The Importer - Business Review Webinars
The Importer - Business Review Webinars
The Importer - Business Review Webinars
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USA – Import process, Clinical Pharmaceuticals<br />
Document Check List:<br />
Invoice – Complete with all data that will be entered by the US customs broker,<br />
including relevant OGA statements. This should be on shipper/exporter company<br />
letterhead. Copies are OK, however in the case of shipments requiring certain<br />
USDA permits, original signed invoices are required. This is a critical document<br />
and must always be provided.<br />
End Use Letter – This is in the form of a letter with a statement from the shipper or<br />
importer as to the reason for the import. E.g. To test the safety and efficacy of XYZ<br />
pharmaceutical as apart of FDA approved phase XX clinical trial. Again this is a<br />
back-up document that may be required after initial entry has been filed.<br />
IND Application (FDA form 1571) – This is the orig. application that was<br />
completed by the sponsor (or their authorized representative), in order to conduct<br />
the clinical trial in the US. This is a back-up document that may be requested after<br />
the initial entry has been filed.
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