Poisons Standard 2013
Ampoules, pre-filled syringes and injectAmpoules, pre-filled syringes and injection vials
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Ampoules, pre-filled syringes and injection vials
- 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) the selected container or ampoule is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(2) the selected container or ampoule is:
(a) packed in a primary pack labelled in accordance with paragraph 7; and
(b) labelled with:
(i) the approved name of the poison and the quantity, proportion or strength of the poison in accordance with paragraph 8; and
(ii) 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
(iii) if the poison is for the treatment of animals, with the cautionary statement –
FOR ANIMAL TREATMENT ONLY
written in sans serif capital letters.
- 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) the selected container is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip, is for a therapeutic good and is labelled in the manner prescribed by orders made under subsection 10(3) of the Commonwealth Therapeutic Goods Act 1989; or
(2) the selected container is a plastic ampoule that is continuous with a strip of the same material and opens as it is detached from the strip, is:
(a) packed in a primary pack labelled in accordance with paragraph 7; and
(b) the strip is labelled in accordance with paragraph 10; and
(c) the ampoule is labelled with:
(i) the approved name of the poison or the trade name of the product; and
(ii) the quantity, proportion or strength of the poison in accordance with paragraph 8.