22General offences relating to this Part

#### 22 General offences relating to this Part (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. Penalty: 60 penalty units. (2) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion; and (d) either: (i) the use of the goods for the advertised indication has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods for the advertised indication, if the goods were so used, would result in, or would be likely to result in, harm or injury to any person. Penalty: Imprisonment for 5 years or 4,000 penalty units, or both. (3) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (5) A person commits an offence if: (a) the person, by any means, advertises therapeutic goods for an indication; and (b) the therapeutic goods are included in the Register; and (c) the indication is not an indication accepted in relation to that inclusion. Penalty: 100 penalty units. (5A) An offence against subsection (5) is an offence of strict liability. (6) A person commits 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 or authority 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; 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: 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 (7) instead: see section 53A. > Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (7) A person commits 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 or authority 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. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (7AA) 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 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 or authority 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. Penalty: 100 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. 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. > Note 3: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (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. 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.