Key Takeaways from the July 15 and July 29 Brazil Special Interest Group sessions
- On July 13, ANVISA started the final “countdown” to the April 2022 deadline with its revised draft of its Normative Instruction.
- Discussions continued on when and how an Activation Event is triggered for SNCM reporting based on unpublished feedback from ANVISA.
- An initial TraceLink analysis has revealed significant differences between the ANVISA and EPCIS data sets that may affect customers using a 3PL in Brazil.
- TraceLink’s Serialized Traceability application will be integrated with Serialized Operations Manager for “horizontal” data exchange with trading partners.
Latest Normative Instruction puts industry on notice
On July 13, ANVISA released an updated version of its Normative Instruction for SNCM reporting. The final draft mirrors the law as far as requirements and reduces pre-deadline requirements to the Serialization Plan that each MAH must provide prior to April 28, 2022. The TraceLink Customer Community recognized the draft as the “starting gun” for meeting the April, 2022 deadline and noted that any possible legal challenges would likely extend past the deadline.
Read ANVISA Normative Instruction Spurs Industry Action Ahead of April 2022 Deadline for a more detailed look at the major provisions of the July 13 draft.
The “who,” “when,” and “where” of Activation Events
Responding to questions from the Community, TraceLink provided an update on when companies must report an Activation Event—the point at which a product enters the Brazil supply chain—based on the latest feedback from ANVISA. The time and place of activation depends on whether a product is manufactured in Brazil or manufactured outside the country and imported. TraceLink Brazil Director Luca Gabrielli explained that products manufactured in Brazil are activated when they are “quality released” by the manufacturer at a specific location identified by its government tax identification number—the CNPJ. For imported products, activation takes place at the location—also identified by its CNPJ—that receives the product after it is released from Brazil customs.
Troubleshooting ANVISA data formats and data exchange
With the sudden pivot to an “all hands” approach to meeting the April ANVISA deadline, the Brazil Special Interest Group is turning its attention from questions of “When?” to questions of “How?” TraceLink project manager Greg Firestone offered an initial analysis of the differences between the transactional data schemas of the ANVISA reporting format and the industry-standard EPCIS format and whether the ANVISA format is viable for exchanging data between a Marketing Authorization Holder (MAH) and a Third-Party Logistics Provider (3PL) using TraceLink’s Serialized Operations Manager (SOM). Greg also provided an overview of how TraceLink’s Serialized Traceability application will integrate with SOM to facilitate data exchange with trading partners—horizontal integration.
Stay informed with TraceLink’s Brazil Special Interest Group
TraceLink's Brazil Special Interest Group will continue to be the dedicated space for TraceLink customers to share interpretations of regulatory requirements; discuss the business challenges they create and how fellow members are meeting them; and get updates on TraceLink’s track and trace solutions. TraceLink’s Brazil SIG meets every two weeks on Thursdays, with meetings scheduled for August 12 and 26. To join the TraceLink Community, visit the TraceLink communication preference center:
- Select “Join the TraceLink Community” checkbox
- Once the new options appear, select the “Brazil” check box
- Scroll to the bottom of the page and select the “Update Communication Preference” box to submit your request