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Database of consents to import, supply or export therapeutic goods that do not comply with standards

4 December 2021

Medicines and other therapeutic goods must comply with applicable standards to be supplied in Australia.

Under the Therapeutic Goods Act 1989 prior consent must be given under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. The Secretary can impose conditions on the consent under section 15 of the Act.

The records below include information about these decisions, and any subsequent review of such decisions. All records below which relate to a single consent decision will have the same consent number.

Information about decisions made before 29 January 2016 are on the Federal Register of Legislation website.

In July 2020, TGA created a special consent process for prescription medicine manufacturers experiencing difficulties in introducing new TGO91 labels into their manufacturing process due to COVID-19. These decisions are displayed in a separate database: Database of consents for prescription medicines that do not comply with TGO 91 labelling due to COVID-19

Displaying 41 - 50 of 4156

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-865

ORSPEC Pharma Pty Ltd

Product: RUZURGI amifampridine 10 mg tablet bottle

ARTG number: 352630

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subsections 9(1), 9(2) and 9(3) of Therapeutic Goods Order No. 95 - Child‑resistant packaging requirements for medicines 2017

Date of consent: 10 September 2021

Duration: The consent is effective from 10 September 2021 until 10 September 2023.

​The product does not conform to the requirements of subsections 9(1), 9(2) and 9(3) of Therapeutic Goods Order No. 95 - Child‑resistant packaging requirements for medicines 2017, in that testing of child resistance has not yet been completed and documented.

From consent no. CON-863

dōTERRA Australia Pty Ltd

Product: doTERRA Peppermint

ARTG number: 332583

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 9 September 2021

Duration: The consent is effective from 9 September 2021 until 1 September 2022.

​The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text.

From consent no. CON-863

dōTERRA Australia Pty Ltd

Product: doTERRA Bergamot

ARTG number: 336053

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 9 September 2021

Duration: The consent is effective from 9 September 2021 until 1 September 2022.

​The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text.

From consent no. CON-863

dōTERRA Australia Pty Ltd

Product: doTERRA Roman Chamomile

ARTG number: 337232

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 9 September 2021

Duration: The consent is effective from 9 September 2021 until 1 September 2022.

​The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text.

From consent no. CON-863

dōTERRA Australia Pty Ltd

Product: doTERRA Cardamom

ARTG number: 335587

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 9 September 2021

Duration: The consent is effective from 9 September 2021 until 1 September 2022.

​The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text.

From consent no. CON-863

dōTERRA Australia Pty Ltd

Product: doTERRA Clary Sage

ARTG number: 337228

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 9 September 2021

Duration: The consent is effective from 9 September 2021 until 1 September 2022.

​The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text.

From consent no. CON-863

dōTERRA Australia Pty Ltd

Product: doTERRA Cypress

ARTG number: 338888

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 9 September 2021

Duration: The consent is effective from 9 September 2021 until 1 September 2022.

​The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text.

From consent no. CON-863

dōTERRA Australia Pty Ltd

Product: doTERRA Marjoram

ARTG number: 336054

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 9 September 2021

Duration: The consent is effective from 9 September 2021 until 1 September 2022.

​The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text.

From consent no. CON-863

dōTERRA Australia Pty Ltd

Product: doTERRA Eucalyptus

ARTG number: 336052

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 9 September 2021

Duration: The consent is effective from 9 September 2021 until 1 September 2022.

​The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text.

From consent no. CON-863

dōTERRA Australia Pty Ltd

Product: doTERRA Fennel

ARTG number: 335588

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 9 September 2021

Duration: The consent is effective from 9 September 2021 until 1 September 2022.

​The products do not conform to the requirements of Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines, in that the names of the medicines on the main labels are not presented in a continuous, uninterrupted manner and are broken up by additional information and background text.

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