How To Register Goods With The TGA: A Guide For Australian Businesses

Planning to launch a health, wellness or medical product in Australia? If your product makes therapeutic claims or is intended to diagnose, treat, prevent or influence health, you’ll likely need to deal with the Therapeutic Goods Administration (TGA) before you can legally sell it.

The TGA manages the Australian Register of Therapeutic Goods (ARTG), which is the official list of therapeutic goods that can be supplied in Australia. For many products, getting your goods included on the ARTG is a key step to market entry-though there are some exemptions and special pathways depending on your product and risk level.

In this guide, we’ll explain what the TGA and ARTG are, when registration (inclusion) is required, the steps to apply, and the other laws you’ll need to consider. We’ll also cover the legal documents that help protect your business as you scale. If you’re ready to enter Australia’s regulated health market with confidence, read on.

What Is The TGA And The ARTG?

The Therapeutic Goods Administration (TGA) is Australia’s national regulator for therapeutic goods. This includes medicines, medical devices, biologicals, certain disinfectants, complementary medicines and some cosmetics that make therapeutic claims (for example, “treats acne”).

The Australian Register of Therapeutic Goods (ARTG) is the database of therapeutic goods that can be legally supplied in Australia. If your product is a therapeutic good, it generally must be entered on the ARTG before importation, advertising and supply. Depending on the risk, goods are either “listed” (AUST L or AUST L(A)) or “registered” (AUST R); higher-risk goods undergo a more rigorous evaluation.

Important note: Veterinary medicines and agricultural chemicals are usually regulated by the Australian Pesticides and Veterinary Medicines Authority (APVMA), not the TGA. If your product is intended for animals, check the APVMA’s framework rather than the ARTG pathway.

Do Your Goods Need ARTG Inclusion?

Whether you need ARTG inclusion depends on what your product is, what it contains, how it is used, and the claims you make in your labelling and marketing. As a quick sense check:

• Medicines and supplements: Prescription and over‑the‑counter medicines, complementary medicines (vitamins, minerals, herbal products) and certain disinfectants generally need inclusion (listed or registered) on the ARTG.
• Medical devices: Products ranging from low‑risk bandages through to implantables and software as a medical device (SaMD) are typically regulated. Devices are classified by risk (Class I through to Class III/Active Implantable). In vitro diagnostic (IVD) devices follow a separate classification scale.
• Cosmetics vs therapeutic goods: If your cosmetic only has cosmetic effects (e.g. cleanses, perfumes, changes appearance) it usually isn’t regulated by the TGA. But if you claim to treat or prevent a condition or influence physiological processes, it may become a therapeutic good and need ARTG inclusion.
• Borderline products: Some wellness products and apps cross into “therapeutic” territory based on functionality or claims, even if they look like consumer goods.

There are also exemptions and alternative pathways in specific scenarios. These include the Special Access Scheme and Authorised Prescriber pathways (for unapproved goods supplied to specific patients), clinical trial exemptions, certain low‑risk excluded goods, export‑only listings, and the personal importation scheme. If you think one of these might apply, get advice early and keep clear records of why your pathway is appropriate.

Because classification and claims drive your obligations, it’s smart to map out your intended indications and marketing early. Small changes to how you describe the product can shift you into a stricter regulatory category.

Step‑By‑Step: How To Register Goods With The TGA

Every product is different, but most ARTG pathways follow a similar rhythm. Here’s a practical roadmap to help you plan ahead.

1) Confirm Your Product Category And Claims

Start with the basics: what is the good, how is it used, and what claims will you make? Build a short “intended purpose” statement and list your proposed indications. This helps determine if your product is a medicine, device, biological, IVD, or excluded/exempt good, and which pathway applies.

2) Choose The Right Business Structure (And Who Will Be The Sponsor)

The “sponsor” is the legal entity in Australia responsible for the ARTG entry, ongoing compliance, adverse event reporting and interactions with the TGA. If you manufacture overseas or import goods, the Australian sponsor will typically be you or your distributor.

Decide whether to operate as a sole trader, partnership or company. Many founders use a company to separate personal assets and centralise compliance. If you’re weighing up options, it helps to understand the differences between a business name vs company name and, if you’re ready, proceed with a company set up that suits your growth plans.

3) Prepare Technical Documentation And Evidence

Gather the core evidence for your application. The exact documents vary by pathway and risk classification, but often include:

• Product specifications, raw materials/ingredients, and a full description of the intended use and indications.
• Manufacturing information, quality management evidence and, where required, Good Manufacturing Practice (GMP) certification or clearance for the manufacturer.
• Safety and performance evidence, including clinical or literature evidence for higher‑risk medicines and devices, and conformity assessment documentation for devices.
• Labelling, packaging and instructions for use, ensuring claims align with your evidence and meet TGA formatting and warning requirements.

Consistency between your indications, evidence and labelling is critical. Mismatches are a common cause of delays and requests for further information.

4) Create Your TGA Business Services Account And Apply

Applications are lodged through TGA Business Services. You’ll select the appropriate application type (e.g. listing vs registration for medicines; device class for medical devices), complete the forms, upload your evidence and pay the fees. Expect questions during evaluation-plan timelines with that in mind.

5) Prepare For Audits, Questions And Possible Testing

The TGA may ask for additional information, conduct a desktop review, request samples, or in the case of medical devices, audit your conformity assessment evidence or the manufacturer’s quality system. Prompt, complete responses keep the process moving.

6) Receive ARTG Inclusion (And Keep It Up To Date)

When approved, your entry appears on the ARTG and you’ll be issued an AUST L/AUST L(A) or AUST R number (for medicines), or a device ARTG entry number. You then have ongoing obligations, including:

• Post‑market vigilance and reporting of adverse events and safety issues.
• Maintaining up‑to‑date technical documentation and evidence for as long as the product is supplied.
• Managing changes to your product (variations) and notifying or seeking approval where required.
• Paying annual charges and cooperating with TGA reviews, recalls or audits if they arise.

Think of ARTG inclusion as the beginning of compliance-not the end. Build internal processes for monitoring complaints, version control of documents and supplier/manufacturer oversight.

7) Keep Your Advertising Compliant

Therapeutic goods advertising is tightly regulated. Your marketing must comply with the Therapeutic Goods Advertising Code, as well as the Australian Consumer Law (ACL). Avoid misleading claims, ensure mandatory statements are included where required, and keep your claims within the scope of your ARTG indications and evidence.

Other Laws And Permits You’ll Need To Consider

ARTG inclusion is only one piece of the compliance puzzle. Depending on your business model, you may need to follow additional federal, state and local rules.

• Business registrations: Make sure you hold an ABN and, if operating through a company, your ACN. If you decide to incorporate, adopt a structure that supports your compliance and growth goals from day one.
• Manufacturing and import controls: Manufacturers may need GMP licences or clearances; importers should check any border controls for therapeutic goods and ensure the Australian sponsor details are correct.
• State and local laws: Depending on the product and where you operate, you may need authorisations for storage, handling or sale of certain chemicals or scheduled substances, as well as local council permissions for premises.
• Consumer protection: The Australian Consumer Law regulates warranties, product safety, refunds and advertising. Your labels and product information must be accurate and not misleading.
• Privacy and data: If you collect personal or health information (for example, through an app or warranty registration), have a compliant Privacy Policy and handle data in line with the Privacy Act.
• Intellectual property: Protect your brand early to reduce copycat risk and marketplace confusion. Consider filing to register your trade mark for names and logos you’ll use in market.
• Employment law: If you’re hiring, ensure proper contracts, award compliance and workplace policies. Clear roles and responsibilities help you meet ongoing obligations like vigilance and quality control.

A proactive compliance mindset will save time and cost. Map out relevant laws during planning so you can bake compliance into your operations, rather than retrofitting it later.

What Legal Documents Will Help Protect Your Business?

Strong contracts and policies support your TGA obligations, set expectations with partners and customers, and reduce the risk of disputes. The right suite depends on your model, but most therapeutic goods businesses consider:

• Supply Agreement: If you rely on third‑party ingredients or components, a Supply Agreement can lock in quality standards, delivery terms, change control and liability allocations.
• Distribution Agreement: If you sell through wholesalers or retailers, a Distribution Agreement should address order processes, pricing, marketing claims, recall cooperation and regulatory responsibilities.
• Manufacturing Agreement: For contract manufacturing, set clear specifications, GMP responsibilities, audits, corrective actions and confidentiality. This helps maintain the evidence base behind your ARTG entry.
• Website Terms & Conditions: Set rules for site use, IP ownership and limitations of liability if you sell online or provide product information digitally.
• Privacy Policy: If you collect personal data (for orders, subscriptions or device apps), a compliant, accessible Privacy Policy is essential.
• Non‑Disclosure Agreement (NDA): Use NDAs when sharing product concepts, formulas, clinical data or manufacturing know‑how with partners during development.
• Employment and Contractor Agreements: Align staff and contractors to your quality, vigilance and data requirements. Clear contracts support training and accountability across regulated processes.
• Shareholders Agreement: If you have co‑founders or investors, set out decision‑making, roles and exit arrangements so governance stays steady while you manage compliance.

You won’t need everything at once, but locking in the essentials before launch makes day‑to‑day operations smoother and supports your regulatory position (especially during audits or post‑market reviews).

Alternative Paths: Distributing Or Acquiring Existing ARTG Goods

Not every business starts with a brand‑new ARTG application. Many Australian businesses enter the market by distributing goods already included on the ARTG or by acquiring a product line or business that holds ARTG entries.

If you go this route, prioritise due diligence. Confirm the status and scope of each ARTG inclusion, review the sponsor’s technical documentation, check vigilance history and post‑market actions, and understand any conditions or variations in flight. Your contracts should allocate who does what-especially around safety reporting, recalls, label updates and advertising controls.

For channel partnerships, a well‑drafted Distribution Agreement can define territories, marketing claims and regulatory cooperation. If you depend on a third‑party manufacturer or ingredient supplier, a robust Supply Agreement helps you meet your sponsor obligations with confidence.

Key Takeaways

• The TGA regulates therapeutic goods supplied in Australia and manages the ARTG; many medicines, medical devices and complementary medicines must be included before legal supply.
• Classification depends on product type, risk and your claims-cosmetics with therapeutic claims may become therapeutic goods, while animal health products are typically regulated by the APVMA.
• There are exemptions and special pathways (such as Special Access and clinical trials), so inclusion isn’t always required; confirm the correct pathway early and document your reasoning.
• The core steps are to define your intended purpose, choose your sponsor and structure, prepare evidence and technical documentation (including GMP where required), apply through TGA Business Services and maintain ongoing compliance.
• Advertising must align with the Therapeutic Goods Advertising Code and the ACL; keep claims within the scope of your evidence and ARTG indications.
• Beyond the ARTG, plan for business registrations, privacy, IP protection and clear contracts (for example, Supply Agreement, Distribution Agreement and a Privacy Policy) to manage risk as you grow.

If you would like a consultation on getting your goods registered with the TGA or setting up a compliant therapeutic goods business in Australia, you can reach us at 1800 730 617 or team@sprintlaw.com.au for a free, no‑obligations chat.