Document ID: chunk:federal_register_of_legislation:C2018A00007:clause:1_9
Version: federal_register_of_legislation:C2018A00007
Segment Type: clause
Provision Reference: sch 1 cl 9
Character Range: 15055–15984

9  Paragraph 25(1)(d)
Repeal the paragraph, substitute:
 (c) unless the application is one referred to in paragraph (d)—whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established; and
 (d) for an application for provisional registration of a medicine:
 (i) whether, based on preliminary clinical data, the safety and efficacy of the medicine for the purposes for which it is to be used have been satisfactorily established; and
 (ii) whether the quality of the medicine for the purposes for which it is to be used has been satisfactorily established; and
 (iii) whether, if the Secretary were to register the medicine, the Secretary is satisfied with the applicant's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that registration would commence; and