• Recall guidelines

    This document contains information on the action/s required from the holder of a product registration and the Australian Pesticides and Veterinary Medicines Authority (APVMA) when an agricultural or veterinary (agvet) chemical product must be recalled…

  • Devices, equipment and physical barrier products

    Devices and equipment that are used to assist in veterinary medical or surgical procedures, are chemically inert and act by physical rather than biochemical means, and make no claim other than that arising from their physical action, generally do not…

  • Guideline for registering generic veterinary chemical products

    Introduction

    This document provides guidance for applicants proposing to register generic veterinary chemical products, including recommendations for when bioequivalence data should be submitted. The guidance may also be relevant for…

  • Limits on use and disclosure of information

    <p>Previously known as &#39;data protection&#39;, provides an explanation on the exceptions to these limits, use of information, eligibility information and limitation periods. Includes information on how to make an application, prepare a…

  • Overseas GMP documentation

    Registrants of veterinary chemical products where one or more steps of manufacture are conducted overseas need to provide certain types of documentation as evidence of overseas Good Manufacturing Practice (GMP) compliance.

    …

  • Adopted international technical guidance material – Agricultural

    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…

  • Toxicology (Part 3)

    Introduction

    This chapter sets out the guidelines for submitting toxicology data—or scientific argument in the absence of data—as part of applications for approval of new active constituents, registration of veterinary chemical products…

  • Additional data guidelines for chemistry and manufacture (Part 2)

    The Australian Pesticides and Veterinary Medicines Authority (APVMA) has adopted a number of VICH guidelines that outline the procedures recommended for generating relevant chemistry and manufacture data for your application.

    Applicants…

  • Primary and secondary applications

    Applicants sometimes apply to register or vary a suite of agricultural and veterinary (agvet) chemical products containing the same chemical in different concentrations. Examples include products with the same active constituent but different…

  • Identification, applicant and nominated agent details

    <p>Completing the identification, applicant and agent sections of the online application.</p>