General Overview
Brazil represents one of the world’s largest pharmaceutical markets, with end-to-end traceability regulations that affect manufacturers, importers, distributors, and dispensers. Complying with Brazil serialization / traceability regulations means meeting a complex set of business rule and data management requirements which will be highly connected to your supply network operations.
Brazilian Health Regulatory Agency (ANVISA) is responsible for the approval and supervision of 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.
Pharmaceutical companies has been aware of Brazil’s ANVISA requirements since December 2016, following the enactment of Law No. 13.410/2016. This law established serialization requirements and timelines for the country’s pharmaceutical supply chain through the National Drug Control System (SNCM) – “Sistema Nacional de Controle de Medicamentos”. The SNCM is a centralized government database that follows the flow of pharmaceutical items from the point of manufacture to the point of consumption, including the stages of manufacture, import, distribution, transport, storage, and dispensation.
From April 28, 2022, pharmaceutical companies have to complied with the serialization, reporting, and traceability requirements set out in the National Medicine Control System (SNCM), as the Brazil Health Regulatory Agency (ANVISA) had 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
- Batch number/ LOT
- Expiry date
Brazil law requires companies to apply a unique identifier (IUM) to each commercial unit of medication (serialization) and a serial shipping container code (SSCC) to packages that contain multiple individual serialized units (aggregation).
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.
For serialization plans in the SNCM portal, manufacturers and importers must provide information about their relevant product lines and medicines.