{"id":284810,"date":"2026-02-03T15:48:21","date_gmt":"2026-02-03T18:48:21","guid":{"rendered":"https:\/\/noticiaempauta.com\/portal\/?p=284810"},"modified":"2026-02-03T15:48:23","modified_gmt":"2026-02-03T18:48:23","slug":"anvisa-publica-regras-para-producao-de-cannabis-medicinal-no-pais","status":"publish","type":"post","link":"https:\/\/noticiaempauta.com\/portal\/anvisa-publica-regras-para-producao-de-cannabis-medicinal-no-pais\/","title":{"rendered":"Anvisa publica regras para produ\u00e7\u00e3o de cannabis medicinal no pa\u00eds"},"content":{"rendered":"\n
A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) publicou, nesta ter\u00e7a-feira (3), a regulamenta\u00e7\u00e3o para o cultivo da Cannabis medicinal no Brasil. A medida autoriza a produ\u00e7\u00e3o da planta por pessoas jur\u00eddicas, destinada \u00e0 fabrica\u00e7\u00e3o de medicamentos e fins farmac\u00eauticos.<\/p>\n\n\n\n
At\u00e9 ent\u00e3o, o cultivo da Cannabis era proibido no pa\u00eds, apesar de a legisla\u00e7\u00e3o permitir a manipula\u00e7\u00e3o, o registro e a comercializa\u00e7\u00e3o de produtos derivados da planta. Na pr\u00e1tica, isso obrigava empresas a importar a mat\u00e9ria-prima, o que encarecia a produ\u00e7\u00e3o de medicamentos e restringia o avan\u00e7o de pesquisas cient\u00edficas.<\/p>\n\n\n\n<\/figure>\n\n\n\n
A mudan\u00e7a atende uma determina\u00e7\u00e3o do Superior Tribunal de Justi\u00e7a (STJ), que, em novembro de 2024, definiu a legalidade da produ\u00e7\u00e3o da Cannabis “para fins exclusivamente medicinais e\/ou farmac\u00eauticos atrelados \u00e0 prote\u00e7\u00e3o do direito \u00e0 sa\u00fade\u201d.<\/p>\n\n\n\n
\u201cAo dar previsibilidade e seguran\u00e7a para pesquisa e fins medicinais, abrimos caminho para que a ci\u00eancia e o setor produtivo do pa\u00eds desenvolvam solu\u00e7\u00f5es de qualidade para crian\u00e7as, adolescentes, adultos e idosos, colocando o cuidado em primeiro lugar e aproximando inova\u00e7\u00e3o de quem mais precisa\u201d, disse o diretor-presidente da Anvisa, Leandro Safatle.<\/p>\n\n\n\n
Ao todo, foram aprovadas tr\u00eas resolu\u00e7\u00f5es. A primeira prev\u00ea a emiss\u00e3o de uma Autoriza\u00e7\u00e3o Especial (AE) para produ\u00e7\u00e3o de Cannabis exclusivamente por pessoas jur\u00eddicas, com inspe\u00e7\u00e3o sanit\u00e1ria pr\u00e9via e exig\u00eancia de mecanismos de rastreabilidade, controle e seguran\u00e7a. A produ\u00e7\u00e3o dever\u00e1 ser restrita ao teor de THC de at\u00e9 0,3%, conforme estabelecido pelo STJ.<\/p>\n\n\n\n
Segundo a portaria, todo o processo ser\u00e1 fiscalizado por um comit\u00ea coordenado por Anvisa, Minist\u00e9rio da Justi\u00e7a, Minist\u00e9rio da Sa\u00fade (MS) e Minist\u00e9rio da Agricultura e Pecu\u00e1ria (Mapa). Em caso de padr\u00e3o n\u00e3o justificado ou outra poss\u00edvel irregularidade, as atividades podem ser suspensas e a produ\u00e7\u00e3o destru\u00edda.<\/p>\n\n\n\n
No caso da resolu\u00e7\u00e3o que trata de pesquisas, os requisitos de seguran\u00e7a e controle tamb\u00e9m est\u00e3o previstos e envolvem inspe\u00e7\u00e3o pr\u00e9via do local pela autoridade sanit\u00e1ria, exig\u00eancia de barreiras f\u00edsicas de prote\u00e7\u00e3o e vigil\u00e2ncia 24 horas por dia \u2014 com sistema de c\u00e2meras e alarmes, acesso restrito e controle de entrada e sa\u00edda.<\/p>\n\n\n\n
Os produtos resultantes da pesquisa n\u00e3o poder\u00e3o ser comercializados, mas poder\u00e3o ser compartilhados com outras institui\u00e7\u00f5es, devidamente autorizadas pela Anvisa, para realiza\u00e7\u00e3o de an\u00e1lises e outras atividades inerentes \u00e0 pesquisa. Produtos para pesquisa com THC acima de 0,3%, dever\u00e3o ser obtidos por meio de importa\u00e7\u00e3o com autoriza\u00e7\u00e3o pr\u00e9via da Anvisa e atendimento das exig\u00eancias estabelecidas pelas Na\u00e7\u00f5es Unidas.<\/p>\n\n\n\n
J\u00e1 a terceira resolu\u00e7\u00e3o cria um instrumento espec\u00edfico para associa\u00e7\u00f5es de pacientes sem fins lucrativos, que tamb\u00e9m n\u00e3o prev\u00ea autoriza\u00e7\u00e3o para comercializa\u00e7\u00e3o. O objetivo \u00e9 avaliar, em ambiente controlado e supervisionado, a viabilidade sanit\u00e1ria da produ\u00e7\u00e3o e opera\u00e7\u00e3o em pequena escala, fora do modelo industrial; e produzir dados e evid\u00eancias sobre qualidade e seguran\u00e7a da produ\u00e7\u00e3o por essas institui\u00e7\u00f5es para decis\u00e3o regulat\u00f3ria futura da Anvisa.<\/p>\n\n\n\n
A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) publicou, nesta ter\u00e7a-feira (3), a regulamenta\u00e7\u00e3o para o cultivo da Cannabis medicinal no Brasil. A medida autoriza a produ\u00e7\u00e3o da planta por pessoas jur\u00eddicas, destinada \u00e0 fabrica\u00e7\u00e3o de medicamentos e fins farmac\u00eauticos. At\u00e9 ent\u00e3o, o cultivo da Cannabis era proibido no pa\u00eds, apesar de a legisla\u00e7\u00e3o permitir a […]<\/p>\n","protected":false},"author":2,"featured_media":284811,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mi_skip_tracking":false,"footnotes":""},"categories":[25,1,16],"tags":[192],"class_list":["post-284810","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-destaques-site","category-geral","category-todas","tag-destaqueprincipal"],"acf":[],"yoast_head":"\n
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