-
RE: MAH transfers - do products automatically appear in list for Marketing Status Report?
Please note that RPIs have no relationship with marketing status submissions. All "Authorisation Products" have a parent RPI, and multiple authorisation products may share the same RPI, for example in the case of duplicates, informed consent, orphan and non-orphan products containing the same active substance(s).
Marketing status submissions must be done for an "Authorisation Product" which has a valid Marketing Authorisation, not for an RPI.
Regarding transfers:- an RPI can be transferred to another location of the same organisation, or to a different organisation, directly by the current RPI owner via an IRIS submission. The process is completely automated and is almost immediate.
- On the other hand, a transfer of MAH for an authorised product is a different procedure, requires a decision from the EC, and is not currently managed in IRIS. Once a transfer of MAH for an authorised product is completed, the new MAH is (manually) updated in IRIS as well. This may require a few days. If you suspect that this update has not been done in IRIS, please raise a ServiceNow incident.
-
RE: New Scientific Advice for MRP procedures
This is a bug in the system. An incident has been raised in the internal development database, Azure DevOps (n. 29838). -
RE: ORG-ID & LOC-ID linked to the Authorized Products
Dear Beatriz Ugalde, your IRIS account is not affiliated to any organization. As such, it is expected that you cannot see any authorized product: the system only shows the products authorised to the organization(s) that you are affiliated to. Please request affiliation as detailed in the IRIS guide to registration, included in the IRIS guidance page: Home - news · IRIS (europa.eu). -
RE: Affiliated organisation - no responses from help desk
Dear Stian Morch Aaen, in our records there is no request for affiliation to any organisation for your user role. Please consult the instructions provided in the IRIS guide to registration and request affiliation to your organisation(s) in the EMA Account Management System.
Of note, we see that you have a different email in your ServiceNow account than the one you used for the EMA Account Management System. This may lead to confusion when you ask for support, as these are effectively two different accounts. -
RE: New IRIS affiliation role available in IAM: IRIS Industry Coordinator
Dear Mr Petric, please try again and see if you can see the submissions now. If not, please let us know here and raise a Servicedesk request. Please note that you only have the Coordinator role, but not that of Manager, which means that in any case you won't be able to create new submission, or send/withdraw existing one unless you request and obtain the Manager role as well.
-
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.
-
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).
You’re offline. This is a read only version of the page.
