Therapeutic Goods (Listing) Notice 2008 (No. 5) (Cth)
Therapeutic Goods Act 1989
Therapeutic Goods (Listing) Notice 2008 (No. 5)
I, ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, and the 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 ARTG’) for listed goods:
preparations for the purposes of Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 that contain, as its therapeutically active ingredient, potassium chloride subject to the conditions that such preparations are suitable for use as active ingredients in listed medicines with the following conditions:
-the route of administration is restricted to dental use only, being use on the teeth; and
-the total potassium content in the product must not exceed an amount equivalent to a 3.75% concentration of potassium chloride, which will restrict the potassium ion in the product to 20 g/kg.
preparations for the purposes of Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 that contain, as its therapeutically active ingredient, potassium nitrate subject to the conditions that such preparations are suitable for use as active ingredients in listed medicines with the following conditions:
-the route of administration is restricted to dental use only, being use on the teeth; and
-the total potassium content in the product must not exceed an amount equivalent to a 5% concentration of potassium nitrate, which will restrict the potassium ion in the product to 20 g/kg.
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 Therapeutic Goods Regulations 1990 come into effect to require inclusion of the therapeutic goods specified in this Notice in the part of the ARTG for listed goods.
Dated this 27th day of November 2008
Signed by
Dr Rohan Hammett
Delegate of the Minister for Health and Ageing
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