Brazil Regulatory Compliance

General Overview

Brazilian Health Regulatory Agency (ANVISA)  is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others. The agency is connected to the Ministry of Health. The ANVISA`s mission is to promote and protect public health, as well as to intervene in the risks caused by the production and use of products regulated by health surveillance.


The Pharmaceuticals has been aware of the Brazil ANVISA requirements since December 2016. That`s when the National Medicine Control System (SNCM) was signed into law (Law No. 13.410/2016), establishing serialization requirements and timelines for Brazil’s pharmaceutical supply chain.


28th April 2022 is the official deadline for meeting Track & Trace requirements as the Brazil Health Regulatory Agency (ANVISA) has approved its final Normative Instruction (NI 100).

Barcode Requirements

  Global Trade Item Number (GTIN)

  13-digit ANVISA Medicine Registry Number

  Unique 13-digit Serial number

  Expiry date

  Batch/ Lot number

Key requirements

1. All prescription medicines must be serialized – all products must have a GS1 2D Data Matrix barcode.

2. All manufacturers and importers must have a “serialization plan” in the portal of the National Medicine Control System (SNCM)

3. All supply chain stakeholders must submit product event reports to the SNCM

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