9Information to be included on the main label

9 Information to be included on the main label

(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:

(d) the name of the dosage form; and

(e) the quantity of the medicine; and

(f) if the medicine is:

(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

(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

(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

(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) 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)(j); or

(B) subsection 11(6); or

(ii) in relation to identifying the different formulations of the medicines contained in a composite pack.

(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.

(4) All text required by this Order to be on the main label must be oriented in the same direction.

(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.

(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.