{"id":8246,"date":"2025-04-28T11:19:30","date_gmt":"2025-04-28T10:19:30","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8246"},"modified":"2025-04-28T11:28:40","modified_gmt":"2025-04-28T10:28:40","slug":"cannabis-based-products-medicinal-purposes-in-brazil","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/cannabis-based-products-medicinal-purposes-in-brazil\/","title":{"rendered":"Public Consultation on the Revision of RDC 327\/2019: Main Changes and Criticisms"},"content":{"rendered":"<p data-pm-slice=\"1 1 []\">On March 26, 2025, the public consultation on the revision of <strong>RDC 327\/2019<\/strong>, which regulates the health authorization, manufacture, import, marketing, prescription and inspection of <strong>cannabis-based products for medicinal purposes<\/strong> in Brazil, was approved. Below are the main changes discussed at the meeting.<\/p>\n<h3>Main changes proposed<\/h3>\n<h4><strong>1.Prescription<\/strong><\/h4>\n<p>Products with<strong> less than 0.2% THC<\/strong> can be prescribed with a <strong>special control prescription<\/strong>, without the need for a Type B <strong>Prescription Notification<\/strong>.<\/p>\n<p>Products with<strong> more than 0.2% THC<\/strong> will be restricted to <strong>patients with serious illnesses<\/strong> and cannot be prescribed to children <strong>under 18, pregnant women or nursing mothers<\/strong>.<\/p>\n<p>Prescription will be allowed by <strong>legally qualified doctors and dental surgeons<\/strong>, with adjustments to the type of prescription according to the <strong>THC<\/strong> content.<\/p>\n<h4><strong>2. Good Manufacturing Practices (GMP)<\/strong><\/h4>\n<p><strong>GMP certification<\/strong> required for final products.<\/p>\n<p><strong>Active pharmaceutical ingredients<\/strong> must comply with <strong>GMP<\/strong> in accordance with <strong>RDC 654\/22<\/strong>, without the need for additional certification by Anvisa.<\/p>\n<h4><strong>3. Routes of Administration and Manipulation Pharmacies<\/strong><\/h4>\n<p>Expansion of administration routes, allowing<strong> oral, buccal, sublingual, inhalation and dermatological<\/strong> forms. <strong>Injectable<\/strong> products and <strong>smoking<\/strong> are still prohibited.<\/p>\n<p>Handling pharmacies will only be able to operate with <strong>purified CBD<\/strong> (\u226598% purity), ensuring greater quality control.<\/p>\n<h4>4. Imports and production<\/h4>\n<p>Regulations for the <strong>import of raw materials and products in bulk<\/strong>.<\/p>\n<p>Exclusion of the possibility for compounding pharmacies to import <strong>CBD phytopharmaceuticals<\/strong> directly.<\/p>\n<h4>5. Advertising<\/h4>\n<p><strong>Advertising<\/strong> restrictions, similar to those for <strong>medicines subject to special control<\/strong>, allowed only for <strong>health professionals<\/strong>.<\/p>\n<h3>Criticism of RDC 660\/22<\/h3>\n<p><strong>RDC 660\/22<\/strong> allows importation by individuals without health registration, which can create risks to <strong>patient safety<\/strong>.<\/p>\n<p>International studies indicate<strong> inconsistencies in the levels of CBD and THC<\/strong> in imported products, suggesting a lack of quality control.<\/p>\n<p>It was proposed that <strong>RDC 660\/22 be revised<\/strong> to align the regulatory framework and strengthen <strong>inspection<\/strong>.<\/p>\n<h3>Next Steps and Public Consultation<\/h3>\n<p>The revision of <strong>RDC 660\/22<\/strong> will be discussed at <strong>another meeting<\/strong>, due to the lack of a quorum for deliberation at this session. <strong>Director Daniel Pereira<\/strong> will be in charge.<\/p>\n<p>The public consultation will remain open for <strong>60 days<\/strong>, allowing society to participate in discussions on the proposed changes.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On March 26, 2025, the public consultation on the revision of RDC 327\/2019, which regulates the health authorization, manufacture, import, marketing, prescription and inspection of cannabis-based products for medicinal purposes in Brazil, was approved. <\/p>\n","protected":false},"author":9,"featured_media":8268,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[80,164,54,189,149,102,220,95],"tags":[104,221,154,62,103],"class_list":["post-8246","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cosmetics","category-els-group-en","category-general","category-geral-en","category-medicinal-cannabis","category-noticias-en","category-portugal-en","category-regulations","tag-anvisa-en","tag-cannabis-en","tag-medicinal-cannabis","tag-news","tag-regulations"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Public Consultation on the RDC 327\/2019&#039;s revision<\/title>\n<meta name=\"description\" content=\"The public consultation on the revision of RDC 327\/2019, regulating cannabis-based medicinal products in Brazil, was 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