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Changes

Human therapeutics and medicines

Effective from 16 August 2019

A 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: