- 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…
- <p>Previously known as 'data protection', 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…
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.
…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…
- 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…
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…
- <p>Completing the identification, applicant and agent sections of the online application.</p>
- <p>Using the e-label form, label content and e-label approval process.</p>
- <p>Checklist, fees and declaration.</p>
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…