Therapeutic Goods Act 1989
32CPOffences for breaching a condition of an exemption, approval or authority
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32CP Offences for breaching a condition of an exemption, approval or authority
(1) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches: (i) a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or (ii) a condition of an exemption under section 32CB; or (iii) a condition of an approval under section 32CK; or (iv) a condition applicable under regulations made for the purposes of section 32CL; or (v) a condition of an authority under section 32CM; or (vi) a condition of an approval under subsection 32CO(1), (1A) or (2); and (c) the act or omission: (i) except for a breach of a condition referred to in subparagraph (b)(ii)—has resulted in, will result in, or is likely to result in harm or injury to any person; or (ii) for a breach of a condition referred to in subparagraph (b)(ii)—has caused, will cause, or is likely to cause a serious risk to public health.
Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (2) instead: see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
(2) A person commits an offence if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches: (i) a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or (ii) a condition of an exemption under section 32CB; or (iii) a condition of an approval under section 32CK; or (iv) a condition applicable under regulations made for the purposes of section 32CL; or (v) a condition of an authority under section 32CM; or (vi) a condition of an approval under subsection 32CO(1), (1A) or (2).
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(3) A person commits an offence of strict liability if: (a) the person does an act or omits to do an act; and (b) the act or omission breaches: (i) a condition of an exemption applicable under regulations made for the purposes of subsection 32CA(3); or (ii) a condition of an exemption under section 32CB; or (iii) a condition of an approval under section 32CK; or (iv) a condition applicable under regulations made for the purposes of section 32CL; or (v) a condition of an authority under section 32CM; or (vi) a condition of an approval under subsection 32CO(1), (1A) or (2).
Penalty: 100 penalty units.