Document ID: chunk:federal_register_of_legislation:C2024C00632:section:21a:p4
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 21A (pt 4/5)
Character Range: 174779–177416

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