Regulatory Open Forum

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  • 1.  Export Certificate Requirement

    Posted 17-Jan-2013 13:54

    Would like to receive feedback on whether or not export certificates are required for exporting investigational drug product.  Our understanding is there is no US FDA requirement to have export certification per 21 CFR 312.110, as long as there is an open/active IND on file.  

    The only instances when an export certificate would be required are:

    • If the study protocol has not been submitted to the IND, or
    • If the IND is on clinical hold


    I would appreciate any feedback/experience on export certification requirements.


    Thank you,

    Alka Majethia, MS, RAC
    Gaithersburg, MD

  • 2.  RE:Export Certificate Requirement

    Posted 18-Jan-2013 19:02

    You can also ship materials for clinical investigation without an export certificate as long as shipping to one of the listed countries as listed 802(b)(1)(A) of the Act.


    Robert Blanks RAC
    VP Chemistry Manufacture and Control
    Auburndale MA
    United States