Module232025

07/05/2025

When is a PIP required?

• All applications for Marketing Authorisation (MA) for new active substance must have an agreed PIP (includes agreed waivers and deferrals) • The requirement also applies for marketed products which are covered by intellectual property rights when a company is seeking: • A new indication

• A new pharmaceutical form • A new route of administration

The Organisation for Professionals in Regulatory Affairs

PIP Development

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Timing of the initial PIP submission

• As per the regulation: Not later than upon completion of the human pharmacokinetic (PK) studies in adults • Latest: Submission of PIP application after initiation of confirmatory/Phase III study or after initiation of clinical studies with paeds would not be justified • Other considerations: • Scientific advice • Considerations of timing vs adult clinical development • Development outside of EU • Global harmonisation

The Organisation for Professionals in Regulatory Affairs

PIP Development

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