According to Phil Taylor, writing for SecuringPharma, Brazil’s 191 million inhabitants represent the biggest pharmaceutical market in South America, valued at around $17bn in 2008. He notes it is the tenth largest drug market in the world. Soon, the country plans to implement a drug serialization mandate that will affect you if your company sells pharmaceuticals in Brazil.
Specifically, Mr. Taylor writes: Last year, the national regulatory agency – ANVISA - implemented a series of healthcare reforms to shore up patient safety as well as to encourage domestic production of pharmaceuticals… In November 2009, additional details on the proposed tracking system were disclosed. It will cover the whole pharmaceutical supply chain from producer to end-user, with each transaction in the chain recorded, i.e. manufacturing, importation, distribution, transportation, storing and dispensing of medicine… The latest communications from ANVISA also indicate that the serialisation codes will be compliant with the standards set out by the GS1 organisation…
There are several kinks in the system yet, which are covered extensively in the SecuringPharma report. But this much seems quite clear: anyone wishing to market pharmaceuticals in the world’s 10th largest market after 2011 had better get on board with GS1 and GS1-compliant labeling quick. Did I mention, this happens to be our specialty?
GHS and Regulatory Labeling Challenges in the New Era 
