Therapeutic Goods Regulations 1990

1

Application fee under paragraph 23B(2)(b) of the Act:

(a) for an N1 application

2,077

(b) for an N2 application

2,077

(c) for an N3 application

3,338

(d) for an N4 application

4,876

(e) for an N5 application

7,224

(f) for a C1 (section 23) application

2,077

(g) for a C2 (section 23) application

2,077

(h) for a C3 (section 23) application

2,077

(i) for a C4 (section 23) application

3,338

2

Evaluation fee under subsection 24(1A) of the Act:

(a) for an N1 application

5,133

(b) for an N2 application

7,297

(c) for an N3 application

11,245

(d) for an N4 application

18,699

(e) for an N5 application

27,500

(f) for a C2 (section 23) application

5,133

(g) for a C3 (section 23) application

8,617

(h) for a C4 (section 23) application

11,245

3

If, at the time a person submits an application of a kind mentioned in paragraph (a), (b), (c), (d) or (e) of item 1:

(a) the person also submits an additional application or applications of the same kind; and

(b) each application relates to goods that contain the same therapeutically active ingredient; and

(c) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made;

the application fee under paragraph 23B(2)(b) of the Act for each additional application is:

(d) for an additional N1 application

1,051

(e) for an additional N2 application

1,051

(f) for an additional N3 application

1,676

(g) for an additional N4 application

1,676

(h) for an additional N5 application

1,676

4

If, at the time a person submits an application of a kind mentioned in paragraph (c), (d) or (e) of item 2:

(a) the person also submits an additional application or applications of the same kind; and

(b) each application relates to goods that contain the same therapeutically active ingredient; and

(c) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made;

the evaluation fee under subsection 24(1A) of the Act for each additional application is:

(d) for an additional N3 application

5,696

(e) for an additional N4 application

5,696

(f) for an additional N5 application

5,696

5

Application fee under paragraph 9D(7)(f) of the Act, for any of the following requests in relation to up to 20 entries in the Register:

(a) a C1 (section 9D) application

2,077

(b) a C2 (section 9D) application

7,224

(c) a C3 (section 9D) application

10,706

(d) a C4 (section 9D) application

14,544

7

Fee for providing advice in relation to a registered OTC medicine at the request of the sponsor of the medicine for the purpose of listing the medicine as a pharmaceutical benefit:

(a) if the request does not contain clinical data

2,040

(b) if the request contains clinical data or a justification as to why such data is not needed

10,463