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Veterinary Vaccines
General requirements
All imports of veterinary vaccines require an AQIS import permit. A completed application form must be submitted to the Biologicals Program with supporting documents. AQIS are now requesting that dossiers of supporting documents are compiled and submitted in electronic format, where possible, as well as hard copy. This will assist with searching, storage and retrieval of files and help to improve turnaround times for risk assessments.Fees
Fess apply- refer to the Veterinary Vaccine Charging Guidelines 
PDF [46kb] 
Word [76kb]
Applications to import new veterinary vaccines
AQIS requires a considerable amount of information for assessment of new vaccines in order to carry out a detailed risk assessment against the requirements of the relevant policies. Information required by AQIS includes;
- details of the manufacturing plant
- the master seeds
- all production steps and ingredients used in the manufacture of the vaccine.
For further information regarding the policies, the information required and how to present this information to AQIS for assessment contact Biologicals Program.
Applications to import veterinary vaccines that have previously been fully assessed and issued a permit (renewals)
AQIS Import Permits for inactivated vaccines are usually valid for two years after which an application for a new permit and a reassessment is required. Permits for live vaccines are issued for a specific batch and a new permit is required for each new batch to be imported. An exception is made for some live cat and dog vaccines and a non batch specific permit for two years is issued.
AQIS requests that importers complete and submit a Declaration Regarding Information Required for Re-assessment of Veterinary Vaccines. This will assist assessors to complete an assessment within a firm timeframe usually ten working days.
Information Required for Re-assessment of Veterinary Vaccines PDF [54kb] Word [94kb]
The following information should be checked with the manufacturer prior to completion and submission of the declaration:
- have any changes been made to the maufacture of the vaccines?
- confirm the testing of the media used during production of a batch, and
- confirm the end product testing for a batch.
- obtain a manufacturer's declaration that nothing has changed, or a recently signed and dated AQIS permit certificate.
- the manufacturer should confirm the identity of the master seed, all media used, the method of inactivation, and all end products testing for a batch.
- a current licence to manufacture this vaccine in the country of origin
- the manufacturer should provide most recent GMP licence
- an Outline of Production with a flow chart, or equivalent Quality Assurance document, to demonstrate the manufacture of the vaccine. Higlight any animal materials used in the manufacture of the vaccine, and
- current raw material specifications or equivalent Quality Assurance document for all ingredients of biologicals origin.
Live cat and dog vaccines
Live viral and bacterial cat and dog vaccines that have a history of importation can be issued with on-going two year Import Permits with the following conditions:
- 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, and
- AQIS has the confidence that the manufacturer has an adequate system of documentation.
