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:
Veterinary Vaccine Charging Guidelines 
PDF [43kb]
Veterinary Vaccine Charging Guidelines 
Word [77kb]
Applications to import new veterinary vaccines
AQIS requires a considerable amount of information for new vaccine applications in order to carry out a detailed 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 further information on the vaccine policies, information required and how to present this information to AQIS for assessment contact the AQIS Biologicals Imports Program.
Applications to import veterinary vaccines that have previously been fully assessed (renewals)
AQIS import permits for inactivated vaccines are normally valid for two years. Before the 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. An exception is made for some live cat and dog vaccines where AQIS may issue a non-batch specific permit for two years.
AQIS requests that importers complete and submit a Declaration Regarding Information Required for Re-assessment of Veterinary Vaccines. This will assist AQIS assessors to complete the assessment within a reasonable timeframe.
Information Required for Re-assessment of Veterinary Vaccines PDF [50kb]
Information Required for Re-assessment of Veterinary Vaccines Word [97kb]
In order 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 in order 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 accepted code of GMP
- 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 specification (or equivalent Quality Assurance) documents have been made.
AQIS reserves the right to undertake a full risk assessment using complete dossiers detailing compliance with the relevant policy requirements at all stages from production of master seeds to final product with every application.
Live cat and dog vaccines
Live viral and bacterial cat and dog vaccines, with a history of importation into Australia, can be issued with non-batch specific, two year import permits providing that:
- the vaccine has been imported on a batch-by-batch basis for at least two years or five or more batches
- the importer can demonstrate that the method of manufacture, media sourcing, media testing, media treatment and end product testing have remained the same for this period
- AQIS has the confidence that the manufacturer operates according to the requirements of an accepted Quality Management System (QMS).
During this period there will have been no breakdowns in any aspect of the QMS. It is the importer's responsibility to satisfy AQIS of importation and use history of the product.