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Guidance: Guideline on Paediatric Investigation Plans, waivers, deferrals and compliance check

Medicines Healthcare Products Regulatory Agency

October 9
15:10 2019

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This document follows the format of the European Commissions best practice guidance on paediatric applications. This UK guidance is for applicants requiring information on:

  • the required format and content of applications for agreement on or modification of a Paediatric Investigation Plan
  • requests for waiver and deferrals
  • the operation of the compliance check

This should be read in conjunction with:

Published 9 October 2019

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