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Export investigational product to unlisted country - experience with FDA export certificates

  • 1.  Export investigational product to unlisted country - experience with FDA export certificates

    This message was posted by a user wishing to remain anonymous
    Posted 27-Mar-2019 12:32
    This message was posted by a user wishing to remain anonymous

    Good Morning

    I am researching exporting investigational product manufactured in US to an unlisted country for use in a clinical investigation using the fourth option described in the "312 program" requirements .  I appreciate feedback from others on the following:

    1) experience successfully obtaining an FDA export certificate under such circumstances,  (ie without obtaining an FDA IND), and whether the applicants typically have a preliminary meeting with the FDA export office about expectations for the required documents / the expected GMP and bar to meet prior to submitting the export certification application. 

    2) Also given that the Certificate of Exportability request form has a field for inserting the FEI, whether registration is an additional requirement to obtain export certification (eg in circumstance where the manufacturer is not yet registered given has not yet produced any commercially available product).

    Thank you!