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1996 No. 131 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 4

4. Schedule 9 (Fees)
4.1 Item 2:
Omit "if regulation 43A does not apply", substitute "if regulation 43A does
not apply and the application is not an application to which item 2AA
applies".

4.2 After item 2, insert:
  "2AA    Application fee for the purposes of paragraph 23 (2) (a) of

the Act for the registration of therapeutic goods if the
previous registration was cancelled solely because of
failure to pay the annual registration charge and the
application is made within 30 days of the cancellation
380".

4.3 Item 3: Omit "if regulation 43A does not apply", substitute "if regulation
43A does not apply and the application is not an application to which item 3AA
applies".

4.4 After item 3, insert:
  "3AA    Application fee for the purposes of paragraph 23 (2) (a) of

the Act for the listing of therapeutic goods if the previous
listing was cancelled solely because of failure to pay the
annual listing charge and the application is made within 30
days of the cancellation
200".

4.5 After item 6, insert:
  "6AA    fee for evaluation of data to determine whether the

manufacturing and quality control procedures used in the
manufacture of goods, a step in the manufacture of which was
carried out outside Australia, are acceptable for the
purposes of paragraph 25 (1) (g), 26 (1) (g), or 31 (1) (e)
of the Act (in addition to any other fee payable under this
Schedule in relation to an evaluation or assessment of an
application to include therapeutic goods in the Register)
120
  "6AB    fee for evaluation of data for the purposes of subsection 32


(3) , (4) or (5) of the Act in relation to goods if a step in
the manufacture of the goods has been carried out outside
Australia
120".

4.6 Item 9: Omit the item, substitute:
  "9    inspection fee for the purposes of paragraphs 38 (1) (c), 41


(1) (f) and 58 (3) (b) of the Act is as follows:

   (a)  in relation to the manufacture of a single sterile or
non-sterile type of therapeutic device:

        (i)    initial period of inspection (up to 4 hours):
        (A) for inspection within Australia; or            1,400


                (B)  for inspection outside Australia;
         and                                               1,800


        (ii)   each additional period of 2 hours, or in part of 2
hours:
        (A) for inspection within Australia; or              450

        (B) for inspection outside Australia;                600


   (b)  in relation to the manufacture of a single sterile or
non-sterile drug:

        (i)    initial period of inspection (up to 4 hours):
        (A) for inspection within Australia; or            1,400


                (B)  for inspection outside Australia;
        and                                                1,800


        (ii)   each additional period of 2 hours, or a part of 2 hours:
        (A) for inspection within Australia; or              450

        (B) for inspection outside Australia;                600


   (c)  in relation to the manufacture of therapeutic goods, to
which paragraph (a) or (b) does not apply, that are or are
represented to be sterile:

        (i)    initial period of inspection (up to 4 hours):
        (A) for inspection within Australia; or            2,700

        (B) for inspection outside Australia; and          3,400


        (ii)   each additional period of 2 hours, or a part of 2 hours:
        (A) for inspection within Australia; or              800

        (B) for inspection outside Australia;              1,100


   (d)  in relation to the manufacture of therapeutic goods to
which paragraph (a) or (b) does not apply that are not
sterile:

        (i)    initial period of inspection (up to 4 hours):
        (A) for inspection within Australia; or            2,700

        (B) for inspection outside Australia; and          3,400


        (ii)   each additional period of 2 hours, or a part of 2 hours:
        (A) for inspection within Australia; or              800

        (B) for inspection outside Australia;              1,100


   (e)  in relation to a single step in the manufacture of
therapeutic goods:

        (i)    initial period of inspection (up to 4 hours):
        (A) for inspection within Australia; or            1,400

        (B) for inspection outside Australia; and          1,800


        (ii)   each additional period of 2 hours, or a part of 2 hours:
        (A) for inspection within Australia; or              450

        (B) for inspection outside Australia;                600


   (f)  in relation to the manufacture of ingredients or
components for use in the manufacture of therapeutic goods,
and paragraph (e) does not apply:

        (i)    initial period of inspection (up to 4 hours):
        (A) for inspection within Australia; or            1,400

        (B) for inspection outside Australia; and          1,800


        (ii)   each additional period of 2 hours, or a part of 2 hours:
        (A) for inspection within Australia; or              450

        (B) for inspection outside Australia;                600


   (g)  in relation to the manufacture of herbal or homoeopathic
preparations that are not included in a Schedule of the
Poisons Standard:

        (i)    initial period of inspection (up to 4 hours):
        (A) for inspection within Australia; or            1,400

        (B) for inspection outside Australia; and          1,800


        (ii)   each additional period of 2 hours, or a part of 2 hours:
        (A) for inspection within Australia; or              450

        (B) for inspection outside Australia;                600


   (h)  in relation to the manufacture of herbal or homoeopathic
preparations that are included in Schedule 5 or 6 of the
Poisons Standard:

        (i)    initial period of inspection (up to 4 hours):
        (A) for inspection within Australia; or            1,400

        (B) for inspection outside Australia; and          1,800


        (ii)   each additional period of 2 hours, or a part of 2 hours:

                (A)  for inspection within Australia; or 450

                (B)  for inspection outside Australia; 600

   (j)  in relation to the manufacture of diagnostic goods for in
vitro use:

        (i)    initial period of inspection (up to 4 hours):
        (A) for inspection within Australia; or            1,400

        (B) for inspection outside Australia; and          1,800


        (ii)   each additional period of 2 hours, or a part of 2 hours:
        (A) for inspection within Australia; or              450

        (B) for inspection outside Australia                 600".


4.7 Schedule 9 is amended as set out in the following table:
  Column 1               Column 2                       Column 3

  Item, paragraph or      Omit                         Substitute

  2 (a)                    360                           380

  2 (b)                    460                           500

  2 (c)                  1,200                         1,300

  2 (d)                    600                           630

  2 (e)                    230                           250

  2 (f)                    180                           200

  2 (g)                    360                           380

  2A (a)                   360                           380

  2A (b)                   150                           200

  2A (c)                   150                           200

  3                        150                           200

  4 (a) (i)              3,600                         3,800

  4 (a) (ii)            11,400                        12,000

  4 (a) (iii)           25,600                        27,000

  4 (a) (iv)            49,700                        52,500

  4 (a) (v)             61,400                        65,000

  4 (b) (i)              7,100                         7,500

  4 (b) (ii)            25,600                        27,000

  4 (b) (iii)           39,800                        42,000

  4 (c) (i)                460                           500

  4 (c) (ii)             4,200                         4,400

  4 (c) (iii)            9,100                         9,600

  4 (c) (iv)            12,500                        13,120

  4 (c) (v)             20,100                        21,100

  4 (c) (vi)            27,800                        29,200

  5 (a)                  2,100                         2,200

  5 (b)                    460                           500

  5A                     2,100                         2,200

  6 (a)                  8,300                         8,800

  6 (b)                  4,800                         5,000

  6 (c)                  4,800                         5,000

  6 (d)                  9,500                        10,000

  6A                       460                           500

  7 (a)                  2,700                         2,900

  7 (b)                  1,600                         1,700

  7 (c)                  2,400                         2,500

  7 (d)                  9,500                        10,000

  7 (e)                  3,200                         3,360

  8                        360                           380

  9A                     3,200                         4,000

  14 (a)                   150                           175

  14A                      150                           175


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