4 April 2024
This Animal Biosecurity Advice notice announces the publication of the Issues Paper ‘Review of the biosecurity risks associated with veterinary immunobiologicals’. The department is undertaking this review with the intention of publishing new import policies for veterinary immunobiologicals, including vaccines.
The department invites stakeholders to put forward preliminary submissions in anticipation of the review. Interested stakeholders should provide submissions by close of business Thursday, 6 June 2024.
The Issues Paper is available for review and comment on our Have Your Say website haveyoursay.agriculture.gov.au.
The Department of Agriculture, Fisheries and Forestry (the department) regulates imports of veterinary immunobiologicals into Australia. Immunobiologicals include:
- Antigenic substances (e.g., vaccines and toxoids)
- Antibody-containing preparations (e.g., globulins and antitoxins) from human or animal donors
- Recombinantly derived immunoglobulins, and
- Nucleic acids that are translated in vivo into antigenic substances.
Current biosecurity import policies for inactivated and live veterinary vaccines were published in December 1997 and November 1999 respectively.
The department is conducting a review of the biosecurity risks associated with importing veterinary immunobiologicals into Australia from all countries. An outcome of this review will be the publication of new policy which establishes import conditions that are aligned with the contemporary biosecurity risk profile of veterinary immunobiologicals.
The review will consider new and relevant peer-reviewed scientific information, international standards, relevant changes in industry practices and operational practicalities.
An Issues Paper on this topic is now available for stakeholder review on our Have Your Say page.
The Issues Paper gives stakeholders an opportunity to put forward preliminary submissions to the department in anticipation of the policy review. The following is a list of questions that respondents may wish to consider as part of their submission to the department:
- What has been your experience in working with the department on importing veterinary immunobiologicals into Australia?
- Australia’s biosecurity policies impact the availability of veterinary immunobiological products in Australia. Are there products marketed offshore that would be useful to you that are not currently available in Australia?
- How can the department’s biosecurity policies better support Australia’s immunobiological production sector?
- As a domestic producer of veterinary immunobiologicals, what challenges do you face when importing biological goods that are produced offshore?
- What new manufacturing technologies for veterinary immunobiologicals need to be recognised in Australia’s biosecurity policies?
- As a manufacturer of immunobiologicals, what production standards are relevant to the biosecurity risks posed by the importation of veterinary immunobiologicals.
- Are there any pathogen species associated with imports of veterinary immunobiologicals that have not been listed by the department in ‘Attachment A – Hazard Identification’ of the Issues Paper?
- What changes have you seen in demand for immunobiological products in Australia or overseas? What are the drivers for this change in demand?
Submissions should be received by close of business Thursday, 6 June 2024 through the Have Your Say page at haveyoursay.agriculture.gov.au
To receive information and updates on biosecurity risk analyses subscribe to Biosecurity Risk Analysis Animal at subscribe.agriculture.gov.au/subscribe. Subscribers will receive biosecurity advice notices and other notifications about animal biosecurity policy.
Dr Peter Finnin
Assistant Secretary Animal Biosecurity
Email: animalbiosecurity@aff.gov.au