If you plan to import vitamins, minerals, herbal products or fish oil capsules to sell in Australia, the first question is not about freight or customs. It is whether your product is a medicine under Australian law.
The Therapeutic Goods Administration (TGA) says that supplements, vitamins and complementary medicines are often considered therapeutic goods, regulated as non-prescription medicines. This means they must comply with TGA legislation and be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia.
This guide explains when a supplement is a therapeutic good, where the line with food sits, what the sponsor is responsible for, and how the two main pathways differ: listed medicines, which carry an AUST L number, and registered complementary medicines, which carry an AUST R number. It covers commercial import and supply by a business. Importing for your own personal use falls under the TGA's separate Personal Importation Scheme and is outside the scope of this article.
This article is general information, not legal or regulatory advice. TGA requirements change, so always confirm the current rules on the TGA website before you import or supply a product.
When is a vitamin or supplement a therapeutic good?
The TGA uses the definition of a therapeutic good in the Therapeutic Goods Act 1989 (the Act) to decide whether a product is a medicine. In general, the TGA considers a product to be a therapeutic good if it:
- is represented to be for therapeutic use
- does not have a food standard in the Australia New Zealand Food Standards Code
- does not have a tradition of use as a food in Australia or New Zealand in the form in which it is presented, or
- has been determined or declared to be a therapeutic good under the Act.
In general, a product is not a therapeutic good if there is a food standard for it, if it has a tradition of use as a food in Australia and New Zealand in the form presented, or if it has been determined or declared not to be a therapeutic good.
Presentation matters. The TGA's own example is garlic: minced or crushed garlic in a jar is likely to be a food, because garlic has a tradition of food use in that form. If chemicals in the garlic are extracted, concentrated and sold in a capsule with a claim to relieve cold and flu symptoms, it might be considered a medicine.
The TGA is clear that you need to work out whether your product is a therapeutic good yourself, and that it cannot make this decision for you. It offers interactive tools to help, including “Is my product a therapeutic good?”, the Food-Medicine Interface Guidance Tool (FMIGT) and “Is my sports supplement a therapeutic good?”.
The food–medicine boundary in brief
Food and medicines are regulated under separate laws in Australia, with different rules for manufacturing, labelling, advertising and the evidence needed to back up claims:
- The TGA regulates medicines and other therapeutic goods under the Act.
- Food Standards Australia New Zealand (FSANZ) develops the Food Standards Code, and state and territory food regulators enforce it.
- The Department of Agriculture, Fisheries and Forestry (DAFF) regulates imported food under the Imported Food Control Act 1992.
A health claim on its own does not make a product a medicine, and some products that look like medicines are actually foods. The TGA calls this overlap the food–medicine interface. The most common question is whether a product falls under Food Standard 2.9.4 (Formulated supplementary sports food). If that standard applies, the product is not a therapeutic good, even if it makes therapeutic claims, although it may then breach food or other laws.
Label wording does not decide the question either. According to the TGA, statements such as “dietary supplement” or “not intended to diagnose, treat, cure or prevent any disease” are not determinative. The FMIGT can show you which regime is likely to apply, but it will not tell you whether your product complies. That responsibility stays with the manufacturer or importer.
If your product sits close to the line, such as a powder, drink or gummy, work through the FMIGT and keep a written record of your reasoning before you order stock.
The sponsor: who is responsible for your product
Generally, therapeutic goods must be entered on the ARTG before you can legally import them into Australia, unless they are exempt. Every ARTG entry belongs to a sponsor, who is responsible for applying for and maintaining that entry.
Under the Act, a sponsor is a person who imports, or arranges the import of, the goods into Australia. The definition also covers people who export goods, or who manufacture goods in Australia (or arrange their manufacture) for supply. It does not include a person who does any of these things on behalf of another person who is a resident of, or carrying on business in, Australia. In that case the Australian person or business is the sponsor.
Being the sponsor is an ongoing role, not a one-off application. After a listed or registered medicine is on the market, the TGA says you must:
- manage your product's inclusion in the ARTG and keep its details up to date
- notify the TGA of changes through the variation processes
- pay regulatory charges
- monitor product safety and report issues or adverse events
- provide the TGA with any information it requests.
Sponsor certifications carry real weight. The TGA warns that an incorrect certification could result in a listing being cancelled from the ARTG, and that other compliance action, such as fines or a product recall, could also be taken.
If you are an overseas brand, decide early who will act as your Australian sponsor, because that person or business holds the ARTG entry and the legal responsibility that comes with it.
Three pathways, two you will mostly meet
The TGA uses a three-tier, risk-based framework for complementary medicines. Products are sorted by the ingredients they contain and the therapeutic indications (claimed health benefits) they make:
- Listed medicines (AUST L): the lowest-risk tier, and the pathway most vitamins and supplements use.
- Assessed listed medicines (AUST L(A)): a middle pathway, introduced on 19 March 2018, for products with at least one intermediate-level indication. The sponsor self-certifies safety and quality, and the TGA assesses the efficacy evidence before listing.
- Registered complementary medicines (AUST R): the higher-risk tier, with full TGA assessment before the product can be supplied.
All three pathways require the medicine to be manufactured under Good Manufacturing Practice (GMP). The table below compares the two pathways most importers meet.
Table 1: Listed (AUST L) vs registered (AUST R) complementary medicines
| Listed medicine (AUST L) | Registered complementary medicine (AUST R) | |
|---|---|---|
| Ingredients | Only from the permitted ingredients list; no ingredient in a schedule to the Poisons Standard | Permitted ingredients and/or Poisons Standard ingredients, other than Schedules 4, 8 or 9 |
| Indications | Low-level indications drawn only from the permitted indications list | High-level indications not suitable for listing, plus intermediate and low-level indications |
| Application | Sponsor self-certifies that all legislative requirements are met | Full pre-market assessment by the TGA |
| Evidence | Held by the sponsor and provided to the TGA on request | Safety, quality and efficacy assessed by the TGA before supply |
| Manufacturing | GMP | GMP |
| Presentation | Cannot state that the product has been assessed by the TGA | Can use a claimer that safety, quality and efficacy have been independently assessed |
| After supply | May be selected for random or targeted compliance review | Ongoing sponsor obligations, including variations and safety monitoring; the TGA may act on adverse event reports or complaints |
Source: TGA, “The three-tiered risk-based framework for complementary medicines” and “Monitoring and compliance for registered complementary medicines”.
Listed medicines (AUST L)
Listed medicines are low-risk, non-prescription products. The TGA says they include medicines with ingredients such as vitamins, minerals, herbal substances and fish oil, and it also gives Traditional Chinese Medicines and some sunscreens as examples. Its example of a listed medicine is a calcium supplement with bone health claims.
To be listed, a product:
- can contain only low-risk ingredients, in acceptable amounts, that the TGA permits for use in listed medicines
- must be manufactured under the principles of GMP
- can make only indications for health maintenance and health enhancement, or certain indications for non-serious, self-limiting conditions.
The TGA does not assess a listed medicine before it is supplied. Instead, the sponsor certifies that the medicine meets the requirements for safety, quality and efficacy. This includes certifying that the sponsor holds the evidence to support every indication and claim, and will give that evidence to the TGA on request. The TGA's evidence guidelines explain what level of evidence is needed.
Claims must stay within the permitted indications. The TGA notes that they must not be about treating serious illnesses, such as influenza or chronic asthma.
Registered complementary medicines (AUST R)
Registered complementary medicines are considered higher risk than listed medicines, because of their ingredients or the indications they make. They can use any complementary medicine ingredient that is not in Schedules 4, 8 or 9 of the Poisons Standard, and they can make high-level indications.
Before a registered medicine can go on the ARTG and be marketed, the TGA fully evaluates it for quality, safety and efficacy. The applicant must submit a detailed dossier that shows the medicine meets these standards. The Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines set out the data package required.
Once registered, the sponsor must keep managing the ARTG entry, lodge variation applications for changes, pay regulatory charges, monitor safety and report issues promptly. The TGA itself notes that sponsors with no previous experience registering a medicine in Australia may wish to seek the services of an Australian regulatory affairs consultant.
If a single ingredient or claim is what pushes your product into the AUST R pathway, compare the time and cost of registration with changing the formula or claims so the product fits the listed pathway.
Listing a medicine on the ARTG: the basics
Listed medicines go on the ARTG through an online process, which gives faster market access than registration. In outline:
- Get portal access. New sponsors register for the TGA Business Services (TBS) portal.
- Check eligibility. Confirm that every ingredient is permitted for listed medicines and that every indication comes from the permitted indications list.
- Have everything ready first. The TGA says sponsors should not apply on the basis that information, evidence or manufacturing arrangements will be finalised after listing. The formulation, manufacturing arrangements, specifications, shelf life and supporting evidence should already be established and documented.
- Apply and certify. Lodge the application in the TBS portal and certify that the product meets the legislative requirements, including the certifications in section 26A(2)(a) to (k) of the Act and, if applicable, section 26A(2A).
- Pass validation. The TGA's Electronic Listing Facility (ELF) checks the application. If it passes validation, the medicine is listed on the ARTG and given an AUST L number. Passing validation does not mean the TGA has confirmed that the medicine meets all requirements. That remains the sponsor's responsibility.
- Meet ongoing obligations. Comply with the Conditions of Listing Determination and section 28 of the Act. The TGA can impose new conditions and can run a compliance review at any time while the medicine stays on the ARTG.
The TGA's interactive tool, “What do I require to have a listed medicine in the ARTG?”, and its listed medicines application user guide walk through these steps in more detail.
Labelling cues: AUST L, AUST L(A) and AUST R
The ARTG number is the quickest way to tell which pathway a product has used. Listed medicines must show their AUST L number on the label and packaging, and registered medicines must show their AUST R number. The Therapeutic Goods Regulations 1990 set the requirements for displaying AUST R, AUST L(A) and AUST L numbers.
Labels must also give essential information such as the product name, ARTG number, ingredients, directions for use and any warnings. The labelling standard for non-prescription medicines changed recently:
- Therapeutic Goods Order No. 116 (TGO 116), the standard for labelling non-prescription medicines, commenced on 30 September 2026 and replaced TGO 92.
- A five-year transition period applies, during which non-prescription medicines may comply with either TGO 92 or TGO 116.
- All medicines released for supply after 1 October 2031 must comply with the new standards.
Listed medicines cannot claim to have been assessed by the TGA, while assessed listed and registered medicines can use an approved claimer. Our guide to what “TGA assessed” means on a medicine label explains this in more detail.
Check imported stock before it ships. A label designed for another market will not carry an AUST L or AUST R number, and it may need to be relabelled to meet Australian requirements.
Fees at a high level
Sponsors pay TGA fees for applications and annual charges to keep each entry on the ARTG. Registered medicines are evaluated case by case, so their costs depend on the application. The TGA sets these amounts and updates them each financial year.
For the current figures, including listed medicine application fees and annual charges, see our guide How much does TGA approval cost?. Government fees are separate from consultant fees. For a quote on R2 Pharma Solutions' services, please contact us.
Next steps
Before you place a first order with an overseas supplier, confirm three things: whether your product is a therapeutic good or a food, which pathway its ingredients and claims fit, and who will act as the Australian sponsor. Our medicines and chemicals services page explains how we support medicine sponsors. If you would like help working out the right pathway for your range, get in touch.
Related reading: Therapeutic goods regulation in Australia; Understanding “TGA assessed” on medicine labels; How much does TGA approval cost?.