October 2021 - rfxcel.com

Brazil ANVISA Update: Manufacturers, Distributors, and Dispensers Must Meet April 2022 Serialization Deadline

The Brazilian Health Regulatory Agency (ANVISA) has approved its final Normative Instruction (NI 100), meaning the April 28, 2022, deadline for meeting serialization, reporting, and traceability requirements is officially set in stone. Let’s take a look at what supply chain stakeholders can expect with Brazil ANVISA when the law goes into effect just six months from now.

Key Brazil ANVISA requirements for April 28, 2022

The pharma industry has been aware of the Brazil ANVISA requirements since December 2016, when the National Medicine Control System (SNCM) was signed into law (Law No. 13.410/2016), establishing serialization requirements and timelines for Brazil’s pharmaceutical supply chain.

There are three key requirements for April 2022:

  1. All prescription medicines must be serialized.
  2. All manufacturers and importers must have a “serialization plan” in the SNCM portal.
  3. All supply chain stakeholders must submit product event reports to the SNCM.

To meet serialization requirements, all products must have a GS1 2D Data Matrix barcode that houses a Global Trade Item Number (GTIN), a 13-digit ANVISA Medicine Registry Number, a unique 13-digit serial number, an expiration date (in the MM/YY format for human-readable form), and a lot/batch number (up to 20 alphanumeric characters).

The ANVISA Medicine Registry Number, serial number, expiration date, and lot/batch number make up the Unique Medicine Identifier (Identificador Único de Medicamentos), or IUM, which must be printed on every product. Compliant labeling might look something like this:


For their serialization plans in the SNCM portal, manufacturers and importers must provide information about their relevant product lines and medicines. Furthermore, manufacturers must submit a serialization plan that includes all steps and actions they will take to become compliant by April 2022.

Final thoughts

What’s the most important takeaway for Brazil ANVISA? The clock is ticking and you have to be prepared. You should be coordinating with your supply chain partners. You should be registering your products with ANVISA. You should have access to the SNCM portal and be uploading the required reporting data.

You should also register for our “SNCM-ANVISA Serialization and Traceability Compliance” webinar on Wednesday, Nov. 17, 8:30 – 9:15 a.m. Eastern Time. Thiago Alegreti, director of our Latin American operations, will discuss the latest SNCM updates and let you know what you need to be doing to be ready for April 2022.

rfxcel has fine-tuned our traceability software to help manufacturers operating in the Brazilian market comply with the SNCM requirements, and we have an experienced team on the ground in Brazil that can help make sure you’re ready for the regulations. Register for the webinar and contact us today if you have any questions or want more information.

Mobilogix and rfxcel Announce Strategic Partnership in IoT Solutions

Irvine, Calif., Oct. 13, 2021 (PRNewswire). Mobilogix, the leading provider of cost-optimized state-of-the-art cellular IoT solutions, today announced a strategic partnership with rfxcel, part of Antares Vision Group and a leading serialization and traceability enterprise solution provider. Together, the companies will offer innovative supply chain and logistics IoT solutions that complement each other’s strengths to greater serve growing market demands, including asset tracking and traceability for full end-to-end supply chain visibility.

Mobilogix will support rfxcel with an array of its solutions, including the BAT-X IoT tracker and BTM250 Bluetooth beacon sensor. rfxcel’s track and trace software solutions meet the growing demand for smart, scalable asset-tracking optimized for logistics and supply chain use cases. “It is a critical time to serve the market’s growing needs,” said Charlie Williams, EVP Sales and Marketing at Mobilogix. “We are pleased to leverage our synergies to penetrate the market for both partners.”

“We are excited about partnering with Mobilogix to provide track and trace solutions that utilize the latest and best IoT technologies,” said rfxcel CEO Glenn Abood. “By combining Mobilogix’s innovative hardware with our best-in-class track and trace software, we offer better data and operational outcomes for any market and any industry.”

For more information about rfxcel and the Mobilogix partnership, contact rfxcel Vice President of Marketing and Strategic Initiatives Herb Wong at 925-791-3235 or hwong@rfxcel.com.

About Mobilogix

Mobilogix is the world’s leading provider in IoT asset optimization and management solutions. The company’s solutions are deployed by leading companies in Agriculture, Automotive, Construction, Industrial and Transportation to track, monitor, and optimize their assets with actionable real-time data. Mobilogix is headquartered in Irvine, California, and has global offices in BrazilIndiaHong Kong and China. For more information, please call +1.949.748.8895, e-mail info@mobilogix.com.

About rfxcel

Part of Antares Vision Group, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, protect their products and brand reputations, and engage consumers. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s Traceability System to power end-to-end supply chain solutions in track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. Founded in 2003, the company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin AmericaRussiaIndiaJapan, the Middle East, and the Asia-Pacific region.

About Antares Vision Group

Antares Vision Group protects products, people, and brands with inspection systems featuring 6,500 quality controls, track and trace software solutions for end-to-end transparency and visibility in digital supply chains, and smart data management tools for maximum operational efficiency, from raw materials to final consumers. It provides solutions to five primary industries: pharmaceuticals and life sciences (medical devices and hospitals), food and beverage, cosmetics, and consumer packaged goods. Active in more than 60 countries, Antares Vision Group has seven production facilities and three Innovation and Research Centers in Italy, 22 foreign subsidiaries, and a global network of more than 40 partners. Today, 10 of the world’s 20 leading pharmaceutical companies use its solutions to secure their production and supply chain operations; worldwide, it has deployed more than 25,000 inspection systems and more than 3,500 serialization modules. Antares Vision Group has been listed on the Italian Stock Exchange’s AIM Italia market since April 2019 and in the STAR Segment of the Mercato Telematico Azionario (MTA) since May 2021.