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Requirements for the authorisation of Hendra Virus vaccine in horses

First published 7 July 2011

The APVMA is aware of the Hendra vaccine development project for horses and recognises the benefits that a safe and effective horse vaccine could provide.

The APVMA has yet to receive an application to assess and authorise the supply and use of such a vaccine in horses in Australia.

Should a vaccine be developed to the point where it can be supplied for use, application can be made to the APVMA for a permit or product registration.

The APVMA can also issue an Emergency Use Permit to allow supply and use of the vaccine in Australia. Applications for these permits are subject to the same criteria as for registration. Essentially these are:

  • the demonstration that the chemical product and its proposed use is safe for people, animals and the environment;
  • will not affect our international trade; and
  • is effective.

Taking into account that the use may be small, for a limited duration or only being undertaken by certain qualified persons, the assessment and data required for an emergency use permit is tailored to the risks associated with the proposed use. The APVMA also consults with the relevant state or territory government authorities when assessing an emergency use permit.

Emergency use permit applications are exempt from the payment of a fee. The APVMA assigns such applications a high priority to ensure response is as rapid as possible, provided it has all the information required in support of the application.

More information on the national approach to managing the Hendra Virus is available from the Department of Agriculture Fisheries and Forestry website.

Contact

Dr John Owusu
Principal Evaluator
Australian Pesticides and Veterinary Medicines Authority

Ph: +61 2 6210 4730
Email: john.owusu@apvma.gov.au

Last updated on 1 August, 2011
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