Statutory Rules 1993   No. 1411

__________________

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 22 June 1993.

 

 BILL HAYDEN

 Governor-General

By His Excellency’s Command,

 

 

ROSEMARY CROWLEY

Minister for Family Services

____________

1.   Commencement

1.1   These Regulations commence on 1 July 1993.

2.   Amendment

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

3.   Schedule 9 (Fees)

3.1   Item 2:

Omit “23 (c)”, substitute “23 (2) (a)”.

3.2   Item 2, paragraph (a):

Omit “300”, substitute “320”.

3.3   Item 2, paragraph (b):

Omit “nil”, substitute “390”.

3.4   Item 2, paragraph (c):

Omit “1,000”, substitute “1,100”.

3.5   Item 2, paragraph (d), column 2:

Omit all the words before subparagraph (i), substitute “subject to paragraphs (e) and (f), if a person submits more than one application at the same time and:”.

3.6   Item 2, paragraph (d), column 3:

Omit “500”, substitute “530”.

3.7   Item 2:

Add at the end:

 

 “(e) if a person submits at the same time more than one application relating to item 4 (c) (i) and (ii):

 (i) each of which relates to goods that contain the same therapeutically active ingredient; and

 (ii) the information in support of each of which is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made;

  for each additional application of less than 50 pages

200

 

 (f) if a person submits at the same time more than one application relating to item 5 and:

 (i) each of which relates to goods that contain the same therapeutically active ingredient; and

 (ii) the information in support of each of which is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made;

  for each additional application

160”.

3.8   After item 2, insert:

“2A

fee for processing (not including evaluation) of data  for the purposes of 32 (3), (4) or (5) of the Act in relation to the variation of an entry in the Register in respect of therapeutic goods :

 

 

 “(a) if the variation is in respect of:

 (i) a drug to which item 4 or 5 applies; or

 (ii) a therapeutic device to which Part 1 of Schedule 3 applies

    320

 

 (b) if the variation is in respect of a therapeutic device to which Part 2 of Schedule 3 applies

     90

 

 (c) if the variation is in respect of the listing of therapeutic goods

90”.

3.9   Item 3, column 2:

Omit “23 (c)”, substitute “23 (2) (a)”.

3.10   Item 3, column 3:

Omit “60”, substitute “90”.

3.11   Item 4, subparagraph (a) (i):

Omit “3,000”, substitute “3,200”.

3.12   Item 4, subparagraph (a) (ii):

Omit “9,600”, substitute “10,200”.


3.13   Item 4, subparagraph (a) (iii):

Omit “21,600”, substitute “22,900”.

3.14   Item 4, subparagraph (a) (iv):

Omit the subparagraph, substitute:

 

 “(iv) more than 2,000 pages but not more than 5,000 pages

44,500

 

 (v) more than 5,000 pages

54,600”.

3.15   Item 4, subparagraph (b) (i):

Omit “6,000”, substitute “6,400”.

3.16   Item 4, subparagraph (b) (ii):

Omit the subparagraph, substitute:

 

 “(ii) more than 200 pages but not more than 2,000 pages

22,900

 

 (iii) more than 2,000 pages

35,300”.

3.17   Item 4, subparagraph (c) (i):

Omit “350”, substitute “390”.

3.18   Item 4, subparagraph (c) (ii):

Omit “3,480”, substitute “3,700”.

3.19   Item 4, subparagraph (c) (iii):

Omit the subparagraph, substitute:

 

 “(iii) more than 50 pages but not more than 100 pages

8,200

 

 (iv) more than 100 pages

10,600”.

3.20   Item 5:

Omit the item, substitute:

“5

fee for evaluation:

 

 

 (a) for the purposes of subsection 24 (1) of the Act in respect of a drug to which item 4 does not apply;

 1,800

 

 (b) of data for the purposes of subsection 32 (3), (4) or (5) of the Act in relation to an entry in the Register relating to a drug, other than a drug entered in the Register because of payment of a fee specified in item 4”.

390”.

3.21   Item 5A:

Omit “1,700”, substitute “1,800”.

3.22   Item 6:

After “therapeutic device”, insert “to which Part 1 of Schedule 3 applies”.

3.23   Item 6, paragraph (a):

Omit “7,000”, substitute “7,500”.

3.24   Item 6, paragraphs (b) and (c):

Omit “4,000”, substitute “4,300”.

3.25   Item 6, paragraph (d):

Omit “8,000”, substitute “8,500”.

3.26   After item 6, insert:

“6A

fee for evaluation of data for the purposes of  subsection 32 (3), (4) or (5) of the Act in relation to an entry in the Register relating to a therapeutic device to which Part 2 of Schedule 3 applies

390”.

3.27   Item 7:

Omit “registered device”, substitute “therapeutic device to which Part 1 of Schedule 3 applies”.

3.28   Item 7, paragraph (a):

Omit “2,300”, substitute “2,500”.

3.29   Item 7, paragraph (b):

Omit “1,300”, substitute “1,400”.

3.30   Item 7, paragraph (c):

Omit “2,000”, substitute “2,200”.

3.31   Item 7, paragraph (d):

Omit “8,000”, substitute “8,500”.

3.32   Item 8:

Omit “300”, substitute “320”.

3.33   Item 9, subparagraph (a) (i):

Omit “2,400”, substitute “2,600”.


3.34   Item 9, subparagraph (a) (ii):

Omit “1,400”, substitute “1,500”.

3.35   Item 9, subparagraph (b) (i):

Omit “2,400”, substitute “2,600”.

3.36   Item 9, subparagraph (b) (ii):

Omit “1,400”, substitute “1,500”.

3.37   Item 9, subparagraph (c) (i):

Omit “2,400”, substitute “2,600”.

3.38   Item 9, subparagraph (c) (ii):

Omit “1,400”, substitute “1,500”.

3.39   Item 9, subparagraph (d) (i):

Omit “1,200”, substitute “1,300”.

3.40   Item 9, subparagraph (d) (ii):

Omit “800”, substitute “850”.

3.41   Item 9, subparagraph (e) (i):

Omit “1,200”, substitute “1,300”.

3.42   Item 9, subparagraph (e) (ii):

Omit “800”, substitute “850”.

3.43   Item 9, subparagraph (f) (i):

Omit “1,200”, substitute “1,300”.

3.44   Item 9, subparagraph (f) (ii):

Omit “800”, substitute “850”.

3.45   After item 9, insert:

“9A

fee in respect of the evaluation of steps in the manufacture of therapeutic goods under paragraph 25 (1) (g) or (h), 26 (1) (g) or (h), 38 (1) (c), 41 (1) (f) or 58 (3) (b) of the Act by reference to data relating to premises where manufacture of the goods takes place, being data contained in a file that is commonly called the plant master file

2,000”.

 


3.46   Item 12:

Omit all the words in column 2, substitute:

 

“fee for evaluation of data in relation to therapeutic goods specified in Schedule 10 for the purposes of  subsection 32 (3), (4) or (5) of the Act”

 

3.47   Item 14:

Omit “60”, substitute “90”.

3.48   Item 15 (first occurring):

Omit “350”, substitute “390”.

3.49   Item 15 (second occurring), column 1:

Omit “15”, substitute “16”.

_________________________________________________

NOTES

1. Notified in the Commonwealth of Australia Gazette on  25 June 1993.

2. Statutory Rules 1990 No. 394 as amended by 1991 Nos. 84 and 485; 1992 Nos.19, 89, 109, 332, 370  and 430.