The Anti-Falsification Directive: Europe’s Answer to Global Supply Chain Threats
This article was originally published in The Gold Sheet
The European Union July 1 published its directive on falsified medicines, setting into motion a tightening of Europe’s pharmaceutical supply chain that will for the most part take place over the next 18 months – and that could cost pharmaceutical companies billions of Euros.
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The European Commission has set out new packaging rules requiring manufacturers to attach “unique identifiers” to their products to thwart drug counterfeiters under the Falsified Medicines Directive. The new rule takes effect in April 2016.
More objections to EU GMP requirements for active substances; clarification of import requirements under FMD; new GMP guides incorporate ICH Q10.
U.S. and EU Regulators and Industry Grappling with Track-and-trace Standards to Combat Drug Counterfeiting
Pharmaceutical industry groups and lawmakers in the U.S. and the EU are continuing to grapple with what a pharmaceutical track-and-trace system will look like to thwart drug counterfeiting. The EU has three different track-and-trace models with various levels of traceability in each, while in the U.S., efforts to attach a national traceability system to the user fee legislation failed to garner consensus on the best approach, and meanwhile industry is instituting brand protection programs.