Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_35:p2
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 35 (pt 2/3)
Character Range: 56525–59004

therapeutic goods (other than goods exempt under section 18A); and
 (b) the goods are for supply for use in humans; and
 (c) none of the following applies:
 (i) the goods are exempt goods;
 (ii) the person is an exempt person in relation to the manufacture of the goods;
 (iii) the person is the holder of a licence that is in force that authorises the carrying out of that step in relation to the goods at those premises.

Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

 (5) A person commits an offence if:
 (a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods; and
 (b) the goods are for supply for use in humans; and
 (c) the goods are exempt under section 18A; and
 (d) the person is not the holder of a licence that:
 (i) is in force; and
 (ii) authorises the carrying out of that step in relation to the goods at those premises; and
 (e) 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
 (f) the harm or injury has resulted, will result, or would result, because the person carried out the step in the manufacture of the goods.

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 (9) instead: see section 53A.

 (6) Strict liability applies to paragraph (5)(c).

Note: For strict liability, see section 6.1 of the Criminal Code.

 (7) A person commits an offence if:
 (a) the person, at premises in Australia, carries out a step in the manufacture of therapeutic goods; and
 (b) the goods are for supply for use in humans; and
 (c) the goods are exempt under section 18A; and
 (d) the person is not the holder of a licence that:
 (i) is in force; and
 (ii) authorises the carrying out of that step in relation to the goods at those premises; and
 (e) the use of the goods, if the goods were used, would be likely to result in harm or injury to any person; and
 (f) the harm or injury would be likely to result because the person carried out the step in the manufacture of the goods.

Maximum penalty: 2,000 penalty units.

 (8) Subsection (7) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

 (9) A person commits an offence if: