Therapeutic Goods (Listing) Notice 2008 (No. 6) (Cth)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2008 (No. 6)

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 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 dimethyl sulfone as a therapeutically active ingredient.

AND

• preparations for the purposes of Item 3 of Part 1 of Schedule 4 of the Regulations for oral use that contain vegetable oil phytosterol esters, as a therapeutically active ingredient.

subject to the following conditions applicable to vegetable oil phytosterol esters:

The product label must include advisory statements to the effect of the following:

-     “There is no benefit from taking more than 3g/day of phytosterols from all sources”; and

-     “Not suitable for pregnant or lactating women”.

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      27^th          day of November 2008

Signed by

Dr Rohan Hammett

Delegate of the Minister for Health and Ageing