Case Glossary

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Case: Human therapeutics and medicines Effective 03 Feb 2016 to 06 Feb 2016

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.
approved pharmaceutical excipients	Pharmaceutical excipients are highly processed substances that are components of commercially packaged human therapeutic products. The following substance groups are considered pharmaceutical excipients for human therapeutic products only: Alcohol Purified amino acids (excluding those derived from neutral material) Essences Esters Fish oil (other than salmon oil) Gelatine Glucosamine, chondroitin and chitosan of aquatic animal origin (unless derived from fish of the family Salmonidae) Homeopathics Pectins Plant acids Plant extracts Plant flours Plant gums Plant juices Plant oils Plant waxes Polysorbates Purified antibiotics/antimycotics manufactured without the use of materials of animal origin Purified avermectin compounds manufactured without the use of materials of animal origin Refined chemicals derived from wool grease, including cholesterol, cholecalciferol vitamin D3, lanolin or lanolin alcohols Resins Starches Stearates Sugars (including lactose) Tinctures Vinegars Vitamins Water
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.
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.
list of pharmaceutical excipients for human therapeutics	Pharmaceutical excipients are highly processed substances that are components of commercially packaged human therapeutic products. The following substance groups are considered pharmaceutical excipients for human therapeutic products only: Alcohol Purified amino acids (excluding those derived from neutral material) Essences Esters Fish oil (other than salmon oil) Gelatine Glucosamine, chondroitin and chitosan of aquatic animal origin (unless derived from fish of the family Salmonidae) Homeopathics Pectins Plant acids Plant extracts Plant flours Plant gums Plant juices Plant oils Plant waxes Polysorbates Purified antibiotics/antimycotics manufactured without the use of materials of animal origin Purified avermectin compounds manufactured without the use of materials of animal origin Refined chemicals derived from wool grease, including cholesterol, cholecalciferol vitamin D3, lanolin or lanolin alcohols Resins Starches Stearates Sugars (including lactose) Tinctures Vinegars Vitamins Water