Therapeutic Goods (Listing) Notice 2008 (No. 4)
Federal Register of Legislative Instruments (FRLI): Legislative Instrument - F2008L02820 (31 July 2008)
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COMMONWEALTH OF AUSTRALIA
Therapeutic Goods Act 1989
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 (ARTG) for listed goods:
- preparations, referred to in Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 that contain, as their therapeutically active ingredient, Rhodiola rosea, subject to the conditions that such preparations are for oral use only and may only be in the following forms:
- the dried root (powdered) of Rhodiola rosea;
- the dried root (powdered) of Rhodiola rosea as an aqueous extract; or
- the dried root (powdered) of Rhodiola rosea as a hydroethanolic extract with up to 70% ethanol v/v.
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 listed in this Notice in the part of the ARTG for Listed goods.
Dated this 22nd day of July 2008
Dr Rohan Hammett
Delegate of the Minister for Health and Ageing