RE: IRIS doesnt display my OrganisationDear 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 OrganisationThere 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 OrganizationPlease 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.
RE: Add additional member or delegate role to employeeIt is not clear what the desired function is, but in IRIS there is no concept of delegate or team member.
An organisation can have any number of affiliated users, who can create and manage submissions on behalf of the organisation. To be able to see a specific submission, an affiliated uer must be added to that submission as a manager or contributor. It is also possible for Industry Users, in the IRIS portal, to reassign the "Portal contact" role of a given submission (the person who receives all emails by default) to any other user who is already added to that particular submission.
For additional information, please check the IRIS guide to registration (chapters 5 and 6) and the IRIS guide for applicants (chapters 2.4, 2.5, 2.6) in the IRIS guidance page.
RE: I can not register one of our IRIS managers as an iSPOCThe affiliation of users as IRIS Industry managers (or any other Industry role) is subject to the authorisation by the IRIS Industry Admin user of the relevant Organisation. EMA is not involved in granting new affiliations to organisations for users, as the authorisation process is managed by Industry. If a technical malfunction is suspected for a specific situation, please raise a ticket in the EMA Servicedesk, providing the name of the users involved and any relevant screenshot.
RE: Harmonisation of locations used in IRISAt present, it is not possible to transfer Regulatory Entitlement records of the type "Marketing Authorisation" via a submission in the IRIS portal. As the transfer of the Marketing Authorisation is agreed by the European Commission, similarly to the transfer of an Orphan designation, a specific procedure will be developed in the future, once also initial Marketing Authorisations and Variations/Extensions are onboarded to IRIS. However, if any misattributed records are identified, please submit a incident report via EMA Servicedesk, so that the Marketing authorisation record can be updated in the back end by EMA.
RE: I cannot choose submission type "i-SPOC"Please try once again, the issue should be sorted now.
RE: Harmonisation of locations used in IRISWhen creating a new application in IRIS, the system does allow to choose among all the locations associated to the parent organisation (legal entity). However, it is recommended to use always the same location, ideally that where the legal seat of the organisation is situated. Unfortunately OMS, the master data system for organisations which is used by IRIS, does not specify which of the locations corresponds to the legal seat of the organisation, but this information should be available to applicants, of course.
Once a (draft) application is created, the location associated to the application cannot be changed in the IRIS Portal anymore, irrespective of the status of the submission (draft, ongoing or completed). However, all submissions are visible in the portal, regardless of the location chosen, to users that are affiliated to the parent organisation.
It is however possible to transfer an RPI to a different location of the same organisation, or to any location of another organisation, via the specific submission in IRIS. In addition, it is possible to transfer a Scientific Advice "regulatory entitlement" (outcome) via a self-service, automated procedure in IRIS. Other types of regulatory entitlements, such as an Orphan Designation, can also be transferred via IRIS but as the procedure requires an EMA Opinion and an EC decision, the procedure cannot be automated.
Please note that when creating a new application on behalf of a given location, only RPIs and Regulatory Entitlements also assigned to the same location will be selectable for the submission; this is one of the reasons why it is advisable to use the same location (legal seat) consistently across all IRIS procedures for a given organisation.
RE: Updated IRIS guide for applicants - Registering an i-SPOC
As reported in the initial message of this thread:
Marketing authorisation holders for all authorised medicines in the EU are required to appoint a so-called Industry single point of contact (i-SPOC) who can provide nformation directly to EMA about the supply and availability of critical medicines identified in the context of a major event or a public health emergency. This applies to products authorised via any procedure, whether centrally via EMA, or using national, mutual recognition or decentralised procedures.
RE: Organization IssueFor specific technical issues with IRIS or SPOR-OMS, please create a ticket in the EMA Servicedesk system. Note that an organisation must be listed in the OMS system of SPOR, to be visible in IRIS. Organisations should be added, modified or deleted directly in OMS, not in IRIS.
To be able to create submissions on behalf of an organisation, an IRIS user must be affiliated to that organisation, with the role of IRIS Industry Manager; the affiliation request must be done in the EMA account management system. We note that your IRIS user account is not affiliated to any organisation.