MHRA guidance post transition period

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  • #12291

    Dear PIPA

    I am a member of your organisation.

    We have seen the new guidance from MHRA regarding the regulation of medicines after the transition period;

    I wondered if you were able to help to clarify a couple of points please which I am sure are also questions your other members have following this guidance:

    -UK PSMF and the UKQPPV Role appear to be completely absent from the new PV procedures guidance.  Is that because this is no longer required or is this guidance to follow soon?

    -The PV guidance mentions the UK becoming MAH for medicines yet the specific guidance on this has not been re-issued.  Does the MAH need to be in the UK?

    If you could help to provide some further clarification on these topics I would be really grateful.

    Thank you.

    #12293

    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 pharmacovigilance regulatory legislation, guidelines and your own company procedures.

    Dear PIPA Member,

    Thank you for your enquiry regarding the guidance following the end of the transition period concerning the UK PSMF & the UK QPPV role.

    Today (4th September), the MHRA published new guidance concerning the legal obligations of the QPPV & PSMF as from 1st January 2021.

    I can confirm that both the QPPV and PSMF need to be established for the UK and is a legal requirement as from 1st January 2021.

    The guidance states that for all UK Marketing authorisations (MAs), including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the marketing authorisation holder (MAH) must have permanently and continuously at its disposal a QPPV who resides and operates in the EU or the UK, and is responsible for the establishment and maintenance of the pharmacovigilance system.

    This is provided for by regulation 182 of the Human Medicines Regulations 2012 (as amended).

    For MAs that cover the whole of the UK or are specific to Northern Ireland, the legal requirements concerning the qualifications and responsibilities of the QPPV> that are outlined in Article 10 of the Commission Implementing Regulation EU No 520/2012 (CIR) will remain unchanged.

    https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf-from-1-january-2021?utm_source=487d5bda-3862-4d7a-8aa4-0d7a19d6f8c3&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate

    I do hope this helps in answering your query.

    Kind regards

    PIPA

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