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.
IRIS Industry User Admins are responsible for removing any user affiliated to their Organisation, when such need arises – for example, if the user leaves the Company. EMA is not responsible for maintaining the affiliation lists of Organisations. A guide on how to accept and remove affiliations for IRIS Industry User Admins is available here: User Administrator Guide · EMA Account Management (europa.eu).
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:
- 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);
- 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".
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).
REMINDER ON THE FUNCTIONS AVAILABLE TO DIFFERENT USER ROLES IN IRISEvery IRIS Industry Manager or Contributor affiliated to an Organisation can see all the Research Products associated to the Organisation, the Marketing Status of the Authorisation products as communicated to EMA by the Organisation itself, and all Regulatory Entitlements associated to the Organisation (such as Orphan Designations and Scientific Advice outcome).
Regarding submissions, users with the IRIS Industry Manager or IRIS Industry contributor role can only see those submissions created by themselves, or where they have been explicitly added as additional Managers or Contributors by another IRIS user already associated with that submissions. Users with the IRIS Industry Manager or IRIS Industry contributor role therefore cannot see all previous, ongoing or draft submissions of their affiliated Organisation.
EMA is developing a new role, called IRIS Industry Global Coordinator, which will enable creating, editing, submitting and withdrawing ANY application associated with the Organisation, whether or not they have been added explicitly to the submission. This is expected to go live in Q1 2022.
To use IRIS, you need to have been granted at least one of the following affiliation roles for the organisation on whose behalf you will be acting:
Scientific Procedures and Inspections:
- Individual role:
- IRIS Individual User: (this role is approved automatically by the system)
- Affiliated roles:
- IRIS Industry User Admin: can assign the other roles to those who request them for the organisation, including him/herself (but cannot do anything else).
- IRIS Industry Manager: can create, edit, submit and withdraw applications.
- IRIS Industry Contributor (this role is automatically assigned also to IRIS Industry Managers): can edit applications (but not create, submit or withdraw them).
- IRIS Industry Global Coordinator (in development): this role will allow IRIS Industry Manager capabilities for any submission/application made on behalf of an organisation (and not only those where the user is the creator or has been added as a manager/contributor.
Parallel Distribution procedures
- Affiliated roles:
- IRIS Parallel Distribution User Admin: can assign the other roles to those who request them for the organisation, including him/herself (but cannot do anything else).
- IRIS Parallel Distribution Manager: can create, edit, submit and withdraw applications.
- IRIS Parallel Distribution Contributor: can edit applications (but not create, submit or withdraw them).
For additional information, please consult the IRIS guide to registration.
- Individual role: