• When will MAHs become available for i-SPOC registration?

    There are only 10 working days left until the deadline September 2nd is reached.
    10 days ago I asked EMD Service desk for support because the MAHs I am affiliated to are not displayed in IRIS:
    until today only 2 MAHs from 30 MAHs are available in IRIS for i-SPOC submission.
    Are there plans to extend the deadline?
    Do you have any advice for me?
    Many thanks in advance, Susanne
  • RE: Harmonisation of locations used in IRIS

    I understand that for SA and OD procedures I can use the submissions types "transfer".
    But how can I harmonise the location of the MAH for Marketing Authorisations?
    Is there a submission type available in IRIS that can be used for this purpose?
    Kind regards, Susanne
  • RE: Harmonisation of locations used in IRIS

    Thank you, Paolo, for this useful comments!
    Kind regards, Susanne
  • Harmonisation of locations used in IRIS

    The IRIS guide for applicants strongly recommends to use only one location for all IRIS submissions, RPIs and regulatory entitlements. 
    We started with different locations for the same MAH in IRIS.
    Now, we have transferred all RPIs to one location.
    Unfortunately, in various submissions types still the different locations are used.
    Can you please advise how to harmonise locations in IRIS?
  • RE: Automatic deletion of inactive submissions

    This is what I found out about deletion of a draft submission:
    1. Draft submissions can be deleted by the user.
    2. However, if a submission had been submitted to report marketing status and is then under"ongoing", then validated and there were errors, the submission is back to "draft" - these draft submissions cannot be deleted by the user.
  • CPP request without Marketing status reporting via IRIS

    EMA service desk informed us about an issue with PMS integration.
    Therefore, we are not able to report initial launch date via IRIS.
    However, reporting via IRIS is a requirement for CPP request.
    Did you inform the EMA department responsible for CPP creation?
    Will they allow CPP creation without an entry in IRIS?
  • RE: How to report the Marketing Status of presentations that have never been on the market

    Thank you, Paolo, for this good news!
    Should we use this new status for baseline submissions of initial launch dates?
    Formerly when we tried to submit bulk notifications we had to delete the rows with products "Never marketed".
    Could this be the reason why our bulk submissions are not completed but still in progress?
    Kind regards, Susanne
  • RE: GMP Inspections in IRIS

    I would like to add to the question above. 
    "IRIS notification will be generic (assumption) and only to one person (as informed only to the Product Contact for the application already notified to EMA", which is often the portal contact as well, which is a risk in terms of speed and eventually availability of this person (if he/she is out of office). What is done to limit this risk? Can we provide to EMA a generic email address to be copied for all inspections notifications?"
    The answer from above is:
    "The announcement of inspections via the old procedure has also only been to the product contact so there is no change with the implementation of IRIS."
    The process has not changed but the tool is now different: email vs IRIS:
    A received mail can be forwarded to a deputy or to a generic email address per rule; so in case of unavailibility of the contact person the announcement of inspections.
    The announcement of inspections in IRIS can only be opened by the contact person, and only this contact person can add additional IRIS managers.
    Is this understanding correct?
    What is done to limit the risk of the contact person being ooo?
    Will the new role "IRIS Industry Global Coordinator IRIS Industry Global Coordinator " be able to open the announcement in IRIS?
  • RE: Questions and answers on Marketing Status reporting submissions

    I noticed that the process had been improved:
    Bulk notifications with errors are NOT closed, but re-set to draft submission. The error can be corrected and the notification can be re-submitted.
    That's great because it is still the same case number!
    Unfortunately, we did NOT receive any mail notification for this re-submitted bulk notification. In the submission form all chapters have a green tick.
    We created an EMA Servicedesk ticket, the answer is not yet available.
    It would be great if you could please provide some guidance concerning this improved process.
  • RE: Questions and answers on Marketing Status reporting submissions

    We sucessfully submitted bulk notifications as baselines for already authorised products: completed positively, case closed, no validation errors
    Independly from the format of the uploaded table (Excel or csv as stated in the guidance) the markeitng status report has not been updated.
    Data are not available in the report nor in a drafted submission.
    Therefore, we are not able to submit a 2. notification as recommend to report a change (see 1. question/answer above).
    EMA Service Desk was not able to solve this issue.
    Could you please advise how to proceed?