{"id":15663,"date":"2025-04-03T11:56:10","date_gmt":"2025-04-03T09:56:10","guid":{"rendered":"https:\/\/www.clarkemodet.com\/?p=15663"},"modified":"2025-04-03T16:12:44","modified_gmt":"2025-04-03T14:12:44","slug":"drug-price-adjustment-authorized-by-cmed-for-2025","status":"publish","type":"post","link":"https:\/\/oldweb2025.clarkemodet.com\/en\/articles\/drug-price-adjustment-authorized-by-cmed-for-2025\/","title":{"rendered":"Brazil authorizes drug price adjustments for 2025"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\"><strong>CMED Resolution No. 1\/2025<\/strong>, published in Brazil\u2019s Official Gazette on <strong>March 31, 2025<\/strong>, authorizes the adjustment of prices for medicines sold in the country. The price update is <strong>already in effect<\/strong> and must be applied in accordance with the limits and requirements established in the regulation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:16px\">The annual adjustment is an important step to ensure a balance between <strong>access to medicines<\/strong> for the population and the <strong>economic sustainability<\/strong> of the pharmaceutical sector.<\/p>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\"><strong>Maximum adjustment percentages<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The authorized rates vary according to the level of participation of generic medicines within each therapeutic class:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Level 1<\/strong> \u2013 up to <strong>5.06%<\/strong><br>For classes with generic participation <strong>equal to or greater than 20%<\/strong><\/li>\n\n\n\n<li><strong>Level 2<\/strong> \u2013 up to <strong>3.83%<\/strong><br>For classes with generic participation <strong>between 15% and 20%<\/strong><\/li>\n\n\n\n<li><strong>Level 3<\/strong> \u2013 up to <strong>2.60%<\/strong><br>For classes with generic participation <strong>below 15%<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">These percentages must be applied to the most recent <strong>Factory Price (PF)<\/strong>, available on the CMED price list published on Anvisa\u2019s official portal.<\/p>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\"><strong>Key points for companies<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Correct application of the price adjustment requires attention to several regulatory obligations. The main ones include:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Submission of the Marketing Report<\/strong>. Submitting the report to CMED is <strong>mandatory<\/strong>, even for companies that choose not to apply the adjustment. Inconsistent, incomplete, or late submissions may result in <strong>fines and sanctions<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Price update and disclosure<\/strong>. Companies must ensure that updated prices are published <strong>in specialized media<\/strong>. Market prices <strong>must not exceed<\/strong> the official ceilings established by CMED. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Retail compliance<\/strong>. Pharmacies and drugstores must maintain updated price lists, available to both consumers and regulatory agencies. <strong>Transparency and alignment<\/strong> with official prices are essential to avoid penalties.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Importers<\/strong>. Companies authorized to import medicines must also submit the Marketing Report with detailed sales and billing data by presentation, as required by CMED.<\/p>\n\n\n\n<p class=\"has-medium-font-size wp-block-paragraph\"><strong>Risks of non-compliance<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Failure to comply with the requirements of <strong>CMED Resolution No. 1\/2025<\/strong> may result in:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Administrative fines<\/li>\n\n\n\n<li>Warnings<\/li>\n\n\n\n<li>Suspension of commercialization<\/li>\n\n\n\n<li>Reputational damage<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">That\u2019s why it\u2019s essential to review internal processes, align pricing, regulatory, and commercial teams, and ensure timely submission of all required information.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Review your company\u2019s compliance to avoid fines and regulatory penalties.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If your company operates in the pharmaceutical sector and needs support to properly apply the adjustment and meet CMED\u2019s regulatory requirements, feel free to contact our team.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>We\u2019re ready to help.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CMED Resolution No. 1\/2025, published in Brazil\u2019s Official Gazette on March 31, 2025, authorizes the adjustment of prices for medicines sold in the country. The price update is already in effect and must be applied in accordance with the limits and requirements established in the regulation. The annual adjustment is an important step to ensure [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":15654,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[76],"tags":[],"country":[30],"industry":[97],"class_list":["post-15663","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","country-br","industry-pharma-and-biotechnology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Brazil authorizes drug price adjustments for 2025 - ClarkeModet<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Drug price adjustment authorized by CMED for 2025\" \/>\n<meta property=\"og:description\" content=\"CMED Resolution No. 1\/2025, published in Brazil\u2019s Official Gazette on March 31, 2025, authorizes the adjustment of prices for medicines sold in the country. 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