Guidance

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

This guidance document from the MHRA provides information on the format and content of paediatric applications in the UK if there is a no-deal Brexit.

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This document follows the format of the European Commission’s 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