Australia #3352 (v.4)
Datos básicos
- Notificada en
-
G/MA/QR/N/AUS/7 30/09/2024G/MA/QR/N/AUS/8 20/10/2026
- Validez de la versión
-
01/10/2024 -
actual
Versión activa actual v.4
- Miembro informante
- Australia
- En vigor desde
- Fecha de supresión
- En vigor
- Descripción general
-
Therapeutic substances and goods
- Fundamento jurídico nacional
-
Therapeutic Goods Act 1989, and its Regulations.
Customs (Prohibited Imports) Regulations 1956. - Mecanismo administrativo
-
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.
- Entidades responsables
-
Department of Health and Aged Care
- Versión del SA
-
HS 2022
- Signatura de la OMC a que se hace referencia
Metadatos
- Justificaciones en el marco de la OMC
-
XX:(b) - (b) necessary to protect human, animal or plant life or health;
GATT 1994 (GATT 1947 provisions)
Notificada como: Article XX(b) of the GATT. - Compromisos Internacionales (distintos de los asumidos en el marco de la OMC)
-
- Interlocutores afectados
- Interlocutores no afectados
Medidas
- Restricciones notificadas
- NAL
| Signatura |
|---|
|
NAL
|
Líneas arancelarias
|
00
|
Various
|
Importation into Australia of therapeutic goods for human use is controlled under the Therapeutic Go...
|
|