Commonwealth Consolidated Acts Commonwealth Consolidated ActsOffences 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); and
(c) the statement is false or misleading in a material particular; and
(d) either:
(i) the use of the medicine has resulted in, or will result in, harm or injury to any person; or
(ii) the use of the medicine, if the medicine were used, would result in harm or injury to any person.
Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: 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.
(2) 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); and
(c) the statement is false or misleading in a material particular; and
(d) the use of the medicine, if the medicine were used, would be likely to result in harm or injury to any person.
Maximum penalty: 2,000 penalty units.
(3) Subsection (2) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code .
(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); and
(c) the statement is false or misleading in a material particular.
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
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, or will result in, harm or injury to any person.
Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: 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.
(6) 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 is likely to result in harm or injury to any person.
Maximum penalty: 2,000 penalty units.
(7) Subsection (6) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code .
(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.
Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
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, or will result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would result in harm or injury to any person; and
(e) the harm or injury has resulted, will result, or would 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).
Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(7A) instead: see section 53A.
(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; 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) the use of the goods, if goods were used, would be likely to result in harm or injury to any person; and
(e) the harm or injury 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).
Maximum penalty: 2,000 penalty units.
(11) Subsection (10) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code .
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, or will 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, or will result in, harm or injury to any of those persons.
Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(8) instead: see section 53A.
(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); and
(e) either:
(i) if the person used the goods in the treatment of another person--the use of the goods, if the goods were used, 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, if the goods were used, is likely to result in harm or injury to any of those persons.
Maximum penalty: 2,000 penalty units.
(14) Subsection (13) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code .
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