Case Glossary
Search Import Questions Import Conditions Onshore Outcomes
Case: Human therapeutics and medicines Effective 25 Sep 2021 to 01 Oct 2021
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. |
goods |
Goods include:
Goods does not include ballast water or human remains. It also does not include a conveyance, except in certain circumstances. |
human therapeutic use |
Under Section 3 of the Therapeutic Goods Act 1989, therapeutic use means use in or in connection with:
|
human tissue |
Human tissue does not include:
|
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. |
Medical Devices included Class III |
The TGA have classified these goods as high risk. |
Section 3 of the Therapeutic Goods Act 1989 |
See human therapeutic use |
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. |
therapeutic use |
See human therapeutic use |
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