Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p25
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 25/27)
Character Range: 67102–70054

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 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 with the quantity or proportion of active ingredient expressed consistently across the series in terms of the same stated dose volume; and

                       Example: Where the dose volume is 5 mL after preparation, 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.

              (ii) for any other medicines - as the weight or volume of active ingredient in a stated weight or volume of the medicine, after preparation in accordance with the instructions included in the label of the medicine;

           (e) for a transdermal patch, as the total quantity of the active ingredient in each patch and the quantity of the active ingredient released in a stated time;

           (f) for pressurised metered dose inhalers, dry powder inhalers and other metered dose products such as nasal sprays, the quantity of the active ingredient is:
               (i)                 the quantity delivered per actuation; or

           where the Secretary, when registering the medicine, has accepted that the dose of products containing those active ingredients was clinically established as the metered dose, then:

           (ii) the quantity metered per actuation;

           (g) for preparations applied to the skin and mucous membranes, other than those covered by paragraph (f) - as a percentage expressed in terms of w/w, w/v, v/v or v/w, as appropriate, or as the weight or volume in a stated weight or volume of the medicine, as appropriate;

           (h) for the purposes of paragraphs 11(2)(a) – 11(2)(d), for oral preparations that contain active ingredients intended for mineral supplementation, it is sufficient that the quantity or proportion of that active ingredient to be included on a label be expressed as:

           (i) the name of the active ingredient; and

              (ii) the name and quantity of the element intended for mineral supplementation.

           (i) In addition to the requirements of paragraphs 11(2)(a) –11(2)(g), the following requirements apply in the circumstances specified in the following subparagraphs:

              (i) where the active ingredient is a herbal material, such as a dry, fresh, milled or powdered herb, as the weight of the herbal material; except               where standardisation is claimed on the label, then the minimum dry or fresh weight of herbal material and also the quantity of standardised constituents(s) in the herbal material;

              (ii) where the active ingredient is a herbal preparation,