Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) The Secretary may, by written notice given to a person in relation to whom therapeutic goods are included in the Register, suspend the registration or listing of the goods if:
(a) the Secretary is satisfied that:
(i) there is a potential risk of death, serious illness or serious injury if the therapeutic goods continue to be included in the Register; and
(ii) it is likely that the person will, within the period of the suspension, be able to take the action necessary to ensure that the therapeutic goods would not cause a potential risk of death, serious illness or serious injury if the therapeutic goods were to continue to be included in the Register; or
(b) the Secretary is satisfied that it is likely that there are grounds for cancelling the registration or listing of the goods under paragraph 30(1)(da), (e), (ea), (f), (fa), (fb) or (g) or subsection 30(1A), (1C), (1D) or (2).
Notice of proposed suspension in some cases
(2) However, before suspending the registration or listing of the goods because of paragraph (1)(b), the Secretary must:
(a) inform the person by written notice that the Secretary proposes the suspension and set out the reasons for it; and
(b) give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.
(3) The Secretary is not to make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).
(4) A notice under subsection (1) must specify the period of the suspension. The period must not exceed 6 months.
Note: Section 29E deals with when the suspension takes effect and extensions of the suspension.
(5) As soon as practicable after giving a notice under
subsection (1), the Secretary must cause to be published in the Gazette
or on the Department's website a notice setting out particulars of the
suspension.