The legislative basis for the APVMA’s role in manufacturing quality and licensing

The Agvet Code requires that all chemical products manufactured in Australia are manufactured in compliance with their registered particulars and any with applicable standards. The Agvet Code also requires products to be manufactured in premises licensed by the APVMA, unless exempt. The Agvet Code allows the APVMA to issue licences to Australian manufacturers of veterinary chemical products.

For imported veterinary chemical products, it is the responsibility of the registration holder to ensure the products are not supplied unless they have been manufactured to a standard equivalent to the APVMA’s Manufacturing Principles and GMP Code. Evidence of compliance must be provided to us on request.

This means both Australian and overseas manufacturers are required to maintain the same standards of GMP compliance.

Manufacturing Principles

The Agricultural and Veterinary Chemicals (Manufacturing Principles) Determination 2014 defines the basic principles that manufacturers of veterinary chemical products must comply with to obtain and to retain a manufacturing licence.

If the APVMA believes that a prospective licence holder will be unable to comply with the Manufacturing Principles, we must not issue a licence to that person.

Australian Code of Good Manufacturing Practice for Veterinary Chemical Products 2007 (the GMP Code)

The GMP Code applies to all types of veterinary chemical products and to all types of manufacturing premises that produce or are involved in any step in the manufacture of such products.

Elements in the GMP Code provide guidance on the standards of practice necessary to satisfy the relevant Manufacturing Principle. Alternative practices may be acceptable, provided they satisfy the requirements in the Manufacturing Principles.

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