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Regulatory Focus™ > News Articles > Brazil Proposes Electronic Tracking System for Drugs

Brazil Proposes Electronic Tracking System for Drugs

Posted 04 April 2013 | By Louise Zornoza

Brazil's National Health Surveillance Agency (Anvisa) has proposed the formation of an electronic tracking system for drugs that would follow a drug from the point of manufacture to its dispensation to a patient.

The proposal was outlined in a consultation announced by Anvisa on 4 April 2013.

The proposed tracking system is to be based on the two-dimensional barcode, the Datamatrix, which will be included on sales packaging as well as secondary packaging such as pill packs and hospital packs. 

According to the CEO of Anvisa, Dirceu Barbano, "Companies holding registration with Anvisa will be responsible for placing on each package a Unique Drug Identifier (IUM) formed by the drug registration number for the product containing thirteen (13) digits, plus the serial number, expiration date and lot number."

The drug industry would have 180 days to comply with the new requirement and retail sales outlets would have 360 days.  The comment period will be open from 10 April through 9 May 2013.


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Tags: brazil