This template is intended for use by APVMA External Scientific Reviewers only. It is to be completed using the the veterinary medicines technical report guidance material on our website.
Use the following guidance material to complete the veterinary medicines risk technical assessment report template.
The guidance material is intended for use by APVMA External Scientific Reviewers only.
A link to…
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has adopted guidelines developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) for generating…
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has adopted relevant international technical guidance materials within its data guidelines that should be used to generate data to satisfy the APVMA of legislative criteria for…
The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (also known as VICH) was officially launched in Paris in April 1996, as a cooperative effort between members of the regulatory…
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has updated Appendix B (aquatic species) of the Risk Assessment Manual for Environment and the associated higher tier methodology for assessment of runoff. The documents reflect…
- Introduction
Applicants seeking to register herbicides for use in Australian forests should submit efficacy data to support all label claims. This guideline is intended to provide advice on what data should be submitted for the…
Applicants planning and conducting efficacy and safety trials should consider how the trial data will be collected, documented and prepared for presentation to the APVMA to support an application to register or vary a product. This guideline provides…
- Introduction
All veterinary actives must be approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA) prior to their use in the manufacture of registered veterinary products, or be covered by an exemption from…