Commonwealth legislation

Therapeutic Goods (Listing) Notice 2009 (No. 7)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

2/10 complexity

What this does: This notice allows herbal medicines containing Terminalia bellirica (a plant also known as bibhitaki, used in traditional Ayurvedic medicine) to be sold in Australia as "listed" medicines without individual pre-approval assessment.

Who it affects:

Manufacturers and importers of complementary medicines containing this ingredient
Consumers purchasing herbal supplements containing Terminalia bellirica

Key restrictions:

The ingredient must be a water-based extract of the fruit skin only (not the seeds)
The medicine must be for swallowing/oral use only (not creams, injections, etc.)

Why it matters: Normally, ingredients not already approved require extensive safety data. This notice creates a temporary legal pathway for these specific products to be sold immediately, provided they meet the safety conditions above. It remains in force only until permanent regulations are made to cover this ingredient.

JSON API Health / NDIS / medicines

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Current sections

Direct links to the current provisions in Therapeutic Goods (Listing) Notice 2009 (No. 7).

Therapeutic Goods (Listing) Notice 2009 (No. 7)

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Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2009 (No. 7)

I, CHARLES MASKELL-KNIGHT, Acting 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 purpose of Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘Terminalia bellirica’ as a therapeutically active ingredient, subject to the following conditions:

- the ingredient consists of aqueous extract of the fruit pericarp (all fruit tissue without the seeds) only; and

- the ingredient is included in medicines for oral administration only.

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 10th day of November 2009

(as signed by)

Charles Maskell-Knight

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 2009 (No. 7)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2009 (No. 7)

preparations, for the purpose of Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘Terminalia bellirica’ as a therapeutically active ingredient, subject to the following conditions:

- the ingredient consists of aqueous extract of the fruit pericarp (all fruit tissue without the seeds) only; and

- the ingredient is included in medicines for oral administration only.

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

Dated this 10th day of November 2009

(as signed by)

Charles Maskell-Knight

Delegate of the Minister for Health and Ageing