Understanding Medicine Categories in Australia
Understanding Medicine Categories in Australia
The Therapeutic Goods Administration (TGA) regulates all therapeutic goods supplied in Australia. Every medicine must be included in the Australian Register of Therapeutic Goods (ARTG) and is assigned one of three AUST numbers based on its risk level and regulatory pathway.
The TGA describes this as a "risk-based approach to regulation where we have more rigorous controls on higher risk registered medicines than lower risk listed medicines."
The Three AUST Categories Explained
Listed medicines are considered lower risk by the TGA. They may only contain pre-approved ingredients and make health claims from the permitted indications list. They are not individually assessed for efficacy before supply, but sponsors must self-certify compliance. They are subject to post-market compliance reviews by the TGA. Most complementary medicines (vitamins, minerals, herbal medicines) fall into this category.
π Listed medicines β TGA
Assessed listed medicines make slightly higher-risk health claims than standard listed medicines. Unlike AUST L products, their health claims have been assessed for efficacy by the TGA before going on sale. They may use a "TGA assessed" claim on the label. They still contain pre-approved ingredients, but their indications are evaluated pre-market.
π Understanding assessed listed medicine requirements β TGA
Registered medicines are considered higher risk and undergo the most rigorous regulatory process. The TGA fully evaluates safety, quality and efficacy before they go on sale. The medicine label is also approved pre-market. Most over-the-counter medicines and all prescription medicines are registered. Examples include paracetamol, ibuprofen and prescription medications.
π How we regulate medicines β TGA
Side-by-Side Comparison
| Attribute | AUST L (Listed) | AUST L(A) (Assessed Listed) | AUST R (Registered) |
|---|---|---|---|
| Pre-market efficacy assessment | No | Yes | Yes |
| Ingredients | Pre-approved list only | Pre-approved list only | Assessed pre-market |
| Health claims | Permitted indications only | Assessed pre-market | Assessed pre-market |
| GMP required | Yes | Yes | Yes |
| Post-market compliance reviews | Yes | Yes | No (pre-market assessed) |
| Available off-the-shelf | Yes | Yes | Some |
| Prescription required | No | No | Some |
Source: TGA β How we regulate medicines
Where LDV20 Sits
LDV20 is classified as an AUST L Listed Medicine with ARTG number 502251. This means:
- It contains pre-approved ingredients: sugar cane wax alcohols, Berberis aristata, Silybum marianum and chromic chloride hexahydrate.
- Its health claims are drawn from the TGA's permitted indications.
- It is manufactured in accordance with GMP standards.
- It is available off-the-shelf without a prescription.
- 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 is the difference between AUST L and AUST R?
AUST L (Listed) medicines are lower-risk products that contain pre-approved ingredients and use permitted health claims. AUST R (Registered) medicines are higher-risk products that undergo full pre-market evaluation by the TGA for safety, quality and efficacy. Both categories require GMP manufacturing.
What does AUST L(A) mean?
AUST L(A) stands for "Assessed Listed" medicine. These products have had their health claims assessed for efficacy by the TGA before going on sale, and may use a "TGA assessed" claim on their label. They still contain pre-approved ingredients like standard AUST L medicines.
Is AUST L the same as "unregulated"?
No. AUST L medicines are regulated by the TGA. They must be included in the ARTG, contain only pre-approved ingredients, use only permitted health claims, be manufactured under GMP standards, and are subject to post-market compliance reviews. They are not unregulated products.
Where can I find the AUST number on a medicine?
The AUST number (AUST L, AUST L(A) or AUST R) is displayed on the product label and packaging. For LDV20, the label shows "AUST L 502251". You can verify this on the TGA ARTG database.
References
- Therapeutic Goods Administration. How we regulate medicines. β TGA β How we regulate medicines
- 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. Understanding assessed listed medicine requirements. β TGA β Assessed listed
- 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.