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Changing sponsor details in Product Information (PI) and labels of prescription medicines

Version 1.0, October 2020

The process to change sponsor details in PI and labels

Last updated

This guidance describes how to change sponsor details in the Product Information (PI) and labels for prescription medicines.

Contents

  • About this guidance
  • Timeframe
  • Supplying products with former sponsor details
  • Applying for a variation to change sponsor details
  • Fees
  • Application process
  • When PI changes are approved
Version history
Version Description of change Author Effective date
V1.0 Original publication Regulatory Guidance Team October 2020

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