Western Australian Consolidated Regulations Western Australian Consolidated Regulations [ Omitted under the
Reprints Act 1984 s.7 (4) (e). ]
[ 3. Deleted by
Gazette 6 March 1987 p.554.]
[Heading amended by Gazette 21 December 1990 p.6251.]
In these regulations
unless the context requires otherwise —
common name means a name or description which
indicates the true nature of the drug, ingredient or the constituent, as the
case may be, to which it is applied, but does not include any word claiming or
implying superior quality or purity and which is, where appropriate, a
specific and not a generic name or description.
Where a regulation lays down a compositional standard and specifies the
name of the product to which such standard applies, that name shall he deemed
to be its common name. But nothing in this regulation shall prevent the use of
a more specific name as a common name except where a precise designation is
required by these regulations;
celsius, (o C) means a measure of temperature;
grams per kilogram (g/kg) means grams per kilogram
by mass (mass in mass — m/m);
joule (j) means a metric measurement of energy and
is the one‑thousandth part of a kilojoule;
kilojoule (kj) means a metric measurement of
energy;
label includes every tag, brand, mark, pictorial
or other descriptive matter written, printed, stencilled, marked, embossed or
impressed on or attached to any drug;
litre (l) means a metric measurement of volume;
micrograms per kilogram (ug/kg) means micrograms
per kilogram by mass (mass in mass — m/m);
milligrams per kilogram (mg/kg) means milligrams
per kilogram by mass (mass in mass — m/m);
millilitre (ml) means a metric measurement of
volume and is the one thousandth part of a litre;
millimetre (mm) means a metric measurement of
length and is the one thousandth part of a metre (m);
package or container includes any form of
enclosing or encasing a drug as a single item, whether by completely or
partially enclosing the drug and includes wrappers, confining bands, jars,
cans and boxes;
parts per million (p.p.m.) means parts per million
by mass (mass in mass — m/m) unless otherwise indicated;
per centum means percent by mass (mass in
mass — m/m) unless otherwise indicated;
the Act means the Health Act 1911 (as
amended); and
trade name in relation to a drug is a distinctive
arbitrary, or fancy name which clearly distinguishes such drug from any other
drug but shall not —
(a)
represent any single constituent of the drug;
(b)
misrepresent the composition or any property or quality of a drug; or
(c) give
false indication of origin, character or place of manufacture.
[A.01.001 inserted by Gazette
19 April 1978 pp.1165‑9; amended by Gazettes
16 May 1980 pp.1508‑11; 15 May 1981 pp.1485‑8;
6 March 1987 p.554.]
For the purposes of
section 245 of the Act the substances contained in those therapeutic
goods included in the Register of Therapeutic Goods maintained under
section 17 of the Therapeutic Goods Act 1989 of the Commonwealth
are therapeutic substances for the purposes of these regulations.
[Regulation A.01.001A inserted by Gazette
9 March 1993 p.1509.]
(a)
Unless exempted by these regulations, every package in which any drug is
enclosed for sale shall bear a label on or attached to it containing such
information, in the English language as is required by the Act or by these
regulations and such information shall appear conspicuously in a prominent
position in the label and shall be clearly discernible to the purchaser under
the customary conditions of purchase and use.
(b) The
contents of the label shall include —
[ (i) deleted]
(ii)
the name of the manufacturer, packer, importer or vendor
and his address, not being a post office, cable, telegraphic or code address,
but where a manufacturer, packer, importer or vendor is a company incorporated
in accordance with the appropriate law of any State or Territory of the
Commonwealth, or is a firm registered under the Business Names Act of any
State or Territory, the inclusion in the label of the registered name of the
company or firm and the city or town in which its registered office or address
is situated shall be deemed to comply with this requirement.
[(iii) deleted]
(iv)
the place of manufacture of the contents of the package
or the country of origin, if required to be declared by these regulations.
[A.01.002 amended by Gazette
6 March 1987 p.554.]
[ A.01.002A, A.01.002B, A.01.002C, A.01.002D, A.01.002E, A.01.002F.
Deleted by Gazette 6 March 1987 p.554.]
(a) Any
particulars, directions, statements, letters or words required by the Act or
these regulations to be written in the label, shall —
(i)
be in durable characters;
(ii)
be in boldface sans serif capital letters of at least the
prescribed size, but the name of the manufacturer, importer, vendor or packer
may appear in letters other than sans serif capital letters;
(iii)
be in such colour or colours as to afford a distinct
colour contrast to the ground;
(iv)
unless otherwise prescribed be of 1.5 mm face depth
measurement, but when the package or container is of a size that prevents the
use of the prescribed size, a proportionately reduced size consistent with
legibility, may be used; and
(v)
be in letters of uniform size, description and colour.
[(b) deleted]
(c)
Where in these regulations a reference is made to a size of type to be used
that size shall be in accordance with the measurement made in millimetres (mm)
in conformity with metrication requirements, but where the point system of
type size is used in these regulations the following conversion schedule to
the metric measurement system shall apply.
Conversion Schedule
Point Size Millimetres
(mm) Size
6 1.5
8 2.0
10 2.5
12 3.0
18 4.5
24 6.0
36 9.0
48 12.0
60 15.0
72 18.0
(d) The
size of type to be used shall be in accordance with the following
scale —
1.5
millimetre —
ABCDEFGHIJKLMNOPQRSTUVWXYZ
2.0
millimetre —
ABCDEFGHIJKLMNOPQRSTUVWXYZ
2.5
millimetre —
ABCDEFGHIJKLMNOPQRSTUVWXYZ
3.0
millimetre —
ABCDEFGHIJKLMNOPQRSTUVWXYZ
4.5
millimetre —
ABCDEFGHIJKLMNOPQRSTUVW
6.0
millimetre —
ABCDEFGHIJKLMNOP
9.0
millimetre —
ABCDEFGHIJKL
12.0
millimetre —
ABCDEFGH
15.0
millimetre —
ABCDEF
18.0
millimetre —
ABCDE
[A.01.003 amended by Gazette
6 March 1987 p.554.]
(a) The
label on or attached to any package of a drug shall not
contain —
(i)
any statement, claim explicit or implicit, design,
device, fancy name or abbreviation which either directly or by implication is
false or misleading in any particular concerning the ingredients, or the
quality, or the physiological or therapeutic action, or the place of origin of
the drug;
(ii)
any comment on, reference to, or explanation of any
statement required by the Act or these regulations which directly or by
implication, contradicts, qualifies or modifies such statement;
(iii)
the word “pure” or the word
“health” or any word of similar import used in conjunction with
the common name or trade mark of the drug; and
(iv)
the word “imitation” or any word implying
that the article is a substitute for any drug unless the use of the word is
specifically permitted by these regulations.
[(b) deleted]
[A.01.004 amended by Gazette
5 March 1987 p.554.]
[ A.01.005 and A.01.006 . Deleted by Gazette
6 March 1987 p.554.]
(a)
Notwithstanding anything contained in these regulations, the Executive
Director, Public Health may grant an exemption from any requirement regarding
labelling in respect of any drug where he is satisfied that —
(i)
the information required by these regulations is
available from the label although not specifically contained thereon; and
(ii)
for reasons beyond the control of the manufacturer, it is
impractical to amend the label.
[(b) deleted]
[A.01.007 amended by Gazettes
29 June 1984 p.1781; 6 March 1987 p.555.]
[A.02 to A.13 Repealed by Gazette
6 March 1987.]
[Part B inserted by Gazette 21 December 1990 p.6251.]
In this Part, unless
the contrary intention appears —
authorized means authorized in writing by the
Executive Director, Public Health to use or direct the use of kits or systems
for testing for the presence of human immunodeficiency virus, its antibodies
and antigens;
HIV means human immunodeficiency virus, its
antibodies and antigens.
[B.01.001 inserted by Gazette
21 December 1990 p.6251.]
For the purposes of
section 245 of the Act a substance or compound comprising a kit or system
for testing for the presence of HIV is a therapeutic substance when the kit or
system is used for the prescribed purpose of testing for the presence of HIV.
[B.01.002 inserted by Gazette
21 December 1990 p.6251.]
A person shall not use
a kit or system for testing for the presence of HIV unless the
person —
(a) is
authorized; or
(b) acts
under the direction of a person who is authorized.
[B.01.003 inserted by Gazette
21 December 1990 p.6251.]
A person who sells or
supplies a kit or system for testing for the presence of HIV shall ensure that
the person to whom the kit or system is sold or supplied is authorized.
[B.01.004 inserted by Gazette
21 December 1990 p.6251.]
[ Parts C to Q. Deleted by Gazette
6 March 1987 p.555.]
[Part R inserted by Gazette 6 March 1987 pp.555‑6; amended by
Gazette 9 March 1993 p.1514.]
The label on or
attached to a package containing therapeutic substances, drugs or medicines or
any advertisement relating to therapeutic substances, drugs or medicines shall
not contain a statement, claim or representation, pictorial or otherwise,
which directly or by implication —
(a)
indicates or suggests any matter or thing with respect to the use of those
therapeutic substances, drugs or medicines for the purpose of or in connection
with —
(i)
abortifacient action;
(ii)
AIDS — see immune system diseases;
(iii)
alcoholism;
(iv)
anaemia;
(v)
arthritis (all forms including rheumatoid
arthritis) — other than the temporary relief of pain;
(vi)
asthma;
(vii)
baldness, including hair growth, hair loss or hair
thinning;
(viii)
blindness;
(ix)
boils — other than treatment by topical
application;
(x)
breast development;
(xi)
bronchitis — other than relief of cough;
(xii)
carbuncles — other than treatment by
topical application;
(xiii)
cardiovascular system diseases ailments or defects
(including high or low blood pressure) other than —
(A) the advertising of blood pressure
appliances where the advertisement includes a statement to the effect that a
medical practitioner is the only person qualified to evaluate the meanings of
recorded blood pressure; or
(B) the advertising of cholesterol
measurement appliances where the advertisement includes a statement to the
effect that a medical practitioner is the only person qualified to evaluate
the meanings of recorded cholesterol levels; or
(C) the advertising of purpose specific
bandages for the relief or treatment of circulation related ailments; or
(D) a statement to the effect of
“aids or assists in the maintenance of peripheral circulation”,
other than a statement to the effect of “aids or assists in the
treatment of fluid retention” provided the advertisement carries a
warning to the effect of —
“
If fluid retention persists, seek medical advice.
”;
(xiv)
cataract;
(xv)
catarrh, other than temporary relief;
(xvi)
chilblains, other than temporary relief of symptoms;
(xvii)
colds, other than temporary relief;
(xviii)
coughs, other than temporary relief;
(xix)
croup;
(xx)
deafness, other than relief by an appliance;
(xxi)
diabetes, other than the advertising of urine testing or
blood glucose monitoring products or insulin syringes;
(xxii)
diphtheria;
(xxiii)
eczema, other than temporary relief of symptoms;
(xxiv)
endocrine system diseases, ailments or defects;
(xxv)
erysipelas;
(xxvi)
fertility;
(xxvii)
fungus infections, including tinea (athlete’s
foot), other than for relief or treatment by topical application;
(xxviii)
gall bladder diseases, ailments or defects;
(xxix)
gastric, peptic or duodenal ulcer;
(xxx)
genito‑urinary system diseases, ailments or
defects — other than for products offering temporary relief of
the pain and burning sensation associated with cystitis provided the
advertisement carries a warning to the effect —
“
If pain or irritation persists for more than 48 hours, consult
your doctor.
”;
and
“
The presence of blood in the urine warrants immediate medical
attention.
”;
(xxxi)
glandular diseases, ailments or defects (including
glandular enlargement);
(xxxii)
glaucoma;
(xxxiii)
goitre;
(xxxiv)
gout;
(xxxv)
haemorrhoids, other than —
(A) temporary relief of discomfort by local
application and where the directions for use include the statement that
sufferers should consult a medical practitioner if the symptoms persist; or
(B) reference to bulk producing laxatives
being of indirect benefit to people suffering from haemorrhoids;
(xxxvi)
hair and scalp — see baldness;
(xxxvii)
headaches, other than temporary relief;
(xxxviii)
height increase;
(xxxix)
hernia or rupture, other than advertising hernia
appliances;
(xl)
herpes virus infections, other than —
(A) the relief of symptoms of cold sores;
or
(B) reduction of risk of the transmission
of genital herpes by the use of condoms;
(xli)
hormonal disease, ailments or defects;
(xlii)
immune system diseases, ailments or defects, including HIV induced diseases or
ailments, such as Acquired Immune Deficiency Syndrome (AIDS), other than the
reduction in the risk of the transmission of disease by the use of condoms;
(xliii)
impetigo, other than treatment by topical application;
(xliv)
impotence;
(xlv)
indigestion, other than temporary relief or treatment of digestive disorders,
provided the advertisement carries a warning to the effect
of —
“ If symptoms persist, seek medical advice. ”;
(xlvi)
infertility;
(xlvii)
influenza, other than temporary relief of symptoms;
(xlviii)
liver diseases, ailments, defects or injuries;
(xlix)
lupus;
(l)
menopause or menopausal ailments or defects;
(li)
menstrual cycle diseases, ailments or defects other than the temporary relief
of menstrual pain;
(lii)
pre‑menstrual symptoms where the advertisement includes a statement to
the effect of —
“
Use only as directed and consult your doctor if pain or symptoms
persist.
”;
(liii)
mental diseases, ailments or defects;
(liv)
mouth ulcers, other than temporary relief;
(lv)
muscular aches and pains, other than temporary relief;
(lvi)
neoplastic diseases (including cancer and leukaemia), other than use of
sunscreening preparations as an aid in the prevention of skin cancer (being
S.P.F. 4 or greater) and premature skin ageing (being a broad spectrum sun
screen as defined in the current Australian Standard) but without implying
that long hours of exposure in the sun are desirable;
(lvii)
nervous system diseases, ailments, defects or injuries (including convulsions,
epilepsy, fits or paralysis);
(lviii)
obesity including the reduction of subcutaneous fat also referred to as
“cellulite”;
(lix)
overweight, other than suppression of appetite in conjunction with a balanced
low joule (calorie) diet;
(lx)
phlebitis;
(lxi)
pregnancy testing kits — see sexual intercourse;
(lxii)
prostate gland disease, ailments or defects;
(lxiii)
psoriasis, other than for the relief or treatment of the effects of psoriasis
on the skin provided the advertisement carries a warning to the effect
of —
“
Do not use for prolonged periods without consulting a medical
practitioner.
”
and provided an
advertisement for products which contain coal tar carries an additional
warning to the effect of —
“
Do not use this product with other forms of psoriasis therapy such as
ultraviolet radiation or prescription drugs unless directed to do so by a
medical practitioner.
”;
(lxiv)
psychiatric disease, ailments or defects;
(lxv)
purpura;
(lxvi)
pyorrhoea;
(lxvii)
rheumatism, other than temporary relief of pain;
(lxviii)
scabies, other than relief by topical application;
(lxix)
sexual intercourse, other than —
(A) reduction in the possibility of
conception; or
(B) pregnancy test kits where the
advertisement includes a statement to the effect that a medical practitioner
is the only person qualified to evaluate the test results;
(lxx)
sexually transmissible diseases, other than the reduction of the risk of
transmission of sexually transmissible disease by the use of condoms;
(lxxi)
sexual function potency or virility;
(lxxii)
short stature;
(lxxiii)
sinus infection, other than temporary relief of sinusitis;
(lxxiv)
sleeplessness, other than temporary relief;
(lxxv)
sun screening — see neoplastic diseases;
(lxxvi)
thrombosis, other than for the relief or treatment of circulation related
ailments by means of purpose specific bandages;
(lxxvii)
tuberculosis;
(lxxviii)
varicose ulcers or varicose veins, other than the temporary relief by
the use of elastic hosiery;
(lxxix)
whooping cough.
(b) with
respect to the use or consumption of those therapeutic substances, drugs or
medicines —
(i)
depicts excessive pain or suffering;
(ii)
induces or is likely to induce persons to believe that
they are suffering from a serious ailment;
(iii)
induces or is likely to induce persons to believe that
harmful consequences will result if those therapeutic substances, drugs or
medicines are not used or consumed;
(iv)
disparages any physical or mental affliction or
deformity; or
(v)
claims or implies or induces or is likely to induce
persons to infer that those therapeutic substances, drugs or medicines or
their sales are recommended or used generally by medical practitioners,
pharmacists, dentists, nurses or physiotherapists or by other persons having
or purporting to have a qualification in a health care field; or
(c)
indicates or suggests with respect to the use or consumption of those
therapeutic substances, drugs or medicines that those therapeutic substances,
drugs or medicines —
(i)
are a universal panacea;
(ii)
possess infallible, unfailing, sure, magical or
miraculous curing properties;
(iii)
possess unique or absolute properties;
(iv)
act immediately or rapidly;
(v)
are a natural remedy or nature’s remedy;
(vi)
possess stimulant properties;
(vii)
promote vitality; or
(viii)
must be used for the relief of symptoms of any disease,
ailment, defect or injury.
[Regulation R.01.001 inserted by Gazette
6 March 1987 pp.555‑6; amended by Gazette
9 March 1993 pp.1510‑4.]
A fictitious
testimonial or the name of a fictitious person shall not be included in the
label on or attached to or in an advertisement relating to therapeutic
substances, drugs or medicines.
[Regulation R.01.002 inserted by Gazette
6 March 1987 p.556; amended by Gazette 9 March 1993
p.1514.]
A person shall not
publish or display in any manner or cause to be published or displayed in any
manner an advertisement that contravenes these regulations.
[Regulation R.01.003 inserted by Gazette
6 March 1987 p.556.]
This regulation shall
not be construed so as to prohibit the publication of advertisements relating
to therapeutic substances, drugs or medicines in medical journals, bona fide
trade journals or price lists for the use of the retail trade.
[Regulation R.01.004 inserted by Gazette
6 March 1987 p.556; amended by Gazette 9 March 1993
p.1514.]
[Heading inserted by Gazette 21 December 1990 p.6252.]
[ S.01.001 . Deleted]
[(a) and (b) deleted]
(c) No
person shall sell any package on which the word DISINFECTANT, or the word
GERMICIDE, is written in any label accompanying it which does not contain a
substance or compound which, when used in the strength or proportion and for
the time set forth in the label, is effective for the purpose of killing
micro‑organisms.
[(a) and (b) deleted]
(c) No
person shall sell any package on which the word “Antiseptic,” is
written in any label accompanying it which does not contain a substance or
compound which when used in the strength or proportion set forth in the label
is effective for the purpose of preventing the development of
micro‑organisms and the decomposition of animal or vegetable substances.
[ S.01.004. Deleted]
No person shall pack a
disinfectant or poisonous substance of any description in a package or
container which bears upon it any brand, mark, or statement indicating the
presence in that package or container of food, or which may be capable of
misleading a purchaser into the belief that the contents of that package or
container are for the purposes of human consumption.
[Heading inserted by Gazette 10 October 1986.]
T.01.
In this
Part —
the Standard means Australian Standard AS
2604‑1986 entitled “Sunscreen
Products — Evaluation and Classification” published by
the Standards Association of Australia.
[Regulation T.01.001 inserted by Gazette
10 October 1986 p.3837; amended by Gazette 9 March 1993
p.1514.]
This Part applies to
sunscreen products in accordance with clause 2 of the Standard.
[Regulation T.01.002 inserted by Gazette
10 October 1986 p.3838.]
The performance of
sunscreen products to which this Part applies shall be determined in
accordance with the Standard.
[Regulation T.01.003 inserted by Gazette
10 October 1986 p.3838.]
Sunscreen products to
which this Part applies shall be labelled in accordance with the Standard.
[Regulation T.01.004 inserted by Gazette
10 October 1986 p.3838.]
[ Schedule to Part T.
Deleted by Gazette 9 March 1993 p.1514.]
[ Y.01 . Deleted by
Gazette 6 March 1987 p.557.]
[Heading inserted by Gazette 21 December 1990 p.6252.]
(a)
Where in relation to any drug a standard is appointed by any provision
contained in these regulations, a person shall not have in his possession for
sale or shall not, in the course of or for the purposes of sale, consign to
any other person any quantity of such drug which does not in all respects
conform with the standard appointed by these regulations in relation to such
quantity of drug.
(b) No
person shall sell or offer or expose for sale any drug, disinfectant,
antiseptic, deodorant, therapeutic good, drug or medicine, or sunscreen
product which is not labelled as prescribed by these regulations.
(c) No
person shall use or shall attach or cause to be attached to any drug,
disinfectant, antiseptic deodorant, therapeutic good, drug or medicine, or
sunscreen product or to any package or container containing any drug,
disinfectant, antiseptic deodorant, therapeutic good, drug or medicine, or
sunscreen product any label which be reason of any matter contained therein or
omitted therefrom contravenes, or is not in conformity with any provision of
the regulations.
(d)
Provided that this regulation shall not apply so as to prohibit the offering
for sale of any quantity of drug which does not in all respects conform with
the standard appointed in relation thereto by these regulations when the
Executive Director, Public Health expressly sanctions the sale of such
quantity of drug upon and subject to any conditions which the Executive
Director, Public Health may think fit to impose, and such quantity of drug is
offered for sale strictly in compliance with such conditions.
A person who
contravenes subregulation Z.01.001 (a), (b) or (c) or a provision of the
subregulations specified in the Table to this subregulation commits an
offence.
Table
Subregulations B.01.004, R.01.003, S.01.002 (c),
S.01.003 (c) and S.01.005.
A person who commits
an offence under subregulation Z.01.002 is liable to —
(a) a
penalty which is not more than $1 000 and not less
than —
(i)
in the case of a first offence, $100;
(ii)
in the case of a second offence, $200; and
(iii)
in the case of a third or subsequent offence, $500; and
(b) if
that offence is a continuing offence, a daily penalty which is not more than
$100 and not less than $50.
[Z.01 amended by Gazettes 29 June 1984
p.1781; 6 March 1987 p.557; 23 December 1988
pp.4971‑72; 21 December 1990 p.6252.]