-
How to correspond with PDCO about ongoing initial PIP submissions in clock stop?
I have searched both EMA's and IRIS homepages for information on how to submit responses to questions raised by PDCO in their Day60 assessment report to an initial PIP which has been transferred to IRIS.
This is the only location where I have found some info about correspondence for ongoing procedures ( eSubmission: Projects (europa.eu) (Paediatric submissions)):"17-05-2024
New Paediatric submissions are mandatory via IRIS platform from 4 June 2024
Please note that from 4 June 2024, the following types of new paediatric submissions must be carried out via IRIS:
- Initial paediatric investigation plan (PIP)
- .........
The gateway is open for ongoing paediatric procedures only."
My interpretation is that the responses to Day60 assessment questions should be sent via the gateway (despite the PIP has been transferred to IRIS) is this true?
For how long time does this apply?
You’re offline. This is a read only version of the page.
