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Posted Mon, 30 Sep 2024 11:59:07 GMT by Tatiana Sonnati
Once a submission is made, the case has been created in IRIS and after receipt of IRIS notification of the positive validation, how to extract the timetable that can be found in the IRIS portal in order to have a PDF/ official document of the agency communication? Will the Confirmation of start of the procedure not be sent anymore?
 
Posted Tue, 22 Oct 2024 12:23:20 GMT by Caterina Scarpati
Dear Tatiana,

Please refer to the Industry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS. You will still receive notifications from the EMA at relevant milestones of the procedure. In addition, in the IRIS industry portal you will have an overview of the procedures where you have the appropriate role(s), which includes the procedural timetable.

Best regards,
IRIS Change Management Team
Posted Tue, 22 Oct 2024 12:54:46 GMT by Tatiana Sonnati
Dear Caterina,
Thank you for your kind reply. The procedural timetable are indeed indicated within the submission details in IRIS and I know how to retrieve it. What I would need to know is if it is possible to download/ extract an official PDF of the timetable avoiding to capture the information as image.
Could you please let me know?
Thank you
Kindest Regards,
Tatiana

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