OMC Restrictions quantitatives

Australie #3352 (v.4)

Données de base

Notifiée dans
Validité de la version
01/10/2024 - actuelle
Version active v.4
Membre présentant le rapport
Australie
En vigueur depuis
Date de fin
En vigueur
Description générale
Therapeutic substances and goods
Base légale nationale
Therapeutic Goods Act 1989, and its Regulations.
Customs (Prohibited Imports) Regulations 1956.
Mécanisme administratif
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.
Entités responsables
Department of Health and Aged Care
Version du SH
HS 2022
Cote du document de l'OMC mentionné

Métadonnées

Justifications au regard de l'OMC

XX:(b) - (b) necessary to protect human, animal or plant life or health;

GATT 1994 (GATT 1947 provisions)

Signalé comme: Article XX(b) of the GATT.
Engagements internationaux (hors OMC)
Partenaires concernés
Partenaires non concernés

Mesures

Restrictions signalées
NAL
Cote
NAL

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