What is an AUST L Number?
The acronym AUST L stands for 'Australian Listed'. When you see this designation on the packaging of a medicine or therapeutic product in Australia, it signifies that the product has been included in the Australian Register of Therapeutic Goods (ARTG) as a 'listed medicine'. This inclusion is a legal requirement for the product to be supplied in Australia. The ARTG is the central database managed by the Therapeutic Goods Administration (TGA), Australia's regulatory body for therapeutic goods.
AUST L medicines are typically considered lower risk than their 'registered' counterparts (AUST R). They are often complementary medicines, which include vitamins, minerals, herbal medicines, and some types of sunscreen. The TGA has a risk-based approach to regulation, which means the level of assessment a product undergoes is proportional to its risk level.
The Regulatory Process for Listed Medicines
Unlike higher-risk products that undergo a full pre-market evaluation for efficacy, AUST L medicines are not individually assessed by the TGA for therapeutic effectiveness before being sold. Instead, their manufacturers are responsible for ensuring the product meets a set of stringent requirements, including safety and quality standards, and that the product's ingredients come from a pre-approved list. The manufacturer also certifies that the product's claims align with a list of permitted indications for lower-risk health conditions.
To become 'listed,' a sponsor (the Australian company responsible for the product) submits a TGA application, certifying that the product meets all regulatory requirements. While the TGA does not pre-evaluate every product, it conducts random post-market audits to ensure compliance. This process provides consumers with a degree of assurance that the product is manufactured according to quality standards and contains low-risk ingredients.
AUST L vs. AUST R: A Comparison
Understanding the distinction between AUST L (listed) and AUST R (registered) is crucial for consumers. It is the key to understanding the level of evaluation and evidence behind a product. The most significant difference is the level of efficacy assessment by the TGA before the product is sold.
The Assessed Listed Medicine (AUST L(A))
In between the standard listed (AUST L) and registered (AUST R) categories is a third type: 'assessed listed' (AUST L(A)). These products are similar to AUST L medicines in that they use low-risk, pre-approved ingredients. However, their health claims have been pre-assessed for efficacy by the TGA. This allows them to make more specific health claims than standard AUST L products, but they still don't undergo the full clinical trial evaluation required for AUST R medicines.
Comparison of Australian Therapeutic Good Listings
| Feature | AUST L (Listed) | AUST L(A) (Assessed Listed) | AUST R (Registered) |
|---|---|---|---|
| Risk Level | Low | Low (with intermediate claims) | Higher (prescription, some over-the-counter) |
| Efficacy Assessment | Not pre-assessed by TGA | Claims pre-assessed by TGA | Fully evaluated by TGA (strong evidence) |
| Ingredients | Must use pre-approved, low-risk ingredients | Must use pre-approved, low-risk ingredients | Rigorously assessed, not limited to pre-approved lists |
| Evidence Required | Sponsor certifies compliance, subject to audit | Sponsor provides evidence for claims, pre-assessed by TGA | Comprehensive clinical trial data reviewed by TGA |
| Examples | Vitamins, minerals, some herbal supplements | Some complementary medicines with specific health claims | Prescription drugs, many over-the-counter medications, vaccines |
Why the AUST L Number Matters for Consumers
Seeing an AUST L number on a product label is a sign that it is legitimately sold and regulated in Australia. It reassures consumers that at a minimum, the product meets baseline safety and quality standards. However, it also informs consumers that the product has not undergone the same level of scientific scrutiny as an AUST R medicine regarding its effectiveness. This knowledge empowers consumers to make more informed choices, especially when comparing complementary medicines or dietary supplements.
For instance, if a herbal product has an AUST L number, the consumer knows its ingredients are on a pre-approved list and the manufacturing quality is audited by the TGA. In contrast, a prescription painkiller with an AUST R number has been extensively evaluated by the TGA for both safety and effectiveness.
Using the ARTG to Check a Product
Every AUST L, AUST L(A), and AUST R number corresponds to an entry in the online ARTG database. This tool is freely available on the TGA website and allows consumers to verify that a product's inclusion is active and view a public summary of its details. A quick search can reveal information such as:
- The product's active ingredients.
- The intended purpose or indications listed.
- The name of the sponsor (the company responsible for the product).
This simple check can help consumers avoid counterfeit or illegally imported products that may not carry a valid ARTG number or may have a fake one. A product that does not display one of these numbers on its packaging is not legally permitted for sale in Australia as a therapeutic good.
Conclusion
The AUST L number on a medicine's label is a simple but powerful indicator for Australian consumers. It signifies that the product is a lower-risk, 'listed' therapeutic good, regulated by the TGA, and included on the ARTG. While it confirms quality manufacturing and the use of approved ingredients, it does not guarantee a TGA assessment of the product's efficacy, a key difference from higher-risk 'registered' (AUST R) medicines. By understanding what an AUST L number means, consumers can better evaluate the products they purchase and use the ARTG to make informed decisions about their health. For comprehensive information, always refer to the official Therapeutic Goods Administration website.
What do the different AUST L, AUST L(A), and AUST R numbers mean?
- AUST L: Listed medicine (lower risk, not individually assessed for efficacy).
- AUST L(A): Assessed listed medicine (lower risk ingredients, but TGA has assessed the product's health claims).
- AUST R: Registered medicine (higher risk, fully assessed by TGA for safety, quality, and efficacy).
