Module232025

07/05/2025

PIP CONDITION

Indication 1 Adult Indication (Covered by the PIP)

Indication 2 (Covered by the PIP)

Indication 4 (Covered by the PIP)

Indication 5 (Covered by the PIP)

Indication 3 - most relevant for children

PIP

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Avoid bad surprises

For an MAA/Variation/Line extension to be valid, it must include

Results of all studies, The PIP decision and

The positive compliance check documentation. A new indication not covered by the condition(s) of the PIP/waiver decision would require a new decision. To avoid coming into trouble at MAA validation, you can request confirmation from PDCO of whether an indication is part of a condition (in an agreed PIP or waiver decision) Consult point 13.2 in the document: Procedural advice on paediatric applications

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