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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 41 - 50 of 215

Consent no.: CON-TGO91-331

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUSTR 15497 - RESONIUM A sodium polystyrene sulfonate powder jar

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 25 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-TGO91-330

Baxter Healthcare Pty Ltd

Products:

  • AUST R 56336 - BAXTER CARDIOPLEGIA SOLUTION A, 1000mL solution bag

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 25 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-TGO91-316

Novartis Pharmaceuticals Australia Pty Ltd

Products:

  • AUST R 160228 - RITALIN LA methylphenidate hydrochloride 10 mg modified release tablet
  • AUST R 82957 - RITALIN LA methylphenidate hydrochloride 20 mg modified release tablet
  • AUST R 82958 - RITALIN LA methylphenidate hydrochloride 30 mg modified release tablet
  • AUST R 82959 - RITALIN LA methylphenidate hydrochloride 40 mg modified release tablet
  • AUST R 236251 - RITALIN LA methylphenidate hydrochloride 60 mg modified release
  • AUST R 11052 - RITALIN 10 methylphenidate hydrochloride 10 mg table blister pack
  • AUST R 117306 - ARTIGE methylphenidate hydrochloride 10 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 24 September 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 30 April 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-TGO91-329

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 165934 - IMOVANE zopiclone 7.5 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 24 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-TGO91-318

Pfizer Australia Pty Ltd

Products:

  • AUST R 177111- DBL SODIUM NITROPRUSSIDE CONCENTRATED INJECTION sodium nitroprusside 25 mg/mL concentrated injection vial, Batch number 190673

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 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-TGO91-321

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 79021 - ISCOVER clopidogrel (as hydrogen sulfate) 75 mg tablet blister pack
  • AUST R 151257 - PLAVIX clopidogrel (as hydrogen sulfate) 300 mg tablet blister pack
  • AUST R 148947 - CLOPIDOGREL WINTHROP clopidogrel (as hydrogen sulfate) 75 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 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-TGO91-322

Baxter Healthcare Pty Ltd

Products:

  • AUST R 92418 - CERNEVIT multivitamin powder for injection vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 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-TGO91-328

LINK Medical Products Pty Ltd

Products:

  • AUST R 144062 - RELISTOR methylnaltrexone bromide 12 mg/0.6 mL solution for injection vial, Batch number SRTB04

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 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-TGO91-319

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 27523 - NEULACTIL periciazine 10 mg tablet blister pack
  • AUST R 27524 - NEULACTIL periciazine 2.5 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 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-TGO91-323

Baxter Healthcare Pty Ltd

Products:

  • AUST R 19459 - BAXTER CHLORHEXIDINE ACETATE 0.02% w/v antiseptic Aqueous Solution bottle AHF7980/AHF7981
  • AUST R 19461 - BAXTER Chlorhexidine Acetate 0.05% AHF7977 aqueous antiseptic solution bottle
  • AUST R 19463 - BAXTER CHLORHEXIDINE ACETATE 0.1% aqueous solution bottle AHF7978/7985/7986

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 23 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.

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