PIP submission via IRIS

Are you working on a PIP? 

Please note that paediatric submissions must be submitted via the IRIS platform from 4 June 2024.


The following submission types are affected:

• Initial paediatric investigation plan (PIP)

• Modification of PIP

• Product-specific waiver

• Compliance check

• Annual report 

• Confirmation on class waiver, or inclusion of an indication 

• Discontinuation of paediatric development.


Not familiar with IRIS? We are. Please  reach out at info@regfile.se

PIP submissions via IRIS