In plain English
The Therapeutic Goods Administration (TGA) is the Australian Government body that regulates medicines and medical devices. It keeps an official list called the Australian Register of Therapeutic Goods, or ARTG [1].
If a medicine is on the ARTG, it has been approved for supply in Australia. Its label shows an “AUST number”, which is its ID on the register [3]. Anyone can search the ARTG online for free [1].
Not every product on the ARTG has been checked in the same way. Higher-risk medicines, such as all prescription medicines, are fully assessed before sale. Some lower-risk medicines are not assessed for whether they work [2].
Most peptides promoted online are not on the ARTG. The TGA says these products have not been assessed for safety, quality or effectiveness [5].
The short version
- The ARTG is the TGA’s list of approved therapeutic goods [1].
- Approved medicines show an AUST R, AUST L or AUST L(A) number [3].
- AUST R and AUST L(A) medicines are assessed for efficacy; AUST L medicines are not [3].
- “Not on the ARTG” means “not assessed by the TGA” [4].
What is the ARTG?
The ARTG is a register established under section 9A of the Therapeutic Goods Act 1989. The Act says it is maintained “for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans” [6].
The Act divides the register into five parts [6]:
| Part of the ARTG | What it holds |
|---|---|
| Registered goods | Higher-risk medicines, including all prescription medicines |
| Provisionally registered goods | Medicines included with provisional registration |
| Listed goods | Lower-risk medicines made from pre-approved ingredients |
| Biologicals | Biologicals included under Part 3-2A of the Act |
| Medical devices | Devices included under Chapter 4 of the Act |
The TGA’s public search page describes the ARTG as covering medicines, medical devices and biologicals that can be supplied within Australia [1]. When we checked on 11 October 2026, its filters showed more than 34,000 medicine entries and more than 62,000 medical device entries [1].
Registered vs listed medicines: AUST R, AUST L and AUST L(A)
All medicines supplied in Australia must be included in the ARTG, either as registered or as listed medicines [2]. The AUST number on the label tells which [2, 3].
| Attribute | Listed (AUST L) | Assessed listed (AUST L(A)) | Registered (AUST R) |
|---|---|---|---|
| Pre-market efficacy assessment | No | Yes | Yes |
| Ingredients | Pre-approved list only | Pre-approved list only | Assessed pre-market |
| Indications (conditions the product is for) | Pre-approved list only | Assessed pre-market | Assessed pre-market |
| Post-market adverse event monitoring | Yes | Yes | Yes |
| May carry a “TGA assessed” claim | No | Yes | Yes, for registered complementary medicines |
| Prescription medicines | None | None | All |
Source: TGA, How we regulate medicines [2].
The TGA describes this as a risk-based approach: higher-risk registered medicines are fully assessed for safety, quality and efficacy before sale, and the TGA approves their labels [2]. Listed medicines are not individually assessed for efficacy before sale. Instead, sponsors certify that the medicine complies with the regulations and that they hold evidence for its claims, and the TGA may select listed medicines for post-market review [2].
Whether registered or listed, a medicine on the ARTG must be manufactured in a licensed or approved facility under the principles of good manufacturing practice (GMP) [2].
What does “unapproved” mean?
Unapproved therapeutic goods are products that are not included in the ARTG. The TGA states that this means they have not been assessed by the TGA for safety, quality or effectiveness [4].
“Unapproved” does not always mean “illegal to access”. Certain registered health practitioners can access unapproved goods for patients through defined pathways, such as the Special Access Scheme, the Authorised Prescriber Scheme and the clinical trial schemes, each with its own conditions [4]. A medicine supplied through these pathways will not carry an AUST number [3].
The TGA also notes that a medicine without an AUST number that was not supplied through one of these pathways “may have been supplied illegally” [3].
How to check whether a medicine is on the ARTG
The ARTG can be searched on the TGA website by product name, ARTG ID or sponsor (the company responsible for the product) [1].
- Find the AUST number. Medicines on the ARTG must show their AUST R, AUST L or AUST L(A) number on the label. The number is the product’s ARTG ID [3].
- Search the ARTG. Go to the TGA’s ARTG search page and enter the number, the product name or the sponsor [1].
- Compare the entry with the product. Search results include the product name, formulation details, sponsor and manufacturer details [1]. Check that these match the label.
- Read the official documents. Where available, the entry links to the Consumer Medicine Information (CMI) and Product Information (PI). Not every CMI and PI is available online [1].
- Note what kind of entry it is. AUST R and AUST L(A) medicines have been assessed for efficacy; AUST L medicines have not [3].
- If nothing is found, the product is not on the ARTG. Unless it was supplied through one of the TGA’s access pathways, the TGA notes that it may have been supplied illegally [3, 4].
Are peptides on the ARTG?
Some peptide medicines are. The TGA gives insulin products as an example of peptide-based medicines that are approved and included on the ARTG [5].
Most peptides promoted online are not. In April 2026 the TGA named BPC-157, GHK-Cu, TB-500 and CJC-1295 among its examples of unapproved peptide products, and stated that these products have not been evaluated by the TGA for safety, quality or effectiveness [5]. See Research Peptides vs Approved Peptide Medicines.
Why ARTG status matters for quality
Without ARTG inclusion, there is no TGA check on what a product contains. The TGA has stated that labelling of unapproved peptide products may be inaccurate or misleading, and that important information, such as how they are manufactured, whether they are sterile, and what they actually contain, remains unknown [5]. In July 2026 it reported increasingly intercepting unlabelled vials at the border, with no identifying information about their contents or origin [7].
Independent testing shows why this matters. A 2024 study made test purchases of semaglutide (a peptide medicine) from illegal online pharmacies selling without a prescription. All the vials received were judged probable substandard or falsified products: measured purity was 7.7% to 14.37%, against 99% claimed on the labels, and endotoxin was detected in every sample [9].
What this means in Australia
- ARTG. Inclusion in the ARTG is what makes a therapeutic good approved for supply in Australia. Products not on it have not been assessed by the TGA for safety, quality or effectiveness [1, 4].
- Poisons Standard. ARTG inclusion and scheduling are separate. The Poisons Standard states that including a substance in a Schedule does not mean it is approved or available, and does not remove the need for registration [8]. Several peptides that are not on the ARTG are named in Schedule 4 (prescription-only) and Appendix D, clause 5 (possession without authority is illegal), including BPC-157, TB-500 and CJC-1295 [8]. See The Poisons Standard Explained.
- TGA position. In April 2026 the TGA stated that “research use only” disclaimers do not make supply lawful, and do not change a product’s regulatory status, permit importation, or remove advertising or supply obligations [5]. In July 2026 it stated that advertising unapproved therapeutic goods to Australian consumers is generally unlawful, including on websites [7].
- Reporting. Suspected unlawful supply or advertising can be reported to the TGA [10].
This is general information, not legal advice. Laws change; check the current Poisons Standard and TGA guidance.
Frequently asked questions
What does ARTG stand for?
Australian Register of Therapeutic Goods. It is the TGA’s register of medicines, medical devices and biologicals that can be supplied in Australia [1, 6].
What is the difference between AUST R and AUST L?
AUST R medicines are registered and assessed by the TGA for safety, quality and efficacy before sale. AUST L medicines are listed, use pre-approved low-risk ingredients, and are not assessed for efficacy before sale. AUST L(A) medicines are listed but have had their claims assessed [2, 3].
Does an AUST number mean a product works?
Not necessarily. AUST R and AUST L(A) medicines have been assessed for efficacy, but AUST L medicines have not [3].
Is BPC-157 on the ARTG?
No. The TGA names BPC-157 as an example of an unapproved peptide product [5]. It is also listed in Schedule 4 and Appendix D, clause 5 of the Poisons Standard [8].
What does it mean if a product is not on the ARTG?
It is an unapproved therapeutic good. The TGA has not assessed it for safety, quality or effectiveness, and lawful access is limited to defined pathways with their own conditions [4].
References
- Therapeutic Goods Administration. Australian Register of Therapeutic Goods (ARTG). tga.gov.au/resources/artg. Accessed 11 October 2026.
- Therapeutic Goods Administration. How we regulate medicines. tga.gov.au. Accessed 11 October 2026.
- Therapeutic Goods Administration. AUST numbers on medicine labels. tga.gov.au. Accessed 11 October 2026.
- Therapeutic Goods Administration. Unapproved therapeutic goods. tga.gov.au/products/unapproved-therapeutic-goods. Accessed 11 October 2026.
- Therapeutic Goods Administration. Understanding your responsibilities when importing, compounding and supplying unapproved peptide products. Safety advisory, 13 April 2026. tga.gov.au. Accessed 11 October 2026.
- Australian Government. Therapeutic Goods Act 1989. Federal Register of Legislation. legislation.gov.au/C2004A03952/latest/text. Accessed 11 October 2026.
- Therapeutic Goods Administration. Unapproved peptide product promoters and suppliers are put on notice. Media release, 20 July 2026. tga.gov.au. Accessed 11 October 2026.
- Commonwealth of Australia. Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327). Federal Register of Legislation. legislation.gov.au/F2026L01327/latest/text. Accessed 11 October 2026.
- Ashraf AR, Mackey TK, Vida RG, et al. Multifactor quality and safety analysis of semaglutide products sold by online sellers without a prescription: market surveillance, content analysis, and product purchase evaluation study. J Med Internet Res. 2024;26:e65440. doi:10.2196/65440. PMID: 39509151
- Therapeutic Goods Administration. Report a breach. tga.gov.au. Accessed 11 October 2026.
Important information and disclaimer
General information only. This article is published for general educational and informational purposes. It summarises published scientific literature and public regulatory information as at the “last reviewed” date shown above. It is not medical, health, pharmaceutical, veterinary or legal advice, and it must not be relied on as a substitute for advice from a qualified professional about your circumstances.
Not for human or animal use. Nothing in this article recommends, endorses or describes the use of any substance in humans or animals. Findings from cell, animal or early human studies cannot be assumed to apply to people. The compounds discussed have not been evaluated by the Therapeutic Goods Administration (TGA) for safety, quality or efficacy unless the article expressly states otherwise. Any research materials offered by Iconic Peptides are supplied solely for in vitro and laboratory research.
No therapeutic claims. Iconic Peptides makes no claim that any product treats, cures, prevents, alleviates or diagnoses any disease, condition or symptom. References to published studies, clinical trials or medicines approved by regulators are factual descriptions of the scientific and regulatory record. They are not representations about any product we supply.
Regulatory status. Many peptides are scheduled substances under the Poisons Standard. Some are prescription-only (Schedule 4), and some may not be possessed without authority (Appendix D). The TGA has stated that a “research use only” label does not make supply lawful, change a product’s regulatory status, or remove advertising or supply obligations. State and territory laws may also apply. You are responsible for knowing and complying with all laws that apply to you. Regulatory information in this article may change after the review date.
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