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.
Documents
Details
This guidance provides detailed information on:听
-
the required format and content of applications for agreement on or modification of a paediatric investigation plan (PIP)听
-
requests for waiver and deferrals听
-
the operation of the compliance check in accordance with the Human Medicines Regulations 2012 (HMRs).听
This guidance should be read in conjunction with:听
-
User reference guides on using the MHRA Submissions homepage for PIP-related submissions (available from the MHRA Submissions homepage)
Updates to this page
Published 31 December 2020
Last updated 28 February 2025
show all updates
-
Updated with respect to the Windsor Framework and clarity of instructions.
-
First published.