Therapeutic Goods Regulations 1990
Sch 9AFees—biologicals
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Schedule 9A—Fees—biologicals
(regulation 43)
Part 1 Interpretation of table
Part 1—Interpretation of table
1 Definitions
1 Definitions
In this table:
major variation, for a biological, means a change to the entry of the biological in the Register for any of the following, other than a change that would result in the biological becoming separate and distinct from other biologicals:
(a) a change requiring submission and evaluation of clinical data;
(c) a new strength;
(d) a new route of administration;
(e) a change in the intended patient group;
(f) a change in dosage.
minor variation, for a biological, means a change to the entry of the biological in the Register that requires the evaluation of quality and manufacturing information, other than a change that is a major variation for the biological or that would result in the biological becoming separate and distinct from other biologicals.
Part 2 Table of fees
Part 2—Table of fees
| Item | Matter | Fee $ |
|---|---|---|
| 1 | Application for inclusion of a Class 1 biological in the Register for paragraph 32DA(2)(d) of the Act | 1,330 for each application |
| 2 | Application for inclusion of a Class 2, Class 3 or Class 4 biological in the Register for paragraph 32DDA(2)(b) of the Act | 1,330 for each application |
| 2AA | Application fee for the purposes of paragraph 32DCA(2)(c) of the Act for an application to include an export only biological in the Register | 1,330 for each application |
| 2A | Application fee for the purposes of paragraph 32DEA(3)(d) of the Act for a biologicals (priority applicant) determination in relation to a biological | 15,880 |
| 3 | Application for a manufacturing licence for paragraph 37(1)(g) of the Act | 1,330 for each application |
| 3A | Fee for a notice and declaration under subregulation 43AAE(2) relating to an exemption from liability to pay an annual charge for inclusion of a biological in the Register for a financial year: | |
| (a) if the notice and declaration relate to not more than 5 entries in the Register |