{"id":"F2024L00847","name":"Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024","slug":"therapeutic-goods-vaping-goods-possession-and-supply-determination-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":105292,"registerId":"commonwealth-F2024L00847-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\nThis instrument is the Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\nThis instrument is made under section 41R of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n(a) current Poisons Standard;\n\n(b) health practitioner;\n\n(c) included in the Register;\n\n(d) Register;\n\n(e) registered goods;\n\n(f) Secretary;\n\n(g) sponsor;\n\n(h) supply;\n\n(i) vaping goods;\n\n (j) vaping substance.\n In this instrument:\n\n> ABN has the same meaning as in the A New Tax System (Australian Business Number) Act 1999.\n\nAct means the Therapeutic Goods Act 1989.\n\napproved importer means a person specified in, or in a class of persons specified in, an approval under subregulation 5A(5) of the CPI Regulations.\n\nauthorised disposer means:\n\n(a) 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; or\n\n(b) an authority with functions relating to waste destruction or disposal.\n\nauthority means:\n\n(a) a Commonwealth authority; or\n\n(b) a department of State of the Commonwealth or a State; or\n\n(c) a department or administrative unit of the Public Service of a Territory; or\n\n(d) an authority of the Commonwealth, a State or Territory (including a local council or other body responsible for local government).\n\n> cease supply determination, in relation to vaping goods, means 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.\n\nCPI Regulations means the Customs (Prohibited Imports) Regulations 1956.\n\ndestroy means render a thing unusable and unidentifiable.\n\nMD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\nmedicinal cannabis products has the same meaning as in the Regulations.\n\n> notified vaping goods means vaping goods that:\n\n (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 sponsor notice; and\n (b) are not the subject of a cease supply determination.\n\npermitted exporter, in relation to vaping goods, means:\n\n(a) a person engaged in the business of exportation to whom the Secretary has given a consent under subsection 41RC(1) of the Act to possess the vaping goods; or\n\n(b) a person specified in column 3 of item 17 in the table in Schedule 2.\n\npermitted health practitioner means a person mentioned in subsection 41QB(10) of the Act.\n\npermitted importer, in relation to vaping goods, means a person authorised under regulation 5 or 5A of the CPI Regulations to import the vaping goods, other than an approved importer.\n\npermitted manufacturer means a person mentioned in paragraph 41QA(5)(b) of the Act.\n\npermitted recipient, in relation to vaping goods, means:\n\n(a) a person mentioned in paragraph 41QB(8)(b) of the Act; or\n\n(b) a person engaged in the business of manufacture, wholesale supply or retail supply to whom the Secretary has given a consent under subsection 41RC(1) of the Act to possess the vaping goods.\n\npermitted supplier, in relation to vaping goods, means:\n\n(a) a person mentioned in paragraphs 41QB(7)(a), (b), (c) or (d) of the Act; or\n\n(b) a person engaged in the business of importation, manufacture, wholesale supply or retail supply to whom the Secretary has given a consent under subsection 41RC(1) of the Act to supply the vaping goods; or\n\n(c) a person specified in column 3 of item 7 in the table in Schedule 2.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\n> sponsor notice, in relation to vaping goods that are exempt goods or an exempt device, means 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.\n\n> storage business means 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.\n\ntherapeutic cannabis vaping good has the same meaning as in the MD Regulations.\n\n> transport business means a person with an active ABN who is engaged principally in the business of freighting goods.\n\nvisiting group means a group of persons specified in an approval under subregulation 5A(5) of the CPI Regulations.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Circumstances in which specified vaping goods may be possessed","content":"#### 5 Circumstances in which specified vaping goods may be possessed\n\nIn 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.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Circumstances in which specified vaping goods may be possessed and supplied","content":"#### 6 Circumstances in which specified vaping goods may be possessed and supplied\n\nIn 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.\n\n \n\nSchedule 1—Possession of specified vaping goods\n\nNote: See section 5.\n\n```html\n

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

2

vaping goods

a person who is a member of a visiting group to Australia

all of the following:

(a) the goods were imported by an approved importer in accordance with an approval under subregulation 5A(5) of the CPI Regulations;

(b) the goods were given to the person by the approved importer

4

one or more of the following:

(a) notified vaping goods;

(b) goods that are or contain a vaping substance that is a medicinal cannabis product or a medicine that contains synthetic cannabis;

(c) therapeutic cannabis vaping goods

a storage business

all of the following:

(b) the other person (storer) who has engaged the storage services of the person is:

(i) a person in relation to whom item 6 of this Schedule applies; or

(ii) a person in relation to whom item 7, 8 or 9 of Schedule 2 to this Determination applies; or

(iii) a permitted importer, a permitted exporter, a permitted supplier or a permitted recipient; or

(iv) a sponsor, or a principal investigator, of a clinical trial involving the goods;

(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; and

(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 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 storage of a substance to which Schedule 4 to the current Poisons Standard applies;

(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 to the current Poisons Standard applies

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:

(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 to 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; and

(ii) the amount or quantity of goods destroyed; and

(iii) a description of the goods destroyed; and

(iv) the method of destruction; and

(v) the name and signature of the person recording the information

6

vaping goods

a person engaged in bona fide medical or scientific research or testing of vaping goods

all of the following:

(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

(iii) 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; and

(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 to 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; and

(ii) the amount or quantity of goods; and

(iii) a description of the goods; and

(iv) the method of destruction; and

(v) the name and signature of the person recording the information

\n```\n\n \n\nSchedule 2—Possession and supply of specified vaping goods\n\nNote: See section 6.\n\n```html\n

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

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 aeroplane 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

a person 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

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

a person engaged in the business of importation or supply

all of the following:

(b) the goods are possessed by the person for the sole purpose of supplying the goods to a permitted recipient or a permitted supplier (receiver);

(c) in the case of goods mentioned in paragraph (a) of column 2—the goods are supplied by the person to a receiver;

(d) in the case of goods mentioned in paragraph (b) of column 2 that are included in the Register—the goods are supplied by the person to a receiver;

(e) in the case of goods mentioned in paragraph (b) of column 2 that are not included in the Register—the goods are supplied by the person to a receiver who is not a person engaged in the business 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) 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) 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;

(e) the goods must be delivered to the street address stated in the written agreement referred to in paragraph (a);

(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 receiver, or a person purportedly acting on behalf of, the receiver;

(g) 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; and

(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

8

nicotine in solution

a person who is the holder of a licence under Part 3-3 of the Act (relevant licence holder) that authorises the manufacture of vaping goods

the goods were manufactured by the relevant licence holder in Australia

all of the following:

(a) the goods must be manufactured in compliance with the licence of the relevant licence holder;

(b) the goods may only be supplied by the licence holder to another person who is the holder of a Part 3-3 licence that authorises the manufacture of vaping goods

9

goods that are or contain a vaping substance that is a medicinal cannabis product or a medicine that contains synthetic cannabis

a person who is:

(a) the holder of a licence and permit granted under subregulation 5(5) of the CPI Regulations that applies to the vaping goods; or

(b) the holder of a licence under Part 3-3 of the Act

the goods are:

(a) imported in accordance with paragraphs 5(1)(a) to (d) of the CPI Regulations; or

(b) manufactured in Australia under a licence granted under Part 3-3 of the Act

all of the following:

(a) the goods may only be supplied to a permitted health practitioner;

(c) 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 4 to the current Poisons Standard applies;

(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 supply of a substance to which Schedule 8 to the current Poisons Standard applies

10

one or more of the following:

(a) notified vaping goods;

(b) therapeutic cannabis vaping goods;

(c) goods that are or contain a vaping substance that is a medicinal cannabis product or a medicine that contains synthetic cannabis

a transport business

all of the following:

(b) the person obtains or receives the goods from another person (sender) who is:

(i) a person in relation to whom item 6 of Schedule 1 to this Determination applies; or

(ii) a person in relation to whom item 7, 8 or 9 of this Schedule applies; or

(iii) a permitted supplier or a permitted importer; or

(iv) a sponsor, or a principal investigator, of a clinical trial involving the goods;

(c) the person possesses the goods for the sole purpose of transporting the goods to a permitted supplier, 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; 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;

(ba) 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 supply, possession and transportation of a substance to which Schedule 4 to 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 supply, possession and transportation of a substance to which Schedule 8 to 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; and

(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

11

vaping goods

a transport business

all of the following:

(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; and

(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 to 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; and

(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

12

one or more of the following:

(a) therapeutic cannabis vaping goods;

(b) goods that are or contain a vaping substance that is a medicinal cannabis product or a medicine that contains synthetic cannabis

a permitted health practitioner

all of the following:

  1. the goods are:

(i) registered goods; or

(ii) included in the Register; or

(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; or

(v) exempt under regulation 12A of the Regulations; or

(vi) exempt under regulation 7.2 of the MD Regulations;

  1. 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;

  1. 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:

(aa) if the goods contain a substance included in Schedule 4 to the current Poisons Standard—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;

  1. 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 to the current Poisons Standard applies;
  2. 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:

(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

(iii) 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; or

(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; or

(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 to the current Poisons Standard applies

14

vaping goods

the following persons:

(a) an authority; or

(b) an agent or employee of an authority

all of the following:

(a) the vaping goods are possessed or supplied by the person for the purpose of facilitating, or in connection with, one or more of the following:

(i) an investigation as to whether the applicable laws of the Commonwealth, a State or a Territory have been complied with;

(ii) proceedings in respect of which the vaping goods may afford evidence;

(iii) surrender, seizure, forfeiture, transportation, storage, destruction or disposal of the vaping goods;

(iv) bona fide medical or scientific research or testing of vaping goods;

(b) in the course of supply—the person reasonably believes that:

(i) the recipient can lawfully possess the vaping goods under the Act and all other applicable laws of the Commonwealth, a State or a Territory; and

(ii) the vaping goods will not be used by any person;

(c) if the vaping goods are possessed or supplied by an agent or employee of an authority—the agent or employee is acting solely in their official capacity

15

vaping goods

a person who is:

  1. a party to a contract with an authority to transport, store, destroy or dispose of vaping goods; or
  2. subcontracted by a person specified in paragraph (a) to provide services under that contract; or
  3. an agent or employee of a person specified in paragraphs (a) or (b)

all of the following:

(a) the vaping goods are possessed or supplied by the person for the sole purpose of performance of the contract;

(b) in the course of supply—the person reasonably believes that:

(i) the recipient can lawfully possess the vaping goods under the Act and all other applicable laws of the Commonwealth, a State or a Territory; and

(ii) the vaping goods will not be used by any person;

(c) if the vaping goods are possessed or supplied by a person specified in paragraph (c) of column 3—the person is acting solely in their capacity as an employee or agent

16

vaping goods that are therapeutic goods

a person who is:

(a) the sponsor of the goods; or

(b) the wholesaler of the goods; or

(c) a permitted manufacturer

all of the following:

(a) the possession or supply of the goods occurs within 6 months of one of the following:

(i) the date a sponsor notice is withdrawn;

(ii) the date a cease supply determination is made;

(iii) the date the goods cease to be registered, listed or included in the Register, or are suspended from the Register;

(b) the goods are possessed or supplied by the person for the sole purpose of:

(i) destroying or disposing of the goods; or

(ii) supplying to an authorised disposer for the goods to be disposed of or destroyed; or

(iii) carrying out a further step in the manufacture of the goods; or

(iv) supplying to a permitted manufacturer

all of the following:

(a) the person must keep evidence that records:

(i) the quantity in the person’s possession or that the person has supplied; and

(ii) the date of the possession or supply; and

(iii) who the goods were supplied to (if applicable); and

(iv) the destruction or disposal of the goods (if applicable); and

(v) the carrying out of a further step in the manufacture of the goods (if applicable);

(b) where subparagraph (b)(iii) in column 4 applies—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

17

vaping goods that are registered, listed or included in the Register

a person who obtains the goods in the course of their exportation business

the goods are possessed or supplied by the person for the sole purpose of exporting the goods

the person must keep evidence that records the circumstances of the exportation and the volume of the goods exported

18

vaping goods

a pharmacy, hospital or other healthcare facility

all of the following:

(a) the goods were provided to the person for the purpose of disposal;

(b) the goods are possessed by the person for the sole purpose of destroying or disposing of the goods;

(c) the goods are supplied to:

(i) an authorised disposer for the goods to be disposed of or destroyed; or

(ii) a transport business for the sole purpose of delivering the goods to an authorised disposer

all of the following:

(a) the person must keep evidence that records the supply to the authorised disposer or transport business;

(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 to the current Poisons Standard applies

19

vaping goods that are therapeutic goods

a pharmacy, hospital or other healthcare facility

all of the following:

(a) the goods are not suitable for supply to a patient, or the person wants to return the goods;

(b) the goods are supplied to:

(i) 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

(ii) a transport business 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

all of the following:

(a) the person must keep evidence that records the circumstances of the supply 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 possession and supply of a substance to which Schedule 8 to the current Poisons Standard applies

20

vaping goods that are therapeutic goods

a person engaged in the business of wholesale supply of therapeutic goods

all of the following:

(a) the goods were returned to the person from a pharmacy, hospital or other healthcare facility;

(b) the goods are supplied to:

(i) 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

(ii) a transport business for the sole purpose of delivering the goods to the sponsor of the goods

the person must keep evidence that records the following (as applicable):

(a) the circumstances of the supply of the goods;

(b) the destruction or disposal of the goods,

(c) the carrying out of a further step in the manufacture of the goods

\n```","sortOrder":4}],"analysis":{"flash_summary":{"complexity_score":8,"scope_assessment":{"changed":false,"description":"The Determination operates within the authority conferred by section 41R of the Therapeutic Goods Act 1989 (see section 3). It does not, on its face, expand the statute’s substantive regulatory remit but specifies conditional exemptions and permissions (Schedules 1 and 2) and procedural controls (definitions and conditions) for possession and supply under that authority."},"complexity_factors":["Cross‑references to primary and delegated instruments: made under s41R of the Therapeutic Goods Act 1989 (see section 3) and repeatedly refers to the Act, the Regulations, the CPI Regulations and the MD Regulations (Definitions, s4; Schedules 1–2).","Extensive definitional matrix: many specialised defined classes (permitted importer/exporter/manufacturer/recipient/supplier, approved importer, permitted health practitioner, sponsor notice, notified vaping goods) that gate access to permissions (Definitions, s4).","Two‑tier structure of permissions: separate tables for possession (Schedule 1 via s5) and possession+supply (Schedule 2 via s6), each with multiple items and bespoke conditions, increasing branching logic and compliance permutations.","Numerous procedural and documentary requirements: recurring obligations to keep written agreements, lists of goods, receipts and retention periods (commonly 12 months), and evidence of written agreements (multiple Schedule items).","Operational controls on storage/transport/destruction: locked/secured storage, limits on leaving goods unattended, delivery to specified street addresses, destruction marking and destruction records (many Schedule entries).","State/Territory law overlap: repeated requirement to comply with applicable State/Territory laws where goods contain substances listed in Schedule 4 or 8 of the current Poisons Standard (multiple Schedule items), creating multi‑jurisdictional compliance risk.","Time‑limited and conditional allowances: transitional/specific time windows (eg item 16 limits possession/supply of therapeutic goods to within 6 months of certain regulatory events), and conditions tied to Secretary consents and cease supply determinations.","Differing permissions by actor and purpose: permissions vary by actor type and purpose (research, clinical trials, export, return, manufacture, wholesale, disposal), producing many fine distinctions (Schedules 1–2 items 2–20).","Administrative discretion points: concepts like ‘permitted’ persons requiring Secretary consent, sponsor notices, approvals under CPI Regulations and cease supply determinations introduce administrative gating and potential delay.","Record‑keeping creates enforcement surface: detailed, itemised record obligations and retention periods increase compliance burden and create audit trails that regulators can enforce (various Schedule conditions)."],"plain_english_summary":"This Determination sets out when specific vaping products may lawfully be possessed and/or supplied in Australia and by whom. It lists classes of people (importers, exporters, sponsors, health practitioners, transport/storage businesses, authorised disposers, researchers, authorities and others) and attaches conditions such as secure storage, record‑keeping, transport rules, destruction procedures and compliance with State/Territory poison laws. It matters because it translates the Therapeutic Goods Act power into detailed, conditional permissions and obligations for market participants."},"kimi_summary":{"_metrics":{"completionTokens":1120},"content_quality":"ok","complexity_score":8,"scope_assessment":{"changed":false,"description":"The instrument appears to implement the intended scope of the parent Act (Therapeutic Goods Act 1989, section 41R) which empowers the Secretary to determine circumstances for possession and supply of vaping goods. The detailed tabular structure and extensive categories reflect the complexity of regulating a restricted product across medical, commercial, research, and waste management contexts, rather than scope creep."},"complexity_factors":["Extensive cross-referencing to multiple other instruments (Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990, Therapeutic Goods (Medical Devices) Regulations 2002, Customs (Prohibited Imports) Regulations 1956, Poisons Standard)","19 defined terms in section 4, many themselves defined by reference to other legislation","Dual-schedule structure (Schedule 1 for possession only, Schedule 2 for possession and supply) with overlapping but distinct categories","Nested conditional logic: each table entry requires satisfaction of multiple cumulative circumstances (column 4) AND multiple cumulative conditions (column 5)","Multiple overlapping categories of permitted persons (permitted importer, permitted supplier, permitted recipient, permitted health practitioner, permitted manufacturer, approved importer, visiting group, authorised disposer, storage business, transport business) with subtly different meanings","Heavy reliance on external registration status (\"included in the Register\", \"registered goods\", \"sponsor notice\", \"cease supply determination\") that can change independently of this instrument","State/Territory law compliance requirements layered on top of Commonwealth requirements, particularly for scheduled poisons","12-month record retention requirements with specific content requirements","Detailed security specifications (locked areas, receptacles, reasonable belief about public access) that create subjective compliance tests","Item 7 in Schedule 2 contains 7 separate conditions with nested sub-paragraphs (i)-(iii) and further sub-sub-paragraphs (A)-(B)","Item 10 in Schedule 2 (transport business) contains 8 separate conditions with extensive nested structure","Multiple temporal limitations (e.g., 6-month window in item 16 for dealing with deregistered goods)"],"plain_english_summary":"This Determination creates a detailed permit-and-exception regime for possession and supply of vaping products in Australia, tightly restricting most consumer access while enabling specific lawful uses. It affects importers, suppliers, researchers, healthcare providers, transporters, waste handlers, visiting groups and exporters by setting security, record-keeping, agreement and compliance conditions.\n\nWhy it matters: it decides who can legally handle vaping goods and under what safeguards, balancing public‑health controls with medical, scientific, disposal and trade needs."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-vaping-goods-possession-and-supply-determination-2024","history":"/api/acts/therapeutic-goods-vaping-goods-possession-and-supply-determination-2024/history","analysis":"/api/acts/therapeutic-goods-vaping-goods-possession-and-supply-determination-2024/analysis","conflicts":"/api/acts/therapeutic-goods-vaping-goods-possession-and-supply-determination-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-vaping-goods-possession-and-supply-determination-2024/important-cases","documents":"/api/acts/therapeutic-goods-vaping-goods-possession-and-supply-determination-2024/documents"}}