Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) This section applies if:
(a) therapeutic goods of a particular kind are exempt under section 18A; and
(b) a person supplies a batch of goods of that kind; and
(c) the Secretary is satisfied that the goods included in that batch:
(i) do not conform to a standard applicable to goods of that kind; or
(ii) are otherwise not fit to be used for their intended purposes.
(2) The Secretary may, by written notice given to the person, require the person to take steps to recall the goods included in that batch (except any of those goods that cannot be recalled because they have been administered to, or applied in the treatment of, a person).
(3) The notice may specify one or more of the following requirements:
(a) the steps to be taken to recall the goods;
(b) the manner in which the steps are to be taken;
(c) a reasonable period within which the steps are to be taken.
(4) The Secretary must, as soon as practicable after giving the notice, cause particulars of it to be published in the Gazette or on the Department's website.
Written notice is not a legislative instrument
(4A) A written notice given to a person by the Secretary under this section is not a legislative instrument.
Offences
(4B) A person commits an offence if:
(a) the Secretary gives a notice to the person under subsection (2); and
(b) the notice specifies a particular requirement mentioned in subsection (3); and
(c) the person fails to comply with that requirement; and
(d) either:
(i) the use of the goods has resulted in, will result in, or is likely to result in, harm or injury to any person; or
(ii) the use of the goods, if the goods were used, would result in, or would be likely to result in, harm or injury to any person; and
(e) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the person failed to comply with that requirement.
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 (5) instead: see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(5) A person commits an offence if:
(a) the Secretary gives a notice to the person under subsection (2); and
(b) the notice specifies a particular requirement mentioned in subsection (3); and
(c) the person fails to comply with that requirement.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(6) A person commits an offence if:
(a) the Secretary gives a notice to the person under subsection (2); and
(b) the notice specifies a particular requirement mentioned in subsection (3); and
(c) the person fails to comply with that requirement.
(6A) An offence against subsection (6) is an offence of strict liability.
Saving of other laws
(7) This section is not intended to exclude or limit the operation of any other law of the Commonwealth or any law of a State or Territory.