Therapeutic Goods Act 1989
Therapeutic Goods (Listing) Notice 2011 (No. 1)
I, ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, delegate of the Minister for Health and Ageing for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) and acting under that provision, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods:
(1) goods containing Leptospermum scoparium oil as a therapeutically active ingredient in a concentration of 25 per cent or less that are presented as topical or mouthwash preparations;
(2) goods containing Leptospermum scoparium oil as a therapeutically active ingredient that are presented as topical or mouthwash preparations that are either:
a) packed in containers having a nominal capacity of 15 mL or less, where:
(i) the container is fitted with a restricted flow insert; and
(ii) the container and any other packaging is labelled with the warnings:
KEEP OUT OF REACH OF CHILDREN; and
NOT TO BE TAKEN; or
b) packed in containers having a nominal capacity of 25 mL or less, where:
(i) the container is fitted with a restricted flow insert and child-resistant closure; and
(ii) the container and any other packaging is labelled with the warnings:
KEEP OUT OF REACH OF CHILDREN; and
NOT TO BE TAKEN.
In this Notice, “restricted flow insert” and “child-resistant closure” have the same meaning as in the Poisons Standard 2010 as at 1 January 2011.
This Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.
Pursuant to subsection 9A(6) of the Act this Notice ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the Register for listed goods.
Dated this 27th day of July 2011
(signed by)
Rohan Hammett
Delegate of the Minister for Health and Ageing
