Brazil's Track and Trace Regulations Overview

Companies selling drug product in Brazil face particularly challenging regulations, with requirements for serialization, traceability, verification, and government reporting. A long-debated regulatory bill, PL 4069, was used as the basis for the new law, No. 13.410, which was officially signed into law and published on December 28, 2016 – setting the wheels in motion for Brazil’s multi-stage implementation. This new law, which amends the previous regulation in Brazil, is based on extensive industry stakeholder feedback.

Before implementation begins, ANVISA will finalize the law's new rules, which have been discussed and debated throughout 2016. Then the following schedule begins, as soon as May 2017: 

  • A 1-year pilot that includes at least 3 batches of serialized product.
  • An 8-month period to review pilot results, and for rules to be modified if necessary.
  • A 3-year deployment for all industry stakeholders, including pharmaceutical companies, wholesale distributors, and pharmacy dispensers, to deploy solutions for: unit-level serialization, tracking and capture of required product movements and events, and government reporting of such information.

While final rules and regulations are being determined, several facets of the requirements are fairly clear, based on draft publications of the RDC rules and meetings with ANVISA and other industry stakeholders.

Serialization and Tracking/Reporting Highlights

Serialization: Brazil requires serialization at the unique item level and the transport packing container, or case, level. Aggregation is required, and each case must contain an identifier linking to the unit identifiers within that case. 

Tracking and ReportingEvery member of the Brazil supply chain—manufacturers/importers, wholesale distributors, and pharmacies—must capture and store key transaction events for drug product coming into and leaving their company, as well as for certain movement and events that takes place within the company. This information must be stored for at least one year after the drug’s expiration date. It is expected that all reporting will go to a centralized reporting system managed by ANVISA, but details for implementing that system are not yet determined.

The challenge for stakeholders will be not only to enable integrated electronic connections with the new government system, but also to add the required serialized inventory tracking capability to their internal operations. This will enable companies to capture regulated events and data effectively while staying operationally efficient.

How TraceLink Can Help

TraceLink became deeply involved in the Brazil market in 2013, working closely with partners such as SPI and associations like Interfarma and Sindusfarma, to prepare for the nation’s complex regulations. Since then, TraceLink's close involvement has continued, as we track regulatory and business requirements to ensure that TraceLink solutions can manage all of Brazil’s distinctive requirements, including:

  • Creating serial numbers following Brazil's unique IUM format, while cost-effectively managing the scalability issues serialization management creates for companies.
  • 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 your 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.

TraceLink will continue to draw on our experience in the U.S., the EUChina, and other track and trace markets, partnering with GS1 Brazil to help establish any new regulatory data exchange standards, and help international and domestic companies navigate the new compliance territory throughout the Brazil rollout.

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Brazil at a Glance     

Government agency ANVISA
Regulatory scope Serialization; product tracking; reporting
Product scope All pharmaceuticals, including samples; ANVISA can determine scope of medicines covered
Participants All supply chain members
Next deadline To be determined; in 2017, following ANVISA's completion of final rules
Serial # format Up to 20 digit, manufacturer issued; GS1 (expected)
Reporting flow Supply chain stakeholders to a central system accessed by ANVISA