Veterinary Vaccines

General requirements

All imports of veterinary vaccines require an AQIS import permit. A completed application form must be submitted to the AQIS Biological Imports Program with supporting documents. AQIS requests that dossiers of supporting documents are compiled and submitted in electronic and hard copy format. This will assist with searching, storage and retrieval of files and help to minimise turnaround times for permit assessments.

Fees

Fess apply—refer to the Veterinary Vaccine Charging Guidelines:

Applications to import new veterinary vaccines

To assess applications to import new veterinary vaccines AQIS requires a lot of information including significant detail on to 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 by AQIS includes:

  • registration and Good Manufacturing Practice (GMP) approvals issued to the manufacturing facility
  • details of the establishment of all master seeds
  • all production steps and ingredients used in the manufacture of the vaccine
  • testing used at all stages of vaccine manufacture 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 AQIS Biologicals Imports Program.

Applications to import veterinary vaccines that have been previously assessed by AQIS

AQIS import permits for inactivated vaccines are normally valid for two years. Before the two year permit expires an application must be submitted for a new import permit. This application will be subject to another AQIS assessment. Permits for live vaccines are issued for a specific batch and a new permit is required for each batch to be imported.

AQIS requires importers to complete and submit a Declaration Regarding Information Required for Reassessment of Veterinary Vaccines. This will assist AQIS assessors in completing the assessment within a reasonable timeframe.

To complete the Declaration applicants must contact the manufacturer to confirm that no changes have been made to any aspect of the vaccine manufacturing process since AQIS last issued an import permit for the vaccine. If changes have been made AQIS will require details of all changes to complete the assessment.

AQIS will also require documentation to confirm:

  • that the vaccine manufacturer has been licensed to manufacture the specific vaccine in the country of origin
  • that the vaccine manufacturer has current approval under an AQIS approved code of Good Manufacturing Practice
  • that no changes have been made to the Outline of Production (or equivalent Quality Assurance) document for the vaccine
  • that no changes to raw material specifications (or equivalent Quality Assurance) documents have been made.

AQIS may at any time require applicants to subject any vaccine product to a full risk assessment requiring complete dossiers detailing compliance with the relevant vaccine policies.

Last reviewed:
28 Oct 2011
Contact:
Email DAFF Biosecurity - Animal Import Operations Branch
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