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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 4061 - 4070 of 4179

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-66

Accord Healthcare Pty Ltd

Product: Midazolam (as hydrochloride) (MIDAZOLAM MYX) 5 mg/ 5 mL solution for injection ampoules

ARTG number: 207239

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 16 June 2016

Duration: The consent is effective from 16 June 2016 until 30 June 2017

​The labels do not include the name and address details of the current sponsor.

  1. The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor.
From consent no. CON-66

Accord Healthcare Pty Ltd

Product: Midazolam (as hydrochloride) (MIDAZOLAM MYX) 5 mg/ 1 mL solution for injection ampoules

ARTG number: 207241

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 16 June 2016

Duration: The consent is effective from 16 June 2016 until 30 June 2017

​The labels do not include the name and address details of the current sponsor.

  1. The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor.
From consent no. CON-66

Accord Healthcare Pty Ltd

Product: Midazolam (as hydrochloride) (MIDAZOLAM MYX) 15 mg/ 3 mL solution for injection ampoules

ARTG number: 207245

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 16 June 2016

Duration: The consent is effective from 16 June 2016 until 30 June 2017

​The labels do not include the name and address details of the current sponsor.

  1. The labels to which this consent applies are those previously approved for the former sponsor, Mayne Pharma International Pty Ltd and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to Accord Healthcare Pty Ltd, the current sponsor.
From consent no. CON-68

Sanofi Pasteur Australia Pty Ltd

Product: TRIPACEL pertussis vaccine - acellular combined with diptheria and tetanus toxoids (adsorbed) 0.5 mL injection vial

ARTG number: 63120

Batches: lot C5079A Expiry 30 September 2018, Quantity 165,000 doses

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Clause 3(2)(b) and Clause 3(2)(c) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines.

Date of consent: 16 June 2016

Duration: The consent is effective from 16 June 2016 until 30 September 2018.

  • The names of all active ingredients in the goods and the quantity or proportion of all active ingredients in the goods are not on the vial label.
  • The European Pharmacopoeia, in that it is tested to international/Canadian, rather than Australian specifications, as detailed in the application letter.
  1. a 'Dear Healthcare Professional' letter identical to that provided to the TGA on 16 June 2016 (TGA ref: R16/460939) will be supplied with each affected batch, warning about the different age indication on the international vial label;
  2. the vials will be repacked into the approved Australian carton together with the approved Australian Product Information leaflet at the proposed site in the letter dated 3 June 2016;
  3.  the company will provide TGA with a copy of the Biologics and Genetic Therapies Directorate (BGTD) release certificate for lot C5079A; and
  4. normal TGA lot release processes will apply to this batch except that the Canadian lot release protocol is different from the Australian version.
From consent no. CON-67

Norgine Pty Ltd

Product: MOVICOL LIQUID ORANGE FLAVOUR oral liquid concentrate bottle

ARTG number: 212114

Batches: Batches 245415 and 245354

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclauses 3(2)(e) and 3(2)(f) of the Therapeutic Goods Order No 69- General requirements for labels for medicines.

Date of consent: 10 June 2016

Duration: The consent is effective from 10 June 2016 until April 2018.

​The bottle labels do not include the expiry date prefix and the batch number prefix.

From consent no. CON-69

Pfizer Australia Pty Ltd

Product: Centrum Specialist Energy Plus

ARTG number: 264900

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 10(b) of the Therapeutic Goods Order No. 78 – Standards for Tablets and Capsules.

Date of consent: 3 June 2016

Duration: The consent is effective from 3 June 2016 until 31 May 2018.

​ That content of the active ingredient ‘Panax ginseng standardised root extract’ (the herbal active ingredient) is more than 120.0% of the stated content on the label.

  1. The content of the herbal active ingredient, ‘Panax ginseng standardised root extract’, must not be less than 90.0% and not more than 125.0% of the stated content of the label.
From consent no. CON-65

Aspen Pharma Pty Ltd

Product: bicalutamide (CALUTEX) blister pack 50 mg tablets blister pack

ARTG number: 135858

Batches: 1942524

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: subclause 3(13)(a) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines.

Date of consent: 2 June 2016

Duration: The consent is effective from 2 June 2016.

​one batch only of the product (Batch 1942524) that does not conform to the requirements of the Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69) in that the blister foil label does not include the required pre-fixes for batch number and expiry date.

  1. The 'Dear Healthcare Professional/Pharmacist' letter identical to that provided to the TGA on 31 May 2016 will be supplied with the affected batch of product.
  2. The blister foil label to which this consent applies is that provided with your application.

 

From consent no. CON-63

Sanofi-Aventis Australia Pty Ltd

Product: VIVAXIM 1mL injection syringe composite pack

ARTG number: 82745

Batches: Batch: L5177-5, quantity: 8924, expiry: 31/03/2017, packaging: Standard International labelling. Batch: L5 l 00-1, quantity: 13031, expiry: 28/02/2017, packaging: South African labelling. Batch: L5536-2, quantity: 12015, expiry: 31/10/2017, packaging: South African labelling.

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subclause 3(2)(a); 3(2)(c) and 4(7)(c) of the Therapeutics Goods Order No. 69 - General requirements for labels for medicines.

Date of consent: 30 May 2016

Duration: The consent is effective from 30 May 2016 until the date of expiry of the affected batch, as applicable to each of the three batches, and no later than 31 October 2017.

​the product is labelled with the Standard International syringe label or the South African syringe label that do not contain the name and quantity of active ingredients.

  1. Dear Healthcare Provider' letter identical to that provided to the TGA on 27 May 2016 (TGA reference R16/387527) will be supplied with each affected batch warning that "VIVAXIM in the Standard International labelling is exactly the same vaccine as the one currently available in Australia, with the exception of the syringe label. As the batches were originally intended for other countries, the syringe label is written in multi-languages. The carton and package leaflet are the Australian approved labels"]
  2. The carton and package leaflet for the affected batches will be repackaged with the Australian carton and package leaflet, at TGA-approved packaging and labelling site
  3. No aspects of the quality information have been changed, including manufacturing procedures and equipment and raw material and finished product specifications, other than the labelling change nominated in the application.
From consent no. CON-62

Link Medical Products Pty Ltd

Product: procarbazine (as hydrochloride)(Natulan) capsule 50 mg in blister pack

ARTG number: 231199

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Sub-clause 3(13)(a) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines.

Date of consent: 24 May 2016

Duration: The consent is effective from 24th May 2016 until 31 May 2018.

​The product does not comply with TGO No. 69 because the blister foil label to be used does not include the name or registered trademark of the sponsor.

  1. The 'Dear Healthcare Professional' letter identical to that provided to the TGA via the electronic mail of 24 May 2016 will be supplied with each affected batch of the product.
  2. The blister foil label to which this consent applies is that provided with the application.
  3. Upon receipt in Australia, the product will be re-packed into currently approved Australian cartons with the Australian printed leaflet.

 

 

From consent no. CON-64

Grifols Australia Pty Ltd

Product: normal immunoglobulin (Human) (FLEBOGAMMA 5% DIF) 0.5 g/10 mL intravenous use injection vial

ARTG number: 140602

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.

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