2Interpretation

2 Interpretation

2(1) In this Order -

‘Act’ means the Therapeutic Goods Act 1989, as amended from time to time;

‘active ingredient’ means a therapeutically active substance included in a medicine;

‘adjuvant’ means an ingredient which, when administered with an antigen, modifies the immune response to that antigen;

‘antimicrobial preservative’ means an ingredient added to a medicine to inhibit the growth of micro-organisms in the medicine;

‘Australian Approved Names List’ has the same meaning as in regulation 2 of the Regulations

[NOTE: the definition as at the date of this Order is as follows:

Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.

Note 1 Australian Approved Names List includes:

(a) Australian Approved Names - Chemicals List; and

(b) Australian Approved Names - Biological Lists; and

(c) the Herbal Substances AAN List.

Note 2 Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Medicines];

‘batch number’ means a number, or a combination of numerals, symbols or letters, which is given by a manufacturer to a batch of goods, 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 clearly indicates that the number is the batch number. Examples of acceptable batch number prefixes include ‘Batch Number’, ‘BATCH NUMBER’, ‘Batch No.’, ‘BATCH NO.’, ‘Batch’, ‘BATCH’, B in circle ‘B’, ‘(B)’, ‘B/N’, ‘Lot Number’, ‘LOT NUMBER’, ‘Lot No.’, ‘LOT NO.’, ‘Lot’ or ‘LOT’; or words or symbols to this effect;

‘complementary healthcare practitioner’ means a person described in paragraph 4(1)(c) of the Regulations

[NOTE: as at the date of this Order, this is as follows:

"persons who are registered under a law of a State or Territory as herbalists, homoeopathic practitioners, chiropractors, naturopaths, nutritionists, practitioners of traditional Chinese medicine, podiatrists or osteopaths"];

‘concentrated solution for injection’ means a liquid which must be diluted with another liquid in order to prepare an injection;

‘container’ means an article that immediately covers the goods, and includes an ampoule, blister pack, bottle, sachet, dial dispenser pack, strip pack, syringe, tube, vessel, vial, wrapper or other similar article, but does not include an article intended for ingestion;

‘date of manufacture’ means:

(a) for a biological product, the date (month and year) of the latest quality control analysis performed on the product and which may be preceded by a period during which the product is stored under conditions which have been shown to preserve the potency of the product; or

(b) for a product other than a biological product, the date (month and year) during which the processing of the bulk product, from which the goods are to be packaged, is completed;

‘delivered dose’ means in relation to:

(a) pressurised metered dose preparations for inhalation, the dose delivered from the inhaler to the patient. For those preparations established as a metered dose, the metered dose is determined by adding the amount deposited within the device to the delivered dose. It may be determined directly; and

(b) powders for inhalation, the dose delivered from the inhaler. For those preparations established as metered dose, the dose is determined by adding the amount deposited within the device to the delivered dose. It may be determined directly;

‘diluent’ means a liquid which is used to dilute a medicament for injection in order to prepare a dosage form;

‘directions for use’ means directions that include:

(a) where the goods are intended for ingestion or are intended for parenteral use, the method, dose and frequency of administration of the goods except where:

(i) the goods, other than vaccines, are specified in Schedule 4 or Schedule 8 of the Poisons Standard; or

(ii) the dose of the goods is usually determined for each individual patient by a medical practitioner, dentist, complementary healthcare practitioner, or by any other person authorised under relevant State/ Territory legislation to determine the dose; and

(b) where the goods are not intended for ingestion or are not intended for parenteral use, the method and frequency of administration, unless the goods are specified in Schedule 4 or Schedule 8 of the Poisons Standard; and

(c) in any case where the goods require some preparation, such as dissolving, suspending, diluting or reconstituting before use, instructions for preparation and statement of the conditions of storage and the maximum period of storage between preparation and use;

dispensing pack’, in relation to complementary healthcare, means a pack which is to be supplied solely to complementary healthcare practitioners for supply to a person after affixing an instruction label following a consultation with that person;

‘excipient’ means an ingredient of a medicine other than an active ingredient;

‘expiry date’ means the date (month and year) after which the goods should not be used, being a date not more than five years after the date of manufacture;

‘expiry date prefix’ means the prefix which precedes the expiry date, and clearly indicates that the following information is the expiry date. Examples of acceptable prefixes include ‘Expiry Date’, ‘EXPIRY DATE’, ‘Expiry’, ‘EXPIRY’, ‘Expires’, ‘EXPIRES’, ‘Exp. Date’, ‘EXP. DATE’, ‘Use before’, ‘USE BEFORE’, ‘Use By’, ‘USE BY’, ‘Exp’, or ‘EXP’ but terms such as ‘Best by’ or words to this effect are not acceptable;

‘goods’ means a medicine;

‘herbal substance’ has the same meaning as in regulation 2 of the Regulations

[NOTE: the definition as at the date of this Order is as follows:

herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):

(a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and

(b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form];

‘homoeopathic potency’ means the dilution factor 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;

‘homoeopathic preparation’ has the same meaning as in regulation 2 of the Regulations

[NOTE: the definition as at the date of this Order is as follows:

homoeopathic preparation means a preparation:

(a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and

(b) prepared according to the practices of homoeopathic pharmacy using the methods of:

(i) serial dilution and succussion of a mother tincture in water, ethanol, aqueous ethanol or glycerol; or

(ii) serial trituration in lactose];

‘hypertonic’, in relation to the tonicity of large volume injections, means an injection with an osmolality of more than 350 milliosmoles per kilogram of solvent;

‘hypotonic’, in relation to the tonicity of large volume injections, means an injection with an osmolality of less than 250 milliosmoles per kilogram of solvent;

‘isotonic’, in relation to the tonicity of large volume injections, means an injection with an osmolality within the range 250 milliosmoles to 350 milliosmoles per kilogram of solvent;

‘label’ means a display of printed information upon, or securely affixed to, the container and any primary pack containing the goods;

‘large volume injection’ means an injection having a volume of greater than 100 millilitres;

‘letter height’ means the height of upper case (capital) letters or lower case letters having an ascender or descender, unless otherwise stated;

‘listing or registration number’ means the combination of numbers, symbols and letters assigned to the goods under section 27 of the Act;

‘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 product name is more or most conspicuously shown; or

(b) where the product name is equally conspicuous on two or more labels or portions of a label - each such label or portion;

‘medicament for injection’ means a substance in a container to which a sterile diluent is added to prepare an injection;

‘medicine’ has the same meaning as defined in subsection 3(1) of the Act

[NOTE: the definition as at the date of this Order is as follows:

medicine means:

(a) therapeutic goods that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or animal; and

(c) any other therapeutic goods declared by the Secretary, for the purpose of the definition of therapeutic device, not to be therapeutic devices];

‘name and address’ in respect of a sponsor or supplier, means the name of the sponsor or supplier and sufficient information to allow the Australian sponsor or supplier to be uniquely identified so as to facilitate public contact on matters of complaint, use or general enquiry. The address must include information such as the city or suburb of the sponsor’s/supplier’s principal place of business in Australia, (not being a post office, cable, telegraphic or code address). The Australian telephone number may also be included;

‘name of an active ingredient’ means:

(a) the name of the active ingredient that is approved 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 approved for inclusion in the Australian Approved Names List, together with a statement of the homoeopathic potency; or

(ii) until such time as a name appears 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 approved for inclusion in the Australian Approved Names List;

‘name of the dosage form’ means a word or words denoting the usual name of the pharmaceutical form of the medicine;

‘non-proprietary name’ means the name used to describe the goods in a specific standard. It includes the name of the dosage form. If no specific standard exists, a name comprising
the name(s) of the active ingredient(s) and the name of the dosage form;

‘Poisons Standard’ means the current Poisons Standard as defined in section 52A of the Act;

‘primary pack’ has the same meaning as in subsection 3(1) of the Act

[NOTE: the definition as at the date of this Order is as follows:

primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers];

‘product name’ means the proprietary name of the goods, or if there is no proprietary name, the non-proprietary name of the goods;

‘proprietary name’ means the registered trademark of the therapeutic goods or the unique name assigned to the goods by the sponsor and appearing on a label;

‘quantity of the goods’ means:

(a) where the goods consist of discrete units, such as tablets or capsules - the stated number of units in the container; or

(b) where the goods are -

(i) a solid or semi-solid, other than a biological product or a medicine for injection - the stated weight of the solid or semi-solid in the container;

(ii) a liquid, other than a biological product - the stated volume of the liquid in the container;

(iii) a pressurised metered-dose preparation or dry powder inhaler - the stated number of doses in the container;

(iv) a non-pressurised metered dose preparation - the minimum number of doses in the container;

(v) a solid biological product - the stated number of doses or potency units in the container;

(vi) a liquid biological product - the stated volume of liquid in the container and, in addition, either the total number of doses or potency units in the container or the number of doses or potency units per unit volume.

‘registration or listing number’ means the combination of numbers, symbols and letters assigned to the goods under section 27 of the Act;

‘Regulations’ means the Therapeutic Goods Regulations 1990, as amended from time to time;

‘small volume injection’ means an injection having a volume of less than or equal to 100 millilitres;

‘solid ophthalmic medicine’ means a substance in a container to which a sterile diluent is added to prepare eye drops or an eye lotion;

‘Sponsor’ has the same meaning as in subsection 3(1) of the Act

[NOTE: the definition as at the date of this Order is as follows:

sponsor in relation to therapeutic goods, means:

(a) a person who exports, or arranges the exportation of, the goods from Australia; or

(b) a person who imports, or arranges the importation of, the goods into Australia; or

(c) a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere);

but does not include a person who:

(d) exports, imports or manufactures the goods; or

(e) arranges the exportation, importation or manufacture of the goods;

on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia];

‘standard’ has the same meaning as in subsection 3(1) of the Act

[NOTE: the definition as at the date of this Order is as follows:

standard, in relation to therapeutic goods, means a standard that:

(a) is specified in an order under section 10 that is applicable to the goods; or

(b) if no such order is applicable to the goods but the goods are the subject of a monograph in:

(i) in the case of goods for use in humans - the British Pharmacopoeia; or

(ii) in the case of goods for use in animals - the British Pharmacopoeia (Veterinary)

is constituted by the statements in that monograph];

Note: New editions of, or additions or amendments to, the British Pharmacopoeia or British Pharmacopoeia (Veterinary) apply from the day specified by the Minister administering the Act by Order published in the Commonwealth of Australia Gazette;

‘warning statements’ means:

(a) any advisory statements that are required to be included in a medicine’s label as specified in the Medicines Advisory Statements Specification 2014, a legislative instrument made by the Minister under subsection 3(5A) of the Act, as in force from time to time;

(b) any warning statements specified in the standard that applies to the medicine;

(c) a warning statement indicating that incorrect route or method of administration may be hazardous;

(d) any warning required by the Secretary of the Department of Health to be included as a condition of registration or listing in relation to the medicine;

(e) any warning statement specified in the Regulations that applies to the medicine;

(f) any warning statements specified in the Poisons Standard that applies to the medicine.

2(2) In this Order, unless indicated to the contrary, a reference to:

(a) a section or a subsection is a reference to a provision in the Act;

(b) a regulation or subregulation is a reference to a provision in the Regulations; and

(c) a clause or a subclause is a reference to a provision of this Order.