Guideline on the Format and Content of Applications for Agreement or Modification of a Paediatric Investigation Plan

Legal requirements for UK-PIPs are set out in the Human Medicines Regulations 2012. Guidance on procedures for UK-PIPs from 1 January 2021.

In the UK, the following definitions apply to PIP and waiver applications. Each measure in a PIP may contain one or more specific key elements. Key elements are binding and provide the basis for the operation of the compliance check.

The MHRA will be following the principles from the EMA policy on the determination of the condition(s) for a Paediatric Investigation Plan/Waiver (scope of the PIP/waiver).

PIP related templates are available to download from the PIP templates section of the PIP tile homepage. For a request to modify an agreed PIP, the request for modification of an agreed PIP template should be used. The application should be based on all available information relevant to the evaluation, whether favourable or unfavourable to the product and its development.

Source: MHRA guideline on Guideline on the format and content of applications for agreement or modification of a Paediatric Investigation Plan