Commonwealth legislation

Therapeutic Goods (Listing) Notice 2008 (No. 4)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

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Commonwealth

Collection

legislative instrument

Plain English Summary

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This notice allows complementary medicines whose main active ingredient is Rhodiola rosea (golden or Arctic root) to be supplied in Australia as lower‑risk "listed" goods, affecting manufacturers and retailers of herbal supplements. Permission is limited to oral products made from dried powdered root or specified aqueous or hydroethanolic extracts, and is temporary until regulations are formally amended.

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Therapeutic Goods (Listing) Notice 2008 (No. 4)

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Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2008 (No. 4)

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

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Therapeutic Goods (Listing) Notice 2008 (No. 4)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2008 (No. 4)

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.

Dated this 22nd day of July 2008

Dr Rohan Hammett

Delegate of the Minister for Health and Ageing