Therapeutic Goods (Listing) Notice 2009 (No. 5) (Cth)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2009 (No.5)

I, ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, delegate of the Minister for Health 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 Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) for oral use that contain “bovine whey Ig-rich fraction” as a therapeutically active ingredient subject to the following conditions:

o   the product label includes the following advisory statements:

-      “Derived from cow’s milk”;

and

-      “Not suitable for use in children under the age of 12 months, except on health professional advice (or words to that effect)”.

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 15^th day of September 2009

(signed by)

Rohan Hammett

Delegate of the Minister for Health