35Criminal offences relating to manufacturing therapeutic goods

#### 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 or 32CB); 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, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and (e) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the person carried out the step in the manufacture of the goods. Penalty: Imprisonment for 5 years or 4,000 penalty units, or both. > Note 1: 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. > Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (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 or 32CB); 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. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (4A) 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 or 32CB); 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. Penalty: 100 penalty units. (4B) An offence against subsection (4A) is an offence of strict liability. (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 or 32CB; 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, will result in, or is likely to result in, harm or injury to any person; or (ii) the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and (f) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the person carried out the step in the manufacture of the goods. Penalty: Imprisonment for 5 years or 4,000 penalty units, or both. > Note 1: 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. > Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA. (9) 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 or 32CB; 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. Penalty: Imprisonment for 12 months or 1,000 penalty units, or both. (10) 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 or 32CB; 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. Penalty: 100 penalty units. (11) An offence against subsection (10) is an offence of strict liability.