Top drugmaker gets ready for Brazil's traceability mandate

A leading pharmaceutical company has started implementing an item-level serialisation project in Brazil, using systems provided by Systech and partner Videojet, in anticipation of the country's forthcoming traceability requirements for medicines.

The unidentified drugmaker is adding serialisation capabilities to all of its Brazilian packaging lines in response to Law 11.903, which was passed in 2009 and requires the "tracking of manufacturing and consumption of medicine by means of data capturing, storing, and electronic transmission technology."

Initial plans to combine 2D datamatrix codes incorporating GS1-compliant serial numbers with a security label supplied by Brazil's mint were dropped in March in the face of staunch resistance from the pharmaceutical industry, and a working group was set up to explore alternatives (see Brazil backs away from security label initiative).

While the working group has yet to deliver a verdict on the revised requirements, the drugmaker has taken the decision to implement a system that can accommodate the original security level proposal in addition to printing of serialised codes directly onto medicine packs, which some observers believe will be the eventual requirement. It can also handle aggregation of serialisation data to establish item, case and pallet relationships.

"With Brazil's legislation still subject to changes, and in light of the diversity in global regulations, the manufacturer realised the strategic importance of implementing a solution with this built-in flexibility," said Systech.