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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 101 - 110 of 215

Consent no.: CON-TGO91-246

Phebra Pty Ltd

Products:

  • AUST R 48349 - PHEBRA SODIUM CHLORIDE 0.9% 100 mL injection BP 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-TGO91-247

Phebra Pty Ltd

Products:

  • AUST R 48354 - PHEBRA WATER FOR INJECTION 100 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-TGO91-249

Phebra Pty Ltd

Products:

  • AUST R 46841 - DROLEPTAN droperidol 2.5 mg/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-TGO91-250

Phebra Pty Ltd

Products:

  • AUST R 161711 - HAEMOROL oily phenol 250 mg/5 ml injection vial - Batch number 14664

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Date of consent: 28 August 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-TGO91-251

Phebra Pty Ltd

Products:

  • AUST R 13396 - SYNTOMETRINE oxytocin/ergometrine maleate 1mL 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-TGO91-252

Phebra Pty Ltd

Products:

  • AUST R 165709 - TADIM colistimethate sodium 1million IU powder for nebuliser solution 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-TGO91-242

Phebra Pty Ltd

Products:

  • AUST R 23101 - QUININE DIHYDROCHLORIDE 6% sterile concentrate (600 mg/10 mL) 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.
Consent no.: CON-TGO91-241

Phebra Pty Ltd

Products:

  • AUST R 23119 - PHEBRA SODIUM CHLORIDE 40mEq/10 ml 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.
Consent no.: CON-TGO91-240

Phebra Pty Ltd

Products:

  • AUST R 23076 - PHEBRA MAGNESIUM SULFATE HEPTAHYDRATE 50% 2.5 g/5 mL injection vial
  • AUST R 160885 - PHEBRA MAGNESIUM SULFATE HEPTAHYDRATE 50% 5 g/10 mL 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.
Consent no.: CON-TGO91-239

Phebra Pty Ltd

Products:

  • AUST R 223583 - METHYLENE BLUE 50 mg/5 mL 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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