Module232025

07/05/2025

Section 3 – Application for waiver(s)

• Used for both PSWs or for waivers proposed in specific sub-sets • Overview: Summary of proposed justification of proposed waiver(s), linking to points raised in Section 2 • More than one ground for each proposed waiver can be used, but proposal for most appropriate should be proposed in summary • Justifications should be based on scientific data/evidence

Grounds: 1. the disease or condition for which the specific medicinal product is intended does not occur in the specified paediatric subset(s) 2. the specific medicinal product does not represent a significant therapeutic benefit 3. the specific medicinal product is likely to be ineffective or unsafe

All paediatric sub-sets must be covered by a waiver or development plan

The Organisation for Professionals in Regulatory Affairs

PIP Development

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Section 4 – Proposed PIP - overview

Quality Aspects

Existing pharmaceutical forms

Proposed paedpharmaceutical forms

Non-clinical Aspects

Proposed non-clinical development to support paeds

Existing non-clinical data

Clinical Aspects

Existing clinical data and planned adult studies

Proposed paedclinical development

The Organisation for Professionals in Regulatory Affairs

PIP Development

18