Document ID: chunk:federal_register_of_legislation:C2024C00632:section:15b
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 15B
Character Range: 123159–125274

15B  Application of this Part to a biological
 (1) Subject to this section, this Part does not apply to a biological on and after the commencement of this section.

Biologicals currently included in the Register
 (2) If, immediately before the commencement of this section, therapeutic goods that are a biological were registered goods or listed goods, this Part continues to apply to the biological on and after that commencement until the time the biological is included in the Register under Part 3‑2A.
Note: Section 32DN deals with including the biological under Part 3‑2A.

Pending applications
 (3) If:
 (a) before the commencement of this section, an application was made under this Part for the registration or listing of therapeutic goods that are a biological; and
 (b) immediately before that commencement, the application was not finally determined; and
 (c) the application had not been withdrawn before that commencement;
this Part continues to apply to the biological on and after that commencement until the earliest of the following:
 (d) the time the biological is included in the Register under Part 3‑2A;
 (e) if the application is unsuccessful when it is finally determined—the time the application is finally determined;
 (f) the time the application is withdrawn;
 (g) the time the application lapses.
Note: Section 32DN deals with including the biological under Part 3‑2A.
 (4) For the purposes of this section, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.

Transitional
 (5) This Part applies to a biological on and after the commencement of this section in relation to things done, or omitted to be done, in relation to the biological before the commencement of this section.
 (6) If this Part continues to apply to a biological during a period described in subsection (2) or (3), then this Part also applies to the biological after the end of that period in relation to things done, or omitted to be done, in relation to the biological during that period.