Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_35:p1
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 35 (pt 1/3)
Character Range: 54251–56750

35  Criminal offences relating to manufacturing therapeutic goods

 (1) A person commits an offence if:
 (a) the person, at premises in Australia, carries out a step in the manufacture of 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; 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 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 (4) instead: see section 53A.

 (2) A person commits an offence if:
 (a) the person, at premises in Australia, carries out a step in the manufacture of 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; and
 (d) the use of the goods, if the 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 the person carried out the step in the manufacture of the goods.

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, at premises in Australia, carries out a step in the manufacture of 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