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

6 July 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 3382

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-800

Bayer Australia Ltd

Product: CANESORAL DUO fluconazole 150 mg capsule blister pack and clotrimazole 10 mg/g cream tube composite pack

ARTG number: 203513

Batches: AUD012, AUD013, AUD014

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Import and supply

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

Date of consent: 22 June 2021

Duration: The consent is effective from 22 June 2021 until 31 December 2021.

The products do not comply because the tube label for clotrimazole cream and the inner carton label for clotrimazole cream are not compliant with Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines but are compliant with the requirements of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines.

From consent no. CON-799

Specialites Septodont Pty Ltd

Product: Xylonor Pellets

ARTG number: 20752

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: 22 June 2021

Duration: The consent is effective from 22 June 2021 until 22 December 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-798

Specialites Septodont Pty Ltd

Product: XYLONOR GEL tube

ARTG number: 20750

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: 10 June 2021

Duration: The consent is effective from 10 June 2021 until 10 December 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-798

Specialites Septodont Pty Ltd

Product: Ziagel lidocaine (lignocaine) 50 mg/g topical gel pump actuated bottle

ARTG number: 128897

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: 10 June 2021

Duration: The consent is effective from 10 June 2021 until 10 December 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-798

Specialites Septodont Pty Ltd

Product: XOGEL lidocaine (lignocaine) 50 mg/g cherry flavour topical gel pump actuated bottle

ARTG number: 273805

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: 10 June 2021

Duration: The consent is effective from 10 June 2021 until 10 December 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-797

Alphapharm Pty Ltd

Product: RAFEN ibuprofen 200 mg film coated tablet blister pack

ARTG number: 217313

Batches: 4C0275, 4C0276, 4C0278 & B10245

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: 10 June 2021

Duration: The consent is effective from 10 June 2021 until 10 October 2021.

​The product does 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 carton labels do not include all of the required warning statements specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2019 (RASML No. 5).

From consent no. CON-794

Smith & Nephew Pty Ltd

Product: IODOSORB cadexomer iodine 500 mg/g medicated ointment tube

ARTG number: 62773

Batches: BEA 111, BEB 071, BDL 271

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: 9 June 2021

Duration: The consent is effective from 9 June 2021 until 28 February 2022.

​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 carton labels do not include the required warning statement specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2019 (RASML No. 5).

From consent no. CON-794

Smith & Nephew Pty Ltd

Product: IODOSORB cadexomer iodine 600 mg/g medicated dressing sachet

ARTG number: 62774

Batches: CEB 013

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: 9 June 2021

Duration: The consent is effective from 9 June 2021 until 28 February 2022.

​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 carton labels do not include the required warning statement specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2019 (RASML No. 5).

From consent no. CON-793

Smith & Nephew Pty Ltd

Product: IODOSORB cadexomer-iodine 3g dusting powder sterile sachet

ARTG number: 43364

Batches: ADL 261

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: 8 June 2021

Duration: The consent is effective from 8 June 2021 until 31 December 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 carton labels do not include the required warning statement specified in the Therapeutic Goods (Medicines Advisory Statements) Specification 2019 (RASML No. 5).

From consent no. CON-792

Novartis Pharmaceuticals Australia Pty Ltd

Product: ZOLGENSMA onasemnogene abeparvovec 2 x e13 vg/mL injection for intravenous infusion pack

ARTG number: 327907

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: Therapeutic Goods Order No. 100 Microbiological Standards for Medicines

Date of consent: 4 June 2021

Duration: The consent is effective from 4 June 2021 until 31 December 2021.

​The products do not conform to the requirements of Section 9(a) of Therapeutic Goods Order No. 100 Microbiological Standards for Medicines in that the sampling schedule does not comply with the Test for Sterility of a default standard.

​This exemption only applies to the batches specified in the request.

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