Understanding and Preparing for Brazil Serialization

(An Official publication of PharmaSecure)

Brazil is one of the largest pharmaceutical markets in the world. Track and Trace solutions act as an important step in fighting against counterfeit drugs, increasing the transparency of the entire drug supply chain, all the way from the manufacturers to the pharmacies.

The Brazilian pharmaceutical industry is regulated by a government agency called ANVISA. ANVISA (in 2009) had established a dedicated division named SNCM, whose primary responsibility was to develop and manage technical solutions for drug traceability. In-Law RDC 157/2017, drafted in 2017, ANVISA defined that they will be going live in April 2022.

At the technical level, Track & Trace architecture in Brazil is complex. Which We can distinguish as vertical and horizontal, which increases the complexity of the project. As shown in the image below.

The interactions with ANVISA/SNCM is called vertical communications. All stakeholders in the market need to communicate the serial number status of the supply chain.

An example for such interactions may be an activation message from the MAH that refers to which products are to be commercialized on the market, indicating the movement from point A to point B, etc.

Horizontal communication is not regulated. This means that stakeholders do not need to exchange messages with partners, they only exchange messages with ANVISA. The issue here becomes even more important, as the logistics effort will be high if the partner has no communication. For example, if you need to read all serial numbers for ingress and you already have all datastores in your system, you only need to read the top-level aggregation. With the help of GS1 Brazil and a few key figures, the market was able to define standards using the ANVISA format and SOAP technology.

Finally, in addressing the requirements to fully understand the Brazilian market, we identified three main scenarios, each with its unique message and tailored solution. Scenario:

• Local Production Scenario – CMO and MAH are in Brazil
• Importation Scenario – CMO is located out of Brazil and MAH in Brazil
• Wholesaler Scenario – solution for horizontal communication
  • The 3PL can receive and send expeditions messages from/to the market partners
  • Send expeditions, receipt, and completion messages to ANVISA