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.

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Displaying 1 - 10 of 676

Enter a sponsor, product name, consent, batch or ARTG number.
From consent no. CON-209

Sandoz Pty Ltd

Product: CURAM DUO FORTE 875/125 amoxicillin 875 mg (as trihydrate) and clavulanic acid 125 mg (as potassium) tablet strip pack

ARTG number: 82829

Batches: HB8086 and HB8087

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 5 September 2017

Duration: The consent is effective from the 5 September 2017 until the batches HB8086 and HB8087 are depleted.

​The foil strip label does not include batch number and expiry date prefixes immediately followed by the batch number and expiry date.

​A ‘Dear Healthcare Professional’ letter identical to that provided to the TGA in your s31 response will be supplied with each affected batch to individual pharmacy to ensure that the patients are instructed to keep the foil strips in the product pack for these affected batches.

From consent no. CON-207

Toowoomba Maranatha Foundation

Product: Necessity Fixaderm Lotion

ARTG number: 179095

Therapeutic type: Listed complementary medicines

Supply/Import or Export: Supply

Relevant requirement: Sections 7(1) and 8(1)(i) of the Therapeutic Goods Order No. 92 – (TGO 92)-Standard for labels of non prescription medicines

Date of consent: 4 September 2017

Duration: The consent is effective from the 4 September 2017 until 04 September 2019.

Section 7(1) requires the labels on the container and primary pack to comply with the requirements of the Order. Section 8(1)(i) requires the name and contact details of the sponsor or distributor on the labels.
From consent no. CON-208

Mylan Health Pty Ltd

Product: BRUFEN ibuprofen 400 mg tablet blister pack

ARTG number: 80659

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 4 September 2017

Duration: The consent is effective from the 4 September 2017 until 14 April 2019.

​The carton and blister foil labels do not bear the current sponsor's name and address.

​The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address.

From consent no. CON-208

Mylan Health Pty Ltd

Product: LUVOX fluvoxamine maleate 100 mg tablet blister pack

ARTG number: 57633

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 4 September 2017

Duration: The consent is effective from the 4 September 2017 until 14 April 2019.

​The carton and blister foil labels do not bear the current sponsor's name and address.

​The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address.

From consent no. CON-208

Mylan Health Pty Ltd

Product: LUVOX fluvoxamine maleate 50 mg tablet blister pack

ARTG number: 57632

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 4 September 2017

Duration: The consent is effective from the 4 September 2017 until 14 April 2019.

​The carton and blister foil labels do not bear the current sponsor's name and address.

​The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address.

From consent no. CON-208

Mylan Health Pty Ltd

Product: FENOFIBRATE MYLAN fenofibrate 48 mg tablet blister pack

ARTG number: 230444

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 4 September 2017

Duration: The consent is effective from the 4 September 2017 until 14 April 2019.

​The carton and blister foil labels do not bear the current sponsor's name and address.

​The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address.

From consent no. CON-208

Mylan Health Pty Ltd

Product: FENOFIBRATE MYLAN fenofibrate 145 mg tablet blister pack

ARTG number: 230443

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 4 September 2017

Duration: The consent is effective from the 4 September 2017 until 14 April 2019.

​The carton and blister foil labels do not bear the current sponsor's name and address.

​The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address.

From consent no. CON-208

Mylan Health Pty Ltd

Product: LIPIDIL fenofibrate 48 mg tablet blister pack

ARTG number: 118642

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 4 September 2017

Duration: The consent is effective from the 4 September 2017 until 14 April 2019.

​The carton and blister foil labels do not bear the current sponsor's name and address.

​The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address.

From consent no. CON-208

Mylan Health Pty Ltd

Product: LIPIDIL fenofibrate 145 mg tablet blister pack

ARTG number: 118634

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 4 September 2017

Duration: The consent is effective from the 4 September 2017 until 14 April 2019.

​The carton and blister foil labels do not bear the current sponsor's name and address.

​The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address.

From consent no. CON-208

Mylan Health Pty Ltd

Product: TRICHODIL fenofibrate 48 mg tablet blister pack

ARTG number: 233991

Therapeutic type: Prescription medicines

Supply/Import or Export: Import and supply

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

Date of consent: 4 September 2017

Duration: The consent is effective from the 4 September 2017 until 14 April 2019.

​The carton and blister foil labels do not bear the current sponsor's name and address.

​The labels to which this consent applies are the current labels approved for the former sponsor BGP Products Pty Ltd and arrangements are in place to redirect all correspondence to current sponsor address.

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