8 Information to be included on the label

(1) Subject to the qualifications and requirements specified in subsections 8(2) and 8(3) and sections 9 and 10 below, the labels of a 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) the batch number of the medicine preceded by the batch number prefix; and

(g) the expiry date of the medicine, preceded by the expiry date prefix; and

(h) the storage conditions applicable to the medicine; and

(i) the name and contact details of the sponsor or distributor of the medicine; and

(j) where:

(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;

(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

(iii) 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,

then:

(iv) a statement:

(A) indicating that the medicine contains the substance expressed using the Name stated in Column 4 of Schedule 1; and

(B) 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); and

(k) relevant warning statements, where these are required in relation to a particular medicine or in specified circumstances applying to a particular medicine, such as the following:

(i) where the medicine is for external use the required statement is ‘Caution: Not to be Swallowed’ or ‘For External Use Only’ or words to this effect;

(ii) where:

(A) the medicine is for oral use; and

(B) the medicine contains active ingredient(s) included in category 'B' (including 'B1', 'B2, 'B3') or category 'C' in the document titled ‘Prescribing medicines in pregnancy database’ published on the TGA website as on the date of commencement of this Order; and

(C) the medicine is not subject to other specific warning statement(s) relating to use during pregnancy,

the required statement is: ‘If pregnant or likely to become pregnant, consult a pharmacist or a doctor before use’ or words to this effect; and

(iii) where:

(A) the medicine is a registered goods for oral use; and

(B) the medicine contains active ingredient(s) included in category ‘D’ (except nicotine for smoking cessation) in the document titled ‘Prescribing medicines in pregnancy database’ published on the TGA website as at the date of commencement of this Order; and

(C) the medicine is not subject to other specific warning statements(s) relating to use during pregnancy,

the required statement is ‘Do not use this medicine if pregnant or likely to become pregnant’ or words to this effect; and

(l) directions for use of the medicine except where:

(i) the dose of the medicine is usually determined for each individual patient by a health professional authorised under a law of a State or Territory to determine the dose; or

(ii) there is insufficient space on the label of either the container or the primary pack, or both, to include directions for use, and:

(A) those directions for use are set out in a package insert provided in the primary pack of the medicine; and

(B) a statement is included on whichever label on the container, or the primary pack, or both, that does not set out the directions for use itself, that those directions are set out in the package insert; and

(m) 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:

(i) there is insufficient space on the label of either the container or the primary pack, or both, to include this information; and

(ii) this information is set out in a package insert provided in the primary pack of the medicine; and

(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 this information is set out in the package insert; and

(n) a statement of the purpose or purposes for which it is intended that the medicine be used, except where:

(i) the medicine is:

(A) supplied solely to a complementary healthcare practitioner for supply to a person after affixing by the practitioner of an instruction label on the medicine following a consultation with that person; and

(B) the label of the medicine includes the words ‘For Practitioner Dispensing Only’; and

(o) 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) (a) Subject to paragraphs (b), (c) and (d), where the medicine is registered goods, the critical health information must be displayed on the label of the primary pack in a tabulated form.

(b) The critical health information must be presented under appropriate headings and in the following order:

(i) Active ingredients

(ii) Indications

(iii) Warnings

(iv) Directions for use

(v) Other information.

(c) The information provided under paragraph 8(2)(b)(i) may include words describing the purpose of the active ingredient(s) by indicating the pharmacological category or the principal intended actions that are not required by this Order.

(d) The information provided under paragraph 8(2)(b)(iii) may include safety related information not required by this Order (such as allergen advice, caution, additional warning or advisory statements).

(e) If information other than the critical health information or information of a kind mentioned in subsections 8(2)(c) or 8(2)(d) is to be included, it must be placed under the ‘Other information’ heading or under another separate appropriate heading(s) that follow immediately below the headings mentioned in 8(2)(b) and must not contain any additional information other than:

1. requirements relating to storage conditions
2. information about package features to prevent tampering
3. names of all excipients
4. sponsor or distributor contact details.

(f) The presentation of the critical health information, and any information mentioned in paragraphs 8(2)(c), 8(2)(d) or 8(2)(e) that is included, must be presented in black or other dark coloured texts, using only one colour, on a white or other contrasting background.

(3) If the medicine is registered goods and

(a) both:

(i) the medicine is a medicated throat lozenge or an inorganic salt-based antacid that is in a solid dosage; and

(ii) the space available for a label on the primary pack is less than seventy square centimetres;

or

(iii) the medicine is intended for use as a skin antiseptic:

(A) for hand-hygiene; or

(B) by a health professional as a patient pre-operative preparation; or

(iv) the medicine is a paste or gel for the cleaning of teeth,

then subsection 8(2) does not apply.

(4) If the information required on the label on the container is obscured by intermediate packaging, then the label on the intermediate packaging 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 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) the name of the sponsor or distributor, or a registered trademark if it readily identifies the sponsor or distributor of the medicine.

(5) 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.