Brazil Pharmaceutical Traceability Requirements

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Global Regulations

This country has no regulations specific to track and trace of pharmaceuticals within their geographic boundaries. However, manufacturers and distributors in that geography still must meet the regulatory requirements of the countries that their products are delivered to.

Summary

Brazil previously planned to implement a national pharmaceutical serialization system known as the National Drug Control System (SNCM) under the authority of the Brazilian Health Regulatory Agency (ANVISA). The program aimed to establish full traceability of medicines across the supply chain using serialization and electronic reporting.

However, the national serialization mandate was revoked before full nationwide implementation. The Brazilian government formally withdrew the SNCM traceability mandate, and there is currently no active national requirement for pharmaceutical serialization or serial level reporting in Brazil.

Pharmaceutical traceability in Brazil therefore operates primarily through batch level identification, supply chain documentation, and regulatory oversight managed by ANVISA.

Labelling Requirements 

Brazil does not currently require serialized DataMatrix barcodes for pharmaceutical products.

Medicines marketed in Brazil must include standard identification information on the packaging, including:

  • Product name and strength
  • Batch or Lot Number
  • Expiry Date
  • Manufacturer or marketing authorization holder information

Barcodes may be used for internal supply chain or commercial purposes, typically encoding a GTIN, but serialization of individual packs is not mandated.

Human readable packaging information must match the information encoded in any barcode used.

Regulatory Timeline 

2009 – Brazilian government introduces legislation aimed at strengthening pharmaceutical supply chain security.

2013 – Law No. 11.903 establishes the National Drug Control System (SNCM) with the goal of implementing serialization and traceability.

2016 – ANVISA publishes regulations defining serialization and reporting requirements for the SNCM system.

2018 to 2021 – Pilot implementations and industry preparations take place.

2022 – The Brazilian government withdraws the national serialization mandate, effectively suspending the SNCM implementation.

There is currently no mandatory national serialization program in force.

Reporting Requirements 

Operation
Data to Report
When to Report
Product Registration
Product information submitted to ANVISA
Before market authorization
Batch Identification
Batch or lot number and expiry date
During manufacturing and packaging
Import Documentation
Product identification and batch information
During importation
Distribution Records
Batch level shipment and distribution records
During supply chain transfers
Recall Reporting
Batch identification and distribution records
During product recalls or investigations

Traceability is maintained at the batch level rather than individual pack serialization.

Operational Timelines for Industry 

  • Register pharmaceutical products with ANVISA before placing medicines on the Brazilian market.
  • Ensure packaging includes required product identification, batch numbers, and expiry information.
  • Maintain batch level traceability records for manufacturing, importation, and distribution.
  • Ensure distributors maintain shipment documentation that supports product traceability.
  • Maintain recall readiness by ensuring batch distribution records are complete and accessible.
  • Provide traceability records to ANVISA during regulatory inspections or product safety investigations.

Reporting Hub

Brazil does not operate a national pharmaceutical serialization repository or centralized track and trace reporting system.

The previously proposed SNCM platform is no longer implemented, and supply chain participants are not required to report serialization events to a national hub.

Regulatory oversight is maintained through:

  • Manufacturing and distribution records
  • Import documentation
  • Batch level traceability records
  • Product recall reporting procedures

ANVISA relies on these records during inspections and investigations.

Aggregation Requirements 

There is no national regulatory requirement for aggregation or packaging hierarchy reporting in Brazil.

Manufacturers and distributors may use logistics identifiers such as SSCC for internal warehouse and transportation operations.

Aggregation structures may be implemented voluntarily for operational efficiency but are not mandated by regulation.

Common Errors to Avoid 

  • Assuming Brazil currently requires pharmaceutical serialization or serial level traceability reporting.
  • Printing serialized DataMatrix barcodes for regulatory compliance purposes when not required.
  • Failure to maintain accurate batch level traceability records.
  • Incomplete distribution records that prevent effective product recalls.
  • Mismatch between packaging batch information and manufacturing records.

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