Australia #3352 (v.2)
Datos básicos
- Notificada en
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G/MA/QR/N/AUS/5 30/09/2020
- Validez de la versión
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30/09/2020 -
28/09/2022
Versión anterior v.2
- Miembro informante
- Australia
- En vigor desde
- Fecha de supresión
- En vigor
- Descripción general
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Therapeutic substances and goods
- Fundamento jurídico nacional
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Therapeutic Goods Act 1989, and its Regulations.
Customs (Prohibited Imports) Regulations 1956. - Mecanismo administrativo
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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. - Entidades responsables
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- Versión del SA
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HS 2022
- Signatura de la OMC a que se hace referencia
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Metadatos
- Justificaciones en el marco de la OMC
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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)
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- Interlocutores afectados
- Interlocutores no afectados
Medidas
- Restricciones notificadas
- NAL
| Signatura |
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NAL
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Líneas arancelarias
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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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