PIP Initial Submission and use of IRIS from 04 June 2024

Luis Vaz
Posted Tue, 16 Apr 2024 11:47:12 GMT by Luis Vaz Mr

We are aware of the introduction of the extension of the IRIS platform from 04-Jun-24 where initial PIP will have to be submitted using the IRIS platform.
We would like to ask for advice on initial PIP applications that are submitted before this deadline using the previous process and how the application will be handled once the 04-Jun-24 timepoint has passed for example if there are validation issues.
Many thanks.
Kind regards

Answer
Paolo Tomasi
Posted Wed, 17 Apr 2024 07:14:45 GMT by Paolo Tomasi EMA
A final decision has still to be made on this issue, however it is likely that for submissions sent before 4 Jun the current (non-IRIS) process will apply, for validation and the initial assessment. Special arrangements may prove indicated for applications for initial Paediatric Investigation Plans, if a Request for Modifications is issued. Please check the What's New in IRIS forum regularly, closer to the go-live of IRIS for Paediatrics, for updated information. 

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