Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 42W

Supply etc. of therapeutic goods that are subject to recall requirements

             (1)  A person commits an offence if:

                     (a)  the person supplies therapeutic goods in Australia; and

                     (b)  either:

                              (i)  the person knows that the therapeutic goods are of a kind, or are included in a batch, in respect of which requirements have been imposed under section 42V, on that person or another person, to recall therapeutic goods; or

                             (ii)  the therapeutic goods are of such a kind, or are included in such a batch, and the person is reckless as to that fact; and

                     (c)  the Secretary has not consented in writing to the supply.

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

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

             (2)  A person commits an offence if:

                     (a)  the person exports therapeutic goods from Australia; and

                     (b)  either:

                              (i)  the person knows that the therapeutic goods are of a kind, or are included in a batch, in respect of which requirements have been imposed under section 42V, on that person or another person, to recall therapeutic goods; or

                             (ii)  the therapeutic goods are of such a kind, or are included in such a batch, and the person is reckless as to that fact; and

                     (c)  the Secretary has not consented in writing to the exportation.

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

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

             (3)  The Secretary must not give consent relating to an exportation unless satisfied that there are exceptional circumstances that justify giving the consent.



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