Document ID: chunk:federal_register_of_legislation:F2023C00456:schedule:3:p22
Version: federal_register_of_legislation:F2023C00456
Segment Type: schedule
Provision Reference: sch 3 (pt 22/27)
Character Range: 59262–62160

the medicine.

           (b) If, in relation to a medicine referred to in (a) there are:

              (i) four or more active ingredients in the medicine and the medicine is intended to be, or is, registered goods; or

              (ii) two or more active ingredients in the medicine and the medicine is intended to be, or is, listed goods,

           then, in relation to compliance of the label on the strip, blister or dial dispenser pack with sections 8 and 9, it shall be sufficient if the following information is displayed:

           (iii) the name of the medicine; and

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

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

              (vi) the name of the sponsor or distributor, or registered trademark if it readily identifies the sponsor or distributor of the medicine.

           (c) In addition to the requirements referred to in paragraphs 10(9)(a) and (b) as relevant, if each dosage unit is enclosed in the strip or blister such that an individual segment containing the dosage unit can be readily detached, then the following information must appear on the label of the strip or blister at least once in relation to every two dosage units:

              (i) for a medicine to which paragraph 10(9)(a) applies – the name of the medicine, the name(s) of all active ingredients in the medicine and the quantity or proportion of all active ingredients in the medicine; and

              (ii) for a medicine to which paragraph 10(9)(b) applies – the name of the medicine.

       (10) Plastic ampoules

           (a) Subject to paragraph (b), if:

              (i) a medicine is contained in a plastic ampoule; and

              (ii) the capacity of the container of the medicine in the plastic ampoule is 8 millilitres or less; and

              (iii) two or more ampoules are attached to a connecting strip; and

              (iv) the ampoules and their connecting strip are enclosed in a primary pack that complies with the requirements of this Order,

           then the information required by this Order to appear on the label of the container of the medicine may be divided between the ampoule and the connecting strip.

           (b) Whether or not the seal is broken when an ampoule is detached from the strip, the following information must appear on the label of each ampoule:

              (i) the name of the medicine; and

              (ii) the name(s) of all the active ingredients in the medicine; and

              (iii) the quantity or proportion of 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