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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 4101 - 4110 of 4179

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: xylometazoline hydrochloride (OTRIVIN JUNIOR NASAL SPRAY) 0.5 mg/mL pump actuated metered dose aerosol

ARTG number: 142227

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

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

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: xylometazoline hydrochloride (OTRIVIN JUNIOR NASAL DROPS) 0.5 mg/mL bottle (new formulation)

ARTG number: 142226

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

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

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: pump actuated metered dose aerosol (OTRIVIN PLUS NASAL SPRAY)

ARTG number: 178401

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

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

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: oxerutins (PAROVEN) 250 mg capsule blister pack

ARTG number: 60271

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

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

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: oxerutins (PAROVEN FORTE) 500 mg tablet blister pack

ARTG number: 52171

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

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

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: diclofenac diethylamine (VOLTAREN OSTEO GEL) 11.6 mg/g tube

ARTG number: 175889

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

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

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: diclofenac potassium (VOLTAREN RAPID 12.5 LIQUID CAPSULE) 12.5 mg soft capsule blister pack

ARTG number: 171307

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

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

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: diclofenac potassium (VOLTAREN RAPID 12.5) 12.5 mg film coated tablet blister pack (reformulation)

ARTG number: 168061

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

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

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: Diclofenac Potassium (VOLTAREN RAPID 25) 25 mg tablet

ARTG number: 42942

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

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

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

From consent no. CON-50

GlaxoSmithKline Consumer Healthcare Australia Pty Ltd

Product: diclofenac diethylamine (VOLTAREN EMULGEL) 11.6 mg/g gel tube

ARTG number: 47676

Therapeutic type: Over-the-counter medicines

Supply/Import or Export: Supply

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

Date of consent: 6 April 2016

Duration: The consent is effective from 6 April 2016 until 5 April 2018.

​The product labels do not include the name and address of the current sponsor or supplier of the goods.

​1. Arrangements are in place for the prompt referral of any queries or complaints concering the products to the current sponsor.

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