The Therapeutic Goods Administration (TGA) heavily regulates the production of medicines and medical devices, and even some cosmetic products in Australia. If you want to sell or supply therapeutic goods in Australia, you will generally need to obtain market authorisation from the TGA. Launching a new business selling therapeutic goods is complicated, so it is important to understand the regulations and rules that apply to the products you sell. This article will discuss these rules and provide an overview of the registration process for therapeutic goods in Australia.
What is the TGA?
The TGA is the regulator for all therapeutic goods, which include:
- prescription medicines;
- some vitamins;
- medical devices; and
- blood and blood products.
Additionally, therapeutic goods include goods that make therapeutic claims. Generally, a therapeutic good must be entered on the Australian Register of Therapeutic Goods (ARTG) before it can lawfully be imported, supplied, or exported in Australia.
What are Therapeutic Goods?
According to Australian Law, therapeutic goods are any products that are represented as having a therapeutic use. For example, this includes products used in connection with:
- preventing, diagnosing, curing, or alleviating a disease, illness, defect or injury;
- influencing, inhibiting, or modifying a physiological process;
- testing the susceptibility of persons to a disease or illness;
- influencing, controlling, or preventing conception; or
- testing for pregnancy.
For example, some therapeutic goods include pregnancy tests, birth control, and COVID-19 rapid antigen tests. Some cosmetic products may also be considered therapeutic goods. However, this will ultimately depend on how you represent and market them, and the ingredients they contain.
An Overview of the Registration Process
Once you have determined that your product is a therapeutic good and eligible for registration, there are additional steps you will need to take to register it with the TGA. The following sections details an overview of the steps you will need to follow.
1. Determine Who Will Sponsor the Product
A sponsor imports or manufactures therapeutic products for supply in Australia. You should complete an initial search of the ARTG to determine whether similar or identical products are already on the register and currently sold in Australia. If your product is already listed on the ARTG, your best option may then be to contact the registered sponsor and negotiate a distribution agreement. This could, for instance, be a commercial option to limit your legal responsibilities and application fees.
2. Determine the Category of Your Therapeutic Product
Your product's categorisation will affect the ARTG registration pathways as well as the fees required.
The first question to ask is whether your product is a medicine or medical device. For example, the table below outlines the distinction between the two.
|Medicines||This could include prescription items, over-the-counter products, and complementary medicines, such as paracetamol or vitamins.|
|Medical Devices||These are typically used to treat illness and monitor or modify
bodily functions through physical, chemical, or mechanical
These can include implants and appliances, such as replacement joints or asthma puffers, as well as diagnostic tools such as bowel cancer screening kits.
These two categories can be broken down further. For example, medicines contain three separate categories.
|Listed medicines||These products only contain specific low-risk ingredients and make low-level health claims. There is less focus on the effectiveness of the product, and sponsors must assess and self-certify the quality and safety of the product.|
|Assessed listed medicines||These products also contain certain low-risk ingredients but make intermediate level health claims. As part of the registration pathway, the TGA will evaluate the efficacy of the product.|
|Registered medicines||These products contain high-risk ingredients and make high-risk health claims. The TGA will need to assess the product safety, quality, and efficacy of the medicine, including all prescription medicines.|
The law also divides medical devices into five separate categories, which predominantly focus on the risk of potential harm to the user. Moreover, it is important to note that each category will have different registration and application requirements.
3. Check What the Application Will Cost
When considering applying for registration, it is important to be aware of the costs. This is because you will need to factor in the set-up costs to ensure your product is compliant with the TGA regulations. Moreover, this will be in addition to registration application fees and ongoing compliance fees. The TGA also regularly updates the application and ongoing fees. These fees are therefore dependent on the category of your therapeutic goods.
4. Learn More About the Requirements for TGA Approval
If the TGA approves your product, you will also have ongoing legal obligations concerning its manufacturer and sale. You will need to consider the following:
- manufacturing standards;
- product and labelling standards; and
- advertising regulations.
For example, if your product is a complementary medicine, you must:
- substantiate your advertising claims and have evidence to support them;
- limit your advertising of health benefits to low-level claims;
- ensure your manufacturing facilities meet the TGA Advertising Code and regulatory requirements of the Good Manufacturing Practice (GMP) codes; and
- ensure your product only contains low-risk ingredients approved by the TGA.
While this is not an exhaustive list of all the requirements registrants must meet, it is important to be aware of the extensive obligations before commencing the application process.
5. Understand the Legal Responsibilities of Sponsorship
If you import, export, or manufacture therapeutic goods, you will have ongoing legal obligations. Indeed, you must:
- maintain records on the product ingredients, manufacturing process and product health benefits;
- share product information with the TGA as necessary on request;
- comply with advertising requirements under the TGA Advertising Code;
- communicate with the TGA if there are any adverse reactions to manufacturing events that will affect the product; and
- depending on the product, you may also be responsible for recording the people that you supply the product to.
Similarly, this is not a complete list of obligations. However, these are some key considerations before embarking on the registration process.
In summary, therapeutic goods are heavily regulated in Australia. Whether you import or manufacture therapeutic goods, you will likely have obligations under the Therapeutic Goods Administration and may need to register your goods with the Australian Register of Therapeutic Goods (ARTG).
Registration with the ARTG can be costly and depends on the type of good, and you will have ongoing legal obligations if your registration is successful.