Worldwide Regulatory Updates

November 22, 2020

European Union

  • November 22: EMVO has confirmed the production deployment of EU Hub release 1.8, which will begin on December 5 at 20:00 CET and continue until December 6 at 08:00 CET at the latest. Most of the enhancements are on the back end.
  • November 22: SecurMed released a statement from the UK FMD Working Group for Community Pharmacy, outlining the future of FMD Safety Features in Northern Ireland and Great Britain. It confirmed that end users, including wholesalers, pharmacies, and hospitals that are not based in Northern Ireland (but not manufacturers who are connected to the EU Hub) will be automatically disconnected from SecurMed on December 31, 2020.
  • November 22: The Medicines/Devices Bill, which confers powers on the UK government to regulate medicines and a falsified medicine system, continues to undergo vigorous debate in the House of Lords, with additional amendments made to the bill this week.

Brazil

  • November 22: The Normative Instruction was not on the DICOL (ANVISA Directorate) November 17 meeting agenda. The next meeting will be on December 1, when a new draft of the regulation may be approved or when proposed phased deadlines based on discussions between ANVISA and domestic pharmaceutical industry associations may be addressed.

Russia

  • November 22: The Ministry of Industry and Trade expanded its phone and email “Drug Labeling Hotline” to offer stakeholders across the supply chain assistance on MDLP issues, reporting of delays and shipments caused by the MDLP, and advice on legislative acts related to traceability.

UAE

  • November 22: The government circulated a formal announcement for their forthcoming track-and-trace system which was mentioned in their 2019 future vision document. No specifics on requirements or deadlines were included.

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