{"id":"F2016L01285","name":"Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines","slug":"therapeutic-goods-order-no-91-standard-for-labels-of-prescription-and-related-medicines","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":94754,"registerId":"commonwealth-F2016L01285-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"7","sectionType":"section","heading":"General requirements, including label presentation","content":"7 General requirements, including label presentation\n\n(1) The container, intermediate packaging (if any) and primary pack in which a medicine is packed must each bear a label or labels that comply with the requirements of this Order that are applicable in relation to that medicine.\n\n(2) The information required by this Order to be included on a label or labels must:\n\n(a) be clearly visible and not be obscured; and\n\n(b) be in English; and\n\n(c) be in durable and legible characters; and\n\n(d) unless otherwise specified elsewhere in this Order, be displayed in text size of not less than 1.5 millimetres, except\n\n(i) in the case of the registration number, which must be in a text size of not less than 1.0 millimetre height as required by subparagraph 15(1)(c)(i) of the Regulations; and\n\n(e) be in a colour or colours contrasting strongly with the background, except for:\n\n(i) the expiry date and expiry date prefix; and\n\n(ii) the batch number and batch number prefix\n\nwhen that information is embossed or debossed and not printed; and\n\n(f) unless otherwise specified elsewhere in this Order, be in metric units of measurement.\n\n","sortOrder":0},{"sectionNumber":"8","sectionType":"section","heading":"Information to be included on the label","content":"8 Information to be included on the label\n\n(1) Subject to the qualifications and requirements specified in sections 9 and 10 below, the labels of a medicine must include:\n\n(d) the name of the dosage form; and\n\n(e) the quantity of the medicine; and\n\n(f) the batch number of the medicine preceded by the batch number prefix; and\n\n(g) the expiry date of the medicine, preceded by the expiry date prefix; and\n\n(h) the storage conditions applicable to the medicine; and\n\n(i) the name and contact details of the sponsor or distributor of the medicine; and\n\n(j) where:\n\n(i) a substance or substance within the group of substances referred to in Column 1 of Schedule 1 to this Order is present in the medicine; and\n\n(ii) the circumstances as set out in Column 2 of Schedule 1 exist in relation to such a substance or no circumstances are set out in Column 2; and\n\n1. the medicine is intended to be administered via any one or more of the route(s) of administration referred to in Column 3 of Schedule 1,\n\nthen:\n\n1. a statement:\n\n1. indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1; and\n2. where any of the circumstances and requirements set out in Column 2 of Schedule 1 exist in relation to the substance – a statement of the kind referred to as a ‘requirement’ in that Column (if any)\n\nexcept where a statement is included on the label advising consumers to refer to the Consumer Medicine Information for information about other ingredient(s) present in the medicine that are referred to in Column 1 of Schedule 1 to this Order and where any of the circumstances and requirements in column 2 of Schedule 1 exist in relation to the ingredient (s); and\n\n(k) relevant warning statements, where these are required in relation to a particular medicine; and\n\n(l) if the medicine requires some preparation, such as dissolving, suspending, diluting or reconstituting before use - instructions for its preparation and, where relevant, a statement of the conditions of storage and the maximum period of storage between preparation and use, except where:\n\n(i) there is insufficient space on either the label of the container or the primary pack, or both, to include this information; and\n\n(ii) this information is set out in a package insert provided in the primary pack of the medicine; and\n\n(iii) a statement is included on whichever label on the container, or the primary pack, or both, that does not set out the information itself, that those instructions are set out in the package insert; and\n\n(m) if the medicine is:\n\n(i) an injection or infusion - the approved route(s) of administration, such as 'intravenous', 'intramuscular', or 'subcutaneous' or other phrase, word or abbreviation denoting the approved route(s) of administration; or\n\n(ii) contained in an ampoule but is not an injection - 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; and\n\n(n) a machine readable code, except where the medicine is a starter pack; and\n\n(o) where the medicine is packaged in a primary pack that is a carton, the name of the medicine on at least three non-opposing sides of the carton.\n\n(2) The label on a container for a medicine must include a minimum space of 70 x 30 millimetres for the dispensing label, except where:\n\n(a) the medicine and its container are supplied in a primary pack, in which case the space must be included on the label of the primary pack ; or\n\n(b) this is precluded by the dimensions of either the container or the primary pack; or\n\n(c) the medicine is intended only for use in a clinical setting where self-administration will not occur; or\n\n(d) the medicine is a starter pack.\n\n(3) If the information required on the label on the container is obscured by intermediate packaging, then the label on the intermediate packaging must include:\n\n(d) the batch number of the medicine preceded by the batch number prefix; and\n\n(e) the expiry date of the medicine preceded by the expiry date prefix; and\n\n(f) the name of the sponsor or distributor, or a registered trademark if it readily identifies the sponsor or distributor of the medicine.\n\n(4) If the container is enclosed in a delivery device such that it cannot be removed, the information required on its label under subsection 8(1) must be applied on the delivery device and not the container.\n\n(5) In addition to the requirements under this section, if the medicine comprises both a medicine in a container and an article that is not a device under the provisions of the Act but is included in the primary pack for such purposes as delivery of and/or measuring the medicine, the label on the primary pack must include a description of any such articles.\n\n","sortOrder":1},{"sectionNumber":"9","sectionType":"section","heading":"Information to be included on the main label","content":"9 Information to be included on the main label\n\n(1) Subject to the qualifications and special requirements specified in this section and section 10 of this Order, the information on the main label of the medicine must include:\n\n(d) the name of the dosage form; and\n\n(e) the quantity of the medicine; and\n\n(f) if the medicine is:\n\n(i) an injection or infusion - the approved route(s) of administration, such as 'intravenous', 'intramuscular', or 'subcutaneous' or other phrase, word or abbreviation denoting the approved route(s) of administration; or\n\n(ii) contained in an ampoule but is not an injection - 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; and\n\n(g) if the medicine is a solution for injection, powder for injection or concentrated solution for injection and the route of administration is only for infusion – then in addition to the requirement set out in paragraph (f), the words ‘for infusion’ must be displayed adjacent to the name of the dosage form\n\n(2) The name of the medicine on the main label must be presented in a continuous, uninterrupted manner and not be broken up by additional information or background text.\n\n(3) The name of the medicine and the name(s) of active ingredient(s) on the main label must:\n\n(a) appear as a cohesive unit by the placing of the name and quantity of each active ingredient together on separate lines of text either\n\n(i) immediately below the name of the medicine; or\n\n(ii) where the trademark of the medicine might be disrupted or obscured, adjacent to the name of the medicine; and\n\n(b) not be separated by any text or graphics, except where additional information is:\n\n(i) required or permitted by:\n\n(A) paragraph 11(2)(j); or\n\n(B) subsection 11(6); or\n\n(ii) in relation to identifying the different formulations of the medicines contained in a composite pack.\n\n(3A) Where medicines are supplied as part of a composite pack, the names of each active ingredient, together with its quantity or proportion, must be provided separately in relation to each medicine’s formulation, on the main label of the composite pack.\n\n(4) All text required by this Order to be on the main label must be oriented in the same direction.\n\n(5) Subject to subsections 9(6), 9(7), 9(8) and 9(9), the name of the active ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed in a text size of not less than 3.0 millimetres.\n\n(6) Subject to subsections 9(7) and 9(8), if there are four or more active ingredients in the medicine, the names of each active ingredient, together with its quantity or proportion, may be included on a side panel or side label or on a rear panel or rear label, displayed in a text size of not less than 2.5 millimetres.\n\n(7) If the medicine is\n\n(a) either\n\n(i) for use as an intravenous infusion; or\n\n(ii) is a haemofiltration or haemodiafiltration solution; and\n\n(b) is supplied in a flexible bag container,\n\nthen subsections 9(3) and 9(4) do not apply to the medicine and, where there are eight or more active ingredients in the medicine, subsections 9(5) and 9(6) also do not apply to the medicine.\n\n(8) For subsection 9(6), where medicines are supplied as part of a composite pack:\n\n(a) the total number of active ingredients in all of the medicines in the composite pack are to be counted; and\n\n(b) if the same active ingredient is contained in two or more medicines in the composite pack, each of those active ingredients is to be counted separately;\n\nfor the purposes of determining if subsection 9(6) applies to the composite pack; and\n\n(c) the required information under subsection 9(6) must be provided separately in relation to the formulation of each medicine in the composite pack.\n\n(9) Where the name of an active ingredient included in the medicine comprises an ingredient name specified in Schedule 2 to this Order, either alone or in combination with any other descriptors, then the names of all active ingredients in the medicine, together with their quantity or proportion, must be displayed in a text size of not less than 2.5 millimetres.\n\n(10) Subsection 9(9) does not apply:\n\n(a) where the medicine is supplied in a small container or a very small container; or\n\n(b) where the medicine is not supplied in a small container or a very small container and is labelled in accordance with subsection 9(11) and Part 1 of Schedule 2—after 30 April 2026; or\n\n(c) where the medicine is not supplied in a small container or a very small container and is labelled in accordance with subsection 9(13) and Part 2 of Schedule 2—after 30 April 2028.\n\nNote: The minimum text sizes for active ingredients on labels of small containers and very small containers are less than 2.5 millimetres and specified elsewhere in this Order.\n\n(11) An active ingredient specified in Part 1 of Schedule 2, either alone or in combination with any other descriptors, may be included on the main label of a medicine containing that ingredient as specified in that Part for medicine released for supply before 1 May 2026.\n\n(12) To avoid doubt, an active ingredient specified in Part 1 of Schedule 2 must be included on the main label of a medicine containing that ingredient in accordance with the Australian Approved Names List for medicine released for supply on or after 1 May 2026.\n\n(13) An active ingredient specified in Part 2 of Schedule 2, either alone or in combination with any other descriptors, may be included on the main label of a medicine containing that ingredient as specified in that Part for medicine released for supply before 1 May 2028.\n\n(14) To avoid doubt, an active ingredient specified in Part 2 of Schedule 2 must be included on the main label of a medicine containing that ingredient in accordance with the Australian Approved Names List for medicine released for supply on or after 1 May 2028.\n\n","sortOrder":2},{"sectionNumber":"10","sectionType":"section","heading":"Qualifications and special requirements","content":"10 Qualifications and special requirements\n\n1. Preparations for ophthalmic use\n\nIn 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:\n\n(a) the name of any antimicrobial preservative in the medicine;\n\n(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;\n\n(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;\n\n(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.\n\n(e) if the medicine consists of a solid ophthalmic medicine for preparing eye drops for multidose use - the words ‘for eye drops’.\n\n1. Injections in a container with capacity greater than 100 millilitres\n\nIn 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:\n\n(a) the name and quantity of each excipient in the stated volume of fill of the injection in the container; and\n\n(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\n\n(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\n\n(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\n\n(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\n\n(f) the statement ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’ or words to that effect; and\n\n(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:\n\n(i) for potassium chloride—the equivalent quantity of potassium chloride in weight (in relation to the stated volume of fill of the injection); and\n\n(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).\n\n1. Injections in a container with a capacity of 100 millilitres or less\n\nExcept 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:\n\n(a) the name and quantity of each excipient in the medicine, expressed:\n\n(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;\n\n(ii) for a powder for injection - as the nominal mass of that excipient (not including any overage) in the container;\n\n(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\n\n(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\n\n(c) where the medicine is a concentrated solution for injection, a direction not to administer the solution undiluted; and\n\n(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\n\n(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:\n\n(i) for potassium chloride—the equivalent quantity of potassium chloride in weight (in relation to the stated volume of fill of the injection); and\n\n(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).\n\n1. Injections in a container with a capacity of 25 millilitres or less\n\nExcept where subsection 10(5) applies, if a medicine is an injection that:\n\n(a)is in a container with capacity of 25 millilitres or less; and\n\n(b) the container is enclosed in a primary pack, the label of which complies with sections 8 and 9 and subsection 10(3)\n\nthen, 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:\n\n(c) the name of the medicine; and\n\n(d) the name(s) of all active ingredients in the medicine;\n\nand the following information is displayed in a text size of not less than 1.5 millimetres:\n\n(e) the quantity or proportion of all active ingredients in the medicine; and\n\n(f) the name of the dosage form; and\n\n(g) the quantity of the medicine; and\n\n(h) the batch number of the medicine preceded by the batch number prefix; and\n\n(i) the expiry date of the medicine preceded by the expiry date prefix; and\n\n(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\n\n(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\n\n(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\n\n(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:\n\n(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\n\n(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).\n\n1. Injections in a container with a capacity of 3.0 millilitres or less\n\nIf a medicine is an injection that:\n\n(a) is in a container with a capacity of 3.0 millilitres or less; and\n\n(b) the container is enclosed in a primary pack, the label of which complies with the sections 8 and 9 and subsection 10(3)\n\nthen, in relation to compliance of the label on the container with sections 8 and 9 and subsection 10(3), it shall be sufficient if:\n\n(c) the name of the medicine is displayed in a text size of not less than 1.5 millimetres; and\n\nthe following information is displayed in a text size of not less than 1.0 millimetre:\n\n(d) the quantity of the medicine; and\n\n(e) the batch number of the medicine preceded by the batch number prefix; and\n\n(f) the expiry date of the medicine preceded by the expiry date prefix; and\n\n(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\n\n(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\n\n1. 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.\n\n1. Injections with a stated volume of fill of 100 millilitres or more\n\nIn 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:\n\n(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\n\n(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\n\n(c) a statement specifying whether the injection is hypotonic, hypertonic or isotonic; and\n\n(d) the osmolality of the injection solution; and\n\n(e) the pH range of the injection solution.\n\n1. Haemofiltration and haemodiafiltration solutions\n\nThe 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:\n\n1. the name and quantity of each active ingredient per litre of solution following preparation in accordance with directions; and\n2. the name and quantity of each active ingredient in terms of millimoles per litre of solution following preparation in accordance with directions; and\n3. a statement specifying whether the solution is hypotonic, hypertonic or isotonic; and\n4. the osmolality of the solution; and\n5. the pH range of the solution; and\n6. a statement ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’ or words to that effect.\n\n1. Peritoneal dialysis solutions\n\nThe 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:\n\n(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\n\n(b) the calculated osmolarity expressed in milliosmoles per litre; and\n\n(c) the nominal volume of the solution in the container; and\n\n(d) a statement that the solution is free from bacterial endotoxins, or where applicable, that it is apyrogenic; and\n\n(e) a statement that the solution is not to be used for intravenous infusion; and\n\n(f) a statement ‘Use in one patient on one occasion only. Contains no antimicrobial preservative’ or words to that effect; and\n\n(g) if a concentrate, the statement ‘Dilute before use.’\n\n(8A) Neuromuscular blocking agent-containing medicines\n\nIn 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:\n\n(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\n\n(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:\n\n(i) where subsection 10(5) applies, in which case this warning statement may be shortened to ‘Warning: Paralyser’ or ‘Paralyser’; or\n\n(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.\n\n1. Preparations for use on skin and/or mucous membranes or by inhalation, and metered nasal sprays\n\nThe 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.\n\n1. Starter packs\n\nWhere 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:\n\n(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\n\n(b) the statement ‘starter pack’ or words to that effect.\n\n1. Small containers (not including injections)\n\nIf:\n\n(a) the medicine is enclosed in a small container (but is not a very small container) and is not an injection; and\n\n(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),\n\nthen, 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:\n\n(c) the name of the medicine; and\n\n(d) the name(s) of all active ingredients in the medicine, unless there are four or more active ingredients;\n\nand the following information is displayed in a text size of not less than 1.5 millimetres:\n\n(e) where there are four or more active ingredients, the name(s) of all active ingredients in the medicine; and\n\n(f) the quantity or proportion of all active ingredients in the medicine; and\n\n(g) the name of the dosage form; and\n\n(h) the quantity of the medicine in the container; and\n\n(i) the batch number of the medicine preceded by the batch number prefix; and\n\n(j) the expiry date of the medicine preceded by the expiry date prefix; and\n\n(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\n\n(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\n\n(m) if the medicine:\n\n(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\n\n(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;\n\n1. Very small containers (not including injections)\n\nIf:\n\n(a) the medicine is enclosed in a very small container but is not an injection; and\n\n(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),\n\nthen, 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:\n\n(c) the quantity of the medicine in the container; and\n\n(d) the batch number of the medicine preceded by the batch number prefix; and\n\n(e) the expiry date of the medicine preceded by the expiry date prefix; and\n\n(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\n\n(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.\n\n1. Individually wrapped medicines\n\n(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\n\n(ii) each dosage unit is enclosed in an individual wrapper or blister, whether sealed or unsealed; and\n\n(iii) one or more dosage units are enclosed in a primary pack; and\n\n(iv) the label on the primary pack complies with sections 8 and 9,\n\nthen, 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:\n\n(v) the name of the medicine; and\n\n(vi) the name(s) of all active ingredients in the medicine; and\n\n(vii) the quantity or proportion of all active ingredients in the medicine; and\n\n(viii) the batch number of the medicine preceded by the batch number prefix; and\n\n(ix) the expiry date of the medicine preceded by the expiry date prefix; and\n\n(x) the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.\n\n(b) If:\n\n(i) the medicine consists only of pastilles or lozenges; and\n\n(ii) each dosage unit is enclosed in an unsealed individual wrapper; and\n\n(iii) each dosage unit is, after being so wrapped, enclosed in a primary pack that complies with sections 8 and 9,\n\nthen, 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.\n\n1. Strip, blister and dial dispenser packs\n\n(i) a medicine consists of individual dosage units such as tablets, capsules, pills, pastilles, cachets, lozenges, pessaries, suppositories or single doses of powder; and\n\n(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\n\n(iii) the strip, blister or dial dispenser pack is enclosed in a primary pack, the label of which complies with sections 8 and 9,\n\nthen, 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:\n\n(iv) the name of the medicine; and\n\n(v) the name(s) of all active ingredients in the medicine; and\n\n(vi) the quantity or proportion of all active ingredients in the medicine; and\n\n(vii) the batch number of the medicine preceded by the batch number prefix; and\n\n1. the expiry date of the medicine preceded by the expiry date prefix; and\n\n1. the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.\n\n(b) If, in relation to a medicine referred to in (a) there are:\n\n(i) four or more active ingredients in the medicine,\n\nthen, 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:\n\n(ii) the name of the medicine; and\n\n1. the batch number of the medicine preceded by the batch number prefix;\n\n1. the expiry date of the medicine preceded by the expiry date prefix; and\n\n(v) the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.\n\n(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:\n\n1. 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\n2. for a medicine to which paragraph 10(14)(b) applies – the name of the medicine.\n\n1. Plastic ampoules\n\n(i) a medicine is contained in a plastic ampoule, whether or not it is a medicine for injection; and\n\n(ii) the capacity of the plastic ampoule is 8 millilitres or less; and\n\n(iii) two or more ampoules are attached to a connecting strip; and\n\n(iv) the ampoules and their connecting strip are enclosed in a primary pack that complies with the requirements of this Order,\n\nthen 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.\n\n(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:\n\n(i) the name of the medicine; and\n\n(ii) the name(s) of all the active ingredients in the medicine; and\n\n(iii) the quantity or proportion of all active ingredients in the medicine; and\n\n(iv) the batch number of the goods preceded by the batch number prefix; and\n\n(v) the expiry date of the goods preceded by the expiry date prefix; and\n\n(vi) the approved route(s) of administration followed by the word ‘only’ and/or warnings against use by other routes of administration.\n\n(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.\n\n(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.\n\n1. Composite packs\n\n(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.\n\n(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.\n\nNote: The label on the container and primary pack (if any) of each medicine comprising a composite pack must comply with this Order.\n\n## 11 How information is to be expressed\n\n# 11 How information is to be expressed\n\n1. Use of appropriate metric units\n\n(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:\n\n(i) a statement of quantity for 1 microgram up to 999 micrograms inclusive must be expressed in terms of micrograms;\n\n(ii) a statement of quantity for 1000 micrograms may be expressed as either 1000 micrograms or 1 milligram;\n\n(iii) a statement of quantity for more than 1 milligram up to 999 milligrams inclusive must be expressed in terms of milligrams;\n\n(iv) a statement of quantity for 1000 milligrams may be expressed as either 1000 milligrams or 1 gram; and\n\n(v) a statement of quantity for more than 1 gram up to 999 grams inclusive must be expressed as grams.\n\n(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.\n\nExample: 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.\n\nNote: 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.\n\n(c) Where the active ingredient is in liquid form, the equivalent metric units of volume must be expressed in the same manner.\n\nExample: 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.\n\nNote: 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.\n\n(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.\n\n(e) Where a statement of quantity is expressed as less than one (1) unit, the statement of quantity must include the leading zero.\n\n1. Expression of quantity or proportion of active ingredients\n\nSubject 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:\n\n(a) for a discrete dosage unit - as the quantity of the active ingredient in the dosage unit;\n\n(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;\n\n(c) subject to paragraph (d) below, if the medicine is a liquid for ingestion:\n\n(i) as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid; or\n\n(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.\n\nExample: 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.\n\n(d) for a medicine required to be prepared before use, and:\n\n(i) where the process results in a medicine that is a liquid for ingestion:\n\n(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\n\n(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\n\nExample: 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.\n\n(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;\n\n(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;\n\n(f) for a medicine for injection:\n\n(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;\n\n(ii) where the stated volume of the medicine for injection is greater than 100 millilitres and the medicine is intended:\n\n1. for electrolyte replacement or nutritional therapy; or\n2. as a plasma volume expander; or\n3. as an additive to any of these types of injection,\n\nthen:\n\n(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\n\n(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;\n\n(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;\n\n(iv) where the medicine for injection is intended for multidose use:\n\n(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\n\n(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;\n\n(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;\n\n(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:\n\n(A) for potassium chloride—as the number of millimoles of potassium chloride in the stated volume of fill of the injection in the container;\n\n(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;\n\n(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;\n\n(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:\n\n(i) the quantity delivered per actuation; or\n\nwhere 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:\n\n(ii) the quantity metered per actuation;\n\n(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;\n\n(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:\n\n(i) the name of the active ingredient; and\n\n(ii) the name and quantity of the element intended for mineral supplementation.\n\n(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:\n\n(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;\n\n(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;\n\n(l) for any other medicines:\n\n(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;\n\n(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;\n\n(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;\n\n(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;\n\n(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.\n\n1. Expression of potency in biological medicines\n\n(a) For a liquid biological medicine or a biological medicine required to be prepared before use, the potency:\n\n(i) must be included on the label of the medicine; and\n\n(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.\n\n1. The potency unit to be used must be:\n\n1. the International Unit (IU) established by the World Health Organization;\n2. a unit defined in an applicable default standard; or\n3. 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.\n\n1. Expression of activity of radionuclides in radiopharmaceutical preparations\n\nThe quantity or proportion of an active ingredient which is a radionuclide and is included in a radiopharmaceutical preparation must be:\n\n1. included on labels; and\n2. expressed in terms of the total activity of the radionuclide in the container, in becquerels, at a specified date and hour.\n\n1. Permitted statements of storage temperature conditions\n\nFor the purposes of this Order, the following statements of storage temperature conditions are permitted:\n\n(i) ‘Store below –18oC (Deep freeze)’;\n\n(ii) ‘Store below –5oC (Freeze)’;\n\n(iii) ‘Store at 2oC to 8oC (Refrigerate. Do not freeze)’;\n\n(iv) ‘Store below 25oC’;\n\n(v) ‘Store below 30oC’; and\n\n(vi) any other storage temperature conditions as specified in the approved product details in relation to the medicine.\n\n1. Inclusion of common names of vitamins\n\nWhere 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:\n\n1. 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\n2. 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.\n\n","sortOrder":3},{"sectionNumber":"12","sectionType":"section","heading":"Application, savings and transitional provisions","content":"12 Application, savings and transitional provisions\n\nSection 11, as in force immediately before the amendments made by the Therapeutic Goods (Therapeutic Goods Order No. 91– Standard for labels of prescription and related medicines) Amendment Order 2024, continues to apply to medicines manufactured or imported before 1 December 2026.\n\n \n\n| Schedule 1Substances or Groups of substances present in medicines that are required to be declared on the label of medicines |\n| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| |\n| Column 1 includes a general descriptor for the substance or group of substances required to be declared on the label of medicines, and a number of indicative substances names for particular groups of substances.Column 2 specifies the circumstance, such as specified concentration of the substance when present in the medicine or specified amounts of substances contained in the medicine, where if it occurs require the particular declaration on the label identifying the particular substance or group of substances set out in column 1, and provides additional required statements that are supplemental to the required declaration on the label. Where there are no circumstances specified in column 2, then the presence of the substance or group of substances is required to be declared on the label irrespective of any circumstance, concentration or amount of the substance or group of substances present in the medicine.Column 3 identifies those routes of administration of the medicine containing the substance or group of substances, where for the purposes of this Schedule and taking into consideration any circumstance specified in column 2, the substance or group of substances must be declared on the label.Column 4 identifies the name of the substance, the group of substances or a general descriptor of the substance to be included on the label of the medicine where the particular substance or group of substances are present in the medicine. The name also describes a group of substances that have similar characteristics and is to be used irrespective of whether one or more of the substances in the group are present in the formulation. Presentation on the label must be in the form “Contains ‘Name (as set out under Column 4)’”. Where more than one name (as set out under Column 4) is required to be declared, they may be combined to form simple sentences where appropriate. |\n\n```html\n

Column 1

Substance name or Group of substances name

Column 2

Circumstances (if any) and additional requirements (if any)

Column 3

Route of administration

Column 4

Name to be included on the label

aspartame

Oral

aspartame

antibiotics

When the antibiotic is not an active ingredient and is present only as a residual impurity

All

Contains residual ‘antibiotic name’

benzoates, including:

benzoic acid

sodium benzoate

All

benzoates

crustacea and crustacean products (see Note 1), including:

crab

lobster

white shrimp

All

crustacea; or

crustacean products

egg, egg products, and products manufactured in eggs including:

dried egg yolk

egg lecithin

influenza vaccine

All

egg; or

egg products or manufactured in eggs

ethanol

Circumstance: Where present in a concentration of 3% v/v or more.

Requirement: To declare on the label the quantity of ethanol as % v/v.

All

alcohol

fish and fish products (see Note 2), including:

cod

cod – liver oil

halibut

tuna

All

fish; or

fish products

galactose

Oral

galactose

gluten or ingredient derived from gluten-containing grain (see Note 3)

Circumstance: Where gluten is present in a concentration of 20 parts per million or more.

All, other than skin and mucous membrane applications

gluten

hydroxybenzoic acid esters, including:

ethyl hydroxybenzoate

methyl hydroxybenzoate

propyl hydroxybenzoate

sodium ethyl hydroxybenzoate

sodium methyl hydroxybenzoate

sodium propyl hydroxybenzoate

All

hydroxybenzoates

lactose (see Note 4)

Oral

lactose

milk and milk products, including (see Note 4):

casein

hydrolysed milk protein

nonfat dry milk

whey powder

whole dry milk

All

milk; or

milk products

peanuts and peanut products, including:

Arachis hypogaea

arachis (peanut) oil

All

peanuts; or

peanut products

phenylalanine (see Note 5)

All, other than skin and mucous membrane applications

phenylalanine

pollen

Oral

pollen

potassium salts, including:

potassium bicarbonate

potassium chloride

Circumstance: Where the total potassium content of the maximum recommended daily dose is greater than 39 mg (1mmol) elemental potassium.

Requirement: To declare on the label (in mg) the quantity of elemental potassium per dosage unit or in a stated weight or volume of the medicine.

Oral

potassium

propolis

Oral

propolis

royal jelly

Oral

royal jelly

saccharin, including:

saccharin calcium

saccharin sodium

Oral

saccharin

sesame seeds and sesame seed products, including:

sesame seed

sesame oil

Sesamum indicum

All

sesame seeds; or

sesame seed products

sodium salts, including:

sodium bicarbonate

sodium chloride

Circumstance: Where the total sodium content of the maximum recommended daily dose is greater than 120 mg of elemental sodium.

Requirement: To declare on the label (in mg) the quantity of elemental sodium per dosage unit or in a stated weight or volume of the medicine.

Oral

sodium

soya beans and soya bean products, including:

Glycine max

soya bean

soya oil

excluding:

  • soya oil that is fully refined;
  • d-alpha tocopherol, d-alpha tocopheryl acetate, d-alpha tocopheryl acid succinate, mixed (high-alpha type) tocopherols concentrate, or mixed (low-alpha type) tocopherols concentrate when derived from soybean sources;
  • vegetable oils derived phytosterols and phytosterol esters from soybean sources;
  • plant stanol ester produced from vegetable oil sterols from soybean sources.

All

soya beans; or

soya bean products

sorbic acid and sorbic acid salts, including:

potassium sorbate

All

sorbates

sucralose

Oral

sucralose

sugar alcohols (see Note 5A), including:

erythritol

isomalt

lactitol

maltitol

mannitol

polydextrose

sorbitol

xylitol

Circumstance: Where the total sugar alcohol content of the formulation exceeds 2 g per maximum recommended daily dose.

Requirement: To declare on the label the quantity of sugar alcohols present per recommended maximum daily dose; and a statement 'Products containing (name of sugar alcohol) may have a laxative effect or cause diarrhoea'.

Oral

sugar alcohols; or name of sugar alcohol

sugars – monosaccharides and disaccharides (see Note 6), including:

fructose

glucose

honey (as a mixture of sugars)

invert sugar

lactose

maltose

sucrose

Circumstance: Where the presence of sugars may have a significant glycaemic effect and the total sugar content (including lactose which requires a separate declaration) exceeds 100 mg per maximum recommended daily dose.

Oral

sugars

sulfites, including: (see Note 7)

potassium metabisulfite

sodium bisulfite

sodium metabisulfite

sodium sulfite

sulfur dioxide

All

sulfites

tartrazine

All

tartrazine

tree nuts and tree nut products (see Note 8), including:

almond oil

Juglans nigra

macadamia nut oil

Macadamia ternifolia

Prunus dulcis

walnut

All

tree nuts; or

tree nut products

Note 1: Crustacea include various species of aquatic animals which have an inedible chitinous outer shell. These include but are not limited to crab, crayfish, lobster, prawn and shrimp.

Note 2: Fish includes freshwater fish, diadromous fish and marine fish, including shark.

Note 3: Gluten – some formulations of medicines may contain gluten that is present naturally as a constituent of an ingredient such as wheat starch.

Note 4: Lactose, where obtained from milk, does not require the ‘contains milk product’ statement.

Note 5: Phenylalanine - In the context of complementary medicines that contain phenylalanine, the Schedule 1 requirements apply in the following instances:

Where phenylalanine is an ingredient in a medicine formulation.

For medicines containing ingredients such as Spirulina, legumes, nuts or soy products that are naturally high in phenylalanine.

Where processing of an ingredient, prior to inclusion in a pharmaceutical dosage form, results in enrichment of the phenylalanine content.

Note 5A: Sugar alcohols – It is generally accepted that while glycerol is a sugar alcohol, it does not have a laxative effect. Therefore, glycerol is not required to be declared in relation to sugar alcohols and their associated laxative effect.

Note 6: Sugars – monosaccharides and disaccharides – some sugar derivatives may not have a significant impact on glycaemic control. Lactose forms part of total sugars for the purposes of determining if the sugars will have a significant glycaemic effect and for calculating the total daily dose. Where lactose is present in the medicine, the entries under ‘lactose', ‘sugars –monosaccharides and disaccharides' and ‘milk and milk products’ (if of dairy origin) each apply.

Note 7: Sulfur dioxide – some formulations of medicines may contain sulfur dioxide as a residue, for example, gelatin, but must be identified.

Note 8: Tree nuts are the seeds of a variety of trees and shrubs which are characterised by a hard inedible shell enclosing an oily seed. Tree nuts include almond, Brazil, cashew, chestnut, and walnut. Coconut is the fruit of the palm (Cocos nucifera) and is not considered to be a tree nut.

\n```\n\n","sortOrder":4},{"sectionNumber":"Sch 2","sectionType":"schedule","heading":null,"content":"Schedule 2\n\nSpecified ingredient names\n\n","sortOrder":5},{"sectionNumber":"Part 1","sectionType":"part","heading":"Dual labelling name permitted from 1 May 2023 until 30 April 2026","content":"Part 1—Dual labelling name permitted from 1 May 2023 until 30 April 2026\n\n| Ingredient name |\n| ----------------------------------------------- |\n| amobarbital (amylobarbitone) |\n| amphotericin B (amphotericin) |\n| asparaginase (colaspase) |\n| calcitonin salmon (salcatonin) |\n| dactinomycin (actinomycin D) |\n| doxycycline hyclate (hydrochloride) |\n| estropipate (piperazine oestrone) |\n| formoterol (eformoterol) |\n| furosemide (frusemide) |\n| glycopyrronium bromide (glycopyrrolate) |\n| lidocaine (lignocaine) |\n| mecobalamin (co-methylcobalamin) |\n| pentoxifylline (oxpentifylline) |\n| phenobarbital (phenobarbitone) |\n| procaine benzylpenicillin (procaine penicillin) |\n| tetracosactide (tetracosactrin) |\n\n \n\n","sortOrder":6},{"sectionNumber":"Part 2","sectionType":"part","heading":"Dual labelling name permitted from 1 May 2025 until 30 April 2028","content":"Part 2—Dual labelling name permitted from 1 May 2025 until 30 April 2028\n\n| Ingredient name |\n| ------------------------------ |\n| dosulepin (dothiepin) |\n| hydroxycarbamide (hydroxyurea) |\n| tetracaine (amethocaine) |\n| trihexyphenidyl (benzhexol) |\n\n","sortOrder":7},{"sectionNumber":"Part 3","sectionType":"part","heading":"Dual labelling name","content":"Part 3—Dual labelling name\n\n| Ingredient name |\n| --------------------------------------------------------------- |\n| alimemazine (trimeprazine) |\n| mercaptamine (cysteamine) |\n| Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) |\n\n \n\n","sortOrder":8},{"sectionNumber":"Sch 3","sectionType":"schedule","heading":null,"content":"Schedule 3\n\nSpecified neuromuscular blocking agents (or salts thereof)\n\n| alcuronium |\n| -------------------- |\n| atracurium |\n| cisatracurium |\n| dimethyltubocurarine |\n| doxacurium |\n| fazadinium |\n| gallamine |\n| hexafluronium |\n| mivacurium |\n| pancuronium |\n| pipecuronium |\n| rocuronium |\n| suxamethonium |\n| tubocurarine |\n| vecuronium |","sortOrder":9}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":9,"scope_assessment":{"changed":true,"description":"This version expands and specifies labelling obligations beyond a simple statement-of-content regime. New or clarified scope elements include: (1) mandatory machine-readable GTIN barcodes on most packs (section 8(1)(n)); (2) much more prescriptive formatting and minimum text-size rules, with phase-in dates for particular ingredient names (sections 9(5)–(14) and Schedule 2); (3) expanded mandatory declarations of non-active substances and excipients with circumstance-dependent wording (Schedule 1); (4) additional injection-specific declarations including electrolyte and millimole reporting for products manufactured/imported on or after 1 December 2026 (section 10 subsections); and (5) explicit, colour-coded warning requirements for neuromuscular blocking agents (subsection 10(8A)). Together these changes increase the substantive reach and operational impact of the Order compared with a basic labelling standard by adding serialization/traceability, staged renaming obligations, and new quantitative reporting duties for certain injectable and electrolyte-containing preparations."},"complexity_factors":["Very large interpretation section with 120+ defined terms that determine multiple downstream obligations (section 6).","Multiple nested conditional rules for label content by product type (e.g., injections) and by container capacity (3 mL, 25 mL, 100 mL, >100 mL) in section 10.","Extensive cross-references to the Therapeutic Goods Act, Regulations, approved product details and the Register (numerous external legal hooks).","Schedules with detailed declarable substances and circumstance-specific requirements (Schedule 1 contains many rows and conditional wording).","Phased transitional compliance dates and staggered dual-labelling permissions (Schedule 2 and transitional clause), creating temporal complexity.","Multiple minimum text-size rules with exceptions and staged relaxations (section 9 and various subsections).","Different labelling rules depending on packaging configuration (container, intermediate pack, primary pack, composite pack, blister/strip/dial/dispenser, ampoules).","Mandatory machine-readable code (GTIN) requirement except for starter packs, with allowances for additional encoded data (section 8 and definition of machine readable code).","Special-purpose requirements (neuromuscular blocking agent red warning, electrolyte millimole reporting, radionuclide activity) requiring different presentation formats and colour/contrast rules (section 10, Schedules 2–3).","Multiple exemptions and savings provisions that must be checked against specific product pathways (section 5 and section 12)."],"plain_english_summary":"**What this Order does (mechanically)\n\n- Sets detailed mandatory labeling rules for prescription and related medicines supplied in Australia. It tells manufacturers/sponsors and distributors what must appear on every label (container, intermediate packaging and primary pack) and how that information must be presented.\n\n- Provides an extensive definitions section (what words like \"medicine\", \"main label\", \"batch number\", \"starter pack\", \"small container\" mean) that determines how the rules apply in different packaging and product types.\n\n- Lists exemptions (section 5) where the labelling rules do not apply — for example certain authorised emergency supplies, export-only medicines, medicines not at their final stage of manufacture, extemporaneously compounded medicines made to individual prescriptions, experimental trial supplies, some personal import cases, and others.\n\n- Specifies what information must appear on labels (section 8) including: medicine name; all active ingredient names and their quantities; dosage form and quantity; batch number and expiry date (with prescribed prefixes); storage conditions; sponsor or distributor contact details; route of administration where required; required warning statements; a machine-readable GTIN barcode (except for starter packs); and that the medicine name appear on at least three non-opposing sides of a carton.\n\n- Sets special rules for the \"main label\" (section 9): how the medicine name and active ingredient(s) must be grouped and displayed, minimum text sizes for active ingredients (with reductions for particular situations), orientation rules, and phased requirements for some ingredient names (Schedules 2 parts with staged compliance dates).\n\n- Provides numerous qualification and special requirements (section 10) that add or relax label content depending on product type and container size, for example: injections (different rules for >100 mL, 100 mL or less, 25 mL or less, 3.0 mL or less), ophthalmic preparations, haemofiltration solutions, peritoneal dialysis solutions, neuromuscular blocking agents (specific red-warning requirement), small and very small containers, individually wrapped units, blister/strip packs, plastic ampoules and composite packs.\n\n- Sets rules for how to express quantities and units (section 11): required metric units, when to use micrograms vs milligrams vs grams, how to show active ingredient quantities for different dosage forms (tablets, liquids, injections, patches, inhalers), rules for biological potency units, radionuclide activity, permitted storage-temperature phrases, and other measurement conventions.\n\n- Includes Schedule 1 — a detailed list of non-active substances or groups (allergens, preservatives, sugar alcohols, ethanol, sodium/potassium salts, etc.) that must be declared on the label in particular circumstances (and the exact wording to use).\n\n- Includes Schedule 2 — specific ingredient names for which dual-labelling (alternate names) is allowed for limited transition periods, and Schedule 3 — a list of named neuromuscular blocking agents that trigger the special warning-label requirement.\n\n- Provides transitional savings: an earlier version of section 11 continues to apply to medicines manufactured or imported before 1 December 2026 (so some date-staged changes apply only to new stock after that date).\n\nWho this affects\n\n- Primary duty-bearers: sponsors, manufacturers, importers and distributors of prescription and related medicines — they must design, print and affix compliant labels and ensure packaging meets the Order.\n- Downstream actors: pharmacists, hospitals and other health professionals who dispense or handle medicines (because packaging must leave space for dispensing labels and, in some cases, primary packs must contain certain information); companies that operate contract packaging or serialization services; and regulators (the Secretary) who will assess compliance and can require particular warning statements as a registration condition.\n- Exempt groups: certain trial supplies, extemporaneously compounded medicines made to individual prescriptions, some authorised emergency uses, export-only goods, and other categories listed in the exemptions.\n\nWhy it matters (intended purpose, and practical trade-offs)\n\n- The stated policy purpose is to improve patient safety, traceability and transparency by standardising what information appears on medicine labels, how it is shown, and when specific allergens, excipients or risks must be declared (see sections 8–11 and Schedule 1). The instrument also builds in machine-readable identification (GTIN barcodes) to support scanning and supply-chain traceability.\n\n- Costs and incentives: sponsors and manufacturers pay the direct costs — label redesign, printing, repackaging, IT/serialization changes, and stock-management to segregate pre- and post-change inventory. The Order creates stronger incentives to list clear ingredients and warnings (which can reduce information asymmetry for prescribers and patients) but also increases compliance complexity.\n\n- Trade-offs and opportunity costs: Packaging space is a constrained resource. The Order requires minimum text sizes, repeated labelling on cartons and containers, and mandated wording for many scenarios; that forces sponsors to reallocate space that might otherwise be used for branding or marketing. Smaller containers and starter packs get permitted relaxations, but the primary pack still usually must carry full information.\n\n- Implementation and operational risk: The rules are heavily conditional (different rules by container size, product type and route of administration) and include phased dates. Sponsors must track which stock was manufactured/imported before transition dates (e.g., different rules apply before/after 1 December 2026 and other staged dates for Schedule 2 entries). Misclassification of container size or failure to meet text-size/formatting rules creates compliance risk and potential regulatory action.\n\n- Compliance burden and administrative discretion: Many elements depend on cross-references (to the Act, Regulations and approved product details), and the Secretary may require particular warning statements as a condition of registration. That amplifies regulatory discretion in individual cases and requires sponsors to monitor registration conditions.\n\nConcrete effects on private choices and markets\n\n- Sponsors/manufacturers will need to revise label artwork and packaging runs, and to upgrade printing/serialization or supplier arrangements to include GTIN barcodes and batch/expiry data in machine-readable form.\n- Importers must segregate pre-amendment stock to rely on transitional savings and ensure product released after set dates complies with new labelling, creating inventory management costs.\n- Pharmacies and hospitals may benefit from clearer ingredient/allergen statements and machine-readable codes (faster scanning, fewer dispensing errors), but may face short-term disruption if product supply shifts because of labeling non‑compliance.\n\nKnown timing or phased requirements to note (sources in the Order)\n\n- Machine-readable code is required on labels except for starter packs (section 8(1)(n)).\n- Certain active-ingredient name changes or dual-labelling are allowed only within transition windows set in Schedule 2 (Part 1: dual labelling permitted up to 30 April 2026; Part 2: to 30 April 2028; Part 3: permanent provisions). After those dates, main labels must use the Australian Approved Names List forms (sections 9(10)-(14)).\n- Specific electrolyte declaration requirements for some injections apply for products manufactured or imported on or after 1 December 2026 (section 10(2)(g), 10(3)(e), and related subsections).\n\nBottom line (what sponsors must do now)\n\n- Review product portfolios against the Order's definitions, exemptions and special cases; redesign container and primary-pack labels to include all required items (including machine-readable GTIN where applicable); apply minimum text-size rules and the special statements listed for particular product classes; and manage inventory and supply so that products manufactured/imported before the transitional cut-offs can continue to be supplied under the older labelling rules where permitted.\n\n(References: exemptions section 5; interpretation/definitions section 6; general/required label content sections 7–9; qualifications and many product-specific rules section 10; how-to-express information section 11; Schedules 1–3 for declarable substances, dual-labelling schedules and neuromuscular blocking agents.)"},"kimi_summary":{"_metrics":{"provider":"moonshot","completionTokens":3060},"content_quality":"ok","complexity_score":8,"scope_assessment":{"changed":false,"description":"The instrument remains focused on its original purpose of establishing mandatory labeling standards for prescription and related medicines. While it has been amended over time (notably to update allergen labeling requirements and dual-naming conventions for ingredients), its scope has not expanded beyond packaging and label content requirements."},"complexity_factors":["Approximately 45 defined terms in Section 6, including highly technical pharmaceutical concepts (e.g., 'haemodiafiltration', 'osmolality', 'delivered dose', 'adjuvant').","Extensive conditional logic structured around physical container characteristics: different rules apply for containers >100mL, ≤100mL, ≤25mL (small), and ≤3mL (very small), each with varying text size and content requirements.","Multiple cross-references to the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990, including specific sections on approvals, exemptions, and registration numbers.","Three detailed Schedules: Schedule 1 contains a complex four-column table linking substances, concentration thresholds, routes of administration, and required label names; Schedule 2 establishes transitional 'dual labelling' periods for ingredient names; Schedule 3 lists specific neuromuscular blocking agents requiring high-visibility warnings.","Nested exceptions throughout, particularly in Section 5 (13 distinct exemption categories) and Section 10 (16 subsections covering special cases like ophthalmic preparations, plastic ampoules, and composite packs).","Precise technical specifications for measurement expression (e.g., micrograms vs milligrams, millimoles for electrolytes, International Units for antibiotics) and physical label attributes (text heights specified in millimetres down to 1.0mm)."],"plain_english_summary":"This legislation is the rulebook for what must appear on the labels of prescription medicines in Australia. It ensures that anyone handling the medicine—doctors, pharmacists, nurses, and patients—can identify it correctly, understand what’s inside, and use it safely.\n\n**Who it affects**\n* **Pharmaceutical sponsors and distributors**: Companies responsible for bringing medicines to market (manufacturers, importers).\n* **Pharmacists**: Specifically those who make up custom medicines for individual patients (called *extemporaneous compounding*—mixing ingredients on the spot for a specific prescription).\n* **Healthcare professionals**: Anyone supplying medicines directly to patients.\n\n**What it requires**\n\nMedicine labels must display specific information in English, using durable, legible text (usually at least 1.5 millimetres high) in colours that contrast with the background:\n\n* **Identity**: The medicine’s name, its dosage form (e.g., tablet, injection, eye drops), and the quantity in the pack.\n* **Active ingredients**: The chemical components that make the medicine work must be listed with their strength. For the main label (the most prominent display), this often requires larger text (3.0mm or more).\n* **Safety and traceability**: Batch numbers (for recalls), expiry dates, and storage conditions (e.g., \"Refrigerate\").\n* **Allergen warnings**: Mandatory declarations if the medicine contains common allergens like peanuts, gluten, sulfites, egg, or certain colorings (see Schedule 1).\n* **Specific warnings**: Special bright red warning labels for *paralysing agents* (neuromuscular blocking agents) and preservative warnings for eye drops.\n\n**Special rules for different containers**\nThe law recognises that not all packaging is the same. It creates tiers based on size:\n* **Tiny containers (3mL or less)**: Can use much smaller text (down to 1.0mm) and list less information directly on the vial, provided the outer box is fully labeled.\n* **Injections**: Must state the route of administration (e.g., \"intravenous\" or \"intramuscular\"). Large infusion bags (over 100mL) must also list excipients (inactive ingredients) and state whether the solution is hypotonic, isotonic, or hypertonic.\n* **Starter packs**: Small trial packs must leave space for the pharmacist to write dispensing instructions.\n\n**Important exemptions**\nThis Order does **not** apply to:\n* Medicines made up individually by a pharmacist for a specific patient (*extemporaneous compounding*).\n* Medicines used only for clinical trials or experimental purposes.\n* Export-only medicines.\n* Starting materials (bulk ingredients) not yet in their final package.\n\n**Why it matters**\nClear, standardised labels prevent medication errors. They ensure a patient with a peanut allergy can see if a medicine contains peanut oil, allow pharmacists to verify they have the correct drug and strength, and enable rapid recall of specific batches if safety issues arise."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-order-no-91-standard-for-labels-of-prescription-and-related-medicines","history":"/api/acts/therapeutic-goods-order-no-91-standard-for-labels-of-prescription-and-related-medicines/history","analysis":"/api/acts/therapeutic-goods-order-no-91-standard-for-labels-of-prescription-and-related-medicines/analysis","conflicts":"/api/acts/therapeutic-goods-order-no-91-standard-for-labels-of-prescription-and-related-medicines/conflicts","importantCases":"/api/acts/therapeutic-goods-order-no-91-standard-for-labels-of-prescription-and-related-medicines/important-cases","documents":"/api/acts/therapeutic-goods-order-no-91-standard-for-labels-of-prescription-and-related-medicines/documents"}}