Commonwealth Numbered Regulations

1994 No. 150 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 16

16.1 Item 3:
Omit the item, substitute:              (a) before starting to use the

  "3 Therapeutic goods used solely      goods, the sponsor must notify the

for experimental purposes in humans     Secretary:


        (i)    in a form approved by the
Secretary; and

        (ii)   in accordance with the
requirements (if any) determined
by the Secretary for the form of
notification;
that the sponsor intends to
sponsor a clinical trial using
specified goods; and

   (b)  the notification must be
accompanied by the relevant
notification fee referred to in
item 14 or 14A of Schedule 9; and

   (c)  the approval of the goods for
this purpose must be given by the
sponsor (if the sponsor is
conducting the trial), or by the
body or organisation conducting
the trial for the sponsor, having
regard to the advice of the ethics
committee that has, or will
assume, responsibility for
monitoring the conduct of the
trial; and

   (d)  the terms of the approval by
the sponsor, body or organisation
referred to in paragraph (c) must
be no less restrictive than the
terms advised by the ethics
committee; and

   (e)  the Secretary must not, at any
time:

        (i)    have become aware that to
conduct or continue the trial
would be contrary to the public
interest; and

        (ii)   have directed that the
trial not be conducted, or be
stopped; and

   (f)  the sponsor (if the sponsor is
conducting the trial), or the
body or organisation conducting
the trial for the sponsor, must
not receive, or have received,
advice from the ethics committee
that is inconsistent with the
continuation of the trial.
4 Therapeutic goods that are imported   (a) the group must be visiting

by a member of a group of persons       Australia to participate in

a national or an international
sporting event; and

   (b)  the goods must be for use in
the treatment of a member or
members of that group; and

   (c)  the importation of the goods
must not be prohibited under the
Customs (Prohibited Imports)
Regulations; and

   (d)  the goods must not be supplied
to, or used in the treatment of, a
person who is not a member of the
visiting group; and

   (e)  any portion of the goods that
is unused at the end of the visit
must be destroyed or removed from
Australia; and

   (f)  a member of the group must be
responsible for the control and
custody of the goods while the
group is in Australia; and

   (g)  the person referred to in
paragraph (f) must:

        (i)    carry a list, in English, of
the quantity and nature of the
therapeutic goods imported; and

        (ii)   for each of the goods that
is not a therapeutic
device-include in the list the
generic name and strength of the
active ingredient of the goods;
and

        (iii)  keep a record of the use
of the goods while the group is in
Australia; and

        (iv)   produce the list or the
record for inspection at the
request of a customs officer or a
person who is an authorised
officer for the purposes of a
provision of Part 5 of these
Regulations".