Paolo Tomasi EMA

<a href="https://iris.ema.europa.eu/public/e9393f08-878e-e911-a89e-000d3a265cb7/forum-posts" title="Robert Castelow-Sturges">Robert Castelow-Sturges</a>, there are currently 354 completed submissions for Marketing Status in IRIS. That said, we acknowledge that there are unfortunately a number of bugs in the functionalities for marketing status reporting, which we are currently addressing. Please bear with us while the issues are fixed. You are welcome to report general difficulties in the other Forum (General Discussion and self-help · IRIS (europa.eu)), as this thread is being closed. Also, for specific errors you can raise a <a href="https://servicedesk.ema.europa.eu/jira/servicedesk/customer/portals">Servicedesk </a>request.&nbsp;

sSwapna Bapatla please note that in the IRIS system I can see only one submission in your name, and it is marked as "Cancelled from Industry" (EMA/PA/0000081147).
As such, you won't receive further notifications.

A new versions of the IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants (europa.eu) has been published in the Guidance and Support section of the IRIS website. It contains a new section on how Marketing Authorisation Holders can submit Annual statements and ad-hoc Signal management submissions. These procedures are now available in the IRIS website.

A specific Marketing Status category has been added for products that have never been on the market.
‘Never marketed’ should be chosen from the list of Marketing Status options. Reason for Cessation and the Date of Marketing Status change can be left blank since they won't be mandatory fields when this option is chosen. Newly authorized products will be showing in IRIS with the status ‘Never marketed’ by default. The Regulatory guidance and the IRIS guide for applicants will be updated shortly to include this new feature.
 

The GVP section is still in early development, and will be released after GCP. 

In answer to your questions:

Q: Can we provide to EMA a generic email address to be copied for all inspections notifications?
A: This is currently not possible. At present, product contacts are imported from SIAMED2. We intend to develop, in the future, a feature to allow direct self-management of product contacts by Industry in IRIS (this requires implementation of the Global Coordinator role, see below).  

Q: The announcement of inspections in IRIS can only be opened by the contact person, and only this contact person can add additional IRIS managers. Is this understanding correct?
A: Your understanding is correct. 

Q: What is done to limit the risk of the contact person being out of office?
A: EMA is unable to keep track of the absences of Industry contact persons. You are welcome to contact the Inspections Office for specific arrangements, should a prolonged absence of the contact person cause difficulties. 

Q: Will the new role "IRIS Industry Global Coordinator " be able to open the announcement in IRIS?
A: Yes, this will be one of the advantages of the new role. An "IRIS Industry Global Coordinator" will be able to manage every submission for the Organisation(s) he/she is affiliated to, with that role. 

When a submission is processed by IRIS and the data have been correctly updated in the system, the following happens:

1. you receive an email with the subject like "Case closed: EMA/PA/XXXXXXXXX Marketing Status Notification" that informs you of the correct processing and closure of your submission (see attached email example);
2. your submission in the IRIS Industry Portal changes status, from "In Progress" "Processed", and is now visible in the list of "Completed submissions" rather than "Draft Submissions" or "Ongoing submissions".

For your other question, see IRIS Marketing Status - New deadline for submission of Mkt status reports for marketed CAPs · IRIS (europa.eu)

Please see the other thread 11 reasons for cessation vs 8 in the guidance · IRIS (europa.eu)

Please report any bugs you see in the system via a EMA Servicedesk ticket, rather than in the Forums. Regarding the issue at hand, this is indeed a regression bug, and EMA is aware of it: there should be 8, not 11 reasons. We are working to solve it in the next release of IRIS (new releases are deployed fortnightly).