Document ID: chunk:federal_register_of_legislation:F2024C00531:reg:7:p3
Version: federal_register_of_legislation:F2024C00531
Segment Type: reg
Provision Reference: reg 7 (pt 3/3)
Character Range: 9601–11009

the manufacture of a single human tissue at manufacturing premises covered by the licence—$8,798;
 (i) for a licence for 2 or more steps in the manufacture of human tissues at manufacturing premises covered by the licence—$17,206;
 (j) despite paragraphs (a) to (i)—for a licence for the manufacture of a biological only—nil.

Only highest applicable charge is payable
 (6) If, but for this subsection, more than one charge referred to in subsection (1) or any of paragraphs (5)(a) to (i) would otherwise apply in respect of a charge year in relation to:
 (a) the registration or listing of particular goods; or
 (b) a particular licence;
only the highest applicable charge (other than a charge payable under any of paragraphs (5)(a) to (i) only because biologicals are manufactured) applies in respect of the registration or listing of those goods or in relation to that licence in that year.
Note 1: Under regulation 43AAJ of the Therapeutic Goods Regulations 1990, the annual charge for a licence under Part 3‑3 of the Therapeutic Goods Act 1989 payable by a person whose wholesale turnover of therapeutic goods in a charge year is not more than $118,064 is half the amount mentioned in subsection (5) for the person. The reduction in the annual charge does not apply to a licence for the manufacture of human blood and blood components.
Note 2:  For provisional registration of a medicine, see section 9.