Document ID: chunk:federal_register_of_legislation:F2024C00531:reg:7:p2
Version: federal_register_of_legislation:F2024C00531
Segment Type: reg
Provision Reference: reg 7 (pt 2/3)
Character Range: 7162–9859

(other than an export only biological) in the Register under Part 3‑2A of the Therapeutic Goods Act 1989 are:
 (a) for a Class 1 biological whose inclusion in the Register is in force at any time during the charge year—$855; and
 (b) for a Class 2, Class 3 or Class 4 biological whose inclusion in the Register is in force at any time during the charge year—$8,500.

Medical devices
 (4) For the purposes of subsection 4(1B) of the Act, the annual charges in respect of the inclusion of kinds of medical devices (other than medical devices produced for export) in the Register under Chapter 4 of the Therapeutic Goods Act 1989 that has effect at any time during the charge year are as follows:
 (a) for a Class I medical device (other than a Class I medical device to which paragraph (b) applies)—$111;
 (b) for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function—$804;
 (c) for a Class IIa medical device or Class IIb medical device—$1,195;
 (d) for a Class III medical device—$1,521;
 (e) for an IVD medical device (of a class other than a Class 4 in‑house IVD medical device)—$867;
 (f) for a Class 4 in‑house IVD medical device—nil.

Licences
 (5) For the purposes of subsection 4(2) of the Act, the annual charge for a licence that is in force at any time during the charge year is as follows:
 (a) for a licence for one or more steps in the manufacture of sterile or non‑sterile therapeutic goods—$5,840;
 (b) for a licence for the manufacture of containers in which therapeutic goods are to be packed—$5,840;
 (c) for a licence for the manufacture of ingredients or components for use in the manufacture of therapeutic goods—$5,840;
 (e) for a licence for the manufacture of herbal or homoeopathic preparations that are not included in a Schedule to the current Poisons Standard (other than Schedule 5 or 6)—$5,840;
 (f) for a licence for the manufacture of human blood and blood components (other than haematopoietic progenitor cells) at manufacturing premises covered by the licence:
 (i) for the principal premises in the capital city of a State or Territory where human blood and blood components are manufactured—$204,297; and
 (ii) for a fixed (non‑mobile) manufacturing site—$10,057;
 (g) for a licence for the manufacture of haematopoietic progenitor cells at manufacturing premises covered by the licence—$8,798;
 (h) for a licence for a single step in 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)