Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_21a:p3
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 21A (pt 3/4)
Character Range: 33554–36149

(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;