{"id":12572,"date":"2025-08-11T12:07:03","date_gmt":"2025-08-11T15:07:03","guid":{"rendered":"https:\/\/passarini.com.br\/argentina-medical-device-opportunity-2\/"},"modified":"2025-08-11T14:18:51","modified_gmt":"2025-08-11T17:18:51","slug":"anvisa-certificate-validity-change","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-certificate-validity-change\/","title":{"rendered":"ANVISA Sets New Rule for Good Practice Certificate Validity"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left center;--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-margin-top:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.webp\" alt=\"newsletter passarini\" width=\"1920\" height=\"500\" class=\"wp-image-7421\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:10px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h2 class=\"headingpostinterno\">ANVISA Changes How Certificate Validity is Counted, Providing Clarity for Renewals<\/h2>\n<div class=\"x_elementToProof\">\n<p>The Brazilian Health Regulatory Agency (<a href=\"https:\/\/en.wikipedia.org\/wiki\/Brazilian_Health_Regulatory_Agency\">ANVISA<\/a>) has published a crucial update that directly impacts the industry and regulated sector, bringing more clarity and legal certainty to certification processes. From now on, the way the validity period for Good Manufacturing Practice Certificates (CBPF) and Good Distribution and\/or Storage Practice Certificates (CBPD) is counted has been changed, with a specific rule for renewals.<\/p>\n<p><strong>The new rules work as follows:<\/strong><\/p>\n<\/div>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><ul style=\"--awb-line-height:23.8px;--awb-icon-width:23.8px;--awb-icon-height:23.8px;--awb-icon-margin:9.8px;--awb-content-margin:33.6px;--awb-circlecolor:#3bafbf;--awb-circle-yes-font-size:12.32px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<div class=\"x_elementToProof\" role=\"presentation\"><strong>For new certifications:<\/strong> The 24-month validity period will be counted from the certificate&#8217;s date of issuance. Previously, the counting started from the date of the sanitary inspection conducted by ANVISA.<\/div>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<div class=\"x_elementToProof\" role=\"presentation\"><strong>For certificate renewals:<\/strong> ANVISA has determined that the new 2-year validity period will begin to be counted after the last day of the current certificate&#8217;s validity. This ensures that the company is not disadvantaged if the renewal process is completed before the expiration of the current certificate.<\/div>\n<\/div><\/li><\/ul><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-2\"><div class=\"x_elementToProof\" data-olk-copy-source=\"MessageBody\">\n<p><strong>Here is a practical example:<\/strong><\/p>\n<p>If a certificate expires on December 31, 2025, and the renewal is published on October 31, 2025, the new 2-year validity period will only begin on January 1, 2026, and not on October 31, 2025, as was the previous rule.<\/p>\n<p>This change demonstrates ANVISA&#8217;s effort to align its processes with the needs of the sector, eliminating possible discrepancies and ensuring the full validity of certificates. Passarini Group emphasizes the importance of closely monitoring ANVISA&#8217;s regulatory updates. Remaining in compliance is essential for the success and safety of operations in the sector. Our team is available to help your company understand and adapt to this and other regulations.<\/p>\n<\/div>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><a class=\"awb-lightbox awb-lightbox-1\" href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/08\/feed-news-passarini-group-boas-praten-copiar.webp\" data-rel=\"iLightbox\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/08\/feed-news-passarini-group-boas-praten-copiar-200x250.webp\" alt=\"ANVISA Sets New Rule for Good Practice Certificate Validity\"><\/a><div class=\"fusion-align-block\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"width:calc(100%);\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2025\/anvisa-altera-forma-de-contagem-da-validade-do-certificado-de-boas-praticas\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">ACCESS NEWS<\/span><\/a><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-margin-top:10px;\"><div class=\"x_elementToProof\" data-olk-copy-source=\"MessageBody\">\n<p>ANVISA&#8217;s changes require attention and careful planning. Don&#8217;t let the complexity of the new rules compromise the validity of your certificates.<\/p>\n<p>Count on Passarini Group to ensure your company is always in compliance. Contact us and discover how we can simplify your regulatory routine. Send an email to <strong><a href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/strong><\/p>\n<\/div>\n<p><strong>Fly higher with Passarini Group!<\/strong><\/p>\n<\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-stacked\" style=\"background-color:#f6f6f6;--awb-separator-border-sizes:0px;--awb-layout:row;--awb-alignment-small:space-between;--awb-stacked-align-small:center;\" data-title=\"ANVISA Sets New Rule for Good Practice Certificate Validity\" data-description=\"ANVISA Changes How Certificate Validity is Counted, Providing Clarity for Renewals\r\n\r\n\r\nThe Brazilian Health Regulatory Agency (ANVISA) has published a crucial update that directly impacts the industry and regulated sector, bringing more clarity and legal certainty to certification processes. 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