I want to export medicines, blood, human tissue or related materials - do I need an export permit?
Generally speaking, any medicine which is being
exported for commercial purposes must be either:
- listed in the ARTG (Australian Register of
Therapeutic Goods) for export only;
- listed or registered in the ARTG for supply in
Australia; or
- have been granted an exemption by the TGA from the
need to be in the ARTG under Section 19 of the
Therapeutic Goods Act 1989 (the Act), for example,
goods for experimental uses.
Anyone who is intending to export a medicine from
Australia for commercial supply which is not included
in the Australian Register of Therapeutic Goods (ARTG),
with the name of the exporter as the sponsor, can
either:
-
Submit an application to include the goods in the
ARTG prior to export as the sponsor of the goods; or
- Arrange the exportation of the goods on behalf of the
sponsor who already has the medicines included in the
ARTG.
The exportation from Australia of human blood, organs
and substances derived from human blood is prohibited,
unless:
-
approval is obtained in writing from the Secretary of
the Australian Government Department of Health and
Ageing and such approval is produced to the Collector
of Customs; or
- the goods are exempt from the above requirement.
For more information visit the Therapeutic Goods Administration Import and Export page.
For more advice on exporting sees Austrade's Guide to Exporting and market / industry profiles including aged care, health and medical.