Therapeutic Goods (Listing) Notice 2006 (No. 2)

Administered by Department of Health, Disability and Ageing

Legislation au F2006L00589 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

THERAPEUTIC GOODS (LISTING) NOTICE 2006 (No. 2)

Conifer Green Needle Complex

Section 9A(5), Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods (Listing) Notice 2006 (No. 2) (the Listing Notice) is a Notice made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).

The Listing Notice permits the use of conifer green needle complex as an active ingredient in low risk (Listed) complementary medicines for oral and topical use.

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

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 (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 (ARTG) before being supplied in, imported into, manufactured in, or exported from Australia (subsection 20(1) 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 such as vitamins, minerals, nutritional supplements and herbal, aromatherapy and homoeopathic products are regulated as ‘complementary’ medicines. Most, but not all, complementary medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, and are Listed in the ARTG. Listed medicines may only contain ingredients that have been approved by the TGA as being of low risk and may only make certain 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.

In order to facilitate the timely approval of new Listable substances, subsection 9A(5) of the Act allows the Minister for Health and Ageing to publish a Listing Notice that has the effect of permitting the use of particular substances in Listed medicines subject to any specified conditions.

Pursuant to subsection 9A(6) of the Act, when the Regulations are amended to require any of those goods that have been the subject of a Listing Notice to be included in the part of the Register for Listed goods, the Listing Notice ceases to have effect.

Conifer green needle complex is a mixture of various compounds made by petroleum ether extraction from the needles of two conifer species, Pinus sylvestris (Scotch Pine) and Picea abies (Norwegian Spruce), and the removal of essential oils.

Conifer green needle complex has a relatively long history of therapeutic use in the former USSR, and more recently in Russia and Latvia. Early therapeutic uses of the material were for the treatment of wounds and burns, and as an ingredient in medicated tampons and cosmetics and products such as toothpastes, soaps and shaving creams.

The long history of use of conifer green needle complex and its low propensity for producing adverse reactions both in oral and topical use supported its safety and suitability for use as a therapeutically active ingredient in Listed medicines for oral and topical use.

CONSULTATION

This substance has been reviewed by the Complementary Medicines Evaluation Committee (CMEC), which is comprised of some of Australia’s leading experts on complementary medicines. CMEC provides scientific and policy advice to the TGA relating to controls on the supply and use of complementary medicines, with particular reference to safety, quality and where appropriate, efficacy.

CMEC recommended that the conifer green needle complex is suitable for use as an active ingredient in Listed medicines for oral and topical use.

REGULATION IMPACT STATEMENT

No Regulation Impact Statement is necessary in relation to the Listing Notice as the regulation change is minor and machinery in nature.

Overview

The Therapeutic Goods (Listing) Notice 2006 (No. 2) was enacted to address the need for timely and efficient approval of new active ingredients for use in Listed medicines in Australia. This Notice was issued under subsection 9A(5) of the Therapeutic Goods Act 1989 by the Minister for Health and Ageing, with the aim of facilitating the inclusion of substances that have been deemed safe and suitable for use in Listed medicines, which are generally considered to be of lower risk compared to prescription and over-the-counter medicines. The Notice allows for the use of conifer green needle complex as an active ingredient in such Listed medicines for oral and topical applications, reflecting its long history of safe use and low propensity for adverse reactions. The Therapeutic Goods Administration (TGA) administers the Act, ensuring that all therapeutic goods meet quality, safety, efficacy, and timely availability standards before they can be supplied in Australia.

Scope and Application

The Therapeutic Goods (Listing) Notice 2006 (No. 2) applies to the use of conifer green needle complex as an active ingredient in low-risk complementary medicines for oral and topical use, facilitating its inclusion in the Australian Register of Therapeutic Goods (ARTG). This notice is made under the Therapeutic Goods Act 1989, which governs the quality, safety, efficacy, and timely availability of therapeutic goods in Australia and exports from the country. The notice was issued by the delegate of the Minister for Health and Ageing and took effect immediately upon registration on the Federal Register of Legislative Instruments. The Act mandates that therapeutic goods be listed in the ARTG unless exempted or authorised, with complementary medicines such as vitamins, minerals, and herbal products being regulated as Listed medicines due to their relatively low risk profile. The Therapeutic Goods Administration (TGA) administers the Act and ensures that only approved low-risk ingredients are used in Listed medicines, which may only make certain therapeutic claims. The inclusion of conifer green needle complex in the ARTG for Listed medicines follows a review by the Complementary Medicines Evaluation Committee, which confirmed its safety and suitability for use based on its long history of therapeutic use in former USSR, Russia, and Latvia.

Key Provisions

The Therapeutic Goods (Listing) Notice 2006 (No. 2) (section 9A(5)) permits the use of conifer green needle complex as an active ingredient in low-risk (Listed) complementary medicines for oral and topical use. This means that manufacturers can legally include this substance in their products intended for such uses, provided they adhere to the conditions specified in the Notice. The Notice came into effect on the day following its registration on the Federal Register of Legislative Instruments. Entities and individuals involved in the manufacture, supply, or importation of these medicines must ensure that the conifer green needle complex is used in accordance with the conditions outlined in the Notice. They must also comply with the broader requirements of the Therapeutic Goods Act 1989, which includes maintaining the quality, safety, and efficacy of the therapeutic goods. The Therapeutic Goods Administration (TGA) oversees these processes and may require additional information or testing to verify compliance. Failing to comply with the provisions of the Listing Notice or the Act may result in legal consequences. Under the Therapeutic Goods Act 1989, non-compliance could lead to offences that might attract civil or criminal penalties. For instance, supplying therapeutic goods that do not meet the required standards could result in fines or imprisonment. The specific penalties depend on the severity of the breach, but they are designed to enforce the high standards of safety and quality expected in the Australian therapeutic goods market.

Area of Law: Medical Law
Instrument: Notice
Concepts: Definitions & Interpretation; Licensing & Registration; Regulatory Standards

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.

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