Updating XEVMPD for UK MAs to the country code XI

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  • #42285

    Dear Colleagues,
    I wanted to ask you if you have received any updated information on ‘Q1: Updating XEVMPD for UK MAs to the country code XI. Does the MAH, QPPV, and PSMF associated with the product entry need to be established in NI, or can they be in GB?’
    I was aware from the PV Webinar on 09th march 2021 that we are waiting for clarity from MHRA. I just wanted to check if anyone has received any update on this.
    Thank you very much in advance.

    #42286

    Dear Member

    Thank you for your query.

    Please note that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.

    No update has been provided by the MHRA regarding Q1: Updating XEVMPD for UK MAs to the country code XI. Does the MAH, QPPV, and PSMF associated with the product entry need to be established in NI, or can they be in GB?. Should you wish to contact the MHRA for further clarity, you can email them via pharmacovigilanceservice@mhra.gov.uk with urgent questions.

    Kind regards

    PIPA

    #42287

    Thank you for your attention and feedback.

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