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

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.

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Displaying 1 - 10 of 937

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-243

Ipsen Pty Ltd

Product: CABOMETYX cabozantinib (as (S)-malate) 60 mg film-coated tablet bottle

ARTG number: 283799

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclauses 3(2)(j) and 3(2)(l), of the Therapeutic Goods Order No. 69 General requirements for labels for medicines.

Date of consent: 22 January 2018

Duration: The consent is effective from the 22 January 2018 until 1 June 2018.

​The labels do not include the storage conditions, nor the name and address of the Australian sponsor or supplier.

​1. The tablets are otherwise the same as those registered; and

2. The tablets are labelled as detailed in the email from dr Whittaker on 30 November 2017; and

3. The carton is overstickered or otherwise marked with information identifying the Australian sponsor and the ARTG number on one panel.

From consent no. CON-243

Ipsen Pty Ltd

Product: CABOMETYX cabozantinib (as (S)-malate) 40 mg film-coated tablet bottle

ARTG number: 283801

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclauses 3(2)(j) and 3(2)(l), of the Therapeutic Goods Order No. 69 General requirements for labels for medicines.

Date of consent: 22 January 2018

Duration: The consent is effective from the 22 January 2018 until 1 June 2018.

​The labels do not include the storage conditions, nor the name and address of the Australian sponsor or supplier.

​1. The tablets are otherwise the same as those registered; and

2. The tablets are labelled as detailed in the email from dr Whittaker on 30 November 2017; and

3. The carton is overstickered or otherwise marked with information identifying the Australian sponsor and the ARTG number on one panel.

From consent no. CON-243

Ipsen Pty Ltd

Product: CABOMETYX cabozantinib (as (S)-malate) 20 mg film-coated tablet bottle

ARTG number: 283800

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclauses 3(2)(j) and 3(2)(l), of the Therapeutic Goods Order No. 69 General requirements for labels for medicines.

Date of consent: 22 January 2018

Duration: The consent is effective from the 22 January 2018 until 1 June 2018.

​The labels do not include the storage conditions, nor the name and address of the Australian sponsor or supplier.

​1. The tablets are otherwise the same as those registered; and

2. The tablets are labelled as detailed in the email from dr Whittaker on 30 November 2017; and

3. The carton is overstickered or otherwise marked with information identifying the Australian sponsor and the ARTG number on one panel.

From consent no. CON-242

Pfizer Australia

Product: ADVIL RAPID RELEASE ibuprofen sodium dihydrate 256 mg tablet bottle

ARTG number: 288707

Batches: W24301, W31815, W22477

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 3(2)(h) of the Therapeutic Goods Order No. 69– General requirements for labels for medicines.

Date of consent: 17 January 2018

Duration: The consent is effective from the 17 January 2018 until 17 January 2020.

​ The bottle labels do not include the batch number prefix.

From consent no. CON-245

Guerbet Australia Pty Ltd

Product: ASPEN PATENT BLUE V 50 mg/2 mL injection ampoule

ARTG number: 27539

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines

Date of consent: 12 January 2018

Duration: The consent is effective from the 12 January 2018 until 9 January 2019

The product labels do not display the name and contact details of the current sponsor in Australia.

​1. The sponsor has set-up re-direction of all mails addressed to Aspen Pharmacare Australia Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address.

2. An agreement between Aspen Pharmacare Australia and Guerbet Australia is in place to ensure all email and/or telephone contact inadvertently made to Aspen Pharmacare Australia regarding a product of Guerbet Australia is and will be redirected appropriately.

From consent no. CON-245

Guerbet Australia Pty Ltd

Product: LIPIODOL ultra fluid iodised oil 10 mL injection BP ampoule

ARTG number: 34371

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 7(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines

Date of consent: 12 January 2018

Duration: The consent is effective from the 12 January 2018 until 9 January 2019

The product labels do not display the name and contact details of the current sponsor in Australia.

​1. The sponsor has set-up re-direction of all mails addressed to Aspen Pharmacare Australia Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address.

2. An agreement between Aspen Pharmacare Australia and Guerbet Australia is in place to ensure all email and/or telephone contact inadvertently made to Aspen Pharmacare Australia regarding a product of Guerbet Australia is and will be redirected appropriately.

From consent no. CON-244

Guerbet Australia Pty Ltd

Product: DOTAREM gadoteric acid 279.32 mg/mL injection 20 mL pre-filled syringe

ARTG number: 160800

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017.

Date of consent: 12 January 2018

Duration: The consent is effective from the 12 January 2018 until 30 November 2018.

​The product labels do not display the name and contact details of the current sponsor in Australia.

​1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address.

2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately.

From consent no. CON-244

Guerbet Australia Pty Ltd

Product: DOTAREM gadoteric acid 279.32 mg/mL injection 15 mL pre-filled syringe

ARTG number: 160799

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017.

Date of consent: 12 January 2018

Duration: The consent is effective from the 12 January 2018 until 30 November 2018.

​The product labels do not display the name and contact details of the current sponsor in Australia.

​1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address.

2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately.

From consent no. CON-244

Guerbet Australia Pty Ltd

Product: DOTAREM gadoteric acid 279.32 mg/mL injection 10 mL pre-filled syringe

ARTG number: 160798

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017.

Date of consent: 12 January 2018

Duration: The consent is effective from the 12 January 2018 until 30 November 2018.

​The product labels do not display the name and contact details of the current sponsor in Australia.

​1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address.

2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately.

From consent no. CON-244

Guerbet Australia Pty Ltd

Product: DOTAREM gadoteric acid 279.32 mg/mL injection 20 mL vial

ARTG number: 76923

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 7(2)(l) of the Therapeutic Goods Order No.69 - General requirements for labels for medicines 2017.

Date of consent: 12 January 2018

Duration: The consent is effective from the 12 January 2018 until 30 November 2018.

​The product labels do not display the name and contact details of the current sponsor in Australia.

​1. The sponsor has set-up re-direction of all mails addressed to Apollo Imaging Solutions Pty Ltd at the previous address which appears on the non-compliant label, to the current sponsor business address.

2. An agreement between Apollo Imaging Solutions and Guerbet Australia Pty Ltd is in place to ensure all email and/or telephone contact made to Apollo Imaging Solutions regarding a product of Guerbet Australia is and will be redirected appropriately.

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