Guidance

Format and content of applications for agreement or modification of a Paediatric Investigation Plan

Also covering requests for waivers or deferrals and concerning the operation of the compliance check.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 December 2020
• Last updated: 28 February 2025
  Show all updates

  1. 28 February 2025

     Updated with respect to the Windsor Framework and clarity of instructions.

  2. 31 December 2020

     First published.

Documents

Format and content of paediatric investigation plans and related applications in the United Kingdom (UK) 

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Details

This guidance provides detailed information on: 

• the required format and content of applications for agreement on or modification of a paediatric investigation plan (PIP) 

• requests for waiver and deferrals 

• the operation of the compliance check in accordance with the Human Medicines Regulations 2012 (HMRs). 

This guidance should be read in conjunction with: 

• Guidance on procedures for UK-PIPs 

• User reference guides on using the MHRA Submissions homepage for PIP-related submissions (available from the MHRA Submissions homepage)