Ampoules, pre-filled syringes and injectAmpoules, pre-filled syringes and injection vials

Ampoules, pre-filled syringes and injection vials

10. The requirements of paragraph 7 do not apply to a selected container, or an ampoule (other than an ampoule to which paragraph 11 applies) when:

(1) packed in a primary pack labelled in accordance with paragraph 7; and

(2) labelled with:

(a) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and

(b) with the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for the poison; and

(c) if the poison is for the treatment of animals, with the cautionary statement –

FOR ANIMAL TREATMENT ONLY

written in sans serif capital letters.

11. The requirements of paragraph 7 do not apply to a selected container that is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip when:

(1) packed in a primary pack labelled in accordance with paragraph 7; and

(2) the strip is labelled in accordance with paragraph 10; and

(3) the ampoule is labelled with:

(a) the approved name of the poison or the trade name of the product; and

(b) the quantity, proportion or strength of the poison in accordance with paragraph 8.