Section 10 - Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines - Qualifications and special requirements | Zoe
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
10Qualifications and special requirements
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Turn the raw legal text into a practical explanation grounded in Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines.
In addition to the requirements of sections 8 and 9 above, if a medicine is a preparation for ophthalmic use, the label on the container and on the primary pack or, where subsections 10(11) or 10(12) applies, on the primary pack, must include:
(a) the name of any antimicrobial preservative in the medicine;
(b) if the medicine, other than an ophthalmic ointment, does not contain an antimicrobial preservative - the statement ‘Contains no antimicrobial preservative. Use once only and discard residue’ or words to that effect;
(c) if the medicine is for multidose use - a statement to the effect that ‘the medicine should not be used more than four weeks’, or such shorter period as specified in the approved product details in relation to the medicine, after the container is first opened;
(d) if the medicine consists of a solid ophthalmic medicine for preparing eye drops for multidose use - a statement to the effect that the medicine when prepared should not be used more than four weeks or such shorter period as specified in the approved product details in relation to the medicine, after the container is first opened.
(e) if the medicine consists of a solid ophthalmic medicine for preparing eye drops for multidose use - the words ‘for eye drops’.
Injections in a container with capacity greater than 100 millilitres
In addition to the requirements under sections 8 and 9 applying to the label on the container and on the primary pack, a medicine that is an injection in a container having a capacity of greater than 100 millilitres must, except where subsection 10 (7) applies, include the following information or statements on the label on the container and on the primary pack:
(a) the name and quantity of each excipient in the stated volume of fill of the injection in the container; and
(b) where the medicine contains an active ingredient that is not intended for electrolyte replacement or nutritional therapy and is not intended for use as a radio-contrast agent or as a plasma volume expander or replacement - the information must include a statement of the proportion of that active ingredient expressed in terms of weight (or potency, if appropriate) in the stated volume of fill of the injection in the container; and
(c) where the medicine contains more than three active ingredients belonging to the same class of substances, such as amino acids, carbohydrates or electrolytes in the medicine – the information must include the class of substances and the name of the dosage form; and
(d) where the medicine contains iodine and is intended for use as a radio-contrast agent - a statement of the equivalent amount of iodine in terms of milligrams of iodine per millilitre; and
(e) where the medicine is intended for use as a radio-contrast agent or as a plasma volume expander or replacement - the product name must include a statement of the proportions of dissolved, emulsified or suspended active ingredient(s) in the goods; and
(f) the statement ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’ or words to that effect; and
(g) where the medicine is intended for electrolyte replacement, has a stated volume of 100 millilitres or less, and is manufactured or imported on or after 1 December 2026 – a statement, located immediately below the text mentioned in subsection 9(3), of:
(i) for potassium chloride—the equivalent quantity of potassium chloride in weight (in relation to the stated volume of fill of the injection); and
(ii) for all other active ingredients—the equivalent quantity of each active ingredient in millimoles (in relation to the stated volume of fill of the injection).
Injections in a container with a capacity of 100 millilitres or less
Except where subsection 10(4) or 10(5) below applies in relation to the label on a container, if a medicine is an injection in a container with capacity of 100 millilitres or less, then in addition to the requirements of sections 8 and 9 above, the label on the container and on the primary pack must include:
(a) the name and quantity of each excipient in the medicine, expressed:
(i) for single dose injections (including concentrated solutions for injection) - as the nominal mass of that excipient (not including any overage) in the stated volume of fill of the injection in the container;
(ii) for a powder for injection - as the nominal mass of that excipient (not including any overage) in the container;
(iii) where the injection is intended for multidose use - as the quantity of that excipient in one millilitre of the injection or where the dose volume is less than one millilitre as the quantity in that dose volume; and
(b) where the medicine is supplied in a container with potential for multidose use, such as a vial or pre-filled syringe, and an antimicrobial preservative is not included in the medicine - the statement ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’ or words to that effect; and
(c) where the medicine is a concentrated solution for injection, a direction not to administer the solution undiluted; and
(d) where the medicine is an injection containing iodine and is intended for use as a radio-contrast agent - a statement of the equivalent amount of iodine in terms of milligrams of iodine per millilitre; and
(e) where the medicine is intended for electrolyte replacement and is manufactured or imported on or after 1 December 2026 – a statement, located immediately below the text mentioned in subsection 9(3), of:
(i) for potassium chloride—the equivalent quantity of potassium chloride in weight (in relation to the stated volume of fill of the injection); and
(ii) for all other active ingredients—the equivalent quantity of each active ingredient in millimoles (in relation to the stated volume of fill of the injection).
Injections in a container with a capacity of 25 millilitres or less
Except where subsection 10(5) applies, if a medicine is an injection that:
(a)is in a container with capacity of 25 millilitres or less; and
(b) the container is enclosed in a primary pack, the label of which complies with sections 8 and 9 and subsection 10(3)
then, in relation to compliance of the label on the container with sections 8 and 9 and subsection 10(3), it shall be sufficient if the following information is displayed in a text size of not less than 2.0 millimetres:
(c) the name of the medicine; and
(d) the name(s) of all active ingredients in the medicine;
and the following information is displayed in a text size of not less than 1.5 millimetres:
(e) the quantity or proportion of all active ingredients in the medicine; and
(f) the name of the dosage form; and
(g) the quantity of the medicine; and
(h) the batch number of the medicine preceded by the batch number prefix; and
(i) the expiry date of the medicine preceded by the expiry date prefix; and
(j) the name of the sponsor or distributor as it appears on the primary pack, or registered trademark if it readily identifies the sponsor or distributor of the medicine; and
(k) the approved route of administration for the medicine, such as ‘intravenous’, ‘intramuscular’ or ‘subcutaneous’ or other phrase, word or abbreviation denoting the approved route(s) of administration; and
(l) where the medicine is an injection containing iodine and is intended for use as a radio-contrast agent - a statement of the equivalent amount of iodine in terms of milligrams of iodine per millilitre; and
(m) where the medicine is intended for electrolyte replacement and is manufactured or imported on or after 1 December 2026 – a statement, located immediately below the text mentioned in subsection 9(3), of:
(i) for potassium chloride, and unless precluded by the container size—the equivalent quantity of potassium chloride in weight (in relation to the stated volume of fill of the injection); and
(ii) for all other active ingredients—the equivalent quantity of each active ingredient in millimoles (in relation to the stated volume of fill of the injection).
Injections in a container with a capacity of 3.0 millilitres or less
If a medicine is an injection that:
(a) is in a container with a capacity of 3.0 millilitres or less; and
(b) the container is enclosed in a primary pack, the label of which complies with the sections 8 and 9 and subsection 10(3)
then, in relation to compliance of the label on the container with sections 8 and 9 and subsection 10(3), it shall be sufficient if:
(c) the name of the medicine is displayed in a text size of not less than 1.5 millimetres; and
the following information is displayed in a text size of not less than 1.0 millimetre:
(d) the quantity of the medicine; and
(e) the batch number of the medicine preceded by the batch number prefix; and
(f) the expiry date of the medicine preceded by the expiry date prefix; and
(g) the approved route of administration for the medicine, such as ‘intravenous’, ‘intramuscular’ or ‘subcutaneous’ or other phrase, word or abbreviation denoting the approved route(s) of administration; and
(h) if the medicine contains only one active ingredient - the name of the active ingredient and the quantity or proportion of the active ingredient in the medicine, or suitable unambiguous abbreviation of the name and quantity, unless the name of the medicine includes this information; and
if the medicine is available in more than one strength, the quantity or proportion of each active ingredient, unless the name of the medicine includes this information.
Injections with a stated volume of fill of 100 millilitres or more
In addition to the requirements under subsection 10(2) or 10(3), a medicine that is an injection with a stated volume of fill equal to or greater than 100 millilitres must also include the following information on the label on the container and the primary pack:
(a) where the medicine contains one or more active ingredients that are amino acids and/or protein - a statement giving the total amount of nitrogen, in grams, in the stated volume of fill of the injection in the container; and
(b) where the medicine is intended for use as an energy source - a statement of the energy equivalent, in kilojoules, of the stated volume of fill of the injection in the container; and
(c) a statement specifying whether the injection is hypotonic, hypertonic or isotonic; and
(d) the osmolality of the injection solution; and
(e) the pH range of the injection solution.
Haemofiltration and haemodiafiltration solutions
The label on the container and on the primary pack of a medicine that is a haemofiltration or haemodiafiltration solution must, in addition to the requirements referred to in sections 8 and 9, include:
the name and quantity of each active ingredient per litre of solution following preparation in accordance with directions; and
the name and quantity of each active ingredient in terms of millimoles per litre of solution following preparation in accordance with directions; and
a statement specifying whether the solution is hypotonic, hypertonic or isotonic; and
the osmolality of the solution; and
the pH range of the solution; and
a statement ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’ or words to that effect.
Peritoneal dialysis solutions
The label on the container and on the primary pack of a medicine that is a solution for use in peritoneal dialysis must, in addition to the requirements referred to in sections 8 and 9, include:
(a) the formulation of the solution expressed in grams per litre and in millimoles per litre, including, if it is a concentrate for a peritoneal dialysis solution, the formulation both before and after dilution; and
(b) the calculated osmolarity expressed in milliosmoles per litre; and
(c) the nominal volume of the solution in the container; and
(d) a statement that the solution is free from bacterial endotoxins, or where applicable, that it is apyrogenic; and
(e) a statement that the solution is not to be used for intravenous infusion; and
(f) a statement ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’ or words to that effect; and
(g) if a concentrate, the statement ‘Dilute before use.’
In addition to the requirements of sections 8 and 9, and the requirements in subsections 10(3), (4), (5) and (15) as applicable, if a medicine contains a neuromuscular blocking agent, then:
(a) the label on the primary pack must include the warning statement ‘Warning: Paralysing agent’ in black text on a fluorescent red or warm red background; and
(b) the label on the container must include the warning statement ‘Warning: Paralysing agent’ in black text on a fluorescent red or warm red background, except:
(i) where subsection 10(5) applies, in which case this warning statement may be shortened to ‘Warning: Paralyser’ or ‘Paralyser’; or
(ii) where subsection 10(15) applies, in which case this warning statement must be on the label of each ampoule, and may be shortened to ‘Warning: Paralyser’ or ‘Paralyser’, and may be in any colour text with no background colour.
Preparations for use on skin and/or mucous membranes or by inhalation, and metered nasal sprays
The label on a container and on a primary pack (if any) of a medicine that is a preparation for use on skin and/or mucous membranes or is for inhalation or is a metered nasal spray, must, in addition to the requirements referred to in sections 8 and 9 above, include the name of any antimicrobial preservative in the medicine.
Starter packs
Where a medicine is presented in a starter pack, in addition to the requirements referred to in sections 8 and 9, the label on the container or primary pack (if any) must include:
(a) sufficient space to accommodate a prescriber’s addition of at least the following dispensing details: patient’s name, prescriber’s name and telephone number, directions for use including dose, and date of supply; and
(b) the statement ‘starter pack’ or words to that effect.
Small containers (not including injections)
If:
(a) the medicine is enclosed in a small container (but is not a very small container) and is not an injection; and
(b) the container is enclosed in a primary pack, the label of which complies with sections 8 and 9 and subsection 10(1) (if applicable),
then, in relation to compliance of the label on the container with sections 8 and 9 and subsection 10(1) (if applicable), it shall be sufficient if the following information is displayed in a text size of not less than 2.0 millimetres:
(c) the name of the medicine; and
(d) the name(s) of all active ingredients in the medicine, unless there are four or more active ingredients;
and the following information is displayed in a text size of not less than 1.5 millimetres:
(e) where there are four or more active ingredients, the name(s) of all active ingredients in the medicine; and
(f) the quantity or proportion of all active ingredients in the medicine; and
(g) the name of the dosage form; and
(h) the quantity of the medicine in the container; and
(i) the batch number of the medicine preceded by the batch number prefix; and
(j) the expiry date of the medicine preceded by the expiry date prefix; and
(k) the name of the sponsor or distributor as it appears on the primary pack, or registered trademark if it readily identifies the sponsor or distributor of the medicine; and
(l) if the medicine is contained in an ampoule - a statement of the approved route of administration for the medicine, such as ‘inhalation’, ‘For oral use only’ or other phrase, word or abbreviation denoting the approved route(s) of administration of the medicine; and
(m) if the medicine:
(i) is an ophthalmic preparation for multidose use - a statement to the effect that the medicine should not be used later than four weeks, or another shorter period as specified in the approved product details in relation to the medicine, after the container is first opened ; or
(ii) consists of a solid ophthalmic medicine for preparing eye drops for multidose use - a statement to the effect that the medicine when prepared should not be used later than four weeks, or another shorter period as specified in the approved product details in relation to the medicine, after the container is first opened;
Very small containers (not including injections)
If:
(a) the medicine is enclosed in a very small container but is not an injection; and
(b) the container is enclosed in a primary pack, the label of which complies with sections 8 and 9 and subsection 10(1) (if applicable),
then, in relation to compliance of the label on the container with sections 8 and 9, and subsection 10(1) (if applicable), it shall be sufficient if the name of the medicine is displayed in a text size of not less than 1.5 millimetres, together with the following information displayed in a text size of not less than 1.0 millimetre:
(c) the quantity of the medicine in the container; and
(d) the batch number of the medicine preceded by the batch number prefix; and
(e) the expiry date of the medicine preceded by the expiry date prefix; and
(f) if the medicine is contained in an ampoule - a statement of the approved route of administration for the medicine, such as ‘inhalation’, ‘For oral use only’ or other phrase, word or abbreviation denoting the approved route(s) of administration of the medicine; and
(g) if the medicine contains only one active ingredient - the name of the active ingredient and the quantity or proportion of the active ingredient in the medicine, or suitable unambiguous abbreviation of the name and quantity.
Individually wrapped medicines
(i) a medicine consists of individual dosage units such as tablets, capsules, pills, pastilles, cachets, lozenges, pessaries, suppositories, single doses of a powder, single doses of a liquid, or a transdermal patch; and
(ii) each dosage unit is enclosed in an individual wrapper or blister, whether sealed or unsealed; and
(iii) one or more dosage units are enclosed in a primary pack; and
(iv) the label on the primary pack complies with sections 8 and 9,
then, in relation to compliance of the label on each individual wrapper or blister with sections 8 and 9, it shall be sufficient if the following information is displayed:
(v) the name of the medicine; and
(vi) the name(s) of all active ingredients in the medicine; and
(vii) the quantity or proportion of all active ingredients in the medicine; and
(viii) the batch number of the medicine preceded by the batch number prefix; and
(ix) the expiry date of the medicine preceded by the expiry date prefix; and
(x) the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.
(b) If:
(i) the medicine consists only of pastilles or lozenges; and
(ii) each dosage unit is enclosed in an unsealed individual wrapper; and
(iii) each dosage unit is, after being so wrapped, enclosed in a primary pack that complies with sections 8 and 9,
then, in relation to compliance of the label for each individual wrapper with sections 8 and 9, it shall be sufficient if the name of the medicine is displayed.
Strip, blister and dial dispenser packs
(i) a medicine consists of individual dosage units such as tablets, capsules, pills, pastilles, cachets, lozenges, pessaries, suppositories or single doses of powder; and
(ii) two or more dosage units are individually enclosed in a strip, blister or dial dispenser pack such that the dosage units can only be extracted individually; and
(iii) the strip, blister or dial dispenser pack is enclosed in a primary pack, the label of which complies with sections 8 and 9,
then, in relation to compliance of the label on the strip, blister or dial dispenser pack with sections 8 and 9, it shall be sufficient if the following information is displayed:
(iv) the name of the medicine; and
(v) the name(s) of all active ingredients in the medicine; and
(vi) the quantity or proportion of all active ingredients in the medicine; and
(vii) the batch number of the medicine preceded by the batch number prefix; and
the expiry date of the medicine preceded by the expiry date prefix; and
the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.
(b) If, in relation to a medicine referred to in (a) there are:
(i) four or more active ingredients in the medicine,
then, in relation to compliance of the label on the strip, blister or dial dispenser pack with sections 8 and 9, it shall be sufficient if the following information is displayed:
(ii) the name of the medicine; and
the batch number of the medicine preceded by the batch number prefix;
the expiry date of the medicine preceded by the expiry date prefix; and
(v) the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.
(c) In addition to the requirements referred to in paragraphs 10(14)(a) and (b) as relevant, if each dosage unit is enclosed in the strip or blister such that an individual segment containing the dosage unit can be readily detached, then the following information must appear on the label of the strip or blister at least once in relation to every two dosage units:
for a medicine to which paragraph 10(14)(a) applies – the name of the medicine, the name(s) of all active ingredients in the medicine and the quantity or proportion of all active ingredients in the medicine; and
for a medicine to which paragraph 10(14)(b) applies – the name of the medicine.
Plastic ampoules
(i) a medicine is contained in a plastic ampoule, whether or not it is a medicine for injection; and
(ii) the capacity of the plastic ampoule is 8 millilitres or less; and
(iii) two or more ampoules are attached to a connecting strip; and
(iv) the ampoules and their connecting strip are enclosed in a primary pack that complies with the requirements of this Order,
then the information required by this Order to appear on the label of the container of the medicine may be divided between the ampoule and the connecting strip.
(b) Whether or not the seal is broken when an ampoule is detached from the strip, the following information must appear on the label of each ampoule:
(i) the name of the medicine; and
(ii) the name(s) of all the active ingredients in the medicine; and
(iii) the quantity or proportion of all active ingredients in the medicine; and
(iv) the batch number of the goods preceded by the batch number prefix; and
(v) the expiry date of the goods preceded by the expiry date prefix; and
(vi) the approved route(s) of administration followed by the word ‘only’ and/or warnings against use by other routes of administration.
(c) If a medicine is contained in a plastic ampoule with a capacity of 25 millilitres or less, but greater than 8 millilitres, then the requirements of subsection 10(4), or subsection 10(11), as relevant, apply notwithstanding the container being a plastic ampoule.
(d) If a medicine is contained in a plastic ampoule with a capacity greater than 25 millilitres, then the requirements of subsection 10(2) or subsection 10(3), as relevant, apply notwithstanding the container being a plastic ampoule.
Composite packs
(a) The expiry date on the package that, together with medicines, constitutes a composite pack must be the earliest of the expiry dates of the medicines that constitute the composite pack.
(b) The storage conditions on the package that, together with medicines, constitutes a composite pack must be the most restrictive of the storage conditions of the medicines that constitute the composite pack.
Note: The label on the container and primary pack (if any) of each medicine comprising a composite pack must comply with this Order.
11 How information is to be expressed
11 How information is to be expressed
Use of appropriate metric units
(a) For active ingredient(s), where a particular is a statement of mass for which there is a metric unit of measurement, the metric units must be expressed as follows:
(i) a statement of quantity for 1 microgram up to 999 micrograms inclusive must be expressed in terms of micrograms;
(ii) a statement of quantity for 1000 micrograms may be expressed as either 1000 micrograms or 1 milligram;
(iii) a statement of quantity for more than 1 milligram up to 999 milligrams inclusive must be expressed in terms of milligrams;
(iv) a statement of quantity for 1000 milligrams may be expressed as either 1000 milligrams or 1 gram; and
(v) a statement of quantity for more than 1 gram up to 999 grams inclusive must be expressed as grams.
(b) Where a range of medicines contains the same active ingredient(s) in the same dosage form in a series of strengths then the label must state the quantity of each active ingredient in terms of either the highest or lowest metric unit of measurement in the series of strengths.
Example: A range of expressions for active ingredient may be stated as 0.5 milligram, 1 milligram and 5 milligrams, or 500 micrograms, 1000 micrograms and 5000 micrograms, but not 500 micrograms, 1 milligram and 5 milligrams.
Note: The abbreviations ‘mg’ and ‘g’ can be used on all labels but ‘microgram’ should be used in full unless the medicine is in a small or very small container. Then the abbreviation ‘g’ may be used.
(c) Where the active ingredient is in liquid form, the equivalent metric units of volume must be expressed in the same manner.
Example: A statement of volume for more than 1 millilitre up to 999 millilitres inclusive must be expressed in terms of millilitres, but a statement of volume for 1000 millilitres may be expressed as either 1000 millilitres or 1 litre.
Note: The abbreviations ‘mL’ and ‘L’ can be used on all labels, but 'microlitre' should be used in full unless the medicine is in a small or very small container. Then the abbreviation 'L' may be used.
(d) Where the information is a statement of mass or volume, the unit of measurement must be consistent with the unit of measurement used in any warning statement required for that ingredient.
(e) Where a statement of quantity is expressed as less than one (1) unit, the statement of quantity must include the leading zero.
Expression of quantity or proportion of active ingredients
Subject to subsections 11(3) or 11(4) below, the quantity or proportion of an active ingredient to be included on a label must be expressed:
(a) for a discrete dosage unit - as the quantity of the active ingredient in the dosage unit;
(b) 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;
(c) subject to paragraph (d) below, if the medicine is a liquid for ingestion:
(i) as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid; or
(ii) in the case where the liquid for ingestion is one of a series of strengths containing the same active ingredient – as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid with the quantity or proportion of active ingredient expressed consistently across the series in terms of the same stated dose volume.
Example: Where the dose volume is 5 mL, and there are strengths of 1 mg/mL and 5 mg/mL, these must be labelled as 5 mg in 5 mL and 25 mg in 5 mL, respectively.
(d) for a medicine required to be prepared before use, and:
(i) where the process results in a medicine that is a liquid for ingestion:
(A) 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 medicine; or
(B) in the case where the medicine is one of a series of strengths containing the same active ingredient - 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 medicine with the quantity or proportion of active ingredient expressed consistently across the series in terms of the same stated dose volume; and
Example: Where the dose volume is 5 mL after preparation, and there are strengths of 1 mg/mL and 5 mg/mL, these must be labelled as 5 mg in 5 mL and 25 mg in 5 mL, respectively.
(ii) for any other medicines - as the weight or volume of active ingredient in a stated weight or volume of the medicine, after preparation in accordance with the instructions included in the label of the medicine;
(e) for a transdermal patch, intrauterine drug delivery system or implant - as the total quantity of the active ingredient in each patch, drug delivery system or implant and the quantity of the active ingredient released in a stated time;
(f) for a medicine for injection:
(i) where the medicine is a powder for injection or a concentrated solution for injection, and is not intended for electrolyte replacement – as the stated weight of the active ingredient in the container;
(ii) where the stated volume of the medicine for injection is greater than 100 millilitres and the medicine is intended:
for electrolyte replacement or nutritional therapy; or
as a plasma volume expander; or
as an additive to any of these types of injection,
then:
(D) 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
(E) 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;
(iii) where the stated volume of the medicine for injection is greater than 100 millilitres and the medicine contains 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;
(iv) where the medicine for injection is intended for multidose use:
(A) where the stated volume in the container is greater than 1 millilitre - as the quantity of the active ingredient in one millilitre of the injection; and
(B) the volume in the container is less than or equal to 1 millilitre - as the quantity of the active ingredient in a suitable dose volume of the injection;
(v) where the medicine for injection is intended for use as a single dose (whether dilution is required or not), and is not intended for electrolyte replacement - as the stated weight of the active ingredient in the stated volume of fill of the injection in the container;
(vi) where the stated volume of the medicine for injection is 100 millilitres or less, and the medicine is intended for electrolyte replacement - the following:
(A) for potassium chloride—as the number of millimoles of potassium chloride in the stated volume of fill of the injection in the container;
(B) for all other active ingredients—as the stated weight of each active ingredient in the stated volume of fill of the injection in the container;
(g) 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;
(h) for pressurised metered dose inhalers, dry powder inhalers and other metered dose products such as nasal sprays, the quantity of the active ingredient is:
(i) the quantity delivered per actuation; or
where the Secretary, when registering the medicine, has accepted that the dose of products containing those active ingredients was clinically established as the metered dose, then:
(ii) the quantity metered per actuation;
(i) for preparations applied to the skin and mucous membranes, other than those covered by paragraphs (g) and (h) - 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 medicine, as appropriate;
(j) for the purposes of paragraphs 11(2)(a) – 11(2)(d), for oral preparations that contain active ingredients intended for mineral supplementation, it is sufficient that the quantity or proportion of that active ingredient to be included on a label be expressed as:
(i) the name of the active ingredient; and
(ii) the name and quantity of the element intended for mineral supplementation.
(k) In addition to the requirements of paragraphs 11(2)(a) –11(2)(i), the following requirements apply in the circumstances specified in the following subparagraphs:
(i) for preparations containing Vitamin A or a derivative of Vitamin A - as the equivalent quantity or proportion of Vitamin A expressed in terms of microgram retinol equivalents;
(ii) for a preparation containing biological organisms - as the number of organisms present per metric unit for liquids and powders and as the number of organisms present per dosage unit for other dosage forms;
(l) for any other medicines:
(i) where the medicine is a liquid and includes 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 medicine;
(ii) where the medicine is a liquid and includes an active ingredient which is a solid - as the weight of active ingredient in a stated volume of the medicine;
(iii) where the medicine is a liquid and includes an includes an active ingredient which is a gas - as the weight of the active ingredient in a stated volume of the medicine;
(iv) where the medicine is a solid or semi-solid and includes 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 medicine;
(v) where the medicine is a solid or semi-solid and includes an active ingredient which is a solid - as the weight of the active ingredient in a stated weight of the medicine.
Expression of potency in biological medicines
(a) For a liquid biological medicine or a biological medicine required to be prepared before use, the potency:
(i) must be included on the label of the medicine; and
(ii) must be expressed as potency units, or weight of active ingredient per dose or per unit volume, or as the volume which contains the recommended dose.
The potency unit to be used must be:
the International Unit (IU) established by the World Health Organization;
a unit defined in an applicable default standard; or
where IU or pharmacopoeial monographs have not been established, then the potency unit to be used is that specified in the approved product details in relation to the medicine.
Expression of activity of radionuclides in radiopharmaceutical preparations
The quantity or proportion of an active ingredient which is a radionuclide and is included in a radiopharmaceutical preparation must be:
included on labels; and
expressed in terms of the total activity of the radionuclide in the container, in becquerels, at a specified date and hour.
Permitted statements of storage temperature conditions
For the purposes of this Order, the following statements of storage temperature conditions are permitted:
(i) ‘Store below –18oC (Deep freeze)’;
(ii) ‘Store below –5oC (Freeze)’;
(iii) ‘Store at 2oC to 8oC (Refrigerate. Do not freeze)’;
(iv) ‘Store below 25oC’;
(v) ‘Store below 30oC’; and
(vi) any other storage temperature conditions as specified in the approved product details in relation to the medicine.
Inclusion of common names of vitamins
Where a medicine contains an active ingredient that is a vitamin, then the word ‘vitamin’, or any suitable unambiguous abbreviation of the word vitamin, together with the common name of that vitamin, may appear on a main label of the medicine either:
on the same line of text - between the approved name of the active ingredient that is a vitamin and the quantity of that active ingredient; or
on a separate line of text - immediately below the related name of the active ingredient that is a vitamin and the quantity of that active ingredient.