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Worldwide Regulatory Updates

April 7, 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.

Brazil

  • The official pilot phase for serialization in Brazil will end in April 2019. At that time, the government will use learnings from the pilot program to create the final technical guidelines and will publish them in the next few months. The final implementation deadline of April 2022 will not shift, but the implementation timeline is now 24 months instead of 36 months and will begin in April 2020.

Egypt

  • The Egyptian Minister stated that the upcoming pharmaceutical barcoding deadline for June will include both serialization and compliance reporting, and not just serialization as previously thought. Final requirements and guidelines for Egyptian barcoding will be published in late April according to current plans.

European Union

  • The EMVO published the latest update to the NMVO's Fee Models Status, including a discussion of the fee model types; annual operational fee; and the volume and turnover-based models.

Saudi Arabia

  • Full guidance for the Saudi Unique Device Identifier (UDI) program is expected to be published next month.

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