Document ID: chunk:federal_register_of_legislation:C2024C00632:section:28:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 28 (pt 1/5)
Character Range: 287306–290012

28  Conditions of registration or listing
 (1) The registration or listing of therapeutic goods is subject to the conditions set out in a determination under subsection (2).
 (2) The Minister may, by legislative instrument, make a determination setting out conditions for the purposes of subsection (1), being conditions that relate to:
 (a) the manufacture of the goods; or
 (b) the custody, use, supply, disposal or destruction of the goods; or
 (c) the keeping of records relating to the goods; or
 (d) matters dealt with in, or matters additional to matters dealt with in, standards applicable to the goods; or
 (e) such other matters relating to the goods as the Minister thinks appropriate.
 (2A) Without limiting subsection (2), different conditions may be specified for:
 (a) the registration of therapeutic goods; and
 (aa) the provisional registration of medicine; and
 (b) the listing of therapeutic goods; and
 (c) different classes of therapeutic goods.
 (2AA) Despite subsection 14(2) of the Legislation Act 2003, a determination under subsection (2) of this section may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.
 (2B) If the Secretary includes therapeutic goods in the Register in relation to a person, the Secretary may, by notice in writing given to the person, impose conditions on the registration or listing of those goods.
 (3) The Secretary may, by notice in writing given to the person in relation to whom therapeutic goods are registered or listed, impose new conditions on the registration or listing or vary or remove conditions imposed under subsection (2B) or this subsection.
 (3A) The Secretary's power under subsection (3) may be exercised at the request of the person concerned or of the Secretary's own motion. A request must be accompanied by the prescribed fee.
 (4) The imposition or variation or removal of a condition under subsection (3) takes effect:
 (a) if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the notice is given to the person; or
 (aa) in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day; or
 (ab) in the case of a removal to which paragraph (a) does not apply—on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person