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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

22 October 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 are experiencing difficulty in introducing labels that have been 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 have introduced a special section 14 application process specifically for these instances.

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 214

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-TGO91-365

Merck Sharp and Dohme Australia Pty Limited

Products:

  • AUST R 55088 - LIVIAL tibolone 2.5 mg tablet blister pack, 28 tablets.

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 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-TGO91-364

LINK Medical Products Pty Ltd

Products:

  • AUST R 210672 - ADRENALINE-LINK 1:10,000 1mg/10mL adrenaline (epinephrine) acid tartrate injection BP pre filled syringe - Batch number 0130731

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 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-TGO91-363

Juno Pharmaceuticals Pty Ltd

Products:

  • AUST R 219054 - Neostigmine Juno neostigmine methylsulfate 2.5 mg/1 ml solution for injection ampoule - Batch number 021011

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 12 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-TGO91-362

Sanofi-Aventis Australia Pty Ltd

Products:

  • AUST R 134367 - SODIUM VALPROATE SANDOZ sodium valproate 200mg enteric coated tablet blister pack
  • AUST R 134368 - SODIUM VALPROATE SANDOZ sodium valproate 500mg enteric coated tablet blister pack
  • AUST R 286315 - VALPRO EC200 sodium valproate 200 mg enteric coated tablet blister pack
  • AUST R 286316 - VALPRO EC500 sodium valproate 500 mg enteric coated tablet blister pack
  • AUST R 125620 - VALPROATE WINTHROP EC200 sodium valproate 200mg tablet blister pack
  • AUST R 125621 - VALPROATE WINTHROP EC500 sodium valproate 500mg tablet blister pack
  • AUST R 15369 - EPILIM EC200 sodium valproate 200mg tablet blister pack (OF)
  • AUST R 15373 - EPILIM sodium valproate 100mg crushable tablet blister pack
  • AUST R 15370 - EPILIM EC500 sodium valproate 500mg tablet blister pack (OF)

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 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-TGO91-269

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.
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-TGO91-361

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-TGO91-360

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.

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