Jolanda de Bruijn Miss

We have done one PIP Annual report and are doing a PIP modification. We have reported to the EMA that the button "generate form" does not generate a form with the data of the PIP included instead it generates a form that is called ODD and that does not include all fields filled in by the submitter/ sponsor. 

The EMA has advised that this button will be removed for PIP submissions. We do worry about this as this button is the ONLY way to get the fields filled into the KEF form out of IRIS. The Submitter / Sponsor would require to store the information submitted and if the EMA would remove the button "generate form" this is very difficult. Could the EMA fix the button so that when we generate the form in IRIS this would include the information the Submitter / Sponsor has filled in in the IRIS platform for their PIP submissions?

 

Dear Poonam 

Following on from Susanne's question. Would "all IRIS admin users", and or "all IRIS managers"  or "all IRIS users (admin, manager and contributor) of the company receive an email from IRIS to notify of an inspection?

In an earlier response to Isha (https://iris.ema.europa.eu/forums/general-discussion/f9ed2c6b-7d1b-ec11-b76a-0003ff4a48b7)  you stated that the user is: Product Contact for the application already notified to EMA, and the Portal Contact (a.k.a. Submission Contact) for the Marketing Authorisation Holder/Applicant. Will they require to be admin or manager or contributor in the IRIS portal or would they receive the notification in their email even without IRIS access?

Would the company solely receive an email via the IRIS platform or would MAH contact person be notified via their email address?
Is there any other way that the MAH would receive the notification of an inspection (for example email to a user not registered in IRIS but registered as contact person for this company). 

Looking forward to hearing from you
Jolanda