IS DRUG TRACEABILITY MANDATORY IN BRAZIL?
Drug traceability is not yet mandatory in Brazil, but regulations are in place that require pharmaceutical companies to deploy the technology for a group of drugs by April 2022. This will be done through a new platform that Anvisa has created, named the National Drug Control System (Sistema Nacional de Controle de Medicamentos, SNCM).
LAW ON TRACEABILITY
The law that makes drug traceability mandatory in Brazil is Law 13.140 of December 2016. In addition to this law on traceability, there is also RDC 319/19 and IN100/21, which make up the directives on the implementation of traceability.