For registration, veterinary chemical products must be shown to be safe and effective when used in accordance with any approved directions for use. Product labels must adequately reflect these directions, including restraints, contraindications, precautions and side effects of the product where applicable.

Restraints are absolute limitations or restrictions placed on the use of the product, usually to manage a risk associated with the product related to human safety, public health or environmental protection.

Legislation

A registered chemical product can be marketed under more than one brand name. An application can be made for the approval of a label for a container for a registered chemical product under Schedule 6 Part 2 Item 10A of the Agvet Code Regulations.

A registered chemical product can be marketed under more than one product name. The approval of an additional marketing name is processed as an Item 10A. There is no technical assessment and no data is required. This application type can only be submitted by the holder of the existing product or their agent.

Registering a new product that is the same as a registered reference product is also known as a ‘repack’.

The new product must be the same formulation with the same ingredients as the reference product, be in the same containers and be manufactured by a manufacturer of the reference product. The use pattern, label claims and use instructions for the new product must be the same as those of the reference product. The legislated definition of 'the same' can be found in the legislation section of the application guidance provided below.

Schedule 6 of the Agvet Code Regulations provides statutory definitions of when a proposed product is similar or closely similar to a reference product. To determine the appropriate Item number, you need to first establish whether your product meets the statutory definition of similar or closely similar in relation to your nominated reference product.