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RE: I can not register one of our IRIS managers as an iSPOC
The 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 IRIS
At 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 IRIS
When 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.
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RE: Organization Issue
For 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. -
Deleting a draft submission removes it definitively
To all IRIS Industry applicants:
please note that once a draft submission is deleted from the system, either by the applicant or automatically by the system after 7 months of inactivity, it is not possible to recover it in any way. The same applies to the files that were uploaded with it. This IRIS feature was included at the request of Industry representatives, who stressed the requirement for Industry to be able to remove definitively any draft data or documents, should the application not be submitted. It is of course always possible to create a new submission, at any time.
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RE: Scope for marketing status data in IRIS: centralised only?
Dear Betina Berthelsen, this "followup" question is about a different issue altogether, and should be asked in a separate thread with an appropriate subject. -
RE: Harmonize submissions of orphan designation annual reports
The IRIS system does not send notifications or reminders to solicit annual reports on orphan designations. According to Art. 5.10 of the Orphan Regulation, it is the responsibility of the Sponsor to provide an annual report on the state of the development of the designated product. More information can be found in the specific page on the EMA website: Submitting annual reports on medicine development.
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RE: Access to the submissions of former colleagues
As a general rule, it is always advisable to nominate more than one manager for each submission in IRIS. In this way, the submission will still be visible, and the portal contact can be changed, even if the creator of the submission or one of the managers associated to it leaves the company, or is unavailable.
In addition, a new role of "IRIS Industry Coordinator" will soon be introduced, and made available to be requested in the EMA Account Management System. Users affiliated to an Organisation with this role will be able to see all submissions for all locations of the Organisation, and will be able to assign new Managers (including themselves) to a submission, and to change the submission contact (a.k.a. portal contact, the person that receives IRIS communications by default). The role has just passed the User Acceptance Testing, and should be introduced in production soon. An announcement will be made in the "What's new" Forum, once a beta-test is completed in the production system.