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If you’re a business in Australia hoping to manufacture or sell therapeutic goods, it’s vital that you understand your obligations and other responsibilities set out by the Therapeutic Goods Administration (TGA). This is because you may need TGA approval to sell these products.
The TGA is the regulatory body for the sale, supply and manufacture of therapeutic goods. This includes different types of medicine and medical devices.
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.
This article will focus on the TGA and what you need to know if it applies to you.
What Are Therapeutic Goods?
If you’re selling or manufacturing therapeutic goods in any way, the TGA’s requirements will apply to your business activities. As such, you need to ensure that you are compliant.
However, what is actually considered a therapeutic good?
Well, the Department of Health has listed a number of therapeutic goods that attract the regulations. For example, medicines, medicaldevices, vaccines and even sunscreens all count as therapeutic goods.
The TGA provides a pretty broad definition for therapeutic goods. For instance, it includes products that are used for preventing or diagnosing a disease, influencing conception or testing for pregnancy.
It’s important to read more about what therapeutic goods are to clarify whether the TGA applies to you.
What Is The TGA?
The TGA is also known as the Therapeutic Goods Advertising Code. While this is considered a framework, it’s important to note that it is enforceable under the law as it falls under the Therapeutic Goods Act 1989.
Do I Need TGA Approval?
If you want to sell or manufacture a therapeutic good, you’ll need to ensure it has been approved by the TGA. You can do this by checking the Australian Register of Therapeutic Goods (ARTG).
If your product is not listed, you may need to seek TGA approval. To do so, you need to follow the process of market authorisation. In other words, you need to submit an application for your therapeutic good to be included in the ARTG.
Therapeutic goods are added to the ARTG once they have satisfied certain criteria set out by the TGA. It usually involves assessing the risk and quality of the product.
TGA Sponsor Application
Every ARTG entry comes from a sponsor. So, this sponsor should apply for that product to be included. A sponsor can import, export or manufacture the therapeutic goods. They must also be a resident of Australia or be conducting business in Australia.
There are different application forms for what you wish to do. For example, there is a form for changing the sponsor of a therapeutic good, and a sponsor six monthly reporting form. It’s worth going through this list to see which application form you need to complete and submit.
TGA Application Form To Use Unapproved Therapeutic Goods
If you are a health practitioner and you want to provide someone with a treatment using a product that has not been approved by the TGA, you must acknowledge that it has been unapproved. This is because the TGA cannot guarantee its safety for use.
This also means the practitioner must hold themselves responsible for anything that comes from the use of that unapproved product.
To do this, you need to submit an application through the SAS & Authorised Prescriber Online System. This allows you to submit your application to the TGA as well as your State or Territory Health Department at the same time.
Advertising Therapeutic Goods
If you’re a business or an influencer who is advertising certain therapeutic goods, you are subject to certain obligations and rules under the Code. For example, you cannot mislead or deceive consumers about what the product does for you.
Further, you need to ensure you are encouraging safe use of those products. This may require disclosing certain health risks associated with the product you’re advertising.
Some recent changes in 2022 tightened the requirements under the Code with respect to advertising therapeutic goods. For example, it places strict limitations around providing testimonials for the advertisement of certain therapeutic goods, such as where it was paid or incentivised.
Another change involves mandatory statements when it comes to advertising certain therapeutic goods. These relate to health warnings for consumers, and ensure that businesses selling therapeutic goods are held to a high standard to maintain the health and safety of Australian customers.
So, as you can see, the TGA places strict rules when it comes to the advertising and sale of therapeutic goods. You want to make sure you’re compliant with these laws to avoid the consequences.
Where Can I Get Advice?
The TGA is quite a complex legal framework. So, understandably, lots of businesses want to seek the right legal help to ensure they’re taking steps in the right direction.
Luckily, our team of expert lawyers at Sprintlaw offer a TGA Advice package which includes the following:
- A phone consultation with a Sprintlaw lawyer
- An email summary of advice around whether the TGA applies to your goods
Managing health information as a business in Australia means you have a number of responsibilities, not just under the TGA. Dealing with health information means you are held to a relatively higher standard under a number of different laws.
For example, regardless of your annual turnover, if your business is handling health information, the requirements under the Privacy Act 1988 apply to your business. This means you’ll need to have an appropriate Privacy Policy in place to ensure you are transparent with users about how you hold their personal health information, and for what purposes.
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 lawyers are happy to chat you through your options.
You can reach us at 1800 730 617 or team@sprintlaw.com.au for a free, no-obligations
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