Regulatory & Safety

Brazil gives drugmakers 3 years to set up 2D track and trace system

17-Dec-2013 - By Gareth MacDonald+
Brazil gives drugmakers 3 years to set up 2D track and trace system
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Firms selling drugs in Brazil have three years to implement track and trace systems capable of monitoring drugs from the factory floor to the pharmacy under a new plan approved by Anvisa.

Brazil’s National Health Surveillance Agency, Anvisa, approved the new rules last week (available here in Portuguese) explaining that, within 36-months, all drugs must have a 2D barcode with a unique medicines identifier (UMI) number that can be used to track them through supply chains.

Anvisa said: “Companies holding registration with Anvisa will be responsible for producing, generating and affixing Identifier Single Medicines (UMI) to the packaging of all medicinal products marketed and distributed in the country.”

The UMI has to be a 13-digit sequence of numbers and letters that allows the unique and unambiguous identification of each specific drug unit sold according to Anvisa.

For prescription pharmaceutical products the new measures go further. Anvisa chief Dirceu Barbano said that: “In the case of prescription drugs, the system will provide information from the producer to the buyer."

Under the new requirements, manufacturers will need to submit a traceability report for at least three batches of each product within two years.

The report will serve to be clear that the company has already created the system and have it running on. And the company would have an extra year to buy more equipment," Barbano said.

He also suggested that: “The packaging with monitoring data should be created by the industry, possibly in partnership with pharmacies and distributors.”

Mussolini Nelson, chief executive of Sindusfarma (Association of the Pharmaceutical Industry in the State of São Paulo), said the move brings certainty to the industry and the consumer adding that he believes the drug industry can meet the three year deadline.

Like their US counterparts who recently passed legislation, regulators and politicians in Brazil have debated pharmaceutical track and trace for many years. The new rules are based on proposals Anvisa issued in 2011.

Related topics: Regulatory & Safety, Packaging machinery & supplies, QA/QC