While companies await the final approval of ANVISA’s Normative Instruction for implementing their track and trace solutions before the April 2022 deadline, TraceLink’s Brazil Special Interest Group (SIG) is analyzing the agency’s latest proposals to determine the best path for moving forward despite the uncertainty about the newly proposed “assisted implementation” testing period under consideration.
January’s Brazil SIG meetings have also focused on the challenge of horizontal data exchange—also referred to as horizontal integration or horizontal communication—between upstream and downstream supply chain partners. This month’s discussions have included the December 10 presentation from the GS1 Brazil working group on horizontal integration, as well as analysis of the group’s initial technical recommendations on message exchange and security.
ANVISA’s testing period and phased reporting deadlines
Based on the December 2020 draft of ANVISA’s Normative Instruction, TraceLink has outlined ANVISA’s proposed plan for a period of “assisted implementation”, which would require Marketing Authorization Holders (MAHs), wholesalers, and dispensers to report a specific percentage of serialized lots to the SNCM implementation system during a one-year testing period from April 2021 to April 2022.
- As ANVISA continues to postpone its final approval of the Normative Instruction—it was not on the agenda for the January 26 directors’ meeting—MAHs are becoming more concerned about their ability to have their track and trace solutions in place in time to begin testing in April 2021. The concern is even greater for Brazil-based manufacturers who may not have their serialized line systems in place yet.
- Once testing is completed and the SNCM production system is fully ready in April 2022, ANVISA has proposed that reporting deadlines would be phased in based on a percentage of their packaging lines.
The next meeting of the ANVISA directors is February 9. TraceLink’s local Brazil team is monitoring the situation closely and will continue to update the Brazil SIG.
The growing importance—and challenge—of horizontal integration
Throughout 2020 TraceLink has stressed the importance of horizontal integration—the ability to exchange serialized product data with supply chain partners—as critical to success in meeting both regulatory and business requirements in Brazil. Recent Brazil SIG meetings have been largely focused on the challenge of horizontal integration and how the industry is responding.
- TraceLink’s Local Brazil team briefed the SIG on the progress of the GS1 Brazil working group on horizontal communication, which presented its status report on December 18 and a working document on initial use cases on January 24th.
- In recognition of the short time remaining for testing and implementation before the final 2022 deadline, the GS1 working group has proposed a horizontal communication approach that repurposes the basic data format that companies must use to send event data to SNCM for sending transaction data to trade partners.
- TraceLink’s local Brazil team presented an analysis of the GS1 approach to determine how the basic data might be extended to include more robust transaction data or to deliver an EPCIS data “payload” in order to meet more complex business requirements, including product aggregation data and exception management messaging.
Questions and concerns: Upcoming TraceLink Brazil SIG topics
As 2021 gets underway, TraceLink’s Sr. Director of Industry Marketing and Community, Allan Bowyer, continues to collect ideas from members of the Brazil SIG on areas of key concern. Future topics under consideration include:
- Understanding how to meet the newly published reporting deadline under Assisted Implementation
- Understanding the requirements for horizontal data exchange and options available
- Examples of message form and information inside the reports, especially for those who prepare for validation/verification of processes
- Fleshing out use cases, especially around importation, and how TraceLink’s Brazil solution will address them
- Potential requirements of CMOs and use cases in which they would need to connect to the SNCM
- Differences between the current staging SNCM system and the final version in 2022
- Clarifying the aggregation and coding requirements at different levels of the hierarchy, and understanding industry best practices
TraceLink’s Brazil SIG meets every two weeks on Thursdays, with upcoming meetings scheduled for February 11 and 25. Contact TraceLink to learn more about joining TraceLink Community discussions.