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If you’re a business in Australia hoping to manufacture or sell therapeutic goods in 2025, it’s vital that you understand your obligations and responsibilities set out by the Therapeutic Goods Administration (TGA). This is crucial because many therapeutic products require TGA approval before they can be sold or supplied.
The TGA is the regulatory body responsible for overseeing the sale, supply, and manufacture of therapeutic goods – including a wide range of medicines, medical devices, and other health-related products. With evolving standards in 2025, maintaining compliance is more important than ever.
If this sounds like your business, you’ve come to the right place. In addition to the TGA’s requirements, you also have obligations around data privacy due to your management of health information, as mandated by the Privacy Act 1988 and related updates for 2025.
This article will focus on the TGA and what you need to know if it applies to you as you navigate the therapeutic goods landscape in 2025.
What Are Therapeutic Goods?
If you’re selling or manufacturing therapeutic goods, the TGA’s requirements will apply to your business activities. It’s essential to ensure that you are compliant with both product safety and advertising regulations.
But what exactly is considered a therapeutic good? The Department of Health identifies a range of products – including medicines, medical devices, vaccines, sunscreens, and diagnostic tests – that attract TGA regulations.
The TGA uses a broad definition that covers products used for preventing or diagnosing disease, influencing conception, or testing for pregnancy, among other uses. It’s important to review what therapeutic goods are in detail to decide whether the TGA’s requirements apply to your products.
What Is the TGA?
The Therapeutic Goods Administration (TGA) is the government agency that enforces the standards for therapeutic goods in Australia. Its authority—derived from the Therapeutic Goods Act 1989—means that its guidelines and approval processes are fully enforceable, ensuring that only safe and effective products reach the market.
Do I Need TGA Approval?
If you want to sell or manufacture a therapeutic good, you must ensure it has been approved by the TGA. You can verify this by checking the Australian Register of Therapeutic Goods (ARTG).
If your product is not listed on the ARTG, you will need to seek TGA approval. This involves following the market authorisation process by submitting an application for your therapeutic good to be included in the ARTG.
Products are added to the ARTG once they have satisfied the criteria set out by the TGA, which typically involves a thorough assessment of the product’s risk, quality, and efficacy.
TGA Sponsor Application
Every entry in the ARTG is submitted by a sponsor. The sponsor is responsible for applying for the inclusion of the product in the ARTG, whether they are importing, exporting, or manufacturing the therapeutic goods. To qualify, the sponsor must be either a resident of Australia or be conducting business within the country.
There are different application forms depending on your specific requirements. For example, there is a form for changing the sponsor of a therapeutic good, as well as a sponsor six monthly reporting form. It’s worthwhile to review this list to identify the correct application form for your situation.
TGA Application Form to Use Unapproved Therapeutic Goods
If you are a health practitioner wishing to provide treatment using a product that has not been approved by the TGA, you must acknowledge its unapproved status. This is critical because the TGA cannot guarantee the product’s safety for use.
In such cases, the practitioner accepts full responsibility for any outcomes resulting from the use of the unapproved product.
To proceed, you must submit an application via the Special Access Scheme & Authorised Prescriber Online System. This streamlined system allows you to apply to the TGA while simultaneously notifying your State or Territory Health Department.
Advertising Therapeutic Goods
If you’re a business or an influencer involved in advertising therapeutic goods, you must adhere to specific obligations under the Therapeutic Goods Advertising Code. For instance, you must not mislead or deceive consumers about the benefits or safety of your product.
You are also required to promote the safe use of these products by clearly disclosing any potential health risks. In recent updates leading into 2025, the Code has imposed even stricter limitations on using incentivised or paid testimonials and on the presentation of health claims.
Furthermore, mandatory statements regarding health warnings must be included in your advertisements. These measures ensure that businesses remain accountable and that consumers are provided with accurate and safe information about therapeutic goods.
In summary, the TGA’s rules on advertising are rigorous, and non-compliance can result in serious penalties. Staying informed and regularly reviewing your advertising content is essential.
Where Can I Get Advice?
The regulatory framework surrounding the TGA can be quite complex. It’s no surprise that many businesses seek expert legal guidance to ensure they’re navigating these obligations correctly.
Luckily, our team of expert lawyers at Sprintlaw offer a comprehensive TGA Advice package which includes:
- A phone consultation with a Sprintlaw lawyer
- An email summary of advice tailored to your situation, including whether the TGA applies to your goods
Managing health information as a business in Australia means you’re held to a high standard under multiple laws. Along with TGA compliance, ensure you have an up-to-date Privacy Policy that transparently outlines how you handle personal health information.
Looking ahead to 2025, regulatory expectations continue to evolve. With increased scrutiny on online marketing and the rise of digital platforms, it’s more important than ever to regularly review your compliance procedures. This includes ensuring that any claims about your therapeutic goods are substantiated and that your product labels and advertisements meet the latest standards set by the TGA and the Australian Consumer Law. It’s also wise to safeguard your brand – consider the benefits of trademark registration and ensure your business is properly registered by checking our guide on registering your business in Australia.
Need Help?
If you need advice on your obligations under the TGA, the Privacy Act, or any other relevant laws and frameworks in Australia, our experienced lawyers are here to help. You can reach us at 1800 730 617 or email us at team@sprintlaw.com.au for a free, no-obligations consultation to discuss your legal options.
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