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Database of consents to import, supply or export therapeutic goods that do not comply with standards

10 January 2022

Medicines and other therapeutic goods must comply 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 comply with an applicable standard. The Secretary can impose conditions on the consent under section 15 of the Act.

The records below include information about these decisions, and any subsequent review of such decisions. All records below which relate to a single consent decision will have the same consent number.

Information about decisions made before 29 January 2016 are on the Federal Register of Legislation website.

In July 2020, TGA created a special consent process for prescription medicine manufacturers experiencing difficulties in introducing new TGO91 labels into their manufacturing process due to COVID-19. These decisions are displayed in a separate database: Database of consents for prescription medicines that do not comply with TGO 91 labelling due to COVID-19

Displaying 4111 - 4120 of 4179

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: diclofenac diethylamine (VOLTAREN OSTEO GEL 12 HOURLY) 23.2 mg/g gel tube

ARTG number: 219514

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

Relevant requirement: Subclause 3(2)(l) of Therapeutic Goods Order No.69 - General requirements for labels for medicines.

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

From consent no. CON-49

Roche Products Pty Ltd

Product: pirfenidone (ESBRIET) 267 mg hard capsule bottle

ARTG number: 235577

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: Subclauses 3(2)(a) and (g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines.

Date of consent: 5 April 2016

Duration: The consent is effective from 5 April 2016 until the 1 December 2016.

The product label does not state the product name or the appropriate warning statements.

  1. The labels to which this consent applies are those provided with the letter of application, over-stickered with the AUST R number as per the assurance provided 29/03/2016 and;
  2. Supply of the affected batches will be to practitioners already familiar with the above mentioned labels.
From consent no. CON-48

Alphapharm Pty Ltd

Product: lisinopril (as dihydrate) (ZINOPRIL 10) 10 mg tablet blister pack

ARTG number: 152717

Batches: EZX015001

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclauses 3(2)(h) and (i) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines.

Date of consent: 5 April 2016

Duration: The consent is effective from the 5 April 2016 for batch number EZX015001 until 04 April 2017.

​The batch number and expiry date of the product are not preceded by the appropriate prefixes on the blister foil.

  1. A 'Dear Healthcare Provider' letter identical to that provided to the TGA on 02 March 2016 (TGA reference R16/179766) advising them to remind patients to keep the blister packs with the correctly labelled carton, must be provided with the affected batch.
From consent no. CON-51

Mallinckrodt Australia Pty Ltd

Product: ioversol (OPTIRAY 320) 13.56 g/20 mL injection vial

ARTG number: 20034

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines.

Date of consent: 5 April 2016

Duration: The consent is effective from 5 April 2016 until 31 March 2017.

​The product labels state the Sponsor's previous name.

  1. The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name.
From consent no. CON-51

Mallinckrodt Australia Pty Ltd

Product: ioversol (OPTIRAY 240) 636.25 g/125 mL injection syringe (power injector)

ARTG number: 46640

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines.

Date of consent: 5 April 2016

Duration: The consent is effective from 5 April 2016 until 31 March 2017.

​The product labels state the Sponsor's previous name.

  1. The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name.
From consent no. CON-51

Mallinckrodt Australia Pty Ltd

Product: ioversol (OPTIRAY 320) 678 mg/mL 50 mL injection syringe (hand held and power injector)

ARTG number: 46641

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines.

Date of consent: 5 April 2016

Duration: The consent is effective from 5 April 2016 until 31 March 2017.

​The product labels state the Sponsor's previous name.

  1. The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name.
From consent no. CON-51

Mallinckrodt Australia Pty Ltd

Product: ioversol (OPTIRAY 320) 678 mg/mL 125 mL injection syringe (power injector)

ARTG number: 46642

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines.

Date of consent: 5 April 2016

Duration: The consent is effective from 5 April 2016 until 31 March 2017.

​The product labels state the Sponsor's previous name.

  1. The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name.
From consent no. CON-51

Mallinckrodt Australia Pty Ltd

Product: ioversol (OPTIRAY 350) 74% w/v 22.23 g/30 mL injection vial

ARTG number: 47856

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines.

Date of consent: 5 April 2016

Duration: The consent is effective from 5 April 2016 until 31 March 2017.

​The product labels state the Sponsor's previous name.

  1. The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name.
From consent no. CON-51

Mallinckrodt Australia Pty Ltd

Product: ioversol (OPTIRAY 350) 74% w/v 37.05 g/50 mL injection vial

ARTG number: 47856

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines.

Date of consent: 5 April 2016

Duration: The consent is effective from 5 April 2016 until 31 March 2017.

​The product labels state the Sponsor's previous name.

  1. The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name.
From consent no. CON-51

Mallinckrodt Australia Pty Ltd

Product: ioversol (OPTIRAY 350) 74% w/v 55.575 g/75 mL injection vial

ARTG number: 47997

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 3(2)(l) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines.

Date of consent: 5 April 2016

Duration: The consent is effective from 5 April 2016 until 31 March 2017.

​The product labels state the Sponsor's previous name.

  1. The labels to which this consent applies are those previously approved for the former sponsor name (Mallinckrodt), provided with the application letter, and including the assurance that the same contact details stated on the labels are applicable to the new sponsor name.

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