If you are in the pharmaceutical industry and export to Brazil, you may have heard about drug traceability. After many years of debate and uncertainty about the deadline, we now see April 28, 2022, as the date Brazil’s National Drug Control System (SNCM) will come into effect. But how will track-and-trace work in Brazil? Below we seek to explain the requirements, process and parties involved.
HOW SHOULD DRUG SERIALIZATION AND AGGREGATION TAKE PLACE IN BRAZIL?
To market prescribed drugs in Brazil, pharmaceutical companies will need to implement track-and-trace systems, meaning they will need to serialize and aggregate products. In Brazil, this process involves providing one’s smallest saleable unit (i.e., a carton) with a unique identifier composed of the following information:
- Anvisa drug registration number
- Serial code of up to 20 digits
- Expiration date
- Production batch number
This information must be presented in human-readable format, as well in a 2D Data Matrix code.