Commonwealth: Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (Cth)

Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 No. 50, 2024 An Act to amend the Therapeutic Goods Act 1989 and other legislation in relation to vaping goods, and for related purposes Contents 1 Short title 2 Commencement 3 Schedules 4 Review of operation of amendments Schedule 1—Amendment of the Therapeutic Goods Act 1989 Part 1—Definitions and objects of Act Therapeutic Goods Act 1989 Part 2—Regulation of vaping goods Division 1—Main amendments Therapeutic Goods Act 1989 Division 2—Other amendments Therapeutic Goods Act 1989 Division 3—Application and transitional provisions Part 3—Advertising relating to vaping goods Division 1—Main amendments Therapeutic Goods Act 1989 Division 2—Other amendments Therapeutic Goods Act 1989 Division 3—Application and transitional provisions Part 4—Enforceable directions and forfeiture Therapeutic Goods Act 1989 Part 5—Entry, searches and warrants Therapeutic Goods Act 1989 Part 6—Delegation and authorised persons Therapeutic Goods Act 1989 Part 7—Release of information Therapeutic Goods Act 1989 Part 8—Laboratory testing Therapeutic Goods Act 1989 Part 9—Approvals for certain Part 3‑2 exempt goods Therapeutic Goods Act 1989 Part 10—Offences and civil penalty provisions for breach of condition of certain exemptions or approvals Therapeutic Goods Act 1989 Part 11—Other amendments Therapeutic Goods Act 1989 Schedule 2—Amendment of the Customs Act 1901 Customs Act 1901 Schedule 3—Amendments of other Acts Industrial Chemicals Act 2019 Public Health (Tobacco and Other Products) Act 2023 Schedule 4—Supply of therapeutic vaping goods by pharmacists without prescription Part 1—Amendments Therapeutic Goods Act 1989 Therapeutic Goods (Medical Devices) Regulations 2002 Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022 Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024 Therapeutic Goods Regulations 1990 Part 2—Application and other provisions Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 No. 50, 2024 An Act to amend the Therapeutic Goods Act 1989 and other legislation in relation to vaping goods, and for related purposes [Assented to 27 June 2024] The Parliament of Australia enacts: 1 Short title This Act is the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024. 2 Commencement (1) Each provision of this Act 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. Sections 1 to 4 and anything in this Act not elsewhere covered by this table The day this Act receives the Royal Assent. 27 June 2024 2. Schedule 1, Parts 1 to 3 The later of: 1 July 2024 (a) 1 July 2024; and (paragraph (a) applies) (b) the day after this Act receives the Royal Assent. 2A. Schedule 1, items 50 to 57 The later of: 1 July 2024 (a) 1 July 2024; and (paragraph (a) applies) (b) the day after this Act receives the Royal Assent. 2B. Schedule 1, items 57A and 57B Immediately after the commencement of the provisions covered by table item 2. 1 July 2024 2C. Schedule 1, Parts 5 to 11 The later of: 1 July 2024 (a) 1 July 2024; and (paragraph (a) applies) (b) the day after this Act receives the Royal Assent. 3. Schedule 2 The day after this Act receives the Royal Assent. 28 June 2024 4. Schedule 3 At the same time as the provisions covered by table item 2. 1 July 2024 5. Schedule 4 1 October 2024. 1 October 2024 Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act. (2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act. 3 Schedules Legislation that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. Note 1: Subject to item 20 of Schedule 4, the provisions of the Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022 amended or inserted by this Act, and any other provisions of that instrument, may be amended or repealed by an instrument made under subsection 19(7A) of the Therapeutic Goods Act 1989 (see subsection 13(5) of the Legislation Act 2003). Note 2: Subject to item 20 of Schedule 4, the provisions of the Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024 amended or inserted by this Act, and any other provisions of that instrument, may be amended or repealed by an instrument made under subsection 52D(2) of the Therapeutic Goods Act 1989 (see subsection 13(5) of the Legislation Act 2003). Note 3: Subject to item 20 of Schedule 4, the provisions of the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990 amended or inserted by this Act, and any other provisions of those regulations, may be amended or repealed by regulations made under section 63 of the Therapeutic Goods Act 1989 (see subsection 13(5) of the Legislation Act 2003). 4 Review of operation of amendments (1) The Minister must cause an independent review to be conducted of the operation of the amendments made by Schedules 1, 3 and 4 to this Act and any regulations or other legislative instruments made for the purposes of those amendments. (2) The review must commence no later than 1 July 2027. (3) The persons who conduct the review must give the Minister a written report of the review within 6 months after the commencement of the review. (4) The Minister must cause a copy of the report to be tabled in each House of the Parliament within 15 sitting days of that House after the report is given to the Minister. Schedule 1—Amendment of the Therapeutic Goods Act 1989 Part 1—Definitions and objects of Act Therapeutic Goods Act 1989 1 Subsection 3(1) (after paragraph (b) of the definition of therapeutic goods) Insert: or (ba) determined to be therapeutic goods under subsection 7AAA(1); 2 Subsection 3(1) (paragraphs (e) and (f) of the definition of therapeutic goods) After "section 7", insert "and goods determined to be therapeutic goods under subsection 7AAA(1)". 3 At the end of subsection 4(1) Add: ; (d) provide for the establishment and maintenance of a national system of controls relating to the regulation of vaping goods that are: (i) imported into Australia; or (ii) manufactured in Australia; or (iii) supplied in Australia, whether manufactured in Australia or elsewhere; or (iv) exported from Australia. 4 After section 7 Insert: 7AAA Minister may determine that goods are therapeutic goods (1) The Minister may, by legislative instrument, determine that, for the purposes of this Act, specified goods (other than goods declared not to be therapeutic goods under an order in force under section 7 and goods covered by a determination under subsection 7AA(1) or (2) (excluded goods)): (a) are therapeutic goods; or (b) when used, advertised, or presented for supply in a particular way, are therapeutic goods. (2) Before making a determination under subsection (1), the Minister: (a) must have regard to the following matters: (i) whether it is likely that the specified goods, if not regulated under this Act, might harm the health of members of the public; (ii) whether it is appropriate in all the circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by this Act to regulate the specified goods; (iii) whether the kinds of risks from the specified goods to which members of the public might be exposed could be more appropriately dealt with under another regulatory scheme; and (b) may have regard to any other relevant matter. 5 After paragraph 8(1)(b) Insert: (ba) goods in relation to which the Minister is considering making a determination under subsection 7AAA(1) (goods that are therapeutic goods); or Part 2—Regulation of vaping goods Division 1—Main amendments Therapeutic Goods Act 1989 6 Subsection 3(1) Insert: commercial quantity of a kind of vaping goods means the quantity of that kind of vaping goods prescribed by the regulations. evidential burden, in relation to a matter, means the burden of adducing or pointing to evidence that suggests a reasonable possibility that the matter exists or does not exist. 7 Subsection 3(1) (definition of manufacture) After "therapeutic goods", insert ", or vaping goods,". 8 Subsection 3(1) Insert: medical practitioner means a person who is registered or licensed as a medical practitioner under a law of a State or an internal Territory that provides for the registration or licensing of medical practitioners. nurse practitioner means a person who is registered, or authorised (however described) to practise, as a nurse practitioner by or under a law of a State or an internal Territory that provides for the registration of nurse practitioners, or the authorisation of persons to practise as nurse practitioners. pharmacist means a person who is registered as a pharmacist under a law of a State or an internal Territory that provides for the registration of pharmacists. 9 Subsection 3(1) (paragraph (c) of the definition of supply) After "goods", insert "or vaping goods". 10 Subsection 3(1) Insert: unit of vaping goods has the meaning prescribed by the regulations. vaping accessory has the meaning given by section 41P. vaping device has the meaning given by section 41P. vaping goods has the meaning given by section 41P. vaping substance has the meaning given by section 41P. 11 After Chapter 4 Insert: Chapter 4A—Vaping goods Part 4A‑1—Introduction Division 1—Introduction 41N Simplified outline of this Chapter The importation into Australia of vaping goods, and the manufacture, supply or possession of vaping goods in Australia, is prohibited, subject to some exceptions. A person may commit an offence or be liable to a civil penalty for contravening the prohibitions (see Part 4A‑2). Definitions of vaping goods and related terms are set out in Division 2 of this Part. Vaping goods includes vaping substances, vaping accessories, vaping devices and goods determined by the Minister to be vaping goods. The Minister may, by legislative instrument, determine that specified vaping goods, or a specified class of vaping goods, may be supplied or possessed in Australia: (a) by a specified person, or a specified class of persons; and (b) in the circumstances (if any) specified in the determination; and (c) subject to the conditions (if any) specified in the determination (see Part 4A‑3). The Secretary may, on application by a person, give the person consent to manufacture, supply or possess vaping goods. The consent may be given unconditionally or subject to conditions, and in respect of particular vaping goods or classes of vaping goods. In deciding whether to give a consent, the Secretary must comply with the decision‑making principles (if any) determined by the Minister by legislative instrument. A person may commit an offence or be liable to a civil penalty if conditions of a consent are breached (see Part 4A‑3). 41NA Relationship with other Chapters of this Act An offence provision or civil penalty provision in this Chapter does not limit the generality of an offence provision or civil penalty provision in any other Chapter, and those provisions in other Chapters do not limit the generality of offence provisions or civil penalty provisions in this Chapter. Division 2—Interpretation 41P Meaning of vaping goods and related terms (1) In this Act: vaping accessory means a cartridge, capsule, pod or other vessel: (a) that is for use in, or with, a vaping device; and (b) whether or not the cartridge, capsule, pod or other vessel: (i) contains a vaping substance; or (ii) is designed or intended to be refilled. vaping device means: (a) a device (whether or not filled with a vaping substance) that generates or releases, or is designed or intended to generate or release, using a heating element and by electronic means, an aerosol, vapour or mist for direct inhalation by its user; or (b) a device to which paragraph (a) would apply if the device were not temporarily or permanently inoperable, incomplete, damaged or unfinished. Note: Examples of devices that are not vaping devices include the following: (a) humidifiers; (b) diffusers; (c) nebulisers; (d) inhalers. vaping goods means any of the following goods: (a) a vaping substance; (b) a vaping accessory; (c) a vaping device; (d) goods the presentation of which includes an express or implied representation that the goods are of a kind referred to in paragraph (a), (b) or (c); (e) goods that are, or are included in a class of goods that are, determined to be vaping goods under subsection (3). Note: This definition is affected by subsection (2). vaping substance: (a) means: (i) nicotine in solution in any concentration (including in a salt or base form); or (ii) any liquid or other substance for use in, or with, a vaping device; and (b) includes a container (other than a vaping accessory or vaping device), or part of such a container, in which a liquid or other substance referred to in subparagraph (a)(i) or (ii) is present. (2) For the purposes of paragraph (d) of the definition of vaping goods in subsection (1): (a) the presentation of goods includes matters in relation to: (i) the name of the goods; and (ii) the labelling and packaging of the goods; and (iii) any advertising or informational material associated with the use or supply of the goods; and (b) goods are taken to be presented as being a particular kind of goods even if the presentation: (i) is capable of being misleading or confusing as to the content or proper use or identification of the goods; or (ii) suggests that the goods have ingredients, components or characteristics that they do not have. Minister may determine that goods are or are not vaping goods etc. (3) The Minister may, by legislative instrument, determine that, for the purposes of this Act, specified goods or specified classes of goods: (a) are or are not vaping goods; or (b) when used, advertised, or presented for use or supply in a particular way, are or are not vaping goods. Part 4A‑2—Offences and civil penalty provisions relating to vaping goods Division 1—General 41Q Offences and civil penalty provision—importing vaping goods into Australia Offences (1) A person commits an offence if the person imports vaping goods into Australia. Penalty: Imprisonment for 7 years or 5,000 penalty units, or both. Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (2) A person commits an offence of strict liability if the person imports vaping goods into Australia. Penalty: 200 penalty units. Civil penalty provision (3) A person contravenes this subsection if the person imports vaping goods into Australia. Maximum civil penalty: (a) for an individual—7,000 penalty units; and (b) for a body corporate—70,000 penalty units. (4) A person who contravenes subsection (3) commits a separate contravention of that subsection in respect of each unit of vaping goods imported by the person into Australia. Note: For unit of vaping goods, see subsection 3(1). Exception (5) Subsections (1) to (4) do not apply if the importation of the vaping goods is not prohibited under the Customs Act 1901. Note: The person bears an evidential burden in relation to the matter in subsection (5): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act. 41QA Offences and civil penalty provision—manufacturing vaping goods in Australia Offences (1) A person commits an offence if the person manufactures, or carries out a step in the manufacture of, vaping goods in Australia. Penalty: Imprisonment for 7 years or 5,000 penalty units, or both. Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (2) A person commits an offence of strict liability if the person manufactures, or carries out a step in the manufacture of, vaping goods in Australia. Penalty: 200 penalty units. Civil penalty provision (3) A person contravenes this subsection if the person manufactures, or carries out a step in the manufacture of, vaping goods in Australia. Maximum civil penalty: (a) for an individual—7,000 penalty units; and (b) for a body corporate—70,000 penalty units. (4) A person who contravenes subsection (3) commits a separate contravention of that subsection in respect of the manufacture, or the carrying out of the step in the manufacture, by the person of each unit of vaping goods. Note: For unit of vaping goods, see subsection 3(1). Exceptions (5) Subsections (1) to (4) do not apply if: (a) the vaping goods are therapeutic goods; and (b) one of the following subparagraphs applies: (i) the person is the holder of a licence in force under Part 3‑3 that authorises the manufacture of the vaping goods, or the carrying out of the step in the manufacture of the vaping goods, at the manufacturing site where the manufacture, or the step, is carried out; (ii) the person is the holder of a conformity assessment document that applies to the vaping goods; (iii) the Secretary has given the person a consent under subsection 41RC(1) to manufacture the vaping goods, or carry out the step in the manufacture of the vaping goods, and the manufacture, or the step, is carried out in accordance with the consent. Note: The person bears an evidential burden in relation to the matter in subsection (5): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act. 41QB Offences and civil penalty provision—supplying vaping goods Offences (1) A person commits an offence if the person supplies vaping goods in Australia. Penalty: Imprisonment for 7 years or 5,000 penalty units, or both. Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (2) A person commits an offence of strict liability if the person supplies vaping goods in Australia. Penalty: 200 penalty units. Civil penalty provision (3) A person contravenes this subsection if the person supplies vaping goods in Australia. Maximum civil penalty: (a) for an individual—7,000 penalty units; and (b) for a body corporate—70,000 penalty units. (4) A person who contravenes subsection (3) commits a separate contravention of that subsection in respect of each unit of vaping goods supplied by the person in Australia. Note: For unit of vaping goods, see subsection 3(1). Exceptions—general (5) Subsections (1) to (4) do not apply if: (a) subsections (6), (7) and (8) apply in relation to the supply of the vaping goods by the person; or (b) subsections (9), (10) and (11) apply in relation to the supply of the vaping goods by the person. Note: The person bears an evidential burden in relation to the matters in subsections (6), (7) and (8) or subsections (9), (10) and (11): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act. Exceptions—wholesale supply chain (6) This subsection applies in relation to the supply of the vaping goods by the person if: (a) the vaping goods are therapeutic goods that are entered on the Register; or (b) both of the following apply: (i) the vaping goods are therapeutic goods that are exempt goods under regulations made for the purposes of subsection 18(1) or an exempt device under regulations made for the purposes of subsection 41HA(1), and the sponsor has given the Secretary a notice in compliance with the exemption; (ii) the vaping goods 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; or (c) the vaping goods are covered by a determination made by the Minister under section 41R. (7) This subsection applies in relation to the supply of the vaping goods by the person if: (a) the person: (i) is the holder of a licence and a permission, granted under regulations made for the purposes of section 50 of the Customs Act 1901, to import the vaping goods; or (ii) is otherwise approved under those regulations to import the vaping goods; or (b) the person is the holder of a licence in force under Part 3‑3 that authorises a step in the manufacture of the vaping goods; or (c) the person is the holder of a conformity assessment document that applies to the vaping goods; or (d) both of the following apply: (i) the person is a wholesaler who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the supply occurs; (ii) the supply occurs in accordance with the licence or authority; or (e) both of the following apply: (i) the Secretary has given the person a consent under subsection 41RC(1) to supply the vaping goods; (ii) the supply occurs in accordance with the consent; or (f) in the case of vaping goods that are covered by a determination made by the Minister under section 41R: (i) the person is specified in the determination, or is included in a class of persons specified in the determination, in relation to those goods; and (ii) the supply occurs in accordance with the determination. (8) This subsection applies in relation to the supply of the vaping goods by the person if: (a) the person (the recipient) to whom the vaping goods are supplied is the holder of a licence in force under Part 3‑3 of this Act that authorises a step in the manufacture of vaping goods; or (b) the recipient is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; or (c) the Secretary has given the recipient a consent under subsection 41RC(1) to supply the vaping goods; or (d) in the case of vaping goods that are covered by a determination made by the Minister under section 41R—the recipient is specified in the determination, or is included in a class of persons specified in the determination, in relation to those goods. Exceptions—retail supply chain (9) This subsection applies in relation to the supply of the vaping goods by the person if: (a) the vaping goods are therapeutic goods that are entered on the Register; or (b) both of the following apply: (i) the vaping goods are therapeutic goods that are exempt goods under regulations made for the purposes of subsection 18(1) or an exempt device under regulations made for the purposes of subsection 41HA(1), and the sponsor has given the Secretary a notice in compliance with the exemption; (ii) the vaping goods 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; or (c) the vaping goods are covered by a determination made by the Minister under section 41R. (10) This subsection applies in relation to the supply of the vaping goods by the person if: (a) the person is a pharmacist; or (b) the person is a medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the supply occurs. (11) This subsection applies in relation to the supply of the vaping goods by the person if: (a) the supply is: (i) to another person for use by that person for smoking cessation, management of nicotine dependence or another indication determined by the Minister under section 41RA; or (ii) to another person, who is the carer of a third person, for use by the third person for smoking cessation, management of nicotine dependence or another indication determined by the Minister under section 41RA; and (b) if the vaping goods are, or contain, a vaping substance—the vaping substance is in final dosage form; and (c) the supply is: (i) in accordance with this Act (apart from this section); and (ii) consistent with the person's authority to supply the vaping goods under a law of the State or Territory in which the supply occurs. Meaning of final dosage form (12) For the purposes of paragraph (11)(b), a vaping substance is in final dosage form if the vaping substance is in a form that can be administered to a person without any change or modification (other than vaporisation). 41QC Offences and civil penalty provision—possessing at least commercial quantity of vaping goods Offences—possessing at least commercial quantity but less than 100 times commercial quantity (1) A person commits an offence if: (a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity, of that kind of vaping goods. Penalty: Imprisonment for 2 years or 1,000 penalty units, or both. Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (2) Absolute liability applies to paragraph (1)(b). (3) A person commits an offence of strict liability if: (a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity, but less than 100 times the commercial quantity, of that kind of vaping goods. Penalty: 120 penalty units. Offences—possessing at least 100 times commercial quantity but less than 1,000 times commercial quantity (4) A person commits an offence if: (a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least 100 times the commercial quantity, but less than 1,000 times the commercial quantity, of that kind of vaping goods. Penalty: Imprisonment for 4 years or 3,000 penalty units, or both. Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (5) Absolute liability applies to paragraph (4)(b). (6) A person commits an offence of strict liability if: (a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least 100 times the commercial quantity, but less than 1,000 times the commercial quantity, of that kind of vaping goods. Penalty: 240 penalty units. Offences—possessing 1,000 times commercial quantity or more (7) A person commits an offence if: (a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is 1,000 times the commercial quantity, or more, of that kind of vaping goods. Penalty: Imprisonment for 7 years or 5,000 penalty units, or both. Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (8) Absolute liability applies to paragraph (7)(b). (9) A person commits an offence of strict liability if: (a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is 1,000 times the commercial quantity, or more, of that kind of vaping goods. Penalty: 420 penalty units. Civil penalty provision (10) A person contravenes this subsection if: (a) the person possesses a quantity of a kind of vaping goods in Australia; and (b) the quantity is at least the commercial quantity of that kind of vaping goods. Maximum civil penalty: (a) for an individual—7,000 penalty units; and (b) for a body corporate—70,000 penalty units. (11) A person who contravenes subsection (10) in relation to a kind of vaping goods commits a separate contravention of that subsection in respect of each unit of the quantity of vaping goods of that kind possessed by the person in Australia. Note: For unit of vaping goods, see subsection 3(1). Exception—possession for personal use (11A) Subsections (1) to (3) and (10) and (11) do not apply in relation to the possession of a quantity of a kind of vaping goods by the person if: (a) the vaping goods have been lawfully supplied to the person; and (b) the vaping goods are for use by the person personally; and (c) the quantity is less than 5 times the commercial quantity of that kind of vaping goods. Note: The person bears an evidential burden in relation to the matters in subsection (11A): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act. Exceptions—general (12) Subsections (1) to (11) do not apply if subsections (13) and (14) apply in relation to the possession of the vaping goods by the person. Note: The person bears an evidential burden in relation to the matters in subsections (13) and (14): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act. (13) This subsection applies in relation to the possession of the vaping goods by the person if: (a) the vaping goods are therapeutic goods that are entered on the Register; or (b) both of the following apply: (i) the vaping goods are therapeutic goods that are exempt goods under regulations made for the purposes of subsection 18(1) or an exempt device under regulations made for the purposes of subsection 41HA(1), and the sponsor has given the Secretary a notice in compliance with the exemption; (ii) the vaping goods 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; or (c) the vaping goods are covered by a determination made by the Minister under section 41R. (14) This subsection applies in relation to the possession of the vaping goods by the person if: (a) the person: (i) is the holder of a licence and a permission, granted under regulations made for the purposes of section 50 of the Customs Act 1901, to import the vaping goods; or (ii) is otherwise approved under those regulations to import the vaping goods; or (b) the person is the holder of a licence in force under Part 3‑3 of this Act that authorises a step in the manufacture of the vaping goods; or (c) the person is the holder of a conformity assessment document that applies to the vaping goods; or (d) both of the following apply: (i) the person is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the person possesses the goods; (ii) the possession of the goods is in accordance with the licence or authority; or (e) both of the following apply: (i) the Secretary has given the person a consent under subsection 41RC(1) to possess the vaping goods; (ii) the possession is in accordance with the consent; or (f) in the case of vaping goods that are covered by a determination made by the Minister under section 41R: (i) the person is specified in the determination, or is included in a class of persons that is specified in the determination, in relation to those goods; and (ii) the possession is in accordance with the determination. 41QD Offences and civil penalty provision—possessing less than commercial quantity of vaping goods Offences (1) A person commits an offence if: (a) the person is a retailer in relation to retail premises in Australia; and (b) the person possesses a quantity of a kind of vaping goods at the retail premises; and (c) the quantity is less than the commercial quantity of that kind of vaping goods. Penalty: Imprisonment for 12 months or 500 penalty units, or both. Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (2) Absolute liability applies to paragraph (1)(b). (3) A person commits an offence of strict liability if: (a) the person is a retailer in relation to retail premises in Australia; and (b) the person possesses a quantity of a kind of vaping goods at the retail premises; and (c) the quantity is less than the commercial quantity of that kind of vaping goods. Penalty: 60 penalty units. Civil penalty provision (4) A person contravenes this subsection if: (a) the person is a retailer in relation to retail premises in Australia; and (b) the person possesses a quantity of a kind of vaping goods at the retail premises; and (c) the quantity is less than the commercial quantity of that kind of vaping goods. Maximum civil penalty: (a) for an individual—1,000 penalty units; and (b) for a body corporate—10,000 penalty units. (5) A person who contravenes subsection (4) in relation to a kind of vaping goods commits a separate contravention of that subsection in respect of each unit of the quantity of vaping goods of that kind possessed by the person at the retail premises in Australia. Note: For unit of vaping goods, see subsection 3(1). Exceptions—general (6) Subsections (1) to (5) do not apply if subsections (7) and (8) apply in relation to the possession of the vaping goods by the person. Note: The person bears an evidential burden in relation to the matters in subsections (7) and (8): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act. (7) This subsection applies in relation to the possession of the vaping goods by the person if: (a) the vaping goods are therapeutic goods that are entered on the Register; or (b) both of the following apply: (i) the vaping goods are therapeutic goods that are exempt goods under regulations made for the purposes of subsection 18(1) or an exempt device under regulations made for the purposes of subsection 41HA(1), and the sponsor has given the Secretary a notice in compliance with the exemption; (ii) the vaping goods 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; or (c) the vaping goods are covered by a determination made by the Minister under section 41R. (8) This subsection applies in relation to the possession of the vaping goods by the person if: (a) both of the following apply: (i) the person is a pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the person possesses the goods; (ii) the possession of the goods is in accordance with the licence or authority; or (b) both of the following apply: (i) the Secretary has given the person a consent under subsection 41RC(1) to possess the vaping goods; (ii) the possession is in accordance with the consent; or (c) in the case of vaping goods that are covered by a determination made by the Minister under section 41R: (i) the person is specified in the determination, or is included in a class of persons that is specified in the determination, in relation to those goods; and (ii) the possession is in accordance with the determination. Exception—possession for personal use (9) Subsections (1) to (5) do not apply in relation to the possession of a quantity of a kind of vaping goods by the person if: (a) the vaping goods are for use by the person personally; and (b) the quantity is not more than the permitted quantity of that kind of vaping goods. Note: The person bears an evidential burden in relation to the matters in subsection (9): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act. Definitions (10) In this section: permitted quantity of a kind of vaping goods means the quantity of that kind of vaping goods prescribed by the regulations. retailer in relation to retail premises in Australia means any of the following: (a) an owner, lessee or occupier of retail premises in Australia; (b) a person conducting a business or undertaking at, or in connection or association with, retail premises in Australia; (c) a director, officer or agent of a person referred to in paragraph (a) or (b); (d) a person performing work in any capacity (including, but not limited to, an employee or a contractor) for, or on behalf of, a person referred to in paragraph (a), (b) or (c) at, or in connection or association with, retail premises in Australia. retail premises means premises: (a) from which goods or services are available for supply, or are supplied, to a consumer; or (b) that are used in connection with the supply of goods or services to a consumer; (whether or not the premises are used wholly or predominantly for that purpose). Note: For premises, see subsection 3(1). Division 2—Miscellaneous 41QE Exceptions etc. to civil penalty provisions—burden of proof If, in proceedings for a pecuniary penalty order against a person for a contravention of a civil penalty provision in this Chapter, the person wishes to rely on any exception, exemption, excuse, qualification or justification that applies in relation to the civil penalty provision, then the person bears an evidential burden in relation to that matter. Part 4A‑3—Other provisions Division 1—Determinations by Minister 41R Minister may determine that specified vaping goods may be supplied or possessed in Australia in specified circumstances etc. The Minister may, by legislative instrument, determine that specified vaping goods, or a specified class of vaping goods, may be supplied or possessed in Australia: (a) by a specified person, or a specified class of persons; and (b) in the circumstances (if any) specified in the determination; and (c) subject to the conditions (if any) specified in the determination. Note: Conditions may, for example, relate to the value or amount of specified vaping goods or the manner in which specified vaping goods may be supplied. 41RA Minister may determine other indications for which vaping goods may be used The Minister may, by legislative instrument, determine, for the purposes of paragraph 41QB(11)(a), indications (other than smoking cessation or management of nicotine dependence) for which vaping goods may be used. Division 2—Consent of Secretary 41RB Application to Secretary for consent to manufacture, supply or possess vaping goods (1) A person may apply to the Secretary for consent to manufacture, supply or possess vaping goods. (2) An application under subsection (1) must be in accordance with a form approved by the Secretary. Further information (3) The Secretary may, by notice in writing given to the applicant, require the applicant to give to the Secretary, within such reasonable time as is specified in the notice, such further information concerning the application as is specified in the notice. Applications or information may be given electronically (4) An approval of a form referred to in subsection (2), or a notice referred to in subsection (3), may require or permit an application or information to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. 41RC Secretary may give consent (1) If: (a) a person (the applicant) has applied to the Secretary under section 41RB for consent to manufacture, supply or possess vaping goods; and (b) the applicant has complied with any requirements made by the Secretary under subsection 41RB(3) in relation to the application; the Secretary must decide whether to give, or refuse to give, the consent. (2) The Secretary may give a consent under subsection (1): (a) unconditionally or subject to conditions; or (b) in respect of particular vaping goods or classes of vaping goods. Note: A person may commit an offence or be liable to a civil penalty if the person does an act or omits to do an act and the act or omission breaches a condition of a consent given under subsection (1): see section 41RD. (2A) In making a decision under subsection (1), the Secretary must comply with the decision‑making principles (if any) determined under subsection (2B). (2B) The Minister may, by legislative instrument, determine principles (decision‑making principles) that the Secretary must comply with in making a decision under subsection (1). (2C) Without limiting subsection (2B), the decision‑making principles may set out any of the following: (a) circumstances in which a consent under subsection (1) must not be given; (b) matters that must be taken into account in making a decision under subsection (1); (c) matters that must not be taken into account in making a decision under subsection (1); (d) matters that may be taken into account in making a decision under subsection (1). (3) The Secretary must, as soon as practicable after making a decision to give a consent under subsection (1), cause particulars of the decision to be published on the Department's website. (4) If the Secretary decides to refuse to give a consent under subsection (1), the Secretary must, within 28 days after making the decision, notify the applicant in writing of the decision and the reasons for the decision. 41RD Offences and civil penalty provision—breaching condition of a consent Offences (1) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2); and (c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person. Penalty: 2,000 penalty units. Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (2) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2). Penalty: 500 penalty units. (3) A person commits an offence of strict liability if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2). Penalty: 100 penalty units. Civil penalty provision (4) A person contravenes this subsection if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches a condition of a consent imposed under subsection 41RC(2). Maximum civil penalty: (a) for an individual—3,000 penalty units; and (b) for a body corporate—30,000 penalty units. Division 2—Other amendments Therapeutic Goods Act 1989 12 Paragraph 14B(a) After "(13AA)", insert "or 41Q(1) or (2)". 13 Paragraph 14B(a) After "or (3)", insert "or 41Q(3)". 14 Subsection 19(9) Repeal the subsection. 15 Subsection 30EK(6) Repeal the subsection. 16 Subsection 30EL(1) Omit "(1)" (first occurring). 17 Subsection 30EL(2) Repeal the subsection. 18 Subsection 32CM(8) Repeal the subsection. 19 At the end of section 41BG Add: Note: This section applies in relation to vaping goods that are a medical device. 20 Subsection 41HC(7) Repeal the subsection. 21 Section 53A (after table item 33) Insert: 33AA subsection 41RD(1) subsection 41RD(2) 22 Section 54BA (after table item 43) Insert: 43AA Subsection 41Q(1) 43AB Subsection 41QA(1) 43AC Subsection 41QB(1) 43AD Subsection 41QC(1), (4) or (7) 43AE Subsection 41QD(1) 43AF Subsection 41RD(1) 23 After subsection 56A(4A) Insert: (4B) In proceedings for: (a) an offence against a provision of section 41QA, 41QB, 41QC or 41QD; or (b) the contravention of subsection 41QA(3), 41QB(3), 41QC(10) or 41QD(4) (civil penalty provisions); a certificate by the Secretary to the effect that: (c) the Secretary did not consent to the manufacture, supply or possession that is the subject of the proceedings; or (d) the Secretary consented to that manufacture, supply or possession subject to conditions specified in the certificate; is prima facie evidence of the matters specified in the certificate. 24 Subsection 57(10) After "18A(1)", insert "or 41P(3)". 25 Subsection 60(1) (after paragraph (k) of the definition of initial decision) Insert: (ka) refusing to give a consent under subsection 41RC(1), or giving such a consent subject to conditions imposed under subsection 41RC(2); or Division 3—Application and transitional provisions 26 Application of amendments The amendments of the Therapeutic Goods Act 1989 made by this Part apply in relation to acts or omissions that occur on or after the commencement of this Part. Part 3—Advertising relating to vaping goods Division 1—Main amendments Therapeutic Goods Act 1989 27 After Part 5‑1 Insert: Part 5‑1A—Vaping goods Division 1—Preliminary 42DZA This Part not to apply to certain advertisements for exported goods This Part does not apply to advertisements that are solely for vaping goods that have been exported, or are intended exclusively for export, if the advertisements are not available to consumers in Australia. 42DZB Definitions In this Part: generic information, in relation to vaping goods, includes any statement, pictorial representation or design, however made, about the composition, properties or other characteristics of the vaping goods, but does not include: (a) an advertisement about the goods; or (b) generic information included in an advertisement about the goods; or (c) bona fide news. Division 2—General provisions about advertising vaping goods 42DZC Authorised advertisements etc. Secretary may authorise advertising (1) The Secretary may, by legislative instrument, authorise the advertising, or a class of advertising, of specified vaping goods or a specified class of vaping goods. Conditions (4) An authorisation under this section may be subject to conditions specified in the authorisation. (5) Without limiting subsection (4), conditions in an authorisation of advertising may relate to any of the following: (a) the nature of the audience to which the advertising is targeted; (b) the form of the advertising; (c) the content of the advertising; (d) representations or information on: (i) the labels of specified vaping goods or a specified class of vaping goods; or (ii) the packages in which specified vaping goods or a specified class of vaping goods are contained; or (iii) any material included with the package in which specified vaping goods or a specified class of vaping goods are contained. Division 3—Offences and civil penalty provisions 42DZD Offences—no authorisation or conditions of authorisation not complied with (1) A person commits an offence if: (a) the person: (i) advertises, by any means, vaping goods; or (ii) causes the advertising, by any means, of vaping goods; and (b) either: (i) no authorisation under section 42DZC is in force in relation to the advertising; or (ii) an authorisation under section 42DZC is in force in relation to the advertising, but the advertising does not include representations or information as specified in the authorisation, or the advertising is not otherwise in accordance with the authorisation, or the advertising does not comply with a condition to which the authorisation is subject. Penalty: Imprisonment for 7 years or 5,000 penalty units, or both. Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (2) A person commits an offence of strict liability if: (a) the person: (i) advertises, by any means, vaping goods; or (ii) causes the advertising, by any means, of vaping goods; and (b) either: (i) no authorisation under section 42DZC is in force in relation to the advertising; or (ii) an authorisation under section 42DZC is in force in relation to the advertising, but the advertising does not include representations or information as specified in the authorisation, or the advertising is not otherwise in accordance with the authorisation, or the advertising does not comply with a condition to which the authorisation is subject. Penalty: 200 penalty units. Continuing offences (3) A person who contravenes subsection (1) or (2) commits a separate offence in respect of each day (including a day of a conviction for the offence or any later day) during which the contravention continues. (4) The maximum penalty for each day that an offence against subsection (1) or (2) continues is 10% of the maximum pecuniary penalty that can be imposed in respect of that offence. 42DZE Civil penalty—no authorisation or conditions of authorisation not complied with (1) A person contravenes this subsection if: (a) the person: (i) advertises, by any means, vaping goods; or (ii) causes the advertising, by any means, of vaping goods; and (b) either: (i) no authorisation under section 42DZC is in force in relation to the advertising; or (ii) an authorisation under section 42DZC is in force in relation to the advertising, but the advertising does not include representations or information as specified in the authorisation, or the advertising is not otherwise in accordance with the authorisation, or the advertising does not comply with a condition to which the authorisation is subject. Maximum civil penalty: (a) for an individual—7,000 penalty units; and (b) for a body corporate—70,000 penalty units. Continuing contraventions (2) A person who contravenes subsection (1) commits a separate contravention of that subsection in respect of each day during which the contravention continues (including the day the order under subsection 42Y(2) is made or any later day). (3) The maximum civil penalty for each day that a contravention against subsection (1) continues is 10% of the maximum civil penalty that can be imposed in respect of the contravention. Division 4—Secretary may require information or documents 42DZF Secretary may require information or documents Advertisements (1) The Secretary may, by written notice given to a person apparently responsible for advertising vaping goods, or for causing the advertising of vaping goods, require the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to the advertisement. Generic information (2) The Secretary may, by written notice given to a person apparently responsible for disseminating, or for causing the disseminating of, generic information in relation to vaping goods to the public or a section of the public, require the person to give to the Secretary specified information, or to produce to the Secretary specified documents, relating to the dissemination. Manner of compliance (3) The person must give the information, or produce the documents, to the Secretary: (a) within the period, of not less than 14 days after the day the notice is given, specified in the notice or within such longer period as the Secretary allows; and (b) in the form specified in the notice. Note: A person may commit an offence under section 42DZG for failing to comply with the notice or giving false or misleading information or documents and may be liable to a civil penalty under section 42DZH for giving false or misleading information or documents. (4) The form may require or permit the information to be given, or the documents to be produced, in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. Notice not a legislative instrument (5) A notice under subsection (1) or (2) is not a legislative instrument. 42DZG Offences—failing to comply with a notice etc. (1) A person commits an offence if: (a) the person is given a notice under subsection 42DZF(1) or (2); and (b) the person fails to comply with the notice. Penalty: 500 penalty units. (2) A person commits an offence of strict liability if: (a) the person is given a notice under subsection 42DZF(1) or (2); and (b) the person fails to comply with the notice. Penalty: 100 penalty units. (3) A person commits an offence if: (a) the person is given a notice under subsection 42DZF(1) or (2); and (b) the person gives information or produces a document in compliance or purported compliance with the notice; and (c) the information or document is false or misleading in a material particular. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (4) A person commits an offence of strict liability if: (a) the person is given a notice under subsection 42DZF(1) or (2); and (b) the person gives information or produces a document in compliance or purported compliance with the notice; and (c) the information or document is false or misleading in a material particular. Penalty: 100 penalty units. 42DZH Civil penalty—giving false or misleading information or document in compliance with a notice A person contravenes this section if: (a) the person is given a notice under subsection 42DZF(1) or (2); and (b) the person gives information or produces a document in compliance or purported compliance with the notice; and (c) the information or document is false or misleading in a material particular. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. 42DZJ Self‑incrimination (1) A person is not excused from giving information or producing a document under section 42DZF on the ground that the information or the production of the document might tend to incriminate the person or expose the person to a penalty. (2) However, in the case of an individual: (a) the information given or the document produced; and (b) giving the information or producing the document; and (c) any information, document or thing obtained as a direct or indirect consequence of giving the information or producing the document; are not admissible in evidence against the individual: (d) in criminal proceedings, except proceedings for an offence against subsection 42DZG(3) or (4); or (e) in civil proceedings, except proceedings under section 42Y for a contravention of section 42DZH. Division 5—Directions about advertisements or generic information 42DZK Directions about advertisements or generic information Advertisements (1) If, in relation to the advertising of vaping goods, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for advertising the vaping goods, or for causing the advertising of the vaping goods, to do one or more of the following: (a) cease the advertisement; (b) make a retraction; (c) make a correction; (d) recover any advertisement that is still in circulation; (e) destroy the advertisement; (f) cease making a particular claim or representation made by the advertisement. Generic information (2) If, in relation to the dissemination of generic information in relation to vaping goods to the public or a section of the public, the Secretary is satisfied that there has been a contravention of this Act or the regulations, the Secretary may, in writing, direct a person apparently responsible for the dissemination, or for causing the dissemination, to do one or more of the following: (a) withdraw the generic information; (b) make a retraction; (c) make a correction; (d) recover any generic information that is still in circulation; (e) destroy the generic information; (f) cease making a particular claim or representation made by the generic information. Conditions (3) A direction under subsection (1) or (2) may be subject to conditions specified in the direction. (4) Without limiting subsection (3), the conditions may relate to one or more of the following: (a) the period for doing a thing the subject of the direction; (b) in relation to the making of a retraction or correction—either or both of the following: (i) the form and manner of the retraction or correction; (ii) the period for which the retraction or correction must be made publicly available; (c) the reporting to the Secretary of compliance with the direction. Direction not a legislative instrument (5) A direction under subsection (1) or (2) is not a legislative instrument. Publication (6) As soon as practicable after giving a direction under subsection (1) or (2), the Secretary must cause the direction to be published on the Department's website. 42DZL Offences—contravening direction under section 42DZK (1) A person commits an offence if: (a) the Secretary has given a direction to the person under subsection 42DZK(1) or (2) in relation to vaping goods; and (b) the person does an act or omits to do an act; and (c) the act or omission contravenes the direction or a condition of the direction; and (d) either: (i) the use of the vaping goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the vaping goods, if the vaping goods were used, would result in, or would be likely to result in, harm or injury to any person; and (e) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because of the contravention. Penalty: Imprisonment for 5 years or 4,000 penalty units, or both. Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (2) instead: see section 53A. Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (2) A person commits an offence if: (a) the Secretary has given a direction to the person under subsection 42DZK(1) or (2); and (b) the person does an act or omits to do an act; and (c) the act or omission contravenes the direction or a condition of the direction. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (3) A person commits an offence of strict liability if: (a) the Secretary has given a direction to the person under subsection 42DZK(1) or (2); and (b) the person does an act or omits to do an act; and (c) the act or omission contravenes the direction or a condition of the direction. Penalty: 100 penalty units. 42DZM Civil penalty—contravening direction under section 42DZK A person contravenes this section if: (a) the Secretary has given a direction to the person under subsection 42DZK(1) or (2); and (b) the person does an act or omits to do an act; and (c) the act or omission contravenes the direction or a condition of the direction. Maximum civil penalty: (a) for an individual—5,000 penalty units; and (b) for a body corporate—50,000 penalty units. Division 6—Public warning notices 42DZN Secretary may issue a public warning notice (1) The Secretary may issue to the public a written notice containing a warning about vaping goods if: (a) the Secretary reasonably suspects that there has been a contravention of this Act or the regulations in relation to: (i) the advertising of the vaping goods; or (ii) the dissemination of generic information in relation to the vaping goods to the public or a section of the public; and (b) the Secretary is satisfied that it is in the public interest to issue the notice. (2) If: (a) the Secretary has given a person a notice (the substantiation notice) under subsection 42DZF(1) or (2); and (b) the person fails to comply with the substantiation notice; and (c) the Secretary is satisfied that it is in the public interest to issue a notice under this subsection; the Secretary may issue to the public a written notice containing a warning that the person has failed to comply with the substantiation notice, and specifying the matter to which the substantiation notice related. (3) Subsection (2) does not limit subsection (1). (4) A notice under this section is not a legislative instrument. Division 2—Other amendments Therapeutic Goods Act 1989 28 Subsection 3(1) (definition of advertise) After "therapeutic goods", insert "or vaping goods". 29 Section 5A Omit "and sections 22A, 32DO, 41FE", substitute ", sections 22A, 32DO and 41FE, subsections 42DZD(1) and (2) and sections 42DZG, 42DZL". 30 Subparagraph 25(1)(fa)(ii) After "5‑1", insert "or 5‑1A". 31 Paragraphs 30(1)(f) and (fa) After "42DV(1)", insert "or 42DZK(1)". 32 Paragraph 30(1)(fb) After "5‑1", insert "or 5‑1A". 33 Paragraphs 30(2)(eaa) and (eab) After "42DV(1)", insert "or 42DZK(1)". 34 Subparagraph 30(2)(ea)(ii) After "5‑1", insert "or 5‑1A". 35 Subparagraph 31(1)(h)(ii) After "5‑1", insert "or 5‑1A". 36 Subparagraph 31(2)(gaa)(ii) After "5‑1", insert "or 5‑1A". 37 Subparagraph 41FD(h)(ii) After "5‑1", insert "or 5‑1A". 38 Paragraphs 41GL(g) and (ga) After "42DV(1)", insert "or 42DZK(1)". 39 Paragraph 41GL(h) After "5‑1", insert "or 5‑1A". 40 Paragraphs 41GN(1)(i) and (j) After "42DV(1)", insert "or 42DZK(1)". 41 Subparagraph 41GN(1)(k)(ii) After "5‑1", insert "or 5‑1A". 42 Subparagraph 41JA(1)(h)(ii) After "5‑1", insert "or 5‑1A". 43 After section 42AC Insert: 42AD This Part not to apply to advertisements about vaping goods (1) This Part does not apply in relation to advertisements about vaping goods. (2) Part 5‑1A applies in relation to advertisements about vaping goods. 44 After subsection 42DLB(10) Insert: Continuing contraventions (10A) A person who contravenes subsection (1) commits a separate contravention of that subsection in respect of each day during which the contravention continues (including the day the order under subsection 42Y(2) is made or any later day). (10B) The maximum civil penalty for each day that a contravention against subsection (1) continues is 10% of the maximum civil penalty that can be imposed in respect of the contravention. 45 After subsection 42DMA(2) Insert: Continuing contraventions (2A) A person who contravenes subsection (1) commits a separate contravention of that subsection in respect of each day during which the contravention continues (including the day the order under subsection 42Y(2) is made or any later day). (2B) The maximum civil penalty for each day that a contravention against subsection (1) continues is 10% of the maximum civil penalty that can be imposed in respect of the contravention. 46 Section 53A (after table item 33D) Insert: 33E subsection 42DZL(1) subsection 42DZL(2) 47 Secti