Document ID: chunk:federal_register_of_legislation:C2018A00007:clause:2_16
Version: federal_register_of_legislation:C2018A00007
Segment Type: clause
Provision Reference: sch 2 cl 16
Character Range: 34201–35724

16  Subsections 28(6) and (7)
Repeal the subsections, substitute:
 (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.