On July 7, Brazil’s national health regulatory agency, ANVISA, assigned priority status to the development and implementation of the country’s National Drug Control System (SNCM), delivering a clear message to pharmaceutical companies that they will be expected to keep pace with the agency’s aggressive series of milestones beginning in December 2020.
As ANVISA finalizes its Normative Instructions and Technical Guidelines for meeting Brazil’s product serialization and track-and-trace regulations, integration with the agency’s reporting system, SNCM, will be a critical focus for both domestic and multinational manufacturers in the weeks and months ahead. In addition to “vertical integration” with SNCM, each company must also implement “horizontal” peer-level data exchange to ensure that their supply chain partners have accurate product and aggregation data for SNCM reporting.
With the first deadline less than 6 months away, you need to start now.
With unmatched regulatory expertise, proven serialization solutions, and local “on-the-ground” resources, TraceLink is already helping companies prepare to meet Brazil’s complex government and business requirements.
Register for the on-demand version of Brazil Readiness: ANVISA's Normative Instructions and Preparing for December Deadlines to hear the latest insights into ANVISA’s guidelines, including meetings with industry stakeholders and discussions at ANVISA public meetings. You’ll also learn about the challenges of horizontal supply chain integration and hear considerations for multinational companies and their local affiliates. Don’t miss this opportunity to get expert guidance on ANVISA’s directives and to begin finalizing your Brazil readiness plan.