Module232025

07/05/2025

Documentation to support PIP submission

• Submission completed on EMA’s IRIS portal • Application and other key information added via forms on IRIS • Documents needed: • Scientific document (submitted as Word doc, EMA template) • Literature references used in scientific document (ZIP file) • Pre-submission meeting minutes (if applicable) • Supporting docs as applicable (copies of non-CHMP scientific advice, IB, SmPC, RMP, iPSP)

Documents no longer needed: • Letter of intent • Cover letter • Separate key elements form

The Organisation for Professionals in Regulatory Affairs

PIP Development

13

Scientific document - overview

• EMA templates subject to change, check the most recent via EMA website Section 1 - Application Summary (overview of application) Section 2 – Overview of the disease(s), condition and pharmacological rationale • Information on the target diseases/conditions/indications, product and mechanism of action • Current methods of diagnosis, prevention or treatment in paediatric populations • Fulfilment of therapeutic needs/significant benefit • Summary of regulatory advice and feedback from networks/experts/patient groups Section 3 – Application for waiver(s)

• Detailed justification, proposed grounds Section 4 – Proposed paediatric investigation plan • Existing data, description of and justification for planned measures/studies Section 5 – Timelines and deferral(s) • Study start/end dates, justification of any deferrals Section 6 – References

The Organisation for Professionals in Regulatory Affairs

PIP Development

14