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). The date is set and all pharma supply chain participants have just 6 months from now to be fully prepared.
The Brazil ANVISA has three key requirements towards pharma manufacturers, distributors and dispensers:
- All prescription medicines must be serialized – all products must have a GS1 2D Data Matrix barcode. The barcode must consist of 4 elements: GTIN, a 13-digit ANVISA Medicine Registry Number, a unique 13-digit serial number, an expiration date* and lot/batch number**
- All manufacturers and importers must have a “serialization plan” in the portal of the National Medicine Control System (SNCM) – the participants must provide information about their production lines and medicines. Specifically, the manufacturers must submit all steps/ actions that they will take to become compliant by April 2022
- All supply chain stakeholders must submit product event reports to the SNCM
*in human-readable form – MM/YY format
**up to 20 alphanumeric characters, assigned by the manufacturer
Unique Medicine Identifier (Identificador Único de Medicamentos) – IUM must be printed on every product. It includes the ANVISA Medicine Registry Number, serial number, expiration date, and lot/batch number.
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.