Commonwealth legislation

Therapeutic Goods (Listing) Notice 2008 (No. 3)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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 permits oral supplements containing Arabinogalactan‑Larix (larch extract) to be sold in Australia as "listed medicines" — a lower‑risk regulatory category — provided they meet standards for source species (Larix occidentalis or L. larcinia), ≥85% polysaccharides, and a maximum daily dose of 15 g. It’s a temporary pathway until formal regulation is updated.

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Therapeutic Goods (Listing) Notice 2008 (No. 3)

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Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2008 (No. 3)

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, for oral use that contain, as their therapeutically active ingredient, Arabinogalactan - Larix, being a substance that is to be mentioned in Division 2 of Part 5 of Schedule 4 of the Therapeutic Goods Regulations 1990, and which comply with the following requirements:

- the ingredient Arabinogalactan – Larix is derived from Larix occidentalis or Larix larcinia;

- the concentration of polysaccharides in the ingredient Arabinogalactan – Larix is greater than or equal to 85 percent; and

- the maximum recommended daily dose of the ingredient Arabinogalactan – Larix is not to exceed 15 grams.

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 30th day of June 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. 3)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2008 (No. 3)

preparations, referred to in Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990, for oral use that contain, as their therapeutically active ingredient, Arabinogalactan - Larix, being a substance that is to be mentioned in Division 2 of Part 5 of Schedule 4 of the Therapeutic Goods Regulations 1990, and which comply with the following requirements:

- the ingredient Arabinogalactan – Larix is derived from Larix occidentalis or Larix larcinia;

- the concentration of polysaccharides in the ingredient Arabinogalactan – Larix is greater than or equal to 85 percent; and

- the maximum recommended daily dose of the ingredient Arabinogalactan – Larix is not to exceed 15 grams.

This Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.

Dated this 30th day of June 2008

Dr Rohan Hammett

Delegate of the Minister for Health and Ageing