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    European Regulatory Roundup: EMA Looks to Harmonize Definition of Drug Shortage (28 January 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Calls for Harmonized Definition of Medicine Shortages Following Industry Consultation The European Medicines Agency (EMA) has called for the establishment of a harmonized definition of a medicine shortage after meeting with the industry to discuss the development of proactive approaches to preventing shortages in supply. Officials at EMA left the meeting with a strong b...
  • Report: EU Anti-counterfeiting Directive Attracting Industry Praise, Scorn

    • 30 April 2012
    A rash of counterfeit drugs invading the European pharmaceutical supply chain is spurring EU legislators to develop a new anti-counterfeiting directive that has attracted both the praise and scorn of regulated industry, reports Reuters . The European Commission's planned Directive involves requiring pharmaceutical products "to be sold in tamper-proof packs from 2016, each with a unique identifier allowing them to be tracked through the supply chain," writes Reuters . ...