Regulatory requirements | Overview and updates

July 3, 2025

As many of you know, we’re in the midst of a wave of important regulatory updates. To help you stay on top of what matters most, we’re launching a 7-day series where we’ll highlight one key regulatory change each day.

Today’s Focus: Product Management Service (PMS)

Quick summary:

  • For CAPs:
    • PMS data comes from SIAMED + xEVMPD integration.
    • No need to submit pack size updates — existing SIAMED data has been migrated.
    • Commercialization status is handled in IRIS, not PMS.
  • For non-CAPs:
    • Structured data (e.g., pack sizes, manufacturers) must be enriched via PUI or PMS API.

 

Check out the image for the full picture!

At the end of the 7-day updates, we’ll share a full summary so you have everything in one place.

Contact us for further information or questions: [email protected]

 

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