• Guideline for data to support efficacy of disinfectants for veterinary use

    Introduction

    Applicants seeking to register a disinfectant product for veterinary use should submit efficacy and safety data to support all label claims. This guideline is intended to provide advice on what data you should submit for…

  • Approval of active constituents for which information is not readily available - Veterinary

    The Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, normally requires the APVMA to be satisfied about a number of things before granting an approval…

  • Using PubCRIS

    <p>Search for details of registered, stopped, cancelled and archived products, and approved, suspended and archived active constituents.</p>

  • Overseas trade (Part 5B)

    Introduction

    The APVMA must be satisfied that a chemical product meets the trade criteria—that use of the chemical product according to the use pattern on the approved label would not unduly prejudice trade or commerce between Australia…

  • Statutory criteria

    We must grant an application for approval, registration or variation if we are satisfied that the statutory criteria, including the safety criteria, efficacy criteria, trade criteria and labelling criteria have been met. In addressing the criteria,…

  • Residues (Part 5A)

    When applying to register new veterinary chemical products to be used in or on food-producing animal species, in support of your application you should submit appropriate pharmacokinetic, residue kinetic and residues depletion data, or…

  • Analytical methodology for veterinary medicine residues

    This guideline is based on the International Co-operation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products guideline (VICH GL) 49, which was intended to provide a general description of the criteria that…

  • Labelling requirements in permit applications

    When assessing an application for a permit the labelling criteria is not applicable. However, when assessing a permit that may require a condition that the product only be supplied with a particular label for attachment to the container of…

  • Veterinary drug residues in food commodities and overseas trade

    The Agvet Code provides that before granting an application for a veterinary chemical product, the Australian Pesticides and Veterinary Medicines Authority (APVMA) must be satisfied that the chemical product meets the trade criteria. This means that…

  • Comparative metabolism studies, selection of marker residues and ratios of marker residues to total residues

    This guideline is based on the International Co-operation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products guidelines (VICH GLs) 46 and 47. These were intended to provide a general description…