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:

  • GTIN
  • 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.

Aggregation_Pharma_Blister

Once cartons receive this label, products must be aggregated, which entails linking one or more of these labels to a shipping box. See illustration on the left. This information must then be sent to the Anvisa National Drug Control System. Note that in Brazil, the deadline for both serialization and aggregation is April 28, 2022.

The main objective of this new system is to ensure full access to information about each drug and its movement along the supply chain, from the drug’s origin, manufacturing, storage, transport, all the way to its dispensing. This will allow stakeholders to verify product authenticity, batch information, expiry date and more. Understand how each stakeholder is involved in this process below.

ISC_Pharma_ANVISA

1.MANUFACTURER

The registration holder, also referred to as the manufacturer, is responsible for registering the drug through serialization. The data is sent to Anvisa’s National Drug Control System (SNCM) for activation by the registration holder. No prescribed drug will be able to be moved in the Brazilian market without prior activation. Then, the manufacturer must also communicate to Anvisa when it sends the product to its next supply chain stakeholder.

2. DISTRIBUTOR

The distributor is responsible for the drug’s storage. Once the drugs are in the distributors’ possession, this must be communicated to the SNCM. What is done next with the drugs must also be communicated to Anvisa, such as when a drug is sent to the next link, has disappeared or been stolen, has been confiscated, etc.

3.DISPENSERS

Dispensers, such as pharmacies and hospitals, are responsible for providing medicines to consumers or patients. They also communicate with the SNCM when receiving the products and when dispensing them to the final consumer.

FINAL CONSUMER

When patients and consumers receive drugs, they will be able to see information about the product and authenticate it through mobile applications. The information on the label will certify the origin and authenticity of the drug.

NEXT STEPS TO COMPLY WITH TRACK-AND-TRACE REGULATIONS

Whichever link in the chain you belong to, OPTEL has the ideal solution to comply with Brazil’s traceability regulation. If you would like to learn more about the most recent directives, please refer to our article: Brazil’s New Drug Traceability Regulation. Make sure you also reach out to our experts to guarantee you are on the right track to meet next year’s deadline.

 

 

Contact Us

Traceability Solutions