Changes
Human therapeutics and medicines
Effective from 16 August 2019A review has been completed for the Human therapeutics and medicines BICON case which has resulted in changes to import conditions.
Who does this change notice affect:
Importers of Human therapeutics and medicines
Background:
The pathways (questions and answers) in the BICON case for this commodity type have been streamlined and simplified. Importers are asked to select one of the following options.
Personal use (commercially prepared and packaged)
Human derived materials (excluding antibodies and cell lines)
Containing approved ingredients only
TGA AUST R human therapeutics and medicines
Human therapeutics and medicines for use in a clinical trial (incl. accountability and disposal)
Therapeutics with ingredients of plant or mushroom origin only
Complementary medicines (including Chinese medicines) of animal origin
Other
Directions to alternative BICON cases that may be relevant have been included.
Standard permits have been developed for the following goods
TGA AUST R human therapeutics and medicines
Human therapeutics and medicines for use in a clinical trial (incl. accountability and disposal)
Standard permits are permits with established pre-assessed conditions. If the goods cannot meet the conditions or if the importer prefers to have product names listed on the import permit they will need to apply for a permit in the ‘Other’ pathway.
Complementary medicines (incl. Chinese medicines) of animal origin
This new pathway will contain a product questionnaire to provide importers with the information needed to be provided with an application for a non-standard permit.
Other
Addition of a product questionnaire to the ‘Other’ pathway to provide importers with the information needed to be provided with an application for a non-standard permit.
Further information:
Contact the Business and Review team on 1800 900 090 (prompt 1, then prompt 1 and ask for the ABIB Import Conditions Review section) or email at ABIBBusinessandReform@agriculture.gov.au
This Change applies to the following Cases: