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Global Compliance

Brazil

TraceLink became involved in the Brazil market in 2013, working closely with associations such as Interfarma and Sindusfarma to prepare for the nation’s complex regulations, and co-chairing the GS1 Brazil working group that was focused on developing traceability and serialization guidelines for the country. TraceLink was prepared to help customers meet Brazil’s complex and unique requirements — such as creating serial numbers following Brazil's unique IUM format and managing supply chain partner data exchange — when the country’s original regulations were amended based on industry feedback.

Evolving Regulations

A new law, No. 13.410, was officially signed and published on December 28, 2016. It officially amended the original 11.903 law for the SNCM (National Medicines Control System); set the stage for ANVISA to finalize the law’s rules, which were discussed and debated throughout 2016; and kicked off a 3-stage implementation:

  • September 2017-September 2018. A 1-year pilot experimental that includes at least 3 batches of serialized product.
  • September 2018-May 2019. Review of pilot results and final technical guidelines.
  • May 2019-May 2022. Implementation of unit-level serialization, tracking and capture of required product movements and events, and government reporting for all covered medicines for all industry stakeholders (including pharmaceutical companies, wholesale distributors, and pharmacy dispensers).

Looking Forward

TraceLink will continue to monitor developments, partner with GS1 Brazil to help establish any new regulatory data exchange standards, and help international and domestic companies navigate the new requirements. The core flexibility in TraceLink’s architecture — along with our long history of implementing and supporting Brazil and other market’s specific requirements — will allow us to adapt quickly and help customers achieve compliance on time, and with the lowest possible cost and risk.

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