GST-free Supply (Health Goods) Determination 2011

Administered by Department of the Treasury

Legislation au F2011L02714 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Health and Ageing

 

A New Tax System (Goods and Services Tax) Act 1999

 

GST-free Supply (Health Goods) Determination 2011

 

Purpose

 

The purpose of this determination is to broaden the range of nicotine replacement therapy products that are granted GST-free status under a determination.  Specifically, all nicotine replacement therapies for transdermal and oromucosal use used as an aid in withdrawal from tobacco smoking will receive GST free status under this determination.

 

A new determination is being issued to maintain the existing GST-free treatment of certain nicotine replacement therapies where these products would have otherwise become taxable from 1 January 2012 through being removed from the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

 

This Determination revokes the determination titled GST-free Supply (Health Goods) Determination 2005 (previous Determination) from 31 December 2011.

 

Paragraph 177-10(4)(b) of the A New Tax System (Goods and Services Tax) Act 1999 (the GST Act) provides that the Health Minister may make a determination in respect to subsection 38-47(1) of the GST Act. This sub-section of the GST Act provides that a supply is GST-free if it is a supply of goods of a kind that the Health Minister, by determination in writing, declares to be goods the supply of which is GST-free.

 

This Determination

 

This determination expands the entry for nicotine from that covered by the previous determination. The new entry for nicotine covers all forms of nicotine replacement therapy where the product is for use as an aid in withdrawal from tobacco smoking and the nicotine is administered through a preparation for transdermal or oromucosal use.  In addition, for the purpose of sub-section 38-47(1) of the GST Act, for the goods in Schedule 1 of the determination to be GST-free, they must under the Therapeutic Goods Act 1989 be required to be included in the Australian Register of Therapeutic Goods, or be goods in a class of goods required to be in the Australian Register of Therapeutic Goods. 

 

In September 2011, a delegate to the Secretary of the Department of Health and Ageing announced a final decision to exempt from listing in the SUSMP from 1 January 2012, nicotine in preparations for human therapeutic use for use as an aid in withdrawal from tobacco smoking, in preparations for oromucosal or transdermal use. To effect this decision, the delegate decided to delete the Schedule 2 entry for nicotine and amend Schedule 4 by exempting nicotine in preparations for human therapeutic use except for use as an aid in withdrawal from tobacco smoking in preparations for oromucosal or transdermal use. As a result of this decision, certain forms of nicotine replacement therapies would be permitted to be sold in non-pharmacy settings (such as supermarkets) from 1 January 2012. The consequence of this decision is that these products will lose GST-free status if a determination is not made.

 

 

 

Consultation

Consultation was not conducted, in accordance with Section 18 of the Legislative Instruments Act 2003, on the grounds that the instrument is minor and does not substantially change the law. 

 

The changes made by this determination are minor and machinery in nature.  

 

Supply of the items being added to this determination are currently GST-free or have not been available for sale in Australia and the purpose of this determination is to maintain the GST-free status of items already GST-free and extend the GST-free status to items that are not currently sold in Australia where it is anticipated that they will be available in the future.  Therefore the issue of this determination will retain the status quo and will not impact on business or restrict competition.

 

General

 

This legislative instrument commences on 31 December 2011.

 

This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

A provision by provision description of this Instrument is contained in the Attachment.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ATTACHMENT

 

PROVISION BY PROVISION DESCRIPTION OF THE GST-FREE SUPPLY (HEALTH GOODS) DETERMINATION 2011

Section 1 Name of Determination

This section provides that the name of the determination is the GST-free Supply (Health Goods) Determination 2011.

Section 2 Commencement

This section provides that this Determination commences on 31 December 2011.

Section 3 Definition

This section provides definitions of terms used in this Determination.

Section 4 GST-free supplies

This section provides that the supply of goods included in Schedule 1 are GST free only if under the Therapeutic Goods Act 1989, the goods are required to be included in the Australian Register of Therapeutic Goods or are goods in a class of goods required to be included in the Australian Register of Therapeutic. ‘Australian Register of Therapeutic Goods’ is defined in section 3.

Section 5 Revocation of GST-free Supply (Health Goods) Determination 2005

This section provides that this Determination revokes the GST-free Supply (Health Goods) Determination 2005 from 31 December 2011.

Schedule 1 Health goods the supply of which may be GST-free

This Schedule lists the health goods the supply of which may be GST-free under this Determination.

 

 

Overview

The GST-free Supply (Health Goods) Determination 2011, enacted under the A New Tax System (Goods and Services Tax) Act 1999, addresses the problem of maintaining the GST-free status for certain nicotine replacement therapies as these products were scheduled to lose their GST-free status due to changes in the Standard for the Uniform Scheduling of Medicines and Poisons. This legislation, introduced by the Health Minister, aims to ensure that nicotine replacement therapies for transdermal and oromucosal use, which assist in tobacco smoking withdrawal, remain exempt from GST. The determination expands the previous list of GST-free nicotine replacement therapies to include all forms used as an aid in withdrawal from tobacco smoking, administered via transdermal or oromucosal preparations. It also mandates that for these goods to retain their GST-free status, they must be included in the Australian Register of Therapeutic Goods under the Therapeutic Goods Act 1989. This legislative instrument, which does not require consultation due to its minor nature, maintains the GST-free status of existing products and extends it to future products, ensuring continuity and supporting public health efforts by keeping these essential health goods accessible.

Scope and Application

The GST-free Supply (Health Goods) Determination 2011 applies to all nicotine replacement therapies used as an aid in withdrawal from tobacco smoking, administered through a preparation for transdermal or oromucosal use. This legislation, issued under the authority of the Minister for Health and Ageing, amends the previous GST-free Supply (Health Goods) Determination 2005 to ensure that these products remain exempt from Goods and Services Tax (GST) beyond the removal of certain nicotine products from the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) as of 1 January 2012. The products must be included in the Australian Register of Therapeutic Goods under the Therapeutic Goods Act 1989 to qualify for GST-free status. This determination revokes the previous determination from 31 December 2011, maintaining the GST-free status of existing products and extending it to new products that will be available in the future. The changes are considered minor and administrative, with no substantial impact on businesses or competition.

Key Provisions

The GST-free Supply (Health Goods) Determination 2011 (sections 4 and 5) extends GST-free status to a range of nicotine replacement therapies for transdermal and oromucosal use, specifically those used as aids in tobacco smoking withdrawal. These products, to be GST-free, must be included in the Australian Register of Therapeutic Goods or be classified as such under the Therapeutic Goods Act 1989. The determination revokes the previous GST-free Supply (Health Goods) Determination 2005 from 31 December 2011, establishing this new set of provisions to maintain the GST-free status for these health goods. The expanded entry for nicotine now encompasses all forms of nicotine replacement therapies that meet the specified criteria, ensuring continuity in the tax treatment of these essential health products. The obligations under this Act primarily focus on ensuring that the specified nicotine replacement therapies are included in the Australian Register of Therapeutic Goods or are classified appropriately under the Therapeutic Goods Act 1989. Suppliers of these goods must comply with these requirements to maintain the GST-free status of their supplies. This includes ensuring that any changes in the scheduling or classification of these products under the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) are reflected in their GST treatment. Additionally, suppliers must be aware of the changes brought about by this determination and adjust their practices accordingly to continue enjoying the GST-free status for these health goods. Failure to comply with the provisions of this determination can result in civil and criminal penalties. Although the specific penalties are not detailed within the determination, it is understood that breaches of GST laws generally carry significant consequences. For example, under the A New Tax System (Goods and Services Tax) Act 1999, penalties can include fines and imprisonment for serious or repeated breaches. The exact penalties would depend on the nature and extent of the breach, but they are designed to ensure compliance with the tax laws and the proper application of GST exemptions. This underscores the importance of adhering to the requirements set forth in this determination to avoid potential legal repercussions.

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.