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Database of consents to import, supply or export therapeutic goods that do not comply with standards
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25 October 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
Records of consent decisions
Displaying 1 - 10 of 4135
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.
Non-compliance with standard:
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.
Conditions:
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.
Non-compliance with standard:
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.
Conditions:
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.
Non-compliance with standard:
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.
Conditions:
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.
Non-compliance with standard:
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.
Conditions:
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.
Non-compliance with standard:
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.
Non-compliance with standard:
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.
Non-compliance with standard:
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.
Non-compliance with standard:
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.
Non-compliance with standard:
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.
Conditions:
A Customer letter identical to that provided to the Therapeutic Goods Administration on 29 September 2021 will be supplied with each affected batch.
From consent no.
CON-870
Biocelect Pty Ltd
Product: RAPIVAB peramivir 200 mg / 20 mL concentrate for intravenous infusion glass vial
ARTG number: 285559
Batches: C2000129
Therapeutic type: Prescription medicines
Supply/Import or Export: Import and supply
Relevant requirement: Paragraphs 8(1)(d), 8(1)(f), 8(1)(g), 8(1)(h), 9(1)(g) and 9(3)(a); and Subparagraphs 10(3)(a)(i) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)
Date of consent: 27 September 2021
Duration: The consent is effective for batch number C2000129 of the product from 27 September 2021 until 27 September 2026, or until the batch is depleted, whichever is sooner.
Non-compliance with standard:
The product does not conform with the requirements of Section 6 ‘main label’; Paragraphs 8(1)(d), 8(1)(f), 8(1)(g), 8(1)(h), 9(1)(g) and 9(3)(a); and Subparagraphs 10(3)(a)(i) of TGO 91 in that the product packaging does not comply with the following:
• The carton label does not include the medicine name more conspicuously on the main panel; does not include the approved name of the dosage form ‘Concentrated Injection’; does not indicate the location of the batch and expiry prefixes; does not include the statement ‘Protect from light’; does not include the words ‘for infusion’ adjacent to the name of the dosage form; does not include the name and quantity of the active ingredient together on one line immediately below the medicine name; and does not state the amount of the excipient ‘sodium chloride’ in the volume of fill of the injection in the container (i.e. 20 mL).• The vial label does not include the approved name of the dosage form ‘Concentrated Injection’; does not indicate the location of the batch and expiry prefixes; and does not include the statement ‘Protect from light’.Conditions:
• A ‘Dear Healthcare Professional’ letter identical to that provided in the email correspondence to the Therapeutic Goods Administration dated 22 September 2021 will be supplied with each affected batch outlining the non-compliance in the product labelling.
• The labels to which this consent applies are those provided in the email correspondence to the Therapeutic Goods Administration dated 22 September 2021