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Database of consents to import, supply or export therapeutic goods that do not comply with TGO 91 due to COVID-19

12 November 2020

Medicines and other therapeutic goods must conform 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 conform with an applicable standard. The Secretary can impose conditions on the consent under section 15 of the Act.

As a direct result of COVID-19, some prescription medicine manufacturers experienced difficulty in introducing labels that were assessed to be compliant with TGO91 into their manufacturing process by the end of the transition period from TGO 69 (1 September 2020). In recognition of this problem, we introduced a special section 14 application process specifically for these instances. The expedited process ceased on 9 October 2020. Any further section 14 requests should apply via the standard section 14 process.

The records below include information about these decisions, and any subsequent review of such decisions.

To view records of all other consent decisions, refer to Database of consents to import, supply or export therapeutic goods that do not comply with standards

Displaying 91 - 100 of 215

Consent no.: CON-TGO91-278

Pfizer Australia Pty Ltd

Products:

  • AUST R 75106 - PAMISOL pamidronate disodium 15 mg/5 mL injection vial - Batch number H034925AB
  • AUST R 75108 - PAMISOL pamidronate disodium 60 mg/10 mL injection vial - Batch number H014915AC
  • AUST R 75109 - PAMISOL pamidronate disodium 90 mg/10 mL injection vial - Batch number H034947AD

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 3 September 2020

Duration: The duration of consent is for the batches specified above.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-279

Baxter Healthcare Pty Ltd

Products:

  • AUST R 19458 - BAXTER 0.015% Chlorhexidine & 0.15% Cetrimide Antiseptic Solution bottle
  • AUST R 19460 - BAXTER Chlorhexidine 0.05% Cetrimide 0.5% AHF7979 antiseptic solution bottle
  • AUST R 19462 - BAXTER CHLORHEXIDINE 0.1% CETRIMIDE 1% aqueous solution bottle

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 3 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 August 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-280

Sanofi Aventis Australia Pty Ltd

Products:

  • AUST R 221717 - CLEXANE enoxaparin sodium 20mg/0.2mL injection syringe with automatic safety lock system
  • AUST R 221718 - CLEXANE enoxaparin sodium 40mg/0.4mL injection syringe with automatic safety lock system
  • AUST R 221719 - CLEXANE enoxaparin sodium 60mg/0.6mL injection syringe with automatic safety lock system
  • AUST R 221720 - CLEXANE enoxaparin sodium 80mg/0.8mL injection syringe with automatic safety lock system
  • AUST R 221721 - CLEXANE enoxaparin sodium 100mg/1mL injection syringe with automatic safety lock system
  • AUST R 221722 - CLEXANE FORTE enoxaparin sodium 120mg/0.8mL injection syringe with automatic safety lock system
  • AUST R 221723 - CLEXANE FORTE enoxaparin sodium 150mg/1mL injection syringe with automatic safety lock system

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 3 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 March 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-281

ANSTO

Products:

  • AUST R 297380 - MDP Kit for preparation of Technetium(99mTc) medronate injection

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 3 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 30 March 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-282

Teva Pharma Australia Pty Ltd

Products:

  • AUST R 218615 - COPAXONE glatiramer acetate 40 mg/1 mL solution for injection prefilled syringe - Batch numbers 11898 and 11898(B)

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 3 September 2020

Duration: The duration of consent is for the batches specified above.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-283

ANSTO

Products:

  • AUST R 22926 - PENTASTAN Kit for preparation of Technetium(99mTc) pentetate powder for injection multidose vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 3 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 30 March 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-275

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • ARTG 96742 - CO-DIOVAN 160/25 valsartan 160 mg and hydrochlorothiazide 25 mg tablet blister pack
  • ARTG 96741 - CO-DIOVAN 160/12.5 valsartan 160 mg and hydrochlorothiazide 12.5 mg tablet blister pack
  • ARTG 96740 - CO-DIOVAN 80/12.5 valsartan 80 mg and hydrochlorothiazide 12.5 mg tablet blister pack
  • ARTG 135782 - CO-DIOVAN 320/12.5 mg valsartan 320 mg/hydrochlorothiazide 12.5 mg film-coated tablet blister pack
  • ARTG 135812 - CO-DIOVAN 320/25 mg valsartan 320 mg/hydrochlorothiazide 25 mg film-coated tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 1 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 August 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-243

Phebra Pty Ltd

Products:

  • AUST R 121873 - RETINOFLUOR fluorescein sodium 10% injection 500 mg/5 mL vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 28 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 August 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-244

Phebra Pty Ltd

Products:

  • AUST R 57306 - NARCAN naloxone hydrochloride 400 microgram/1 mL injection ampoule

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 28 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 August 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.
Consent no.: CON-TGO91-245

Phebra Pty Ltd

Products:

  • AUST R 23183 - PHEBRA POTASSIUM DIHYDROGEN PHOSPHATE 13.6% (1.361 g in 10 mL) vial potassium phosphate - monobasic 10 mmol/10 mL concentrated injection vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 28 August 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 August 2021.

The product(s) do not conform with the requirements of TGO 91 but are supplied with label(s) that have been approved by the TGA.

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