Document ID: chunk:federal_register_of_legislation:C2006A00002:clause:1_12
Version: federal_register_of_legislation:C2006A00002
Segment Type: clause
Provision Reference: sch 1 cl 12
Character Range: 5914–6649

12  Before subsection 26B(1)
Insert:

 (1A) A certificate is required under subsection (1) in relation to an application for registration or listing of therapeutic goods only if:
 (a) the applicant is required to submit evidence or information to establish the safety or efficacy of the goods as part of the process of applying for registration or listing; and
 (b) in order to satisfy that requirement, the applicant relies (in whole or in part) on evidence or information that another person submitted to the Secretary:
 (i) to establish the safety or efficacy of other therapeutic goods that have already been registered or listed; and
 (ii) as part of the process of applying for the registration or listing of those other goods.