• RE: EMA Inspections GMP is available on IRIS portal from 21 September 2021

    Dear Poonam 

    Following on from Susanne's question. Would "all IRIS admin users", and or "all IRIS managers"  or "all IRIS users (admin, manager and contributor) of the company receive an email from IRIS to notify of an inspection?

    In an earlier response to Isha (https://iris.ema.europa.eu/forums/general-discussion/f9ed2c6b-7d1b-ec11-b76a-0003ff4a48b7)  you stated that the user is: Product Contact for the application already notified to EMA, and the Portal Contact (a.k.a. Submission Contact) for the Marketing Authorisation Holder/Applicant. Will they require to be admin or manager or contributor in the IRIS portal or would they receive the notification in their email even without IRIS access?

    Would the company solely receive an email via the IRIS platform or would MAH contact person be notified via their email address?
    Is there any other way that the MAH would receive the notification of an inspection (for example email to a user not registered in IRIS but registered as contact person for this company). 

    Looking forward to hearing from you
    Jolanda