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    EU Regulatory Roundup: Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System   Ireland has extended the “use and learn” phase of the implementation of the Falsified Medicines Directive (FMD) for a second time. The implementation phase will now end in a staggered manner starting sometime after the end of September.   When the FMD safety feature requirements ca...
  • EU Regulators Warn of Counterfeit Copies of Cancer Drug Herceptin

    EU regulators have issued a warning that several batches of the cancer medicine Herceptin (trastuzumab) have been "tampered with," falsified and reintroduced into the supply chain, potentially putting patients at risk. Background High-cost cancer medications like Herceptin have become an increasingly tempting target for thieves and counterfeiters in recent years. While they lack the ready market that some drugs like Viagra have, their extraordinary cost means extraordin...