Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024
I, Nicholas Henderson, as delegate of the Minister for Health and Aged Care, make the following determination.
Dated 30 June 2024
Nicholas Henderson
Acting Deputy Secretary
Health Products Regulation Group
Department of Health and Aged Care
Contents
1 Name
2 Commencement
3 Authority
4 Definitions
5 Circumstances in which specified vaping goods may be possessed
6 Circumstances in which specified vaping goods may be possessed and supplied
Schedule 1—Possession of specified vaping goods
Schedule 2—Possession and supply of specified vaping goods
This instrument is the Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information | ||
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. The whole of this instrument | At the same time as Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence. However, this instrument does not commence at all if the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 does not commence. |
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Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
This instrument is made under section 41R of the Therapeutic Goods Act 1989.
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) commercial quantity;
(b) current Poisons Standard;
(c) Customs officer;
(d) essential principles;
(e) health practitioner;
(f) included in the Register;
(g) nurse practitioner;
(h) pharmacist;
(i) Register;
(j) registered goods;
(k) Secretary;
(l) sponsor;
(m) supply;
(n) vaping goods;
(o) vaping substance.
In this instrument:
Act means the Therapeutic Goods Act 1989.
approved importer means a person specified in, or in a class of persons specified in, an approval under subregulation 5A(5) of the CPI Regulations.
authorised disposer means:
(b) an authority with functions relating to waste destruction or disposal.
authority means:
(a) a Commonwealth authority; or
(b) a department of State of the Commonwealth or a State; or
(c) a department or administrative unit of the Public Service of a Territory; or
(d) an authority of the Commonwealth, a State or Territory (including a local council or other body responsible for local government);
with functions relating to vaping goods, therapeutic goods, health, law enforcement or waste disposal.
commercial premises means premises:
(a) from which goods or services are available for supply, or are supplied, to a person other than a consumer; or
(b) that are used in connection with the supply of goods or services to a person other than a consumer; or
(c) from which goods are imported, exported or manufactured; or
(d) that are used in connection with the importation, exportation or manufacture of goods;
whether or not the premises are used wholly or predominantly for that purpose.
CPI Regulations means the Customs (Prohibited Imports) Regulations 1956.
destroy means render a thing unusable and unidentifiable.
MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.
medicinal cannabis products has the same meaning as in the Regulations.
notified vaping goods means vaping goods that:
(a) are exempt goods under regulations made for the purposes of subsection 18(1) of the Act, or an exempt device under regulations made for the purposes of subsection 41HA(1) of the Act, in relation to which the sponsor has given the Secretary a notice in compliance with the relevant exemption; and
(b) are not the subject of a determination by the Secretary, published on the Department’s website, that the supply of the goods be stopped, or should cease, because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods.
permitted cannabis wholesaler, in relation to goods containing one or more substances included in Schedule 4 or Schedule 8 to the current Poisons Standard, means a wholesaler who is the holder of a licence, or is otherwise authorised, to supply and possess the substance or substances under a law of each State or Territory in which the person supplies or possesses the goods.
permitted exporter means:
(a) a person to whom the Secretary has given a consent under subsection 41RC(1) of the Act to possess vaping goods in the course of their exportation business; or
(b) a person covered by a determination under section 41R of the Act in relation to vaping goods possessed by the person in the course of their export business.
permitted health practitioner means a person mentioned in subsection 41QB(10) of the Act.
permitted importer means a person authorised under regulation 5 or 5A of the CPI Regulations to import vaping goods, other than an approved importer.
permitted manufacturer means a person mentioned in paragraph 41QA(5)(b) of the Act.
permitted recipient means:
(a) a person mentioned in paragraph 41QB(8)(b) of the Act; or
(b) a person to whom the Secretary has given a consent under subsection 41RC(1) of the Act to possess vaping goods in the course of:
(i) their practice as a health practitioner, a nurse practitioner or a pharmacist; or
(ii) the person’s importation, manufacturing, wholesale supply or retail supply business; or
(c) a person covered by a determination under section 41R of the Act in relation to vaping goods possessed by them in the course of:
(i) their practice as a health practitioner, a nurse practitioner or a pharmacist; or
(ii) the person’s importation, manufacturing, wholesale supply or retail supply business.
permitted wholesale supplier means:
(a) a person mentioned in paragraph 41QB(7)(a), (b), (c) or (d) of the Act; or
(b) a person to whom the Secretary has given a consent under subsection 41RC(1) of the Act to supply goods in relation to the course of their importation, manufacturing, wholesale supply or retail supply business; or
(c) a person covered by a determination under section 41R of the Act in relation to vaping goods supplied by them in the course of their importation, manufacturing, wholesale supply or retail supply business.
Regulations means the Therapeutic Goods Regulations 1990.
retail premises has the same meaning as in paragraph 41QD(10) of the Act.
therapeutic cannabis vaping good has the same meaning as in the MD Regulations.
visiting group means a group of persons specified in an approval under subregulation 5A(5) of the CPI Regulations.
5 Circumstances in which specified vaping goods may be possessed
In relation to each item in the table in Schedule 1, the specified vaping goods, or specified class of vaping goods, determined in column 2, may be possessed by a specified person or a specified class of persons determined in column 3, in the circumstances specified in column 4 and subject to the conditions, if any, specified in column 5.
6 Circumstances in which specified vaping goods may be possessed and supplied
In relation to each item in the table in Schedule 2, the specified vaping goods, or specified class of vaping goods, determined in column 2, may be possessed and supplied by a specified person or a specified class of persons determined in column 3, in the circumstances specified in column 4 and subject to the conditions, if any, specified in column 5.
Schedule 1—Possession of specified vaping goods
Note: See section 5.
Specified vaping goods, persons, circumstances and conditions (if any) | |||||||
Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | |||
Item | Vaping goods | Persons | Circumstances | Conditions | |||
1 | vaping goods | an individual | all of the following: (a) the possession occurs on or before 30 June 2025; (b) the goods are owned by the person for use by the person or another person in the person’s care; (c) the person is not engaged in, and has at no time after 1 July 2024 been engaged in, the commercial importation, exportation, manufacture, wholesale supply or retail supply of vaping goods; (d) the goods are not beneficially owned by, or under the control of, a body corporate; (e) the goods are not possessed or stored in or at a retail premises or a commercial premises; (f) the amount of goods possessed by the person is less than 5 times the commercial quantity of the kind of vaping goods |
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2 | vaping goods | a person who is a member of a visiting group to Australia | all of the following: (b) the goods were given to the person by the approved importer |
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3 | vaping goods | a person who obtained the goods in the course of their exportation business | all of the following: (a) the goods are possessed by the person before 1 January 2025 for the sole purpose of exporting the goods from Australia; (b) the person: (i) imported the goods into Australia, or (ii) received the goods from: (A) a permitted importer; (B) a permitted wholesale supplier; (C) a permitted recipient; (D) a permitted cannabis wholesaler; or (E)a person supplying vaping goods in accordance with item 6 or 10 of Schedule 2 to this Determination | all of the following: (a) at all times while the goods are in the person’s possession, the goods must be clearly marked for export; (b) the goods must be stored: (i) in an area, or a receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle; and (ii) in an area a member of the public could not access without permission from the person; (c) the person must, for the period in which the goods are in the person’s possession, keep and maintain a record of: (i) the amount or quantity of the goods; and (ii) a description of the goods; (d) the person must, for at least 12 months after the day on which the goods are delivered, retain a copy of the receipt provided by the person to the person who delivered the goods; (e) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—the person must comply with all applicable laws of the State or Territory that apply to the possession and exportation of a substance to which Schedule 8 of the current Poisons Standard applies; (f) the person must, for at least 12 months after the day on which the goods are exported, retain a record of: (i) the date the goods were exported; (ii) the amount or quantity of goods exported; (iii) a description of the goods exported; (iv) the method of export; and (v) the name and signature of the person recording the information; (g) if the person reasonably suspects that any of the goods have been lost or stolen, the person must notify police in the State or Territory in which the person suspects the goods were lost or stolen: (i) as soon as practicable; and (ii) before the end of the next business day; (h) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant | |||
4 | one or more of the following: (a) notified vaping goods; (b) vaping substances that are medicinal cannabis products or medicines that contain synthetic cannabis; (c) therapeutic cannabis vaping goods | a person engaged in the business of providing storage facilities | all of the following: (a) the possession occurs on or before 30 September 2024; (b) the other person (storer) who has engaged the storage services of the person is: (i) a person in relation to whom item 3 of this Schedule applies; or (ii) a person in relation to whom item 6, 7, 8 or 9 of Schedule 2 to this Determination applies; or (iii) a permitted importer, a permitted exporter, a permitted wholesale supplier, a permitted recipient, or a permitted cannabis wholesaler; (c) the storage is in accordance with a written agreement between the person and the storer | all of the following: (a) the person must, for the period in which the goods are in the person’s possession, keep: (i) a copy of the written agreement between the person and the storer; and (ii) a description of the goods (including the amount or quantity of goods) stored, and the name and address of the storer; (b) the goods must be stored: (i) in an area, or a receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle; and (ii) in an area the person reasonably believes that a member of the public could not access without the person’s permission; (c) the person must, for at least 12 months after the day on which the goods are removed from the person’s possession, retain records of: (i) a description of the goods (including the amount or quantity of goods) stored; (ii) the name and address of the storer; and (iii) the written agreement, or a copy of the written agreement, between the person and the storer; (d) if the person reasonably suspects that any of the goods have been lost or stolen, the person must notify police in the State or Territory in which the person suspects the goods were lost or stolen: (i) as soon as practicable; and (ii) before the end of the next business day; (e) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—the person must comply with all applicable laws of the State or Territory that apply to the possession and storage of a substance to which Schedule 8 of the current Poisons Standard applies; (f) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant | |||
5 | vaping goods | a person who holds a licence or written authorisation issued under a law of a State or Territory which authorises the person to destroy or dispose of waste | all of the following: (a) the possession occurs on or before 30 September 2024; (b) the person possesses the goods for the sole purpose of lawful destruction by the person or an agent or employee of the person; (c) the person did not provide any payment or other consideration for the goods | all of the following: (a) at all times while the goods are in the person’s possession, the goods must be clearly marked for destruction; (b) the goods must be destroyed as soon as practicable; (c) the goods must be stored: (i) in an area, or a receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle; and (ii) in an area a member of the public could not access without permission from the person; (d) the person must, for the period in which the goods are in the person’s possession, keep and maintain a record of: (i) the amount or quantity of the goods; and (ii) a description of the goods; (e) the person must, for at least 12 months after the day on which the goods are delivered, retain a copy of the receipt provided by the person to the person who delivered the goods; (f) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—the person must comply with all applicable laws of the State or Territory that apply to the possession and destruction of a substance to which Schedule 8 of the current Poisons Standard applies; (g) the person must, for at least 12 months after the day on which the goods are destroyed, retain a record of: (i) the date the goods were destroyed; (ii) the amount or quantity of goods destroyed; (iii) a description of the goods destroyed; (iv) the method of destruction; and (v) the name and signature of the person recording the information; (h) if the person reasonably suspects that any of the goods have been lost or stolen, the person must notify police in the State or Territory in which the person suspects the goods were lost or stolen: (i) as soon as practicable; and (ii) before the end of the next business day; (i) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant | |||
6 | vaping goods | a person engaged in bona fide medical or scientific research or testing of vaping goods | all of the following: (a) the possession occurs on or before 30 September 2024; (b) the person is: (i) a laboratory accredited by the National Association of Testing Authorities; or (ii) a laboratory or testing facility operated by a university or hospital; or (ii) a person engaged by a laboratory or testing facility referred to in subparagraph (i) or (ii) to conduct or assist with medical or scientific research or testing at the laboratory; (c) the medical or scientific research or testing does not involve research or testing in or on humans; (d) the goods were lawfully: (i) imported into, or manufactured in, Australia; and (ii) supplied to the person; (e) the medical or scientific research or testing occurs, or will occur, solely in a laboratory or facility referred to in paragraph (b) | all of the following: (a) the goods must not be used: (i) for any purpose other than medical or scientific research or testing; (ii) in or on humans; (b) the goods must be stored: (i) in an area, or a receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle; and (ii) in an area the person reasonably believes a member of the public could not access without permission from the person; (c) the person must keep and maintain a record of all goods in the person’s possession, including: (i) the amount or quantity of goods; and (ii) a description of the goods; (d) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—the person must comply with all applicable laws of the State or Territory that apply to the possession and testing of a substance to which Schedule 8 of the current Poisons Standard applies; (e) the person must maintain and keep, for a period of no less than 12 months after the day on which the goods are destroyed, a record of the goods destroyed which includes: (i) the date of destruction; (ii) the amount or quantity of goods; (iii) a description of the goods; (iv) the method of destruction; and (v) the name and signature of the person recording the information; (f) if the person reasonably suspects that any of the goods have been lost or stolen, the person must notify police in the State or Territory in which the person suspects the goods were lost or stolen: (i) as soon as practicable; and (ii) before the end of the next business day (g) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant | |||
Schedule 2—Possession and supply of specified vaping goods
Note: See section 6.
Specified vaping goods, persons, circumstances and conditions (if any) | ||||
Column 1 | Column 2 | Column 3 | Column 4 | Column 5 |
Item | Vaping goods | Persons | Circumstances | Conditions |
1 | vaping goods | an individual | all of the following: (a) the possession and supply occurs on or before 30 June 2025; (b) the amount of goods possessed by the person is less than 5 times the commercial quantity of the kind of vaping goods; (c) the goods are possessed by the person for the sole purpose of supplying the goods to an authorised disposer for destruction; (d) the person is not engaged in, and has at no time after 1 July 2024 been engaged in, the commercial importation, exportation, manufacture, wholesale supply or retail supply of vaping goods | all of the following: (a) the person must not supply the goods other than to another person that the person reasonably believes: (i) is an authorised disposer; and (ii) will lawfully destroy the goods; (b) the person must not supply the goods in return for any payment or other consideration for the goods |
2 | imported vaping goods | a person who has entered Australia on board a ship or aeroplane | the goods are imported in accordance with either subregulation 5A(2) or paragraph 5(2)(b) of the CPI Regulations | the person must not supply the goods to another person (receiver) unless all of the following apply: (a) the receiver was on board the same ship or aircraft as the person; (b) the goods are supplied for use in connection with the treatment of the receiver by the person; (c) the receiver is under the care of the person |
3 | imported vaping goods | an approved importer who has entered Australia on board a ship or aeroplane as part of a visiting group | the importation of the goods by the person is approved under subregulation 5A(5) of the CPI Regulations | all of the following: (a) the goods must not be supplied to, or used in the treatment of, a person who is not a member of the visiting group; (b) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; (c) the person must: (i) carry a list, written in English, of the quantity and nature of the goods imported; and (ii) keep a record of the use of the goods while the group is in Australia; and (iii) produce the list or the record for inspection at the request of a Customs officer or a person who is an authorised officer for the purposes of a provision of Part 5 of the Regulations or an authorised person for the purposes of section 41FN of the Act |
4 | vaping goods | a person who: (a) obtained the goods in the course of their importation, exportation, wholesale supply, retail supply, transportation or storage, business; or (b) manufactured the goods in Australia | all of the following: (a) the possession and supply occurs on or before 30 September 2024; (b) immediately before 1 July 2024: (i) the goods were in the person’s possession or control; (ii) the importation or manufacture, supply, and possession of the goods was done in accordance with all applicable laws of the Commonwealth, a State or a Territory; (c) the person: (i) possesses at least 20 times the commercial quantity of the kind of vaping goods; and (ii) possesses the goods for the sole purpose of surrendering the goods to the Department; and (ii) notified the Department, before 1 August 2024, at vapereturn@health.gov.au that the person intends to surrender the goods to the Department; (d) the goods are supplied to the Department by the person for the purpose of surrender in accordance with a direction of an officer of the Department | all of the following: (a) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession or supply of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant; (b) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—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 of the current Poisons Standard applies; (c) the goods must be stored: (i) in an area, or a receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle; and (ii) in an area the person reasonably believes a member of the public could not access without permission from the person; (d) the person must keep and maintain a record of all goods in the person’s possession, including: (i) the amount or quantity of goods; and (ii) a description of the goods; (e) the person must supply the goods in accordance with a direction of an officer of the Department (including any direction concerning transportation or any other process required to facilitate supply); (f) if the person reasonably suspects that any of the goods have been lost or stolen, the person must notify police in the State or Territory in which the person suspects the goods were lost or stolen: (i) as soon as practicable; and (ii) before the end of the next business day |
5 | vaping goods | a person who: (a) obtained the goods in the course of their importation, exportation, wholesale supply, retail supply, transportation or storage business; or (b) manufactured the goods in Australia | all of the following: (a) the possession and supply occurs on or before 30 September 2024; (b) immediately before 1 July 2024: (i) the goods were in the person’s possession; (ii) the importation or manufacture, possession and supply of the goods was done in accordance with all applicable laws of the Commonwealth, a State or a Territory; (c) the person possesses no more than 20 times the commercial quantity of the kind of vaping goods; (d) the goods are possessed by the person for the sole purpose of supplying the goods to another person that the person reasonably believes: (i) is an authorised disposer; and (ii) will lawfully destroy the goods | all of the following: (a) the person must not supply the goods other than to another person that the person reasonably believes: (i) is an authorised disposer; and (ii) will lawfully destroy the goods; (b) the person must not supply the goods in return for any payment or other consideration for the goods; (c) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—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 of the current Poisons Standard applies; (d) the goods must be stored: (i) in an area, or a receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle; and (ii) in an area the person reasonably believes a member of the public could not access without permission from the person; (e) the person must keep and maintain a record of all goods in the person’s possession, including: (i) the amount or quantity of goods; and (ii) a description of the goods; (f) if the person reasonably suspects that any of the goods have been lost or stolen, the person must notify police in the State or Territory in which the person suspects the goods were lost or stolen: (i) as soon as practicable; and (ii) before the end of the next business day; (g) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; and (ii) the person’s possession or supply of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant |
6 | vaping goods | a person who: (a) obtained the goods in the course of their importation, wholesale supply or retail supply business; or (b) manufactured the goods in Australia | all of the following: (a) the possession and supply occurs on or before 30 September 2024; (b) the goods were imported into, or manufactured in, Australia before 1 July 2024; and (c) the importation or manufacture, possession and supply of the goods was done in accordance with all applicable laws of the Commonwealth, a State or a Territory; (d) the goods are possessed by the person for the sole purpose of supply to: (i) a permitted recipient; or (ii) a permitted wholesale supplier; or (iii) another person outside of Australia; or (iv) a permitted exporter that the person reasonably believes: (A) will lawfully export the goods from Australia before 1 January 2025; and (B) will not use the goods or supply the goods to any person in Australia; (e) the goods are supplied to one of the following persons (receiver): (i) a permitted recipient; or (ii) a permitted wholesale supplier; or (iii) a person outside of Australia; or (iv) a permitted exporter that the person reasonably believes: (A) will lawfully export the goods from Australia prior to 1 January 2025; and (B) will not use the goods or supply the goods to any person in Australia; (f) the goods must only be supplied to a receiver in accordance with a written agreement between the person and the receiver; (g) if, immediately before 1 July 2024, the person possessed more than 20 times the commercial quantity, the person notified the Department of that fact, at vapereturn@health.gov.au, before 1 August 2024 | all of the following: (a) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession or supply of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant; (b) if the goods contain a substance included in Schedule 8 to the current Poisons Standard— the person must comply with all applicable laws of the State or Territory that apply to the possession, supply and export of a substance to which Schedule 8 of the current Poisons Standard applies; (c) if the goods are supplied to a permitted recipient—the goods must: (i) for goods other than medical devices—conform with a standard applicable to the goods; and (ii) for medical devices—comply with the applicable provision of the essential principles; (d) the goods must be stored: (i) in an area, or a receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle; and (ii) in an area the person reasonably believes a member of the public could not access without permission from the person; (e) the person must keep and maintain a record of all goods in the person’s possession, including: (i) the amount or quantity of goods; and (ii) a description of the goods; (f) during transportation: (i) the person must not leave the goods unattended, other than in a secure area; and (ii) the person must take all reasonable steps to ensure that the goods are stored and transported in accordance with the instructions (if any) that are provided by the receiver or specified on the label of the goods; (g) in the course of supply of the goods to a receiver: (i) the supply must be in accordance with a written agreement between the person and the receiver; (ii) the goods must be delivered to the street address stated in the written agreement; (iii) the person must not leave the goods at the street address unless the person obtains a written receipt for the delivery of the goods from the receiver, or a person purportedly acting on behalf of the receiver; (h) the person must retain, for at least 12 months after the day on which supply of the goods occurs: (i) any written receipt, or a copy of the written receipt, provided to the person at the time of supply; (ii) a description of the goods (including the amount or quantity of goods) supplied to any person; and (iii) the written agreement, or a copy of the written agreement referred to in paragraph (f) of Column 5; (i) if the person reasonably suspects that any of the goods have been lost or stolen, the person must notify police in the State or Territory in which the person suspects the goods were lost or stolen: (i) as soon as practicable; and (ii) before the end of the next business day |
7 | one or more of the following: (a) notified vaping goods, other than goods that contain a substance included in a Schedule to the current Poisons Standard; (b) therapeutic cannabis vaping goods; (c) vaping substances that are medicinal cannabis products or medicines that contain synthetic cannabis | a person engaged in the business of importation or wholesale supply | all of the following: (a) if the goods are goods referred to in paragraph (a) or (b) of column 3—the possession and supply occurs on or before 30 September 2024; (b) the goods are possessed by the person for the sole purpose of supplying the goods to a permitted recipient, a permitted cannabis wholesaler or a permitted wholesale supplier (receiver); (c) the goods are supplied by the person to a receiver; (d) if the goods are therapeutic cannabis vaping goods: (i) the person reasonably believes that the goods were lawfully: (A) imported into, or manufactured in, Australia; and (B) supplied to the person; and (ii) the person reasonably believes that the goods are: (A) included in the Register; or (B) approved for supply under subsection 41HB(1) of the Act for use in the treatment of another person; or (C) authorised for supply under subsection 41HC(1) of the Act; (e) if the goods are vaping substances that are medicinal cannabis products or medicines that contain synthetic cannabis: (i) the person reasonably believes that the goods were lawfully: (A) imported into, or manufactured in, Australia; and (B) supplied to the person; and (ii) the goods are: (A) registered goods; or (B) exempt from the operation of Part 3-2 of the Act under regulation 12A of the Regulations; or (C) approved for supply under subsection 19(1) of the Act for use in the treatment of another person; or (D) authorised for supply under subsection 19(5) or (7A) of the Act; (ii) if the goods include a substance included in Schedule 4 to the current Poisons Standard—the person is authorised or licenced under a law of the relevant State or Territory to possess and supply the Schedule 4 substances for the purpose of wholesale supply; (iii) if the goods include a substance included in Schedule 8 to the current Poisons Standard—the person is authorised or licenced under a law of the relevant State or Territory to possess and supply the Schedule 8 substances for the purpose of wholesale supply | all of the following: (a) the goods must only be supplied to a receiver in accordance with a written agreement between the person and the receiver; (b) if the goods contain a substance included in Schedule 4 to the current Poisons Standard—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 of the current Poisons Standard applies; (c) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—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 of the current Poisons Standard applies; (d) the goods must be stored: (i) in an area, or a receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle; and (ii) in an area the person reasonably believes a member of the public could not access without permission from the person; (e) the person must keep and maintain a record of all goods in the person’s possession, including: (i) the amount or quantity of goods; and (ii) a description of the goods; (f) during transportation: (i) the person must not leave the goods unattended, other than in a secure area; and (ii) the person must take all reasonable steps to ensure that the goods are stored and transported in accordance with the instructions (if any) that are provided by the receiver, or that are specified on the label of the goods; (g) the goods must be delivered to the street address stated in the written agreement referred to in paragraph (a); (h) the person must not leave the goods at the street address unless the person obtains a written receipt for the delivery of the goods from the receiver, or a person purportedly acting on behalf of, the receiver; (i) the person must retain, for a period of no less than 12 months after the day on which supply of the goods occurs: (i) the written receipt, or a copy of the written receipt; (ii) a description of the goods (including the amount or quantity of goods) delivered; and (iii) the written agreement, or a copy of the written agreement; (j) if the person reasonably suspects that any of the goods have been lost or stolen, the person must notify police in the State or Territory in which the person suspects the goods were lost or stolen: (i) as soon as practicable; and (ii) before the end of the next business day (k) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession or supply of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant |
8 | nicotine in solution | a person who is the holder of a licence under Part 3-3 of the Act (licence holder) that authorises the manufacture of vaping goods | all of the following: (a) the possession and supply occurs on or before 30 September 2024; (b) the goods were manufactured by the person in Australia; (c) if, immediately before 1 July 2024, the person possessed more than 20 times the commercial quantity, the person notified the Department of that fact, at vapereturn@health.gov.au, before 1 August 2024 | all of the following: (a) the goods must only be supplied to a person who is the holder of a Part 3-3 licence that authorises the manufacture of vaping goods; (b) the goods must be manufactured in compliance with the licence holder’s licence; (c) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession or supply of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant |
9 | imported vaping substances | a person who is the holder of a licence and permit granted under subregulation 5(5) of the CPI Regulations that applies to the vaping goods | the goods are imported in accordance with paragraphs 5(1)(a) to (d) of the CPI Regulations | all of the following: (a) the goods may only be supplied to a permitted recipient, a permitted wholesale supplier, or a permitted cannabis wholesaler; (b) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession or supply of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant |
10 | one or more of the following: (a) notified vaping goods; (b) therapeutic cannabis vaping goods; (c) a vaping substance that is a medicinal cannabis product or a medicine that contains synthetic cannabis | a person engaged in the business of transporting goods | all of the following: (a) the possession or supply occurs on or before 30 September 2024; (b) the person obtains or receives the goods from another person (sender) who is: (i) a person in relation to whom item 3 of Schedule 1 to this Determination applies; or (ii) a person in relation to whom item 6, 7, 8 or 9 of this Schedule applies; or (iii) a permitted wholesale supplier, a permitted cannabis wholesaler, or a permitted importer; (c) the person possesses the goods for the sole purpose of transporting the goods to a permitted wholesale supplier, a permitted cannabis wholesaler, a permitted recipient or a permitted exporter (receiver); (d) the person delivers the goods to the receiver in accordance with a written agreement between the person and a sender or receiver | all of the following: (a) the person must not supply the goods other than to another person that the person reasonably believes is the receiver identified in the written agreement referred to in paragraph (d) of column 4, or an agent or employee of the receiver; (b) while the goods are in the person’s possession: (i) the person must possess evidence of the written agreement referred to in paragraph (d) of column 4; (ii) the person must keep and maintain a record of all goods in the person’s possession, including: (A) the amount or quantity of goods; and (B) a description of the goods; (c) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—the person 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 8 of the current Poisons Standard applies; (d) the goods must be stored: (i) in an area, or a receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle; and (ii) in an area the person reasonably believes a member of the public could not access without permission from the person; (e) during transportation: (i) the person must not leave the goods unattended, other than in a secure area; and (ii) the person must take all reasonable steps to ensure that the goods are stored and transported in accordance with the instructions (if any) that are provided by the receiver, or that are specified on the label of the goods; (f) the goods must be delivered to the street address stated on the packaging of the goods or in the written agreement referred to in paragraph (d) of column 4; (g) the person must not leave the goods at the street address unless the person obtains a written receipt for the delivery of the goods from the receiver or a person purportedly acting on behalf of the receiver; (h) the person must retain, for a period of no less than 12 months after the day on which delivery of the goods occurs: (i) the written receipt, or a copy of the written receipt; (ii) a description of the goods (including the amount or quantity of goods) delivered; and (iii) the written agreement, or a copy of the written agreement; (i) if the person reasonably suspects that any of the goods have been lost or stolen, the person must notify police in the State or Territory in which the person suspects the goods were lost or stolen: (i) as soon as practicable; and (ii) no later than the end of the next business day (j) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession or supply of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant |
11 | vaping goods | a person engaged in the business of transporting goods | all of the following: (a) the possession and supply occurs on or before 30 September 2024; (b) while in possession—the goods are possessed by the person for the sole purpose of delivering the goods to an authorised disposer; (c) in the course of supply— (i) delivery is in accordance with a written agreement between the person and: (A) the authorised disposer; or (B) a third party who possesses the goods that the person reasonably believes is engaging the person’s transportation services to facilitate the lawful destruction of the goods; (ii) the person reasonably believes that the authorised disposer will lawfully destroy the goods | all of the following: (a) while the goods are in the person’s possession: (i) the person must possess evidence of the written agreement referred to in paragraph (c) of column 4; and (ii) the person must keep and maintain a record of all goods in the person’s possession, including: (A) the amount or quantity of goods; and (B) a description of the goods; (b) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—the person 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 8 of the current Poisons Standard applies; (c) the goods must be stored: (i) in an area, or a receptacle in an area, that is locked or otherwise secured in a way that is designed to prevent access to the area or receptacle by a person who is not authorised to access the area or receptacle; and (ii) in an area the person reasonably believes a member of the public could not access without permission from the person; (d) during transportation: (i) the person must not leave the goods unattended, other than in a secure area; and (ii) the person must take all reasonable steps to ensure that the goods are stored and transported in accordance with the instructions (if any) that are provided by the authorised disposer, or that are specified on the label of the goods; (e) the goods must be delivered to the street address stated on the packaging of the goods or in the written agreement referred to in paragraph (c) of Column 4; (f) the person must not leave the goods at the street address unless the person obtains a written receipt for the delivery of the goods from the authorised disposer; (g) the person must retain, for a period of no less than 12 months after the day on which delivery of the goods occurs: (i) the written receipt, or a copy of the written receipt; (ii) a description of the goods (including the amount or quantity of goods) delivered; and (iii) the written agreement, or a copy of the written agreement; (h) if the person reasonably suspects that any of the goods have been lost or stolen, the person must notify police in the State or Territory in which the person suspects the goods were lost or stolen: (i) as soon as practicable; and (ii) before the end of the next business day; (i) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession or supply of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant |
12 | one or more of the following: (a) therapeutic cannabis vaping goods; (b) a vaping substance that is a medicinal cannabis product or a medicine that contains synthetic cannabis | a permitted health practitioner | all of the following: (a) the goods are: (i) registered goods; (ii) included in the Register; (iii) approved for supply under subsection 19(1) or 41HB(1) of the Act for use in the treatment of another person; or (iv) authorised for supply under subsection 19(5), 19(7A), 41HC(1) or 41HC(6) of the Act; (b) while in possession—the goods are possessed by the health practitioner for the sole purpose of supply to: (i) an ultimate consumer of the goods; or (ii) a person who the health practitioner reasonably believes is lawfully obtaining the goods on behalf of the ultimate consumer; (c) in the course of supply—the goods are supplied by the health practitioner to: (i) an ultimate consumer of the goods; or (ii) a person who the health practitioner reasonably believes is lawfully obtaining the goods on behalf of the ultimate consumer | all of the following: (a) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—the health practitioner must comply with requirements under the law of the relevant State or Territory that apply to the possession and supply by a health practitioner of a substance to which Schedule 8 of the current Poisons Standard applies; (b) the person must store the goods in a part of their premises to which the public does not have access |
13 | vaping goods | one or more of the following: (a) the sponsor of the goods; (b) the sponsor, or principal investigator, of the clinical trial | all of the following: (a) the possession and supply occurs on or before 30 September 2024; (b) the goods are: (i) approved for supply under subsection 19(1) or 41HB(1) of the Act for use solely for experimental purposes in humans; or (ii) exempt from the operation of Division 3 of Part 4-11 of the Act under item 2.3 of Schedule 4 of the MD Regulations; or (ii) exempt from the operation of Part 3-2 of the Act under item 3 of Schedule 5A of the Regulations; (c) the goods are possessed by the person for the sole purpose of supply to: (i) if the person is the sponsor of the goods—the clinical trial sponsor; (ii) if the person is the sponsor, or principal investigator, of the clinical trial—a participant enrolled in the trial | all of the following: (a) the vaping goods must only be supplied to: (i) if the person is the sponsor of the goods—the clinical trial sponsor; (ii) if the person is the sponsor, or principal investigator, of the clinical trial—a participant enrolled in the trial; (b) the person must comply with any condition imposed on the person in relation to the approval or exemption; (c) if the goods contain a substance included in Schedule 8 to the current Poisons Standard—the person must comply with all applicable laws of the State or Territory that apply to the possession, testing and supply of a substance to which Schedule 8 of the current Poisons Standard applies; (d) the person must, if requested to do so by the Department, provide any information that the Department requires about: (i) the goods; (ii) the person’s possession or supply of the goods, and any other persons involved in such activities; and (iii) any other matter that the Department determines is relevant |