Brazil

Overview

Brazil continues to define its pharmaceutical serialization and traceability regulations. RDC 157 provides guidance for the implementation of SNCM (National Medicine Control System) and the mechanism and procedures for drug tracking. The country and pharma stakeholders who manufacture or import are in the process of implementing the law through a series of phases with the next big milestone which requires full traceability is not that far. 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. 

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Key Challenges

  • 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 4 walls of an organization

Solutions

Movilitas has the expertise to make compliance simple and efficient for the life science supply chain. Our Track & Trace suite of solutions and consulting services helps customers to reduce the risks of supply chain disruptions, while ensuring compliance with global serialization regulations and unlocking data to realize greater efficiencies and a new level of consumer experience. 

Track and Trace

Bring transparency to your supply chain. Track & Trace provides real-time insights into the global value chain, with harmonized information from raw material to end-of-life.

Movilitas.Cloud

The cloud solution that makes compliance simple. Movilitas.Cloud revolutionizes the way products are serialized and verified.

Warehouse Logistics

Integrated intelligence for the smart warehouse. Leading warehouses use technology to efficiently allocate people and resources while moving shipments through the supply chain.

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