Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) A person must not set out or cause to be set out, on a container or package that contains therapeutic goods or on a label of goods of that kind, a number that purports to be the registration number or listing number of the goods in relation to a particular person if the number is not that number.
Maximum penalty: 60 penalty units.
(5) A person, being the sponsor of therapeutic goods that are included in the Register, must not, by any means, advertise the goods for an indication other than those accepted in relation to the inclusion of the goods in the Register.
Maximum penalty: 60 penalty units.
(6) A person must not make a claim, by any means, that the person or another person can arrange the supply of therapeutic goods (not being exempt goods or goods exempt under section 18A) that are not registered goods or listed goods.
Maximum penalty: 60 penalty units.
(7) A person is guilty of an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission results in the breach of:
(i) a condition of an exemption applicable under regulations made for the purposes of subsection 18(1); or
(ii) a condition of an approval under section 19; or
(iii) a condition applicable under regulations made for the purposes of subsection 19(4A); or
(iv) a condition of an approval under section 19A.
(7AA) An offence against subsection (7) is punishable on conviction by a fine of not more than 60 penalty units.
(7AB) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to therapeutic goods; and
(b) the goods are exempt under section 18A; and
(c) the act or omission results in the breach of a condition of the exemption; and
(d) the act or omission is likely to cause a serious risk to public health.
Maximum penalty: Imprisonment for 5 years or 2,000 penalty units, or both.
Note 1: A person may commit an offence against subsection 20(2A) or (2C), or contravene section 22AA (a civil penalty provision), by breaching a condition of an exemption of therapeutic goods under section 18A that relates to the importation of the goods.
Note 2: A person may commit an offence against subsection 30H(1) or (3) by breaching a condition of an exemption of therapeutic goods under section 18A that relates to records about the goods.
(7AC) Strict liability applies to paragraph (7AB)(b).
Note: For strict liability, see section 6.1 of the Criminal Code .
(7AD) A person commits an offence if:
(a) the person does an act or omits to do an act in relation to therapeutic goods; and
(b) the goods are exempt under section 18A; and
(c) the act or omission results in the breach of a condition of the exemption.
Maximum penalty: Imprisonment for 4 years or 240 penalty units, or both.
(7AE) Strict liability applies to paragraph (7AD)(b).
Note: For strict liability, see section 6.1 of the Criminal Code .
(7A) A person to whom an authority under subsection 19(5) has been granted must not supply the therapeutic goods to which the authority relates except in accordance with:
(a) the authority; and
(aa) the conditions (if any) to which the authority is subject; and
(b) any regulations made for the purpose of subsection 19(7).
Maximum penalty: 500 penalty units.
(8) A person must not use therapeutic goods, other than exempt goods, listed goods, registered goods, goods exempt under section 18A or goods that are the subject of an approval under section 19A:
(a) for use in the treatment of another person; or
(b) for use solely for experimental purposes in humans;
except in accordance with an approval or authority under section 19 or a condition applicable under regulations made for the purposes of subsection 19(4A).
Maximum penalty: 500 penalty units.
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