21AGeneral criminal offences relating to this Part

#### 21A General criminal offences relating to this Part Offences for making a false or misleading statement (1) A person commits an offence if: (a) the person makes a statement; and (b) the statement is made in or in connection with a certification of any matter under subsection 26A(2) or 26AB(2); and (c) the statement is false or misleading in a material particular; and (d) either: (i) the use of the medicine has resulted in, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the medicine, if the medicine were 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. > Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A. > Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (4) A person commits an offence if: (a) the person makes a statement; and (b) the statement is made in or in connection with a certification of any matter under subsection 26A(2) or 26AB(2); and (c) the statement is false or misleading in a material particular. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (4A) A person commits an offence if: (a) the person makes a statement; and (b) the statement is made in or in connection with a certification of any matter under subsection 26A(2) or 26AB(2); and (c) the statement is false or misleading in a material particular. Penalty: 100 penalty units. (4B) An offence against subsection (4A) is an offence of strict liability. Offences relating to breaching a condition of registration or listing of therapeutic goods (5) A person commits an offence if: (a) therapeutic goods are registered or listed in relation to the person; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the registration or listing of the goods; and (d) 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 (8) instead: see section 53A. > Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (8) A person commits an offence if: (a) therapeutic goods are registered or listed in relation to the person; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the registration or listing of the goods. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (8A) A person commits an offence if: (a) therapeutic goods are registered or listed in relation to the person; and (b) the person does an act or omits to do an act; and (c) the act or omission breaches a condition of the registration or listing of the goods. Penalty: 100 penalty units. (8B) An offence against subsection (8A) is an offence of strict liability. Offences relating to the supply of therapeutic goods in breach of authority etc. (9) A person commits an offence if: (a) the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and (b) the person supplies those goods; and (c) any of the following applies: (i) the supply is not in accordance with the authority; or (ii) the supply is not in accordance with the conditions to which the authority is subject; or (iii) the supply is not in accordance with regulations made for the purpose of subsection 19(7); and (d) either: (i) the use of the 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 goods, if the 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: (i) the supply is not in accordance with the authority; or (ii) the supply is not in accordance with the conditions to which the authority is subject; or (iii) the supply is not in accordance with regulations made for the purpose of subsection 19(7). Penalty: Imprisonment for 5 years or 4,000 penalty units, or both. (9A) A person commits an offence if: (a) the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and (b) the person supplies those goods; and (c) any of the following applies: (i) the supply is not in accordance with the authority; (ii) the supply is not in accordance with the conditions to which the authority is subject; (iii) the supply is not in accordance with regulations made for the purpose of subsection 19(7). Penalty: 500 penalty units. (10) A person commits an offence if: (a) the Secretary has authorised, under subsection 19(5), the person to supply therapeutic goods; and (b) the person supplies those goods; and (c) any of the following applies: (i) the supply is not in accordance with the authority; (ii) the supply is not in accordance with the conditions to which the authority is subject; (iii) the supply is not in accordance with regulations made for the purpose of subsection 19(7). Penalty: 100 penalty units. (11) An offence against subsection (10) is an offence of strict liability. (11A) A person commits an offence if: (a) the person is a health practitioner; and (b) the person is included in a class of health practitioners specified in subsection 19(7A) rules; and (c) the person supplies: (i) therapeutic goods specified in those rules; or (ii) therapeutic goods included in a class of therapeutic goods specified in those rules; and (d) any of the following applies: (i) the supply is not in accordance with those rules; (ii) the supply is not in the circumstances specified in those rules; (iii) the supply is not in accordance with the conditions specified in those rules; and (e) either: (i) the use of the 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 goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and (f) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because: (i) the supply is not in accordance with those rules; or (ii) the supply is not in the circumstances specified in those rules; or (iii) the supply is not in accordance with the conditions specified in those rules. Penalty: Imprisonment for 5 years or 4,000 penalty units, or both. (11C) A person commits an offence if: (a) the person is a health practitioner; and (b) the person is included in a class of health practitioners specified in subsection 19(7A) rules; and (c) the person supplies: (i) therapeutic goods specified in those rules; or (ii) therapeutic goods included in a class of therapeutic goods specified in those rules; and (d) any of the following applies: (i) the supply is not in accordance with those rules; (ii) the supply is not in the circumstances specified in those rules; (iii) the supply is not in accordance with the conditions specified in those rules. Penalty: 500 penalty units. (11D) A person commits an offence if: (a) the person is a health practitioner; and (b) the person is included in a class of health practitioners specified in subsection 19(7A) rules; and (c) the person supplies: (i) therapeutic goods specified in those rules; or (ii) therapeutic goods included in a class of therapeutic goods specified in those rules; and (d) any of the following applies: (i) the supply is not in accordance with those rules; (ii) the supply is not in the circumstances specified in those rules; (iii) the supply is not in accordance with the conditions specified in those rules. Penalty: 100 penalty units. (11E) An offence against subsection (11D) is an offence of strict liability. Offences relating to using therapeutic goods without approval etc. (12) A person commits an offence if: (a) the person uses therapeutic goods; and (b) the goods are used: (i) in the treatment of another person; or (ii) solely for experimental purposes in humans; and (c) the goods are not: (i) exempt goods; or (ii) listed goods; or (iii) registered goods; or (iv) goods exempt under section 18A; or (v) goods that are the subject of an approval under section 19A; and (d) the goods are not used in accordance with: (i) an approval or authority under section 19; or (ii) a condition applicable under regulations made for the purposes of subsection 19(4A); and (e) either: (i) if the person used the goods in the treatment of another person—the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to that person; or (ii) if the person used the goods solely for experimental purposes in humans—the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any of those persons. Penalty: Imprisonment for 5 years or 4,000 penalty units, or both. (12A) A person commits an offence if: (a) the person uses therapeutic goods; and (b) the goods are used: (i) in the treatment of another person; or (ii) solely for experimental purposes in humans; and (c) the goods are not: (i) exempt goods; or (ii) listed goods; or (iii) registered goods; or (iv) goods exempt under section 18A; or (v) goods that are the subject of an approval under section 19A; and (d) the goods are not used in accordance with: (i) an approval or authority under section 19; or (ii) a condition applicable under regulations made for the purposes of subsection 19(4A). Penalty: 500 penalty units. (13) A person commits an offence if: (a) the person uses therapeutic goods; and (b) the goods are used: (i) in the treatment of another person; or (ii) solely for experimental purposes in humans; and (c) the goods are not: (i) exempt goods; or (ii) listed goods; or (iii) registered goods; or (iv) goods exempt under section 18A; or (v) goods that are the subject of an approval under section 19A; and (d) the goods are not used in accordance with: (i) an approval or authority under section 19; or (ii) a condition applicable under regulations made for the purposes of subsection 19(4A). Penalty: 100 penalty units. (14) An offence against subsection (13) is an offence of strict liability.