Importing medicines, biologicals and medical devices into Australia? You need to know about the TGA and its rules.

Australia is a wealthy country that has long been an attractive and profitable market for foreigners to sell their therapeutic goods to our population of 25.5 million people.  But beware.  Australia has strict laws and regulations that govern the import and sale of therapeutic goods.  

Your products need to be approved by the Therapeutical Goods Administration (TGA) before you are permitted to import, manufacture, sell or advertise these types of products in Australia.  You will need a sponsor and a regulatory compliance expert to ensure your product(s) meet the strict criteria and can be registered.

Global Alliance Partners are well placed to assist you as a sponsor and advise you on appropriate regulatory compliance organisations for your product.  We have years of experience in the TGA field.

What products are considered “therapeutic goods” in Australia?

The TGA considers the following products as therapeutic goods - 

• Medicines – including product shapes or dosages that looks like medicine ( eg the product is in the form of tablets or capsules), or products that make claims they can prevent or treat a disease or have 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?  The TGA provides a broad guide on its website (Check here) but we recommend you engage a regulatory compliance specialist to ensure your product meets the required standards for registration in Australia.  

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. Their aim is to ensure that the Australian community has access, within a reasonable time, to safe therapeutic products, and advances in those products.

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 appropriate standards. 

What do I need to get TGA approval for my product?

The TGA regulates therapeutic goods through: 

1. Pre-market assessment

2. Post-market monitoring and

3. Enforcement of standards

4. Licensing of Australian manufacturers

5. Verifying overseas manufacturer’s 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?

A sponsor is responsible for applying to the TGA to have a therapeutic good included on the Australian Register of Therapeutic Goods (ARTG).  Only sponsors can do this, and every product must at all times have a sponsor.

Foreign manufacturers often appoint domestic sponsors in Australia to act on their behalf. The sponsor is legally accountable for the product quality in 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?

A 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. Generally this is a resident Australian director.  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.  This is why a regulatory compliance firm is required.

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 it is advantageous that your product has an independent TGA sponsor?

Regularly, overseas manufacturers engage their Australian distributor to not only distribute their products but also act as the sponsor.  Like a marriage, though, this might seem like a good idea before the union is confirmed, but not all marriages last the distance and neither do commercial arrangements. 

In circumstances where disagreements or disputes occur with the local distributor, it may be hard, or expensive, for the manufacturer to reacquire the TGA license from the distributor and pass it onto another Australian sponsor.  

By choosing an independent or third party TGA sponsor, the manufacturer has control over the process of registration, compliance, marketing and distribution.  Global Alliance Partners associates have been sponsors for many overseas manufacturers.

How can Global Alliance Partners assist as your TGA sponsor?

Global Alliance Partners can assist overseas health and medical device manufacturers in many ways.  Our services fall into the broad phase of market entry, being Evaluate, Estabish and Expand. 

In the Evaluate phase we can undertake targeted market research to help you better understand the Australian market for your product and the channels to get your product to market.  That often involves using a distributor.  We can help you find a suitable firm. Or if you intend to set up business in Australia and establish a sales force, we can help there too.  And we can guide you to a suitable regulatory compliance firm for the pre-evaluation of your product to ensure it will meet TGA guidelines.

In the Establish phase, Global Alliance Partners ticks the boxes as a sponsor.  We work with you and your compliance firm to ensure you stay within the guidelines at all times.  More than that, we can assist you run and manage your business interests in Australia - however you choose to do business.

When we act as sponsor for a foreign manufacturer, we do so through an Australian company that is wholly owned by your parent company.  All Australian companies are required to have a resident Australian director.   There is no need for a local shareholder.  

If your product does well in our market, and many overseas manufacturers have been here a long time so they must be doing well, you may wish to consider how to Expand your presence in our market.  Global Alliance Partners can help here too – our principals have years of experience managing businesses in Australia, including international trading businesses exporting products from Australia.  We can be your eyes and ears in Australia because we understand from experience how to successfully grow Australian businesses whilst avoiding the pitfalls that often stifle foreign-owned businesses. 

In summary, if your health or medical device business is looking to enter the Australian market you need to become aware of, and abide by, the rules and regulations set down by the TGA.   

Global Alliance Partners can set up your company in Australia, act as your resident director and TGA sponsor, look after tax compliance and operations in Australia and help you find other organisations you will need to successfully sell products.  Let’s get started and talk about how we can help you be successful in Australia. 

Contact our office to speak to Piers Morgan on +61 2 8324 1436, or email piers.morgan@weringagroup.com.au.