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Michael Räz Dr.

Michael Räz

Joined: 8/29/2020

  • RE: UK (Northern Ireland) Entries - Windsor Framework

    Mon, 02 Dec 2024 08:00:37 GMT – UK (Northern Ireland) Entries - Windsor Framework
    Thank you for the response. I understand no reporting will be required after 01.01.2025, but my question still remains. It is not clear to me if the entries for NI will disappear in IRIS and/or if any action is required on January 1st by the MAH.  For example, if currently one product is listed as Marketed in NI, do we have to change this on January 1st to "No Data Provided" as it is no longer relevant for the EMA? Or is simply no action needed? 

  • UK (Northern Ireland) Entries - Windsor Framework

    Wed, 30 Oct 2024 13:55:08 GMT – UK (Northern Ireland) Entries - Windsor Framework
    Dear IRIS Team

    Could you please clarify the status of UK (Northern Ireland) entries in the IRIS Marketing Status Database from 01.01.2025? As you are likely aware, with the enforcement of the Windsor Framework, regulatory responsibility for Northern Ireland will transition from the EMA to the MHRA. We would like to understand if any action is required from the Marketing Authorization Holder or if the UK (Northern Ireland) entries will simply be removed.

    Best
    Michael