Australia #3352 (v.2)
Base data
- Notified in
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G/MA/QR/N/AUS/5 30/09/2020
- Version validity
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30/09/2020 -
28/09/2022
Old version v.2
- 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 5A, 5G and 5H of the PI Regulations except with the permission of the Secretary of the Australian Department of Health. These substances include antibiotics, certain hormones (included in Schedules 7A of the PI Regulations) and other substances, including anabolic or androgenic substances (included in Schedule 8 of the PI Regulations).
Therapeutic goods imported into Australia for use in a clinical trial must be notified to the Department of Health through the Clinical Trial Notification scheme prior to the goods being supplied to the trial site. - Responsible entities
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- HS version
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HS 2022
- Referenced WTO document symbol
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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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Various
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Importation into Australia of therapeutic goods for human use is controlled under the Therapeutic Go...
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