Commonwealth legislation

Therapeutic Goods (Listing) Notice 2009 (No. 5)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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

This notice temporarily allows specific cow's milk protein supplements to be sold in Australia.

The Therapeutic Goods Administration (TGA) is placing oral preparations containing "bovine whey Ig-rich fraction" (a protein derived from cow's milk whey) onto the Australian Register of Therapeutic Goods (ARTG) as "listed medicines" (a category for lower-risk therapeutic goods).

Key requirements:

Mandatory labeling: Product labels must include:
- "Derived from cow's milk" (warning for people with dairy allergies)
- "Not suitable for use in children under the age of 12 months, except on health professional advice" (infant safety warning)

Why it matters: This creates a legal pathway for these specific supplements to be sold while bypassing the usual lengthy registration process. However, this is only temporary—the notice automatically expires once the Therapeutic Goods Regulations are formally updated to permanently include these products.

This affects supplement manufacturers and consumers purchasing whey protein products with immunoglobulin-rich fractions.

JSON API Health / NDIS / medicines

Deep dive

Want the full deep dive?

Zoe can write the in-depth analysis on top of the summary above: how it works, who it affects and what each part actually does.

Current sections

Direct links to the current provisions in Therapeutic Goods (Listing) Notice 2009 (No. 5).

Therapeutic Goods (Listing) Notice 2009 (No. 5)

View image in the official source

Therapeutic Goods Act 1989

Therapeutic Goods (Listing) Notice 2009 (No.5)

I, ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, delegate of the Minister for Health 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 Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) for oral use that contain “bovine whey Ig-rich fraction” as a therapeutically active ingredient subject to the following conditions:
the product label includes the following advisory statements:

- “Derived from cow’s milk”;

and

- “Not suitable for use in children under the age of 12 months, except on health professional advice (or words to that effect)”.

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 September 2009

(signed by)

Rohan Hammett

Delegate of the Minister for Health

Source text

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

1 Therapeutic Goods (Listing) Notice 2009 (No. 5)