UK PSMF

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  • #43769
    Inam Hassan
    Participant

    Hi,

    UK PSMF- is there a requirement to add third party contract in the ANNEX for Cosmetic, Medical devices that we work with or do we just add the medicinal products contract with third party?

    Thanks

    #43778

    Dear PIPA Member,

    Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

    The obligation on the MAH to maintain and make available a PSMF is provided under section 182 of the Human Medicines Regulations 2012 (as amended) and therefore covers medicinal products only. It is however, worth considering whether the third party contract covers a combination of cosmetic/device and pharmacovigilance services as this may bring the contract into scope of the PSMF.

    Kind regards
    PIPA

    #43779
    Inam Hassan
    Participant

    Hi,

    Thanks for your response. This seems to show that we will need to add the third party contract info for Cosmetics/Medical devices as they cover the PV services.

    #44726
    Adrian Williams
    Participant

    Hi. I’ll be reading the recently issued UK PSMF guidance this afternoon, but can PIPA or members make any comment about amending/aligning the EU PSMF with UK details for a CAP which has been grandfathered to a PLGB? Could, for example, the EU PSMF be the main document with a UK PSMF supplementary document which only outlines additional requirements for the UK, similar to the MHRA GVP Guidance document with the GVP modules? #smallpharmaproblems

    #44755

    Dear PIPA Member,

    Thank you for your enquiry. Please note, the views below are of the PIPA Committee and do not represent any particular Company.

    I will be sure to pass on your comments to the PSMF Working Party.

    Kind regards
    PIPA

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