This document explains the information needed to support an application to register an anthelmintic product under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997.

This document specifies the minimum study and reporting requirements for efficacy and host safety studies submitted in support of an application to register an antimicrobial agent preparation to be applied post- milking to disinfect teats, referred to in future as a teat disinfectant. The requirements also apply to applications to vary the conditions on a registered teat disinfectant.

Agricultural compounds and veterinary medicines are regulated by MPI under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997.

This document specifies the minimum requirements for chemistry (and related
manufacturing process requirements) submitted in support of an application to register
veterinary medicines, or to vary the conditions on registered trade name products
containing veterinary medicines. It also incorporates guidelines, which are intended to
provide more detailed information and guidance to applicants to assist them in complying
with the standard.

The purpose of this operational interpretation is to state the rules to be used when classifying
veterinary medicines in regard to:
• who can authorise them for purchase and use
• who can sell them
• who can use them.
This operational interpretation should be read in conjunction with Operational Interpretation 183:
Classification of veterinary medicines in regard to sale, purchase and use.

The following are guidelines for a documented system that you as a compounding veterinarian must have and must comply with when preparing a compounded veterinary preparation (CVP).

ACVM Registration Information Requirements (available on our website) specify the information that must be in an application to register a trade name product under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997. However, the requirements allow applicants to explain why, in particular cases, certain information should not be necessary or why some alternative information should allow the potential risks to be assessed.

Requirements for preparing and sending e-files for applications under the ACVM Act.

For certain new products, a comparable registered product exists. An applicant may
wish to apply for registration of a new product based on data already held by the ACVM
Group in support of a currently or previously registered product.

Estimated fees for ACVM regulatory assessment of veterinary medicines

International Regulatory Cooperation comes in many forms – from formal treaties to informal information exchanges, to simultaneous and joint reviews, and more. Collaboration with partner regulators in the pre-market and post-market context promotes harmonization of regulatory practices and standards, leverages resources, and facilitates timely access to safe and effective veterinary drugs. Veterinary drug regulators have for many years worked on harmonising requirements and systems, and on the development of internationally-recognised guidance through a number of international forums, such as VICH and CODEX. This important foundational work enables international collaboration in the review of veterinary drug submissions.

Under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997, all substances that are agricultural compounds must be registered unless exempted.

The Ministry of Agriculture and Foresty (MAF) has established a pathway whereby, under certain circumstances, it will consider the decisions of the Australian regulatory body, the Australian Pesticides and Veterinary Medicines Authority (APVMA), in lieu of data assessments to support an application for registration of veterinary medicines under section 21 of the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997. MAF has named this pathway ACVM Registration by Reference to APVMA Registration, shortened to registration by reference.

Special circumstances approval information requirements under section 8C of the ACVM Act.