Required Importation Documents »
Figure 7.
Required Importation Documents
While the apparent change in the application of 21CFR Parts 312 and 201
has dramatically altered the importation of clinical supplies into the US,
it is not the only critical information needed to ensure that your import
proceeds smoothly.
End Use Letter
The End Use Letter is a one-page document that clearly states what the
material is, how much you are importing, and for what specific use.
We recommend including the applicable CFR references (201.122 or
201.125) and the name and number of your IND. If you don’t yet have
an IND number, you can get one pre-assigned by sending in notice of
your intent to file an electronic IND. The End Use Letter should identify
the API manufacturer, the consignee (the site the API is being delivered
to – which should be the drug product manufacturer in the example
scenario), the importer of record (the sponsor of the IND), and the notify
party (your customs broker). Sufficient contact information for each
party, including phone numbers, should be listed.
Prototype Exemption Letter
In addition to the End Use Letter, you may elect to include a Prototype
Exemption (PE) letter to negate the need to pay an import tariff. Per the
Harmonized Tariff Schedule, administered by the US International Trade
Commission,9 imports are assessed a fee based on their value and, in
some cases, the country of import. The actual percentage depends on the
type of material being imported.
Historically, many sponsors would assign a nominal value for clinical
supplies as they are not intended for resale. However, the valuation
placed on the materials must represent its sale price to the sponsor.
that accompanies the shipping documents. Assuming an API batch might
cost $400,000, a 6% (based on our example scenario) additional “tax” of
$24,000 is significant.
Thankfully, a PE may be granted under 19 CFR 10.91: prototypes used
exclusively for product development and testing. The PE letter is a
signed statement drafted by the importer further clarifying that the
clinical material will not be offered for sale. It is important that the
harmonization code (HTSUS) you select based on the product type be
included along with “Prototype Exemption code 9817.85.01” wherever
the HTSUS code is called for in the documentation. In practice, the
PE Letter can be very similar to the End Use Letter, with the following
additional statement:
“Drug XX is being shipped in limited quantity to the US for development,
US Customs provides an excellent summary of the requirements for
testing, or quality control as an investigational new drug and has no
importers and notes examples of omissions and inaccuracies that should
commercial value and will not be sold after importation making it
be avoided. The valuation should be included on a pro forma invoice
eligible for import under duty free status per 9817.85.01.”
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