Document ID: chunk:federal_register_of_legislation:F2024C01255:body:0:p25
Version: federal_register_of_legislation:F2024C01255
Segment Type: other
Provision Reference: 
Character Range: 65352–68344

it shall be sufficient if the following information is displayed:

              (ii) the name of the medicine; and
               1.        the batch number of the medicine preceded by the batch number prefix;
               1.         the expiry date of the medicine preceded by the expiry date prefix; and

              (v) 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(14)(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:

                1.                  for a medicine to which paragraph 10(14)(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
                2.                for a medicine to which paragraph 10(14)(b) applies – the name of the medicine.

        1.      Plastic ampoules

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

              (i) a medicine is contained in a plastic ampoule, whether or not it is a medicine for injection; and

              (ii) the capacity of 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 administration followed by the word 'only' and/or warnings against use by other routes of administration.

           (c) If a medicine is contained in a plastic ampoule with a capacity of 25 millilitres or less, but greater than 8 millilitres, then the requirements of subsection 10(4), or subsection 10(11), as relevant, apply notwithstanding the container being a plastic ampoule.

           (d) If a medicine is contained in a plastic ampoule with a capacity greater than 25 millilitres, then