• 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…

  • Other Australian Government requirements

    <p>Requirements of other regulators for certain types of applications, such as permits for biological imports, and compliance of labelling information with the Dangerous Goods Code.</p>

  • Globally harmonized system of classification and labelling

    GHS implications for agvet chemical products

    The work health and safety legislation requires that, from 1 January 2017, all agricultural and veterinary (agvet) chemical products be labelled in accordance with the Globally Harmonized System of…

  • Chemistry and manufacture of products (Part 2)

    This is a guideline about the types of information you can submit to address the safety criteria for veterinary chemical products. It also provides guidance on how the information might be presented and analysed, and should be considered…

  • Audits to obtain and vary a licence

    New applicants

    As part of the licence application approval process, if an audit is required the manufacturer must engage an Australian Pesticides and Veterinary Medicines Authority (APVMA)-authorised Good Manufacturing Practice (GMP) auditor to…

  • Efficacy standards for equine, porcine, canine, feline and poultry anthelmintics in Australia

    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…

  • Interchangeable Constituent Determination – Item 29

    From 1 July 2016, the Australian Pesticides and Veterinary Medicines Authority (APVMA) is able to determine that specific non-active constituents (excipients) may be substituted for one another without assessment. These determinations can apply to a…