What is a TGA Listed Medicine?
What is a TGA Listed Medicine?
In Australia, all medicines legally supplied to consumers must be included in the Australian Register of Therapeutic Goods (ARTG). The ARTG is managed by the Therapeutic Goods Administration (TGA), the national authority responsible for regulating therapeutic goods including medicines, medical devices and biologicals.
A Listed Medicine carries an AUST L number on its label. This number confirms that the product has been included in the ARTG and that its sponsor has certified compliance with all applicable regulatory requirements for safety, quality and efficacy.
Listed medicines may only contain ingredients from the Therapeutic Goods (Permissible Ingredients) Determination and may only make health claims drawn from the Permitted Indications for Listed Medicines.
How Listed Medicines Differ from General Supplements
In many countries, health supplements can be sold without formal regulatory registration. In Australia, the regulatory framework is significantly more structured:
All medicines β including complementary medicines β must be included in the ARTG before they can be legally supplied in Australia. Products that are not in the ARTG cannot be legally sold.
π Listed medicines overview β TGA
Listed medicines may only contain ingredients that appear in the TGA's Permissible Ingredients Determination. This restricts the use of unapproved or untested substances.
π Understanding listed and registered complementary medicine regulation β TGA
Health claims on listed medicines must be drawn from the TGA's list of permitted indications. Claims about treating serious diseases or conditions are not permitted for listed medicines.
π Permitted indications for listed medicines β TGA
All listed medicines must be manufactured in accordance with recognised GMP standards, ensuring consistent quality throughout production, testing and release.
π Manufacturing for listed medicines β TGA
What This Means for LDV20
LDV20 is a TGA Listed Medicine with the ARTG number AUST L 502251. This means:
- LDV20 is included in the Australian Register of Therapeutic Goods.
- Its ingredients β sugar cane wax alcohols (policosanol), Berberis aristata (berberine), Silybum marianum (milk thistle) and chromic chloride hexahydrate (chromium) β are all TGA-permitted ingredients.
- Its health claims are drawn from permitted indications.
- It is manufactured in accordance with GMP standards.
- It is subject to ongoing post-market compliance reviews by the TGA.
For full product details, see the official LDV20 product page.
Frequently Asked Questions
What does AUST L mean on a product label?
AUST L indicates that the product is a Listed Medicine included in the Australian Register of Therapeutic Goods (ARTG). It confirms that the product has met the regulatory requirements set by the TGA for listed medicines.
Is a TGA Listed Medicine the same as a dietary supplement?
No. In Australia, listed medicines are regulated therapeutic goods that must be included in the ARTG, contain only pre-approved ingredients, and be manufactured under GMP standards. The term "dietary supplement" is not a regulatory category used by the TGA.
Does the TGA test every listed medicine before it goes on sale?
Listed medicines are not individually assessed by the TGA before supply. However, sponsors must self-certify compliance with all regulatory requirements, and the TGA conducts post-market compliance reviews to check that listed medicines meet safety, quality and claims requirements.
How can I verify that LDV20 is a genuine TGA Listed Medicine?
You can verify LDV20 by searching for its AUST L number (502251) on the TGA ARTG database. The record confirms the product name, ARTG ID and listed ingredients.
References
- Therapeutic Goods Administration. Listed medicines. β TGA β Listed medicines
- Therapeutic Goods Administration. Understanding listed and registered complementary medicine regulation. β TGA β Regulation guidance
- Therapeutic Goods Administration. Permitted indications for listed medicines. β TGA β Permitted indications
- Therapeutic Goods Administration. Manufacturing for listed medicines. β TGA β Manufacturing
- Therapeutic Goods Administration. ARTG listing β AUST L 502251. β TGA ARTG 502251
Last updated: April 2026 Β |Β Prepared by: Pure Australia Editorial Team
Always read the label and follow the directions for use.