Brazil Publishes Its Serialization Plan
In September, Peter Schmitt, founder of Montesino Associates, provided an update on Brazil's law in the live Webcast, "Update: Brazil Law 11.903—An "Emerging" Regulation for Traceability & Serialization." Schmitt has continued to follow the evolution of the law, and he has translated the most recent ANVISA notice to educate the industry. continued Sachet Line Provides a Strategic Solution Almac Pharma Services has been processing and packaging up to 20 million sachets per year of a laxative product sold in Ireland and the United Kingdom. When the product license holder wanted to increase output to more than one hundred million sachets per year to expand throughout Europe, the global contract services company decided an expansion was in order. "Demand for our client's product was outstripping what we could supply," says David Downey, vice president of commercial operations, Almac Pharma Services. "We had to work as quickly as we could to build and validate a new facility with the required equipment to meet forecasted demand increases." MediSeal provided a sachet filler and a cartoning system that work together to support production of several million sachets per year. (MediSeal will be exhibiting at Pharmapack under Korber Medipak at Stand 352.) continued Don't Miss the Deadline for the Pharmapack 2011 Awards Pharmapack and BIOMEDevice will be held February 23–24, 2011, in La Grande Halle de la Villette, Paris, France. Now together as an annual co-located event, Pharmapack focuses on pharmaceutical packaging and drug-delivery innovations, while BIOMEDevice narrows in on the development of combination products. The events complement each other nicely, given the convergence of medical device, biopharmaceutical, and pharmaceutical technologies for delivering next-generation drug-delivery systems. Two full days of concurrent conference tracks will offer attendees a plethora of educational opportunities. Conference details are just now taking shape, so attendees can expect to hear the latest developments in packaging technology for drugs and health products, while BIOMEDevice speakers will explore the engineering and regulations behind emerging combination products as well as enabling technologies. continued |
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Industry has been closely following Brazil's law 11.903 requiring serialization for all pharmaceuticals sold in the country. The law and the original ANVISA guidelines detailed a program of serialized code in 2-D Data Matrix format on a security label printed by the national mint that was to be rolled out in June 2010. Subsequent ANVISA announcements delayed the timeline, but in November, ANVISA indicated that it will require all pharmaceuticals sold in Brazil to comply with its program by January 2012.