Module232025

07/05/2025

IRIS for PIP applications

Procedural information • Legal basis • Existing MA in EU •

Scientific information • PIP condition, MedDRA term etc • Date of completion of PK studies in adults • Waiver • Date of PIP completion • Addition of measures and key elements Medicinal product information (existing and proposed): Form, strength, target population, proposed age, length of treatment, min and max dose, pH, Osmolality, medical device, container, release Quality Aspects •

Contact information for public enquiries Orphan designation info Non-EMA scientific advice list

• • •

Financial information

Waiver •

Scope of waiver Subset information

• •

Legal grounds

The Organisation for Professionals in Regulatory Affairs

PIP Development

29

IRIS tips

• Make sure you have everything set up IRIS submission early in the development of the PIP • Complete the IRIS information early to identify missing information – IRIS information is subject to frequent changes • Download the application form and have someone QC the information • Make sure key elements match with info/dates in scientific document • Have at least one additional manager on the PIP application • Only one submission contact can be used, but it’s easy to change this at any stage of the application/procedure • Use autoforwarding on your email to ensure that others receive EMA emails relating to the submission in case of absence

The Organisation for Professionals in Regulatory Affairs

PIP Development

30