In Brazil, Law No. 13.410 of 28 December 2016, together with RDC 157 (Resolução da Diretoria Colegiada, Resolution of the Board of Directors No. 157), gives the pharmaceutical industry until April 2022 to implement traceability in its chain of prescribed drugs. This system must be connected to the central database called the Sistema Nacional de Controle de Medicamentos (National Drug Control System, SNCM), created by the Agência Nacional de Vigilância Sanitária (Brazilian Health Regulatory Agency, ANVISA), in order to deliver better quality and safety to the final consumer.
The implementation of traceability occurs through the serialization and aggregation of the products. This means that drugs will receive a unique identification printed on the packaging, known as the “Identificador Único de Medicamentos” (“Unique Drugs Identifier”, IUM). The IUM is made up of:
- 2D Data Matrix encoded with Global Trade Item Number, GTIN
- ANVISA’s drugs registration code
- Serial number
- Expiry date
- Batch ID