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THERAPEUTIC GOODS ACT 1989 - SECT 41MN Criminal offences relating to breaches of conditions

THERAPEUTIC GOODS ACT 1989 - SECT 41MN

Criminal offences relating to breaches of conditions

Offences relating to breaching a condition of the inclusion of a kind of medical device in the Register

  (1)   A person commits an offence if:

  (a)   a kind of medical device is included in the Register in relation to the person; and

  (b)   the person does an act or omits to do an act; and

  (c)   the act or omission breaches a condition of the inclusion of the kind of device in the Register; and

  (d)   the act or omission has resulted in, will result in, or is 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)   a kind of medical device is included in the Register in relation to the person; and

  (b)   the person does an act or omits to do an act; and

  (c)   the act or omission breaches a condition of the inclusion of the kind of device in the Register.

Penalty:   Imprisonment for 12 months or 1,000 penalty units, or both.

  (4A)   A person commits an offence if:

  (a)   a kind of medical device is included in the Register in relation to the person; and

  (b)   the person does an act or omits to do an act; and

  (c)   the act or omission breaches a condition of the inclusion of the kind of device in the Register.

Penalty:   100 penalty units.

  (4B)   An offence against subsection   (4A) is an offence of strict liability.

Offences relating to breaching a condition of a conformity assessment certificate

  (5)   A person commits an offence if:

  (a)   a conformity assessment certificate is issued in respect of the person; and

  (b)   the person does an act or omits to do an act; and

  (c)   the act or omission breaches a condition of the conformity assessment certificate; and

  (d)   the act or omission has resulted in, will result in, or is likely to result in, harm or injury to a person.

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   (8) instead: see section   53A.

  (8)   A person commits an offence if:

  (a)   a conformity assessment certificate is issued in respect of the person; and

  (b)   the person does an act or omits to do an act; and

  (c)   the act or omission breaches a condition of the conformity assessment certificate.

Penalty:   Imprisonment for 12 months or 1,000 penalty units, or both.

  (8A)   A person commits an offence if:

  (a)   a conformity assessment certificate is issued in respect of the person; and

  (b)   the person does an act or omits to do an act; and

  (c)   the act or omission breaches a condition of the conformity assessment certificate.

Penalty:   100 penalty units.

  (8B)   An offence against subsection   (8A) is an offence of strict liability.

Offence relating to breaching a condition of an exemption or approval, or a condition applicable under regulations

  (9)   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 section   41HA; or

  (ii)   a condition of an approval under section   41HB; or

  (iii)   a condition applicable under regulations made for the purposes of subsection   41HB(7); or

  (iv)   a condition of an approval under subsection   41HD(1), (1A) or (2).

Penalty:   60 penalty units.

Offences relating to breaching a condition of a conformity assessment body determination

  (10)   An Australian corporation commits an offence if:

  (a)   the corporation does an act or omits to do an act; and

  (b)   the act or omission breaches a condition referred to in subsection   41EWA(5); and

  (c)   the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

Penalty:   20,000 penalty units.

  (11)   An Australian corporation commits an offence if:

  (a)   the corporation does an act or omits to do an act; and

  (b)   the act or omission breaches a condition referred to in subsection   41EWA(5).

Penalty:   5,000 penalty units.

  (12)   An Australian corporation commits an offence if:

  (a)   the corporation does an act or omits to do an act; and

  (b)   the act or omission breaches a condition referred to in subsection   41EWA(5).

Penalty:   500 penalty units.

  (13)   An offence against subsection   (12) is an offence of strict liability.

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