This regulation is the Therapeutic Goods Legislation Amendment (Fees and Charges) Regulation 2013.

This regulation commences on 1 July 2013.

This regulation is made under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Charges) Act 1989.

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

Therapeutic Goods (Charges) Regulations 1990

1 Amendments of listed provisions—charges

Amendments relating to charges
Item	Provision	Omit	Substitute
1	Subparagraph 3(1)(a)(i)	$1 280	$1 320
2	Subparagraph 3(1)(a)(ii)	$2 520	$2 590
3	Subparagraph 3(1)(a)(iii)	$1 440	$1 480
4	Subparagraph 3(1)(b)(i)	$6 250	$6 430
5	Subparagraph 3(1)(b)(ii)	$3 750	$3 860
6	Subparagraph 3(1)(c)(i)	$910	$940
7	Subparagraph 3(1)(c)(ii)	$1 280	$1 320
8	Subparagraph 3(1)(c)(iii)	$730	$750
9	Subparagraph 3(1A)(a)(i)	$1 280	$1 320
10	Subparagraph 3(1A)(a)(ii)	$2 520	$2 590
11	Subparagraph 3(1A)(a)(iii)	$1 440	$1 480
12	Subparagraph 3(1A)(b)(i)	$6 250	$6 430
13	Subparagraph 3(1A)(b)(ii)	$3 750	$3 860
14	Subparagraph 3(1A)(c)(i)	$910	$940
15	Subparagraph 3(1A)(c)(ii)	$1 280	$1 320
16	Subparagraph 3(1A)(c)(iii)	$730	$750
17	Paragraph 3(1AA)(a)	$580	$600
18	Paragraph 3(1AA)(b)	$5 810	$5 980
19	Paragraph 3(1B)(a)	$70	$80
20	Paragraph 3(1B)(b)	$580	$600
21	Paragraph 3(1B)(c)	$890	$920
22	Paragraph 3(1B)(d)	$1 150	$1 180
23	Paragraphs 3(2)(a) and (b)	$10 900	$11 200
24	Paragraphs 3(2)(c) to (h)	$5 600	$5 760
25	Subparagraph 3(2)(j)(i)	$140 600	$144 700
26	Subparagraph 3(2)(j)(ii)	$6 920	$7 120
27	Paragraphs 3(2)(ja) and (k)	$6 050	$6 230
28	Paragraph 3(2)(l)	$11 800	$12 100
29	Subregulation 3(3), note	$85 900	$88 400

Therapeutic Goods (Medical Devices) Regulations 2002

2 Amendments of listed provisions—fees

Amendments relating to fees
Item	Provision	Omit	Substitute
1	Paragraph 9.4 (2) (b)	$3 520	$3 620
2	Schedule 5, item 1.1	870	900
3	Schedule 5, item 1.2, paragraph (a)	7 560	7 780
4	Schedule 5, item 1.2, paragraph (b)	7 610	7 830
5	Schedule 5, item 1.3, paragraph (a)	46 400	47 700
6	Schedule 5, item 1.3, paragraph (b)	35 700	36 700
7	Schedule 5, item 1.3A, paragraph (a)	26 100	26 900
8	Schedule 5, item 1.3A, paragraph (b)	55 700	57 300
9	Schedule 5, item 1.3A, paragraph (c)	13 600	14 000
10	Schedule 5, item 1.3A, paragraph (d)	3 280	3 380
11	Schedule 5, item 1.3A, paragraph (e)	36 000	37 000
12	Schedule 5, item 1.3A, paragraph (f)	22 900	23 600
13	Schedule 5, item 1.5, paragraphs (a) and (b)	1 150	1 180
14	Schedule 5, item 1.5, paragraphs (c) to (f)	890	920
15	Schedule 5, item 1.7	15 900	16 400
16	Schedule 5, item 1.8	310	320
17	Schedule 5, item 1.9, paragraph (a)	26 000	26 800
18	Schedule 5, item 1.9, paragraph (b)	51 200	52 700
19	Schedule 5, item 1.9, paragraph (c)	35 700	36 700
20	Schedule 5, item 1.9, paragraph (d)	24 900	25 600
21	Schedule 5, item 1.9, paragraph (e)	22 700	23 400
22	Schedule 5, item 1.9, paragraph (f)	19 400	20 000
23	Schedule 5, item 1.9A, paragraph (a)	26 100	26 900
24	Schedule 5, item 1.9A, paragraph (b)	55 700	57 300
25	Schedule 5, item 1.9A, paragraph (c)	13 600	14 000
26	Schedule 5, item 1.9A, paragraph (d)	3 280	3 380
27	Schedule 5, item 1.9A, paragraph (e)	36 000	37 000
28	Schedule 5, item 1.9A, paragraph (f)	22 900	23 600
29	Schedule 5, item 1.10, paragraph (a)	15 600	16 100
30	Schedule 5, item 1.10, paragraph (b)	30 800	31 700
31	Schedule 5, item 1.10, paragraph (c)	21 500	22 100
32	Schedule 5, item 1.10, paragraph (d)	13 600	14 000
33	Schedule 5, item 1.10, paragraph (e)	11 800	12 100
34	Schedule 5, item 1.12	360	370
35	Schedule 5, item 1.13	3 360	3 460
36	Schedule 5, item 1.14	6 170	6 350
37	Schedule 5, item 1.14A	6 010	6 180
38	Schedule 5, item 1.15	390	400
39	Schedule 5, item 1.17	890	920
40	Schedule 5, paragraph 2.1(b)	$360	$370

Therapeutic Goods Regulations 1990

3 Amendments of listed provisions—fees and charges

Amendments relating to fees and charges
Item	Provision	Omit	Substitute
1	Paragraph 43AAJ (1)(b)	$85 900	$88 400
2	Paragraph 45(4A)(a)	$9 580	$9 860
3	Paragraph 45(4A)(b)	$7 970	$8 200
4	Paragraphs 45(4A)(c) and (ca)	$7 710	$7 930
5	Paragraph 45(4A)(d)	$32 100	$33 000
6	Paragraphs 45(4A)(e) and (f)	$7 710	$7 930
7	Paragraphs 45(9)(a) to (e)	$4 790	$4 930
8	Paragraphs 45(11)(a) to (e)	$1 750	$1 800
9	Regulation 45A	$14 000	$15 000
10	Schedule 9, Part 2, item 1A	410	420
11	Schedule 9, Part 2, item 1, paragraph (a)	1 520	1 560
12	Schedule 9, Part 2, item 1, paragraph (b)	18 900	19 400
13	Schedule 9, Part 2, item 1, paragraph (c)	15 900	16 400
14	Schedule 9, Part 2, item 1, paragraph (d)	2 400	2 470
15	Schedule 9, Part 2, item 2, paragraph (a)	1 370	1 410
16	Schedule 9, Part 2, item 2, paragraph (b)	1 280	1 320
17	Schedule 9, Part 2, item 2, paragraph (ba)	42 000	43 200
18	Schedule 9, Part 2, item 2, paragraph (bb)	14 000	14 400
19	Schedule 9, Part 2, item 2, paragraph (bc)	28 000	28 800
20	Schedule 9, Part 2, item 2, paragraph (bd)	25 000	25 700
21	Schedule 9, Part 2, item 2, subparagraph (be)(i)	8 330	8 570
22	Schedule 9, Part 2, item 2, subparagraph (be)(ii)	5 430	5 590
23	Schedule 9, Part 2, item 2, subparagraph (bf)(i)	16 700	17 200
24	Schedule 9, Part 2, item 2, subparagraph (bf)(ii)	10 900	11 200
25	Schedule 9, Part 2, item 2, paragraph (bg)	16 100	16 600
26	Schedule 9, Part 2, item 2, paragraph (bh)	2 640	2 720
27	Schedule 9, Part 2, item 2, paragraph (bi)	16 300	16 800
28	Schedule 9, Part 2, item 2, paragraph (bj)	960	990
29	Schedule 9, Part 2, item 2, paragraph (c)	3 820	3 930
30	Schedule 9, Part 2, item 2, paragraph (d)	1 910	1 970
31	Schedule 9, Part 2, item 2, paragraph (d)	11 100	11 400
32	Schedule 9, Part 2, item 2, paragraph (f)	600	620
33	Schedule 9, Part 2, item 2, paragraph (g)	1 280	1 320
34	Schedule 9, Part 2, item 2, paragraph (h)	640	660
35	Schedule 9, Part 2, item 2AA	580	600
36	Schedule 9, Part 2, item 2A, paragraph (a)	1 480	1 520
37	Schedule 9, Part 2, item 2A, paragraph (b)	1 370	1 410
38	Schedule 9, Part 2, item 2A, paragraph (c)	360	370
39	Schedule 9, Part 2, item 2A, paragraphs (d) to (g)	390	400
40	Schedule 9, Part 2, item 2AB	370	380
41	Schedule 9, Part 2, item 2AC	960	990
42	Schedule 9, Part 2, item 2B	4 790	4 930
43	Schedule 9, Part 2, item 2C	3 830	3 940
44	Schedule 9, Part 2, item 2CA	4 790	4 930
45	Schedule 9, Part 2, item 3, paragraph (a)	390	400
46	Schedule 9, Part 2, item 3, paragraph (b)	720	740
47	Schedule 9, Part 2, item 3AA	580	600
48	Schedule 9, Part 2, item 3AB	140	150
49	Schedule 9, Part 2, item 4, paragraph (a)	168 100	173 000
50	Schedule 9, Part 2, item 4, subparagraphs (aa)(i) and (ii)	56 100	57 700
51	Schedule 9, Part 2, item 4, subparagraph (aa)(iii)	112 000	115 200
52	Schedule 9, Part 2, item 4, paragraph (b)	99 900	102 800
53	Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(i)(a)	33 300	34 300
54	Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(i)(b)	21 600	22 200
55	Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(ii)(a)	33 300	34 300
56	Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(ii)(b)	21 600	22 200
57	Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(iii)(a)	66 600	68 500
58	Schedule 9, Part 2, item 4, sub‑subparagraph (bb)(iii)(b)	43 400	44 700
59	Schedule 9, Part 2, item 4, paragraph (c)	64 100	66 000
60	Schedule 9, Part 2, item 4, paragraph (d)	10 600	10 900
61	Schedule 9, Part 2, item 4, paragraph (g)	65 000	66 900
62	Schedule 9, Part 2, item 4, paragraph (h)	3 830	3 940
63	Schedule 9, Part 2, item 5, paragraph (a)	9 170	9 440
64	Schedule 9, Part 2, item 5, subparagraph (b)(i)	9 170	9 440
65	Schedule 9, Part 2, item 5, subparagraph (b)(ii)	11 800	12 100
66	Schedule 9, Part 2, item 5, subparagraph (b)(iii)	16 100	16 600
67	Schedule 9, Part 2, item 5, subparagraph (b)(iv)	21 400	22 000
68	Schedule 9, Part 2, item 5, subparagraph (b)(v)	32 100	33 000
69	Schedule 9, Part 2, item 5, subparagraph (b)(vi)	42 800	44 000
70	Schedule 9, Part 2, item 5, subparagraph (b)(vii)	64 100	66 000
71	Schedule 9, Part 2, item 5, paragraph (c)	3 310	3 410
72	Schedule 9, Part 2, item 5, subparagraph (d)(i)	3 310	3 410
73	Schedule 9, Part 2, item 5, subparagraph (d)(ii)	11 800	12 100
74	Schedule 9, Part 2, item 5, subparagraph (d)(iii)	16 100	16 600
75	Schedule 9, Part 2, item 5, subparagraph (d)(iv)	21 400	22 000
76	Schedule 9, Part 2, item 5, subparagraph (d)(v)	32 100	33 000
77	Schedule 9, Part 2, item 5, subparagraph (d)(vi)	42 800	44 000
78	Schedule 9, Part 2, item 5, subparagraph (d)(vii)	64 100	66 000
79	Schedule 9, Part 2, item 5A, paragraphs (a) to (f)	4 790	4 930
80	Schedule 9, Part 2, item 5B	15 900	16 400
81	Schedule 9, Part 2, item 6, paragraph (a)	28 100	28 900
82	Schedule 9, Part 2, item 6, paragraphs (b), (c) and (ca)	19 100	19 700
83	Schedule 9, Part 2, item 6, paragraph (d)	32 100	33 000
84	Schedule 9, Part 2, item 6AA	340	350
85	Schedule 9, Part 2, item 6AB	600	620
86	Schedule 9, Part 2, item 6ABA	1 820	1 870
87	Schedule 9, Part 2, item 6AC	1 020	1 050
88	Schedule 9, Part 2, item 6AD, paragraph (a)	19 100	19 700
89	Schedule 9, Part 2, item 6AD, paragraph (b)	4 790	4 930
90	Schedule 9, Part 2, item 6A	1 280	1 320
91	Schedule 9, Part 2, item 6B	3 210	3 300
92	Schedule 9, Part 2, item 6C	6 980	7 180
93	Schedule 9, Part 2, item 6D, paragraph (a)	9 170	9 440
94	Schedule 9, Part 2, item 6D, paragraph (b)	11 800	12 100
95	Schedule 9, Part 2, item 6D, paragraph (c)	16 100	16 600
96	Schedule 9, Part 2, item 6D, paragraph (d)	21 400	22 000
97	Schedule 9, Part 2, item 6D, paragraph (e)	32 100	33 000
98	Schedule 9, Part 2, item 6D, paragraph (f)	42 800	44 000
99	Schedule 9, Part 2, item 6D, paragraph (g)	64 100	66 000
100	Schedule 9, Part 2, item 7, paragraph (a)	9 580	9 860
101	Schedule 9, Part 2, item 7, paragraphs (b), (c) and (ca)	7 970	8 200
102	Schedule 9, Part 2, item 7, paragraph (d)	32 100	33 000
103	Schedule 9, Part 2, item 7, paragraphs (e) and (f)	7 970	8 200
104	Schedule 9, Part 2, item 7A, paragraph (a)	9 170	9 440
105	Schedule 9, Part 2, item 7A, subparagraph (b)(i)	9 170	9 440
106	Schedule 9, Part 2, item 7A, subparagraph (b)(ii)	11 800	12 100
107	Schedule 9, Part 2, item 7A, subparagraph (b)(iii)	16 100	16 600
108	Schedule 9, Part 2, item 7A, subparagraph (b)(iv)	21 400	22 000
109	Schedule 9, Part 2, item 7A, subparagraph (b)(v)	32 100	33 000
110	Schedule 9, Part 2, item 7A, subparagraph (b)(vi)	42 800	44 000
111	Schedule 9, Part 2, item 7A, subparagraph (b)(vii)	64 100	66 000
112	Schedule 9, Part 2, item 7B, paragraph (a)	9 170	9 440
113	Schedule 9, Part 2, item 7B, subparagraph (b)(i)	9 170	9 440
114	Schedule 9, Part 2, item 7B, subparagraph (b)(ii)	11 800	12 100
115	Schedule 9, Part 2, item 7B, subparagraph (b)(iii)	16 100	16 600
116	Schedule 9, Part 2, item 7B, subparagraph (b)(iv)	21 400	22 000
117	Schedule 9, Part 2, item 7B, subparagraph (b)(v)	32 100	33 000
118	Schedule 9, Part 2, item 7B, subparagraph (b)(vi)	42 800	44 000
119	Schedule 9, Part 2, item 7B, subparagraph (b)(vii)	64 100	66 000
120	Schedule 9, Part 2, item 8	890	920
121	Schedule 9, Part 2, item 9, paragraph (a)	580	600
122	Schedule 9, Part 2, item 9, paragraph (b)	1 190	1 220
123	Schedule 9, Part 2, item 9AA	580	600
124	Schedule 9, Part 2, item 9AB	790	810
125	Schedule 9, Part 2, items 9AC and 9ACA	580	600
126	Schedule 9, Part 2, item 9AD, paragraph (a)	1 150	1 180
127	Schedule 9, Part 2, item 9AD, paragraph (b)	9 920	10 200
128	Schedule 9, Part 2, item 9AD, paragraph (c)	22 100	22 700
129	Schedule 9, Part 2, item 9AD, paragraph (d)	29 600	30 500
130	Schedule 9, Part 2, item 9AD, paragraph (e)	46 300	47 600
131	Schedule 9, Part 2, item 9AD, paragraph (f)	61 500	63 300
132	Schedule 9, Part 2, item 9AD, paragraph (g)	74 900	77 100
133	Schedule 9, Part 2, items 9B and 9C	15 900	16 400
134	Schedule 9, Part 2, item 10	140	150
135	Schedule 9, Part 2, items 14 and 14A	310	320
136	Schedule 9, Part 2, item 17, subparagraph (a)(i)	210	220
137	Schedule 9, Part 2, item 17, subparagraph (a)(ii)	260	270
138	Schedule 9, Part 2, item 17, subparagraph (a)(iii)	410	420
139	Schedule 9, Part 2, item 17, subparagraph (a)(iv)	100	110
140	Schedule 9, Part 2, item 17, paragraph (b)	$180	190
141	Schedule 9, Part 2, item 17, paragraph (c)	100	110
142	Schedule 9, Part 2, item 17A, subparagraph (a)(i)	1 050	1 080
143	Schedule 9, Part 2, item 17A, subparagraph (a)(ii)	550	570
144	Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(iii)(A)	790	810
145	Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(iii)(B)	220	230
146	Schedule 9, Part 2, item 17A, subparagraph (a)(iv)	380	390
147	Schedule 9, Part 2, item 17A, subparagraph (a)(v)	270	280
148	Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(A)	210	220
149	Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(B)	260	270
150	Schedule 9, Part 2, item 17A, sub‑subparagraph (a)(vi)(C)	410	420
151	Schedule 9, Part 2, item 17A, paragraph (b)	$180	190
152	Schedule 9, Part 2, item 18	1 930	1 990
153	Schedule 9A, Part 2, items 1, 2 and 3	$950	$980
154	Schedule 9A, Part 2, item 4	$63 400	$65 200
155	Schedule 9A, Part 2, item 5	$126 700	$130 400
156	Schedule 9A, Part 2, item 6	$205 900	$211 900
157	Schedule 9A, Part 2, item 7	$20 500	$21 100
158	Schedule 9A, Part 2, item 8	$950	$980
159	Schedule 9A, Part 2, item 9	$5 810	$5 980
160	Schedule 9A, Part 2, item 10	$15 300	$15 700
161	Schedule 9A, Part 2, item 11	$30 100	$31 000
162	Schedule 9A, Part 2, item 12	$18 900	$19 400
163	Schedule 9A, Part 2, item 13	$14 300	$14 700
164	Schedule 9A, Part 2, item 14	$580	$600
165	Schedule 9A, Part 2, item 16	$22 800	$23 500
166	Schedule 9A, Part 2, item 17	$300	$310