Veterinary vaccines

​​​​​​General requirements

Importers must have an import permit issued by the Department of Agriculture, Fisheries and Forestry to bring veterinary vaccines into Australia. Import permit applications must be submitted to the department via the Biosecurity Import Conditions System (BICON), with all supporting documentation compiled in a dossier.

Fees

Details of fees payable for these Category 5 permit applications can be found on the Biosecurity cost recovery implementation statements page.

Applications to import new veterinary vaccines

The department requires a lot of information to assess applications to import veterinary vaccines, including significant detail on the vaccine manufacturing process. This information is required to carry out a detailed biosecurity risk assessment against the requirements of the relevant vaccine policies. Information required includes:​

• registration and good manufacturing practice approvals issued to the manufacturing facility
• details of the establishment of all master seeds
• all production steps and components used during manufacturing of the vaccine
• testing used at all stages of vaccine manufacturing, including testing of master seeds.

For inactivated veterinary vaccines applicants are required to review and comply with all requirements of the document:

For live veterinary vaccines applicants are required to review and comply with all requirements of the document:

For further information on any aspect of the import permit assessment process for veterinary vaccines please contact the Import Services Team.

Applications to import veterinary vaccines that have previously been assessed by the department

Import permits for inactivated vaccines are normally valid for three years. An application for a new import permit must be submitted before the existing permit expires. This application will be subjected to another assessment. Permits for live vaccines are usually issued for a specific batch and a new permit is required for each batch.

Manufacturers must complete and submit a Declaration regarding information required for reassessment of veterinary vaccines. This document will help the department’s assessing officers to complete the assessment within a reasonable timeframe.

Manufacturers must confirm that no changes have been made to any aspect of the vaccine manufacturing process since the department issued the last import permit for the vaccine. If changes have been made the department will require details of all changes to complete the assessment.

The department also requires documentation confirming that:

• the manufacturer has been licensed to manufacture the specific vaccine in the country of origin
• the manufacturer has current approval under a code of Good Manufacturing Practice that is acceptable to the department
• no changes have been made to the outline of production (or equivalent quality assurance document) for the vaccine
• no changes to raw material specifications (or equivalent quality assurance documents) have been made.

The department may at any time subject vaccine products to a full risk assessment requiring complete dossiers detailing compliance with the relevant vaccine policies.