Commonwealth Numbered Regulations

1993 No. 141 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 3

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".