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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 1 - 10 of 215

Consent no.: CON-TGO91-367

Southern Cross Pharma Pty Ltd

Products:

  • AUST R 291653 - APO-FENOFIBRATE fenofibrate 48 mg tablet blister pack - Batch numbers 32517 & 32516
  • AUST R 237435 - APO-Levetiracetam Oral levetiracetam 100 mg/mL amber glass bottle - Batch number 20471
  • AUST R 256712 - DROPERIDOL SXP droperidol 2.5 mg/1 mL solution for injection glass ampoule - Batch numbers: D113, D114, D115 & D116

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 November 2020

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-TGO91-366

Merck Sharp and Dohme Australia Pty Limited

Products:

  • AUST R 203694 - ROSUZET Composite Pack 10mg+10mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 10mg tablets composite pack
  • AUST R 203692 - ROSUZET Composite Pack 10mg+20mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 20mg tablets composite pack
  • AUST R 203687 - ROSUZET Composite Pack 10mg+40mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 40mg tablets composite pack
  • AUST R 203690 - ROSUZET Composite Pack 10mg+5mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 5mg tablets composite pack
  • AUST R 203689 - EZALO Composite Pack 10mg+10mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 10mg tablets composite pack
  • AUST R 203691 - EZALO Composite Pack 10mg+20mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 20mg tablets composite pack
  • AUST R 203688 - EZALO Composite Pack 10mg+40mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 40mg tablets composite pack
  • AUST R 203693 - EZALO Composite Pack 10mg+5mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 5mg tablets composite pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 15 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 31 December 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-TGO91-348

Alphapharm Pty Ltd

Products:

  • AUST R 17573 - ALEPAM 30 oxazepam 30 mg tablet bottle - Batch number 8104917

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 13 October 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-TGO91-261

Sandoz Pty Ltd

Products:

  • AUST R 148451 - OLANZAPINE SANDOZ olanzapine 10 mg film coated tablet, blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 January 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-TGO91-265

Sandoz Pty Ltd

Products:

  • AUST R 126158 - RISPERIDONE SANDOZ risperidone 2 mg film-coated tablet in blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 January 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-TGO91-267

Sandoz Pty Ltd

Products:

  • AUST R 221962 - THIOPRINE 50 azathioprine 50 mg film-coated tablet blister pack
  • AUST R 74407 - AZATHIOPRINE SANDOZ azathioprine 50 mg film coated tablet blister pack
  • AUST R 74404 - AZATHIOPRINE SANDOZ azathioprine 25 mg film coated tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 January 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-TGO91-360

Juno Pharmaceuticals Pty Ltd

Products:

  • AUST R 302381 - FLUBICLOX flucloxacillin (as sodium) 2g powder for injection vial
  • AUST R 92841 - FLUBICLOX flucloxacillin (as sodium) 500 mg powder for injection vial
  • AUST R 92842 - FLUBICLOX flucloxacillin (as sodium) 1g powder for injection vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 1 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-TGO91-361

Accord Healthcare

Products:

  • AUST R 187214 - SUMATRIPTAN SANDOZ Tablets 50 mg Sumatriptan (as succinate) 50 mg Tablets Blister
  • AUST R 187215 - SUMATRIPTAN SANDOZ Tablets 100 mg Sumatriptan (as succinate) 100 mg Tablets Blister

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 9 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-TGO91-268

Sandoz Pty Ltd

Products:

  • AUST R 107330 - CYPROTERONE SANDOZ cyproterone acetate 50 mg tablet bottle
  • AUST R 107331- CYPROTERONE SANDOZ cyproterone acetate 100 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 January 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-TGO91-269

Sandoz Pty Ltd

Products:

  • AUST R 121788 - GLIMEPIRIDE SANDOZ glimepiride 3 mg tablet blister pack
  • AUST R 121781 - GLIMEPIRIDE SANDOZ glimepiride 1 mg tablet blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 October 2020

Duration: The consent is effective for all batches manufactured between 1 September 2020 and 29 January 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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