1 April 2025
Who does this notice affect?
Importers and brokers of:
- Human derived materials (excluding antibodies, cell lines and human milk) for therapeutic use only, imported under tariff 3002.12 or 3002.15.
- Human therapeutics and medicines for use in clinical trials (including accountability and disposal), imported under tariff 3002.12 or 3002.15.
- Australian registered (AUST R) human therapeutics and medicines, imported under tariff 3002.12 or 3002.15.
What has changed?
Expansion of Compliance Based Intervention Scheme (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 (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 |
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).
What if I import an eligible commodity import pathway 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.
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?
To qualify for risk-based intervention under CBIS, importers and brokers will need to:
- import an eligible commodity under an eligible tariff
- answer the new profile questions outlined below accurately
- lodge the entry in line mode
- hold a valid import permit
- meet import permit conditions for the goods.
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).
New community protection profile questions on tariffs 3002.12, 3002.15 and 3822.19
The following profile questions will take effect prior to 7 April 2025.
Customs brokers lodging declarations in the Integrated Cargo System (ICS) must answer ‘Y’ to these questions if the goods are to be imported via the commodity import pathways outlined in this notice and become eligible for CBIS.
If the goods are not imported by the commodity import pathway, then customs brokers must answer ‘N’. It is possible that all answers will be ‘N’.
| Tariff code | Profile question | YES response for BICON commodity import pathway and become eligible for CBIS |
|---|---|---|
| 3002.12 3002.15 | Biosecurity: Are the goods imported human fluids and tissues and for human therapeutic use only? This may include human organs, human blood or blood components, human nucleic acids, human fluids, human proteins, enzymes, human secretions, excretions or exudates (excluding milk), human semen, embryos or ova, human tissue extracts, or human tissue. | Human therapeutics — Therapeutic use — Human derived materials (excluding antibodies, cell lines and human milk) |
| Biosecurity: Are the goods human therapeutics and medicines for use in clinical trials (including accountability and disposal), and accompanied with a valid import permit? | Human therapeutics — Therapeutic use — Human therapeutics and medicines for use in clinical trials (including accountability and disposal) | |
| 3002.12 3002.15 3002.41.00.01 | Biosecurity: Are the goods fully finished human therapeutics and medicines with a TGA AUST R number, and accompanied by a valid import permit? | Human therapeutics — Therapeutic use — TGA AUST R human therapeutics and medicines |
Further information
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.
More information on CBIS is available on the department’s webpage Compliance-Based Intervention Scheme (CBIS).
Biosecurity import conditions are available on the department’s Biosecurity Import Conditions database (BICON).