December 18 Update: ANVISA continues to modify its Normative Instruction and certain requirements, deadlines, and terminology may have changed since this article was originally published. Updated information will be published as soon as it becomes available.
The first Brazil deadline is approaching fast: Marketing Authorization Holders (MAHs) and importers will need to be sending serialized product and transaction data to the Brazil reporting system (SNCM) or have an implementation plan registered with the government regulatory agency, ANVISA, by December 1, 2020.
In either case, you need to be finalizing your Brazil serialization implementation plans immediately. For companies that have fallen behind in their planning or who have not chosen a solution provider yet, it’s critical to choose a compliance partner who:
- Fully understands Brazil compliance and business requirements, including horizontal integration
- Has proven experience in delivering solutions for complex regulatory markets
- Offers both local and global serialization and track-and-trace compliance support
During TraceLink’s recent webinar, Brazil Readiness: ANVISA's Normative Instructions and Preparing for December Deadlines, polling questions revealed that many companies were accelerating their preparations, but indicated a need for expert guidance and proven solution expertise to stay on track for December:
More than half do not have a strong understanding of the requirements
Since the law mandating market-wide product traceability was enacted in 2016, the Brazil regulatory agency, ANVISA, has focused on a series of draft proposals followed by periods of public commentary, and has only recently begun to issue definitive instructions and technical guidelines. Staying up to date on Brazil requirements will continue to be a challenge for companies that do not have a reliable source of expert insight into the latest developments as well as reliable forecasts of anticipated actions.
As the trusted compliance partner of more than 850 pharmaceutical manufacturers, CMOs, and CPOs in more than 50 countries, TraceLink offers unmatched expertise in the world’s largest—and most complex—regulated markets, including Brazil. Since 2016, TraceLink’s Brazil team has worked closely with the country’s regulatory agencies and industry associations such as Sinduspharma and GAESI to help TraceLink’s multinational and domestic customers understand and prepare for Brazil’s evolving track-and-trace requirements and technical requirements.
TraceLink is the only solution provider that brings together customers, operational leaders, regulatory experts, and technical innovators twice every month to review the latest serialization, serialized operations, and reporting requirements for Brazil compliance. TraceLink’s Brazil Cloud Community promotes standards-based data exchange and technologies to ensure system-wide interoperability, with increasing focus on the use cases and operational choreographies companies need to implement a successful track-and-trace solution in Brazil.
More than 80% feel Brazil requirements are more or equally challenging as those mandated in other markets
While the majority of companies that attended the webinar had experience in serializing products for other global markets, the Brazil requirements present unique challenges and potential pitfalls that need to be considered in their serialization planning, including:
- Brazil’s implementation guidelines continue to raise questions about exactly when and how companies must begin reporting product transactions to the government system.
- The role of the country’s tax identification system (CNPJ) in triggering a reporting requirement is also just beginning to be understood.
- Brazil regulations require that each partner in the supply chain—manufacturer, distributor, and dispense—reports product movements to the SNCM. However, the reporting timeframes differ for each partner category, making horizontal data exchange essential to avoid reporting errors.
TraceLink’s experience in developing track-and-trace solutions for markets like Russia and China—where reporting requirements may involve multiple agencies or complex public/private partnerships—gives our customers a powerful advantage when it comes to entering a new market like Brazil. TraceLink’s Cloud Community and country-specific special interest groups look beyond the regulations to fully understand the technical and business requirements that are required to comply with the regulations and to sustain successful business relationships with supply chain trading partners.
Two-thirds are planning to coordinate their Brazil plan with local affiliates or partners
The breadth of Brazil’s pharmaceutical supply chain, the complexity of the regulations, and the accelerated timetable for implementation make local coordination a priority for the majority of companies. For multinational companies, however, Brazil is also an important addition to their global compliance operations, and serialized product data can provide valuable insight into global product movement and availability. TraceLink offers the best of both worlds: a local partner with a global serialization experience.
TraceLink’s Brazil team in Sao Paulo offers expert guidance to the Brazil regulations as well as “unwritten” requirements such as horizontal data exchange between upstream and downstream partners. Horizontal integration will be a critical factor in meeting partner and customer business requirements—including product aggregation—and to ensure that partners have the accurate data they need for government reporting. TraceLink’s worldwide digital supply network simplifies and expedites trade partner onboarding and data exchange by allowing partners to Integrate Once, Interoperate with Everyone™ across Brazil—and around the world.
TraceLink: Proven solutions, local expertise, and a global compliance perspective
With only a few weeks before the December 1 deadline, your preparations for managing serialized products across your Brazil importation and distribution operations should already be underway. Any further delay puts your Brazil product strategy—and your patients’ safety—at risk.
With so little time left, TraceLink’s local Brazil team and proven serialization solutions can help you meet the December 1, 2020 implementation requirements. With nearly 50 contributing companies and organizations, TraceLink’s fast-growing Brazil Cloud Community can help you stay ahead of the country’s evolving regulatory landscape, including the latest normative instructions and technical guidelines from ANVISA, and ahead of the competition.