Note 1: The following expressions used in this instrument are defined in the Act:
(a) current Poisons Standard;
(b) poison;
(c) Register;
(d) Secretary;
(e) supply;
(f) therapeutic goods.
Note 2: The definition of poison in the Act is as follows:
poison means an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury and includes any ingredient, compound, material or preparation referred to in a schedule to the current Poisons Standard.
In this instrument:
Act means the Therapeutic Goods Act 1989.
agricultural chemical means:
(a) a substance that is represented, imported, manufactured, supplied or used as a means of directly or indirectly:
(i) destroying, stupefying, repelling, inhibiting the feeding of, or preventing infestation by or attacks of, any pest in relation to a plant, a place or a thing; or
(ii) destroying a plant; or
(iii) modifying the physiology of a plant or pest so as to alter its natural development, productivity, quality or reproductive capacity; or
(iv) modifying an effect of another agricultural chemical; or
(v) attracting a pest for the purpose of destroying it; or
(b) an active ingredient included in a product declared by regulation under the Agricultural and Veterinary Chemicals Code Act 1994 to be an agricultural chemical product;
but does not include a veterinary chemical.
agricultural chemical product has the same meaning as in the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994.
animal means any animal (other than a human being), whether vertebrate or not, and whether a food producing species or not, and includes mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs.
animal feed premix means a concentrated preparation, containing one or more poisons, for mixing with food ingredients to produce a bulk feed for a group of animals (including fish or birds), but does not include a preparation for mixing with an individual animal’s food.
appropriate authority: each of the following is an appropriate authority:
(a) each person who is the head of the body (however described) in a State or Territory that is responsible for the administration of matters relating to health in that State or Territory;
(b) the Deputy Secretary of the Department with responsibility for the part of the Department known as the Therapeutic Goods Administration, or their delegate;
(c) the Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority, or their delegate.
approved name means:
(a) for a poison that is for human therapeutic use—the name for the poison in the Australian Approved Names List within the meaning of the Therapeutic Goods Regulations 1990; or
(b) for a poison that is for animal or agricultural use—the name approved for use by the Australian Pesticides and Veterinary Medicines Authority under the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994; or
(c) for any other poison—the name for the poison mentioned in the first‑occurring of the following paragraphs that applies to the poison:
(i) the name used for the poison in this instrument;
(ii) the name recommended by Standards Australia as the common name for the poison;
(iii) the English name given to the poison by the International Organization for Standardization;
(iv) the name given to the poison by the British Standards Institution;
(v) the English name given to the poison by the European Committee for Standardization (CEN);
(vi) the international non‑proprietary name recommended for the poison by the World Health Organization;
(vii) the International Nomenclature Cosmetic Ingredient name for the poison listed in the International Cosmetic Ingredient Dictionary & Handbook published by the Personal Care Products Council of America;
(viii) the accepted scientific name or the name descriptive of the true nature and origin of the poison.
Australian Dangerous Goods Code means the Australian Code for the Transport of Dangerous Goods by Road & Rail, published by the National Transport Commission, as existing from time to time.
Note: The Australian Dangerous Goods Code could in 2022 be viewed on the Commission’s website (www.ntc.gov.au).
authorised prescriber means any of the following:
(a) a dental practitioner;
(b) a medical practitioner;
(c) a veterinarian;
(d) a person for whom an authorisation, given for the purposes of this paragraph by an appropriate authority, is in effect.
blood means whole blood extracted from human donors.
blood components means therapeutic components that have been manufactured from blood (including red cells, white cells, stem cells, platelets and plasma), except for products derived through fractionation of plasma.
child‑resistant closure means:
(a) a closure that complies with the requirements for a child‑resistant closure in Australian Standard AS 1928‑2007, Child‑resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2015, MOD); or
(b) a closure that complies with the requirements for child‑resistant closures specified in Therapeutic Goods Order No. 95 ‑ Child‑resistant packaging requirements for medicines 2017 (TGO 95); or
(c) a closure that is taken to comply with the requirements mentioned in paragraph (b) under Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021; or
(d) in the case of a can fitted with a press‑on lid, a lid of the design known as “double tight” or “triple tight”.
Note: See also the definition of non‑access packaging.
child‑resistant packaging means packaging that:
(a) complies with the requirements of Australian Standard AS 1928‑2007, Child resistant packaging – Requirements and testing procedures for reclosable packages (ISO 8317:2015, MOD); or
(b) is reclosable and complies with the requirements of at least one of the following:
(i) the International Organization for Standardization Standard ISO 8317:2015, Child‑resistant packaging—Requirements and testing procedures for reclosable packages;
(ii) the British Standards Institution Standard BS EN ISO 8317:2004, Child‑resistant packaging—Requirements and testing procedures for reclosable packages;
(iii) the Canadian Standards Association Standard CSA Z76.1‑06, Reclosable Child‑Resistant Packages;
(iv) the United States Code of Federal Regulations, Title 16, Section 1700.15, Poison prevention packaging standards and Section 1700.20, Testing procedure for special packaging, as in force from time to time; or
(c) a closure that complies with the requirements for child‑resistant packaging specified in Therapeutic Goods Order No. 95 ‑ Child‑resistant packaging requirements for medicines 2017 (TGO 95); or
(d) a closure that is taken to comply with the requirements mentioned in paragraph (c) under Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021; or
(e) is in the form of blister or strip packaging:
(i) in which a unit of use is individually protected until the time of release; and
(ii) that complies with section 3 (Requirements for non‑reclosable packages) of Australian Standard AS 1928‑2001, Child‑resistant packages.
Note: See also the definition of non‑access packaging.
compounded in relation to a substance means combined with one or more other therapeutically active substances in such a way that it cannot be separated from them by simple dissolution or other simple physical means.
cosmetic means a substance or preparation intended for placement in contact with any external part of the human body, including:
(a) the mucous membranes of the oral cavity; and
(b) the teeth;
with a view to:
(c) altering the odours of the body; or
(d) changing its appearance; or
(e) cleansing it; or
(f) maintaining it in good condition; or
(g) perfuming it; or
(h) protecting it.
debitterised neem seed oil means highly purified oil from the neem seed containing only fatty acids and glycerides of fatty acids.
dental practitioner means a person who is registered, in a State or internal Territory, as a dental practitioner (other than a dental therapist, dental hygienist, dental prosthetist or oral health therapist).
dermal use means application to the skin primarily for localised effect.
designated solvent means the following:
(a) acetone;
(b) dimethylformamide;
(c) N‑(N‑dodecyl)‑2‑pyrrolidone;
(d) hydrocarbons, liquid;
(e) methanol when included in Schedule 5;
(f) methyl ethyl ketone;
(g) methyl isoamyl ketone;
(h) methyl isobutyl ketone;
(i) N‑methyl‑2‑pyrrolidone;
(j) N‑(N‑octyl)‑2‑pyrrolidone;
(k) phenyl methyl ketone;
(l) styrene;
(m) tetrachloroethylene;
(n) 1,1,1‑trichloroethane.
dispensing label, for a substance for therapeutic use, means the label attached to the immediate container of the substance at the time of dispensing.
Note: See section 40 and Appendix L.
distributor means a person who imports or supplies a poison.
divided preparation means a preparation manufactured and packed as discrete pre‑measured dosage units prior to supply, and includes tablets, capsules, cachets, single dose powders or single dose sachets of powders or granules.
dosage unit means an individual dose of a poison for therapeutic use and includes a tablet, capsule, cachet, single dose powder or single dose sachet of powders or granules.
drug means a poison intended for human or animal therapeutic use.
essential oils means:
(a) products obtained from natural raw materials by distillation with water or steam or from the epicarp of citrus fruits by a mechanical process, or by dry distillation; or
(b) oils of equivalent composition to products mentioned in paragraph (a) that are derived through synthetic means; or
(c) prepared mixtures of oils of equivalent composition to products mentioned in paragraph (a) that comprise a mixture of synthetic and natural components.
external in relation to the use of a poison means application in the ears, eyes or nose or to a body surface other than in the mouth, rectum, vagina, urethra or other body orifice.
first group paint: see section 67.
free formaldehyde includes all hydrated and non‑hydrated formaldehyde present in aqueous solution, including methylene glycol and formaldehyde released from formaldehyde donors.
graphic material means the material which is to be deposited on another material by a graphic instrument during writing, drawing or marking and includes cores of pencils, school pastels or crayons, blackboard chalks, finger or showcard colours, poster paints and watercolour blocks.
hand sanitiser preparation means an antimicrobial skin care product that:
(a) consists of, contains or generates one or more antimicrobial active substances; and
(b) is represented in any way to be, or is likely to be taken to be (whether because of the way in which it is presented or for any other reason):
(i) for use on hands when soap and water are not available; and
(ii) applied to the hands without rinsing off; and
(iii) intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any microbes on the skin.
hawking means to supply (including peddle or distribute or cause to be distributed) in a public place.
height in relation to letters used for words, expressions or statements on labels means the height of capital letters or lower case letters having an ascender or a descender.
hemp seed oil means the oil obtained by cold expression from the ripened fruits (seeds) of Cannabis sativa.
immediate container includes all forms of containers in which a poison is directly packed but does not include any such container intended for consumption or any immediate wrapper.
immediate wrapper means metal foil, plastic foil, waxed paper, or any other such material not intended for consumption, when used as the first wrapper for a dosage unit or dressing.
internal use means administration:
(a) orally, except for topical effect in the mouth; or
(b) for absorption and the production of a systemic effect:
(i) by way of a body orifice other than the mouth; or
(ii) parenterally, other than by application to unbroken skin.
label:
(a) means a written statement on a container of a poison; and
(b) in relation to therapeutic goods, includes a display of printed information about the product:
(i) on, or attached to, the goods; or
(ii) on, or attached to, a container or primary pack in which the goods are supplied; or
(iii) supplied with such a container or pack.
main label, for a container of poison, means:
(a) the part of the label that is most likely to be displayed, presented, shown, or examined under ordinary or customary conditions of display; and
(b) if there are 2 or more labels:
(i) the label or the part of the label where the product name is more or most conspicuously shown; or
(ii) if the product name is equally more or most conspicuously displayed on more than one of those labels—each of the labels on which the product name is equally more or most conspicuously displayed.
manufacturer of a poison means a person who manufactures, produces, or packs a poison.
marker dyes or pigments means any product that is added to a liquid used in agricultural or veterinary chemicals to identify or distinguish treated from untreated objects, land or organisms by temporarily imparting colour on the relevant object, land or organism through, for example, spot‑ or boom‑spraying.
measure pack means a sealed container which contains a measured quantity of poison for use on one occasion as a pesticide or domestic product and one or more of which is enclosed in a primary pack.
medical practitioner means a person who is registered, in a State or internal Territory, as a medical practitioner.
medicine means any poison for therapeutic use.
midwife means a person who is registered, in a State or internal Territory, as a midwife.
non‑access packaging, for a product that is not intended for human therapeutic use, means packaging that complies with the requirements of AS 4710‑2001, Packages for chemicals not intended for access or contact with their contents by humans.
Note: See also the definitions of child‑resistant closure and child‑resistant packaging.
non‑volatile content in relation to a paint or tinter means that portion of a paint or tinter determined to be the non‑volatile content by Method 301.1 of Australian Standard AS 1580‑301.1‑2005, Paints and related materials – Methods of test – Non‑volatile content by mass.
nurse means a person who is registered, in a State or internal Territory, as a nurse.
oromucosal use means administration to the oral mucosa, specifically the oral cavity and/or the pharynx.
paint includes any substance used or intended to be used for application as a colouring or protective coating to any surface but does not include graphic material or paints for therapeutic use.
pesticide means any substance or mixture of substances used or intended to be used:
(a) for preventing, destroying, repelling, attracting, inhibiting or controlling any insects, rodents, birds, nematodes, bacteria, fungi, weeds or other forms of plant or animal life or viruses, which are pests; or
(b) as a plant regulator, promoter, defoliant or desiccant for food storage, household, industrial, commercial, agricultural and non‑agricultural application, but does not include veterinary drugs, stock medicines, stock feeds, stock feed additives, drugs for human use, food additives or fertilisers.
pharmacist means a person who is registered, in a State or internal Territory, as a pharmacist.
primary pack, in relation to a poison, means the pack in which the poison and its immediate container or immediate wrapper or measure pack are presented for supply.
product sample means a packed poison supplied directly to a consumer:
(a) free of charge or for a nominal charge; and
(b) as a mechanism to promote the supply of the product; and
(c) in the form of:
(i) a small pack produced specifically for the purposes of promotion; or
(ii) a normal commercial pack that in other circumstances could be purchased by the consumer.
public place means any place where members of the public are lawfully entitled, invited or permitted to be present in their capacity as members of the public.
Note: Examples of a public place include a street, road, footway, court, alley or thoroughfare that the public may use in any residential premises or to get from door to door, place to place or house to house.
required advisory statements for medicine labels means the Therapeutic Goods (Medicines Advisory Statements) Specification 2021.
restricted flow insert means a restriction:
(a) that is fitted or moulded in the neck of a container; and
(b) that cannot readily be removed from the container by manual force; and
(c) that limits the delivery of the contents of the container to drops each of which is not more than 200 microlitres.
second group paint: see section 68.
selected container means:
(a) an injection vial having a nominal capacity of 10 ml or less; or
(b) a single use syringe; or
(c) any other container for substances for therapeutic use having a nominal capacity of 10 ml or less.
solid includes powder.
substance has the same meaning as in Part 6‑3 of the Act.
Note 1: In general terms, that definition covers an ingredient, compound, material or preparation which, or the use of which, may cause death, illness or injury to persons or animals.
Note 2: See also section 7.
therapeutic use means use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in human beings or animals; or
(b) influencing, inhibiting or modifying a physiological process in human beings or animals; or
(c) testing the susceptibility of human beings or animals to a disease or ailment; or
(d) influencing, controlling or preventing conception in human beings or animals; or
(e) testing for pregnancy in human beings or animals; or
(f) the replacement or modification of parts of the anatomy in human beings or animals.
tinter means any pigment or admixture of pigment with other substances, in powder, semi‑solid or liquid form, sold or supplied for the purpose of adding to paint in order to change the colour of the paint.
topical use means application of a poison for the purpose of producing a localised effect on the surface of the organ or within the tissue to which it is applied.
toy means an object or number of objects manufactured, designed, labelled or marketed as a plaything for a child or children up to the age of 14 years.
transdermal use means application to the skin primarily for systemic effect.
veterinarian means a person who is registered under the law of a State or Territory as a veterinarian, a veterinary practitioner or a veterinary surgeon.
veterinary chemical means:
(a) a substance that is represented as being suitable for, or is manufactured, supplied or used for, administration or application to an animal by any means, or consumption by an animal, as a way of directly or indirectly:
(i) preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or
(ii) curing or alleviating an injury suffered by the animal; or
(iii) modifying the physiology of the animal:
(A) so as to alter its natural development, productivity, quality or reproductive capacity; or
(B) so as to make it more manageable; or
(iv) modifying the effect of another veterinary chemical; or
(b) any vitamin, mineral substance, or additive, if, and only if, the vitamin, substance or additive is used for a purpose mentioned in paragraph (a); or
(c) any active ingredient included in a product declared by regulation under the Agricultural and Veterinary Chemicals Code Act 1994 to be a veterinary chemical product;
but does not include an agricultural chemical.
veterinary chemical product has the same meaning as in the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994.