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Alerts

Expansion of the CBIS onto multiple import pathways for human therapeutics and medicines

Effective from 28 March 2025

The department is expanding the Compliance-Based Intervention Scheme (CBIS) onto multiple document-controlled commodity import pathways.

Expansion of CBIS eligible tariffs for Australian registered (AUST R) human therapeutics and medicines:
CBIS previously expanded to include AUST R human therapeutics and medicines imported under tariff 3002.41.00.01 (human vaccines, IIAN 246-2024). Starting from 7 April 2025, CBIS will also cover AUST R human therapeutics and medicines lodged under tariffs 3002.12 or 3002.15.

Import pathway

Eligible tariff codes

Intervention measure

Australian registered (AUST R) human therapeutics and medicines (permit required)

3002.41.00.01
3002.12
3002.15

Documentation

Importers will still be required to import goods with a valid import permit and meet the import conditions. There are no changes to the import conditions.

Additional commodity import pathways onto the CBIS:
The department is adding two new document-controlled commodity import pathways onto the CBIS. This change is scheduled to take effect on 7 April 2025. CBIS will manage the document assessment rate of consignment lines at the time of importation. Only the tariff codes specified below will be eligible.

Import pathway

Eligible tariff codes

Intervention measure

Human derived materials (excluding antibodies, cell lines and human milk) for therapeutic use only

3002.12
3002.15

Documentation

Human therapeutics and medicines for use in clinical trials (including accountability and disposal) (permit required)

3002.12
3002.15

Documentation

Importers will still be required to import goods with a valid import permit where applicable. Importers must meet the import conditions. There are no changes to the import conditions.

If biosecurity risks change, or the CBIS is not operating as anticipated, the department may adjust the rate at which we conduct biosecurity document assessments to ensure safe trade while meeting Australia’s appropriate level of protection (ALOP).

Who does this alert affect:
All importers and their agents importing CBIS eligible commodities and any biosecurity operational staff clearing these goods.

Further information:
More information on the CBIS is available on the department's CBIS webpage.

Where products are eligible for CBIS, this will be specified in the relevant BICON case.

If you require further information, please email the CBIS program at CBIS@aff.gov.au. You are welcome to suggest a tariff for an eligible commodity import pathway to the CBIS program by email to CBIS@aff.gov.au. Alternatively, please contact Imports on 1800 900 090 or imports@aff.gov.au.

This Alert applies to the following Cases: