Resources ## Breadcrumb 1. [Home](/) 2. [Resources](/resources/resource-center) 3. [Resource Center](/resources/resource-center) # Brazil Deadline: Final Normative Instruction Means All Segments Must Comply by April 2022 ![banner-image](https://www.tracelink.com/sites/default/files/2021-04/brazil-webinar-ii-cp-thumbnail.png) - [Download PDF](/node/20996/pdf) - [Share](#) - [ LinkedIn ](https://www.linkedin.com/shareArticle?mini=true&url=https://www.tracelink.com/resources/resource-center/brazil-deadline-final-normative-instruction-all-segments&title=Brazil Deadline: Final Normative Instruction Means All Segments Must Comply by April 2022&summary=With only 8 months before the deadline, learn why manufacturers need to start their Brazil compliance projects now.&source=TraceLink "LinkedIn") - [ Facebook ](https://www.facebook.com/share.php?u=https://www.tracelink.com/resources/resource-center/brazil-deadline-final-normative-instruction-all-segments&t=Brazil Deadline: Final Normative Instruction Means All Segments Must Comply by April 2022 "Facebook") - [ Mail ](mailto:?subject=Brazil Deadline: Final Normative Instruction Means All Segments Must Comply by April 2022+|+TraceLink&body=https://www.tracelink.com/resources/resource-center/brazil-deadline-final-normative-instruction-all-segments "Mail") - [ Twitter ](https://twitter.com/intent/tweet?text=Brazil Deadline: Final Normative Instruction Means All Segments Must Comply by April 2022 https://www.tracelink.com/resources/resource-center/brazil-deadline-final-normative-instruction-all-segments&via=TraceLink "Twitter") #### Table of contents On August 20, Brazil’s Health Regulatory Agency, ANVISA, voted to approve the July 13 draft of its Normative Instruction for meeting the country’s drug serialization, traceability, and reporting requirements. The approval of the Normative Instruction is a clear statement to the industry that ANVISA expects all segments—manufacturers, distributors, and dispensers—to comply with the April 28, 2022 deadline. In response to industry questions and concerns about the deadline, ANVISA has stated repeatedly that they do not have the authority to change the date as it is written into the law and is, therefore, required to enforce the law. The approved Normative Instruction includes the following key requirements: - **Article 4** states that by April 28, 2022, all non-exempt drugs must be serialized in order to report supply chain movements to the SNCM (National Medicine Control System). - **Article 5** states that manufacturers and importers must maintain a Serialization Plan in the SNCM portal for in-scope product lines and medicines and provide “partial percentages” of serialized production lines until all in-scope lines are ready for the mandated April 28, 2022 deadline. - **Article 6** states that by April 28, 2022, all supply chain members must report events on serialized and commercialized drugs to the SNCM. With only 8 months before the deadline—including significant holidays and country-wide celebrations—manufacturers must act immediately to avoid possible fines, audits, or other penalties after April, 2022. ### Take action: What TraceLink customers can do now What can TraceLink customers do now to prepare for Brazil’s traceability requirements? - Register their medicines with ANVISA and begin uploading their product and company master data required for SNCM reporting. Registry holders must enter and maintain product master data, commercialization information, and additional metadata such as Anatomical Therapeutic Chemical (ATC) codes. - Begin integrating workstreams between internal packaging lines, contract manufacturers (CMOs), internal warehouses, and third-party logistics providers (3PL). Integration projects can—and should—be started immediately to develop and implement the appropriate transaction software and ensure secure partner on-boarding and connectivity. - Work with TraceLink solution consultants to map use cases and identify workflow triggers for Activation and Shipment reports. - Work with TraceLink’s Network Success Team to onboard and connect their trading partners. Companies that are downstream from manufacturers and importers will need to acquire the data from their upstream partners in order to fulfill their own reporting requirements. - Join TraceLink’s bi-weekly Brazil Special Interest Group and upcoming Brazil Innovation Forum to discuss use cases, workflows, and ideas for product feature enhancements. [Learn more about key provisions of the ANVISA Normative Instruction](/resources/resource-center/brazil-anvisa-normative-instruction-spurs-industry-action-ahead-april "Brazil: ANVISA Normative Instruction Spurs Industry Action Ahead of April 2022 Deadline") ### The race is on in Brazil. Don’t risk falling behind. With so much at stake and time running out, many TraceLink customers did not wait for final approval of the Normative Instruction to get started on designing and developing their Brazil compliance solution. For companies that have not yet begun their projects, the compressed timeline means that any further delay may increase the risk of falling further behind and missing the deadline. TraceLink offers the proven compliance solutions and local support manufacturers need to be sure that they—and their affiliates—can meet Brazil’s complex serialization, traceability, and reporting requirements by April, 2022. And only TraceLink gives manufacturers the ability to Integrate Once, Interoperate with Everyone™ to quickly connect their CMOs and 3PLs and build a downstream partner network without costly, time-consuming integrations. [Contact TraceLink](https://www.tracelink.com/contact-us "Contact TraceLink") to schedule a Brazil Readiness Workshop today. [Brazil](/region-type/brazil) #### Table of contents Contact Us Learn more about Brazil compliance solutions from TraceLink. document.addEventListener("DOMContentLoaded", function() { // Delay the execution by 2 seconds (2000 milliseconds) setTimeout(function() { (function() { 'use strict'; // Load Marketo form MktoForms2.loadForm("//go.tracelink.com", "776-BAW-230", 2259); })(); // Wait until the Marketo form is loaded MktoForms2.whenReady(function(form) { var formElement = document.getElementById('mktoForm_2259'); if (!formElement) { console.error("Form with id 'mktoForm_2259' not found."); return; } var formLocation = formElement.querySelector("input[name=formLocation]"); // Get the current URL and set the formLocation field if (formLocation) { var currentURL = window.location.href; formLocation.value = currentURL; } // Add onSuccess handler form.onSuccess(function(values, followUpUrl) { var formElem = form.getFormElem()[0]; if (formElem) { formElem.style.display = 'none'; } else { console.warn("Form element could not be found to hide it."); } var confirmMessage = document.getElementById('confirmform'); if (confirmMessage) { confirmMessage.style.display = 'block'; } else { console.warn("Confirmation message with id 'confirmform' not found."); } return false; // Prevent the form from submitting normally }); }); }, 2000); // Delay for 2 seconds }); **Thank you for contacting us; we’ll be in touch shortly.** ##### More Brazil Compliance Resources [ ![Brazil webinar](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2021-04/brazil-webinar-ii-cp-thumbnail.png.webp?itok=Lxg24drM) ](/resources/resource-center/brazil-anvisa-normative-instruction-spurs-industry-action-ahead-april) ##### Brazil: ANVISA Normative Instruction Spurs Industry Action Ahead of April 2022 Deadline See key provisions of the ANVISA Normative Instruction and what manufacturers and importers must do to meet the April 2022 deadline. [View More](/resources/resource-center/brazil-anvisa-normative-instruction-spurs-industry-action-ahead-april) [ ![Brazil Webinar](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2021-04/brazil-webinar-cp-thumbnail.png.webp?itok=q9UZgKQ_) ](/resources/resource-center/tracelink-brazil-community-focuses-updated-sncm-documentation) ##### TraceLink Brazil Community Focuses on Updated SNCM Documentation, Customer Questions Read key takeaways on updated SNCM guidelines and questions about reporting during the Implementation Phase. [View More](/resources/resource-center/tracelink-brazil-community-focuses-updated-sncm-documentation) [ ![Basics](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/2021-02/brazil-horizontal-integration-infographic-3d.jpg.webp?itok=xTd4a0Lt) ](/resources/resource-center/brazil-compliance-horizontal-integration-infographic) ##### Horizontal Integration in Brazil: The Key to Compliance, Business Continuity, and Operational Efficiency Download this infographic to learn why horizontal integration in Brazil is the key to compliance, business continuity, and operational efficiency. [View More](/resources/resource-center/brazil-compliance-horizontal-integration-infographic) [ ![brazil-compliance-thumbnail.jpg](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/solutions/compliance-and-track-trace/brazil-compliance-thumbnail.jpg.webp?itok=I7xp_oCy) ](/resources/resource-center/brazil-compliance-risk-factors-of-using-your-lms-provider) ##### 5 Risk Factors of Using Your LMS Provider to Meet Brazil Compliance Requirements Learn why Line Management System (LMS) vendors can’t compare to TraceLink’s enterprise-level data management capabilities for Level 4 - Level 5 serialization. [View More](/resources/resource-center/brazil-compliance-risk-factors-of-using-your-lms-provider) [ ![3d-brazil-serialization-timeline-infographic.gif](https://www.tracelink.com/sites/default/files/styles/resize_image_style_640_480/public/_global-asset/images/insights/3d-brazil-serialization-timeline-infographic.gif.webp?itok=nwt8M6cM) ](/resources/resource-center/brazil-compliance-a-step-by-step-approach-to-serialization) ##### Brazil Compliance: A Step-by-Step Approach to Serialization Begin your Brazil serialization journey and see why you need to start today to meet the April 2022 ANVISA deadline. Download the infographic. [View More](/resources/resource-center/brazil-compliance-a-step-by-step-approach-to-serialization)