Therapeutic Goods (Listing) Notice 2006 (No. 1)

Overview

The Therapeutic Goods (Listing) Notice 2006 (No. 1) was enacted under the authority of the Therapeutic Goods Act 1989 by the Minister for Health and Ageing to address the need for a streamlined process to approve new ingredients for low-risk complementary medicines. This Notice allows for the inclusion of Undaria pinnatifida powder, a brown seaweed traditionally used in Japan, Korea, and China, as an active ingredient in Listed medicines for oral use. This legislative instrument was created to facilitate the inclusion of new substances into the Australian Register of Therapeutic Goods, thereby ensuring that safe and effective complementary medicines are available to the public. The policy objective behind this notice is to maintain a national system of controls for therapeutic goods, ensuring their quality, safety, efficacy, and timely availability in Australia. This notice was developed following extensive consultation with the Complementary Medicines Evaluation Committee (CMEC), an expert body that advises the Therapeutic Goods Administration (TGA) on matters related to the safety, quality, and efficacy of complementary medicines. The CMEC recommended that only the whole dried plant of Undaria pinnatifida, excluding the holdfast, be approved for use in Listed medicines, based on its long history of safe use as a food and traditional medicine in its native regions. The notice was registered and came into effect on the day after its registration on the Federal Register of Legislative Instruments.

Scope and Application

The Therapeutic Goods (Listing) Notice 2006 (No. 1) pertains to the use of Undaria pinnatifida, commonly known as brown seaweed, as an active ingredient in low-risk (Listed) complementary medicines intended for oral consumption. This Notice was issued by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989, which establishes a national system for the quality, safety, efficacy, and timely availability of therapeutic goods used in or exported from Australia. The Therapeutic Goods Administration (TGA) administers this Act. According to the Act, therapeutic goods must be listed in the Australian Register of Therapeutic Goods (ARTG) before being supplied, imported, manufactured, or exported within Australia, unless exempted under the Act. Complementary medicines, including vitamins, minerals, nutritional supplements, and herbal, aromatherapy, and homoeopathic products, are regulated under this framework. These products are typically considered low-risk and are Listed in the ARTG, subject to specific conditions regarding their ingredients and therapeutic claims. The Listing Notice facilitates the timely approval of new substances for Listed medicines by allowing the Minister for Health and Ageing to publish such a Notice, subject to any specified conditions, until the substance is officially included in Schedule 4 of the Therapeutic Goods Regulations 1990.

Key Provisions

The Therapeutic Goods (Listing) Notice 2006 (No. 1) (section 9A(5)) permits the use of Undaria pinnatifida powder as an active ingredient in low-risk complementary medicines for oral use. This notice was issued under the Therapeutic Goods Act 1989 and became effective the day after its registration on the Federal Register of Legislative Instruments. The Notice allows for the inclusion of this brown seaweed in Listed medicines, subject to specific conditions. The Therapeutic Goods Administration (TGA) is responsible for administering the Act and ensuring that therapeutic goods meet the required standards of quality, safety, and efficacy before they can be supplied in, imported into, manufactured in, or exported from Australia. The Australian Register of Therapeutic Goods (ARTG) is the central registry where therapeutic goods must be listed before they can be legally supplied in Australia. Complementary medicines, which include products such as vitamins, minerals, nutritional supplements, and herbal products, are regulated under the Act. Most complementary medicines are considered low risk and are Listed in the ARTG, with specific restrictions on the ingredients and therapeutic claims they can make. The use of Undaria pinnatifida in Listed medicines is subject to the approval of the Minister for Health and Ageing and the evaluation by the Complementary Medicines Evaluation Committee (CMEC). CMEC recommended that only the whole dried plant of Undaria pinnatifida, excluding the holdfast, be suitable for use in Listed medicines for oral use. Entities and parties governed by the Act must ensure that any therapeutic goods they supply, import, manufacture, or export are included in the ARTG. For complementary medicines containing Undaria pinnatifida, this involves adhering to the specific conditions outlined in the Therapeutic Goods (Listing) Notice 2006 (No. 1). This includes ensuring that only the whole dried plant of Undaria pinnatifida, minus the holdfast, is used as an active ingredient. Additionally, entities must comply with all other regulatory requirements set out in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. This includes providing accurate and comprehensive information about the product, including its ingredients, therapeutic claims, and any potential risks or side effects. Failure to comply with these requirements can result in legal action, including fines and other penalties. Breaches of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 can result in significant legal consequences. Under the Act, supplying therapeutic goods that are not included in the ARTG is an offence, which can result in fines and imprisonment. The maximum penalty for individuals can be up to $1.1 million or imprisonment for up to 10 years, or both. For corporations, the penalties can be even higher, with fines up to $5.5 million or imprisonment for up to 50 years, or both. Additionally, the Act provides for the imposition of civil penalties, including pecuniary penalties and the potential for product recalls. The TGA can also take enforcement action, such as issuing infringement notices or initiating legal proceedings, to ensure compliance with the Act and its regulations.