Document ID: chunk:federal_register_of_legislation:C2024C00632:section:9d:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 9D (pt 2/4)
Character Range: 86460–89099

the goods; and
 (b) the only effect of the variation would be:
 (i) to reduce the class of persons for whom the goods are suitable; or
 (ii) to add a warning, or precaution, that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;
the Secretary must vary the entry in accordance with the request.
 (2A) Subsection (2), to the extent to which it relates to subparagraph (2)(b)(i), applies despite subsection 16(1).
 (2C) If:
 (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary the entry in the Register that relates to the goods; and
 (b) the variation is of a kind specified in the regulations; and
 (c) the conditions (if any) specified in the regulations are satisfied;
the Secretary must vary the entry in accordance with the request.
 (2D) Subsection (2C), to the extent that it relates to therapeutic goods that are registered, applies despite subsection 16(1).
 (3) If:
 (a) the person in relation to whom therapeutic goods are registered or listed has requested the Secretary to vary information included in the entry in the Register that relates to the goods; and
 (b) subsection (2) does not apply to the request; and
 (ba) subsection (2C) does not apply to the request; and
 (c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used;
the Secretary may vary the entry in accordance with the request.
 (3AA) If:
 (a) the person in relation to whom a biological is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the biological; and
 (b) the only effect of the variation would be:
 (i) to reduce the class of persons for whom the biological is suitable; or
 (ii) to add a warning, or precaution, that does not include any comparison of the biological with any other therapeutic goods by reference to quality, safety or efficacy;
the Secretary must vary the entry in accordance with the request.
 (3AC) If:
 (a) the person in relation to whom a biological is included in the Register has requested the Secretary to vary the entry in the Register that relates to the biological; and
 (b) the variation is of a kind specified in the regulations; and
 (c) the conditions (if any) specified in the regulations are satisfied;
the Secretary must vary the entry in accordance with the request.
 (3A) If:
 (a) the person in relation to whom a biological is included in the Register has requested the