Brazil
| Regulatory Agency | Agência Nacional de Vigilância Sanitária (ANVISA) |
| Regulation Name |
|
| Compliance Dates | April 28, 2022 – Manufacturers and importers required to serialize and report medicine data to SNCM. Phased implementation originally planned earlier; current framework mandates serialization and event reporting for applicable medicines. |
| Applies to | All prescription medicines and regulated pharmaceutical products intended for commercial distribution in Brazil. Applies to manufacturers, importers, distributors, and dispensers (pharmacies). |
| Barcode Symbology | GS1 2D DataMatrix |
| Barcode Content |
|
| Serial Number Randomization | Yes – unique, randomized serial per unit |
| Serial Number Reuse | Not permitted. |
| Human Readable Expiry Date Format | Printed in standard Brazilian labeling format (typically MM/YYYY or DD/MM/YYYY as applicable) |
| Barcode Data Encoding | GS1 Application Identifiers (01, 17, 10, 21) |
| Product Code Notes | GTIN required; must align with GS1 Brazil registration and ANVISA product registration. |
| Free Samples must be marked? | Yes – must comply with SNCM serialization if entering the supply chain |
| Barcode Symbology | GS1-128 (SSCC – AI 00) |
| Barcode Contents | SSCC and aggregation hierarchy |
| Parent-Child Mapping Aggregation Capture? | Yes – linking units to cases/pallets must be reported |
| Send Unit Data to Government Repository? | Yes – manufacturers/importers must report serialized unit data to SNCM |
| Send Unit Data to Third-Party Repository? | Optional (internal systems), not regulator-mandated |
| Send Unit Data to Trading Partner? | Commercially expected (EPCIS-based exchange possible) |
| Send Aggregation Data to Government Repository? | Yes |
| Send Aggregation Data to Third-Party Repository? | Optional |
| Send Aggregation Data to Trading Partner? | Commercially expected |
| Who Offers Data Repository for Authentication? | SNCM – managed by ANVISA |
| Manufacturers Must Register Shipments in Repository? | Yes – commissioning and movement events must be reported |
| Downstream Trading Partners Must Authenticate on Receipt? | Yes |
| Downstream Trading Partners Must Authenticate on Shipment? | Yes |
| Manufacturer Activity Reported? | Yes |
| Downstream Trading Partner Activity Reported? | Yes |
Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.
For Further Information, please contact our Compliance Team at info@kevision.in
