What is a counterfeiter to do today? Governments around the world are moving toward standardized serialization and track & trace requirements aimed directly at their bottom line. It’s getting harder to fake your way past supply chain workers who are increasingly educated on what to look for and how to raise their suspicions to the authorities. Or is it? Let’s take a closer look.Continue reading Pharma Counterfeiter Strategies In a Track & Trace World
The term “counterfeit” is usually defined as an unauthorized copy of a physical thing. Here is how Dictionary.com defines it:
3. an imitation intended to be passed off fraudulently or deceptively as genuine; forgery.”
Counterfeiters seek to expropriate the good reputation, good will and trust in a recognized brand by deceit to carve out undeserved profit or other gain. Their goal is to Continue reading How RxTrace Became The Target Of A Counterfeiter
The key part of Article 50 of the European Union Delegated Regulation (EUDR) says: “This Regulation…shall apply from 9 February 2019.” That’s the date of the “big bang”—the date everything takes effect. On that date, all drugs entering E.U. markets (except in Italy, Belgium and Greece) must contain the two safety features called out by the regulation on their packaging, including an anti-tamper device and a compliant Unique Identifier (see “The ‘Unique Identifier’ in the EU Delegated Act”). It is the date by which “National Competent Authorities” in each of the EU member states (except the three listed above) must offer a data repository for the covered drug products that are targeted at their local market. And it is the date on which dispensers (called “persons authorised or entitled to supply medicinal products to the public” in the text) must begin using the system of repositories to “…verify the safety features and decommission the unique identifier of any medicinal product bearing the safety features they supply to the public…”. All on the same day. The day of the “big bang”.
This “big bang” start will result in some problems. Continue reading More Concerns With The FMD/EUDR Big Bang Start