Therapeutic Goods (Poisons Standard—October 2024) Instrument 2024
36Ampoules, pre‑filled syringes and injection vials
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36 Ampoules, pre‑filled syringes and injection vials
(1) The requirements of Subdivision B do not apply to a selected container of poison or an ampoule of poison (other than an ampoule to which subsection (2) applies) when:
(a) the poison is therapeutic goods and is labelled in accordance with the standards for the goods specified in orders made under subsection 10(1) of the Act; or
(b) the selected container or ampoule is:
(i) packed in a primary pack labelled in accordance with Subdivision B; and
(ii) labelled with:
(A) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with section 34; and
(B) 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 only for the treatment of animals—the cautionary statement:
written in sans serif capital letters.
(2) The requirements of Subdivision B do not apply to a selected container of poison 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:
(a) the poison is therapeutic goods and is labelled in accordance with the standards for the goods specified in orders made under subsection 10(1) of the Act; or
(b) the poison is not therapeutic goods and all of the following apply:
(i) the ampoule is packed in a primary pack labelled in accordance with Subdivision B;
(ii) the strip is labelled in accordance with this section;
(iii) the ampoule is labelled with:
(A) the approved name of the poison or the trade name of the poison; and
(B) the quantity, proportion or strength of the poison in accordance with section 34.