Document ID: chunk:federal_register_of_legislation:F2024C00531:reg:7:p1
Version: federal_register_of_legislation:F2024C00531
Segment Type: reg
Provision Reference: reg 7 (pt 1/3)
Character Range: 4799–7386

7  Annual charges for biologics and some other goods

Registration or listing of non‑grouped therapeutic goods
 (1) For the purposes of subsection 4(1) of the Act, the annual charges for the registration or listing of therapeutic goods (other than grouped therapeutic goods) are:
 (a) for goods whose registration is in force at any time during the charge year and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:
 (i) if the goods are a medicine—$1,881; and
 (iii) in any other case—$2,085; and
 (b) for goods:
 (i) whose registration is in force at any time during the charge year; and
 (ii) that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and
 (iii) that are a biologic;
  $9,148; and
 (c) for goods (other than goods produced for export) the listing of which is in force at any time during the charge year:
 (i) if the goods are a medicine—$1,429; and
 (iii) in any other case—$1,078.
Note: For goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not a biologic, see section 8.

Registration or listing of grouped therapeutic goods
 (2) For the purposes of subsection 4(1A) of the Act, the annual charge for the registration or listing of grouped therapeutic goods is:
 (a) for grouped goods whose registration is in force at any time during the charge year and that are of a kind not mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990:
 (i) if the goods are medicines—$1,881; and
 (iii) in any other case—$2,085; and
 (b) for grouped therapeutic goods:
 (i) whose registration is in force at any time during the charge year; and
 (ii) that are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990; and
 (iii) that are biologics;
  $9,148; and
 (c) for grouped goods (other than goods all of which are produced for export) the listing of which is in force at any time during the charge year:
 (i) if the goods are medicines—$1,429; and
 (iii) in any other case—$1,078.
Note: For grouped therapeutic goods of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 that are not biologics, see section 8.

Biologicals
 (3) For the purposes of subsection 4(1AA) of the Act, the annual charges for inclusion of a biological (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;