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  • 1.  Physical importation site EU submissions

    This message was posted by a user wishing to remain anonymous
    Posted 19-Sep-2023 09:03
    This message was posted by a user wishing to remain anonymous

    Dear all, 

    I am preparing an EU variation submission for the replacement of the manufacturing site . The new site is outside Europe performing manufacturing and packaging ( primary-secondary). In the supply chain there is an EU physical importation site (warehouse GMP certified) and a separate EU testing& batch release site.

    Should we mention the importation site in the eaf (there is a relevant manufacturing operation in 2.5.2 eaf section_physical importation function ) and consequently in 32p31 section or not mentioned this site at all? Does the inclusion of the importation site triggers additional variation submission? 

    Thank you in advance



  • 2.  RE: Physical importation site EU submissions

    Posted 21-Sep-2023 08:28

    Hello,

    You need to make sure IMPD is updated to mention the new manufacturing site and also the local European depot. You need to submit GMP certification of the local EU depot. Also since the drugs are manufactured outside Europe the local EU depot has to QP release the drugs so they have to provide you QP declaration as well.

    In short you need to submit the following documents: updated IMPD, GMP certification of the local depot, QP declaration.

    Hint: Also please check your labels in case you need to update something there too. 

    Have a great day,

    Olga



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    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    olga.peycheva@solutionsop.co.uk
    United Kingdom
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