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Importing health supplements and pharmaceutical products into Australia

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Two stacks of blister packs containing health supplements for importing to Australia

The Australian market for health and wellness products, such as vitamins, supplements and pharmaceuticals, is booming. This is driven by a growing number of health-conscious consumers. Want to tap into this lucrative market? Read on to discover how to navigate the import process and get your products into the hands of Australian consumers.

According to Statista, the Australian vitamins and minerals market amounted to US$1.4 billion in revenue in 2024, and it is projected to grow annually by 6.41% from 2024 to 2029. If you’re in the business, these figures present a flourishing opportunity to expand your reach and tap into a new growing market. 

However, as these products can affect public health, Australia has strict regulations in place to govern their importation. Therefore, before you import, you must familiarise yourself with Australia’s regulatory landscape and import procedures to avoid potential shipping delays, product seizures, or fines. Additionally, given the temperature-sensitive nature of some pharmaceuticals and health products, you may need extra measures to maintain the cold chain during shipping. 

Australia’s regulatory landscape for health supplements

The Therapeutic Goods Administration (TGA) is the regulatory body responsible for governing the import, manufacture, and supply of health and pharmaceutical goods in Australia. This includes a wide range of products, including prescription medicines, over-the-counter medications, medical devices, and complementary medicines.

Health supplements fall under complementary medicines. Under the TGA’s frameworks, these medicines fall under the non-prescription category and are further classified based on their level of risk to the consumer, ingredients used, and intended use.

Complying with your product’s specific packaging and regulatory requirements is crucial to ensure product integrity and avoid potential delays or issues during the import process.

Listed medicines

These products bear the ‘AUST L’ label and are considered the lowest-risk non-prescription medicines under TGA regulations. Listed medicines are not individually evaluated by the TGA for quality, safety and efficacy before they are imported or enter the Australian market, but their ingredients are selected from a pre-approved list by the TGA. 

You’ll find listed medicines, such as vitamins, herbal medicines, and Traditional Chinese Medicines, in local health food shops, supermarkets, and pharmacies.

However, under the labelling requirements, some medical terms cannot be used to describe these products. For example, serious conditions like rheumatoid arthritis or depression cannot be mentioned on the labels, packaging or other advertising material as these issues are too serious to be self-treated with a listed medicine.

Assessed listed medicines

These products are similar to listed medicines, except that their therapeutic indications are assessed by the TGA for efficacy before they are supplied in the marketplace. This means that there is scientific evidence that it can treat the conditions it states it will treat. 

Like listed medicines, assessed listed medicines contain ingredients from the TGA’s pre-approved list, and they can be found in health food shops, supermarkets and pharmacies. They carry the ’AUST L (A)’ label.

Registered non-prescription medicines

As the higher-risk of the non-prescription category, these products are labelled ‘AUST R’. Therefore, the TGA performs a full pre-market evaluation of their safety, quality and efficacy before they can be imported or supplied to the Australian market. 

Registered non-prescription medicines are further subdivided into over-the-counter (OTC) medicines and registered complementary medicines. OTC medicines can be sold without a doctor’s prescription and are used for mild health problems, such as headaches and sore throats. They usually can be bought off the shelf from supermarkets and pharmacies or after a consultation with a pharmacist. 

Meanwhile, registered complementary medicines primarily contain complementary medicine ingredients, such as herbal materials or vitamins. They might also be intended for use in more serious conditions. As such, they can include a ‘TGA assessed claim’ mark on their label and advertising following their successful efficacy assessment. Examples of these products include high-dose iron supplements and fibre supplements. 

Ensuring product integrity when importing temperature-sensitive products into Australia

For pharmaceuticals and health supplements that need to be stored in specific temperatures, it’s important to maintain the cold chain throughout the shipping journey. From packaging and handling to import documentation and compliance, each aspect plays a crucial role in maintaining the safety and efficacy of temperature-sensitive products

Proper packaging and handling are essential to ensure that the products remain at the right temperature during transit. Here are several best practices to help your products arrive in optimal condition:

  • Use insulated containers: These high-quality containers are designed for cold chain transportation, providing a thermal barrier to protect products from external temperature fluctuations.
  • Include gel packs or Phase Change Materials (PCMs) in packages: These thermal packs absorb and release heat, helping to keep the package’s internal temperature stable. The required temperature range and transit time for your shipment will determine the type and quantity of coolants necessary.
  • Track temperatures: By placing data loggers inside the packaging, you can continuously monitor its temperature conditions during transit. This information can provide valuable insights into potential temperature deviations, as well as enable handlers to adjust temperatures if necessary.
  • Ensure packaging is secure: Using robust and secure packaging materials helps to protect your products from physical damage during handling and transportation. For parcels containing more fragile items, such as glass bottles, you can consider reinforcing the edges and corners of the box for added protection.

Customs clearance and documentation for pharmaceutical products 

Aside from packaging, accurate and complete documentation is paramount when importing into Australia. Ensure that your customs clearance documents are free of errors or omissions to avoid delays, product seizures, or fines. Doing so can also minimise transit times for temperature-sensitive goods. Here's a checklist of essential documents for importing health supplements and pharmaceutical products into Australia:

  • Commercial invoice: This invoice provides details of the transaction, including product descriptions, quantities, and value. It's used to determine customs duties and taxes when importing into Australia.
  • Packing list: This list outlines the contents of each shipment, specifying the number of packages, their weight, and dimensions.
  • Certificate of analysis: This certificate provides details of the product's composition and quality, ensuring it meets Australian import standards.
  • Bill of lading: This document serves as a contract between the shipper and the carrier, detailing the terms of transportation.
  • Import permit: An import permit may be required for certain therapeutic goods, particularly those classified as higher risk.

If you’re shipping from a country that has a preferential trade agreement with Australia, you might also be eligible for certain tariff concessions. Consulting with a customs broker or freight forwarder can help you ensure compliance with customs regulations and pay the right tariffs and duties.

The importance of reliable logistics partners when shipping supplements to Australia

Shipping pharmaceuticals and health supplements to Australia requires careful planning and execution. As these products may need to be stored and shipped at specific temperatures, they would also require specialised handling and swift deliveries to maintain their quality and efficacy. Partnering with an experienced and reliable global logistics provider can simplify this process significantly.

A reliable global logistics partner can handle the entire import process, from shipment preparation to customs clearance and last-mile delivery. They can provide valuable guidance on documentation, labelling requirements, and customs regulations, ensuring your shipments comply with Australian standards. Additionally, they can offer specialised services to ensure the products remain in optimal condition throughout the journey. 

By leveraging the expertise and resources of a trusted logistics provider, such as DHL Express, you can streamline your import operations, reduce risks, and improve business efficiency in the Australian market. 

Streamline your import process with DHL Express

A DHL employee opens a yellow box of imported pharmaceutical products next to a female customer working in health services.

With a comprehensive suite of international shipping solutions tailored to the needs of businesses in the health and wellness industry, DHL Express Australia can help you achieve a smoother shipping experience. Our global network and proven track record make us a trusted partner for businesses looking to enter the Australian market. 

Open a business account with DHL Express Australia today and leverage our expertise to streamline your import process.