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Worldwide Regulatory Updates

September 8, 2019


  • September 8: A new Russian government decree that modifies serialization requirements for pharmaceutical supply chain companies has been published. Among other things, Russia Government Decree No. 1118 shortens required crypto codes and sets 180-day deadlines for payments and reporting.

European Union

  • September 8: The European Medicines Verification Organisation (EMVO) has published a minor update to the User Requirement Specification for the European Union Falsified Medicines Directive (EU FMD) system. The update adds a requirement for a monitoring tool at the European Union level that is designed to identify abuses of the bulk verification functionality by pharmaceutical manufacturers.
  • September 8: The European Commission (EC) has published a new checklist as part of its guidance in the event of a no-deal Brexit. The detailed checklist covers the steps the pharmaceutical industry needs to take to transfer marketing authorization to European Union soil, ensure localization requirements are met, and ensure proper trade and customer procedures. The EC reports that about 80% of affected products are on track for an Oct. 31 Brexit, and batch testing location exemptions are being granted on a narrow basis until Dec. 31.
  • September 8: Belgium has become the first country to formally end its transition period for European Union Falsified Medicines Directive (EU FMD) stakeholders. The country has communicated penalties for non-compliance that range from formal warnings to criminal prosecution.
  • September 8: France’s National Medicines Verification Organization (NVMO) has published a .xls template designed to help pharmaceutical manufacturers systematically report falsification alerts. Many European Union NVMOs require these types of reports from marketing authorization holders.
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