• RE: Wrong MAH address in IRIS

    Pending the release of PMS (SPOR), IRIS data on Authorisation Medicinal Products are derived from SIAMED2. However, due to an incomplete synchronisation of IRIS with SIAMED2, some authorised product are associated with an old location (of the same or another organisation). EMA is aware of the problem and a process has been set up to reconcile the data prospectively and retrospectively.

    For specific cases of urgency, please submit a Servicedesk request, indicating each product and the location ID of the correct marketing authorisation holder. Data will then be updated from the back end. 
  • RE: Translations of registered active substances for OMPD submission

    The complex substance name should be used, not the company code (short synonym).
  • RE: Discrepance between online form and auto-generated application form

    This is an error in the text of the generated application form. Please ignore it, the correct question to be answered is the one in the web form. 
  • Marketing status submissions will be available in IRIS from July 2021

    The IRIS system will include the possibility to upload information on the marketing status of centrally authorised product from July 2021. The feature is expected to be available online between the second and fourth week of July. Updated guidance will be available at the same time on the IRIS home page. 
  • Automatic deletion of inactive submissions

    From today, IRIS will scan all the submissions to identify those that have been inactive (no change in data) for more than 7 months, and send an email to the submission contact (a.k.a. portal contact) to inform of the upcoming deletion of the submission unless a change is made to the submission in the following 2 weeks.
    If no change is made to the submission during that time, it will be deleted and definitively removed from the IRIS system, including any documents uploaded to IRIS. A final email will be sent to the submission contact, to notify the permanent removal of the submission from the system. 
    Replies to the emails will not be read or acknowledged.

    EMA IT systems will undergo planned maintenance starting on Friday 18 June at 18:00 and terminating at the latest on Sunday 20 June at 23.59. During this time, login to the IRIS portal may be unavailable, particularly on Saturday. 

    Detailed info:
    To strengthen information security, EMA Infrastructure Transformation will be performing essential maintenance to components of the EMA IT infrastructure during the weekend of 18 to 20 June. The work will start at 18:00 on Friday, 18 June, and finish by 23:59 on Sunday, 20 June. From 18:30 on Friday, 18 June to 18:30 on Saturday, 19 June, all EMA systems will be unavailable (with the exception of the EMA corporate website, which will not be impacted). From 17:20 on Saturday, 19 June until the conclusion of validation tests (by 23:59 on Sunday, 20 June at the latest), EMA systems might be intermittently unavailable. 

  • Questions and Answers at the IRIS Industry Stakeholders meeting, 21 May 2021

    The questions received for the IRIS Industry Stakeholders meeting of 21 May 2021 are available in the attached Excel file, together with the answers from the IRIS team. Please note that the answers reflect the understanding of the EMA IRIS team at the time of the meeting, but do not state a finalised commitment of the Agency regarding the development of IRIS, or its integrated systems (such as SPOR). 

  • "Dormant" status for Regulatory Entitlements

    The "dormant" status only applies to Parallel Distribution Regulatory entitlements. Please see below the information from the Parallel Distribution FAQs

    If the medicinal product has not been distributed in parallel for the last 12 months it should be updated to the ‘dormant’ status using the ‘update of parallel distribution notice status’ procedure, which does not incur any fees. During the period of dormancy the annual update does not need to be submitted.

    The confirmed dormancy will be reflected in the public register of parallel distribution.  An independent notice will not be sent.

    The product will remain ‘dormant’ until the Agency is notified otherwise. To resume distribution of the product after a period of ‘dormancy’, an ‘annual update’ should be submitted.
  • RE: RMS Lists used in IRIS procedures

    In addition, please note that the attached Excel file contains all the terms in the lookup lists that are internal to IRIS, i.e. not present in RMS. 
  • RE: Final version scientific document

    As a general rule, once an application in IRIS is submitted to EMA for the first time, it becomes locked and it is not possible to edit the data in the portal or upload new documents. EMA staff can reopen the submission, thus allowing the applicant to edit data and upload new documents (before validation) or to upload new documents only (after validation).
    For additional information on a specific application, please reply to an email regarding that procedure, received from the IRIS system. Your reply email will be automatically routed to the appropriate EMA office.