Alerts

The Animal and Biological Imports Branch (ABIB) is taking a more flexible approach when assigning validity periods to import permits for veterinary therapeutics, including veterinary vaccines. The decision regarding the permit validity period for these goods will form another outcome of the biosecurity risk assessment process.

Who does this alert affect:

Importers of veterinary therapeutics, including veterinary vaccines.

Background:

Historically the branch has issued most permits for these goods with a 2-year validity period as standard.

ABIB has continued the review of business practices relating to permit validity periods. A more flexible approach is now being adopted for veterinary medicines with permits potentially being issued that are active for a shorter or longer period of time.

ABIB biosecurity officers will take the following factors into consideration when making a decision regarding the validity period of a particular permit:

• Has the applicant presented evidence of a history of compliant importation and safe use of a particular product in Australia?
  

• Is there a level of certainty that conditions of manufacture related to biosecurity will not change over time e.g. a static list of ingredients of biological origin included in products exported to Australia?
  

• Does the overseas manufacturer have suitable controls in place to manage change? This must include processes for early notification of proposed changes to all affected stakeholders (including regulatory associates in the Australian market) and a requirement for formal endorsement from Australian regulatory associates before changes are implemented.
  

• Is the overseas manufacturer compliant with a code of Good Manufacturing Practice? Are veterinary medicines manufactured using strict formulae and established production methods? Are ingredients sourced from accredited suppliers and assessed against internal company quality specifications? Does the manufacturer maintain in-process controls which manage the risk of contamination of product throughout all stages of manufacture?
  

Consideration of all of these factors will feed into the assessment for validity period for permits issued for veterinary medicines.

The department has updated the Veterinary Therapeutics Production Questionnaire to facilitate the presentation of information outlined above by overseas manufacturers.

This modified ABIB assessment process has commenced and will be applied to permit applications received from 23 April 2020.

Further information:

Contact the Animal and Biological Imports Branch through the department’s Client Contact Group in Canberra on 1800 900 090 or imports@agriculture.gov.au.