Therapeutic Goods Regulations (Amendment) (Cth)

Statutory Rules 1997No. 162 1

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Therapeutic Goods Regulations2 (Amendment)

I, The 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 25 June 1997.

 WILLIAM DEANE

 Governor-General

By His Excellency’s Command,

CHRISTOPHER ELLISON

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 July 1997.

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 the following table:

Paragraph amended	Omit	Substitute
45 (4A) (a) 45 (4A) (b) 45 (4A) (c) 45 (4A) (d) 45 (4A) (e)	2,860 1,665 2,495 10,000 3,360	3,200 1,865 2,790 11,200 3,760

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

Paragraph amended	Omit	Substitute
45 (9) (a) 45 (9) (b) 45 (9) (c) 45 (9) (d)	2,860 1,665 2,495 3,360	3,200 1,865 2,790 3,760

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

Paragraph amended	Omit	Substitute
45 (11) (a) 45 (11) (b) 45 (11) (c) 45 (11) (d)	955 570 830 3,360	1,070 640 930 3,760

4.   Regulation 45A (Charges reduced if annual turnover is not more that $56,000)

4.1   Omit “$50,000”, substitute “$56,000”.

5.   Schedule 9 (Fees)

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

Column 1 Item, paragraph or subparagraph amended	Column 2 Omit	Column 3 Substitute
1 (a) 1 (b) 1 (c) 1 (d) 2 (a) 2 (b) 2 (c) 2 (d) 2 (e) 2 (f) 2 (g) 2AA 2A (a) 2A (b) 2A (c) 3 3AA 4 (a) (i) 4 (a) (ii) 4 (a) (iii) 4 (a) (iv) 4 (a) (v) 4 (b) (i) 4 (b) (ii) 4 (b) (iii) 4 (c) (i) 4 (c) (ii) 4 (c) (iii) 4 (c) (iv) 4 (c) (v) 4 (c) (vi) 5 (a) 5 (b) 5A 6 (a) 6 (b) 6 (c) 6 (d) 6A 6AA 6AB 7 (a) 7 (b) 7 (c) 7 (d) 7 (e) 8 9 (a) (i) (A) 9 (a) (i) (B) 9 (a) (ii) (A) 9 (a) (ii) (B) 9 (b) (i) (A) 9 (b) (i) (B) 9 (b) (ii) (A) 9 (b) (ii) (B) 9 (c) (i) (A) 9 (c) (i) (B) 9 (c) (ii) (A) 9 (c) (ii) (B) 9 (d) (i) (A) 9 (d) (i) (B) 9 (d) (ii) (A) 9 (d) (ii) (B) 9 (e) (i) (A) 9 (e) (i) (B) 9 (e) (ii) (A) 9 (e) (ii) (B) 9 (f) (i) (A) 9 (f) (i) (B) 9 (f) (ii) (A) 9 (f) (ii) (B) 9 (g) (i) (A) 9 (g) (i) (B) 9 (g) (ii) (A) 9 (g) (ii) (B) 9 (h) (i) (A) 9 (h) (i) (B) 9 (h) (ii) (A) 9 (h) (ii) (B) 9 (j) (i) (A) 9 (j) (i) (B) 9 (j) (ii) (A) 9 (j) (ii) (B) 9A 14 (a) 14 (b) 14A	800 10,100 7,000 800 380 500 1,300 630 250 200 380 380 380 200 200 200 200 3,800 12,000 27,000 52,500 65,000 7,500 27,000 42,000 500 4,400 9,600 13,120 21,100 29,200 2,200 500 2,200 8,800 5,000 5,000 10,000 500 120 120 2,900 1,700 2,500 10,000 3,360 380 1,400 1,800 450 600 1,400 1,800 450 600 2,700 3,400 800 1,100 2,700 3,400 800 1,100 1,400 1,800 450 600 1,400 1,800 450 600 1,400 1,800 450 600 1,400 1,800 450 600 1,400 1,800 450 600 4,000 175 300 175	900 11,310 7.840 900 430 560 1,460 710 280 220 430 430 430 220 220 220 220 4,260 13,440 30,240 58,800 72,800 8,400 30,240 47,040 560 4,930 10,750 14,695 23,630 32,700 2,460 560 2,460 9,860 5,600 5,600 11,200 560 130 130 3,250 1,900 2,800 11,200 3,760 430 1,570 2,020 500 670 1,570 2,020 500 670 3,020 3,810 900 1,230 3,020 3,810 900 1,230 1,570 2,020 500 670 1,570 2,020 500 670 1,570 2,020 500 670 1,570 2,020 500 670 1,570 2,020 500 670 4,480 200 340 200

NOTES

1. Notified in the Commonwealth of Australia Gazette on 30 June 1997.

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.