Commonwealth Consolidated Acts Commonwealth Consolidated Acts(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.