Therapeutic Goods Act 1989

The Secretary may, by written notice given to a person in relation to whom a biological is included in the Register, suspend the biological from the Register if:

the Secretary is satisfied that:

there is a potential risk of death, serious illness or serious injury if the biological continues to be included in the Register; and

it is likely that the person will, within the period of the suspension, be able to take the action necessary to ensure that the biological would not cause a potential risk of death, serious illness or serious injury if the biological were to continue to be included in the Register; or

the Secretary is satisfied that it is likely that there are grounds for cancelling the entry of the biological from the Register under Division 7 (other than because of paragraph 32GA(1)(a), (d) or (g)).

However, before suspending a biological from the Register because it is likely that there are grounds for cancelling the entry of the biological from the Register under section 32GC, the Secretary must:

inform the person by written notice that the Secretary proposes the suspension and set out the reasons for it; and

invite the person to make written submissions to the Secretary in relation to the proposed suspension within the period specified in the notice (being not less than 28 days after the day the notice is given).

The Secretary must not make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).

A notice under subsection (1) must specify the period of the suspension (which must not exceed 6 months).

Section 32FB deals with when the suspension takes effect and extensions of the suspension.

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.

A notice under subsection (1) is not a legislative instrument.