Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16x
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16X
Character Range: 280832–281811

16X  Period during which biologicals (priority applicant) determination is in force
 (1) A biologicals (priority applicant) determination in relation to a biological:
 (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and
 (b) subject to subregulation (2) and regulation 16Y, remains in force for 6 months.
 (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:
 (a) the priority applicant withdraws the application; or
 (b) the application lapses in accordance with section 32DH of the Act; or
 (c) the application is finally determined.
Note: See subsection 32DDA(3) of the Act for when an application passes preliminary assessment.