Commonwealth Numbered Regulations

1994 No. 150 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 20

20.1 Item 1 (column 2, paragraph (a)): Omit the paragraph, substitute:
  "(a) if:                                      for each drug-


        (i)    the goods are drugs for use solely for
experimental purposes in humans; and            800".


        (ii)   the evaluation consists of the consideration of:

                (A)  a summary of chemical, pharmaceutical and biological
                     information about the goods; and

                (B)  descriptive information about the proposed clinical trial
                     of the goods; and

                (C)  information about adverse events associated with the use
                     of the goods; and

                (D)  information about the goods provided to the relevant
                     ethics committee for each drug-800".

20.2 Paragraph 1 (c): After "item 3 of", insert "Part 1 of".

20.3 Item 10: Omit the item, substitute:
  "10 fee for an application for certification        50 multiplied

under paragraph 58 (3) (a) of the Act                 by the number

of certifications
sought in the
application".

20.4 Item 14: Omit the item, substitute:

"14 fee for notification of intention to sponsor a clinical trial using a
specified drug:
      (a) if the sponsor of the drug notifies the          90

Secretary, in accordance with item 3 of Schedule
5A, of 1 body or organisation conducting the trial
for the sponsor, including the sponsor, if the
sponsor is conducting the trial (whether or not
the sponsor has previously notified the Secretary
of 1 or more bodies or organisations conducting the trial)
      (b) if the sponsor of the drug notifies the          180

Secretary, in accordance with item 3 of Schedule
5A, of 2 or more bodies or organisations conducting
the trial for the sponsor, including the sponsor,
if the sponsor is conducting the trial (whether or
not the sponsor has previously notified the Secretary
of 1 or more bodies or organisations conducting the trial)
      14A fee for notification of intention to conduct     90".

a clinical trial using a specified therapeutic device,
if the sponsor of the drug notifies the Secretary,
in accordance with item 3 of Schedule 5A, of 1 or
more bodies or organisations conducting the trial
for the sponsor, including the sponsor, if the sponsor
is conducting the trial (whether or not the sponsor
has previously notified the Secretary of 1 or more
bodies or organisations conducting the trial)