Therapeutic Goods Act 1989
32BACriminal offences for importing a biological
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32BA Criminal offences for importing a biological
(1) A person commits an offence if: (a) the person imports into 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 importation into Australia of the biological; (v) the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person; 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 imports into 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 importation into Australia of the biological; (v) the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(4A) A person commits an offence if: (a) the person imports into 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 importation into Australia of the biological; (v) the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person.