EDQM Launches Harmonized Serialization Program eTACT to Strengthen Europe’s Anticounterfeiting Efforts

On January 26th and 27th, the European Directorate for the Quality of Medicines & Healthcare (EDQM) officially launched its “eTACT” anti-counterfeiting IT-based traceability service with a workshop and live demonstration at its Strasbourg, France headquarters.

The workshop, intended both as the formal launch of eTACT and a forum for discussion on its potential problem areas and refinements, included eighty-five participants from 22 countries. Presenters and attendees from the European business, regulatory, and patient advocacy communities discussed the challenges posed by counterfeit medicines and the utility of eTACT as a new tool in that fight.

An estimated 10.5 billion euros of illegal pharmaceuticals are sold in Europe each year, and the number of articles seized at EU borders has risen dramatically in the past decade. In addition, a Pfizer survey of 14,000 Europeans in 2010 revealed that while one in five surveyed admitted to having purchased pharmaceuticals through illicit sources, over two-thirds maintained that their purchasing decision would be impacted if they thought the medicines could be fake.

While some EU countries – including Belgium, Greece and Italy – have begun to put national medicine-tracking systems into place, to date these systems have not been interoperable, nor have they covered Internet transactions.

To this end, the eTACT initiative represents the first major attempt by European regulators to create the mechanics of an internationally harmonized serialization system covering both Internet and in-person purchases, making it a potentially significant new weapon against the mounting counterfeiting crisis (IPQ “The News in Depth” Dec. 1, 2011)

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