Document ID: chunk:federal_register_of_legislation:F2022C00752:reg:5
Version: federal_register_of_legislation:F2022C00752
Segment Type: reg
Provision Reference: reg 5
Character Range: 8110–8942

5  Determination
  Subject to section 6 of this instrument, for the purpose of Industry Innovation and Science Australia (the Board) exercising its power or performing its duty to make a finding pursuant to sections 27B, 27J or 28A of the Industry Research and Development Act 1986, phase 0 clinical trials, phase I clinical trials, phase II clinical trials, phase III clinical trials, pre-market pilot stage clinical trials, and pre-market pivotal stage clinical trials for an unapproved therapeutic good that are:
 (a) notified pursuant to item 3 of Schedule 5A of the Therapeutic Goods Regulations 1990 or item 2.3 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002; or
 (b) approved pursuant to paragraphs 19(1)(b), 32CK(1)(e) or 41HB(1)(e) of the Therapeutic Goods Act 1989;
   are core R&D activities.