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 919

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-235

Sandoz Pty Ltd

Product: LATANOPROST SANDOZ latanoprost 50 micrograms/mL eye drop solution bottle

ARTG number: 290733

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraphs 8(1)(f) and 8(1)(g) of the Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines.

Date of consent: 15 December 2017

Duration: The consent is effective from the 15 December 2017 until 15 December 2019.

The product eye drop bottle label batch and expiry details are not preceded by the appropriate prefixes.

​A 'Dear Pharmacist' letter identical to that provided to the TGA on 14 December 2017 will be supplied to pharmacists instructing them to remind patients to keep the affected bottles in the correctly labelled outer cartons.

From consent no. CON-234

Pharmaco Australia Ltd

Product: DILATREND carvedilol 25 mg tablet blister pack

ARTG number: 61108

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

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

Date of consent: 14 December 2017

Duration: The consent is effective from the 14 December 2017 until 14 December 2018.

​The product carton labels do not bear the current Australian sponsor’s name and address.

​The labels to which this consent applies are those previously approved for Roche Products Pty Ltd. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Locked Bag 1009 GORDON NSW 2072).

From consent no. CON-234

Pharmaco Australia Ltd

Product: DILATREND carvedilol 12.5 mg tablet blister pack

ARTG number: 61107

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

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

Date of consent: 14 December 2017

Duration: The consent is effective from the 14 December 2017 until 14 December 2018.

​The product carton labels do not bear the current Australian sponsor’s name and address.

​The labels to which this consent applies are those previously approved for Roche Products Pty Ltd. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Locked Bag 1009 GORDON NSW 2072).

From consent no. CON-234

Pharmaco Australia Ltd

Product: DILATREND carvedilol 6.25 mg tablet blister pack

ARTG number: 61106

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

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

Date of consent: 14 December 2017

Duration: The consent is effective from the 14 December 2017 until 14 December 2018.

​The product carton labels do not bear the current Australian sponsor’s name and address.

​The labels to which this consent applies are those previously approved for Roche Products Pty Ltd. Arrangements are in place with divisions that operate at this address for the prompt referral of any queries or complaints concerning the products to the current address (Locked Bag 1009 GORDON NSW 2072).

From consent no. CON-233

Mylan Health Pty Ltd

Product: CREON MICRO pancreatic extract 20 g enteric coated granules bottle

ARTG number: 166118

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: Subections 9(1)(c), 9(3), 9(5) and/or 9(7) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines.

Date of consent: 11 December 2017

Duration: The consent is effective from the 11 December 2017 until further notice.

​- The main label does not specify the quantity of the active ingredient in mg (as listed on the ARTG), although the quantity is clearly specified in Ph. Eur.units.

- The name of the medicine and the active ingredient and quantity are not expressed as a cohesive unit on separate lines of text.

- The active ingredient and quantity of the active ingredient is not displayed in a text height of not less than 3mm in height.

​Labels to which this consent applies are those specified in the request submitted.

From consent no. CON-233

Mylan Health Pty Ltd

Product: CREON 40,000 pancreatic extract 400 mg capsules of enteric-coated minimicropsheres bottle

ARTG number: 158451

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: Subections 9(1)(c), 9(3), 9(5) and/or 9(7) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines.

Date of consent: 11 December 2017

Duration: The consent is effective from the 11 December 2017 until further notice.

​- The main label does not specify the quantity of the active ingredient in mg (as listed on the ARTG), although the quantity is clearly specified in Ph. Eur.units.

- The name of the medicine and the active ingredient and quantity are not expressed as a cohesive unit on separate lines of text.

- The active ingredient and quantity of the active ingredient is not displayed in a text height of not less than 3mm in height.

​Labels to which this consent applies are those specified in the request submitted.

From consent no. CON-233

Mylan Health Pty Ltd

Product: CREON 25,000 pancreatic extract 300 mg capsule bottle

ARTG number: 158452

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: Subections 9(1)(c), 9(3), 9(5) and/or 9(7) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines.

Date of consent: 11 December 2017

Duration: The consent is effective from the 11 December 2017 until further notice.

​- The main label does not specify the quantity of the active ingredient in mg (as listed on the ARTG), although the quantity is clearly specified in Ph. Eur.units.

- The name of the medicine and the active ingredient and quantity are not expressed as a cohesive unit on separate lines of text.

- The active ingredient and quantity of the active ingredient is not displayed in a text height of not less than 3mm in height.

​Labels to which this consent applies are those specified in the request submitted.

From consent no. CON-233

Mylan Health Pty Ltd

Product: CREON 10,000 capsule bottle (reformulation)

ARTG number: 158453

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: Subections 9(1)(c), 9(3), 9(5) and/or 9(7) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines and Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines.

Date of consent: 11 December 2017

Duration: The consent is effective from the 11 December 2017 until further notice.

​- The main label does not specify the quantity of the active ingredient in mg (as listed on the ARTG), although the quantity is clearly specified in Ph. Eur.units.

- The name of the medicine and the active ingredient and quantity are not expressed as a cohesive unit on separate lines of text.

- The active ingredient and quantity of the active ingredient is not displayed in a text height of not less than 3mm in height.

​Labels to which this consent applies are those specified in the request submitted.

From consent no. CON-232

Sanofi–Aventis Australia Pty Ltd

Product: ENOXAPARIN WINTHROP enoxaparin sodium 100 mg/1 mL injection syringe

ARTG number: 293891

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 10(5)(c) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines.

Date of consent: 28 November 2017

Duration: The consent is effective from the 28 November 2017 until further notice.

​The letter height for the name of the medicine is not the correct height.

From consent no. CON-232

Sanofi–Aventis Australia Pty Ltd

Product: ENOXAPARIN WINTHROP enoxaparin sodium 80 mg/0.8 mL injection syringe

ARTG number: 293890

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 10(5)(c) of Therapeutic Goods Order No 91-Standard for labels of prescription and related medicines.

Date of consent: 28 November 2017

Duration: The consent is effective from the 28 November 2017 until further notice.

​The letter height for the name of the medicine is not the correct height.

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