With the approval of RDC 319/2019 by ANVISA in early November and the subsequent posting of Public Consultation No. 747, a renewed sense of urgency is being felt across the Brazilian pharmaceutical supply chain. With the 2022 deadline firmly established, the Public Consultation includes a new Normative Instruction for the final rollout of Brazil’s track and trace system over the next two years. And while the government reporting system, SNCM, is still being built out and final technical guidelines are still being revised, companies may be required to begin reporting serialized product transactions to SNCM as early as October 2020.
What you need to know: Milestones and industry input
Key aspects of the revised RDC and Normative Instruction include:
- ANVISA has clearly stated that SNCM will be implemented in the timeframe established by the law. The final 2022 deadline can only be changed by a new or revised law.
- The revised Normative Instruction documents a set of proposed milestones for serialization and reporting and is subject to a 45-day period of industry review which began on 19 November. This review is open to all companies who manufacture, distribute, or dispense medicines in Brazil. ANVISA is expected to finalize its deployment guidelines in January 2020.
- Under the proposed milestones, manufacturers are expected to be serializing and reporting on at least 25% of their commercial production by October 2020; 50% by April 2021; and 75% by September 2021—with full compliance expected by April 2022.
- Distributors and dispensers are expected to be able to report on product receipts and shipments as soon as they begin to accept serialized medicines—which could be as soon as October 2020.
- ANVISA reinforced that manufacturers should have made progress in their serialization planning and implementation because the fundamental requirements for serialized product identification and packaging data were established in 2017.
The operational impact of serialization in Brazil
As seen in other countries with track and trace regulations, the management and distribution of serialized product introduces new technical and business requirements that fundamentally change the supply chain at every level. In Brazil, serialized operations and product aggregation will require precise communication and orchestration across the network of trading partners and that extends beyond government reporting requirements. Brazil technical guidelines specify that manufacturers, wholesalers, and distributors publish reports directly to SNCM, but makes no provision for peer-to-peer data exchange between partners.
To minimize the impact of serialization on operational efficiency, increase the accuracy of event reporting, and take advantage of the potential of aggregation to streamline operations, the industry itself must design and implement a separate solution to share upstream and downstream transaction data—through horizontal integration—independent of the government system.
Brazil serialization and event reporting: What you need to do
If you haven’t already started to think about the impact of serialization and compliance on your operations in Brazil, ANVISA is sending a clear message to companies to begin their planning now. In order to get started, you must:
- Understand your role and reporting responsibilities under the regulations.
- Understand ANVISA serialization, aggregation, and event reporting requirements and how they will impact your manufacturing and packaging lines, business and IT systems, and trade partner network, including logistics providers, wholesalers, and dispensers.
- Understand why “horizontal integration” with trading partners is critical for operational efficiency across your supply chain and the accurate exchange of transaction data to avoid reporting discrepancies and potential audits.
Brazil track and trace and serialization will require a significant amount of planning and resources, and companies doing business in Brazil can’t afford to wait. TraceLink’s extensive global serialization and compliance experience, along with its verified network of 280,000 trading partners, gives companies who manufacture, distribute, or dispense medications in Brazil a critical head start in achieving ANVISA milestones—and a distinct advantage over the competition. Contact TraceLink to learn more.