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New IRIS affiliation role available: IRIS Industry Coordinator
The new IRIS affiliation type "IRIS Industry Coordinator" can now be requested in IAM (the EMA Account Management system).
Users with this role can visualize and edit any submission/application made on behalf of the specific organization of affiliation, in addition to those where the user is the creator or has been added as a manager/contributor (as is the case for users with simply an "IRIS Industry Manager" or "IRIS Industry Contributor" affiliation to an organization).
This is useful, for example, if a previous or ongoing submission was created by a user who then left the company, without any other company users associated to that application. An "IRIS Industry Coordinator" can now see the submission, add himself/herself or any other user affiliated to the same organization as a manager for that submission, and finally change the submission contact (the person who receives all the emails) of the procedure.
The features above are particularly relevant for Inspection procedures, where the submission record is created by EMA and not the applicant, and assigned automatically to the Product contact person as submission contact: if this person is unavailable or has left the company, it is now possible for any "IRIS Industry Coordinator" to add new Managers and then change the submission contact as desired.
Please note that the "IRIS Industry Coordinator" affiliation does not allow to create a new submission of any kind: for that, it is necessary to have the role of "IRIS Industry Manager", in addition to that of "IRIS Industry Coordinator" for the same organization. -
RE: When will MAHs become available for i-SPOC registration?
Yes the new functionality is already available, no changes in the approval process were introduced, approval of roles can take:- up to 2 days for the first user approved by the EMA, which has to be a user with the IRIS Industry Admin role;
- for all subsequent users and affiliation, approval times depend on the IRIS Industry Admin user(s) at each organisation.
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RE: When will MAHs become available for i-SPOC registration?
In general, if an affiliation is visible in the EMA Account Management System, but the organisation is not shown in IRIS when attempting to create a new submission, this suggests that the propagation between the two systems has failed. The re-sync can be obtained via a request to EMA Servicedesk. -
RE: Organisation affiliation
Dear Alex Xuereb, your screenshot does display the affiliation in the EMA Account Management System, however this affiliation has not been propagated to IRIS due to a bug, unfortunately. Please submit a Servicedesk Request to have your account re-synced.
In general, if an affiliation is visible in the EMA Account Management System, but the organisation is not shown when attempting to create a new submission, this suggests that the propagation has failed. The re-sync can be obtained via a request to EMA Servicedesk. -
RE: When will MAHs become available for i-SPOC registration?
Dear Susanne Hense, please raise a ticket with Servicedesk. There may be additional problems, specific to your account - a re-sync may be needed. Meanwhile, please make sure that you request the "IRIS Industry Manager" affiliation in the EMA Account Management System, for all organisations on whose behalf you intend to create submissions. -
RE: When will MAHs become available for i-SPOC registration?
Dear Susanne Hense, I have checked your account and you have the IRIS Industry Manager role for only three organisations, and therefore when creating a new submission you will see only those three. You also have the IRIS Industry Coordinator role for many other organisations (>30), but that does not grant you the right to create new submissions on their behalf; it grants you only the possibility to see all existing submissions for those organisations, and add/remove participants (Managers or Contributors) to those existing submissions. We ackonwledge that, unfortunately, the currently published guidance is not clear on this aspect, and the revised version has not been published yet due to a mistake (but it will be soon).
To be able to create submissions for the companies where you already have only the affiliation as Industry Coordinator, you need to request also (or instead) the affiliation as Industry Manager to each of them. -
RE: IRIS doesnt display my Organisation
Please create a Servicedesk ticket for this type of access problems, as individual requests are necessary. -
RE: IRIS doesnt display my Organisation
Dear Vineet Bajaj, I can see in the system that for Pharmazz Europe Limited you have only the roles of Industry Coordinator and Industry Contributor, but not that of Industry Manager. The role of coordinator allows you to visualise submissions created by other users affiliated to the same organisation: for example, you should be able to see the draft submission EMA/SA/0000100668 already reated by your colleague in IRIS - please confirm if this is the case.
However, if you want to be able to create a new submission on behalf of an Organisation, you need to be affiliated to that Organisation with the role of Industry Manager, to be requested via the EMA Account Management system.
If the above comments do not help to solve your issue, please create a Servicedesk ticket. -
RE: IRIS doesnt display my Organisation
There has been a sync issue between IAM and IRIS that has caused the loss of the affiliation of some users to their organisation(s). We are aware of the issue and working on it. However, at least for two of you (Emna Clam and Vineet Bajaj) I do see an affiliation available in IRIS, can you please try again? -
RE: Linked Organization
Please consult the IRIS guidance, avalaible in this website (Home - news · IRIS (europa.eu)). If you have problems with a specific submission, please create a ticket in the EMA servicedesk site.
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