Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1998No. 247 1

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Therapeutic Goods Regulations2(Amendment)

I, WILLIAM PATRICK DEANE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations under the Therapeutic Goods Act 1989.

Dated 30 July 1998.

 WILLIAM DEANE

 Governor-General

By His Excellency’s Command,

trish worth

Parliamentary Secretary

to the Minister for Health and Family Services

for the Minister for Health and Family Services

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1.   Commencement

1.1   These regulations commence on 1 August 1998.

2.   Amendment

2.1   The Therapeutic Goods Regulations are amended as set out in these regulations.

3.   Regulation 45 (Waiver or reduction of fees)

3.1   Subregulation 45 (4A) is amended as set out in the following table:

Paragraph	Omit	Substitute
45 (4A) (a)	$3,200	$4,800
45 (4A) (b)	$1,865	$2,795
45 (4A) (c)	$2,790	$4,190
45 (4A) (d)	$11,200	$16,800
45 (4A) (e)	$3,760	$5,640

3.2   Subregulations 45 (5), (6) and (7):

Omit the subregulations.

3.3   Subregulation 45 (9) is amended as set out in the following table:

Paragraph	Omit	Substitute
45 (9) (a)	$3,200	$4,800
45 (9) (b)	$1,865	$2,795
45 (9) (c)	$2,790	$4,190
45 (9) (d)	$3,760	$5,640

3.4   Subregulation 45 (11) is amended as set out in the following table:

Paragraph	Omit	Substitute
45 (11) (a)	$1,070	$1,610
45 (11) (b)	$640	$960
45 (11) (c)	$930	$1,390
45 (11) (d)	$3,760	$5,640

4.   Schedule 9 (Fees)

4.1   Item 2, paragraphs (b) and (e):

Omit the paragraphs.

4.2   Schedule 9 is amended as set out in the following table:

Item	Paragraph	Omit	Substitute
1	(a)	900	1,100
1	(b)	11,310	13,500
1	(c)	7,840	9,800
1	(d)	900	1,125
2	(a)	430	540
2	(c)	1,460	1,825
2	(d)	710	890
2	(f)	220	275
2	(g)	430	540
2	(h)	200	300

4.3   Item 2AA:

Omit “430”, substitute “540”.

4.4   Item 2A:

Omit the item, substitute:

“2A	fee for varying an entry in the Register (not including evaluation of data) under subsections 32 (3), (4) or (5) of the Act, if the variation is for:
(a) a registered drug that is mentioned in Part 1 of Schedule 10	500
(b) a registered drug that is mentioned in Part 2 or Part 3 of Schedule 10	540
(c) a listed drug	100
(d) a registered therapeutic device that is mentioned in Part 2 of Schedule 3	300
(e) a registered therapeutic device, other than a device mentioned in paragraph (d)	540
(f) a listed therapeutic device	300”.

4.5   Item 3:

Omit the item, substitute:

“3 application fee for paragraph 23 (2) (a) of the Act for the listing of therapeutic goods (other than for an application to which regulation 43A, or item 3AA applies) if the goods are: (a) listed devices (b) listed drugs 300 270”.

4.6   Item 3AA:

Omit “220”, substitute “270”.

4.7   Item 3A:

Omit the item.

4.8   Item 4:

Omit the item, substitute:

“4	evaluation fee, for subsection 24 (1) of the Act, for therapeutic goods evaluated by the Drug Safety and Evaluation Branch of the Department, for the evaluation of a document: (a) setting out human clinical information, if the document is:
(i) not over 25 pages	5,200
(ii) over 25 pages, but not over 300 pages	16,000
(iii) over 300 pages, but not over 2,000 pages	38,000
(iv) over 2,000 pages, but not over 7,000 pages	70,000
(v) over 7,000 pages, but not over 20,000 pages	80,000
(vi) over 20,000 pages, but not over 40,000 pages	85,000
(vii) over 40,000 pages	90,000
(b) setting out animal toxicological information, if the document is:
(i) not over 25 pages	3,000
(ii) over 25 pages, but not over 200 pages	10,250
(iii) over 200 pages, but not over 2,000 pages	37,000
(iv) over 2,000 pages, but not over 7,000 pages	55,000
(v) over 7,000 pages, but not over 20,000 pages	60,000
(vi) over 20,000 pages	65,000
(c) setting out chemistry, quality control and manufacturing information, if the document is:
(i) not over 10 pages	700
(ii) over 10 pages, but not over 50 pages	6,000
(iii) over 50 pages, but not over 100 pages	13,250
(iv) over 100 pages, but not over 1,000 pages	18,000
(v) over 1,000 pages, but not over 3,000 pages	28,000
(vi) over 3,000 pages, but not over 4,000 pages	37,000
(vii)  over 4,000 pages	45,000”.

4.9   After item 4, insert:

“4A application fee, for subsection 24 (1) of the Act, for a drug to which item 4 applies the lesser of 5,000 and 10% of the relevant fee under item 4”.

4.10   Schedule 9 is amended as set out in the following table:

Item	Omit	Substitute
5A	2,460	3,690
6AA	130	165
6AB	130	165
6A	560	840
8	430	540

4.11   Schedule 9 is amended as set out in the following table:

Item	Paragraph	Omit	Substitute
5	(a)	2,460	3,075
5	(b)	560	700
6	(a)	9,860	14,790
6	(b)	5,600	8,400
6	(c)	5,600	8,400
6	(ca)	5,600	8,400
6	(d)	11,200	16,800
6AC	(a)	2,465.00	4,560
6AC	(b)	1,070.00	1,610
7	(a)	3,250	4,880
7	(b)	1,900	2,850
7	(c)	2,800	4,200
7	(ca)	2,800	4,200
7	(d)	11,200	16,800
7	(e)	3,760	5,640

4.12   Item 9:

Omit the item, substitute:

“9	(a)    fee for paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act for inspection within Australia, per hour, per inspector, for:	355
(i) the manufacture of therapeutic goods; or
(ii) a step in the manufacture of therapeutic goods; or
(iii) the manufacture of ingredients or components for use in the manufacture of therapeutic goods; or
(iv) the manufacture of herbal or homoeopathic preparations; or
(v) the manufacture of diagnostic goods for in vitro use;
(b) fee for paragraphs 38 (1) (c), 41 (1) (f) and 58 (3) (b) of the Act for inspection outside Australia, per hour, per inspector, for inspection of a kind mentioned in paragraph (a):	745”.

4.13   Item 9A:

Omit “4,480”, substitute “5,625”.

4.14   Item 10:

Omit “50”, substitute “70”.

4.15   Item 14:

Omit the item, substitute:

“14 fee for notification of intention to sponsor a clinical trial using a specified drug 200”.

4.16   Item 14A:

Omit “drug”, substitute “device”.

4.17   Item 14A:

Omit “200”, substitute “250”.

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 31 July 1998.

2. Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485; 1992 Nos. 19, 89, 109, 332, 370 and 430; 1993 No. 141; 1994 Nos. 150, 222 and 364; 1995 Nos. 33, 111, 192, 208, 253, 320 and 328; 1996 Nos. 9, 25 (disallowed by the House of Representatives on 10 September 1996), 131, 200 and 208; 1997 Nos. 162, 398, 399, 400 and 401 (disallowed by the Senate on 31 March 1998); 1998 No. 227.