Import and export
Import and export of controlled substances
Licences and permits are required to import and export certain narcotic drugs, psychotropic substances, precursor chemicals, antibiotics and androgenic/anabolic substances.
There are processes and controls that you need to be aware of when applying to import or export prohibited substances, and information for importers and exporters can be found at: Import and export of controlled substances.
Importing therapeutic goods
Most products for which therapeutic claims are made must be listed or registered in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia.
Exporting therapeutic goods
Safety and quality in medicines are not just a local matter. The increasing globalisation of trade means that our responsibilities continue beyond the limit of our territorial waters.
The Therapeutic Goods Act 1989 applies to both the supply of therapeutic goods in Australia and the export of therapeutic goods from Australia.
A key requirement of the legislation is that all therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG), including those that are exported.
There are processes and controls that you need to be aware of when applying to export therapeutic goods.
- Frequently asked questions about exporting therapeutic goods
- Exporting medicines
- Exporting medical devices
- Exporting blood, tissues & biologicals
Import/export of unapproved therapeutic goods for experimental purposes
Approval is required under sections 19(1)(b), 32CK(1) or 41HB(1) of the Therapeutic Goods Act 1989 to import unapproved clinical trial goods for subsequent export or to export unapproved clinical trial goods manufactured in Australia.
Import and export forms
- License and permit application forms and guidance (controlled substances)
Application forms and guidance relating to importing and exporting controlled substances
- Import/export of unapproved therapeutic goods for experimental purposes
Application form and guidance relating to obtaining approval to import/export unapproved clinical trial goods
- European Medical Device Directive - Essential requirements checklist
Checklist for exporting medical devices from Australia to Europe showing Essential Requirements - Annex I, 93/42/EEC as amended by Directive 2007/47/EC