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THERAPEUTIC GOODS ACT 1989 - SECT 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).


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