Source: https://www.legislation.gov.au/Details/F2004B00178
Timestamp: 2019-12-11 20:55:58
Document Index: 138005747

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 2', 'art 1', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2']

Therapeutic Goods Amendment Regulations 2004 (No. 3)
Details: F2004B00178
- F2004B00178
SR 2004 No. 159 Regulations as made
Therapeutic Goods Amendment Regulations 2004 (No. 3)1
Statutory Rules 2004 No. 1592
These Regulations are the Therapeutic Goods Amendment Regulations 2004 (No. 3).
[1] Subparagraph 42ZCAB (1) (a) (i)
(i) subsection 22 (5) or section 42C, 42DL, 42DM or 42DP of the Act; or
[2] Regulation 45 — amendment of fees
$7 025;
$7 240;
Paragraphs 45 (4A) (b), (c) and (ca)
$5 855;
$6 040;
$23 410;
$24 200;
Paragraph 45 (4A) (e)
Paragraph 45 (4A) (f)
$5 855.
$6 040.
Paragraphs 45 (9) (a), (b), (c), (ca) and (d)
$3 515;
$3 630;
Paragraph 45 (9) (e)
$3 515.
$3 630.
Paragraphs 45 (11) (a), (b), (c), (ca) and (d)
$1 285;
$1 330;
Paragraph 45 (11) (e)
$1 285.
$1 330.
45A Charges reduced if annual turnover is not more than $65 000
[4] Subregulation 45A (1)
[5] Schedule 9, Part 1, subclause 1 (1), before definition of major variation
broadcast media has the meaning given by section 42B of the Act.
[6] Schedule 9, Part 1, subclause 1 (1), after definition of page
primary site means the principal manufacturing premises in the capital city of each State and Territory where human blood and blood components are manufactured.
regional area means an area in a State or Territory other than the metropolitan area of the capital city of that State or Territory.
regional station means a radio station or television station that delivers radio programs or television programs to persons in a regional area only.
specified media has the meaning given by section 42B of the Act.
[7] Schedule 9, Part 1, subclause 1 (2)
(2) For paragraph (a) of item 2A and items 2B and 4 in Part 2, an application for registration, or variation of the registration, of therapeutic goods of a kind mentioned in Part 1 of Schedule 10 is taken to be a submission.
[8] Schedule 9, Part 2, item 2B, column 2
medicine — for each submission
[9] Schedule 9, Part 2, item 4, columns 2 and 3, paragraphs (a) and (b)
one-third of the fee specified in paragraph (a)
(ii) documentation relating to pre-clinical studies; or
two-thirds of the fee specified in paragraph (a)
one-third of the fee specified in paragraph (b) or (g) for an evaluation of that nature
two-thirds of the fee specified in paragraph (b) or (g) for an evaluation of that nature
[10] Schedule 9, Part 2, item 9, paragraph (a)
items 9AB and 9AC),
items 9AB, 9AC and 9ACA),
[11] Schedule 9, Part 2, item 9AB, column 2
[12] Schedule 9, Part 2, item 9AC, column 2
metropolitan site,
[13] Schedule 9, Part 2, after item 9AC
[14] Schedule 9, Part 2, item 10, column 3
[15] Schedule 9, Part 2, item 17
The fee applicable under paragraph (a) plus $120 for each additional hour or part of an hour
[16] Schedule 9, Part 2 — amendment of fees
Item 2, paragraph (ba)
5 670;
5 850;
Item 2A, paragraph (a)
Item 2A, paragraphs (f) and (g)
Items 2B and 2C
Item 4, paragraph (c)
Item 4, paragraph (d)
Item 4, paragraph (e)
Item 4, paragraph (f)
Item 4, paragraph (g)
Item 4, paragraph (h)
Item 5, paragraph (a) and subparagraph (b) (i)
Item 5, paragraph (c) and subparagraph (d) (i)
Item 5A, paragraphs (a) to (f)
Item 6AA
Item 6AB
Item 6AC
Item 6AD, paragraph (a)
Item 6AD, paragraph (b)
Item 6D, paragraph (a)
Item 6D, paragraph (b)
Item 6D, paragraph (c)
Item 6D, paragraph (d)
Item 6D, paragraph (e)
Item 6D, paragraph (f)
Item 6D, paragraph (g)
Item 7A, paragraph (a) and subparagraph (b) (i)
Item 7B, paragraph (a) and subparagraph (b) (i)
1. These Regulations amend 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 Nos. 227, 247 and 369; 1999 Nos. 62, 209 and 324; 2000 Nos. 29, 48, 70, 123, 124, 267 and 358; 2001 Nos. 159, 160, 252 and 343; 2002 Nos. 9, 84, 114, 143, 234, 315 and 345; 2003 Nos. 111, 151, 257, 258, 301 and 361; 2004 Nos. 78 and 127.