Brazil has serialization, track-n-trace, and reporting requirements. It holds the manufacturers responsible for tracking the change of ownership of a drug product as it moves through the supply chain. This aspect of the regulation was well intended but difficult to comply. In order for the manufacturers to own track-n-trace, the technology infrastructure must first be in place to allow the exchange of data from the downstream trading partners. In addition, the trading partners must be willing to share data with the manufacturers. The latter may be more challenging than the former. In the pharmaceutical supply chain, wholesale distributors traditionally don’t share the sales data or don’t share the sales data for free with the manufacturers. Unless this changes, manufacturers will find themselves short of meeting the Brazil requirement.
Despite of the real world challenges, companies marketing and selling to Brazil must have three lots serialized by December 10, 2015. Watch the video to learn the next upcoming deadline, ANVISA’s Medical Registration Number, and other serialization requirements from Brazil.