Your Guide To The Therapeutic Goods Administration (TGA)

If you make, import, market or sell products that claim to diagnose, prevent or treat health conditions in Australia, you’ll quickly meet the Therapeutic Goods Administration (TGA). The TGA regulates therapeutic goods to protect public health - which means there are rules you must follow before you launch and while you trade.

Whether you’re planning a new vitamin line, a skincare product with acne claims, a medical device, a wellness app with health features, or you’re importing overseas products to sell locally, understanding the TGA will help you avoid costly mistakes, delays and penalties.

In this guide, we’ll walk through what the TGA does, how to tell if your product is a “therapeutic good”, pathways to get onto the Australian Register of Therapeutic Goods (ARTG), and the ongoing compliance and advertising rules you need to build into your operations from day one.

What Is The TGA And Why Does It Matter?

The Therapeutic Goods Administration is Australia’s national regulator for medicines, medical devices and certain other health-related products. Its job is to make sure therapeutic goods supplied in Australia meet quality, safety and performance standards.

In practical terms, this means most therapeutic goods need to be approved (or formally entered on the Australian Register of Therapeutic Goods, called the ARTG) before you can legally supply them in Australia. There are also strict rules around manufacturing, importation, labelling, storage, complaints handling, recalls and advertising claims.

The TGA typically focuses on the “sponsor” - the Australian person or company legally responsible for the product in Australia. The sponsor is the party that applies to include the product on the ARTG and is accountable for ongoing compliance. If you import or arrange for local manufacture, you’re likely the sponsor.

Do Your Products Fall Under “Therapeutic Goods”?

This is the first and most important question. If your product is a therapeutic good, TGA rules apply. If not, you may fall instead under cosmetic, consumer goods or food regulations (which have their own rules). The line can be subtle and often hinges on what the product is intended to do and what you say about it.

Common Categories Regulated By The TGA

• Medicines: Prescription and over-the-counter medicines, complementary medicines (such as vitamins, minerals, herbal products), and certain disinfectants and antiseptics.
• Medical Devices: Everything from Class I low-risk devices (e.g. basic bandages) to Class III high-risk devices (e.g. implantable devices). Software with health purposes can be a medical device (often called Software as a Medical Device, or SaMD).
• Biologicals: Products derived from human cells or tissues.
• Other Therapeutic Goods: Some sunscreen products, certain disinfectants and sterilants, diagnostic tests and more.

How The TGA Decides

The TGA considers the product’s intended use and claims. If you make therapeutic claims (for example, “treats eczema”, “reduces blood sugar”, “prevents infection”, “relieves anxiety”), you’re more likely to be in TGA territory rather than general consumer products.

Many cosmetics fall outside the TGA if they only provide cleansing, perfuming or altering appearance without therapeutic claims. But the same lotion could be regulated as a medicine if you promote it as “healing eczema”. This is why getting your claims right early is critical.

If you’re unsure, it’s wise to get tailored regulatory advice - building compliance into your product and marketing plan upfront is far easier than changing course after launch. Our team can assist across strategy, labelling and documentation, and general compliance support through our Regulatory Compliance Lawyer service.

How To Get Your Product On The ARTG

There are several pathways to supply therapeutic goods in Australia. The right path depends on what you sell and its risk profile.

1) Listed Medicines (Lower Risk)

Most complementary medicines (e.g. vitamins, mineral supplements, certain herbal products) are “listed” medicines. These products can only contain pre‑approved low-risk ingredients and can make limited, permitted indications (claims). Sponsors self-certify that the product meets TGA requirements, but the TGA can audit and take action if anything is incorrect.

2) Registered Medicines (Higher Risk)

Higher risk medicines must be “registered”. This pathway involves a more rigorous evaluation of safety, quality and efficacy before the TGA will approve supply. This is typically required where you make stronger or novel claims, or for prescription and pharmacist-only medicines.

3) Medical Devices (Class I-III and AIMD)

Medical devices are risk‑classified, and the evidence you need scales with risk. Sponsors must provide “manufacturer evidence” that the device meets applicable standards (including quality management systems) and then apply to include the device on the ARTG. Software that performs medical functions can also be a device, so app developers should assess whether their features push the product into TGA territory.

4) Exemptions and Exclusions

Some low-risk products or specific circumstances are exempt or excluded from some or all TGA requirements. This is specific - don’t assume an exemption applies without checking the criteria.

5) Importing Overseas Products

If you import a therapeutic good into Australia, you (as sponsor) must ensure it is included on the ARTG and meets Australian requirements, even if it’s approved overseas. This includes ensuring the overseas manufacturer has appropriate certifications and can meet TGA evidence requests.

Key Steps In An ARTG Strategy

1. Define your product and claims: Decide what the product is intended to do and draft compliant, supportable claims aligned with your target pathway.
2. Check ingredients and standards: Ensure all ingredients or components are permitted for the chosen pathway and that labelling can meet TGA rules.
3. Select and vet your manufacturer: You’ll need robust quality systems and documentation (e.g. certificates, specifications, batch records). Quality agreements with overseas manufacturers are common.
4. Prepare evidence: Compile the technical file, lab reports, clinical or bibliographic evidence (as required), and safety data.
5. File the application: Apply to include the product or device on the ARTG with supporting manufacturer evidence.
6. Plan for audits and post-market monitoring: Build processes for complaints handling, adverse event reporting and recalls (if ever needed).

Ongoing Compliance: Your Responsibilities After Approval

Getting onto the ARTG is not the end. Sponsors have ongoing obligations to protect consumers and maintain quality throughout the product lifecycle.

Quality, Manufacturing And Supply Chain Controls

• Maintain appropriate quality systems, supplier agreements and documentation to ensure each batch meets specifications.
• Keep technical documentation current and accessible - the TGA can audit you and request evidence at any time.

Labelling, Storage And Distribution

• Ensure labels remain compliant with required information, warnings and claims.
• Distribute and store products to preserve safety and quality (e.g. temperature-control if required).

Complaints, Adverse Events And Recalls

• Have a robust complaints and adverse event procedure. Sponsors must notify the TGA of certain adverse events within set timeframes.
• Maintain a clear recall plan and the ability to trace affected batches and notify customers if ever needed.

Record-Keeping

• Keep thorough records of manufacturing, testing, distribution, complaints and corrective actions. Good records make audits smoother and help demonstrate due diligence.
• If you collect any personal information (for example through a website, app or loyalty program), ensure your retention and deletion practices align with data retention laws and privacy requirements.

Governance And Internal Training

• Train staff who touch regulated processes (quality, advertising, customer support) so they understand the TGA rules relevant to their role.
• Schedule regular compliance reviews to confirm your labels, website and ads still align with your ARTG entry and the current code.

Advertising Therapeutic Goods In Australia: What You Can And Can’t Say

Therapeutic goods advertising is tightly regulated in Australia. In addition to specific TGA requirements (including the Therapeutic Goods Advertising Code), your marketing must comply with the Australian Consumer Law (ACL). Misleading or deceptive conduct is unlawful under section 18 of the ACL, and false or misleading representations are prohibited under section 29.

Claims Must Match Your ARTG Entry

Only make claims that are permitted for your product and supportable by evidence. Avoid disease treatment claims for low-risk (listed) medicines unless specifically allowed. If your website, product label and social posts stray beyond permitted indications, you may be in breach.

Testimonials, Endorsements And Influencers

There are strict rules on testimonials and endorsements for therapeutic goods. Be careful with paid influencer content, before-and-after photos, or statements that imply guaranteed outcomes. You must ensure any sponsored content is transparent, accurate and compliant with both the TGA code and the ACL.

Mandatory Information And Prohibited Content

Certain ads must carry mandatory statements or warnings. Some content is prohibited (e.g. advertising certain prescription medicines to the public). Build compliance checks into your marketing workflow before anything goes live.

Direct Marketing And Email Campaigns

If you use email or SMS to promote your products, make sure your campaigns also comply with spam and consent requirements alongside TGA rules. It’s a good idea to bake these steps into your CRM and signup forms and to align your process with Australia’s email marketing laws.

Legal Documents You’ll Likely Need

Getting your TGA strategy right is only half the picture. Strong contracts and clear policies help you manage risk across your supply chain, sales channels and team.

• Manufacturing Agreement: Sets technical specifications, quality standards, certifications, audits, corrective action, timelines and pricing with your manufacturer (local or overseas).
• Supply or Distribution Agreement: Clarifies territories, performance requirements, pricing, returns, and who handles complaints, adverse event reporting and recalls.
• Quality Agreement (with Manufacturer): Defines quality roles and responsibilities, record-keeping, change control, batch release and inspection rights.
• Customer Terms & Conditions: Your direct-to-consumer or wholesale terms covering orders, delivery, returns, liability, and compliance with therapeutic goods rules.
• Privacy Policy: If you collect personal information via your site or app (orders, accounts, mailing lists, telehealth or app data), you’ll need a compliant Privacy Policy. Health providers or apps that handle health information should consider a dedicated Privacy Policy - Health Service Provider.
• Website Terms & Conditions: Set the rules for using your website or app, including acceptable use and IP ownership, typically alongside your Website Terms and Conditions.
• Non-Disclosure Agreement (NDA): Protects confidential technical information and formulations when dealing with developers, manufacturers, testing labs or marketing partners.
• Employment or Contractor Agreements: If you engage staff or contractors, ensure terms cover confidentiality, IP ownership, training obligations and compliance responsibilities.

Not every business will need every document, but most sponsors and brand owners will need a combination of the above. If you’re unsure where to start, our team can help prioritise the essentials and get key contracts prepared to match your model.

Key Takeaways

• If you make or import products with health claims in Australia, the TGA likely applies - and the sponsor is responsible for ARTG inclusion and ongoing compliance.
• Work out early whether your product is a therapeutic good or a cosmetic/consumer product and align your claims with the correct regulatory pathway.
• Plan your ARTG strategy: define intended use, confirm ingredients/components, vet your manufacturer, compile evidence, and file the correct application.
• Build ongoing compliance into daily operations: quality controls, labelling, complaint handling, adverse event reporting, recalls and strong record-keeping.
• Advertising is tightly regulated: keep claims within your ARTG permissions and comply with the ACL (including misleading conduct and false representation rules), plus the Therapeutic Goods Advertising Code.
• Protect your business with the right contracts and policies, including a tailored Privacy Policy and Website Terms and Conditions, and ensure your marketing aligns with email marketing laws.

If you’d like a consultation on getting your therapeutic goods strategy right - from ARTG pathways and advertising review to contracts and privacy - you can reach us at 1800 730 617 or team@sprintlaw.com.au for a free, no-obligations chat.