Document ID: chunk:federal_register_of_legislation:C2010A00054:clause:1_32de
Version: federal_register_of_legislation:C2010A00054
Segment Type: clause
Provision Reference: sch 1 cl 32DE
Character Range: 80142–81902

32DE  Evaluation of biologicals
 (1) If an application is made in accordance with section 32DD for a biological to be included in the Register in relation to a person, the Secretary must evaluate the biological for inclusion in the Register, having regard to:
 (a) whether the quality, safety and efficacy of the biological for the purposes for which it is to be used have been satisfactorily established; and
 (b) whether the presentation of the biological is acceptable; and
 (c) whether the biological conforms to any standard applicable to it; and
 (d) whether the biological complies with every requirement (if any) relating to advertising applicable under Part 5‑1 or under the regulations; and
 (e) if a step in the manufacture of the biological has been carried out outside Australia and the biological is not exempt from the operation of Part 3‑3—whether the manufacturing and quality control procedures used in the step are acceptable; and
 (f) if a step in the manufacture of the biological has been carried out in Australia, the biological is not exempt from the operation of Part 3‑3 and the person is not exempt from the operation of that Part in relation to that step—whether that step has been carried out in accordance with that Part; and
 (g) whether the biological contains substances that are prohibited imports for the purposes of the Customs Act 1901; and
 (h) whether all of the manufacturers of the biological are nominated as manufacturers of the biological in the application; and
 (i) such other matters (if any) as the Secretary considers relevant.
 (2) For the purposes of paragraph (1)(e), subsections 25(2), (2E), (2F) and (2G) apply in a way corresponding to the way in which they apply for the purposes of paragraph 25(1)(g).