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…
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…
- 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:
… - 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…
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…
- 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…
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,…
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…
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…
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…