Document ID: chunk:federal_register_of_legislation:C2024C00632:section:32bd:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 32BD (pt 1/2)
Character Range: 399569–402212

32BD  Criminal offences for supplying a biological
 (1) A person commits an offence if:
 (a) the person supplies in Australia a biological for use in humans; and
 (b) none of the following subparagraphs applies:
 (i) the biological is included in the Register in relation to the person;
 (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);
 (iii) the biological is exempt under section 32CB;
 (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological;
 (v) the biological is the subject of an authority under subsection 32CM(1) or (7A) that covers the supply of the biological by the person;
 (vi) the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person, being an approval covering the supply in Australia of the biological; and
 (c) either:
 (i) the use of the biological has resulted in, will result in, or is likely to result in, harm or injury to any person; or
 (ii) the use of the biological, if the biological were used, would result in, or would be likely to result in, harm or injury to any person.
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 supplies in Australia a biological for use in humans; and
 (b) none of the following subparagraphs applies:
 (i) the biological is included in the Register in relation to the person;
 (ii) the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);
 (iii) the biological is exempt under section 32CB;
 (iv) the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological;
 (v) the biological is the subject of an authority under subsection 32CM(1) or (7A) that covers the supply of the biological by the person;
 (vi) the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person, being an approval covering the supply in Australia of the biological.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
 (4A) A person commits an offence if:
 (a) the person supplies