Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p23
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 23/27)
Character Range: 61893–64827

all active ingredients in the medicine; and

              (iv) the batch number of the goods preceded by the batch number prefix; and

              (v) the expiry date of the goods preceded by the expiry date prefix; and

              (vi) the approved route(s) of administration followed by the word 'only' and/or warnings against use by other routes of administration.

       (11) Composite packs

           (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.

           (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.

                  Note:  The label on the container and primary pack (if any) of each medicine comprising a composite pack must comply with this Order.

       11 How information is to be expressed

       (1) Use of appropriate metric units

           (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:

              (i) a statement of quantity for 1 microgram up to 999 micrograms inclusive must be expressed in terms of micrograms;

              (ii) a statement of quantity for 1000 micrograms may be expressed as either 1000 micrograms or 1 milligram;

              (iii) a statement of quantity for more than 1 milligram up to 999 milligrams inclusive must be expressed in terms of milligrams;

              (iv) a statement of quantity for 1000 milligrams may be expressed as either 1000 milligrams or 1 gram; and

               (v) a statement of quantity for more than 1 gram up to 999 grams inclusive must be expressed as grams.

           (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.

                   Example: 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.

                   Note: 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 container. Then the abbreviation 'g' may be used.

           (c) Where the active ingredient is 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