Therapeutic Goods (Vaping Goods—Possession and Supply) Amendment Determination (No. 2) 2025

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in, or exported from, Australia. It also provides for the establishment and maintenance of a national system of controls for the importation, manufacture, supply, commercial possession, advertising and export of vaping goods. The Act is administered by the Therapeutic Goods Administration (the TGA) within the Australian Government Department of Health, Disability and Ageing (the Department).

Division 1 in Part 4A-2 of the Act establishes offences and civil penalties relating to the importation, manufacture, supply and commercial possession of vaping goods. The offence and civil penalty provisions prohibit such conduct unless an exception specified in the relevant provision of the Act applies. The intent of these provisions is to deter trade in illicit vaping goods, reduce the use of vaping products in Australia (particularly among youth and young adults), and prevent a new generation of persons being exposed to dangerous chemicals and developing nicotine dependence.

The exceptions to these offences and civil penalty provisions are designed to provide pathways by which a person may lawfully possess or supply vaping goods as part of the legitimate pharmaceutical wholesale and retail supply chains for such goods. These exceptions include persons, vaping goods and activities that are covered by a determination under section 41R of the Act.

Section 41R of the Act provides that the Minister may, by legislative instrument, determine that specified vaping goods, or a specified class of vaping goods, may be supplied or possessed in Australia by a specified person, or a specified class of persons, in the circumstances (if any) and subject to the conditions (if any) specified in the determination. A determination made under section 41R of the Act effectively provides a means by which specified classes of persons may be able to possess or supply vaping goods, without committing the offences or contravening the civil penalty provisions in section 41QB, 41QC or 41QD of the Act.

The Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024 (the Principal Determination) is made under section 41R of the Act. It determines specified vaping goods, or specified classes of vaping goods, that may be supplied or possessed in Australia, and specified persons, or specified classes of persons, who may possess or supply those goods. In the Principal Determination, such persons include transporters, persons involved in the storage of vaping goods, persons involved in waste disposal and management of vaping goods, wholesalers, and exporters. The Principal Determination also specifies the circumstances in which those persons may possess or supply the specified vaping goods, and any applicable conditions that must be complied with.

The Therapeutic Goods (Vaping Goods—Possession and Supply) Amendment Determination (No. 2) 2025 (the Amendment Determination) amends the Principal Determination to:

introduce five additional items that provide conditional exceptions to possess or supply vaping goods in specified circumstances;
continue the operation of several existing exceptions (which would otherwise expire on 31 December 2025) that authorise possession or supply of vaping goods;
repeal items that no longer have effect (i.e. have effectively expired); and
make a small number of other minor consequential and editorial amendments.

Background

Under sections 41QB, 41QC and 41QD of the Act, the possession and supply of vaping goods is prohibited through offences and civil penalties that apply to persons who possess and supply vaping goods. The Act includes some exceptions that expressly permit supply and possession in certain circumstances. In addition, the Minister may authorise the supply and possession of certain vaping goods in a legislative instrument made under section 41R of the Act, which provides sufficient flexibility to specify appropriate circumstances in which vaping goods may lawfully be supplied or possessed where such goods need to move through a legitimate supply chain.

The Principal Determination, which is made under section 41R of the Act, is driven by public health objectives intended to ensure that:

unused stock of unlawful vaping goods in the community may be surrendered, exported, disposed, or destroyed in controlled circumstances that minimise the risk of diversion and support community safety in appropriate disposal of unlawful vaping goods;
the Department has oversight of the supply and possession of lawful vaping goods by certain persons in the pharmaceutical wholesale or retail supply chains who do not otherwise hold a licence or authority to do so; and
adequate protection is afforded to certain specified persons where the supply or possession of vaping goods without a licence or other authority for a bespoke reason outweighs the public health and safety concerns, such as supply or possession for scientific research or testing.

The purpose of these items in Schedules 1 and 2 to the Principal Determination is to specify the persons who may legitimately supply or possess vaping goods in complex circumstances that are not reflected in the Act. As a significant number of persons play a legitimate role in the importation, exportation, manufacture, wholesale and retail supply of vaping goods outside the circumstances reflected in the Act, the circumstances reflected in the Principal Determination are necessarily detailed to mitigate the risk of diversion and to ensure appropriate oversight by the Department of the supply and possession of vaping goods by persons in the pharmaceutical wholesale and retail supply chains who are not already expressly permitted by the exceptions in the Act.

Importantly, persons purporting to rely on the Principal Determination as a means of demonstrating the lawfulness of their possession or supply of vaping goods must ensure that any dealings in those goods also comply with other applicable legislative requirements. In particular, if the vaping goods are therapeutic goods (therapeutic vaping goods), the goods must also comply with Chapter 3 (Medicines and other therapeutic goods that are not medical devices) or Chapter 4 (Medical devices) of the Act, as the case requires. Among other things, those Chapters prohibit the import, export, manufacture or supply of therapeutic goods that are not registered, listed or included in the Australian Register of Therapeutic Goods (the Register), unless the goods or person dealing in the goods are exempt from that requirement or a relevant approval or authority has been granted or applies under the Act.

Purpose

The principal purpose of the Amendment Determination is to specify additional circumstances in which specified persons may lawfully possess or supply vaping goods. It does so by amending Schedule 2 to the Principal Determination to introduce new table items 16, 17, 18, 19 and 20. Persons seeking to rely on one of these items must comply with the conditions that are specified for that item.

Specifically:

new table item 16 applies to therapeutic vaping goods that cease to be registered, listed or included in the Register, or cease to be exempt from being on the Register—this item provides sponsors, wholesalers and manufacturers with 6-months within which they may possess or supply those goods for the sole purposes of destroying, disposing of, or carrying out further steps in the manufacture of, the goods;
new table item 17 applies to therapeutic vaping goods in the Register—this item provides for an exporter to possess or supply the goods for the sole purpose of exporting the goods;
new table item 18 applies to vaping goods that are provided to a pharmacy, hospital or other healthcare facility for disposal—this item authorises the pharmacy, hospital or healthcare facility to possess the goods for the sole purpose of destroying or disposing of the goods, and to supply the goods to an authorised disposer (including through a transport business);
new table item 19 applies to therapeutic vaping goods that are possessed by a pharmacy, hospital or other healthcare facility and no longer suitable or intended for supply to a patient—this item authorises the pharmacy, hospital or other healthcare facility to return the goods to the sponsor or wholesaler (including through a transport business);
new table item 20 applies to therapeutic vaping goods that are possessed by a wholesaler and which were returned from a pharmacy, hospital or other healthcare facility—this item authorises the wholesaler to return the goods to the sponsor (including through a transport business).

Additionally, the Amendment Determination amends the Principal Determination to continue the effect of table items 4, 5 and 6 in Schedule 1, and table items 7, 8, 10 and 11 in Schedule 2, to the Principal Determination. These items are essential to ensuring the continuity of critical activities, including supporting the lawful supply chain for vaping goods, enabling medical and scientific research, and ensuring safe disposal of vaping goods. However, without this amendment, each of these items would expire on 31 December 2025. Therefore, the operation of these items needs to continue.

Finally, the Amendment Determination also amends the Principal Determination to make other more minor amendments. This includes repealing table items 1 and 3 in Schedule 1, and table items 1, 4, 5 and 6 in Schedule 2, to the Principal Determination, as these items have expired and no longer have effect.

Incorporation by reference

The Amendment Determination incorporates by reference the A New Tax System (Australian Business Number) Act 1999. The intended manner of incorporation is as in force from time to time, in accordance with subparagraph 14(1)(a)(i) of the Legislation Act 2003 (the Legislation Act). The A New Tax System (Australian Business Number) Act 1999 is freely available on the Federal Register of Legislation at www.legislation.gov.au.

Consultation

The TGA conducted a targeted consultation from 25 September to 17 October 2025 to seek feedback on proposed amendments to the Principal Determination. The consultation invited input from stakeholders likely to be affected by the proposed changes, including:

state and territory health officials;
transport, storage, and disposal providers engaged under the TGA’s national procurement panel arrangement; and
sponsors of nicotine vaping products and medicinal cannabis vaping products.

Stakeholders were asked to comment on the proposal to repeal expired items, continue the operation of certain items, and add new items that may affect them. In relation to the repeal of the expired items, some responses were supportive, some were out of scope for these proposed amendments, and some responses asked for an extension of these items. Extending the items was not considered appropriate as the original timeframes were sufficient, the items have already expired, and extending the timeframes would not align with the intent of the vaping reforms. In relation to the continued operation of certain items, some responses were out of scope while other responses were given effect in the amendments. In relation to the new items, all feedback that was within the scope of the proposal was carefully considered and, where suggestions aligned with the intended effect of the Principal Determination, the proposed amendments were refined.

Other details

Details of the Amendment Determination are set out in Attachment A.

The Amendment Determination is compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

The Amendment Determination is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences on the day after it is registered on the Federal Register of Legislation.

Attachment A

Details of the Therapeutic Goods (Vaping Goods—Possession and Supply) Amendment Determination (No. 2) 2025

Section 1 – Name

This section provides that the name of the instrument is the Therapeutic Goods (Vaping Goods—Possession and Supply) Amendment Determination (No. 2) 2025 (the Amendment Determination).

Section 2 – Commencement

This section provides that the Amendment Determination commences on the day after it is registered on the Federal Register of Legislation.

Section 3 – Authority

This section provides that the legislative authority for making the Amendment Determination is section 41R of the Therapeutic Goods Act 1989 (the Act).

Subsection 33(3) of the Acts Interpretation Act 1901 relevantly provides that, where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character, the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument. The Amendment Determination is made in accordance with that provision.

Section 4 – Schedules

This section provides that each instrument that is specified in a Schedule to the Amendment Determination is amended or repealed as set out in the applicable items in the Schedule concerned. Any other item in a Schedule to the Amendment Determination has effect according to its terms.

Schedule 1 – Amendments

This Schedule amends the Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024 (the Principal Determination).

Item 1 – Section 4 (note)

This item repeals and replaces the note to section 4 of the Principal Determination, which lists the expressions used in the Principal Determination that are defined in subsection 3(1) of the Act. The purpose of this amendment is to update the note to remove references to defined terms that no longer appear in the Principal Determination due to amendments made by the Amendment Determination and previous amendments to the Principal Determination. The defined terms that have been omitted from the updated note are ‘commercial quantity’, ‘Customs officer’, ‘essential principles’, ‘nurse practitioner’ and ‘pharmacist’.

Item 2 – Section 4

This item introduces two new definitions in section 4 of the Principal Determination: ‘ABN’ and ‘cease supply determination’.

Definition of ‘ABN’

The new definition of ‘ABN’ is defined to have the same meaning as in the A New Tax System (Australian Business Number) Act 1999. The introduction of this definition is consequential to amendments made by item 9 below to introduce definitions of ‘storage business’ and ‘transport business’, both of which include the requirement to have an active ABN.

Definition of ‘cease supply determination’

The new definition of ‘cease supply determination’ defines that expression to mean, in relation to vaping goods, a determination by the Secretary under the regulations, published on the Department’s website, that the supply of the goods be stopped or should cease.

The provisions which provide for the Secretary to make such a determination are:

for therapeutic vaping substances, therapeutic vaping substance accessories, therapeutic vaping kits and goods in a therapeutic vaping pack—paragraph (g) in column 2 of table item 15 in Schedule 5A to the Therapeutic Goods Regulations 1990 (the TG Regulations); and
for therapeutic vaping devices and therapeutic vaping device accessories—paragraph (d) in the column headed “Kinds of medical devices” of table item 2.17 in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations).

The grounds on which the Secretary may make such a cease supply determination are, in short, that:

the Secretary is satisfied that the supply compromises public health and safety; or
the Secretary is satisfied that the goods do not conform with a standard applicable to the goods or the essential principles, as relevant; or
the sponsor has failed to comply with a request by the Secretary for a notice stating that the goods conform with applicable standards or are the subject of a consent to supply non-compliant goods under section 14, 14A, 41MA or 41MAA as applicable (under paragraph (e) of column 3 of table item 15 in Schedule 5A to the TG Regulations or paragraph (e) of the column headed “Conditions” of table item 2.17 in Part 2 of Schedule 4 to the MD Regulations, as relevant).

A decision to make a therapeutic good the subject of a cease supply determination in accordance with the above provisions is a reviewable decision subject to merits review under paragraph 48(1AB)(c) of the TG Regulations and paragraph 10.7(1A)(c) of the MD Regulations.

Item 3 – Section 4 (definition of commercial premises)

This item repeals the definition of ‘commercial premises’ in section 4 of the Principal Determination. This amendment is consequential to item 10 below, which repeals table item 1 in Schedule 1 to the Principal Determination. As table item 1 in Schedule 1 contains the sole reference to ‘commercial premises’ in the Principal Determination, the definition is no longer needed and can be repealed.

Item 4 – Section 4 (definition of notified vaping goods)

This item replaces the definition of ‘notified vaping goods’ in section 4 of the Principal Determination with an amended definition. The purpose of the amendment is to simplify the definition by updating:

paragraph (a) of the definition to refer to ‘sponsor notice’, which is a newly defined term introduced by item 9 below; and
paragraph (b) of the definition to refer to ‘cease supply determination’, which is a newly defined term introduced by item 2 above.

Item 5 – Section 4 (paragraphs (b) and (c) of the definition of permitted exporter)

This item repeals paragraphs (b) and (c) of the definition of ‘permitted exporter’ in section 4 of the Principal Determination, and substitutes new paragraph (b) which refers to “a person specified in column 3 of item 17 in the table in Schedule 2”.

New table item 17 in Schedule 2 to the Principal Determination is introduced by item 35 below. It permits the possession or supply of vaping goods that are registered, listed or included in the Australian Register of Therapeutic Goods (the Register) by persons who obtain the goods in the course of their exportation business, in certain circumstances and subject to certain conditions.

The repeal of current paragraphs (b) and (c) of the definition is consequential to the amendments made by:

item 10 below, which repeals table item 3 in Schedule 1 to the Principal Determination; and
item 21 below, which repeals table items 4 and 5 in Schedule 2 to the Principal Determination.

Items 6 and 7 – Section 4 (paragraphs (b) and (c) of the definition of permitted recipient)

Item 7 repeals paragraph (c) of the definition of ‘permitted recipient’, consequential to the amendments made by item 21 below which repeals table items 4, 5 and 6 in Schedule 2 to the Principal Determination.

Item 6 makes minor amendments to paragraph (b), consequential to the repeal of paragraph (c) by item 7, to reflect that paragraph (b) is now the final paragraph in the definition.

Item 8 – Section 4 (definition of retail premises)

This item repeals the definition of ‘retail premises’ in section 4 of the Principal Determination. This amendment is consequential to item 10 below, which repeals table item 1 in Schedule 1 to the Principal Determination. As table item 1 in Schedule 1 contains the sole reference to ‘commercial premises’ in the Principal Determination, the definition is no longer needed and can be repealed.

Item 9 – Section 4

This item introduces three new definitions in section 4 of the Principal Determination: ‘sponsor notice’, ‘storage business’ and ‘transport business’.

Definition of ‘sponsor notice’

The new definition of ‘sponsor notice’ is defined to mean, in relation to vaping goods that are exempt goods or an exempt device, a notice which a sponsor has given the Secretary in compliance with an exemption under regulations made for the purposes of subsection 18(1) or 41HA(1) of the Act.

Subsection 18(1) of the Act provides that the regulations may exempt specified therapeutic goods or classes of therapeutic goods from the operation of Part 3-2 of the Act (except section 31A and sections 31C to 31F), and thereby exempt certain therapeutic goods from the requirement to be included in the Register. Subsection 18(1) further provides that an exemption may be subject to conditions that are prescribed in the regulations.

Similarly, paragraph 41HA(1)(b) of the Act provides that the regulations may exempt specified kinds of medical devices from the operation of Division 3 of Part 4-11 of the Act, and thereby exempt certain medical devices from the requirement to be included in the Register. Subsection 41HA(2) provides that an exemption may be subject to conditions that are prescribed in the regulations.

Subregulation 12(2) of the TG Regulations exempts therapeutic goods mentioned in column 2 of an item in Schedule 5A to the TG Regulations from the operation of Part 3-2 of the Act (except section 31A and sections 31C to 31F), subject to compliance with the conditions mentioned in column 3. Relevantly, item 15 of the table in Schedule 5A to the TG Regulations exempts certain therapeutic goods that are therapeutic vaping substances, therapeutic vaping substance accessories, therapeutic vaping kits, or goods in a therapeutic vaping pack, subject to several conditions.

Subregulation 7.1(2) of the MD Regulations exempts medical devices mentioned in the column headed “Kinds of medical devices” of an item in Part 2 of Schedule 4 to the MD Regulations from the operation of Division 3 of Part 4-11 of the Act, subject to compliance with the conditions mentioned in the column headed “Conditions”. Relevantly, item 2.17 of the table in Part 2 of Schedule 4 to the MD Regulations exempts medical devices that are therapeutic vaping devices or therapeutic vaping device accessories, subject to the conditions mentioned in the column headed “Conditions” of that item.

In practice, the goods that are the subject of these exemptions are referred to as ‘notified vaping goods’.

The specific requirements and conditions that apply to a sponsor in relation to giving the Secretary a sponsor notice in compliance with the relevant exemption are contained in the following provisions:

for therapeutic vaping substances, therapeutic vaping substance accessories, therapeutic vaping kits and goods in a therapeutic vaping pack—paragraphs (e) and (f) in column 2 and paragraphs (a) to (d) in column 3 of table item 15 in Schedule 5A to the TG Regulations;
for therapeutic vaping devices and therapeutic vaping device accessories—paragraphs (b) and (c) in the column headed “Kinds of medical devices” and paragraphs (a) to (d) in the column headed “Conditions” of table item 2.17 in Part 2 of Schedule 4 to the MD Regulations.

Therefore, a sponsor notice is a notice given by a sponsor to the Secretary under these exemptions in the TG Regulations and MD Regulations.

Definition of ‘storage business’

The new definition of ‘storage business’ is defined to mean a person with an active ABN who is engaged in the business of storing goods and has a lease or licence, or similar right, to occupy premises for the purposes of storage.

The purpose of introducing this definition, in particular the requirements to have an active ABN and lease, licence or similar right, is to help ensure that only persons who legitimately operate a storage business are permitted to store (i.e. possess) vaping goods, principally for the purposes of table item 4 in Schedule 1 to the Principal Determination. Item 11 below makes a related amendment to repeal and replace the cell in column 3 of table item 4 in Schedule 1 to the Principal Determination to refer to the new definition of ‘storage business’.

Definition of ‘transport business’

The new definition of ‘transport business’ is defined to mean a person with an active ABN who is engaged principally in the business of freighting goods.

The purpose of introducing this definition is to help ensure that only persons who legitimately operate a transport business are permitted to possess or supply specified vaping goods under table items 10 and 11 of Schedule 2 to the Principal Determination, or to be supplied vaping goods by another person under table items 18, 19 or 20 of Schedule 2 to the Principal Determination.

The definition refers to persons engaged principally in the business of freighting goods to exclude rideshare services and similar, from the definition of ‘transport business’.

Item 10 – Schedule 1 (table items 1 and 3)

This item repeals table items 1 and 3 in Schedule 1 to the Principal Determination. Both of these table items were intended to be time limited and have subsequently expired, with table item 1 expiring on 30 June 2025 (paragraph (a) in column 4), and table item 3 expiring on 1 January 2025 (paragraph (a) in column 4). As such, both of these items are no longer required and can be removed from the Principal Determination.

Item 11 – Schedule 1 (cell at table item 4, column 3)

This item replaces the cell at column 3 of table item 4 in Schedule 1 to the Principal Determination to specify ‘a storage business’ as the specified person for the purposes of that item. This amendment is related to item 9 above, which introduces a new definition of ‘storage business’ including additional requirements to help ensure that only persons legitimately running a storage business are permitted to store (i.e. possess) specified vaping goods in the circumstances, and subject to the conditions, specified in this item.

Item 12 – Schedule 1 (table item 4, column 4, paragraph (a))

This item repeals paragraph (a) in column 4 of table item 4 in Schedule 1 to the Principal Determination. The effect of paragraph (a) was that the item only applied to possession that occurred on or before 31 December 2025, with the effect that this item would effectively expire on 31 December 2025.

Although it was originally intended that table item 4 in Schedule 1 to the Principal Determination would be time limited, following the implementation of the vaping reforms it has been identified that there is an ongoing need for this item to support the role of storage businesses in the lawful supply chain for vaping goods, as well as in relation to their role providing storage services to support medical and scientific research and clinical trials involving vaping goods. As such, paragraph (a) in column 4 of this item is being repealed in order to extend the application of this item.

Item 13 – Schedule 1 (table item 4, column 4, subparagraph (b)(i))

This item replaces the reference in subparagraph (b)(i) in column 4 of table item 4 in Schedule 1 to the Principal Determination from ‘item 3 of this Schedule’ to ‘item 6 of this Schedule’. This amendment is consequential to item 10 above, which repeals table item 3 of Schedule 1 to the Principal Determination.

Additionally, the amendment made by this item to replace the reference to table item 3 with a reference to table item 6 is intended to ensure that circumstances involving persons engaged in bona fide medical or scientific research or testing of vaping goods engaging the storage services of a storage business are covered by table item 4 in Schedule 1 to the Principal Determination.

Item 14 – Schedule 1 (table item 4, column 4, subparagraph (b)(ii))

This item removes the reference in subparagraph (b)(ii) in column 4 of table item 4 in Schedule 1 to the Principal Determination to item 6 of Schedule 2 to the Principal Determination. This amendment is consequential to item 21 below, which repeals table item 6 of Schedule 2 to the Principal Determination.

Item 15 – Schedule 1 (table item 4, column 4, at the end of paragraph (b))

This item adds an additional subparagraph (iv) at the end of paragraph (b) in column 4 of table item 4 in Schedule 1 to the Principal Determination. The effect of introducing this new subparagraph is to ensure that the circumstances where a sponsor, or a principal investigator, of a clinical trial involving the specified vaping goods engages the storage services of a storage business are covered by table item 4 in Schedule 1 to the Principal Determination.

Item 16 – Schedule 1 (table item 4, column 5, after paragraph (c))

This item inserts a new paragraph (d) in column 5 of table item 4 in Schedule 1 to the Principal Determination. The effect of this new paragraph is to introduce an additional condition that applies where goods containing a substance included in Schedule 4 to the current Poisons Standard are possessed and stored under this item. Where this applies, the storage business must comply with all applicable laws of the state or territory that apply to the possession and storage of a substance to which Schedule 4 to the current Poisons Standard applies.

Item 17 – Schedule 1 (table item 5, column 4, paragraph (a))

This item repeals paragraph (a) in column 4 of table item 5 in Schedule 1 to the Principal Determination. The effect of paragraph (a) is that the item only applied to possession that occurred on or before 31 December 2025, with the effect that this item will effectively expire on 31 December 2025.

Although it was originally intended that table item 5 in Schedule 1 to the Principal Determination would be time limited, there is an ongoing need for this item to facilitate the safe and lawful destruction of vaping goods by legitimate waste disposers. As such, paragraph (a) in column 4 of this item is being repealed in order to extend the application of this item.

Item 18 – Schedule 1 (table item 6, column 4, paragraph (a))

This item repeals paragraph (a) in column 4 of table item 4 in Schedule 1 to the Principal Determination. The effect of paragraph (a) is that the item only applied to possession that occurred on or before 31 December 2025, with the effect that this item will effectively expire on 31 December 2025.

Although it was originally intended that table item 6 in Schedule 1 to the Principal Determination would be time limited, following the implementation of the vaping reforms it has been identified that there is an ongoing need for this item to support medical and scientific research or testing of vaping goods. As such, paragraph (a) in column 4 of this item is being repealed in order to extend the application of this item.

Items 19 and 21 – Schedule 2 (table items 1, 4, 5 and 6)

These items repeal table items 1, 4, 5 and 6 in Schedule 2 to the Principal Determination. All of these table items were intended to be time limited and have subsequently expired as follows:

table item 1 expired on 30 June 2025 (paragraph (a) in column 4);
table item 4 expired on 31 January 2025 (paragraph (a) in column 4);
table item 5 expired on 30 November 2024 (paragraph (a) in column 4);
table item 6 expired on 30 November 2024 (paragraph (a) in column 4).

As each of these items have expired and are no longer required, they are being removed from the Principal Determination.

Item 20 – Schedule 2 (table item 2, column 5, paragraph (a))

This item replaces the reference to ‘aircraft’ in paragraph (a) of column 5 of table item 2 in Schedule 2 to the Principal Determination with ‘aeroplane’. This is a minor editorial amendment for the purposes of achieving consistency with the existing references to ‘aeroplane’ in column 3 of table items 2 and 3 of Schedule 2 to the Principal Determination.

Item 22 – Schedule 2 (table item 7, column 4, paragraph (a))

This item repeals paragraph (a) in column 4 of table item 7 in Schedule 2 to the Principal Determination. The effect of paragraph (a) was that the item only applied to possession or supply that occurred on or before 31 December 2025, with the effect that this item will effectively expire on 31 December 2025.

Although it was originally intended that table item 7 in Schedule 2 to the Principal Determination would be time limited, following the implementation of the vaping reforms it has been identified that there is an ongoing need for this item to support the lawful supply chain for specified vaping goods. As such, paragraph (a) in column 4 of this item is being repealed in order to extend the application of the item.

Item 23 – Schedule 2 (cell at table item 8, column 4)

This item repeals and replaces the cell at column 4 of table item 8 in Schedule 2 to the Principal Determination. The effect of this amendment is to remove paragraphs (a) and (c) in column 4 of this item, with paragraph (b) being the only remaining permitted circumstance – i.e. the goods were manufactured by the relevant licence holder in Australia.

The effect of paragraph (a) in column 4 was that the item only applied to possession or supply that occurred on or before 31 December 2025, with the effect that this item will effectively expire on 31 December 2025.

Although it was originally intended that table item 8 in Schedule 2 to the Principal Determination would be time limited, following the implementation of the vaping reforms it has been identified that there is an ongoing need for this item to support the lawful manufacture of specified vaping goods (in accordance with the conditions specified in column 5 of this item). As such, paragraph (a) in column 4 of this item is being repealed in order to extend the application of the item.

Additionally, paragraph (c) in column 4 of table item 8 in Schedule 2 to the Principal Determination is being removed as it is outdated and no longer required.

Item 24 – Schedule 2 (cell at table item 10, column 3)

This item repeals and replaces the cell at column 3 of table item 10 in Schedule 2 to the Principal Determination to specify ‘a transport business’ as the specified person for the purposes of that item. This amendment is related to item 9 above, which introduces a new definition of ‘transport business’ including additional requirements to help ensure that only persons with a legitimate reason are permitted to possess or supply specified vaping goods for the purposes of transportation in the circumstances, and subject to the conditions, specified in this item.

Item 25 – Schedule 2 (table item 10, column 4, paragraph (a))

This item repeals paragraph (a) in column 4 of table item 10 in Schedule 2 to the Principal Determination. The effect of paragraph (a) is that the item only applied to possession or supply that occurred on or before 31 December 2025, with the effect that this item will effectively expire on 31 December 2025.

Although it was originally intended that table item 10 in Schedule 2 to the Principal Determination would be time limited, following the implementation of the vaping reforms it has been identified that there is an ongoing need for this item to support the role of transport businesses in the lawful supply chain for vaping goods, as well as in relation to their role providing transport services to support medical and scientific research and clinical trials involving vaping goods. As such, paragraph (a) in column 4 of this item is being repealed to extend the application of this item.

Item 26 – Schedule 2 (table item 10, column 4, subparagraph (b)(i))

This item replaces the reference in subparagraph (b)(i) in column 4 of table item 10 in Schedule 2 to the Principal Determination from ‘item 3 of Schedule 1 to this Determination’ to ‘item 6 of Schedule 1 to this Determination’. This amendment is consequential to item 10 above, which repeals table item 3 of Schedule 1 to the Principal Determination.

Additionally, the amendment made by this item to replace the reference to table item 3 in Schedule 1 to the Principal Determination with a reference to table item 6 in Schedule 1 to the Principal Determination is intended to ensure that circumstances where persons engaged in bona fide medical or scientific research or testing of vaping goods engage the storage services of a storage business are covered by table item 4 in Schedule 1 to the Principal Determination.

Item 27 – Schedule 2 (table item 10, column 4, subparagraph (b)(ii))

This item removes the reference in subparagraph (b)(ii) in column 4 of table item 10 in Schedule 2 to the Principal Determination to item 6 of Schedule 2 to the Principal Determination. This amendment is consequential to item 21 above, which repeals table item 6 of Schedule 2 to the Principal Determination.

Item 28 – Schedule 2 (table item 10, column 4, at the end of paragraph (b))

This item adds an additional subparagraph (iv) at the end of paragraph (b) in column 4 of table item 10 in Schedule 2 to the Principal Determination. The effect of introducing this new subparagraph is to ensure that circumstances where a sponsor, or a principal investigator, of a clinical trial involving the specified goods provides the goods to a transport business are covered by table item 10 in Schedule 2 to the Principal Determination.

Item 29 – Schedule 2 (table item 10, column 5, after paragraph (b))

This item inserts a new paragraph (ba) in column 5 of table item 10 in Schedule 2 to the Principal Determination. The effect of this new paragraph is to introduce an additional condition in circumstances where goods containing a substance included in Schedule 4 to the current Poisons Standard are being possessed, supplied or transported under this item. Where this applies, the transport business must comply with all applicable laws of the state or territory that apply to the supply, possession and transportation of a substance to which Schedule 4 to the current Poisons Standard applies.

Item 30 – Schedule 2 (cell at table item 11, column 3)

This item repeals and replaces the cell at column 3 of table item 11 in Schedule 2 to the Principal Determination to specify ‘a transport business’ as the specified person for the purposes of that item. This amendment is related to item 9 above, which introduces a new definition of ‘transport business’ including additional requirements to help ensure that only persons engaged legitimately in operating a transport business are permitted to possess or supply specified vaping goods for the purposes of transportation in the circumstances, and subject to the conditions, specified in this item.

Item 31 – Schedule 2 (table item 11, column 4, paragraph (a))

This item repeals paragraph (a) in column 4 of table item 11 in Schedule 2 to the Principal Determination. The effect of paragraph (a) is that the item only applied to possession or supply that occurred on or before 31 December 2025, with the effect that this item will effectively expire on 31 December 2025.

Although it was originally intended that table item 11 in Schedule 2 to the Principal Determination would be time limited, following the implementation of the vaping reforms it has been identified that there is an ongoing need for this item to support the role of transport businesses in facilitating the safe and lawful destruction of vaping goods. As such, paragraph (a) in column 4 of this item is being repealed to continue the application of this item.

Item 32 – Schedule 2 (table item 12, column 4, at the end of paragraph (a))

This item introduces new subparagraphs (a)(v) and (vi) in column 4 of table item 12 in Schedule 2 to the Principal Determination. These new subparagraphs refer to goods that are exempt under regulation 12A of the TG Regulations and regulation 7.2 of the MD Regulations, commonly known as the Special Access Scheme Category A (SAS A) pathway. Regulation 12A of the TG Regulations and regulation 7.2 of the MD Regulations exempt therapeutic goods supplied on prescription to a person who is a Category A patient, in specified circumstances. A Category A patient is a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.

The purpose of this amendment is to ensure that specified goods that are exempt under the SAS A pathway can be possessed or supplied by permitted health practitioners in accordance with the circumstances and conditions set out in table item 12 of in Schedule 2 to the Principal Determination.

Item 33 – Schedule 2 (table item 12, column 5, before paragraph (a))

This item inserts a new paragraph (aa) in column 5 of table item 12 in Schedule 2 to the Principal Determination. The effect of this new paragraph is to introduce an additional condition in circumstances where goods containing a substance included in Schedule 4 to the current Poisons Standard are being possessed or supplied under this item. Where this applies, the health practitioner must comply with all applicable laws of the state or territory that apply to the possession and supply by a health practitioner of a substance to which Schedule 4 to the current Poisons Standard applies.

Item 34 – Schedule 2 (table item 15, column 3, at the end of paragraph (b))

This item adds ‘or’ to the end of paragraph (b) in column 3 of table item 15 in Schedule 2 to the Principal Determination. This amendment is intended to correct a minor drafting oversight.

Item 35 – Schedule 2 (at the end of the table)

This item introduces new table items 16, 17, 18, 19 and 20 in Schedule 2 to the Principal Determination.

Item 16

New table item 16 in Schedule 2 to the Principal Determination permits the sponsor, wholesaler or a permitted manufacturer (as defined in section 4 of the Principal Determination) of vaping goods that are therapeutic goods to possess or supply the goods within a 6-month period of any of the following occurring:

the date a sponsor notice is withdrawn;
the date a cease supply determination is made;
the date the goods cease to be listed, registered or included in the Register, or are suspended from the Register.

Further, the specified circumstances includes that the goods must only be possessed or supplied by the person during that 6-month period for the sole purpose of:

destroying or disposing of the goods; or
supplying to an authorised disposer (as defined in section 4 of the Principal Determination) for the goods to be disposed of or destroyed; or
carrying out a further step in the manufacture of the goods; or
supplying to a permitted manufacturer (as defined in section 4 of the Principal Determination).

A person seeking to rely on this item must comply with the applicable conditions, which includes keeping evidence that records:

the quantity in the person’s possession or the quantity that the person has supplied;
the date of the possession or supply;
who the goods were supplied to (if applicable);
the destruction or disposal of the goods (if applicable); and
the carrying out of a further step in the manufacture of the goods (if applicable).

A further condition applies in circumstances where the goods are possessed or supplied by the person for the sole purpose of carrying out a further step in the manufacture of the goods (i.e. where subparagraph (b)(iii) in column 4 applies). In those circumstances, the further step in the manufacture must be in accordance with Part 3-3 of the Act, unless the goods are, or the person is, exempt from the operation of that Part.

It is intended that this item will have ongoing application, and as such it is not time limited. However, the 6-month period within which the goods must be disposed of or destroyed, or have undergone further manufacture, is intended to ensure that the goods are not stored by a sponsor, wholesaler or manufacturer indefinitely. This timeframe allows sufficient time for disposal or carrying out a further step in the manufacture of the goods, while mitigating the risk of goods being diverted or used for purposes inconsistent with regulatory requirements.

Item 17

New table item 17 in Schedule 2 to the Principal Determination permits a person who, in the course of their exportation business, obtains vaping goods that are registered, listed or included in the Register, to possess or supply the goods for the sole purpose of exporting the goods.

A person seeking to rely on this item must comply with the condition that the person must keep evidence that records the circumstances of the exportation and the volume of the goods exported.

Any exportation of goods under this item must be in accordance with the applicable requirements in the Act.

Item 18

New table item 18 in Schedule 2 to the Principal Determination permits a pharmacy, hospital or other healthcare facility to possess or supply vaping goods where the goods were provided to the person for the purpose of disposal, and the goods are possessed by the person for the sole purpose of destroying or disposing of the goods.

Further, the specified circumstances includes that the goods are supplied to:

an authorised disposer (as defined in section 4 of the Principal Instrument) for the goods to be disposed of or destroyed; or
a transport business (as defined in section 4 of the Principal Instrument) for the sole purpose of delivering the goods to an authorised disposer.

A person seeking to rely on this item must comply with the condition that the person must keep evidence that records the supply to the authorised disposer or transport business.

An additional condition applies where the goods contain a substance included in Schedule 8 to the current Poisons Standard. In those circumstances, the person must comply with all applicable laws of the state or territory that apply to the possession and supply of a substance to which Schedule 8 to the current Poisons Standard applies.

The effect of this new item is to enable a pharmacy, hospital or other healthcare facility to dispose of vaping goods where the goods are provided to the pharmacy, hospital or other healthcare facility for disposal. This measure ensures that seized or surrendered vaping products are managed by trusted persons, which reduces the risk of these goods re-entering the community or being diverted to the black market.

Item 19

New table item 19 in Schedule 2 to the Principal Determination permits a pharmacy, hospital or other healthcare facility to possess or supply vaping goods that are therapeutic goods in circumstances where the goods are not suitable for supply to a patient (for example, the goods are non-compliant and cannot be lawfully supplied), or the person wants to return the goods (for example, the pharmacy no longer wishes to stock the products for commercial reasons).

Further, the specified circumstances includes that the goods must only be supplied to:

the sponsor of the goods or a person engaged in the business of wholesale supply of therapeutic goods, for the sole purpose of returning the goods; or
a transport business (as defined in section 4 of the Principal Determination) for the sole purpose of delivering the goods to the sponsor of the goods or a person engaged in the business of wholesale supply of therapeutic goods.

A person seeking to rely on this item must comply with the condition that the person must keep evidence that records the circumstances of the supply of the goods.

This item in intended to facilitate the return of goods to a sponsor or wholesaler. In the general course of business, a pharmacy, hospital or healthcare facility may have the need to return stock, for commercial or regulatory purposes. For example, a pharmacy may no longer be able to supply the stock if it no longer complies with regulatory requirements, or the pharmacy may choose to no longer stock certain products. This item would allow for the goods to be returned by the pharmacy to the wholesaler or directly to the sponsor of the goods.

Item 20

New table item 20 in Schedule 2 to the Principal Determination permits a person engaged in the business of wholesale supply of therapeutic goods to possess or supply vaping goods that are therapeutic goods in circumstances where the goods were returned to the person from a pharmacy, hospital or other healthcare facility.

Further, the specified circumstances includes that goods are supplied to:

the sponsor of the goods for the sole purpose of either destroying or disposing of the goods, or carrying out a further step in the manufacture of the goods; or
a transport business (as defined in section 4 of the Principal Determination) for the sole purpose of delivering the goods to the sponsor of the goods.

A person seeking to rely on this item must comply with the applicable conditions, which includes keeping evidence that records the following (as applicable):

the circumstances of the supply of the goods;
the destruction or disposal of the goods;
the carrying out of a further step in the manufacture of the goods.

The effect of this item is, together with item 19, to facilitate a supply pathway through which therapeutic vaping goods may be returned to the sponsor. This item supplements item 19 and provides for a wholesaler to return therapeutic vaping goods to the sponsor. The sponsor may then, under item 17, destroy the goods or carry out a further step in the manufacture of the goods. Alternatively, the sponsor may possess or supply the goods under some other item in the Principal Determination.

Attachment B

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Therapeutic Goods (Vaping Goods—Possession and Supply) Amendment Determination (No. 2) 2025

This disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the legislative instrument

Division 1 in Part 4A-2 of the Therapeutic Goods Act 1989 (the Act) establishes offences and civil penalties relating to the importation, manufacture, supply and commercial possession of vaping goods. The offence and civil penalty provisions prohibit such conduct unless an exception specified in the relevant provision of the Act applies. The intent of these provisions is to deter trade in illicit vaping goods, reduce the use of vaping products in Australia (particularly among youth and young adults), and prevent a new generation of persons being exposed to dangerous chemicals and developing nicotine dependence.

The Therapeutic Goods (Vaping Goods—Possession and Supply) Amendment Determination (No. 2) 2025 (the Amendment Determination) amends the Principal Determination to:

introduce five additional items that provide conditional exceptions to possess or supply vaping goods in specified circumstances;
continue the operation of several existing exceptions (which would otherwise expire on 31 December 2025) that authorise possession or supply of vaping goods;
repeal items that no longer have effect (i.e. have effectively expired); and
make a small number of other minor consequential and editorial amendments.

Background

The Principal Determination, which is made under section 41R of the Act, is driven by public health objectives intended to ensure that:

unused stock of unlawful vaping goods in the community may be surrendered, exported, disposed, or destroyed in controlled circumstances that minimise the risk of diversion and support community safety in appropriate disposal of unlawful vaping goods;
the Department has oversight of the supply and possession of lawful vaping goods by certain persons in the pharmaceutical wholesale or retail supply chains who do not otherwise hold a licence or authority to do so; and
adequate protection is afforded to certain specified persons where the supply or possession of vaping goods without a licence or other authority for a bespoke reason outweighs the public health and safety concerns, such as supply or possession for scientific research or testing.

Purpose

Specifically:

new table item 16 applies to therapeutic vaping goods that cease to be registered, listed or included in the Register, or cease to be exempt from being on the Register—this item provides sponsors, wholesalers and manufacturers with 6-months within which they may possess or supply those goods for the sole purposes of destroying, disposing of, or carrying out further steps in the manufacture of, the goods;
new table item 17 applies to therapeutic vaping goods in the Register—this item provides for an exporter to possess or supply the goods for the sole purpose of exporting the goods;
new table item 18 applies to vaping goods that are provided to a pharmacy, hospital or other healthcare facility for disposal—this item authorises the pharmacy, hospital or healthcare facility to possess the goods for the sole purpose of destroying or disposing of the goods, and to supply the goods to an authorised disposer (including through a transport business);
new table item 19 applies to therapeutic vaping goods that are possessed by a pharmacy, hospital or other healthcare facility and no longer suitable or intended for supply to a patient—this item authorises the pharmacy, hospital or other healthcare facility to return the goods to the sponsor or wholesaler (including through a transport business);
new table item 20 applies to therapeutic vaping goods that are possessed by a wholesaler and which were returned from a pharmacy, hospital or other healthcare facility—this item authorises the wholesaler to return the goods to the sponsor (including through a transport business).

Human rights implications

The Amendment Determination engages the right to health in Article 12 of the International Covenant on Economic, Social and Cultural rights (the ICESCR).

Right to health

Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standards of physical and mental health, and includes an obligation to take reasonable measures within available resources to progressively secure broader enjoyment of the right.

In General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12) (2000), the United Nations Committee on Economic, Social and Cultural Rights states that health is a ‘fundamental human right indispensable for the exercise of other human rights’, and that the right to health is not to be understood as the right to be healthy, but includes the right to a system of health protection which provides equal opportunity for people to enjoy the highest attainable level of health.

The Amendment Determination promotes the right to health by ensuring that legitimate activities involving the supply and possession of vaping goods by persons who are not generally covered by specific approvals, permissions or authorisations under Commonwealth and state and territory laws are permitted. This ensures that intermediate actors in the lawful supply chain may carry on activities associated with legitimate patient access to therapeutic vaping goods for smoking cessation or the management of nicotine dependence. In addition, the Amendment Determination supports the safe surrender, disposal and destruction of potentially harmful illicit vaping goods.

Conclusion

The Amendment Determination is compatible with human rights because it promotes the right to health in Article 12 of the ICESCR and otherwise does not raise any other human rights issues.

Administered by Department of Health, Disability and Ageing

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