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  • 1.  FDA Small Business - Non-acceptance of the English application form 3602A by tax authority

    This message was posted by a user wishing to remain anonymous
    Posted 11-Nov-2021 14:36
    This message was posted by a user wishing to remain anonymous

    Hi all,
    we have problems with our Small Business application because the sales of each affiliate must be proven and in France and Poland, for example, the English application form 3602A is not accepted by the tax authority. Does anyone know this problem and how was this solved?
    Thank you in advance


  • 2.  RE: FDA Small Business - Non-acceptance of the English application form 3602A by tax authority

    Posted 12-Nov-2021 02:02
    Hello Anon,
    Send an email to FDA (DICE - dice@fda.hhs.gov) and explain your problem to them. 

    You will need to show evidence that you made efforts to get the National Tax Authority (NTA) in France and Poland (where your affiliates are located) to sign on FDA Form 3602A. This can be substantiated by email request/signed letter along with the response from the NTA. 

    Hope this helps.

    ------------------------------
    [Shiven]
    [Regulatory Affairs]
    [San Francisco] [CA]
    ------------------------------

    Original Message


  • 3.  RE: FDA Small Business - Non-acceptance of the English application form 3602A by tax authority

    Posted 12-Nov-2021 02:11
    Hi Shiven, thanks for the quick reply. This is a good approach. Have you had positive experience with this yourself, or is it somewhere in the FDA regulations?

    ------------------------------
    Saschka Busch
    Emmendingen
    Germany
    ------------------------------

    Original Message


  • 4.  RE: FDA Small Business - Non-acceptance of the English application form 3602A by tax authority

    Posted 15-Nov-2021 05:36
    Hello,

    what I already did in the past was making a translation of the 3602A form in the language needed and let the authorities fill in that one

    To send to the FDA I combine the English one with the translated one and refer in the English doc to the info in the translated one

    Greetings,

    ------------------------------
    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
    ------------------------------

    Original Message


  • 5.  RE: FDA Small Business - Non-acceptance of the English application form 3602A by tax authority

    Posted 15-Nov-2021 07:29
    Dear Franky,
    thank you for the information. But did the FDA accept the translation or did it not have to be certified by an accredited translation agency?
    Best regards,
    Saschka

    ------------------------------
    Saschka Busch
    Emmendingen
    Germany
    ------------------------------

    Original Message


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