A summary of supplying therapeutic goods in Australia

If you are thinking of supplying a therapeutic good, then you are a potential sponsor. To help you get started, watch this video to find out:

• the six steps you need to follow when considering making an application to the TGA
• where to find relevant information about different types of goods
• what legal and financial responsibilities you need to be aware of
• where to get more information on the regulatory process.

Make sure you also read the Overview of Supplying Therapeutic Goods in Australia.

Transcript

Show transcript for this video

A summary of supplying therapeutic goods in Australia

We have put together this information to help small businesses and individuals thinking about supplying therapeutic goods in Australia.

While the regulatory system may be complex, it is designed to ensure that only safe and good quality therapeutic goods are supplied for use in Australia.

Watch this summary and read the Overview of Supplying Therapeutic Goods in Australia (the Overview), found on the TGA website.

Here are the 6 steps involved

1. Check if your product is a therapeutic good
2. Decide whether you want to have it approved in your name to supply it in Australia
3. Find out what type of therapeutic good the product is and review the relevant guidelines
4. Understand the legal requirements for your product to be approved
5. Understand the legal responsibilities of being a sponsor
6. Check what it will cost you
7. Seek further advice if you need it.

'Supplying' means making the product available for people to buy in Australia. For example, this may include importing a product from overseas and selling it through your business.

Individuals and companies can apply to the TGA to be the 'sponsor' that imports and supplies a therapeutic good in Australia.

STEP 1: Check that the product you want to sell is actually a therapeutic good

Therapeutic goods sold in Australia must be authorised by the TGA and most are entered in the Australian Register of Therapeutic Goods (ARTG).

Therapeutic goods are products such as medicines and medical devices.

This includes prescription, over-the-counter and complementary medicines, and devices from lower risk items like adhesive bandages through to higher risk devices like pacemakers.

Meet Trent

Trent works in the health and fitness industry and he recently travelled to China.

He found a multivitamin/mineral product that he'd like to import and sell to his clients as a sideline to his business.

Trent visits the TGA's website and finds that this multivitamin/mineral product is a therapeutic good, not a food.

If Trent's product was a food, he could visit the Food Standards Australia New Zealand website to find out more.

STEP 2: Find out whether you want to have it approved in your name to supply it in Australia

Search the ARTG on the TGA website for the product. If it is there, we have already authorised it for supply and you may wish to contact the sponsor listed in the ARTG entry to find out if you can become a retail seller.

If it is not there, or you wish to import it directly from the overseas manufacturer yourself, then you will need to get TGA approval.

The Overview contains a link to the ARTG.

Trent searches the ARTG and finds his product is not there.

This means that if he wants to import and supply the product he will need to become that product's sponsor in Australia by having it approved by the TGA.

STEP 3: Find out what type of therapeutic good the product is

The TGA assesses medicines and medical devices supplied in Australia according to what type of product they are, and their associated level of risk. The processes applied in that assessment are also determined by the type of product and level of risk.

Consult the guidelines and other documents that relate to your product.

• Trent's research shows that the multivitamin/mineral fits into the category of 'complementary medicines', which are generally regarded as 'low risk'.
• Trent reviews the Australian Regulatory Guidelines for Complementary Medicines (ARGCM) to find out about the TGA approval processes that will apply in relation to his product.
• Check the Overview for links to the regulatory guidelines that apply to other types of products.

STEP 4: Make sure your product meets the necessary legal requirements for it to be approved

There are legal requirements that apply to all therapeutic goods, such as manufacturing requirements and product and labelling standards, and there must be evidence to support the therapeutic claims made about them. There are also requirements specific to the type of product.

Review the relevant regulatory guidelines to make sure that your product is able to meet all necessary legal requirements.

Because his product is a complementary medicine, before Trent applies to the TGA he needs to be able to certify that:

• only low level claims are made about the health benefits of the product
• he has evidence that supports those claims
• the product has been manufactured in a facility that satisfies TGA regulatory requirements
• the product only contains low-risk ingredients approved by the TGA.

STEP 5: Get up to speed with the legal responsibilities of becoming a sponsor

As well as the legal requirements that must be met before a product is approved, sponsors have ongoing legal responsibilities once their product is on the ARTG. They must:

• hold information about ingredients, manufacturing and health benefits of the product
• provide information to the TGA about the product on request
• comply with advertising requirements
• notify the TGA of any adverse events or problems with the products.

Depending on the product, further restrictions may apply, such as who it can be supplied to.

Trent reviews the ARGCM, the Overview, and relevant parts of the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods Advertising Code so that he can find out the legal responsibilities involved in importing and supplying the product.

STEP 6: Check what it will cost you

Apart from the set-up expenses associated with ensuring your product can meet the legal requirements to be approved, there are up front and ongoing costs associated with becoming a sponsor.

We list an up-to-date summary of fees and charges on our website and they are reviewed annually.

• Trent's investigations show his manufacturer in China is already TGA approved, but he will need to pay an application fee of $740* and an annual charge of $940* to supply the product.
• *fees current for 2013/14 and reviewed annually.

Need further advice?

Contact the TGA for more information or contact a regulatory affairs consultant for business advice.

• Trent finds his industry organisation listed on the TGA website and contacts them for independent advice about engaging a regulatory affairs consultant.

Trent has:

1. Confirmed his product is a therapeutic good
2. Decided whether he wants to become a sponsor and import the product into Australia himself
3. Found out what type of therapeutic good the product is and reviewed the relevant guidelines
4. Made sure his product will meet the legal requirements
5. Familiarised himself with the legal responsibilities of becoming a sponsor
6. Checked what it will cost him
7. Sought further advice as needed.

Trent is now ready to start the process of becoming the sponsor of the product.

For more information, visit

www.tga.gov.au and download the TGA's Overview of Supplying Therapeutic Goods in Australia.

• www.health.gov.au - additional information on therapeutic goods
• www.ipaustralia.gov.au - patenting and intellectual property
• www.customs.gov.au -importing goods
• www.apvma.gov.au - agricultural and veterinary chemical products
• www.industrialchemicals.gov.au - cosmetics
• www.foodstandards.gov.au - food
• www.accc.gov.au - product standards and consumer protection

More information from the TGA

Explore the TGA website and find information related to this presentation with the links below:

Role of the sponsor 
The sponsor is responsible for applying to the TGA to have their therapeutic good included on the ARTG.

Regulatory affairs consultants 
Regulatory affairs consultants offer services, including advice and assistance, in relation to regulatory requirements.

Regulation basics 
The Australian community expects therapeutic goods in the marketplace to meet an acceptable standard of safety and quality.

About TGA eBusiness Services
TGA eBS is an online portal that provides functions for consumers, health professionals and industry.

• Searching the Australian Register of Therapeutic Goods (ARTG)
• Is the therapeutic good available in Australia?
  If you want to find out if a therapeutic good could be available in Australia you can check to see if it is on the ARTG.

Medical devices
Medical devices range from sticking plasters through to products such as pacemakers, artificial hips and contact lenses.

An overview of the regulation of complementary medicines in Australia
Also known as 'traditional' or 'alternative' medicines, these include vitamin, mineral, herbal and aromatherapy products.

Evaluation of a new medicine - The TGA's lifecycle approach to regulation
Before a prescription medicine can be marketed in Australia, the TGA assesses the risks and the benefits from the available evidence.

Useful links

• Overview of supplying therapeutic goods in Australia
• What are therapeutic goods?
• What the TGA doesn't do

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