Therapeutic Goods Order No. 69 - General requirements for labels for medicines (27/08/2001)
4Expression of quantity or proportion of active ingredient in medicines
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4 Expression of quantity or proportion of active ingredient in medicines
Except as provided in clause 6 (Expression of activity of radionuclides in radiopharmaceutical preparations) and subclause 3(7) (Dialysis concentrates), the quantity or proportion of an active ingredient to be included on a label as required by subclause 3(2)(c) must be expressed:
4(1) for a discrete dosage unit - as the quantity of the active ingredient in the dosage unit;
4(2) for a liquid for ingestion - as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid;
4(3) for a solid for ingestion, where there is no discrete dosage unit - as the quantity of the active ingredient contained in the stated weight of a suitable dose of the solid;
4(4) for a transdermal patch - as the quantity of the active ingredient released in a stated time;
4(5) for a homoeopathic preparation, where all the active ingredients are homoeopathic preparations: -
(a) notwithstanding subclauses 4(1), 4(2) and 4(3), as the quantity of the ingredient in one millilitre or in one gram of the preparation; or
(b) where each active ingredient is included in the preparation in the same proportion as every other active ingredient - expressed as ‘Contains equal parts of’ followed by the name of each homoeopathic ingredient;
4(6) for goods which are required to be prepared before use and which after preparation are a liquid for ingestion - as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid, after preparation in accordance with the instructions set out on the label of the goods;
4(7) for a preparation for injection:
(a) where the preparation is a medicament for injection - as the nominal quantity of the active ingredient in the container;
(b) where the injection is intended for multidose use and
(i) the volume in the container is 1 millilitre or greater - as the quantity of the active ingredient in one millilitre of the injection; or
(ii) the volume in the container is less than 1 millilitre - as the quantity of the active ingredient in a suitable dose volume of the injection;
(c) where the injection is a small volume injection and is usually intended for administration as a single dose - as the quantity of active ingredient in the stated volume of the injection in the container.
Note: In justified cases the strength may also be incorporated in the product name as a percentage (w/v or v/v) or another concentration term, but not including the quantity of active ingredient per millilitre;
(d) where the preparation is a large volume injection intended for electrolyte replacement or nutritional therapy or is intended as a plasma volume expander or is intended as an additive to any of these types of large volume injection -
(i) as the number of millimoles in the stated volume of the injection in the container for each active ingredient or ion of precisely known molecular weight; or
(ii) as the weight contained in the stated volume of the injection in the container for each active ingredient for which the molecular weight is not precisely known;
(e) where the preparation is a large volume injection containing an active ingredient which is not intended for electrolyte replacement or nutritional therapy or as a plasma volume expander - as the weight of the active ingredient in the stated volume of injection in the container;
4(8) for antibiotic preparations, where potency units are used as a measure of activity - as the number of such units expressed as International Units (IU) established by the World Health Organization;
4(9) for any other goods which are required to be prepared before use - as the weight or volume of active ingredient in a stated weight or volume of the goods, after preparation in accordance with the instructions included in the label of the goods;
4(10) for preparations applied to the skin and mucous membranes (other than those covered by subclause 4(8) above) - as a percentage expressed in terms of w/w, w/v, v/v or v/w, as appropriate, or as the weight or volume in a stated weight or volume of the goods, as appropriate;
4(11) for preparations including a herbal substance:
(a) where a herbal substance is a dry herb, fresh herb, powder, oil, fresh juice or dry juice preparation - as the quantity of the herbal substance in the preparation;
(b) where a herbal substance is an extract, tincture, decoction, infusion or spagyric - as the quantity of the raw material herb used to make the ingredient expressed as the equivalent dry or fresh weight; or
(c) where a herbal substance is a concentrated or diluted juice - as the quantity of the raw material juice used to make the concentrate or dilution expressed as the equivalent dry weight, fresh volume or fresh weight;
4(12) for preparations containing trace elements as salts intended as mineral supplements - as the quantity of the element with the name of the salt being indicated;
4(13) for preparations containing Vitamin A - as the quantity or proportion of Vitamin A expressed in terms of retinol equivalents (R.E.)
4(14) for pressurised metered dose inhalers and dry powder inhalers - as the delivered dose, except where the medicine is the subject of a monograph of the British Pharmacopoeia (BP) and the dose has been established as a metered dose. Where the powder for inhalation is supplied as a single dose in a capsule, or as a well in a blister tray or other suitable pharmaceutical form - as the quantity of active ingredient in each dosage unit;
4(15) for a preparation containing biological organisms - as the number of organisms present per metric unit for liquids and powders and as the number per dosage unit for other dosage forms;
4(16) for any other goods:
(a) where the goods are a liquid and include an active ingredient which is a liquid - as the appropriate amount of the active ingredient, either by weight or volume, in a stated volume of the goods;
(b) where the goods are a liquid and include an active ingredient which is a solid - as the weight of active ingredient in a stated volume of the goods;
(c) where the goods are a liquid and include an active ingredient which is a gas - as the weight of the active ingredient in a stated volume of the goods;
(d) where the goods are a solid and include an active ingredient which is a liquid - as the appropriate amount of the active ingredient, either by weight or volume, in a stated weight of the goods;
(e) where the goods are a solid and include an active ingredient which is a
solid - as the weight of the active ingredient in a stated weight of the goods; or
(f) where the goods are a solid and include an active ingredient which is a gas - as the weight of the active ingredient in a stated weight of the goods.
Part 4 - Therapeutic Goods Order No. 69 - General requirements for labels for medicines (27/08/2001) - Expression of quantity or proportion of active ingredient in medicines | Zoe