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Worldwide Regulatory Updates

January 12, 2020

European Union

  • January 12:France’s Ministry of Health announced a transition period before companies must comply with the European Union Falsified Medicines Directive (EU FMD). The Ministry did not specify when the transition period will end. The Ministry also reports that there is a 3-5-year plan in place for the European Medicines Verification System (EMVS) to support aggregation. Finally, the Ministry promoted a new means to securely transmit product codes between suppliers and hospitals. 
  • January 12: France’s Medicines Verification Organization (MVO) has issued extensive new guidance for supply chain stakeholders. The guidance includes detailed analysis on how to manage alerts and provides companies with an interactive “Alert Analysis” tool.
  • January 12: France has announced a plan to connect all of the country’s approximately 22,000 pharmacies to the National Medicines Verification System (NMVS). Pharmacies can expect to receive their credentials within a few days.
  • January 12: The EU FMD Expert Working Group, a network of EU Member State regulators, has published its latest meeting minutes. The group expects marketing authorization holder inspections to ramp up in the future. It also expects National Competent Authorities to use newly available analytics reports to enforce EU FMD provisions and identify delinquent actors.

Egypt

  • January 12: Egypt’s regulatory pilot has concluded, and participants have submitted feedback to the Ministry of Health. The Ministry is now expected to publish an updated technical guideline and announce final implementation deadlines, which could be as short as six months.
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