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

10 January 2022

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 4071 - 4080 of 4179

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-64

Grifols Australia Pty Ltd

Product: normal immunoglobulin (Human) (FLEBOGAMMA 5% DIF) 2.5 g/50 mL intravenous use injection vial

ARTG number: 143800

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

Date of consent: 23 May 2016

Duration: The consent is effective from 23 May 2016 until 23 May 2017

Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line.

  1. An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602 because the vial capacity is less than 20 mL.
From consent no. CON-64

Grifols Australia Pty Ltd

Product: normal immunoglobulin (Human) (FLEBOGAMMA 5% DIF) 5 g/100 mL intravenous use injection vial

ARTG number: 143801

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

Date of consent: 23 May 2016

Duration: The consent is effective from 23 May 2016 until 23 May 2017

Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line.

  1. An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602 because the vial capacity is less than 20 mL.
From consent no. CON-64

Grifols Australia Pty Ltd

Product: normal immunoglobulin (Human) (FLEBOGAMMA 5%) 10 g/200 mL intravenous use injection vial

ARTG number: 143802

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

Date of consent: 23 May 2016

Duration: The consent is effective from 23 May 2016 until 23 May 2017

Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line.

  1. An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602 because the vial capacity is less than 20 mL.
From consent no. CON-64

Grifols Australia Pty Ltd

Product: normal immunoglobulin (Human) FLEBOGAMMA 5% DIF 20 g/400 mL intravenous use injection vial

ARTG number: 143803

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

Date of consent: 23 May 2016

Duration: The consent is effective from 23 May 2016 until 23 May 2017

Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line.

  1. An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602 because the vial capacity is less than 20 mL.
From consent no. CON-64

Grifols Australia Pty Ltd

Product: normal immunoglobulin (Human) (FLEBOGAMMA 10% DIF) 5 g/50 mL intravenous use injection vial

ARTG number: 184353

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

Date of consent: 23 May 2016

Duration: The consent is effective from 23 May 2016 until 23 May 2017

Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line.

  1. An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602 because the vial capacity is less than 20 mL.
From consent no. CON-64

Grifols Australia Pty Ltd

Product: normal immunoglobulin (Human) (FLEBOGAMMA 10% DIF) 10 g/ 100 mL intravenous use injection vial

ARTG number: 182358

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

Date of consent: 23 May 2016

Duration: The consent is effective from 23 May 2016 until 23 May 2017

Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line.

  1. An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602 because the vial capacity is less than 20 mL.
From consent no. CON-64

Grifols Australia Pty Ltd

Product: normal immunoglobulin (Human) (FLEBOGAMMA 10% DIF) 20 g/200 mL intravenous use injection vial

ARTG number: 182359

Therapeutic type: Prescription medicines

Supply/Import or Export: Supply

Relevant requirement: subclause 3(2)(l) of Therapeutic Goods Order No 69 – (TGO 69) General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)

Date of consent: 23 May 2016

Duration: The consent is effective from 23 May 2016 until 23 May 2017

Vial labels do not include the name and address of the current sponsor (Grifols Australia; for AUST R 143800, 143801, 143802, 143803, 184353, 182358 and 182359) and carton labels do not show the signal words, PRESCRIPTION ONLY MEDICINES, on the first line.

  1. An assurance that Grifols Australia is seeking exemption for a period of 12 months only. During this period the vial and carton labels will be updated to meet the required standards and submitted as a section 9D(3) application to the TGA.Please note that a commitment to update and implement artwork to meet the requirements of the subclause 3(2)(l) of Therapeutic Goods Order No 69 – General requirements for labels for medicines and Part 2 section 1.3(1)(a) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) is not applicable to container label of AUST R 140602 because the vial capacity is less than 20 mL.
From consent no. CON-60

Link Medical Products Pty Ltd

Product: amifostine (as trihydrate) (ETHYOL) 500 mg powder for injection vial

ARTG number: 63789

Batches: CK 2071

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: sub-clause 3(1)(a) of the Therapeutic Goods Order No. 69.

Date of consent: 18 May 2016

Duration: The consent is effective from the 18 May 2016 until 31 January 2017.

​The information on the carton and vial labels are not in the English language.

  1. ​The 'Dear Healthcare Professional' letter identical to that provided to the TGA by the company must be supplied with each dispensed unit of batch CK 2071 of the product.
  2. The carton and vial labels for batch CK 2071 are identical to the representative French product labels provided in the application. The main panel of the carton label must be over-stickered with the over-label provided with the application.  
  3. The French package insert must be replaced with the Australian package insert in each dispensed unit of batch CK 2071 of the product.
From consent no. CON-61

GlaxoSmithKline Healthcare Australia Pty Ltd

Product: calsource Ca 1000

ARTG number: 146629

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Subclauses 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines.

Date of consent: 6 May 2016

Duration: The consent is effective from 6 May 2016 until 13 March 2018.

​The products will be supplied in labels containing the name and address of the previous sponsor (Novartis Consumer Health Australasia Pty Ltd), rather than the current sponsor (GlaxoSmithKline Consumer Healthcare Australia Pty Ltd).

  1. ​arrangements are in place with the former sponsor (Novartis Consumer Health Australasia Pty Ltd), for the prompt referral of any queries or complaints concerning the product to the current sponsor (GlaxoSmithKline Consumer Healthcare Australia Pty Ltd).
From consent no. CON-57

GlaxoSmithKline Australia Ltd

Product: zanamivir (RELENZA ROTADISKS) 5 mg insufflation blister pack

ARTG number: 66962

Therapeutic type: Prescription medicines

Supply/Import or Export: Import, supply and export

Relevant requirement: Sub-clause 2(1) of Therapeutic Goods Order (TGO) 69 - General requirements for labels for medicines.

Date of consent: 20 April 2016

Duration: The consent is effective from 20 April 2016 until 21 April 2018.

the product is to be supplied with a 10 year shelf life. Sub-clause 2(1) of the Order stipulates that the expiry is a date not more than 5 years after the date of manufacture.

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