Therapeutic Goods Regulations 1990

A therapeutic goods (priority applicant) determination in relation to a medicine:

comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and

subject to subregulation (2) and regulation 16T, remains in force for 6 months.

If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine 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:

the priority applicant withdraws the application; or

the application lapses in accordance with subsection 24(2) of the Act; or

the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or

the application is finally determined.

See subsection 23B(3) of the Act for when an application passes preliminary assessment.