Changes

The import conditions for clinical trial medicines has been reviewed.

The importer declaration has been changed:

• The statements required to be made by the importer have been condensed to address the specific import requirement.
• Clarification that the importer declaration does not have to be consignment specific, however it must clearly identify the goods being imported

Goods imported primarily for use in clinical trials may also be used under the Therapeutic Goods Administration Special Access Scheme.

Who does this notice affect:

Importers of Human therapeutics and medicines for use in clinical trials, Assessment services group, Inspections group, Client services group

Further information:

Please contact the Animal and Biological Imports Branch on 1800 900 090 or email imports@agriculture.gov.au.