Paolo Tomasi EMA

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).

REMINDER ON THE FUNCTIONS AVAILABLE TO DIFFERENT USER ROLES IN IRIS

Every 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:

1. Individual role:
   1. IRIS Individual User: (this role is approved automatically by the system)
2. Affiliated roles:
   1. 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).
   2. IRIS Industry Manager: can create, edit, submit and withdraw applications.
   3. IRIS Industry Contributor (this role is automatically assigned also to IRIS Industry Managers): can edit applications (but not create, submit or withdraw them).
   4. 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

3. Affiliated roles:
   1. 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).
   2. IRIS Parallel Distribution Manager: can create, edit, submit and withdraw applications.
   3. IRIS Parallel Distribution Contributor: can edit applications (but not create, submit or withdraw them).

For additional information, please consult the IRIS guide to registration. 

IRIS receives the "Product contact" from the SIAMED2 database, where it corresponds to the "Person/Company authorised for Communication on behalf of the Applicant during the Procedure". 

In IRIS procedures, only one "Submission contact " is maintained, for the purpose of communicating with the Applicant/Marketing Authorisation Holder. There is no plan to modify the system to enable communication with multiple individuals from the same organisation, for a single procedure/submission.

Of note, the "Submission contact" may be different for separate procedures, and it can be modified by the Applicant/Sponsor in the submission, any number of times, among the other Industry Managers associated to the submission.

For technical issues, including assistance on a specific submission, please create a Servicedesk incident. Please attach screenshots of the submission data in the Industry Portal, to help Servicedesk staff identify the problem and find a solution. 

As already specified in the answers above, the principle in IRIS is that only a single person/email address is maintained as contact person for a product, submission or regulatory entitlement. For Inspection procedures, the contact initially assigned to the Inspection "submission" is the Product Contact as communicated by the Applicant to EMA during the Marketing Authorisation application. Also, as already mentioned above,  it is the responsiblity of the applicant:

1. to update the Product contact as required, at earliest possible convenience and using the procedure described above;
2. to notify other persons, in addition to the Product Contact, within or outside the Company in the preferred way (for example, using autoforward rules).