Exporting an Australian-made supplement: export-only listings and TGA certificates

The same medicine, exported

A medicine listed or registered for sale in Australia is already permitted for export, without a separate ARTG entry, as long as:

• the exporter is the person the medicine is entered for, generally its sponsor, or an agent authorised to act for it in the export; and
• the medicine is unchanged from the one authorised for supply in Australia.

Any change to it, including one made for export, must generally be approved by the TGA before export. To sell it overseas under another name, the sponsor submits a grouping application to add the export name, and the ARTG number stays the same. More on who the sponsor is in our TGA sponsor guide.

An export-only medicine

In the Act, an "export only medicine" is one made in Australia, or imported, for export only, and listable only for that reason. It must be listed on the ARTG and "cannot be supplied in Australia, including Australian duty free outlets". The TGA assesses every application manually, against the listing criteria in section 26 of the Act, for safety and quality, and it aims to process one in 30 working days. What differs from a listing for Australia:

• The label. TGO 116, the labelling order for non-prescription medicines in Australia, doesn't apply to an export-only medicine, and one in its final dosage form can be exported in bulk to be packed and labelled overseas. The TGA still assesses its presentation, and won't approve one that is misleading, confusing or false.
• The standard. Under TGO 114, in force since 30 September 2024, an export-only medicine must meet the monographs of at least one of the British, European, Japanese or United States pharmacopoeias. Where it isn't regulated as a medicine in the country it is going to, it must also meet that country's requirements: if the destination treats it as a food, its food rules.
• The ingredients and claims. Every ingredient needs an Australian Approved Name, and the sponsor must hold evidence for any therapeutic claim. It needn't be a medicine that could be listed for sale here: under the Act, it is listable only because it is made or imported for export.
• Made here, at least in part. At least one step of its manufacture must take place in Australia.
• The importing country's say. An export-only medicine that is new to the importing country may need confirmation that the country will accept it.

Manufacturing for export

Making a medicine in Australia for export takes the same TGA manufacturing licence as making it for sale here, unless the step is exempt, and an export-only medicine must be made to GMP under the TGA's manufacturing principles. The licence has its own fees, paid by the licence holder: $1,003 to apply in 2026–27, plus an annual charge and inspection fees. A licensed manufacturer can ask the TGA for a certificate of GMP compliance, which isn't issued automatically after an inspection: $221 in 2026–27, or $407 for a certificate under a mutual recognition agreement with Canada, the EU, Iceland, Liechtenstein, Norway, Singapore or the UK. It is signed electronically and emailed. More in our manufacturing page.

The TGA's export certificates

"Export certification is not a requirement of the Australian Government", the TGA says, but an importing country may ask for it, as Vietnam does for supplements that are medicines here. The TGA issues four kinds for medicines; for a supplement, two matter:

Certificate	What it says	Fee, 2026–27
Certificate of Pharmaceutical Product (CPP)	Issued under the WHO Certification Scheme: the product's regulatory status in Australia, and that its manufacture conforms to GMP as the WHO recommends. There is a version for export-only medicines.	$221
Certificate of Listed Product (CLP)	Not a WHO certificate: for a single listed complementary medicine, noting that it can be legally supplied in Australia. The TGA says it is "widely accepted in international jurisdictions in place of a Certificate of Free Sale".	$221

• Who applies. The person the medicine is entered for, generally the sponsor, or an agent it authorises, through TGA Business Services. The TGA confirms GMP as part of a CPP application.
• How long. The TGA starts once the invoice is paid, aims to process an application in about 15 working days, and posts the certificate by Express Post.
• What it won't certify. The TGA's certificate of free sale is only for medical devices, not listed or registered medicines, and it doesn't certify kits of several products.
• Vietnam. For products Vietnam regulates as health, dietary or food supplements, a CLP has extra requirements, and the TGA can't advise which product category to put on it.

Export fees for 2026–27

Fee	Amount
New export-only listing	$1,063
Grouping application for an existing export-only listing	$1,063
Varying an export-only listing	$537
Certificate of Pharmaceutical Product, or Certificate of Listed Product	$221 each
Certificate of GMP compliance	$221, or $407 under a mutual recognition agreement

An export-only listing pays no annual charge: the listed medicine's annual charge applies to goods "other than goods produced for export". For a medicine listed for sale in Australia, the annual charge and the other fees in our TGA listing guide still apply.

What the importing country decides

An Australian listing doesn't decide what a supplement can be sold as overseas. The TGA tells exporters to "contact the relevant Embassy, High Commission or Consulate of the importing country" to make sure they meet its requirements, and a product treated there as a food must meet its food rules.

Austrade's report on complementary medicines in China (2022) describes two routes there: a product filing or registration under China's "blue hat" system, or cross-border e-commerce, which sells online direct to consumers only and needs no formal product registration for products on its whitelist, and no entity in China. Austrade called cross-border e-commerce "the most realistic way for many international brands to enter the market", and said firms should check that their products' HS codes are whitelisted first. Rules move, too: an Austrade article in May 2026 reported that Vietnam had introduced stricter rules for registering, testing and importing food supplements.

If the supplement is a food

Australian export law generally doesn't regulate a supplement sold as a food: the Department of Agriculture, Fisheries and Forestry lists nutritional supplements among its examples of "non-prescribed goods", though organic goods are always prescribed, and the department says confirming that goods are non-prescribed "can be complex". The department is "only involved if it is a condition set by the importing country", and can issue government export documents or certificates when the importing country requires them. For a product that isn't a medicine in Australia, the TGA's guidance points to authorities such as the department, under its former name, or the Australian Chamber of Commerce and Industry for a certificate of free sale. Our food pathway covers when a supplement can be a food.

Where we come in

Export works best when it is planned at the brief. As our FAQ puts it: if export is in your plans, we design the formula for both markets from the start. Among our clients are brands that export: a sports and wellness brand selling into New Zealand, the UK and the UAE, and an established natural health company with export customers. More on listed medicines and manufacturing, or book a call.