Module232025

07/05/2025

IRIS – what do I need?

• EMA account and registration on IRIS with appropriate role (IRIS Industry Manager) for Organisation • Organisation must be set up in OMS (SPOR) • Organisation does not need to be based in EU for PIP applications • RPI number for product

• Active substance must be registered in SMS/SPOR • One RPI per product, assigned to one organisation • RPI can be requested via IRIS if needed

The Organisation for Professionals in Regulatory Affairs

PIP Development

27

IRIS for PIP applications

• Latest IRIS guidance on PIP applications can be found on IRIS webpage: Home · IRIS

The Organisation for Professionals in Regulatory Affairs

PIP Development

28