Document ID: chunk:federal_register_of_legislation:C2024C00632:section:28:p4
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 28 (pt 4/5)
Character Range: 294522–297100

to the subject goods, with a notice given to the person under subsection 25AA(1B).
 (5B) The listing of a medicine under section 26A or 26AE is subject to a condition that:
 (a) each step in the manufacture of the medicine that is carried out in Australia is carried out by a person who is the holder of a licence to carry out that step or who is exempt from the operation of Part 3‑3 in relation to that step; and
 (b) each step in the manufacture of the medicine that is carried out outside Australia is the subject of a certification in force under subsection 26A(3), 26AB(4) or 28A(2).
 (5C) Subsection (5B) does not apply if the medicine is exempt from the operation of Part 3‑3.
 (6) If in, or in connection with, an application for the listing of therapeutic goods, a claim (other than a claim that is an indication) is made by the applicant in relation to the goods, the listing of the goods is subject to the following conditions:
 (a) a condition that the sponsor of the goods had, at the time when the claim was made, information or evidence that supported the claim and complied with the requirements (if any) specified in a determination made under subsection 26A(2B);
 (b) a condition that the sponsor retains the information or evidence at all times while the goods remain listed;
 (c) a condition that, at any time while the goods remain listed, the sponsor will, if asked to do so by the Secretary, give the information or evidence to the Secretary.
 (7) If:
 (a) a medicine is listed under section 26A; and
 (b) an indication is accepted in relation to the inclusion of the medicine in the Register;
the listing of the medicine is subject to the following conditions:
 (c) a condition that the person in relation to whom the medicine is listed has, at all times while the medicine remains listed, information or evidence that supports the indication and complies with the requirements (if any) specified in a determination under subsection 26A(2B);
 (d) a condition that, at any time while the medicine remains listed, the person will, if asked to do so by the Secretary, give the information or evidence to the Secretary.
 (8) If:
 (a) a medicine is listed under section 26AE; and
 (b) an indication is accepted in relation to the inclusion of the medicine in the Register;
the listing of the medicine is subject to the following conditions:
 (c) a condition that the person in relation to whom the medicine is listed has, at all times while the medicine remains listed, information or evidence that supports the indication;
 (d) a condition that, at any time