active ingredient means a therapeutically active component in a medicine’s final formulation that is responsible for its physiological or pharmacological action;
antimicrobial preservative means an ingredient added to a medicine to inhibit the growth of micro-organisms in the medicine;
approved product details, in relation to a medicine, means details in relation to the medicine as approved under section 25 of the Act for the registration of the medicine;
Australian Approved Names List has the same meaning as in the Regulations;
batch number means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of medicine, to uniquely identify that batch and from which it is possible to trace that batch through all stages of manufacture and distribution;
batch number prefix means the prefix which precedes the batch number and has the following characteristics:
(a) clearly indicates that the information following the prefix is the batch number; and
(b) is in the following form: ‘BATCH NUMBER’, ‘BATCH NO.’, ‘BATCH’, ‘B’, ‘(B)’, ‘B/N’, ‘LOT NUMBER’, ‘LOT NO.’, or ‘LOT’, or words or symbols to this effect, including a mixture of lower and upper case letters;
calendar pack means a pack containing individual dosage units that is labelled with day/date markings to specify the sequence in which the dosage units in the pack must be used in order to achieve the intended therapeutic activity;
capacity means the volume of the empty container;
Certificate of Listing, in relation to a medicine, means the certificate given to the applicant for listing of the medicine under subsection 26(4) or subsection 26A(9) of the Act in relation to that medicine;
Certificate of Registration, in relation to a medicine, means the certificate given to the applicant for registration of a medicine under subsection 25AB(4) of the Act in relation to that medicine;
complementary healthcare practitioner means a person described in paragraph 42AA(1)(c) of the Act;
composite pack has the same meaning as in the Act;
container has the same meaning as in the Act;
critical health information means information required under paragraphs 8(1)(b), (c), (j), (k), (l) and (n) of this Order, that is critical for safe use of medicines that are self-selected by a consumer;
delivered dose means, in relation to:
(a) metered dose preparations - the dose delivered to the patient in a single actuation or delivery; and
(b) powders for inhalation - the dose delivered from the inhaler in a single delivery;
Part 6 - Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines - Interpretation | Zoe
dial dispenser pack means a container that has the following characteristics:
(a) each of the dosage units is located in individual pockets preformed in a circular rigid tray;
(b) a close-fitting, rotatable, transparent lid which can only be rotated in one direction is located over the tray; and
(c) the individual dosage units can be dispensed by detaching a predefined portion of the lid or tray, and rotating the lid to the appropriate position;
diluent means a liquid used for reconstitution or dilution;
directions for use has the same meaning as in the Act;
distributor means a company or corporate entity, which is not the sponsor, that the sponsor has agreed should be identified on a medicine’s label;
excipient, in relation to a medicine, means an ingredient of the medicine other than the active ingredient;
expiry date, in relation to a product, means the date (month and year) after which the medicine should not be used;
expiry date prefix means a prefix which precedes the expiry date which has the following characteristics:
(a) clearly indicates that the information following the prefix is the expiry date;
(b) is in the following form: 'EXPIRY DATE', 'EXPIRY', 'EXPIRES', 'EXP. DATE', 'EXP' , ‘Use by’ or ‘Use before’ or words to this effect, including a mixture of lower and upper case letters;
(c) is not in the following form: 'Best by' or ‘Best before’ or words to this effect;
external, in relation to the use of a medicine, 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;
health professional includes the following:
(a) a health practitioner of any kind registered under a law of a State or Territory that provides for the registration of health practitioners of that kind; and
(b) a biomedical engineer, prosthetist or rehabilitation engineer;
herbal material means a plant or part of a plant (defined by its botanical scientific name according to the binominal nomenclature system, including author, and the plant part), whether fresh or dried, that is whole, fragmented, cut or ground;
herbal preparation means an ingredient that is the result of the processing of a herbal material;
homoeopathic medicine means a medicine that:
(a) contains one or more homoeopathic preparations; and
(b) may contain excipients necessary for presentation of the medicine in the final dosage form.
homoeopathic potency means the dilution factor of a homoeopathic preparation, expressed as:
(a) ‘nX’ where each dilution is a decimal or ten-fold dilution and 'n' is the number of dilutions such that the total dilution is 10n; or
(b) ‘nC’ where each dilution is a centesimal or hundred-fold dilution and 'n' is the number of dilutions such that the total dilution is 100n; or
(c) ‘nLM’ or ‘LMn’ where, from a 3C starting dilution, each subsequent dilution is a fifty millesimal or fifty thousand fold dilution and 'n' is the number of dilutions such that the total dilution is 50,000n.
Note: Where 1000 centesimal dilutions are performed, the potency is expressed as nM; that is, 1M potency represents a 1,000C dilution, 2M a 2,000C dilution, etc
homoeopathic preparation has the same meaning as in the Regulations.
intermediate packaging means a level of packaging which, if it exists, encloses one or more containers and is itself enclosed in a primary pack;
label means a display of printed information upon, or securely affixed to, the container, any intermediate packaging and any primary pack containing the medicine;
listed goods has the same meaning as in the Act;
listing number means the combination of numbers and letters that are required to be included on the label of therapeutic goods in a manner described in regulation 15 of the Regulations;
main label means:
(a) where there are two or more labels or two or more portions of a single label - that label or portion of the label where the name of the medicine is more or most conspicuously shown; or
(b) where the name of the medicine is equally conspicuous on two or more labels or portions of a label – each label or portion;
medicine has the same meaning as in the Act;
medicine kits has the same meaning as described in Item 12 of Schedule 4 to the Regulations;
medium container means a container that has a capacity less than or equal to 60 millilitres that is not a small container;
name and contact details in respect of a sponsor or distributor, means
(a) the name of the sponsor or distributor and sufficient information to allow the sponsor or distributor to be uniquely identified so as to facilitate public contact on matters of complaint, use or general enquiry. The contact details must include information such as the city or suburb of the sponsor’s/distributor’s principal place of business in Australia (not being a post office, cable, telegraphic or code address). The Australian telephone number, website or email address may also be included; or
(b) where there has been a change in the sponsor’s or distributor’s name or contact details in the previous twelve months, the name and contact details of the previous sponsor or distributor;
name of an active ingredient means:
(a) the name of the active ingredient that is accepted for inclusion in the Australian Approved Names List; or
(b) where the ingredient is a homoeopathic preparation:
(i) either the name of the active ingredient, or the substance from which the dilution was prepared, that is accepted for inclusion in the Australian Approved Names List, together with a statement of the homoeopathic potency; or
(ii) until such time as a name is accepted for inclusion in the Australian Approved Names List, a traditional homoeopathic name in full or as traditionally abbreviated with a statement of the homoeopathic potency;
name of an excipient means the name of the excipient that is accepted for inclusion in the Australian Approved Names List;
name of the dosage form means:
(a) in relation to a medicine that is intended to be, or is, a listed goods or registered goods, the name of the dosage form as entered, or proposed to be entered, in the Register in relation to the medicine; and
(b) in relation to a medicine that is not entered in the Register, the name of the pharmaceutical form of the medicine;
name of the medicine means the following:
(a) where the medicine is intended to be, or is, entered in the Register - the name of the medicine intended to appear or appearing on the Certificate of Registration or Certificate of Listing in relation to the medicine, not including the following information:
(i) the name of the active ingredient (except where the name of the active ingredient is intended by the sponsor to be, or because of the way it is represented, to form part of the name of the medicine);
(ii) the strength (except where numbers or words denoting strength are included in that name to differentiate medicines, by strength);
(iii) the dosage form (except where this is integral to differentiate medicines from other medicines);
(iv) container details;
(v) the pack size;
(vi) ‘new formulation’ or representations to the same effect;
(vii) flavour descriptors (except where this is integral to differentiate medicines from other medicines);
(viii) the name of the sponsor or distributor (or part thereof) (except where the name is intended by the sponsor to be, or because of the way it is represented, to form part of the name of the medicine); and
(b) where the medicine is neither intended to be, nor is, entered in the Register:
(i) the registered trade mark for the medicine; or
(ii) a unique, invented, common or scientific name,
assigned to the medicine by the sponsor and appearing on the label;
Poisons Standard means the current Poisons Standard as defined in section 52A of the Act;
primary pack has the same meaning as in the Act;
quantity of the medicine means:
(a) where the medicine consists of discrete dosage units, such as tablets or capsules or sachets – the stated number of units in the container; or
(b) where the medicine is:
(i) a solid or semi-solid - the stated weight in the container;
(ii) a liquid - the stated volume of fill in the container;
(iii) a pressurised metered-dose preparation or dry powder inhaler - the stated number of deliverable doses in the container;
(iv) a non-pressurised metered dose preparation - the minimum number of deliverable doses in the container;
(c) where the medicine is a medicine of any of the kinds referred to in paragraph (b) and the medicine consists of a number of identical containers within the primary pack – the number of containers (e.g. 5 x 10 mL vials);
(d) for each of the individual containers within the primary pack, the quantity of the medicine to be included on the individual container label would be as described in paragraph (b) (e.g. the stated volume of fill in the container);
Register has the same meaning as in the Act;
registered goods has the same meaning as in the Act;
registration number means the combination of numbers and letters that is required to be included on the label of medicines in a manner described in regulation 15 of the Regulations;
Regulations means the Therapeutic Goods Regulations 1990;
Secretary has the same meaning as in the Act;
small container means a container that has a capacity less than or equal to 25 millilitres;
solid ophthalmic medicine means a substance in a container to which a sterile diluent is added to prepare eye drops;
sponsor has the same meaning as in the Act;
standard has the same meaning as in the Act;
standardisation means the process in which the content of a specific chemical constituent(s) has been determined in a herbal material or herbal preparation.
stated volume of fill means the volume of medicine that the container is specified by the sponsor to contain;
stated weight means the mass of medicine that the container is specified by the sponsor to contain;
supply has the same meaning as in the Act;
text size means the height of upper case (capital) letters or lower case letters having an ascender or descender, unless otherwise stated;
warning statements means:
(a) any labelling requirements specified in the instrument made by the Minister under subsection 3(5A) of the Act, as in force from time to time;
Note: These requirements apply to all medicines other than those described in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990
(b) any warning statements specified in any standard that applies to the medicine;
(c) any warning statements required by the Secretary to be included on the label as a condition of registration or listing in relation to the medicine;
(d) any warning statement required in relation to an ingredient being contained in a medicine as specified a determination made by the Minister under subsection 26BB(1)(b) of the Act; and
(e) any warning statements specified in the Poisons Standard.