Regulatory Focus™ > News Articles > ISO Releases New Voluntary Anti-Counterfeiting Standard

ISO Releases New Voluntary Anti-Counterfeiting Standard

Posted 05 September 2012 | By Alexander Gaffney, RAC 

The International Standards Organization (ISO), whose standards are commonly used by the life sciences industry, has released a new standard to allow for uniform authentication standards to combat counterfeit goods, including medicines and medical devices.

The standard, ISO 12931: 2012 -Performance criteria for authentication solutions used to combat counterfeiting of material goods, discusses several "authentication solutions," including holograms, tags, and marks that ISO says will, "Make it easier to provide reliable evidence to identify genuine products throughout the entire material good life cycle."

"By specifying performance requirements for authentication tools, the new standard will harmonize global action and ensure effectiveness," added ISO in a statement. The standard applies to both products and their packaging.

Counterfeiting can be an especially serious problem for pharmaceutical products, whose contents and quality are not easily determined without the use of complex and expensive equipment, and can cause deadly reactions in unsuspecting patients.

"The problem is getting worse as more and more transactions take place online, making it easier for fakes to cut across territorial borders," wrote Jean-Michel Loubry, chair of the committee that developed the standard. "Counterfeiting covers everything, from electronics to pharmaceuticals. Not only does this prevent fair market competition, but it has some truly scary safety implications."

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