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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 9 October 2019

This publication was withdrawn on 4 February 2020

For current information on paediatric investigation plans see Legal requirements for children’s medicines

Documents

Guideline on the format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check

PDF, 910 KB, 35 pages

Details

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A Brexit deal has been agreed but needs to be ratified. The UK could still leave with no deal on 31 October 2019 if the UK and EU do not approve and sign the withdrawal agreement.

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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:

• Guidance on procedures for UK-PIPs in the event the UK leaves the EU without a deal
• user reference guides on using the MHRA Submissions page for PIP-related submissions

Published 9 October 2019