Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16v
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16V
Character Range: 277460–278237

16V  Application for biologicals (priority applicant) determination
 (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.
 (2) An application under subregulation (1) must:
 (a) be in writing; and
 (b) be in a form approved, in writing, by the Secretary; and
 (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.
 (3) An application under subregulation (1) is taken to not have been made unless:
 (a) the application meets the requirements in subregulation (2); and
 (b) the fee prescribed in item 2A in Part 2 of Schedule 9A for making the application has been paid.