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THERAPEUTIC GOODS ACT 1989 - SECT 41MNB

Criminal offences for breaching a condition of an exemption

             (1)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption; and

                     (d)  the act or omission is likely to cause a serious risk to public health.

Penalty:  Imprisonment for 5 years or 2,000 penalty units, or both.

Note:          For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (2)  Strict liability applies to paragraph (1)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code .

             (3)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Penalty:  Imprisonment for 4 years or 240 penalty units, or both.

             (4)  Strict liability applies to paragraph (3)(b).

Note:          For strict liability, see section 6.1 of the Criminal Code .

             (5)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act in relation to a medical device; and

                     (b)  the device is of a kind covered by an exemption in force under section 41GS; and

                     (c)  the act or omission results in the breach of a condition of the exemption.

Penalty:  60 penalty units.

             (6)  An offence against subsection (5) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code .



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