Commonwealth Numbered Regulations

1990 No. 394 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 8

SCHEDULE 8
Regulation 18
PERSONS EXEMPT FROM THE OPERATION OF PART 4 OF THE ACT
Column 1   Column 2               Column 3

Item No.   Persons                Matter in relation

to which person exempted
 1     medical practitioners,

dentists and other health
care workers registered
under a law of a State or
Territory
the manufacture of:

   (a)  a drug by a medical
practitioner or a dentist
specifically for a patient
under his or her care; or

   (b)  a therapeutic device
by a health care worker
specifically for a
patient under his or her care
 2     pharmacists                 the manufacture of therapeutic

goods produced by the pharmacist:

   (a)  in a pharmacy where the pharmacist
practices and the pharmacy
is open to the public; or

   (b)  on the premises of
a dispensary conducted
by a Friendly Society; or

   (c)  on the premises of a
private hospital;
for supply (other than by
wholesale) on or from
those premises
 3      biomedical

engineers,
radio-chemists
and
pharmacists in
        public hospitals           the manufacture of therapeutic

goods by the person when
employed by a public hospital
or a public institution and
produced by that person
for supply in hospitals or
public institutions in the
same State or Territory
 4      herbalists, nutritionists,

naturopaths or homoeo-pathic
practitioners engaged in
the manufacture of any
herbal, homoeopathic or
nutritional supplement
        preparation                where the preparation is for

use in the course of his
or her business and:

   (a)  the preparations are
manufactured on premises
that the person carrying
on the business occupies and
that he or she is able to
close so as to exclude the
public; and

   (b)  the person carrying on
the business:

        (i)    supplies the
preparation for administration
to a particular person
after consulting with that
person; and

        (ii)   uses his or her
own judgment as to the
treatment required
 5      a person who

applies
supplementary
labelling to a
manufactured
        product                    the application of

supplementary labelling,
where the supplementary label
contains only a name and
address or the registration
or listing number of goods
 6     persons who operate

blood collection centres
the operation of human
blood collection centres
except those that supply plasma
for the manufacture of
blood components