Alerts

A review has been completed for the Human therapeutics and medicines BICON case which will result in changes to import conditions.

It was originally expected that the revised case would be published in May 2019. However, there have been some unexpected delays and the revised case is now expected to be published in BICON in mid-late June 2019.

Who does this alert affect:
Importers of human therapeutics and medicines

Background:
The pathways (questions and answers) in the new BICON case for this commodity type will be streamlined and simplified. The new case will ask users to select one of the following options.
1. Personal use (commercially prepared and packaged)

2. Human derived materials (excluding antibodies and cell lines)

3. Containing approved ingredients only

4. TGA AUST R human therapeutics and medicines

5. Human therapeutics and medicines for use in a clinical trial (incl. accountability and disposal)

6. Paramao Root oil for personal use

7. Complementary medicines (including Chinese medicines) of animal origin

8. Other

Importers will also be directed to alternative BICON cases that may be applicable to the goods they wish to import.

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 Import Conditions Review team on 1800 900 090 (prompt 1, then prompt 1 and ask for the ABIB Import Conditions Review section) or email at ABIABImportConditionsReview@agriculture.gov.au.