(10) Plastic ampoules(10) Plastic ampoules

(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 administration followed by the word ‘only’ and/or warnings against use by other routes of administration.