New law replaces previous regulations, with final decisions still to be made.
Based on extensive industry stakeholder feedback, Brazil's original regulations were amended. A long-debated regulatory bill, PL 4069, was used as the basis for a new law, No. 13.410, officially signed and published on December 28, 2016. This new mandate sets the wheels in motion for a multi-stage implementation.
Before implementation begins, ANVISA will finalize the law's rules, which were discussed and debated throughout 2016. Then the following schedule begins:
- 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.
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.
In-country experience and continued commitment.
TraceLink became deeply involved in the Brazil market in 2013, working closely with associations like Interfarma and Sindusfarma to prepare for the nation’s complex regulations. Since then, we have continued to 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 creates.
- 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.
- TraceLink will continue to partner 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.