• Loading substances error in ‘Request for a Research Product Identifier’

    IRIS industry portal users have reported an occasional problem when all mandatory fields have been filled in a ‘Request for research product’ submission, but the system returns an error ;  the substances keep on loading. This prevents the user from clicking on the ‘Save and Return’ button, thus blocking the progress of the submission.
    Investigation of the events has suggested that the issue is related to cookies in the browser, as it could be resolved by changing browser and/or using private/incognito mode.
    Solution- If the issue occurs; we suggest using the Chrome browser in incognito mode so that old cookies are not present in your session. Make a new request, or reopen the existing one, in incognito mode; add the missing details and click on “save and return”. If you still face issues after deleting cookies from the browser or opening a new session in chrome (incognito mode), please raise a Service Desk ticket


     

  • IRIS Release Information - Week of 18 February 2021 (R2.7)

    Industry Portal Changes

    1. Bug fixed for ‘Clarification on SA’: The "Select previous advice" lookup is now working in the 'Clarification on SA' form. Users will be able to request and submit this submission type.
    2. The ‘Age range' field is made mandatory in “Application for Orphan Designation” and  "Amendment of orphan designation" forms.
    3. Workaround for error messages like ‘Message object reference error’ when creating a new submission:  many users have reported this error in the 'Choose submission Type' section, while drafting a new submission. Users are blocked by this error and cannot proceed further with the creation of the submission. After investigation, there seems to be no technical issue, but this appears to be a caching problem. The simple solution is to refresh the browser (F5). The error will disappear and the user can continue with the application.
  • RE: Marketing Status Reporting

    Please find our responses to your questions:

    Is it still planned to launch of marking status reporting in IRIS in the first week of December (this date is mentioned here in the forum)?
    No. we do not have yet a fixed launch yet but we intend to launch I QTR 2021

    Will there be a staggered roll-out? Meaning the newly granted MA first, followed by older authorised CP products?
    Yes. We plan a staggered approach to be presented and discussed with Industry associations on EMA industry Platform meeting on centralised procedure on 3rd Dec 2020.

    Will the launch data be available for the public?
    The data will not be publicly available.

    Will the use become immediately mandatory or optional?
    There is a legal obligation to report marketing status to EMA. This constitutes a new way of reporting the marketing status to EMA.

    Will marking status data of CP products be migrated or do users have the enter all dates?
    Users will require to enter a baseline data for authorized products. These details are intended to be discussed and agreed with Industry associations on 3rd December

    Will the same granularity be used as for the current EMA template/notification?
    The level of granularity is similar.

    Will training to be offered?
    The system for data entry is very intuitive, similar to all other IRIS submissions. The IRIS guidance is being updated to include information on the new procedures. If needed, training could be considered.