Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16y
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16Y
Character Range: 281811–282654

16Y  Revocation of biologicals (priority applicant) determination
 (1) The Secretary may revoke a biologicals (priority applicant) determination in relation to a biological if:
 (a) either:
 (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or
 (ii) the priority applicant has made such an application, but the application does not pass preliminary assessment; and
 (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.
Note: See subsection 32DDA(3) of the Act for when an application passes preliminary assessment.
 (2) The revocation must be by written notice given by the Secretary to the priority applicant.

Part 4—Licensing of manufacturers