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RE: lookup window for submission type does not open
Dear Petra Heyen, for access and technical problems, please raise an incident in EMA ServiceNow. Of note, you currently have two separate EMA/IRIS accounts, each affiliated to a different organisation; this setup, while technically possible, is not recommended and is likely to lead to confusion. -
RE: New IRIS affiliation role available in IAM: IRIS Industry Coordinator
Any IRIS role can be assigned to multiple users: admin, coordinator, manager, contributor. It is in fact recommended to have more than one Admin user, so that administration of access to IRIS for an Organisation can continue even if an Admin user leaves the organisation temporarily or permanently.
Only the first Admin user for an Organisation needs to be approved by EMA, on the basis of supporting documents; all subsequent affiliations of users for any role (additional admin users, coordinator, manager, contributor) can be approved by the first admin user. Every request for affiliation is forwarded to all active admin users in an organisation. -
RE: ORG-IDs for organisations with the same name
The new release of IRIS now contains the column with the Organisation ID, when choosing the (parent) organisation on behalf of which a new submission will be created.
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RE: ORG-IDs for organisations with the same name
When creating a new submission, a user is presented with a list of (parent) organizations to which he or she is affiliated in IRIS. A parent organization is defined as a legal entity in a country, and as such there should be no duplicate parent organizations with the same name in the same country. The information currently displayed, (parent) organization name and country, should therefore be sufficient to identify univocally the appropriate organization. That said, it is certainly possible to add also a column to display the organization ID in the Idnsutry portal; this will be done in one of the next releases of IRIS. -
RE: Marketing Status Notifications: Query on options for 'Reason for Shortage'
The list of reasons is indeed complete in IRIS, and it is the same list as in RMS list "Reason for Marketing Unavailability" (8 terms) which is based on current legislation. You should therefore choose the term that best approaches your situation.
Note: if you would like to suggest an addition to the terms in the RMS list, this can be done via the established procedure in SPOR (please consult document G in the RMS Documents). -
RE: Not able to see my organisation
Please report this type of specific technical problems via a Servicedesk ticket, rather than in the Forums. -
RE: Problem with Marketing Status Notification - authorised product
RPIs are not the same thing as an authorisation products. Marketing status is reported for authorization products, not for RPIs. If there are no authorized products shown for your organisation and correct location, please raise a Servicedesk ticket, providing as much detail as possible, including screenshots. -
RE: Follow-up scientific advice
It should be requested as a followup to the initial advice. -
IRIS Data Protection notice and ROPA published
The IRIS Data Protection notice and the Records of Data Processing Activity documents have been published on the EMA website. -
Removal of company affiliation when an IRIS Industry user leaves employment
Company users with the "IRIS Industry User Admin" role are reminded that EMA does not check the affiliation status of users to Organisations, as this is a responsiblity of each Organisation.
Users with the "IRIS Industry User Admin" role for an Organisation are therefore advised to run periodical checks on the list of users that are affiliated to their Organisation, and their roles, so that the affiliation can be removed promptly where appropriate, for example when an employee leaves her/his position, or if an external consultant should not be allowed access anymore. Organisations may also wish to implement a standard policy of affiliation removal in their check-out procedures for leavers.
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