Australia #3352 (v.3)
Base data
- Notified in
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G/MA/QR/N/AUS/6 28/09/2022
- Version validity
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28/09/2022 -
01/10/2024
Old version v.3
- Reporting member
- Australia
- In force from
- End date
- In force
- General description
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Therapeutic substances and goods
- National legal basis
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Therapeutic Goods Act 1989, and its Regulations.
Customs (Prohibited Imports) Regulations 1956. - Administrative mechanism
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Under the Therapeutic Goods Act 1989, therapeutic goods may not be imported into Australia unless they are registered, listed or included in the Australian Register of Therapeutic Goods (ARTG) or specifically exempt from this requirement.
Importation of certain substances is prohibited under regulations 5, 5G and 5H of the PI Regulations except with the permission of the Secretary of the Australian Department of Health and Aged Care. These substances include, certain hormones and other substances, including anabolic or androgenic substances (included in Schedule 7A of the PI Regulations).
Therapeutic goods imported into Australia for use in a clinical trial must be notified to the Department of Health and Aged Care through the Clinical Trial Notification scheme prior to the goods being supplied to the trial site.
- Responsible entities
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Department of Health and Aged Care
- HS version
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HS 2022
- Referenced WTO document symbol
Meta data
- WTO justifications
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XX:(b) - (b) necessary to protect human, animal or plant life or health;
GATT 1994 (GATT 1947 provisions)
Reported as: Article XX(b) of the GATT. - Non-WTO commitments
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- Affected partners
- Non-affected partners
Measures
- Reported restrictions
- NAL
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NAL
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Tariff lines
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00
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Various
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Importation into Australia of therapeutic goods for human use is controlled under the Therapeutic Go...
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