Permit applications for releasing out of specifications batches
The term out-of-specification (OOS) includes all test results that fall outside the specifications or acceptance criteria established at the time of registration of the product or during the approval of a permit. The OOS permit evaluation process relates to a specific batch or serial number of a vaccine.
An OOS application should normally be lodged as an Item 23 – miscellaneous permit application. However, in some circumstances, an OOS application may be lodged as an emergency permit application – item 22 with appropriate scientific justification. The applicant should undertake a benefit-risk assessment to justify the basis for the release of an OOS batch. This particularly applies where there is a vaccine registered for the same disease/condition already on the market. Applications for releasing OOS batches will only be considered in exceptional circumstances where there is an urgent health and welfare issue and where registered vaccines that are within specification are not expected to meet the market demand. Applications made on purely commercial grounds will not be considered.
Approval time for out-of-specifications applications
The time taken for the APVMA to complete an evaluation of an OOS permit application can vary from 2 to 8 months depending on the technical assessment module(s) and the complexities of the data required.
Further information on the appropriate modules and time frames can be found on the before you apply for a permit web page. Where there is an urgent request for an OOS batch due to animal health and welfare issues, the APVMA will prioritise this. This guidance document outlines the data requirements for the assessment of OOS vaccine permit applications. The data requirements for this type of application are product- and batch-specific. The guidance provides specific examples and associated technical requirements that would facilitate the issuing of a permit with minimal technical assessment whilst ensuring the quality, safety, and efficacy of the vaccines.
Out-of-specification guidance coverage
This guidance covers conventional classes of veterinary vaccines. For example, live/inactivated vaccines; subunit or toxoids vaccines; live recombinants; and peptide vaccines. For other immunobiologicals, including monoclonal antibodies, applicants are advised to contact the Permits Teams via email enquiries@apvma.gov.au before submitting an OOS permit application.