• Timeframes and fees for changing a holder or nominated agent

    The Australian Pesticides and Veterinary Medicines Authority (APVMA) will assess the application for changing a holder or nominated agent in accordance with APVMA legislation and determine the success of the application within one month of the…

  • Data guidelines

    Data guidelines provide applicants with guidance on what data and information to prepare and provide to support their application. For the Australian Pesticides and Veterinary Medicines Authority (APVMA) to grant approval or registration, we must be…

  • Bromoxynil Chemical Review

    Bromoxynil is the active constituent in a number of herbicide products commonly used to control a wide range of weeds in pastures and food and fodder crops.

  • Approach to managing confidential commercial information (CCI)

    Download the document – Approach to managing confidential commercial information (CCI) (PDF, 373 KB) | (DOC, 224 KB)

  • Novel products

    New or novel products are usually subject to a full assessment against all statutory criteria. In order to grant registration, the Australian Pesticides and Veterinary Medicines Authority (APVMA) must be satisfied that the product meets the safety…

  • Registration models

    A registration model is essentially a template for registration. Chemical products conforming to the model can be registered at reduced cost because we are already satisfied that they comply with the safety, efficacy and trade criteria.

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  • Ability to comply with conditions

    If the Australian Pesticides and Veterinary Medicines Authority (APVMA) is satisfied that an applicant will be unable to comply with any conditions that we think appropriate to apply to a permit, we must not issue the permit.

    For example, if…

  • Guideline on demonstrating efficacy and target animal safety of veterinary products for use in farmed finfish

    This guideline is adapted from the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for…

  • Efficacy experimental design and analysis

    Evidence provided in support of a proposed label claim for efficacy must demonstrate strong correlation between application of the product and the claim. Well-designed, well-conducted efficacy trials are critical to building your…

  • Oral electrolyte products for the treatment of horses in exercise

    Purpose

    The purpose of this guideline is to provide a template for the registration of a class of veterinary chemical products termed ‘orally applied dry-soluble-powder equine electrolyte products’, including parameters for:

    …