South America


Agência Nacional de Vigilância Sanitária (ANVISA)

Brazil continues to define its pharmaceutical serialization and traceability regulations. RDC 157 provides guidance for the implementation of National Medicine Control System (SNCM) and the mechanism and procedures for drug tracking. The country and its pharmaceutical stakeholders who manufacture or import are in the process of implementing the law through a series of phases. The deadline for the  next big milestone, which requires full traceability, is not that far away. The drug value chain encompasses the drug tracking from the activation (at manufacturing or import) of the individual drug until the dispense to the consumer. The scope of SNCM tracking is until the dispensing of the serialized drug, and the consumer or the patient are considered to the post-consumption participants. 

Key Challenges Solved with Movilitas.Cloud

  • Apply unit-level serialization with a GS1 2D data matrix barcode containing GTIN, ANVISA medicine registry number, unique serial number, expirations date and lot/batch number
  • Connect with the government repository (SNCM) for reporting of product movement
  • Exchanging serialization data with business partners including CMOs, MAHs, Third-Party Logistics Service providers, and customers
  • Tracking the movement of the product including aggregated units and carrying out business processes efficiently, as the serialized product moves within the four walls of an organization

As Brazil rolls out its requirements, manufacturers will need to find a solution to implement compliance that will not create production delays and can connect with the government repository and that enables data sharing with business partners. Movilitas.Cloud offers a complete solution to meet all these requirements in Brazil with advanced pharmaceutical track and trace capabilities. Movilitas.Cloud provides a serialization repository and management, and facilitates the exchange of serialization data with the extended supply chain network and the SNCM. The solution enables the country-specific regulatory reporting, full transparency between production, government and business partners, and protects the consumer even before pharmaceutical dispensing. 

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