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Brazil Compliance

Brazil’s original traceability law 11.903 was amended based on extensive industry feedback around the complexity of implementation. In December 2016, a new law was officially signed and published and in September 2017, a multi-phase roll-out schedule began. Based on pilot results and final technical guidelines, implementation of unit-level serialization, tracking and capture of required product movements and events, and government reporting will take place from May 2019 through May 2022.

TraceLink has long collaborated with GS1 Brazil and in-market industry associations around the development of regulatory and business requirements and will continue to be closely involved. Brazil Compliance will be developed to address all final specifications. While still pending, anticipated features include:

  • Managing the ANVISA registration number, serial number, lot number, and expiry date data elements
  • Enabling the creation and management of aggregation relationships across business operations and supply/trade partner relationships
  • Managing warehouse operations and related compliance information for shipment, receipt, destruction, and changing of packaging hierarchies
  • Onboarding supply partner networks, and managing supply partner data exchanges with CMOs throughout the serialization and packaging process
  • Ensuring efficient 3PL connections to manage serialized product and event information requirements throughout 3PL operations
  • Enabling trade partner data exchanges, including sending data such as aggregation information to your supply chain partners to ensure they can efficiently receive the product you sell them
  • Effectively managing operational exceptions and compliance notifications
  • Centrally managing all reporting to ANVISA, whether you manufacture products, import from other companies, distribute or dispense medicines, or have a combination of business operations
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