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

3 August 2020

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 1 - 10 of 2036

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-491

ANSTO t/a ANSTO Health

Product: Sodium iodide(131I) 2000MBq/mL Therapy Solution oral liquid BP vial

ARTG number: 48267

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply and export

Relevant requirement: Subsection 9(1) of Therapeutic Goods Order No. 77 Microbiological Standards for Medicines.

Date of consent: 20 July 2020

Duration: The consent is effective from 20 July 2020 until 20 July 2022 or until the product specifications are updated to include microbiological criteria, whichever occurs first.

​The grandfathered products do not currently include testing criteria for microbiological attributes.

From consent no. CON-491

ANSTO t/a ANSTO Health

Product: AUSTRALIAN RADIOISOTOPES Sodium Iodide (I-131) 50 - 6000MBq Therapy Capsule vial

ARTG number: 22808

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply and export

Relevant requirement: Subsection 9(1) of Therapeutic Goods Order No. 77 Microbiological Standards for Medicines.

Date of consent: 20 July 2020

Duration: The consent is effective from 20 July 2020 until 20 July 2022 or until the product specifications are updated to include microbiological criteria, whichever occurs first.

​The grandfathered products do not currently include testing criteria for microbiological attributes.

From consent no. CON-491

ANSTO t/a ANSTO Health

Product: Sodium iodide(131I) 200MBq/mL Therapy Solution oral liquid BP vial

ARTG number: 22807

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply and export

Relevant requirement: Subsection 9(1) of Therapeutic Goods Order No. 77 Microbiological Standards for Medicines.

Date of consent: 20 July 2020

Duration: The consent is effective from 20 July 2020 until 20 July 2022 or until the product specifications are updated to include microbiological criteria, whichever occurs first.

​The grandfathered products do not currently include testing criteria for microbiological attributes.

From consent no. CON-490

Aspen Pharmacare Australia Pty Ltd

Product: COLOXYL WITH SENNA HOSPITAL film coated tablet bottle

ARTG number: 301713

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

Relevant requirement: Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines.

Date of consent: 20 July 2020

Duration: The consent is effective from 20 July 2020 until 28 February 2021.

The products that do not conform with the Therapeutic Goods Order No.92 – Standard for labels of non-prescription medicines but are fully compliant with all requirements of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines

From consent no. CON-490

Aspen Pharmacare Australia Pty Ltd

Product: STINGOSE GEL aluminium sulfate hydrate 200 mg/mL tube

ARTG number: 10315

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

Relevant requirement: Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines.

Date of consent: 20 July 2020

Duration: The consent is effective from 20 July 2020 until 28 February 2021.

The products that do not conform with the Therapeutic Goods Order No.92 – Standard for labels of non-prescription medicines but are fully compliant with all requirements of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines

From consent no. CON-489

Global Medical Solutions Australia Pty Limited

Product: TECHNELITE Molybdenum(99Mo)/Technetium(99mTc) sterile Generator for production of Sodium pertechnetate(99mTc) injection multidose vial

ARTG number: 130301

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraphs 8(1)(b) and 8(1)(i) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines

Date of consent: 17 July 2020

Duration: The consent is effective from 17 July 2020 until 31 December 2020.

​The name of the ingredients on the medicine carton and container labels are not consistent with the Australian Approved Names, in particular: 

  • Molybdenum Mo 99 should be molybdenum(99Mo)
  • Technetium Tc 99m should be technetium(99mTc)
  • Sodium pertechnetate Tc 99m should be Sodium pertechnetate(99mTc). 

Additionally, the labels do not include the name and address of the current sponsor: Global Medical Solutions Australia Pty Limited, and instead refer to the previous sponsor: Lantheus Medical Imaging.

From consent no. CON-486

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific

Product: CARDIOLITE kit for preparation of technetium (99mTc) sestamibi injection vial

ARTG number: 49688

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraphs 8(1)(i) and 10(4)(j) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines

Date of consent: 16 July 2020

Duration: The consent is effective from 16 July 2020 until 31 December 2020.

​The labels do not include the name and address of the current sponsor; and do not state the active ingredient name as per the Australian Approved Name.

From consent no. CON-487

Global Medical Solutions Australia Pty Limited t/a Radpharm Scientific

Product: DEFINITY perflutren lipid microsphere injection vial

ARTG number: 124808

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraphs 8(3)(b), 9(1)(b) and 10(4)(e) and Section 8(1)(i) and 10(4)(j) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.

Date of consent: 16 July 2020

Duration: The consent is effective from 16 July 2020 until 31 December 2020.

​The products do not state the active ingredient names as per the Australian Approved Name and do not include the name and address of the current sponsor.

From consent no. CON-484

Weleda Australia Pty Ltd

Product: WELEDA RASH RELIEF CREAM

ARTG number: 66835

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines.

Date of consent: 16 July 2020

Duration: The consent is effective from 16 July 2020 until 6 March 2021.

The products that do not conform with the Therapeutic Goods Order No.92 – Standard for labels of non-prescription medicines but are fully compliant with all requirements of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines

From consent no. CON-484

Weleda Australia Pty Ltd

Product: WELEDA ECHINACEA/THUJA COMP. Oral Liquid bottle

ARTG number: 68575

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines.

Date of consent: 16 July 2020

Duration: The consent is effective from 16 July 2020 until 6 March 2021.

The products that do not conform with the Therapeutic Goods Order No.92 – Standard for labels of non-prescription medicines but are fully compliant with all requirements of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines

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