Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(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.