New Import Requirements for Placebos used in Australian Clinical Trials

As of June 1, 2016, companies importing clinical-use placebos into Australia will need to provide information about the placebo’s producer. Currently, Australian food importers are required to provide producer information only for certain, so-called, risk foods. However, a recent announcement by the Australian Department of Agriculture and Water Resources confirmed that importers will need to declare producer information on all food items.

So, why are clinical-use placebos affected by this new food import requirement?  Because Customs considers placebos a food item and not a drug.  For Customs purposes, an imported item is classified according to the Harmonized System (HS) rule which states that an item must be classified under the tariff code that best describes it.  As a result, it has been Customs’ long-standing position that placebos, which do not have a therapeutic effect, and are typically composed largely of sugar, milk or similar products cannot be classified as medicines; instead, they are classifiable under the tariff code(s) for food items.

Beginning June 1st, importers of placebos into Australia will need to provide their broker’s with the following information:

  • The HS classification for the placebo
  • The full name and address of the placebo’s actual producer also referred to as the manufacturer. This information will allow the broker to create and submit a producer code.
  • Sufficient information about the placebo, including a list of ingredients and percentages of those ingredients in a mixed or processed item

Importers should also be prepared to answer additional questions about the placebo since this new reporting requirement may trigger additional scrutiny from the participating regulators.

All too often HS classification is seen as simply a Customs or trade formality. However, this new reporting requirement and the impact on placebo imports into Australia, highlight the importance and practical application of HS classification in trade and regulatory compliance.

Customs and other government agencies often rely on HS classification to determine when and to which degree an item is controlled for import purposes.  Importers should know how their products are classified according to the HS and ensure the HS code and a detailed description of the imported product are clearly written on shipping documents, especially the invoice presented to customs. Document accuracy and completeness is a critical step in ensuring compliance with import regulation and reducing the opportunities for delays at the border.

Marken’s trade compliance team offers support to customers in ensuring an appropriate HS code is identified for their shipments.

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