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:
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: 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 Reporting: Every 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.
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:
TraceLink will continue to draw on our experience in the U.S., the EU, China, 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.
|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|