Document ID: chunk:federal_register_of_legislation:C2024C00632:section:9d:p3
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 9D (pt 3/4)
Character Range: 88861–91480

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 Secretary to vary information included in the entry in the Register that relates to the biological; and
 (aa) subsection (3AA) does not apply to the request; and
 (ab) subsection (3AC) does not apply to the request; and
 (b) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the biological for the purposes for which it is to be used;
the Secretary may vary the entry in accordance with the request.
 (3B) If:
 (a) a particular biological ceases to be a biological because of a determination under subsection 32A(3); and
 (b) the biological is included in the Register under Part 3‑2A;
the Secretary must move the entry relating to the biological from the part of the Register for biologicals to whichever other part of the Register is applicable.
 (3C) If:
 (a) the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the kind of medical device; and
 (b) the only effect of the variation would be:
 (i) to reduce the class of persons for whom the kind of medical device is suitable; or
 (ii) to add a warning, restriction or precaution, that does not include any comparison of the kind of medical device with any other therapeutic goods by reference to quality, safety or performance;
the Secretary must vary the entry in accordance with the request.
 (3CB) If:
 (a) the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary the entry in the Register that relates to the kind of medical device; 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.
 (3D) If:
 (a) the person in relation to whom a kind of medical device is included in the Register has requested the Secretary to vary information included in the entry in the Register that relates to the kind of medical device; and
 (b) subsection (3C) does not apply to the request; and
 (ba) subsection (3CB) 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 performance of the kind of medical device