Brazil’s Regulatory Challenges: What They Are & 5 Ways TraceLink Can Help

What are the Brazil regulatory challenges?

Brazil has passed the most complex Track and Trace requirements in the world. RDC 54 requires serialization of drug product at the unique item level and transport container or case level, as well as aggregation relationships between case and unit. It also mandates that the serial number be globally unique to the legal entity, not just to the specific product.

The most challenging stipulation, though, is that the product manufacturer must capture an extensive set of product movements and events from companies across the supply chain, including both direct and indirect partners. For example, when a pharmacy buys product from a wholesaler or a wholesaler transfers product from one warehouse to another, these events must be captured by the manufacturer even if they do not have a direct business relationship. Thus, Brazil’s regulations present a true network challenge.

Manufacturers are responsible for reporting all movements and events to ANVISA and making their compliance system accessible for ANVISA queries.

The timeline is tight: The Phase 1 deadline for 3 batches of product is December 2015, and the full implementation for all pharmaceuticals is December 2016.

How can TraceLink help?

In anticipation of the complexity of RDC 54, TraceLink began working early in 2013 with companies and organizations from across Brazil. Here are five ways that we are uniquely positioned to help:

#1 –TraceLink has the world’s largest pharmaceutical track and trace network

Brazil regulations present a network challenge, and the TraceLink Life Sciences Cloud offers a network solution with a directory that can help supply chain companies connect. If a dispenser has received your product and needs to report events back to you, they can easily find you through our network directory. And then they can use a variety of data exchange mechanisms to get you the compliance information that you are required to have in whatever data format you need to receive it.

#2 – We are leading supply chain coordination and education

TraceLink is organizing a community of wholesale distributors and pharmacies who are already working towards the Phase 1 deadline with the 8 pharma companies who have selected us for Brazil compliance. If some of these companies who are already on the TraceLink network are also your trading partners, that will reduce your time, cost, and risk in meeting the December deadline. We are also educating trading partners on both their requirements under the law and how they need to work with manufacturers.

#3 – We provide the complete serialization, product tracking, and government reporting solution

TraceLink’s RDC 54 solutions, based on our global platform serving 16 of the top-20 global pharmaceutical companies, meet all of your compliance needs: our serialization modules generate and allocate serial numbers in Brazil-required formats out to line management systems while performing all internal serialized product tracking with warehouse and 3PLs; Product Track Brazil tracks events through the supply chain and delivers them back to the manufacturer; and our Brazil Reporting module will deliver the required information to ANVISA.

#4 – We minimize risk due to the lack of a commonly adopted traceability standard

Even though no formal standard exists for the exchange of required event data between supply chain partners and the manufacturer, TraceLink ensures you capture the events you need. Our unique supply partner enabling solution allows wholesale distributors and pharmacies to capture and publish required events back to the manufacturer.

#5 – We partner with a local Life Sciences expert

TraceLink partners with SPI, a Brazilian company with 20 years of experience in life sciences, IT services, and the automation space. We selected SPI because of this experience, and for the in‑country support they can provide. We recognize the need for our customers to be able to pick up the phone and talk to a local representative in their own language.