A summary of supplying therapeutic goods in Australia


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, found on the TGA web site. Here are the six steps involved. One: Check if your product is a therapeutic
good. Two: decide whether you want to have it
approved in your name to supply it in Australia. Three: find out what type of therapeutic good the product is and review the relevant guidelines. Four: Understand the legal
requirements for your product to be approved. Five: Understand the legal responsibilities
of being a sponsor, and Six: Check what it will cost you. You can also 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 or 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 traveled 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 his multivitamin/mineral
products is a therapeutic good, not a food.
If Trent’s product were 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 the product 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 manufacturing 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 or 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 labeling 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, and
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
responsibility once their product is in 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, and Notify the TGA of any adverse events or problems with the product.
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 at 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 setup expenses associated with ensuring your product
can meet the legal requirements to be approved, there are upfront 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 seven hundred and forty dollars and an
annual charge of nine hundred forty dollars to supply the
product. Please note: fees are current for the 2013 to 2014
financial year and they are reviewed annually. Need further advice?
Contact the TGA for more information or contact to 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:
One – confirmed his product is a therapeutic good;
Two – decided he wants to become a sponsor and import the product into Australia himself;
Three – found out what type of therapeutic good the product is and reviewed the relevant guidelines; Four – made sure his product will
meet the legal requirements Five – familiarised himself with the legal responsibilities of
becoming a sponsor, and Six – checked what it will cost him. He also sought further advice as needed. Trent is now ready to start the process
of becoming a sponsor of the product. For more information visit tga.gov.au and download a copy of the TGA’s Overview of Supplying Therapeutic Goods in Australia.
You can also find useful links to other relevant organisations on our
website.