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

Administered by Department of Health, Disability and Ageing

Legislation au F2009L03632 Not in force Legislative Instrument

Select Document

EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2009 (No. 5)

Bovine whey Ig-rich fraction

Section 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2009 (No. 5) (the Listing Notice) is a Notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).

The Listing Notice has the effect of permitting the use of “bovine whey Ig-rich fraction” as an active ingredient in listed medicines for oral use subject to the inclusion of advisory statements on the label.

The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).

BACKGROUND

The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included in the Australian Register of Therapeutic Goods (the ARTG) before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D of the Act). Medicines are registered or listed in the ARTG, depending on the ingredients they contain and the therapeutic claims that are being made.

In Australia, products that contain low risk ingredients are referred to as listed medicines. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited therapeutic claims.

Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the ARTG for listed medicines. Part 5 of Schedule 4 specifies substances other than vitamins, minerals and plant material that are for use in listed medicines. Division 3 of Part 5 specifies substances that may be ingredients of preparations, subject to the inclusion of a label advisory statement. At present, Schedule 4 of the Regulations does not include a reference to “bovine whey Ig-rich fraction” but it is anticipated that it will when the Regulations are next amended.

In order to facilitate the timely approval of new listable therapeutic goods, subsection 9A(5) of the Act allows the Minister for Health to publish a listing notice that has the effect of permitting the use of particular therapeutic goods in listed medicines subject to any specified conditions.

Pursuant to subsection 9A(6) of the Act, if Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of a listing notice, that listing notice ceases to have effect.

Bovine whey Ig-rich fraction

The ingredient “bovine whey Ig-rich fraction” is a concentrated immunoglobulin protein fraction prepared from whey, which is a by-product of cheese production from bovine (cow) milk. Bovine immunoglobulins have a well established role in providing calves with specific passive immune protection until their own immune system matures.

As milk is sourced exclusively from Australian herds that produce milk for human consumption, there are no issues with transmissible spongiform encephalopathies, such as “mad cow disease”.

The proposed dose range is 600-6000 mg/day, representing an intake of bovine immunoglobulins of approximately 300-3000 mg/day. The minimum dose is similar to the amount that would normally be ingested by consumers of some dairy foods.

As it is a component of milk, whey, and its immunoglobulin component, has a long history of human dietary consumption. Exposure to immunoglobulins across the proposed dose range is expected to be similar to exposure to immunoglobulins in other bovine colostrum products, which have been available in Australia for some time without any known adverse effects.

Bovine colostrum powder and bovine colostrum extract, containing 10-20% immunoglobulins, have been approved for use as active ingredients in listed medicines for several years. The only adverse reactions in the Australian database appear to be allergic reactions in young children ingesting colostrum-containing products.

The Complementary Medicines Evaluation Committee (CMEC) is a statutory committee established under subsection 52G(1) of the Act which gives scientific and policy advice to the Minister for Health and the Secretary to the Department of Health and Ageing regarding controls on the supply and use of complementary listed medicines, with particular reference to the safety and quality of products and, where appropriate, efficacy relating to the claims made for products.

At its meeting in December 2008, the CMEC recommended that this substance is suitable for use as an active ingredient in listed medicines where supported by appropriate evidence for any indications and claims made for the product.

The delegate of the Minister made the Listing Notice, a legislative instrument for the purposes of the Legislative Instrument Act 2003, to provide for “bovine whey Ig-rich fraction” to be used as an active ingredient in oral listed medicines subject to the inclusion of the following advisory statements in the product label, which are required for similar bovine-derived products:

“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”.

Draft Compositional Guidelines are prepared by the TGA and intended to set out the standards and requirements for the specific forms or types of substances for use in listed medicines where there is no monograph in the British Pharmacopoeia or other acceptable monograph.

The TGA has prepared draft Compositional Guidelines in relation to bovine whey Ig-rich fraction, and these will be available on the TGA’s Internet site (www.tga.gov.au) for consultation for six months following the registration of the Listing Notice on the FRLI.

CONSULTATION

Although the listing of the ingredient “bovine whey Ig-rich fraction” is minor and machinery in nature, the CMEC was consulted during the approval process for this ingredient.

REGULATION IMPACT STATEMENT

No Regulation Impact Statement is necessary in relation to the Listing Notice as the listing of the ingredient “bovine whey Ig-rich fraction” is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.

Overview

The Therapeutic Goods (Listing) Notice 2009 (No. 5) was enacted to address the gap in the availability of certain ingredients in listed medicines by allowing the use of "bovine whey Ig-rich fraction" as an active ingredient, subject to specific advisory statements on the product label. This Notice was made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989. The objective is to facilitate the timely approval of new listable therapeutic goods by providing a legislative mechanism to include new substances in the Australian Register of Therapeutic Goods (ARTG). The Notice permits the use of this ingredient in oral listed medicines, thereby expanding the range of available therapeutic goods while ensuring that consumers are appropriately informed about the product’s nature and potential risks through the required label statements.

Scope and Application

The Therapeutic Goods (Listing) Notice 2009 (No. 5) pertains to the inclusion of "bovine whey Ig-rich fraction" as an active ingredient in oral listed medicines, subject to specific label advisory statements. This Notice, made by the delegate of the Minister for Health under the Therapeutic Goods Act 1989, allows for the use of this ingredient in listed medicines, which are typically considered lower risk than other types of medicines due to their limited ingredients and claims. The Notice applies to any entities or individuals intending to supply, import, manufacture, or export therapeutic goods containing bovine whey Ig-rich fraction in Australia, ensuring compliance with national standards for quality, safety, efficacy, and timely availability of therapeutic goods. The scope of the Notice is nationwide, as it falls under the Commonwealth's jurisdiction and aligns with the national system established by the Therapeutic Goods Act 1989. While the Notice itself does not specify exclusions, exemptions, or thresholds, it is contingent upon the Therapeutic Goods Administration’s regulations and guidelines, which may further detail specific conditions or restrictions. The Notice becomes effective upon registration on the Federal Register of Legislative Instruments.

Key Provisions

The Therapeutic Goods (Listing) Notice 2009 (No. 5) (Listing Notice) under the Therapeutic Goods Act 1989 (the Act) allows for the use of "bovine whey Ig-rich fraction" as an active ingredient in listed medicines intended for oral use, provided that specific advisory statements are included on the product label (section 9A(5)). This Notice was made by the delegate of the Minister for Health and took effect on the day following its registration on the Federal Register of Legislative Instruments. The ingredient "bovine whey Ig-rich fraction" is a concentrated immunoglobulin protein derived from whey, a by-product of cheese production from bovine milk, which has a history of safe human consumption due to its presence in milk and dairy foods. The Listing Notice imposes obligations on manufacturers and suppliers of listed medicines containing "bovine whey Ig-rich fraction" to include two specific advisory statements on the product label. These statements are: "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). These advisory statements are intended to inform consumers of the source of the ingredient and to warn against its use in infants without medical guidance. Failure to comply with the requirements of the Listing Notice, including the inclusion of the required advisory statements on the product label, may result in legal consequences. Although the Listing Notice does not explicitly detail specific penalties, any breach of the Act or the Regulations could lead to civil or criminal penalties. Under the Act, penalties for offences can include fines and imprisonment, with the exact penalties varying depending on the specific offence and jurisdiction. Additionally, non-compliance may result in the product being considered unlisted, which could lead to enforcement actions by the Therapeutic Goods Administration (TGA) to remove or restrict the supply of the non-compliant product in the Australian market.

Area of Law: Medical Law
Instrument: Notice
Concepts: Definitions & Interpretation; Regulatory Standards; Consultation Requirements

Interactions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

Legislation content