51茶馆

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

• Guidance on procedures for UK-PIPs听

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