Case Glossary
Search Import Questions Import Conditions Onshore Outcomes
Case: Human therapeutics and medicines Effective 01 Sep 2020 to 05 Dec 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. |
clinical trials |
Clinical trials are regulated by the TGA under the Clinical Trial Notification (CTN) Scheme or the Clinical Trial Exemption (CTX) scheme. |
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:
|
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. |
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. |
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