Regional review
Australia
Australia regulates therapeutic goods through the TGA and industrial chemicals through AICIS, with the Poisons Standard determining scheduling for substances of concern. Biosecurity screening by the Department of Agriculture applies alongside customs and adds a step that many first-time exporters underestimate.
Sourcing considerations
A substance intended for therapeutic use generally requires a TGA pathway before it can be imported for supply, while industrial chemicals require an AICIS introduction category to be determined by the importer. Scheduled substances under the Poisons Standard may require state or territory authorisation in addition to federal clearance.
Documentation requirements
Buyers request a specification, batch COA, and an SDS prepared to the Australian code, together with a clear statement of intended use so the correct regulatory pathway can be identified. Biological or animal-derived components attract additional biosecurity documentation.
Import considerations
Long transit distances and biosecurity inspection mean consignments can be held for physical examination. Packaging cleanliness and accurate declaration of any biological content materially affect clearance time.
Shipping and transport
Air freight follows IATA; the length of the route makes validated cold-chain packaging and a temperature log at destination important rather than optional for sensitive material.
Questions buyers should ask
- What is the intended use and therefore the TGA or AICIS pathway?
- Is the substance scheduled in the Poisons Standard?
- Is the SDS prepared to the Australian code?
- Does the material contain any biological or animal-derived component?
- Who is the Australian importer and do they hold the required permits?