Australia’s Regulatory Landscape 101

At Healthcare Product Specialists, we live and breathe the beautiful, and sometimes rocky landscape that is our rugged Australian regulations. Staying up to date, navigating, and working within these often complex frameworks keeps us engaged and motivated, so who better to show you the scenery than us!

Complementary medicines, also known as Listed medicines

The Therapeutic Goods Administration, TGA for short, are part of the Australian Government Department of Health and are tasked with regulating ‘therapeutic goods’ within Australia. These range from complementary medicines and sunscreens through to prescription medicines and medical devices. A therapeutic good includes products that are designed to prevent, diagnose, cure or alleviate a disease or injury, as well as products that influence or modify a physiological process within the body.

Listed complementary medicines are products such as vitamins, mineral supplements, herbal preparations, nutritional supplements, probiotics and homeopathic preparations. These types of products are considered to have a clear safety profile as well as being clearly identifiable with a history or tradition of use.

To successfully, and legally produce or bring a complementary medicine product to the Australian market there are a number of requirements set by the TGA that must be met. From low-risk ingredient selection and pre-approved manufacturing locations through to the product’s health claims, evidence, and packaging, there are many touch points that require a sound regulatory understanding.

If you are looking to launch a new product to market or import an existing product from overseas to sell in Australia, get in touch today to see how we can help make the journey a little more comfortable.

Foods

Food Standards Australia and New Zealand (FSANZ) monitor and manage the requirements that must be met for food products in Australia and New Zealand. As you can imagine, FSANZ have quite a busy job as they oversee anything from food product ingredients and labelling through to restaurant cleanliness!

Developing, producing and marketing food products in Australia may seem tricky but it can be a straightforward process, once you know how your product fits within the regulatory framework set by FSANZ. It may surprise you that not all foods are ‘general foods’. There are many sub-categories of foods such as Formulated Meal Replacements and Infant Formula products.

To successfully bring a compliant food product to market, it is important that product labelling, ingredients, nutritional details and safety aspects are met. As experts in food regulation, HPS can help you realise your food product dreams. Whether you need help developing a new product from scratch or you have a formula ready to go, we have a number of solutions take out some of the complexity within the food space.

Cosmetics

Cosmetics are only permitted to make claims of a ‘cosmetic nature’, that is, low level claims relating to external parts of the body such as altering the appearance of, cleanliness, smell or hydration (for example). Further, ingredients within cosmetic products are regulated as industrial chemicals which is managed by the Australian Industrial Chemicals Introduction Scheme (AICIS). It is important to check that the ingredients within your product are permitted in Australia.

There are generally no requirements for cosmetic products to be submitted to any regulatory body for approval, however regulatory requirements must still be met. In some cases, where ingredients have not been expressly permitted by AICS, additional approvals may need to be sought.

There are a few important things to consider when it comes to launching or managing a cosmetic product on the Australian market. Ingredient safety profiles, labelling requirements and permissible claims should be carefully considered to avoid falling into therapeutic territory. At HPS, we are well versed in the differences between cosmetics and therapeutic products and can review your product against all cosmetic regulations. Reach out to us today to discuss your cosmetic requirements further.

Other important bodies

Along with the TGA, FSANZ and AICIS, there is another important acronym to factor in as part of the Australian regulatory system and that is the ACCC. The Australian Competition and Consumer Commission helps to ensure that individuals and businesses comply with Australian competition, fair trading, and consumer protection laws – in particular the Competition and Consumer Act 2010.

IP Australia will be important when it comes to any trademarks and patents you may wish to apply to your product, or to ensure you aren’t encroaching on existing trademarks which could land you in hot water.

The Department of Agriculture Fisheries and Forestry and the corresponding BICON (Australian Biosecurity Import Conditions) submissions may be required should you wish to import raw materials or finished products from overseas. It is important that correct import permits and documentation are in place to avoid unnecessary delays or destruction of goods.

It is important to review your product or product range from both a micro and macro level. A product that may look like a simple food concept but desires to make therapeutic claims can mean a very different regulatory outcome than you may have first thought! Similarly, some shiny new ingredients you’ve spotted overseas may look enticing but may not meet standards set for the Australian market.

While the regulatory landscape in Australia may appear complex and vast with a few rocky outcrops and potential pitfalls, with the right guide, your journey can be scenic rather than one of survival! Let us help you navigate the regulations for your chosen product.