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

8 November 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 4131 - 4140 of 4140

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-37

Alphapharm Pty Ltd

Product: pramipexole hydrochloride monohydrate (PRAMIPEXOLE XR GP) 3.75 mg modified release tablet blister pack

ARTG number: 225599

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 15 February 2016

Duration: The consent is effective from the 15 February 2016 until 14 February 2017.

​On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:").

  1. The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted with your application. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:".
  2. During the 12 months  exemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion, the company should ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same.
From consent no. CON-37

Alphapharm Pty Ltd

Product: pramipexole hydrochloride monohydrate (PRAMIPEXOLE XR GP) 4.5 mg modified release tablet blister pack

ARTG number: 225617

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 15 February 2016

Duration: The consent is effective from the 15 February 2016 until 14 February 2017.

​On the blister foil labels of the products, the expiry date precedes the expiry date prefix ("Exp:").

  1. The blister foil label to be used for the products is the same as the sample blister foil label for the 3mg Pramipexole XR GP tablet submitted with your application. For indicating the location of the expiry date, the foil label includes an arrow printed immediately to the left of the expiry date abbreviation "EXP:" while the location of the batch number is indicated by an arrow printed immediately to the right of the batch number abbreviation"Lot:".
  2. During the 12 months  exemption period, the company will take relevant corrective actions to enable the foil labels to be changed to ensure compliance with TGO No. 69. In this regard, in order to avoid confusion, the company should ensure that the batch number and expiry date prefixes printed on the carton and blister foil labels are the same.
From consent no. CON-38

Sanofi-Aventis Australia Pty Ltd

Product: pertussis vaccine – (ADACEL POLIO) acellular diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus 1, 2 and 3 (vero cell) 0.5 mL injection syringe

ARTG number: 106576

Batches: Batch L0376-4, quantity 5,000, Expiry 30 June 2017

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 3(2)(c) of the Therapeutic Goods Order Number 69 – General requirements for labels for medicines.

Date of consent: 12 February 2016

Duration: The consent is effective from 12 February 2016 until 30 June 2017.

​The product will be supplied with syringe labelled with Standard International label, rather than the Australian syringe label.

​A 'Dear Healthcare Provider' letter identical to that provided to the Therapeutic Goods Administration on 8 February 2016 (TGA reference R16/89758) will be supplied with the affected batch, and this batch of ADACEL POLIO is exactly the same as the other batches currently available in Australia, with the exception of the syringe label.

From consent no. CON-39

GlaxoSmithKline Australian Pty Ltd

Product: meningococcal (Groups A, C, W-135 and Y) (MENVEO) oligosaccharide CRM197 conjugate vaccine

ARTG number: 158477

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 3(2)(l) of Therapeutic Goods Order Number 69, General requirements for labels for medicines.

Date of consent: 11 February 2016

Duration: The consent is effective from the 11 February 2016 until 30 November 2016.

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

  1. The labels to which this consent applies are those previously approved for the former sponsor Novartis Vaccines and Diagnostics Pty Ltd,
  2. Arrangements are in place with the former sponsor (Novartis Vaccines and Diagnostics Pty Ltd) for the prompt referral of any queries or complaints concerning the products to the current sponsor GlaxoSmithKline Australia Pty Ltd.
From consent no. CON-39

GlaxoSmithKline Australian Pty Ltd

Product: meningococcal (Groups A, C, W-135 and Y) (MENVEO) oligosaccharide CRM197 conjugate vaccine

ARTG number: 192696

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 3(2)(l) of Therapeutic Goods Order Number 69, General requirements for labels for medicines.

Date of consent: 11 February 2016

Duration: The consent is effective from the 11 February 2016 until 30 November 2016.

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

  1. The labels to which this consent applies are those previously approved for the former sponsor Novartis Vaccines and Diagnostics Pty Ltd,
  2. Arrangements are in place with the former sponsor (Novartis Vaccines and Diagnostics Pty Ltd) for the prompt referral of any queries or complaints concerning the products to the current sponsor GlaxoSmithKline Australia Pty Ltd.
From consent no. CON-33

Generic Health Pty Ltd

Product: PHARMACY ACTION PARACETAMOL PLUS CODEINE 500 mg/10 mg tablets blister pack

ARTG number: 200691

Batches: 450684

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Import and supply

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

Date of consent: 10 February 2016

Duration: The consent is effective from the 10 February 2016 to batch number 450684 until 30 September 2016.

The product labels do not include all of the new warning statements required by the legislative instrument made by the Minister under subsection 3(5A) of the Act ('RASML No 2'), from 12 December 2015.

The labels to which this consent applies are those previously approved by the Therapeutic Goods Administration for these products, copies of which were provided with the request.

From consent no. CON-36

Merck Sharp & Dohme (Australia Pty) Ltd

Product: rizatriptan (as benzoate) (RIZATRIPTAN WAFERS) 10 mg wafer blister pack

ARTG number: 225969

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 3(12)(a) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines.

Date of consent: 9 February 2016

Duration: The consent is effective from from the 9 February 2016 until 31 December 2017.

The blister foil label does not include either the name or the registered trade-mark of the sponsor and the product name of the medicine.

​The blister foil label for use with the product is that provided in the application.

From consent no. CON-34

Octapharma Australia Pty Ltd

Product: OCTAPLAS LG solvent/detergent human plasma solution for injection bag 200 mL

ARTG number: 96613

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: European Pharmacopoeia monograph 1646 ‘Human Plasma pooled and treated for virus inactivation’.

Date of consent: 1 February 2016

Duration: The consent is effective from 1 Feburary 2016 until such time as the requirement for Hepatitis A antibody levels in the monograph ‘Human Plasma pooled and treated for virus inactivation’ (Ph. Eur. monograph 1646) are changed to levels ≤0.3 IU/mL, and is legally binding in Australia.

​The product does not meet the anti-Hepatitis A virus (HAV) antibody limit of ≥ 1 IU/ mL.

  1. The Hepatitis A antibody levels of the product must be ≥ 0.3 IU/mL.
  2. The sensitivity of the Hepatitis A virus nucleic acid test used on the manufacturing pool is ≤13 IU/mL.
From consent no. CON-31

Symbion Pty Ltd

Product: CHEMMART PHARMACY IBUPROFEN 200mg soft gelatin capsule blister pack (20, 40 and 100 tablets pack)

ARTG number: 192234

Batches: VA4005, VA5001

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

Relevant requirement: Subclause 3(2)(g) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines.

Date of consent: 13 January 2016

Duration: The consent is effective from 13 January 2016 until 12 June 2016.

​The medicine labels do not include all of the advisory statements that are required by schedule 2 of the Medicines Advisory Statements Specifications 2014 from 12 December 2015.

​The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 18 December 2015.

From consent no. CON-31

Symbion Pty Ltd

Product: PHARMACY CHOICE IBUPROFEN 200mg soft gelatin capsule blister pack (20, 40 and 100 tablets pack)

ARTG number: 192235

Batches: VG5002

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

Relevant requirement: Subclause 3(2)(g) of the Therapeutic Goods Order No. 69 - General requirements for labels for medicines.

Date of consent: 13 January 2016

Duration: The consent is effective from 13 January 2016 until 12 June 2016.

​The medicine labels do not include all of the advisory statements that are required by schedule 2 of the Medicines Advisory Statements Specifications 2014 from 12 December 2015.

​The labels to which this consent applies are those previously approved for these products, copies of which were provided with the request letter of 18 December 2015.

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