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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 11 - 20 of 4156

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-883

LEO Pharma Pty Ltd

Product: ENSTILAR calcipotriol (as monohydrate) 50 microgram/g and betamethasone (as dipropionate) 500 microgram/g foam aerosol can

ARTG number: 263292

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 22 November 2021

Duration: The consent is effective for all relevant batches released from 22 November 2021 until 1 November 2023.

The product does not conform to the requirements of paragraphs 8(1)(f-g) of Therapeutic Goods Order No. 91 Standard for labels of prescription and related medicines, in that the product does not include batch number and expiry date prefixes immediately preceding the batch number and expiry date printed on the bottom of the can.

From consent no. CON-882

Organon Pharma Pty Ltd

Product: ARCOXIA etoricoxib 60mg tablet blister pack

ARTG number: 81456

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 9 November 2021

Duration: The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022.

​The products do not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd).

From consent no. CON-882

Organon Pharma Pty Ltd

Product: NASONEX aqueous nasal spray mometasone furoate 50 microgram/actuation (as monohydrate) spray bottle

ARTG number: 77112

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 9 November 2021

Duration: The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022.

​The products do not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd).

From consent no. CON-882

Organon Pharma Pty Ltd

Product: IMPLANON NXT etonogestrel 68mg subcutaneous implant blister pack

ARTG number: 198455

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 9 November 2021

Duration: The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022.

​The products do not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd).

From consent no. CON-882

Organon Pharma Pty Ltd

Product: SAPHRIS asenapine (as maleate) 5mg sublingual wafer blister pack

ARTG number: 166562

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 9 November 2021

Duration: The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022.

​The products do not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd).

From consent no. CON-882

Organon Pharma Pty Ltd

Product: ARCOXIA etoricoxib 30mg tablet blister pack

ARTG number: 131797

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 9 November 2021

Duration: The consent is effective for all batches of the products released from the 9 November 2021 until 30 June 2022.

​The products do not conform with the requirement of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines in that the labels do not include the current sponsor details (Organon Pharma Pty Ltd).

From consent no. CON-881

Fresenius Kabi Australia Pty Ltd

Product: SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL

ARTG number: 180546

Batches: 10QE6318

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraphs 8(1)(i), 8(1)(n), 10(2)(a), 10(2)(f), 10(6)(b) and 10(6)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines

Date of consent: 28 October 2021

Duration: The consent is effective from 28 October 2021 until the batch number 10QE6318 has expired (30 April 2023) or until the batch is depleted, whichever is sooner.

The product does not conform with the requirements of the paragraphs 8(1)(i), 8(1)(n), 10(2)(a), 10(2)(f), 10(6)(b) and 10(6)(c) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines the requirements of in that:

  • The name and contact details of the Australian sponsor or distributor are not included;

  • There is no machine-readable code on the primary pack label;

  • The quantity of each excipient in the stated volume of fill of the injection in the container is not listed;

  • The statements "use in one patient on one occasion only. Contains no antimicrobial preservative" are not included;

  • There is no statement specifying the injection is hypertonic;

  • The statement of energy equivalent is not stated in kilojoules.

 

  1. Supply and use of this batch are restricted to the circumstances proposed in the application (use in compounding facilities only).
  2. The affected batch will be labelled with the 'English neutral label'.
  3. The AUST R will be over-stickered on the carton.
  4. The receiving manufacturers will be advised of the situation and will be instructed to keep the bags in the cartons labelled with the AUST R number until required for use. 

From consent no. CON-880

Caruso's Natural Health Pty Ltd

Product: Caruso's GET UP & GO

ARTG number: 370762

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

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

Date of consent: 22 October 2021

Duration: The consent is effective from the 22 October 2021 until 1 September 2022.

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

From consent no. CON-880

Caruso's Natural Health Pty Ltd

Product: Caruso's WEE LESS

ARTG number: 370815

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

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

Date of consent: 22 October 2021

Duration: The consent is effective from the 22 October 2021 until 1 September 2022.

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

From consent no. CON-879

Allergan Australia Pty Ltd

Product: OZURDEX dexamethasone 700 microgram intravitreal implant

ARTG number: 222392

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 9(3)(a) and Subsection 9(5) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 20 October 2021

Duration: The consent is effective from 20 October 2021 until 31 October 2023.

​The product does not conform to the requirements of Paragraph 9(3)(a) and Subsection 9(5) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product does not have the name and quantity of the active ingredient printed immediately below the name of the medicine on the applicator pen label, and are printed in a text size less than 3.0 millimetres in size.

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