Brazil ANVISA Guidelines & Compliance Solutions | rfxcel

Brazil ANVISA Track & Trace Requirements

Pharmaceutical companies manufacturing in or importing into Brazil are required to follow the regulations set forth in the National Medicine Control System (SNCM), as described in Law No. 13.410. rfxcel provides guidance on how to best approach the changes that are coming.

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About Brazil Track & Trace Requirements

The SNCM requires unit-level serialization, tracking and tracing products, and monitoring environmental conditions as products move through the supply chain. These serialization requirements state that every item must be visible at the unit level, and all products must have a list of the following specifications:

  • GS1 2D data matrix bar code that houses a Global Trade Item Number (GTIN)
  • ANVISA Medicine Registry Number
  • Unique serial number
  • Expiration date
  • Lot/batch number

As of May 2022, every supply chain actor importing to or manufacturing in Brazil is responsible for capturing, storing, and exchanging important events electronically. However, in November 2019, the SNCM updated that every pharma stakeholder should be able to serialize 25 percent of its products by October 2020 — a full 18 months earlier than the original deadline. 50 percent by April 2021, 75 percent by September 2021, and 100 percent serialization and reporting by April 2022.

rfxcel can help you meet ANVISA serialization, and track and trace requirements.

rfxcel Meets ANVISA Serialization & Traceability Requirements:

rfxcel Is Your Partner for Brazil ANVISA Compliance

Our team will partner with you to meet Brazilian regulatory requirements and transform business value with a transparent digital supply chain. With dedicated track and trace solutions from rfxcel, you can safeguard your products and brand reputation by ensuring all items are legitimate, marked, and ANVISA-compliant.

rfxcel’s Brazil Team: Compliance, Visibility & Support

rfxcel’s team in Brazil will help you achieve and maintain ANVISA compliance by bringing end-to-end visibility to your supply chain.

Experienced Sao Paulo Team

Our Sao Paulo team has more than 15 years of experience increasing supply chain visibility. This local team will walk you through every step of the process to ensure full integration. rfxcel is prioritizing assisting Brazilian companies to meet compliance deadlines by providing our pre-configured and pre-validated solutions to simplify the implementation process.

Growth-Centered Solutions

rfxcel will develop a fully validated implementation plan tailored to your needs and designed specifically for Brazil. Our systems operate also in the Portuguese and Spanish languages, local currency, and processes, easing the compliance burden for companies any industry. Our goal is to increase company value through insightful and precise data with the aid of automation and digitization of workflows.

Growth-Driven Support

rfxcel provides 24/7 support to all our customers operating in Brazil. We assign a dedicated support team member to our clients so we can quickly and thoroughly resolve any issues that arise.

Secure Your Supply Chain with rfxcel Traceability System (rTS)

Our award-winning track and trace solution, rfxcel Traceability System (rTS), is a fully customizable platform that simplifies and accelerates compliance and increases supply chain visibility no matter where you do business. rTS also integrates seamlessly with your existing systems and enhances scalability by letting you add new features quickly.

Find out more about our Russian compliance solutions today!

Full Guide to Brazil ANVISA Pharma Serialization and Traceability Regulations (Portuguese only)

Your value beyond compliance with rfxcel:

  • Digitize and centralize your entire supply chain in one elegant, easy-to-use, and intuitive platform
  • Enhance performance and reduce processing time in multiple languages
  • Leverage IoT technology to gain new real-time insight into and control of your supply chain
  • Trace your products forward and backward
  • Maintain historical information for a batch or individual product with continuous review and supply chain optimization
  • Drive growth by lowering costs and risks, eliminating inefficiencies, and tracking all activity anywhere in your supply chain, including among suppliers, distributors, and 3PLs
  • Integrate with any trading partner