4 November 2024
Who does this notice affect?
Importers and brokers of:
- Australian registered (AUST R) human therapeutics and medicines imported under tariff 3002.41.00.01 -- Vaccines for human medicine (AUST R human vaccines).
What has changed?
The department is expanding the Compliance Based Intervention Scheme (CBIS) onto document-controlled pathways, commencing with a trial on herbal tea bags (IIAN 236-2024) and AUST R human vaccines.
CBIS will manage the biosecurity document assessment rate of consignment lines of AUST R human therapeutics and medicines lodged under tariff 3002.41.00.01 -- Vaccines for human medicine (AUST R human vaccines) at the time of importation. This change is scheduled to take effect on 18 November 2024.
Only the following AUST R human vaccines are eligible:
- Imported with a valid import permit with permit conditions for AUST R registered human therapeutics and medicines;
- Imported under tariff 3002.41.00.01; and
- Correctly answers the biosecurity profile question: Are the goods fully finished human therapeutics and medicines with a TGA AUST R number, and accompanied by a valid import permit?
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.
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). Human vaccines that are not imported under these conditions, including human vaccines for use in clinical trials and other AUST R registered human therapeutics and medicines, are not eligible for the CBIS.
CBIS will expand to include AUST R human therapeutics and medicines lodged under tariffs 3002.12 and 3002.15 next year. Further information about this initiative will be communicated in early 2025.
What is the CBIS?
The 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 will the CBIS work for AUST R human vaccines?
AUST R human vaccines currently undergo a 100% mandatory biosecurity document assessment at the time of importation. The biosecurity document assessment process includes presentation of a valid import permit, and evidence of the product name, AUST R registration number, and evidence that the product requires no further processing or re-packaging.
AUST R human vaccines 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.
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
- meet import permit conditions for the goods.
AUST R human vaccines eligible for CBIS will still be required to meet other Australian regulatory requirements, including those imposed by the Therapeutic Goods Administration (TGA).
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 departments CBIS webpages:
Biosecurity import conditions are available on the department’s Biosecurity Import Conditions database (BICON).