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

30 April 2021

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 3319

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-780

Lundbeck Australia Pty Ltd

Product: FLUANXOL DEPOT flupentixol decanoate 40 mg/2 mL injection ampoule

ARTG number: 47247

Batches: 2682447, 2680047

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: Paragraph 8(1)(n) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 15 April 2021

Duration: The consent is effective from 15 April 2021 until 1 August 2021.

​The product packaging does not conform with the requirements of paragraph 8(1)(n) of  Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the carton labels for the above mentioned batches include the incorrect Global Trade Item Number (GTIN) code in the 2D matrix and consequently, the GTIN codes within the 2D matrix and linear barcode on the carton are not identical.

​A ‘Dear Healthcare Provider’ letter (as per the copy provided with the application) will be supplied with the affected batches outlining the non -compliance.

From consent no. CON-779

Pfizer Australia Pty Ltd

Product: Pfizer (Australia) LIGNOCAINE 2% GEL lidocaine (lignocaine) 2% w/w sterile pre-filled syringe

ARTG number: 155647

Batches: EP7535A ,ER1688A ,ER1688B

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: 7 April 2021

Duration: The consent is effective from 7 April 2021 until 30 April 2021.

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

From consent no. CON-778

iNova Pharmaceuticals (Australia) Pty Ltd

Product: GOLD CROSS HYDROGEN PEROXIDE 6%w/v solution bottle

ARTG number: 27241

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

Relevant requirement: Paragraph 8(1)(k) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines

Date of consent: 6 April 2021

Duration: The consent is effective from 6 April 2021 until 31 August 2021.

​The products do not conform to the requirements of paragraph 8(1)(k) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines in that the warning statements on the labels do not fully comply with the formatting and positioning requirements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2019 (RASML No. 5).

From consent no. CON-777

Sanofi-Aventis Healthcare Pty Ltd

Product: PHENERGAN ELIXIR promethazine hydrochloride 1 mg/mL bottle (reformulation)

ARTG number: 61576

Batches: 71

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

Relevant requirement: Subsections 8(2), 9(3) and 9(4) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines

Date of consent: 1 April 2021

Duration: The consent is effective from 1 April 2021 until 31 December 2021.

​The products do not conform to the requirements of subsections 8(2), 9(3) and 9(4) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines in that:

  • the carton label does not have the critical health information presented in a tabulated format;
  • the name and quantity of the active ingredient is not placed directly below the name of the medicine on the carton and bottle label; and
  • all the text required by the order to be on the main label are not oriented in the same direction on the carton label.

From consent no. CON-776

Sandoz Pty Ltd

Product: WAGNER HEALTH CHILDREN'S IBUPROFEN 6 MONTHS - 12 YEARS ibuprofen 20 mg/mL oral liquid suspension bottle

ARTG number: 339874

Batches: IA10193, IA10194

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

Relevant requirement: Paragraph 9(7)(a) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines

Date of consent: 1 April 2021

Duration: The consent is effective from 1 April 2021 until 30 November 2021.

​The products do not conform to the requirements of paragraph 9(7)(a) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines in that the text height of the name and quantity of the active ingredient on the bottle main label is less than 3.0 mm.

From consent no. CON-775

GlaxoSmithKline Australia Pty Ltd

Product: PRIORIX-TETRA vaccine 0.5 mL powder for injection vial with diluent syringe

ARTG number: 107286

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 26 March 2021

Duration: The consent is effective from 26 March 2021 until 26 March 2023.

​The product does not conform to the requirements of TGO 91 Section 6 and Subsection 10(3), in that the excipients names on the labels do not align with the AAN and the quantity of all excipients is not specified on the label.

  1. ​Non-compliance is limited to TGO 91 requirements only.
From consent no. CON-772

Seqirus Pty Ltd

Product: RABIPUR rabies virus vaccine (Inactivated) 2.5 IU powder for injection vial with diluent pre-filled syringe

ARTG number: 298194

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Section 6 and paragraph 8(1)(i) of Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 26 March 2021

Duration: The consent is effective from 26 March 2021 until 1 February 2023.

​The product does not conform to the requirements of section 6 and paragraph 8(1)(i) of TGO 91, in that the name and contact details of the current Sponsor are not on the label of the medicine.

  1. ​The labels to which this consent applies are those previously approved for the former Sponsor, GlaxoSmithKline Australia Pty Ltd.
  2. Arrangements are in place until 1 February 2023 with GlaxoSmithKline Australia Pty Ltd for the prompt referral of any queries or complaints concerning the products to Seqirus Pty Ltd.

From consent no. CON-774

Blackmores Ltd

Product: BLACKMORES DUO CELLOIDS S.C.F. tablet

ARTG number: 20248

Therapeutic type: Registered complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 26 March 2021

Duration: The consent is effective from 26 March 2021 until 1 September 2021.

The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92, in that the name of the medicine on the main label is not presented in a continuous, uninterrupted manner and is broken up by additional information and background text.

From consent no. CON-774

Blackmores Ltd

Product: BLACKMORES CELLOIDS S.79 Tablets

ARTG number: 20227

Therapeutic type: Registered complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 26 March 2021

Duration: The consent is effective from 26 March 2021 until 1 September 2021.

The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92, in that the name of the medicine on the main label is not presented in a continuous, uninterrupted manner and is broken up by additional information and background text.

From consent no. CON-774

Blackmores Ltd

Product: BLACKMORES DUO CELLOIDS P.S.M.P. tablet - uncoated bottle

ARTG number: 20262

Therapeutic type: Registered complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subsection 9(2) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines

Date of consent: 26 March 2021

Duration: The consent is effective from 26 March 2021 until 1 September 2021.

The products do not conform to the requirements of subsection 9(2) of Therapeutic Goods Order No. 92, in that the name of the medicine on the main label is not presented in a continuous, uninterrupted manner and is broken up by additional information and background text.

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