Before exporting alternative medicine, a supplier must be the ARTG sponsor or an authorised agent. The exported medicine generally must be included in the ARTG, either as a standard registered or listed product or under a dedicated Export Only listing.
In other words, even if a product will not be sold domestically, it must still be entered in the ARTG first. Exemptions, such as those for certain homeopathic or low-risk goods, are very limited. Any export violation may result in criminal or civil penalties under the Act.
In addition to TGA requirements, exporters must comply with other Australian laws, including Customs, Corporations, the ND Act and Biosecurity regulations, and should also confirm import requirements in the destination country.
When a medicine is supplied in Australia and exported, sponsors can export it automatically with a standard ARTG entry. However, it must meet all domestic regulatory conditions. In contrast, products made solely for export must follow the TGA’s special pathways.
Suppliers can list an “Export Only” medicine under section 26 of the Act. Alternatively, they may use the “Solely for Export” listing under section 26A via the TGA Business Services portal. Importantly, these export-only listings cannot be sold in the Australian market.
To proceed, sponsors must submit a complete dossier, including product specifications, labels, and formulation details. Additionally, the product must comply with Australian quality and safety standards. In practice, each export-only product must be clearly and separately identified.
Therefore, any change in formulation, strength, dosage form, directions, or name requires a new ARTG entry.
Key checklist: Ensure you have a current TGA sponsor ID; prepare complete application files (specifications, product information, labels) via the Export Electronic Lodgement system; and pay any fees. Incomplete applications will be rejected or delayed.
All medicines exported from Australia, including alternatives and supplements, must meet high-quality standards. By law, export-only goods must comply with Good Manufacturing Practice equivalent to Australian standards.
In practice, Australian manufacturers must hold a current TGA manufacturing licence. Meanwhile, overseas manufacturers in the supply chain must have a TGA GMP clearance issued to the sponsor.
Additionally, at least one manufacturing step, such as final formulation or packaging, must occur in Australia.
Exporters should prepare the correct documents to build confidence with overseas regulators. First, the TGA issues certificates under the WHO Pharmaceutical Products scheme to confirm product quality. Common examples include the Certificate of Pharmaceutical Product for registered medicines and the Certificate of Listed Product for listed complementary medicines.
A Certificate of Pharmaceutical Product confirms TGA approval and GMP compliance. Similarly, a Certificate of Listed Product verifies that the item is a listed complementary medicine. In effect, this acts as a free-sale certificate.
These certificates are often required by import authorities to confirm that the product is authorised and safe. Importantly, kits or multi-product sets require separate certificates for each item. In addition, exporters must prepare supporting documents for each shipment.
These include a commercial invoice, packing list, and any required import permits for the destination country. Furthermore, some countries require a TGA statement or a free-sale certificate from an Australian authority.
For example, exporters of non-ARTG dietary supplements may obtain a Certificate of Free Sale through the Australian Chamber of Commerce.
Therefore, always check the specific documentation requirements of each destination market. For instance, Vietnam requires a TGA CLP along with a sponsor’s statement for supplements.
Alternative medicine may be regulated as both a therapeutic good and a narcotic drug, requiring dual approvals. In addition to TGA listing, exporters of cannabis products must obtain an export licence and permit from the Office of Drug Control.
This requirement applies under the Customs (Prohibited Exports) Regulations. Furthermore, any controlled substance, whether narcotic or psychotropic, triggers this obligation. Importantly, the Office of Drug Control will only grant an export licence if specific conditions are met.
For instance, the exporter must hold the appropriate cultivation or production licence. Additionally, they must demonstrate that the domestic patient supply remains secure and uninterrupted.
Process: First, enter the cannabis product in the ARTG (as registered or export-only) under the Therapeutic Goods Act. Second, apply to ODC for a narcotic export licence and permit. You must provide the importing country’s written consent for the shipment. Suppliers should ensure that exports conform to Therapeutic Goods Order No. 93 (Medicinal Cannabis) and to any conditions of their manufacturing licence (ODC checks that exports won’t deprive Australian patients of supply).
Finally, Australian exporters must ensure product information and claims align with each target market. Product names, ingredient lists, and dosage instructions should match the TGA-approved details.
Be aware that a remedy classified as a medicine in Australia may be regulated as a health supplement or food overseas. Even in those cases, the product must be accompanied by the appropriate certifications.
For example, a Certificate of Listed Product is often accepted as a free-sale certificate for dietary supplements in Asia. Sponsors are responsible for pharmacovigilance and must report adverse events as required by law.
In summary, following the alternative medicine export pathway requires meeting all local standards, including ARTG listing, GMP compliance, and correct labelling, while also adhering to foreign regulations such as import permits and local requirements.
Proper preparation and thorough documentation reduce delays and build confidence in your products across international markets. Using a centralised product intelligence platform like The Compendium helps Australian suppliers maintain consistent, accurate data.
Its knowledge base provides up-to-date product details, including formulations, approved indications, and product names, ensuring labelling and documentation remain accurate across jurisdictions. By cross-referencing products in The Compendium, suppliers ensure every market receives the same evidence-based information.
Explore The Compendium to strengthen your export compliance processes and simplify international expansion.
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