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Substances that may be used in Listed medicines in Australia

12 December 2007

Listed medicines contain low-risk ingredients and are entered on the ARTG via a streamlined electronic listing facility. This process for listing products allows for early market access for complementary medicines.

Unlike registered medicines, there is no evaluation prior to the medicine being listed on the ARTG. The TGA therefore uses a variety of mechanisms to assure the safety and quality of the ingredients used, as well as the resultant medicines. One of these mechanisms is that listed medicines may only contain ingredients that have been evaluated and approved by the TGA as being of low risk.

The following substances are eligible for use in medicines Listed on the Australian Register of Therapeutic Goods for supply in Australia. The list includes the approved role of the substance (i.e. active, excipient, and/or component), and any restrictions and conditions that apply to the substance when used in Listed medicines.

Please note substances marked as components (C) are not approved as substances for use in their own right and can only be used in conjuction with an approved source. For example, iodine is not approved as a substance in its own right but is permitted when expressed as a component of fucus vesiculosus (Kelp), which is known to naturally contain iodine.

Some substances are permitted as food excipients only. These substances (e.g. apple, pear) refer only to edible substances fit for human consumption as a food. Only certain preparations are permitted for most food excipients: fresh dry or powdered plant material and fresh, dried or concentrated juices. Juice preparations may only be named where the fresh plant part has a high water content. For further details, refer to the Introduction to the Herbal Substances AAN list in the TGA Approved Terminology for Medicines.

Please note this list does not include substances that may be used as homoeopathic preparations. The Office of Complementary Medicines is currently conducting a review of homoeopathic substance permitted in Listed medicines, and this document will be updated upon completion of the review.

A glossary of abbreviations is provided at the end of the document. For further information on Coded Warnings, refer to the TGA eBusiness Services website.

For further information on conditions related to provisional ingredients (PRVs), refer to the Australian Regulatory Guidelines for OTC Medicines.

This list was last updated on 12 December 2007 and is subject to change from time to time as new substances are approved for use in Listed medicines. Importantly, as a result of a safety concern, substances may be subject to new restrictions or may be removed from the list.

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Log of changes

The list reflects changes made to the document: Substances that may be used in Listed medicines in Australia up to 12 December 2007.