Changes

From 7 April 2025, the CBIS manages the biosecurity document assessment rate for the following import pathways at the time of importation:

• Human derived materials (excluding antibodies, cell lines and human milk)
• Human therapeutics and medicines for use in clinical trials (including accountability and disposal)

Only the following consignment lines at the time of importation are eligible:

• Imported with a valid import permit with permit conditions;
• Imported under tariff 3002.12 or 3002.15; and
• Correctly answers the biosecurity profile questions.

CBIS previously expanded to include AUST R human therapeutics and medicines imported under tariff 3002.41.00.01 (human vaccines, IIAN 246-2024). From 7 April 2025, the department also expanded the tariff eligibility to include those lodged under tariff 3002.12 or 3002.15.

There are no changes to the import conditions. Importers will still be required to meet import conditions, including a valid import permit for human therapeutics for use in clinical trials and AUST R human therapeutics and medicines. Those import permits do not need to be varied to manage incoming consignment lines under CBIS.

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).

Other human therapeutics and medicines that are not imported under these conditions are not eligible for the CBIS.

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

What if I import eligible goods under a different tariff?
Currently only the above tariffs are eligible for the CBIS. You are welcome to suggest a tariff for an eligible commodity import pathway to the CBIS program by email to CBIS@aff.gov.au. The department will consider whether to expand tariff eligibility in the future. Any tariff expansions will be communicated through an Import Industry Advice Notice and the departments Biosecurity Import Conditions database (BICON).

What is the Compliance Based Intervention Scheme (CBIS)?
The Compliance-Based Intervention Scheme (CBIS) is a regulatory compliance tool designed to benefit importers who consistently meet Australia’s biosecurity requirements with reduced intervention. By demonstrating and maintaining good compliance with our import requirements, importers benefit from a more streamlined biosecurity clearance process at the Australian border and reduced regulatory costs.

How does the CBIS work for document-controlled commodity import pathways?
Document-controlled pathways currently undergo a 100% mandatory biosecurity document assessment at the time of importation. This includes presentation of an import permit where required for the commodity import pathway, and further documentation as specified within the import conditions.

Document-controlled pathways must continue to meet biosecurity import conditions, however the CBIS will reduce the % rate at which we conduct biosecurity document assessments based on the importers demonstrated compliance history for those goods.

Reduction in document assessment rates will not take effect immediately as importers will first need to build their compliance history in the CBIS system.

When eligible for a reduced biosecurity document assessment rate, brokers and importers will notice some consignment lines are not referred to the department for biosecurity assessment, and instead receive a clear status. Brokers and importers will also receive a notice from the department advising that the consignment lines have been released from biosecurity control under the CBIS.

The biosecurity document assessment rate will automatically increase back to 100% if non-compliance is detected. Any failures at initial document assessment (eg. missing, non-compliant or expired documentation) will be recorded as a non-compliance in CBIS. Importers will have to rebuild their compliance history again to requalify for a reduced rate of intervention.

What do I need to do?
Brokers will not need to lodge consignments any differently. To qualify for risk-based intervention under CBIS, importers and brokers will need to:

• import an eligible commodity under an eligible tariff
• answer the profile question accurately
• lodge the entry in line mode
• hold a valid import permit (for human therapeutics for use in clinical trials and AUST R human therapeutics and medicines)
• meet import conditions for the goods.

Please note that if you do not lodge consignments correctly then your entry will be ineligible for any benefits that the CBIS program has to offer.

Imported goods eligible for CBIS will still be required to meet other Australian regulatory requirements, such as those imposed by the Therapeutic Goods Administration (TGA).

Further information:
More information on CBIS is available on the Industry Import Advice Notice IIAN 98-2025 and department’s webpage.

If you require further information, please email the CBIS program on CBIS@aff.gov.au. Alternatively, please contact Imports on 1800 900 090 or imports@aff.gov.au.

Biosecurity import conditions are available on BICON.