Case Glossary

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Case: Human therapeutics and medicines Effective 07 Jan 2020 to 01 Feb 2020

Glossary

The following provides a definition of words or phrases that are found within the text. Some of these have a special meaning in relation to the importation or treatment of goods entering Australia and may be important to understand in meeting the requirements for import.

Term	Definition
Approved Arrangement Site (AA Site)	An arrangement approved under Section 406 of the Biosecurity Act 2015 (Cwlth) which permits a biosecurity industry participant to carry out specified activities to manage biosecurity risks associated with particular goods, premises or other things.
AUST R	Australian registered (AUST R) medicines undergo a rigorous and detailed process of assessment and regulation by the TGA. Sponsors of these medicines must provide comprehensive safety, quality and efficacy data. These medicines may contain ingredients that are not approved for import to Australia under alternative conditions in the Biosecurity (Prohibited and Conditionally Non-prohibited Goods Determination) 2016, i.e. an import permit may be required.
clinical trials	Clinical trials are regulated by the TGA under the Clinical Trial Notification (CTN) Scheme or the Clinical Trial Exemption (CTX) scheme. Some clinical trial will be blind trials where the patient, and in some cases also the clinician, is not aware if the patient is being given the medicine or a placebo. In these cases the goods will be imported with a reference number, rather than a product name, on the label and accompanying documentation. Consignments of clinical trial goods will often contain placebos along with the medicine.
goods	Goods include: 1. An animal. 2. A plant. 3. Any other article, substance or thing (including, but not limited to, any kind of moveable property); and, to avoid doubt, includes mail of any kind and ballast water.
human tissue	Human tissue does not include: a deceased human’s body, or part of a deceased human’s body, that is being brought or imported into Australian territory for burial or cremation; or hair, teeth or bones from a human’s body, if without adhering tissue.
import permit application	The department will assess the application and on the basis of that assessment may decide to grant an import permit subject to any conditions deemed necessary for safe importation, use and disposal of those products. It should be noted that applying for an import permit does not automatically result in an import permit being issued. The Director of biosecurity or their delegate issues the import permit. You should ensure that an application is submitted for each product type and that the prescribed fee accompanies the import permit application.
Therapeutic Goods Administration (TGA)	The TGA is part of the Department of Health. The TGA is responsible regulating the supply, import, export, manufacturing and advertising of therapeutic goods. Note: The import of therapeutic goods containing or derived from biological or human material is also regulated by the Department of Agriculture.