• 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.

  • 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.

  • 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

  • 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.

  • RE: Single RPI for different development programs by different organisations?

    <strong>As the scope of the RPI is to allow tracking of a medicinal product development across all its lifecycle, EMA holds a single RPI for every development product, across all indications and even if the product is transferred/sold to another organisations, or if a submission is prepared by a different organisation (e.g. a consultant). It is the responsibility of the holder of the RPI to transfer it to another organisation, which can be done quickly and easily in IRIS - the operation is automated (no EMA validation or assessment) and the transfer is almost instantaneous. The RPI can then be transferred back, or to another organisation, any number of times - there is no limit.&nbsp;</strong>
  • RE: MAH transfers - do products automatically appear in IRIS?

    RPIs and authorisation products are different records, and the parent RPI of an "Authorisation Product" is not transferred automatically if the MA applicant / holder of the "Authorisation Product" changes. Conceptually, there are possible situations in which an RPI is parent to two or more Authorisation Products (e.g. orphan, non-orphan and generic, or duplicates/informed consent), and therefore the Authorisation Products may have different MA holders after a transfer. The current holder of the RPI can transfer the RPI quickly and automatically via the IRIS portal, and the transfer can be repeated any number of times.

    The transferred Authorisation product will be, of course, visible to the new MA applicant / holder in IRIS after the transfer. 

    Please note that the change of the MA holder in IRIS is currently done manually, which can occasionally lead to a temporary desynchronisation of the MA holder between the Packaged Medicinal Product (presentation) record and the Authorisation Product record. If this is noticed, please wait a few days before raising a ServiceNow ticket to inform EMA of the issue.