(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:
(a) the name of the medicine; and
(b) the name(s) of all active ingredients in the medicine; and
(c) the quantity or proportion of all active ingredients in the medicine; and
(d) the name of the dosage form; and
(e) the quantity of the medicine; 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.
(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.
(3) Subject to paragraph (c), the name of the medicine and the name(s) of active ingredient(s) on the main label must:
(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
(i) immediately below the name of the medicine; or
(ii) where the trademark of the medicine might be disrupted or obscured, adjacent to the name of the medicine; and
(b) not be separated by any text or graphics, except where additional information is:
(i) required or permitted by:
(A) paragraph 11(2)(h); or
(B) subparagraphs 11(2)(i)(i) or 11(2)(i)(ii)(A); or
(C) subsection 11(5); or
(ii) in relation to identifying the different formulations of the medicines contained in a composite pack or a medicine kit; and
(c) if the medicine is:
(i) supplied in either a small or a medium container; and
(ii) contains multiple active ingredients
then, in relation to compliance of the label with paragraph 9(3)(a), the names of the multiple active ingredients and their quantities may be presented together on a continuous line, or lines, of text.
(4) All text required by this Order to be on the main label must be oriented in the same direction.
(5) If the medicine contains:
(a) two or more active ingredients; and
(b) at least two of those active ingredients belong to any of the following categories:
(i) a vitamin that is identified by both:
(A) the approved name of the active ingredient that is a vitamin; and
(B) in accordance with subsection 11(5), the word ‘vitamin’, or any suitable unambiguous abbreviation of the word vitamin, together with the common name of that vitamin; or
Part 9 - Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines - Information to be included on the main label | Zoe
(ii) a mineral; or
(iii) a herbal preparation that, under subparagraph 11(2)(i)(ii), is required to be quantified as either:
(A) the dry or fresh weight of herbal material from which the preparation was derived; or
(B) the minimum dry or fresh weight of herbal material from which the preparation was derived,
then:
the names, and quantities or proportions, of all active ingredients in the medicine may appear on a side panel or side label or on a rear panel or rear label instead of on the main label; and
(c) if the medicine is intended to be, or is, registered goods, and
(i) subsection 8(2) does not apply, then the names, and quantities or proportions, of the active ingredients must be displayed on the side or rear panel or label in a text size of not less than 2.5 millimetres; or
(ii) subsection 8(2) applies, then compliance with paragraphs 9(1)(b) and 9(1)(c) is not required.
(6) If the medicine is intended to be, or is, listed goods:
(a) if the medicine is a sunscreen preparation - the name of every active ingredient, together with the quantity or proportion of every active ingredient, and the name of the dosage form, may appear on a side panel or side label or on a rear panel or rear label; or
(b) if there are four or more active ingredients in the medicine - the name of every active ingredient, together with the quantity or proportion of every active ingredient, may appear on a side panel or side label or on a rear panel or rear label.
(7) Subject to subsection 9(9), if the medicine is intended to be, or is, registered goods, then:
(a) where the medicine contains three or fewer active ingredients, the name of the active ingredient(s) and the quantity or proportion of active ingredient(s) must be displayed on the main label in a text size of not less than 3.0 millimetres, except where the medicine is supplied:
(i) in a medium container – in which case, the information must be displayed in a text size of not less than 2.5 millimetres; or
(ii) in a small container – in which case, the information must be displayed in a text size of not less than 2.0 millimetres; but
(iii) if the medium container or the small container is enclosed in a primary pack, the exceptions in subparagraphs 9(7)(a)(i) and (ii) do not apply to the main label on the primary pack;
(b) where the medicine contains four or more active ingredients and subsection 8(2) does not apply, then the names and the quantities or proportions of the active ingredients may be included on a side panel or side label or on a rear panel or rear label, when displayed in a text size of not less than 2.5 millimetres; or
(c) where the medicine contains four or more active ingredients and subsection 8(2) applies, then compliance with paragraphs 9(1)(b) and 9(1)(c) is not required; or
(d) if subsection 8(2) applies and the medicine:
(i) includes one or more active ingredients, the name of which includes descriptors (for example chemical salts or hydration states) that are not therapeutically relevant; and
(ii) the name and quantity or proportion of each of those active ingredients is displayed in accordance with subsection 8(2),
then the name of the therapeutically active moiety(ies) of the active ingredient may be displayed on the main label on the primary pack, instead of the name of the active ingredient, if:
(iii) this is in a text size of not less than 3.0 millimetres; and
(iv) no quantity or proportion information is displayed for any of the active ingredients in the medicine.
(8) Where a medicine is:
(a) supplied as part of either a composite pack or a medicine kit; and
(b) there are different formulations of medicine in that composite pack or medicine kit;
(c) (i) the total number of active ingredients in the different formulations in the composite pack or medicine kit are to be counted; and
(ii) if the same active ingredient is contained in two or more formulations in the composite pack or medicine kit, each of those active ingredients is to be counted separately,
for the purposes of determining if paragraph 9(6)(b) applies to the composite pack or medicine kit, or which paragraph in subsection 9(7) applies to the composite pack or medicine kit; and
(d) the information required under either paragraph 9(6)(b) or subsection 9(7) must be provided separately in relation to each formulation of medicine in the composite pack or medicine kit.
(9) If the medicine is intended to be, or is, registered goods, and 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.
(10) Subsection 9(9) does not apply:
(a) where the medicine is supplied in a small container; or
(b) where the medicine is not supplied in a small container and is labelled in accordance with subsection 9(11) and Part 1 of Schedule 2—after 30 April 2026; or
(c) where the medicine is not supplied in a small container and is labelled in accordance with subsection 9(13) and Part 2 of Schedule 2—after 30 April 2028.
Note: The minimum text size for active ingredients on labels of small containers is less than 2.5 millimetres and specified elsewhere in this Order.
(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.
(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.
(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.
(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.