Paediatric investigation plans: Templates and forms

This page lists the templates and forms required by companies wishing to submit a paediatric application.

Templates and forms

The forms and templates should be downloaded and saved first before being completed. To report any technical issues with the form, please use the EMA Service Desk portal.

It is mandatory to use the latest published version of all templates and forms unless stated otherwise. Please do not re-use previously downloaded documents.

Paediatric investigation plan (PIP) - Key elements form

Reference Number: EMA/283362/2012 Version 8

Notification of discontinuation of an agreed PIP decision

Template for scientific document for paediatric investigation plan or product-specific waiver

Request for modification of an agreed paediatric investigation plan

Template - Request for compliance check on an agreed paediatric investigation plan (PIP)

Response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI) - Re-submission following clock-stop

Additional information - Applicant’s clarifications following Paediatric Committee (PDCO) discussions or re-discussions

Reference Number: EMA/241572/2025