Commonwealth Numbered Regulations

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1991 No. 485 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 12

12. Schedule 9 (Fees)
  12.1   Item 4:
Omit subparagraphs (c) (i) and (ii), substitute:
   "(i)   not more than 10 pages                  350

   (ii)   more than 10 pages but not            2,900

more than 50 pages
   (iii)  more than 50 pages                    6,400".

  12.2   Item 5:
Omit the item, substitute:

"5 evaluation fee for the purposes of subsection 24 (1) of the Act in respect
of:
    (i)   a drug to which item 4 does           1,700

not apply;
    (ii)  modifications to, or variations         350

of, the written information
relating to a drug included in
the Register (other than a drug
included in the Register in
consequence of the payment of a
fee specified in item 4)".
  12.3   Add at the end:

  "15  data submitted for the evaluation          350

of therapeutic devices requiring
total evaluation time not exceeding
half a day". 


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