• 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…

  • 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>

  • Labels

    <p>Using the e-label form, label content and e-label approval process.</p>

  • Submitting an application

    <p>Checklist, fees and declaration.</p>

  • Guide to completing an online application

    This guide will help you to prepare an application using the Australian Pesticides and Veterinary Medicines Authority's (APVMA) Online Services Portal.

    Completing an online application form is the final step in preparing an application for…

  • Final regulatory position: Consideration of the evidence for a formal reconsideration of glyphosate

    The APVMA chose to consider glyphosate for reconsideration following the publication of the IARC Monograph 112 in July 2015. Once a chemical has been nominated for reconsideration, the APVMA examines the new information to determine whether there are…