Document ID: chunk:federal_register_of_legislation:C2024C00632:section:31:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 31 (pt 2/5)
Character Range: 363253–365841

a shortage of the medicine in Australia; or
 (ii) if there is a shortage of the medicine in Australia—the shortage; or
 (iii) any decision of the person to permanently discontinue the supply of the medicine in Australia;
 (k) any other matter prescribed by the regulations for the purposes of this paragraph in relation to goods of that kind.
 (1A) If a notice is given under subsection (1) to a person covered by paragraph (1)(ac), then paragraphs (1)(a) to (k) (to the extent to which they are relevant) apply in relation to that part of the period of 5 years before the notice was given during which the therapeutic goods were registered.
 (1B) If:
 (a) a person makes an application under section 23 for the registration of therapeutic goods in accordance with a form referred to in paragraph 23B(2)(a); and
 (aa) the application has passed preliminary assessment; and
 (b) the form is described as a pre‑submission planning form; and
 (c) the person chooses a number of days specified in the form for the purposes of giving information or documents to the Secretary in the event that the person is given a notice under subsection (1) of this section in relation to the application;
then that number of days must be specified in any such notice as the time within which the person must give the required information or documents to the Secretary. The number of days so specified is taken to be a reasonable time for the purposes of subsection (1).
 (1C) If:
 (a) the person in relation to whom therapeutic goods are registered makes a request under subsection 9D(3) in accordance with a form referred to in subsection 9D(6); and
 (b) the form is described as a pre‑submission planning form; and
 (c) the person chooses a number of days specified in the form for the purposes of giving information or documents to the Secretary in the event that the person is given a notice under subsection (1) of this section in relation to the request;
then that number of days must be specified in any such notice as the time within which the person must give the required information or documents to the Secretary. The number of days so specified is taken to be a reasonable time for the purposes of subsection (1).
 (2) The Secretary may, by notice in writing given to a person:
 (aa) who is an applicant for the listing of therapeutic goods; or
 (ab) in relation to whom therapeutic goods are listed; or
 (ac) in relation to whom therapeutic goods were, at any time during the previous 5 years, listed;
require the person to give to the Secretary, within such reasonable time as is specified in