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Therapeutic Goods (Listing) Notice 2009 (No. 1)

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Therapeutic Goods Act 1989
 
Therapeutic Goods (Listing) Notice 2009 (No. 1)
 
I, CHARLES MASKELL-KNIGHT, Acting 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 ARTG) for listed goods:
 
·        preparations for the purposes of Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) for oral use that contain alpha-casozepine enriched hydrolysed milk protein as a therapeutically active  ingredient subject to the following conditions applicable to alpha-casozepine enriched hydrolysed milk protein:
 
The product label must include advisory statements to the effect of the following:
-        “Derived from cow’s milk”;
and
-        “Not suitable for use in children under the age of 12 months, except on professional advice”.
 
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 ARTG for listed goods.
 
 
Dated this     15th     day of April 2009
 
 
(Signed by)
Charles Maskell-Knight
Delegate of the Minister for Health and Ageing