Commonwealth Numbered Regulations

1990 No. 394 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 7

SCHEDULE 7
Regulation 17
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF PART 4
OF THE ACT UNLESS SUPPLIED AS PHARMACEUTICAL BENEFITS Column 1 Column 2 Item
No. Therapeutic goods
 1        goods prepared for the initial experimental

studies in human volunteers
 2        ingredients, except water, used in the manufacture

of therapeutic goods where the ingredients:

   (a)  do not have a therapeutic action; or

   (b)  are herbs, or oils extracted from herbs, the
sole therapeutic use of which is as starting materials
for use by licensed manufacturers
 3        components for therapeutic devices except where

the devices are intended to be inserted into the human
body (other than devices exempt from the operation of
Part 3 of the Act) and those components come into
direct contact with body tissue or body fluids
 4        therapeutic devices that are not sterile and do

not contain or include any sterile component or
portion, other than:

   (a)  devices for use in contraception or
prevention of transmission of disease between persons;
or

   (b)  materials for restoration or replacement of
teeth or other devices intended to be implanted in the
human body; or

   (c)  bandages (excluding casting bandages),
dressings, gauzes and undercast padding; or

   (d)  soft contact lenses; or

   (e)  lubricants for insertion into body cavities
or orifices; or

   (f)  any other devices included in Schedule 3; or

   (g)  diagnostic goods for in vitro use that are:
               (i)   goods for home use; or


        (ii)   goods that incorporate material of human
origin; or

        (iii)  goods for use in the diagnosis of
infection with Human Immunodeficiency Virus; or

        (iv)   antimicrobic susceptibility discs
 5        containers (other than glass containers) that are

not:

   (a)  designed to contain blood or blood components
(other than containers used to collect blood for
subsequent diagnostic testing); or

   (b)  intended for use with goods for parenteral
administration
 6        dentifrices that contain no therapeutically active

substance other than not more than 1000 milligrams per
kilogram of fluoride
 7        homoeopathic preparations more dilute than a one

thousand fold dilution of a mother tincture and that
are not required to be sterile
 8        antiperspirant preparations that derive their

antiperspirant properties from inorganic salts of
aluminium, zinc or zirconium only
 9        unmedicated anti-acne preparations having only a

cleansing action or purpose
10        medicated insect repellents for dermal use

11        lotions, shampoos or hairdressings for the

prevention or treatment of dandruff
12        medicated soaps other than liquid medicated soaps

13        disinfectants

14        sunscreen preparations for dermal use

15        medicated throat lozenges, where the medication

consists only of volatile oils and their constituents
either alone or in combination with ascorbic acid or
its salts
16        medicated space sprays where the medication

consists only of volatile oils and their constituents