Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) The Secretary may, in writing, impose requirements under this section on a person if:
(a) the person supplies or has supplied therapeutic goods of a particular kind, or a particular batch of therapeutic goods of that kind; and
(b) the Secretary is satisfied that therapeutic goods of that kind, or included in that batch, are, have been or could possibly be, subject to actual or potential tampering.
(2) The requirements may be one or more of the following:
(a) to take specified steps, in the specified manner and within such reasonable period as is specified, to recall therapeutic goods of that kind, or included in that batch, that the person has supplied;
(b) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, that therapeutic goods of that kind, or included in that batch, are, or have been, subject to actual or potential tampering;
(c) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, that therapeutic goods of that kind, or included in that batch, could possibly be subject to actual or potential tampering.
(3) Requirements referred to in paragraph (2)(a) do not apply to therapeutic goods that cannot be recalled because they have been administered to, or applied in the treatment of, a person.
(4) The Secretary must cause to be published in the Gazette or on the Department's website, as soon as practicable after imposing such requirements, a notice setting out particulars of the requirements.
(5) The Secretary may impose requirements under this section whether or not the Secretary has been notified under section 42T.
(6) A person commits an offence if:
(a) the person fails to comply with a requirement under subsection (1) in relation to a supply of therapeutic goods; and
(b) 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
(c) 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 the 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 (6C) instead: see section 53A.
Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(6C) A person commits an offence if the person fails to comply with a requirement under subsection (1) in relation to a supply of therapeutic goods.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(6D) A person commits an offence if the person fails to comply with a requirement under subsection (1) in relation to a supply of therapeutic goods.
(6E) An offence against subsection (6D) is an offence of strict liability.
(7) This section does not prevent the Secretary from taking action under section 29D or 30, Division 6 or 7 of Part 3 - 2A or Division 1 or 2 of Part 4 - 6.