Commonwealth Numbered Acts Commonwealth Numbered Acts
1 At the end of section 29
Add:
Note: The goods are taken not to be included in the Register while their registration or listing is suspended: see section 29G.
2 After section 29C
Insert:
29D Suspension of registration or listing
(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) or (f) or subsection 30(1A), (1C) 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).
Period of suspension
(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.
Publication in Gazette
(5) As soon as practicable after giving a notice under subsection (1), the Secretary must cause to be published in the Gazette a notice setting out particulars of the suspension.
29E When suspension takes effect etc.
(1) A suspension under section 29D takes effect:
(a) if the notice under subsection 29D(1) states that the suspension is necessary to prevent a potential risk of death, serious illness or serious injury--on the day on which the notice is given to the person; or
(b) in any other case--on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.
(2) The suspension has effect until:
(a) the Secretary revokes it under section 29F; or
(b) the end of:
(i) the period specified in the notice under subsection 29D(4); or
(ii) if the period is extended under subsection (3) of this section, the period as so extended.
Extension of suspension
(3) The Secretary may, by written notice given to the person, extend the period specified in the notice under subsection 29D(4) by a further specified period not exceeding 6 months.
Publication in Gazette
(4) As soon as practicable after giving a notice under subsection (3), the Secretary must cause to be published in the Gazette a notice setting out particulars of the extension.
(1) The Secretary must revoke a suspension under section 29D, by written notice given to the person in relation to whom the therapeutic goods are included in the Register, if the Secretary is satisfied that:
(a) the ground on which the registration or listing of the therapeutic goods was suspended no longer applies; and
(b) there are no other grounds for suspending the registration or listing of the therapeutic goods.
(2) The Secretary's power to revoke the suspension may be exercised:
(a) if the person in relation to whom the therapeutic goods are included in the Register applies in writing to the Secretary; or
(b) on the Secretary's own initiative.
Publication in Gazette
(3) As soon as practicable after giving a notice under subsection (1), the Secretary must cause to be published in the Gazette a notice setting out particulars of the revocation.
Notice of refusal to revoke suspension
(4) If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must:
(a) notify the applicant in writing of his or her decision; and
(b) state in the notice the reasons for the decision.
(1) If the registration or listing of therapeutic goods is suspended under section 29D, the goods are taken, for the purposes of this Act (other than sections 28, 29A, 29AA, 29E, 29F, 30 and 31), not to be included in the Register while the suspension has effect.
Note: Dealing in therapeutic goods that are not included in the Register may be an offence or may contravene a civil penalty provision: see Division 1.
(2) While the suspension has effect, the Secretary's power under section 30 to cancel the registration or listing of the therapeutic goods is not affected.
3 Subsection 30EA(1) (after table item 6)
Insert:
|
6A. |
The registration or listing of the goods has been suspended under this Part |
The person in relation to whom the goods were included in the Register |
4 Section 30ED
After "power to", insert "suspend or".
Note: The heading to section 30ED is altered by omitting " Power of " and substituting " Powers of suspension and ".
5 Paragraph 56A(1)(g)
After "had been", insert "suspended or".
6 Paragraphs 61(4)(b) and (ba)
After "or the", insert "suspension or".
7 Application
The amendment made by item 2 applies in relation to therapeutic goods included in the Register before, on or after the commencement of that item.