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 — See all updates

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)

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.