WTO Quantitative Restrictions

Australia #3352 (v.4)

Base data

Notified in
Version validity
01/10/2024 - present
Current active version v.4
Reporting member
Australia
In force from
End date
In force
General description
Therapeutic substances and goods
National legal basis
Therapeutic Goods Act 1989, and its Regulations.
Customs (Prohibited Imports) Regulations 1956.
Administrative mechanism
Under the Therapeutic Goods Act 1989, therapeutic goods may not be lawfully imported into Australia unless the goods are included in the Australian Register of Therapeutic Goods (ARTG) or are the subject of an exemption, approval or authority in relation to the requirement to be included in the ARTG.

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 approved or notified to the Therapeutic Goods Administration, within the Department of Health and Aged Care through the Clinical Trial Approval or Clinical Trial Notification scheme prior to the goods being supplied to the trial site.
Responsible entities
Department of Health and Aged Care
HS version
HS 2022
Referenced WTO document symbol

Meta data

WTO justifications

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
Affected partners
Non-affected partners

Measures

Reported restrictions
NAL
Symbol
NAL

Tariff lines
00
Various
Importation into Australia of therapeutic goods for human use is controlled under the Therapeutic Go...