{"id":12996,"date":"2025-11-05T15:35:01","date_gmt":"2025-11-05T18:35:01","guid":{"rendered":"https:\/\/passarini.com.br\/anvisa-automates-afe-ae-end-of-waiting\/"},"modified":"2025-11-06T10:58:24","modified_gmt":"2025-11-06T13:58:24","slug":"anvisa-new-scheduling-system-compliance-rules","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-new-scheduling-system-compliance-rules\/","title":{"rendered":"New ANVISA System: 3 Essential Compliance Rules and the 5-Year Risk"},"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><b>New ANVISA Scheduling System: 3 Compliance Rules You Need to Master (And the 5-Year Record Keeping Risk)<\/b><\/h2>\n<p>The end of the Parlat\u00f3rio and ANVISA&#8217;s new digital era: Understand how Ordinance 54\/2021 and automation demand Compliance 4.0 to avoid rejections and ensure the legal security of your business.<\/p>\n<p>The <a href=\"https:\/\/en.wikipedia.org\/wiki\/Brazilian_Health_Regulatory_Agency\">National Health Surveillance Agency<\/a> (ANVISA) has taken a definitive step in its digital transformation journey by launching the\u00a0<b>New Appointment Scheduling System<\/b>, formally replacing the old Parlat\u00f3rio. More than a simple\u00a0<i>software<\/i>\u00a0change, this update is a milestone in\u00a0<b>Compliance 4.0<\/b>\u00a0that reorganizes the dynamics of interaction between the regulated sector and the agency.<\/p>\n<p>For companies in the pharmaceutical, food, and health product sectors, mastering this new environment is not just a matter of efficiency; it is a necessity to ensure legal security and the speed of registration and post-registration processes.<\/p>\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><div class=\"fusion-text fusion-text-2\"><h3><b>The Era of Programmed Refusal: Mastering Area Selection<\/b><\/h3>\n<p>The new system, based on Ordinance PT n\u00ba 54\/2021, brought unprecedented rigor to workflow management. The biggest historical point of friction, which generated overload and inefficiency, was the scheduling of appointments in the wrong technical area. A notorious example is the General Management of Medicines and Biological Products (GGMED), which received numerous mistaken requests.<\/p>\n<p>The rule is clear:\u00a0<b>appointments requested to an area that is not competent for the subject of the hearing may be refused<\/b>.<\/p>\n<p>For your business, a refusal means a 100% delay in your regulatory timeline, forcing a restart of the submission cycle. Digitalization, in this context, automates refusal, transforming administrative inaccuracy into a very high cost of regulatory inaction. The key to success is prior regulatory\u00a0<i>due diligence<\/i>, which precisely maps ANVISA&#8217;s Internal Regulations and ensures the correct channeling of the topic.<\/p>\n<h3><b>The 5-Year Legal Commitment: The Recording as Evidence<\/b><\/h3>\n<p>One of the most crucial and often overlooked aspects of the new regulation is the mandatory access and retention of the hearing recording.<\/p>\n<p>Article 24 of Ordinance 54\/2021 assures the individual the right to access the content of the recordings but imposes a retention period of\u00a0<b>5 (five) years<\/b>. This transforms the recording into formal and auditable documentary evidence for half a decade.<\/p>\n<p>For your company, this has serious implications in terms of:<\/p>\n<ol>\n<li><b>Legal Security:<\/b>\u00a0Any verbal statement made during the hearing must be strictly consistent with the company&#8217;s official records. Discrepancies can be used in future litigations.<\/li>\n<li><b>LGPD Compliance:<\/b>\u00a0The storage and processing of this long-term data must be in full compliance with the General Data Protection Law (LGPD) and the Ordinance.<\/li>\n<\/ol>\n<p>Managing and indexing this volume of data for such an extended period requires more than manual methods; it requires a secure\u00a0<b>RegTech<\/b>\u00a0infrastructure.<\/p>\n<h3><b>Post-Digitization Visibility: The Risk of &#8220;Awaiting Submission&#8221;<\/b><\/h3>\n<p>The new system works with detailed flows and statuses. The status\u00a0<b>&#8220;Awaiting submission&#8221;<\/b>\u00a0is a critical point that requires immediate attention. It indicates that ANVISA has already performed its initial analysis and is awaiting the submission of complementary documents or data from the applicant.<\/p>\n<p>Failure to monitor and respond promptly to this status can paralyze the process for weeks, resulting in further delays in product launches or resolution of technical pending issues. Success in scheduling intrinsically depends on\u00a0<b>real-time monitoring<\/b>\u00a0of the\u00a0<i>status quo<\/i>.<\/p>\n<\/div><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-1 fusion-columns-total-3 fusion-content-boxes-1 content-boxes-icon-with-title content-left\" style=\"--awb-hover-accent-color:#3bafbf;--awb-circle-hover-accent-color:#3bafbf;--awb-item-margin-bottom:40px;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-box content-icon-wrapper-yes icon-hover-animation-fade\" data-animationOffset=\"top-into-view\"><div class=\"heading icon-left\"><h2 class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--h2_typography-font-size:22px;--fontSize:22;line-height:1.25;\">1. Immediate Agility and Predictability:<\/h2><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>From now on, as soon as a process for granting or amending an AFE\/AE is completed and approved, the certificate will be generated by the Solicita system within minutes. This is a drastic improvement compared to the previous timelines, which depended on manual verification and signing steps. For companies, this means that operations can start or expand almost instantly after regulatory approval.<\/p>\n<\/div><\/div><\/div><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);\" class=\"fusion-column content-box-column content-box-column content-box-column-2 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-box content-icon-wrapper-yes icon-hover-animation-fade\" data-animationOffset=\"top-into-view\"><div class=\"heading icon-left\"><h2 class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--h2_typography-font-size:22px;--fontSize:22;line-height:1.25;\">2. Error Reduction and Legal Security:<\/h2><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>Automating the issuance process minimizes the risk of human error in generating the final document. Additionally, ANVISA has implemented robust security mechanisms \u2014 including validation via QR Code, Issue Date, Code, and Hash \u2014 all available on the external consultation portal. This transparency and ease of validation strengthen the document\u2019s legal reliability.<br \/>\nHowever, it is crucial that the submission process (the prerequisite for issuance) be impeccable and aligned with the company\u2019s data, as the automatically generated certificate will precisely reflect the approved information in the system.<\/p>\n<\/div><\/div><\/div><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);\" class=\"fusion-column content-box-column content-box-column content-box-column-3 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-box content-icon-wrapper-yes icon-hover-animation-fade\" data-animationOffset=\"top-into-view\"><div class=\"heading icon-left\"><h2 class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--h2_typography-font-size:22px;--fontSize:22;line-height:1.25;\">3. The Focus on Perfect Compliance:<\/h2><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>The key takeaway from this change is that agility applies only to the issuance stage \u2014 not to the petition review itself. With the \u201cend of the waiting line\u201d for certificate generation, the focus now shifts even more toward the quality and compliance of the original petition. Any errors or inconsistencies in company registration or documentation will delay approval, preventing automatic certificate issuance. Excellence in data accuracy and submission quality is now more critical than ever to fully benefit from this new agility.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><div class=\"fusion-image-element fusion-image-align-center in-legacy-container\" style=\"text-align:center;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"400\" height=\"500\" alt=\"Navigating ANVISA&#039;s new digital scheduling system?\" title=\"Navigating ANVISA&#8217;s new digital scheduling system?\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-400x500.webp\" class=\"img-responsive wp-image-13006\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-768x960.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar.webp 1080w\" sizes=\"(max-width: 800px) 100vw, 400px\" \/><\/span><\/div><\/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<h3><b>Your Solution is Compliance 4.0: Passarini Group at the Forefront<\/b><\/h3>\n<p>The New ANVISA System is a\u00a0<i>gatekeeper<\/i>\u00a0of processes. To navigate this more rigorous environment,\u00a0<b>Passarini Group<\/b>\u00a0offers strategic solutions that transform these challenges into competitive advantages:<\/p>\n<ul>\n<li><b>Strategic Pre-Hearing Consulting:<\/b>\u00a0Avoid programmed refusal. Our team precisely maps the technical competence for your agenda, ensuring successful scheduling on the first attempt.<\/li>\n<li><b>Integrated Document Management Platform:<\/b>\u00a0Solve the 5-year retention challenge. Our RegTech securely stores and indexes recordings and minutes, ensuring full compliance with Ordinance 54\/2021 and LGPD.<\/li>\n<li><b>Proactive Regulatory Alert Service:<\/b>\u00a0Eliminate the risk of inaction. Receive instant alerts about status changes (&#8220;Awaiting submission&#8221;), ensuring immediate responses and keeping your process always moving.<\/li>\n<\/ul>\n<p><b>ANVISA has digitized; your regulatory management needs to keep up. Contact Passarini Group and ensure the efficiency of the new system works in favor of your business.<\/b><\/p>\n<p><strong><a href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/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;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/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=\"New ANVISA System: 3 Essential Compliance Rules and the 5-Year Risk\" data-description=\"New ANVISA Scheduling System: 3 Compliance Rules You Need to Master (And the 5-Year Record Keeping Risk)\r\nThe end of the Parlat\u00f3rio and ANVISA&#039;s new digital era: Understand how Ordinance 54\/2021 and automation demand Compliance 4.0 to avoid rejections and ensure the legal security of your business.\r\n\r\nThe National Health Surveillance Agency\" data-link=\"https:\/\/passarini.com.br\/en\/anvisa-new-scheduling-system-compliance-rules\"><h4 class=\"tagline\" style=\"color:#333333;\">Share<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fpassarini.com.br%2Fen%2Fanvisa-new-scheduling-system-compliance-rules&amp;t=New%20ANVISA%20System%3A%203%20Essential%20Compliance%20Rules%20and%20the%205-Year%20Risk\" target=\"_blank\" rel=\"noreferrer\" title=\"Facebook\" aria-label=\"Facebook\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Facebook\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" 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class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-4\"><h3 data-fontsize=\"22\" data-lineheight=\"48\"><strong>Mais not\u00edcias:<\/strong><\/h3>\n<\/div><div class=\"fusion-recent-posts fusion-recent-posts-1 avada-container layout-default layout-columns-1\"><section class=\"fusion-columns columns fusion-columns-1 columns-1\"><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-02-12T17:31:31-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/siud-anvisa-udi-medical-devices-brazil-2026-deadlines\/\">SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 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