Therapeutic Goods Regulations 1990

1

Application for inclusion of a Class 1 biological in the Register for paragraph 32DA(2)(d) of the Act

1,394 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

1,394 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

1,394 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

16,642

3

Application for a manufacturing licence for paragraph 37(1)(g) of the Act

1,394 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

537

(b) if the notice and declaration relate to 6 or more entries in the Register

537 for the first 5 entries plus 62 for each additional entry

4

Evaluation of a Class 2 biological for inclusion in the Register for subsection 32DI(1) of the Act:

(a) for a biological in relation to which a biologicals (priority applicant) determination is in place

96,965 for each evaluation

(b) in any other case

92,766 for each evaluation

5

Evaluation of a Class 3 biological for inclusion in the Register for subsection 32DI(1) of the Act:

(a) for a biological in relation to which a biologicals (priority applicant) determination is in place

194,408 for each evaluation

(b) in any other case

185,655 for each evaluation

6

Evaluation of a Class 4 biological for inclusion in the Register for subsection 32DI(1) of the Act:

(a) for a biological in relation to which a biologicals (priority applicant) determination is in place

314,145 for each evaluation

(b) in any other case

301,645 for each evaluation

7

Evaluation of an ingredient or component of a biological under regulation 16GF, for use in multiple biologicals (for which application for registration would later be made)

30,189 for each evaluation

8

Application under subsection 9D(3AA) or (3A) of the Act to vary the entry of a biological in the Register

1,394 for each application

8A

Evaluation of an application under subsection 9D(3AA) of the Act to vary the entry of a biological in the Register

8,507 for each evaluation

9

Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 2 biological in the Register

8,507 for each evaluation

10

Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 3 or Class 4 biological in the Register, if the variation is a minor variation

22,366 for each evaluation

11

Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 3 or Class 4 biological in the Register, if the variation is a major variation

44,000 for each evaluation

11A

Application fee for processing an application for consent under section 14 or 14A of the Act:

(a) for an application relating to goods that are biologicals to which a single entry in the Register relates

611 (for all the goods to which the application relates)

(b) for an application relating to goods that are biologicals to which both of the following apply:

(i) there are separate entries in the Register in relation to the goods;

(ii) the way in which the goods do not conform with a standard applicable to the goods is the same for all the goods

611 for the first entry plus 123 for each additional entry

12

Inspection fee—initial manufacturing audit (Australia and overseas) for paragraphs 32DE (1) (e), 38(1)(c) and 58(3)(b) of the Act

27,500 for each inspection

13

Inspection fee—subsequent Manufacturing Audit (Australia and overseas) for paragraphs 41 (1)(f) and 58(3)(b) of the Act

20,899 for each inspection

14

Inspection fee—in addition to an inspection fee mentioned in item 12 or 13 above for an inspection that is required to be conducted outside Australia

854 for each hour of preparation by each inspector

15

Inspection fee—in addition to an inspection fee mentioned in item 12 or 13 above for an inspection that is required to be conducted outside Australia

Amount of costs and reasonable expenses of travel by each inspector, including costs for accommodation and allowance outside Australia

16

Evaluation fee for subsection 32CK(4) of the Act

33,489 for each evaluation

16AA

Fee for the purposes of paragraph 32CK(9A)(e) of the Act, for a request under subsection 32CK(9A) of the Act to vary the biological specified in an approval to use the biological solely for experimental purposes in humans, or to vary the conditions of such an approval

9,136

16A

Application fee for a request, under subsection 32GD(1) of the Act, for the revocation of the cancellation of an entry of a biological from the Register:

(a) if the request relates to one entry;

196

(b) if the request relates to more than one entry

196 for the first entry plus 62 for each additional entry

16B

Application fee for a request, under subsection 32GDA(1) of the Act, for the revocation of the cancellation of an entry of a biological from the Register:

(a) if the request relates to one entry;

196

(b) if the request relates to more than one entry

196 for the first entry plus 62 for each additional entry

17

Fee for notification required under item 3 of Schedule 5A for a biological to which that Schedule applies:

(a) of intention to sponsor a clinical trial at a trial site using a biological

464

(b) for each notification of an additional trial site or additional trial sites

464