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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 211 - 215 of 215

Consent no.: CON-TGO91-149

Merck Sharp and Dohme (Australia) Pty Limited

Products:

  • AUST R 18778 - CELESTONE-M betamethasone 0.2mg/g (as valerate) cream tube - Batch numbers - A80101 and A87301
  • AUST R 70406 - ANTROQUORIL betamethasone 0.2mg/g (as valerate) cream tube

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 14 July 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-TGO91-144

Seqirus Pty Ltd

Products:

  • 121845 - TRAMAL SR 50 tramadol hydrochloride 50 mg modified release tablet blister pack
  • 75947- TRAMAL SR 100 tramadol hydrochloride 100 mg modified release tablet blister pack
  • 75948- TRAMAL SR 150 tramadol hydrochloride 150 mg modified release tablet blister pack
  • 75949- TRAMAL SR 200 tramadol hydrochloride 200 mg modified release tablet blister pack
  • 64011- TRAMAL tramadol hydrochloride 50mg capsule blister pack

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 9 July 2020

Duration: The consent is effective for all batches manufactured from 1 September 2020 until 31 December 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-TGO91-148

Seqirus Pty Ltd

Products:

  • AUST R 165357 - PALEXIA SR tapentadol (as hydrochloride) 250 mg sustained release tablet
  • AUST R 165356 - PALEXIA SR tapentadol (as hydrochloride) 200mg sustained release tablet
  • AUST R 165347 - PALEXIA SR tapentadol (as hydrochloride) 150 mg sustained release tablet
  • AUST R 165346 - PALEXIA SR tapentadol (as hydrochloride) 100 mg sustained release tablet
  • AUST R 165332 - PALEXIA SR tapentadol (as hydrochloride) 50 mg sustained release tablet
  • AUST R 165310 - PALEXIA IR tapentadol (as hydrochloride) 50 mg tablet

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Duration: The consent is effective for all batches manufactured from 1 September 2020 until 31 December 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-TGO91-147

Seqirus Pty Ltd

Products:

  • AUST R 175178 - VERSATIS® lidocaine (lignocaine) 5% w/w dermal patch

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Duration: The consent is effective for all batches manufactured from 1 September 2020 until 31 December 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-TGO91-220

CSL Behring Australia Pty Ltd

Products:

  • AUST R 61218 - CSL TETANUS IMMUNOGLOBULIN-VF (human) 250IU injection vial

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

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