Australia has strict laws and regulations to sell and import therapeutic goods in the country. These products need to be approved by the Therapeutical Goods Administration (TGA) before you are permitted to import, manufacture or sell these types of products in Australia.
What products are considered therapeutic goods in Australia?
The TGA considers the following products as therapeutic goods –
- Medicines – including product shapes or dosage that looks like medicine, for example, the product is in the form of tablets or capsules, or products that have claims that they can prevent or treat a disease or has health benefits.
- Complementary medicines – these include vitamin, mineral, herbal, aromatherapy and homoeopathic products. These products are often supplied by practitioners of traditional or alternative medicines. Products that may be considered food supplements or nutritional supplements in other countries such as multi-vitamins, are deemed to be complementary medicines in Australia.
- Medical devices
- Blood and blood products.
Is my product considered a therapeutic product? Check here
Who is the TGA?
The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods, under the Australian Government Department of Health. They are responsible for regulating therapeutic goods with an aim is to ensure that the Australian community has access, within a reasonable time, to therapeutic advances.
In Australia, therapeutic goods must be included on the Australian Register of Therapeutic Goods (ARTG) before they can be sold.
The TGA regulate therapeutic goods in Australia by carrying out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. They also ensure that the products have been properly formulated and manufactured to certain standards.
What do I need to get TGA approval for my product?
The TGA regulates therapeutic goods through:
- Pre-market assessment,
- Post-market monitoring and
- Enforcement of standards,
- Licensing of Australian manufacturers
- Verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts
The TGA has obligations under the Protective Security Policy Framework to secure your intellectual property. The TGA develop, document, implement and review appropriate security measures to protect your business and product information from unauthorised use or accidental modification, loss or release.
What is a TGA sponsor?
The sponsor is responsible for applying to the TGA to have their therapeutic good included on the Australian Register of Therapeutic Goods (ARTG).
Foreign manufacturers often appoint domestic sponsors in Australia to act on their behalf. The TGA sponsor is legally accountable for the product quality on the Australian market.
Do I need a TGA sponsor?
You or your company will need a TGA sponsor if your company does one or more of the following:
- exports or arranges the export of therapeutic goods from Australia
- imports or arranges the import of therapeutic goods into Australia
- manufactures therapeutic goods for supply in Australia or elsewhere
- arranges for another party to import, export or manufacture therapeutic goods.
Who can be a TGA sponsor?
The TGA sponsor must be a resident of Australia or an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia. The sponsor can represent the manufacturer of an overseas company.
The Australian sponsor and overseas manufacturer must have formal contractual agreements in place for compliance. This ensures all pre-market and post-market support for the product or device are met and upheld by the manufacturer and the TGA sponsor ensures compliance with the TGA requirements and holds the ARTG entries.
Note: The Australian Therapeutic Goods (Medical Device) Regulations 2002 as amended requires an Australian address to be associated with any in vitro diagnostic or medical device prior to inclusion on the ARTG.
Why your product needs an independent TGA sponsor
Regularly, overseas manufacturers engage their Australian distributor to not only distribute their products but also as the holder of their TGA license.
In circumstances where disagreements or disputes may occur with the local distributor, it may be hard to reacquire the TGA license from the distributor.
By choosing an independent or third party TGA sponsor, the commercial distribution is separated from the regulatory compliance.
How can Abdera assist as your TGA sponsor?
Abdera can assist overseas health and medical device manufacturers by providing TGA sponsor services. We can provide your business with the regulatory support, assisting with your TGA compliance and getting your health products to market. We can act as the conduit between your overseas company and the TGA and attend to all TGA regulatory compliance.
Alternatively, Abdera can also help you set up business in Australia as a wholly owned subsidiary. The company would be fully owned by your overseas entity (there is no need for a local shareholder) and as 100% shareholders, you can appoint whoever you want as other directors, providing there is one resident director. If you are struggling to comply with the resident director requirements, Abdera also provides resident director services and can act as your resident director or nominee director.
If your health or medical device business is looking to enter the Australian market, Abdera can set up your company in Australia, act as your resident director, TGA sponsor, look after tax compliance and operations in Australia – let’s get started and talk about how we can help you be successful in Australia. Contact us now or call our office on +61 2 8916 6259.
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