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Worldwide Regulatory Updates

January 20, 2019

TraceLink continuously monitors emerging and evolving track and trace regulations around the world. View updates from the past week, and other recent developments below.

Bahrain

  • Version 1.1 of the Medicines Barcoding and Serialization Guidelines document was published. The changes to this version included adjustments to the mandatory and optional fields.

European Union

Indonesia

  • An updated background summary was circulated on the upcoming barcoding, serialization, and reporting requirements that will be phased in from 2020 to 2025.

Japan

  • The Ministry of Health circulated an outline of discussions for a proposed new electronic Product Information Leaflet, which will include a QR code.

Saudi Arabia

  • Formal updates have not yet been published concerning the January 7 deadline and SFDA enforcement of those regulations.
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