Module232025

07/05/2025

PIP modification Procedure Presubmission meeting possible To upload in IRIS: 1. Request modification-agreed-paediatric investigation-plan form 2. Copies of literature references used in the request 3. Other supporting documents 4. Current PIP Decision Key elements must be completed in the IRIS portal. Include only the modified key elements.

Request form

Do not send updated scientific document (part B E)!!  Follow Procedural advice on paediatric applications  Submit according to deadlines

The Organisation for Professionals in Regulatory Affairs

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Request for modification form

Reasons for applying: Summarise briefly – not more than one page - the overall reason for the requested changes E.g. • changes to development programme following regulatory interactions, • changes required due to recruitment difficulties • new clinical guidelines, standard of care

The Organisation for Professionals in Regulatory Affairs

40