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

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.

Open all | Close all
If you want to print all entries, you need to Open all before you print.

Displaying 1 - 10 of 978

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-267

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

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

ARTG number: 231199

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 7(13)(a) of the Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO 69)

Date of consent: 5 June 2018

Duration: The consent is effective from 5 June 2018 until 31 August 2020

​The blister foil label to be used does not include the name or registered trademark of the sponsor.

​1. The blister foil label to which this consent applies is provided with the application.

2. Upon receipt in Australia, the product will be re-packed into currently approved Australian cartons with the Australian printed leaflet.

From consent no. CON-268

Sanofi Aventis Australia Pty Ltd

Product: FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60 mcg, 0.5 mL suspension for injection

ARTG number: 213963

Batches: UI946AA

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: 1. European Pharmacopeia (01/2008:0158) 2. Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)

Date of consent: 4 June 2018

Duration: The consent is effective from 4 June 2018 until 28 February 2019

​1. Passage of the working seed lots UC4216- 13 (A/Michigan/45/2015 X-275), UC4105-30 (B/Brisbane/60/2008) and UC4184-14 (B/Phuket/3073/2013); neuraminidase tests are not performed on the first 3 monovalent bulk lots manufactured from each of the above working seed lots; test for Bacterial Endotoxins (2.6.14) and the assay of Haemagglutinin Antigen by an immunodiffusion test (2.7.1) are not performed on the Final Lot.

2. The batch is packaged in the Standard Export labelling (in Spanish and English), which does not conform with the requirements of the TGO 91 on the following:

  • Paragraph 8(1)(d) the name of the dosage form (missing on carton)
  • Paragraph 8(1)(i) the name and contact details of the sponsor (missing on carton)
  • Paragraph 8(1)(j)(iv)(A) indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1 (statement regarding manufactured in eggs missing on carton)
  • Paragraph 9(1)(b) the name(s) of all active ingredients in the medicine (missing on syringe)
  • Paragraph 9(1)(c) the quantity or proportion of all active ingredients in the medicine (missing on syringe)
  • Subsection 9(3) the name of the medicine and the name of active ingredients on the main label (they are placed separately as the same texts in Spanish are placed before English texts)
  • Paragraph 10(5)(c) the name of the medicine is displayed in a text size of not less than 1.5 millimetres (the trade name "FluQuadri" is less than 1.5 mm on syringe)
  • Paragraph 11(1)(a) use of appropriate metric units (the abbreviation "mcg" is used rather than "microgram" in full on carton)
  • Subsection 11(5) permitted statements of storage temperature conditions ("Store between +2̊ C to +8°C. Do not freeze" is used rather than "Store at 2°C to 8°C" (Refrigerate. Do not freeze) on carton).

​1. This consent applies only to the FluQuadri batch UI946AA.

2. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 28 May 2018 will be supplied with the affected batch.

3. Non-compliance with the European Pharmacopoeia is limited to the working seeds and tests detailed in the application submitted to the TGA on 28 May 2018;

4. Non-compliance with the TGO 91 is limited to specifications detailed in the application form submitted to the TGA on 28 May 2018.

From consent no. CON-266

Arrow Pharma Pty Ltd

Product: AUSGEM gemfibrozil 600 mg tablet bottle

ARTG number: 62099

Batches: 7230543

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 29 May 2018

Duration: The consent is effective from 29 May 2018 until the end of the supply of batch 7230543.

​ The labels of the products do not contain the current sponsor name and contact details.

​The labels of the products to which this consent applies are those previously approved and contain the previous sponsor Aspen Pharma Pty Ltd and arrangements are in place with the former sponsor Aspen Pharma for the prompt referral of any queries or complaints concerning the products to Arrow Pharma Pty Ltd.

From consent no. CON-265

Merck Sharp and Dohme (Australia) Pty Limited

Product: PROQUAD measles mumps rubella varicella live virus vaccine injection vial with prefilled diluent syringe

ARTG number: 126157

Batches: R011831 and R011832

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Section 7(2)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91).

Date of consent: 25 May 2018

Duration: The consent is effective from 25 May 2018 until 25 October 2019.

​The newly implemented double detachable labels for the vaccine vial are obscuring some of the information on the vial label as follows:

  • the name of the medicine
  • the name of the active ingredients in the medicine
  • the name of the dosage form
  • the quantity of the medicine
  • the approved route of administration

​1. This consent applies only to PROQUAD measles mumps rubella varicella live virus vaccine injection vial with prefilled diluent syringe [AUST R 126157], batch R011831 (expiry 25 October 2019, quantity: 27,394) and R011832 (expiry 25 October 2019, quantity: 5,686);

2. Non-compliance with the TGO 91 is limited to the information detailed in the submission;

3. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 18 May 2018 will be supplied with each affected batch warning that some of the text including the trade name on the main label is obscured and upon removal of the detachable labels, the text on the main label is fully visible;

4. The distributor for the labels to which this consent applies is Seqirus and arrangements are in place with the distributor Seqirus' Medical Information Department on 1800 642 865 for the prompt referral of any queries or complaints concerning the product.

From consent no. CON-264

Merck Sharp and Dohme (Australia) Pty Limited

Product: M-M-R II powder for injection vial with pre-filled diluent syringe, single dose

ARTG number: 201877

Batches: R011834

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Section 7(2)(a) of Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91).

Date of consent: 25 May 2018

Duration: The consent is effective from 25 May 2018 until 23 February 2020.

 The newly implemented double detachable labels for the vaccine vial are obscuring some of the information on the vial label as follows:
  • the name of the medicine
  • the name of the active ingredients in the medicine
  • the name of the dosage form
  • the quantity of the medicine
  • the approved route of administration

1.This consent applies only to M-M-R II powder for injection vial with pre-filled diluent syringe, single dose (AUST R 201877), batch R011834 (expiry 23 February 2020, quantity: 50,400).

2. Non-compliance with the TGO 91 is limited to the information detailed in the submission.

3. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 18 May 2018 will be supplied with each affected batch warning that some of the text including the trade name on the main label is obscured and upon removal of the detachable labels, the text on the main label is fully visible.

4. The distributor for the labels to which this consent applies is Seqirus and arrangements are in place with the distributor Seqirus' Medical Information Department on 1800 642 865 for the prompt referral of any queries or complaints concerning the product.

From consent no. CON-263

Sandoz Pty Ltd

Product: VALACICLOVIR SZ valaciclovir (as hydrochloride) 500 mg film-coated tablet blister pack

ARTG number: 154460

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – General Requirements for Labels for Medicines 2017 (TGO No. 69).

Date of consent: 25 May 2018

Duration: The consent is effective from 25 May 2018 until 31 July 2018.

​ The labels of the products do not contain the current company address.

​1. The labels of the products to which this consent applies are those previously approved and contain the previous company address as detailed in the application.

2. Company contact details remain unchanged and arrangements are in place for the prompt re-direction of mails and correspondence to the new company address.

From consent no. CON-262

Sanofi Aventis Australia Pty Ltd

Product: FluQuadri Inactivated Quadrivalent Influenza Vaccine (Split Virion), Influenza virus haemagglutinin 60 mcg, 0.5 mL suspension for injection

ARTG number: 213963

Batches: UI942AC

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: European Pharmacopeia (01/2008:0158) test for Bacterial Endotoxins (2.6.14) and the assay of Haemagglutinin Antigen by an immunodiffusion test (2.7.1) and Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91).

Date of consent: 24 May 2018

Duration: The consent is effective from 24 May 2018 until 28 February 2019.

1. European Pharmacopeia (01/2008:0158) the test for Bacterial Endotoxins (2.6.14) and the assay of Haemagglutinin Antigen by an immunodiffusion test (2.7.1), are performed on the Final Bulk Product only and not performed on the Final Lot.

2. Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO91)‐ The batch is packaged in the Standard Export labelling (in Spanish and English), which does not conform with the requirements of the TGO 91 on the following:

  • Paragraph 8(1)(d) the name of the dosage form (missing on carton)
  • Paragraph 8(1)(i) the name and contact details of the sponsor (missing on carton)
  • Paragraph 8(1)(j)(iv)(A) indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1 (statement regarding manufactured in eggs missing on carton)
  • Paragraph 9(1)(b) the name(s) of all active ingredients in the medicine (missing on syringe)
  • Paragraph 9(1)(c) the quantity or proportion of all active ingredients in the medicine (missing on syringe)
  • Paragraph 9(3) the name of the medicine and the name of active ingredients on the main label (they are placed separately as the same texts in Spanish are placed before English texts)
  • Paragraph 10(5)(c) the name of the medicine is displayed in a text size of not less than 1.5 millimetres (the trade name "FluQuadri" is less than 1.5 mm on syringe)
  • Paragraph 11(1)(a) use of appropriate metric units (the abbreviation "mcg" is used rather than "microgram" in full on carton)
  • Subsection 11(5) permitted statements of storage temperature conditions ("Store between +2oC to +8oC. Do not freeze" is used rather than "Store at 2oC to 8oC" (Refrigerate. Do not freeze) on carton).

 

1. This consent applies only to the FluQuadri batch UI942AC.

2. A 'Dear Healthcare Professional' letter identical to that provided to the TGA on 21 May 2018 will be supplied with the affected batch.

3. Non‐compliance with the European Pharmacopoeia is limited to the tests detailed in the application submitted to the TGA on 18 May 2018.

4. Non‐compliance with the TGO 91 is limited to specifications detailed in the application form submitted to the TGA on 18 May 2018.

 

From consent no. CON-248

Beiersdorf Health Care Australia Pty Ltd

Product: EUCERIN wool alcohols 60 mg/g ointment jar

ARTG number: 34155

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

Relevant requirement: Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – – General Requirements for Labels for Medicines 2017.

Date of consent: 22 May 2018

Duration: The consent is effective from the 22 May 2018 until 31 January 2021

​The labels do not include the correct name of the sponsor or supplier of the products.

​The labels to which this consent applies are those previously approved for the former sponsor Beiersdorf Australia Limited, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to the current sponsor, Beiersdorf Health Care Australia Pty Ltd.

From consent no. CON-248

Beiersdorf Health Care Australia Pty Ltd

Product: EUCERIN wool alcohols 60 mg/g ointment tube

ARTG number: 34154

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

Relevant requirement: Paragraph 7(2)(l) of Therapeutic Goods Order No. 69 – – General Requirements for Labels for Medicines 2017.

Date of consent: 22 May 2018

Duration: The consent is effective from the 22 May 2018 until 31 January 2021

​The labels do not include the correct name of the sponsor or supplier of the products.

​The labels to which this consent applies are those previously approved for the former sponsor Beiersdorf Australia Limited, and arrangements are in place with the former sponsor for the prompt referral of any queries or complaints concerning the products to the current sponsor, Beiersdorf Health Care Australia Pty Ltd.

From consent no. CON-261

Dr Reddy's Laboratories (Australia) Pty Ltd

Product: ALENDRONATE PLUS D3 CALCIUM ACTAVIS alendronic acid (as sodium) 70 mg and colecalciferol 140 microgram tablet and calcium 500 mg tablet composite pack

ARTG number: 222686

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

Relevant requirement: Subsection 11(b) of the Therapeutic Goods Order 78 - Standard for Tablets and Capsules (TGO 78).

Date of consent: 18 May 2018

Duration: The consent is effective from 18 May 2018 until the 18 May 2020.

​The products do not meet the expiry assay limits of 92.5% - 107.5 % for the stated content of colecalciferol.

​The expiry colecalciferol assay limits for the products are 90.0% - 110.0%.

Pages