Purpose of this manual
This manual provides stakeholders, including industry and the general public, with a general description of the APVMA’s approaches and practices for assessing efficacy and target animal safety. The APVMA evaluates these data when determining whether the statutory requirements for approving active constituents and registering veterinary medicine products have been met.
This manual provides more detail about the APVMA’s risk assessment approach. It complements information about the APVMA’s approach to the safeguarding aspects of our science, risk management and regulation according to risk.
Prospective applicants should read this manual in conjunction with the APVMA veterinary guidelines for efficacy and target animal safety.
The manual explains the regulatory framework for APVMA assessments, including the legislative requirements relating to efficacy and target animal safety. It describes the information and data that support risk assessment and analysis, the assessment of label claims, how the APVMA assesses data, and the use of international data in applications.
The manual also provides information about how we approach efficacy risk assessments, the data we require for various products and the risk assessments that we conduct to satisfy the statutory criteria.