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

Version 1.0, October 2020
8 October 2020
Download Changing sponsor details in Product Information (PI) and labels of prescription medicines

Description

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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