Regulatory Focus™ > News Articles > Anvisa Approves Track and Trace System

Anvisa Approves Track and Trace System

Posted 11 December 2013 | By Louise Zornoza 

The board of Brazil's National Health Surveillance Agency, Anvisa, has approved a system that will be used to track drugs from manufacture to the time of sale.

Within three years, drug packaging will have a two-dimensional code, and the industry will need to have in place an electronic system to monitor each step of the package, from the factory to the pharmacy. In the case of prescription drugs, the monitoring will go further, with the ability to know who purchased a particular drug, explains Anvisa Director Dirceu Barbano.

The agency established an intermediate period of two years from the time of approval of the system to allow every drug company to submit a comprehensive report of traceability of at least three product lots that they have manufactured.

"The report will serve to demonstrate that the company has the system in place, and that it's working. And the company would have an additional year to buy more equipment," Barbano said.

Another rule, yet to be issued, will define the process for communicating tracking information to Anvisa. The tracking data, says Barbano, should be created by the industry, possibly in partnership with pharmacies and distributors.

Nelson Mussolini, chief executive of Sindusfarma (Association of the Pharmaceutical Industry in the State of São Paulo), says the move brings certainty to the industry and the consumer. Mussolini said he believes it is possible to meet the deadline established by Anvisa, although there is some concern amongst manufacturers about the cost of the change and the availability of equipment necessary to establish traceability. There is no mention of passing costs to consumers, he said, since drug prices are controlled by the government.

The call for traceability was established by law in Brazil in 2009. In 2011, the agency gave up a proposal for traceability which involved the use of a stamp of the Mint, as it would have made products more expensive.

 

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