Commonwealth Numbered Regulations

1991 No. 84 THERAPEUTIC GOODS REGULATIONS (AMENDMENT) - REG 13

  13.1   After Schedule 5, insert:

               "SCHEDULE 5A                        Subregulation 12(1A)

THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 3
OF THE ACT SUBJECT TO CONDITIONS
Column 1    Column 2                Column 3

Item No.    Therapeutic goods       Conditions

1           Goods imported into     (a) the sponsor must:

            Australia that are         (i) keep records relating to the

            held under the                 source and supply of those goods;

and direct control of the     (ii) if requested by the Secretary, supply

sponsor pending:               those records to the Secretary; and

            (a) approval for        (b) if the goods are the subject of an

                registration or         approval under subsections 19(1) of
the
                listing; or             Act, the supply of those goods must
be
            (b) approval under          in accordance with that approval

subsection 19

(1) of the Act
2           Japanese encephalitis   the vaccine must be:

            vaccine                 (a) imported by the undertaking known as

Commonwealth Serum Laboratories for
supply to Fairfield Hospital in the
State of Victoria; and

   (b)  supplied to that Hospital for use in
patients who have given adequately
adequately informed consent to
the proposed treatment before it
is commenced, being patients who:

        (i)    are to be resident for more than 12 months in an area in which
               Japanese encephalitis is endemic; or

        (ii)   make, or are to make, repeated
short trips to areas in which
Japanese encephalitis is endemic;
encephalitis is endemic; or

        (iii)  intend to visit rural
areas in which there is an
epidemic of Japanese
encephalitis; and

   (c)  approved for administration to
each patient by, or at the
direction of, the Director of
Medical Services at that hospital: and

   (d)  prescribed by a medical
practitioner working at the hospital
who is not the person who approved its
administration to the patient to whom
it is administered." 13.2 Add at the end:
"3         Rherapeutic goods used   (a) before starting to use the goods, the

           used solely for the          sponsor must notify the Secretary in

           experimental purposes in     writing, in accordance with a form

           in humans                    approved by the Secretary, that he or

she intend to undertake a clinical
trial using specified goods; and

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

   (c)  the goods must be approved for
this purpose by the Chairperson
of the Ethics Committee
responsible for the hospital or
institution in which the trial is
to be undertaken; and

   (d)  that Ethics Committee must be
constituted and operate in
accordance with the current
guidelines of the National Health
and Medical Research Council; and

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

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

        (ii)   have directed that the
trial not be undertaken or be
stopped, as appropriate in
the circumstances of the case".