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For shipments of investigational/clinical trial material from the USA to the EU, we have been told to estimate the customs value based on the manufacturing costs. My questions are: (1) should we use the same customs value for all international shipments? For example, if we determine the cost of goods to be $50/vial, should this value be used for shipments to all clinical trial sites, regardless of the country we are shipping to? (2) If/when the investigational product receives approval and becomes commercial, the customs value for the commercial product may be much higher than that for investigational drug product, as we factor in the production of the goods and profit. For example, the commercial value may be increased to $5000/vial. Will this cause any concerns from, say EU or US Customs, when we ship the commercial product?
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