Document ID: chunk:federal_register_of_legislation:F2022C00752:reg:6
Version: federal_register_of_legislation:F2022C00752
Segment Type: reg
Provision Reference: reg 6
Character Range: 8942–10285

6  Exclusions
  None of the following will be core R&D activities for the purposes of section 5 of this instrument:
 (a) clinical trials of generic products;
 (b) clinical trials of biosimilar medicines;
 (c) pre-clinical trial activities or projects;
 (d) phase IV clinical trials;
 (e) market and post-market stage clinical trials;
 (f) activities that are within the scope of subsection 355-25(2) of the Income Tax Assessment Act 1997;
 (g) activities that are not, or will not be, conducted in accordance with all applicable approvals, regulatory requirements, and standards that are in force at the time the 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 are being conducted.
Note:  For the avoidance of doubt, the inclusion of activities in section 6 of this instrument does not mean these activities are not core R&D activities. Activities listed in paragraphs 6(a), (b) (c), (d) (e), (f) and (g) of this instrument may meet the definition of core R&D activities, but they do not come within the scope of section 5 of this instrument and so an R&D entity will need to demonstrate such activities meet the definition of core R&D activities independently, without the support of this instrument.