Case Glossary

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 (Conditionally Non-prohibited Goods Determination) 2021, i.e. an import permit may be required.

See Commercially prepared and packaged

Commercially prepared and packaged goods must contain information about the product either on a label or on commercial documentation accompanying the goods e.g. a commercial invoice.

Handwritten or handmade labels (for example: labels made of fabric/leather/metal/crafty material/handwritten on a label) are not acceptable. Package must be tamper evident or tamper resistant.

The following information must be included:

1. Name or description of the goods,
2. A list of all the ingredients or components (if multiple),
3. Country where the goods were made or produced,
4. The quantity of the package contents (weight, volume, count), AND  

5. At least one of the other components from the below list:

   • Name and address of the manufacturer or supplier of the goods,
   • Serial, batch or lot identification numbers,
   • Branding information (including marks numerals or symbols),
   • Date marking information,
   • Bar codes, Universal Product Codes, and RFID labels,
   • Nutrition information,
   • Directions for use and storage conditions.

Note: Refer to Attachments 1 (Acceptable packaging) and 2 (Unacceptable packaging) for examples of packaging.

Goods include:

1. An animal
2. A plant
3. A sample or specimen of a disease agent
4. A pest
5. Mail; and
6. Any other article substance or thing.

Goods does not include ballast water or human remains. It also does not include a conveyance, except in certain circumstances.

Under Section 3 of the Therapeutic Goods Act 1989, therapeutic use means use in or in connection with:

1. preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons, or
2. influencing, inhibiting or modifying a physiological process in persons, or
3. testing the susceptibility of persons to a disease or ailment, or
4. influencing, controlling or preventing conception in persons, or
5. testing for pregnancy in persons, or
6. the replacement or modification of parts of the anatomy in persons.

Human tissue does not include:

1. 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
   

2. hair, teeth or bones from a human’s body, if without adhering tissue.
   

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.

The TGA have classified these goods as high risk.
Examples include: Coronary artery probes, intrauterine contraceptive devices, medical devices that contain medicines, such as dressings with an anti-microbial agent.

An imported good is considered retail packaged if it has been commercially prepared and packaged overseas and is in a final state that requires no further processing, packaging or labelling prior to retail sale or consumer use in Australia.

See human therapeutic use

The TGA is part of the Department of Health and Aged Care. 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, Fisheries and Forestry.

See human therapeutic use