Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16t
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16T
Character Range: 276404–277268

16T  Revocation of therapeutic goods (priority applicant) determination
 (1) The Secretary may revoke a therapeutic goods (priority applicant) determination in relation to a medicine if:
 (a) either:
 (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; 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 16R(2) are no longer satisfied in relation to the medicine.
Note: See subsection 23B(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 3D—Biologicals (priority applicant) determinations