Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p24
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 24/27)
Character Range: 64577–67342

in liquid form, the equivalent metric units of volume must be expressed in the same manner.

                   Example: A statement of volume for more than 1 millilitre up to 999 millilitres inclusive must be expressed in terms of millilitres, but a statement of volume for 1000 millilitres may be expressed as either 1000 millilitres or 1 litre.

                  Note:  The abbreviations mL and L can be used on all labels, but 'microlitre' should be used in full unless the container is a small container. Then the abbreviation 'L' may be used.

           (d) Where the information is a statement of mass or volume, the unit of measurement must be consistent with the unit of measurement used in any warning statement required for that ingredient.

           (e) Where a statement of quantity is expressed as less than one (1) unit, the statement of quantity must include the leading zero.

       (2) Expression of quantity or proportion of active ingredients

       Subject to paragraph 11(2)( i) and subsection 11(3) below, the quantity or proportion of an active ingredient to be included on a label must be expressed:

           (a) for a discrete dosage unit - as the quantity of the active ingredient in the dosage unit;

           (b) for a solid for ingestion, where there is no discrete dosage unit - as the quantity of the active ingredient contained in the stated weight of a suitable dose of the solid;

           (c) subject to paragraph (d) below, if the medicine is a liquid for ingestion:

              (i) as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid; or

              (ii) in the case where the liquid for ingestion is one of a series of strengths containing the same active ingredient – as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid with the quantity or proportion of active ingredient expressed consistently across the series in terms of the same stated dose volume.

                       Example: Where the dose volume is 5 mL, and there are strengths of        1 mg/mL and 5 mg/mL, these must be labelled as 5 mg in 5 mL and 25 mg in 5 mL, respectively.

           (d) for a medicine required to be prepared before use, and:

              (i)  where the process results in a medicine that is a liquid for ingestion:

                  (A) as the quantity of the active ingredient contained in the stated volume of a suitable dose of the liquid after preparation in accordance with the instructions set out on the label of the medicine; or

                  (B) in the case where the medicine is one of a series of strengths containing the same active ingredient - as the quantity of the active ingredient