Document ID: chunk:federal_register_of_legislation:C2010A00141:clause:2_22
Version: federal_register_of_legislation:C2010A00141
Segment Type: clause
Provision Reference: sch 2 cl 22
Character Range: 32448–33058

22  Before subsection 9D(3A)
Insert:
 (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.