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Worldwide Regulatory Updates

June 28, 2020

European Union

  • June 28: Due to the COVID-19 pandemic, there has been a delay in the implementation of changes to Bulgaria’s Medicines Act that would impose fines for non-compliance with the European Union Falsified Medicines Directive (EU FMD).
  • June 28: Estonia’s NMVO instituted a three-week testing period—from June 22 to July 12—for pharmacies, hospitals, and wholesalers to scan each Data Matrix barcode and submit alert resolutions to the State Agency of Medicines. Estonia’s formal stabilization period ends in September 2020.
  • June 28: Denmark’s NMVO published webinars with details about alert management processes and its online alert management tool. The management tool webinar includes a video tutorial showing onboarding partners (OBPs) how to resolve alerts in the country’s National Medicines Verification System (NMVS).
  • June 28: Austria’s NMVO announced that an EMVS-wide change will be implemented in the fall. When the change is made, the EMVS will match only month and year of the Data Matrix expiry date. Currently, the day is also matched.
  • June 28: Austria’s NMVO held an online event on alert management which included and audience Q&A segment tactics for reducing alerts were presented. Tactics include frequent communication with alert-generating users and filtering out of Indian packs from verification and decommissioning requests. Austria consistently has one of the lowest alert levels in the EU.

Saudi Arabia

  • June 28: Users of Saudi Arabia’s Drug Track and Trace System (RSD) received a government email stating that the deadline for aggregation of medicines has been pushed back to August 20, 2020.
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