Commonwealth legislation

Therapeutic Goods (Listing) Notice 2009 (No. 1)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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 oral therapeutic goods containing alpha-casozepine enriched hydrolysed milk protein (a protein derived from cow's milk) to be listed in the Australian Register of Therapeutic Goods (ARTG).

What this means:

For consumers: Products containing this specific milk-derived ingredient can be legally supplied in Australia as listed medicines (over-the-counter products).
Safety requirements: Product labels must display two warnings:
- "Derived from cow's milk"
- "Not suitable for use in children under the age of 12 months, except on professional advice"

Duration: This is a temporary arrangement that remains in force only until the Therapeutic Goods Regulations are updated to permanently include these products.

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Current sections

Direct links to the current provisions in Therapeutic Goods (Listing) Notice 2009 (No. 1).

Therapeutic Goods (Listing) Notice 2009 (No. 1)

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Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2009 (No. 1)

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 purposes of Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) for oral use that contain alpha-casozepine enriched hydrolysed milk protein as a therapeutically active ingredient subject to the following conditions applicable to alpha-casozepine enriched hydrolysed milk protein:

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

 “Derived from cow’s milk”;

and

 “Not suitable for use in children under the age of 12 months, except on professional advice”.

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 15th day of April 2009

(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. 1)

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2009 (No. 1)

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 alpha-casozepine enriched hydrolysed milk protein as a therapeutically active ingredient subject to the following conditions applicable to alpha-casozepine enriched hydrolysed milk protein:

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

 “Derived from cow’s milk”;

and

 “Not suitable for use in children under the age of 12 months, except on professional advice”.

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

Dated this 15th day of April 2009

(Signed by)

Charles Maskell-Knight

Delegate of the Minister for Health and Ageing