtos-base-cannabis-fins-medicinais-brasil\/","title":{"rendered":"Consulta P\u00fablica sobre a Revis\u00e3o da RDC 327\/2019: Principais Altera\u00e7\u00f5es e Cr\u00edticas"},"content":{"rendered":"<div data-olk-copy-source=\"MessageBody\">\n<div data-olk-copy-source=\"MessageBody\">\n<p data-pm-slice=\"1 3 []\">Em 26 de mar\u00e7o de 2025, foi aprovada a consulta p\u00fablica sobre a revis\u00e3o da <strong>RDC 327\/2019<\/strong>, que regula a autoriza\u00e7\u00e3o sanit\u00e1ria, fabrica\u00e7\u00e3o, importa\u00e7\u00e3o, comercializa\u00e7\u00e3o, prescri\u00e7\u00e3o e fiscaliza\u00e7\u00e3o de produtos \u00e0 base de <strong>Cannabis<\/strong> para fins <strong>medicinais<\/strong> no Brasil. A seguir, as principais mudan\u00e7as discutidas na reuni\u00e3o.<\/p>\n<h3><strong>Principais Altera\u00e7\u00f5es Propostas<\/strong><\/h3>\n<h4><strong>1.Receitu\u00e1rio e Prescri\u00e7\u00e3o<\/strong><\/h4>\n<p>Produtos com <strong>menos de 0,2% de THC<\/strong> poder\u00e3o ser prescritos com <strong>receitu\u00e1rio de controle especial<\/strong>, sem a necessidade de <strong>Notifica\u00e7\u00e3o de Receita<\/strong> tipo B.<\/p>\n<p>Produtos com <strong>mais de 0,2% de THC<\/strong> ser\u00e3o restritos a <strong>pacientes com doen\u00e7as graves<\/strong> e n\u00e3o poder\u00e3o ser prescritos para <strong>menores de 18 anos<\/strong>, <strong>gestantes<\/strong> e <strong>lactantes<\/strong>.<\/p>\n<p>Prescri\u00e7\u00e3o ser\u00e1 permitida por <strong>m\u00e9dicos e cirurgi\u00f5es-dentistas<\/strong> legalmente habilitados, com ajuste no tipo de receita conforme o teor de <strong>THC<\/strong>.<\/p>\n<h4><strong>2. Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o (BPF)<\/strong><\/h4>\n<p>Exig\u00eancia de <strong>certifica\u00e7\u00e3o de BPF<\/strong> para os produtos finais.<\/p>\n<p><strong>Insumos farmac\u00eauticos ativos<\/strong> dever\u00e3o atender \u00e0s <strong>BPF<\/strong> conforme a <strong>RDC 654\/22<\/strong>, sem necessidade de certifica\u00e7\u00e3o adicional pela Anvisa.<\/p>\n<h4><strong>3. Vias de Administra\u00e7\u00e3o e Farm\u00e1cias de Manipula\u00e7\u00e3o<\/strong><\/h4>\n<p>Amplia\u00e7\u00e3o das vias de administra\u00e7\u00e3o, permitindo formas <strong>oral<\/strong>, <strong>bucal<\/strong>, <strong>sublingual<\/strong>, <strong>inalat\u00f3ria<\/strong> e <strong>dermatol\u00f3gica<\/strong>. Produtos <strong>injet\u00e1veis<\/strong> e <strong>fum\u00edgenos<\/strong> continuam proibidos.<\/p>\n<p>Farm\u00e1cias de manipula\u00e7\u00e3o poder\u00e3o operar somente com <strong>CBD purificado<\/strong> (\u226598% de pureza), garantindo maior controle de qualidade.<\/p>\n<h4><strong>4. Importa\u00e7\u00e3o e Produ\u00e7\u00e3o<\/strong><\/h4>\n<p>Regulamenta\u00e7\u00e3o para a <strong>importa\u00e7\u00e3o de insumos<\/strong> e <strong>produtos a granel<\/strong>.<\/p>\n<p>Exclus\u00e3o da possibilidade de farm\u00e1cias de manipula\u00e7\u00e3o importarem <strong>fitof\u00e1rmaco CBD<\/strong> diretamente.<\/p>\n<h4><strong>5. Publicidade<\/strong><\/h4>\n<p>Restri\u00e7\u00f5es de <strong>publicidade<\/strong>, similares \u00e0s de <strong>medicamentos sujeitos a controle especial<\/strong>, permitida apenas para <strong>profissionais de sa\u00fade<\/strong>.<\/p>\n<h3><strong>Cr\u00edticas \u00e0 RDC 660\/22<\/strong><\/h3>\n<p>A <strong>RDC 660\/22<\/strong> permite a importa\u00e7\u00e3o por pessoas f\u00edsicas sem registro sanit\u00e1rio, o que pode criar riscos \u00e0 <strong>seguran\u00e7a do paciente<\/strong>.<\/p>\n<p>Estudos internacionais indicam <strong>inconsist\u00eancias nos n\u00edveis de CBD e THC<\/strong> nos produtos importados, sugerindo falta de controle de qualidade.<\/p>\n<p>Prop\u00f4s-se a <strong>revis\u00e3o da RDC 660\/22<\/strong> para alinhar o marco regulat\u00f3rio e fortalecer a <strong>fiscaliza\u00e7\u00e3o<\/strong>.<\/p>\n<h3><strong>Pr\u00f3ximos Passos e Consulta P\u00fablica<\/strong><\/h3>\n<p>A revis\u00e3o da <strong>RDC 660\/22<\/strong> ser\u00e1 pautada em uma <strong>outra reuni\u00e3o<\/strong>, devido \u00e0 falta de qu\u00f3rum para a delibera\u00e7\u00e3o nesta sess\u00e3o. A responsabilidade ficar\u00e1 com a <strong>diretoria do Diretor Daniel Pereira<\/strong>.<\/p>\n<p>A consulta p\u00fablica ficar\u00e1 aberta por <strong>60 dias<\/strong>, permitindo a participa\u00e7\u00e3o da sociedade nas discuss\u00f5es sobre as propostas de altera\u00e7\u00e3o.<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Em 26 de mar\u00e7o de 2025, foi aprovada a consulta p\u00fablica sobre a revis\u00e3o da RDC 327\/2019, que regula a autoriza\u00e7\u00e3o sanit\u00e1ria, fabrica\u00e7\u00e3o, importa\u00e7\u00e3o, comercializa\u00e7\u00e3o, prescri\u00e7\u00e3o e fiscaliza\u00e7\u00e3o de produtos \u00e0 base de Cannabis para fins medicinais no Brasil. <\/p>\n","protected":false},"author":9,"featured_media":8269,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_joinchat":[],"footnotes":""},"categories":[73,67,68,53,60,69],"tags":[86,75],"class_list":["post-8245","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cannabis","category-els","category-els-group","category-geral","category-noticias","category-questoes-regulatorias","tag-anvisa","tag-cannabis"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - 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