Regulatory Open Forum

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  • 1.  Import dried blood/biological specimen samples into the EU for clinical lab testing

    Posted 17-Feb-2020 12:52
    Hello there,
    I am wondering if there are any requirements for importing dried blood/biological specimen samples into the EU for clinical lab tests?  If there are such requirements, please point me in the right direction.  

    Thank you for your help,

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    Luke Huynh RAC, MS
    Quality and Regulatory Affairs Director
    Westminster CA
    United States
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  • 2.  RE: Import dried blood/biological specimen samples into the EU for clinical lab testing

    Posted 18-Feb-2020 03:04

    Dear Luke, are the samples reasonably expected to contain pathogens of infectious material? Are you collecting them as part of a clinical trial?



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    Marie Moores
    Oslo
    Norway
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  • 3.  RE: Import dried blood/biological specimen samples into the EU for clinical lab testing

    Posted 18-Feb-2020 16:12
    Hello Marie,
    Thank you for your response. These samples are considered research/diagnostic samples to be tested in clinical labs.  I am not sure if they contain pathogens or not.  Are there different sets of requirements?  I have found the document below, which talks about the requirements for importing research and diagnostic samples, however, it alludes to samples of animal origin.  I don't know if this is applicable to us.

    http://apha.defra.gov.uk/documents/bip/iin/abp-30.pdf

    the website that lists the requirements
    https://www.gov.uk/guidance/importing-live-animals-or-animal-products-from-non-eu-countries-general-licences-and-authorisations

    Thank you for your help.
    Luke

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    Loc Huynh RAC, MS
    Quality and Regulatory Affairs Director
    Westminster CA
    United States
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