Authority: Brazilian Health Regulatory Authority (ANVISA)

Request Source: Regulation

Data Carrier: –

Detail: Brazilian Health Regulatory Board, ANVISA regulates the practice of pharmaceutical traceability in Brazil. All pharma manufacturers involved in the supply chain must comply with the regulations of the National System for Drug Control (SNCM). ANVISA has adopted GS1 standards in serialization applications. Although the pilot projects for the serialization application have been successfully completed, the implementation date has been determined as 2022, but there is a possibility that it will be postponed to a later date.

• GTIN
• ANVISA Registration No
• Serial Number
• Batch/Lot
• Expiry Date

Update: On May 11, 2022, according to the new regulation approved by the President, there will be no requirement about traceability, also ANVISA will not impose any sanctions on this issue. Information that has to be on the packaging:

• Serial Number
• Batch Number
• Expiry date
• 2D Barcode*

*This code will redirect to a web page with prospectus information.

Links:
https://www.gov.br/anvisa/pt-br/english
https://in.gov.br/en/web/dou/-/lei-n-14.338-de-11-de-maio-de-2022-399315842