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Worldwide Regulatory Updates

September 18, 2020

European Union

  • September 13: Finland’s National Medicines Verification Organization (NMVO) published instructions for dispenser uses cases that involve pharmacies borrowing packs from one another. The guidance states that community pharmacies should decommission upon dispense to the patient. Hospital pharmacies, which may have already decommissioned the packs upon receipt, should inform the borrower of the pack’s decommissioned status to avoid generating alerts.
  • September 13: Latvia’s State Agency of Medicines issued a list of changes that will take place in that country—and likely in other European Union countries—after the Brexit transition period has ended. Some of the topics covered in the list include licensing considerations, import procedures, and qualified person residency.
  • September 13: Latvia launched a customer portal that enables marketing authorization holders (MAHs) in the country to manage their company information, contracts, invoices, and other information on file with the NMVO.
  • September 13: Norway’s NMVO held a workshop with business leaders and representatives from the European Medicines Verification Organization (EMVO). The group discussed value-added services that can be enabled using European Union Falsified Medicines Directive (EU FMD) serialization requirements as a foundation. Topics covered included improving communication between supply chain entities and using artificial intelligence to detect valuable business insights.
  • September 13: The European Commission published a preparation document for companies doing business in the United Kingdom (UK) after the Brexit transition period ends. The document summarizes the pace of Brexit negotiations, preparedness plans, and customs and licensure rules outlined by the UK government.
  • September 13: The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published 26 guidance documents on various aspects of medicines and devices for the post-Brexit transition period. The packaging guidelines state that EU FMD safety features, including the unique identifier and anti-tamper device, will be allowed on UK packs provided other UK packaging requirements are met.
  • September 13: A second reading of UK’s Medicines and Medical Devices Bill took place in Parliament on September 2. The reading generated a debate on the risks of the UK straying too far from the EU regulatory framework.
  • September 13: Estonia’s NMVO enacted stricter rules for dispenser alert management that allow dispensation of alert-generating packs only if there is documented evidence that falsification has been ruled out.
  • September 13: Sweden’s NMVO announced an extension to the country’s stabilization period. The stabilization period will now end on September 30, 2020.

India

  • September 13: India’s government published version 1.5 of its technical schemas and implementation guidelines.

Ecuador

  • September 13: Ecuador’s government published new regulations mandating that serialization and traceability reporting be implemented in six months.

Middle East

  • September 13: The Abu Dhabi emirate published a circular announcing new coding and serialization requirements for 2021 as well as information on submitting product master data to the United Arab Emirates portal.
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