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

4 December 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 21 - 30 of 4156

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-878

Seqirus Pty Limited

Product: JESPECT japanese encephalitis virus purified inactivated vaccine 0.5mL suspension for injection syringe

ARTG number: 150602

Batches: JEV19F14D (4311 doses) and JEV19J25D (4545 doses)

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply and export

Relevant requirement: Paragraphs 8(3)(e) and 10(5)(f) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 19 October 2021

Duration: The consent is effective from 19 October 2021 until the proposed amended expiry dates (30/09/2022 for batch JEV19F14D and 28/02/2023 for batch JEV19J25D) or until the batches are depleted.

​The product packaging does not conform with the requirements of Paragraphs 8(3)(e) and 10(5)(f) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the carton, blister tray and syringe labels include an incorrect expiry date.

1. ​A ‘Dear Immuniser’ letter (as per the copy provided with the application from Seqirus Pty Limited) will be supplied with each unit in the affected batches outlining the non-compliance in the product labelling (discrepancy in expiry dates).

2. An explanatory letter to customers (i.e. wholesalers and pharmacists), as per the copy provided with the application from Seqirus Pty Limited, detailing the proposed changes, providing directions on where further information can be obtained (e.g. websites) and how replacement product can be obtained, will be distributed.

3. Over-labelling will be performed at a registered secondary packaging site for the carton labels to include the correct expiry date.

4. A record of maintenance of the approved storage conditions for Jespect (i.e. 2℃ to 8℃) during the over-labelling process, including transport, will be provided to TGA as per the email from Seqirus Pty Limited dated 19 October 2021.

From consent no. CON-877

Pfizer Australia Pty Ltd

Product: Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule

ARTG number: 10793

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: Paragraph 11(2)(f) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 18 October 2021

Duration: The consent is effective for all batches of the product released for supply from 18 October 2021 until 18 October 2023.

​The product does not conform with the requirements of Paragraph 11(2)(f) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91) in that the carton label for the product states the strength of the active ingredient as 10mmol (0.75g) in 10mL.

​The carton label to which this consent applies is that provided with the application in the email correspondence from Pfizer Australia Pty Ltd to the TGA dated 8th October 2021.

From consent no. CON-876

Novartis Pharmaceuticals Australia Pty Ltd

Product: ENTRESTO 49/51 sacubitril/valsartan (combined as a sodium salt hydrate complex) 48.6/51.4 mg film-coated tablet blister pack

ARTG number: 234222

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 18 October 2021

Duration: The consent is effective from 18 October 2021 for all batches released for supply until 31 October 2022.

​The product(s) do not conform to the requirements of Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product(s) sample pack carton labels do not include a space for the prescriber to provide dispensing details and the batch number/expiry date prefixes on blister foil labels do not precede the batch number/expiry date.

​1. The product labels to which this consent applies are those provided with the application from Novartis Pharmaceuticals Australia Pty Ltd dated 23 February 2021.

From consent no. CON-876

Novartis Pharmaceuticals Australia Pty Ltd

Product: ENTRESTO 24/26 sacubitril/valsartan (combined as a sodium salt hydrate complex) 24.3/25.7 mg film-coated tablet blister pack

ARTG number: 234219

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 18 October 2021

Duration: The consent is effective from 18 October 2021 for all batches released for supply until 31 October 2022.

​The product(s) do not conform to the requirements of Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product(s) sample pack carton labels do not include a space for the prescriber to provide dispensing details and the batch number/expiry date prefixes on blister foil labels do not precede the batch number/expiry date.

​1. The product labels to which this consent applies are those provided with the application from Novartis Pharmaceuticals Australia Pty Ltd dated 23 February 2021.

From consent no. CON-876

Novartis Pharmaceuticals Australia Pty Ltd

Product: ENTRESTO 97/103 sacubitril/valsartan (combined as a sodium salt hydrate complex) 97.2/102.8 mg film-coated tablet blister pack

ARTG number: 234218

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 18 October 2021

Duration: The consent is effective from 18 October 2021 for all batches released for supply until 31 October 2022.

​The product(s) do not conform to the requirements of Paragraph 10(10)(a) and Paragraph 10(14)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product(s) sample pack carton labels do not include a space for the prescriber to provide dispensing details and the batch number/expiry date prefixes on blister foil labels do not precede the batch number/expiry date.

​1. The product labels to which this consent applies are those provided with the application from Novartis Pharmaceuticals Australia Pty Ltd dated 23 February 2021.

From consent no. CON-875

Organon Pharma Pty Ltd

Product: ANTROQUORIL betamethasone 0.2mg/g (as valerate) cream tube

ARTG number: 70406

Batches: B55001, B55301, B59801, B59501, B59601, B62801, B59701, B63001, B62901, B63101, B69101, B68901, B69001

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

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

Date of consent: 15 October 2021

Duration: The consent is effective from 15 October 2021 until 30 May 2022.

​The product(s) do not conform to the requirements of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product(s) labels do not include the current sponsor details (Organon Pharma Pty Ltd).

From consent no. CON-875

Organon Pharma Pty Ltd

Product: CELESTONE-M betamethasone 0.2mg/g (as valerate) cream tube

ARTG number: 18778

Batches: B54901, B62701, B68701, B68801

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

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

Date of consent: 15 October 2021

Duration: The consent is effective from 15 October 2021 until 30 May 2022.

​The product(s) do not conform to the requirements of Paragraph 8(1)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91), in that the product(s) labels do not include the current sponsor details (Organon Pharma Pty Ltd).

From consent no. CON-874

GlaxoSmithKline Australia Pty Ltd

Product: XEVUDY sotrovimab 500 mg/8 mL concentrated injection solution for infusion, vial

ARTG number: 364110

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

Date of consent: 15 October 2021

Duration: The consent is effective from the 15th October 2021 until 17 August 2023.

​The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that key relevant information (as would be required under TGO 91) is absent from the labels.

From consent no. CON-873

BioQ Pharma Pty Ltd

Product: ROPIVACAINE READYFUSOR ropivacaine hydrochloride 0.2% solution for injection, bottle in dispenser device

ARTG number: 267572

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subsections 7(2) and 9(5), and subparagraphs 9(3)(a)(i) and 9(1)(f)(i), of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines

Date of consent: 14 October 2021

Duration: The consent is effective from 14 October 2021 until 13 October 2022.

​The product does not conform to the requirements of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines, in that the product label does not have text at the minimum height required, does not include the name and quantity of the active ingredient immediately below the name of the product on the main panel, and does not include the approved route of administration on the main panel.

From consent no. CON-872

Pfizer Australia Pty Ltd

Product: Pfizer (Australia) STERILE POTASSIUM CHLORIDE CONCENTRATE potassium chloride 750 mg/10 mL injection ampoule

ARTG number: 10793

Batches: B699, B723, B764, B765, B708

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: Paragraph 11(2)(f) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 6 October 2021

Duration: The consent is effective from the 6 October 2021 until 7 October 2022.

​The product does not conform with the requirements of Paragraph 11(2)(f) of TGO 91 in that the carton label does not state the weight of the active ingredient in the stated volume of fill of the injection in the container.

​A Customer letter identical to that provided to the Therapeutic Goods Administration on 29 September 2021 will be supplied with each affected batch.

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