Data package required to register products

A comprehensive 'data package' must be submitted to the APVMA to register a new product, a new use or a major change in formulation.

Less data is required to register a product that is similar to an already registered product.

A data package must supply information which demonstrates that the product:

• will be effective for the all uses described on the proposed label;
• will be safe to humans, target and non-target species; and
• will not pose unacceptable risks to the environment or trade with other nations.

Technical information on the product's chemistry and manufacture, toxicology, metabolism and toxicokinetics, residues, efficacy, occupational health and safety and environmental effects must be provided. In addition, information on the potential implications for overseas trade of residues from the product or active constituent is required.

Read a summary of specific data requirements

Preparing data

All data submitted to support registration of chemical products must be derived according to accepted scientific principles to ensure that no biased, fallacious or unsubstantiated claims are made.

Laboratory studies must be conducted according to an accepted code of good laboratory practice and certification to this effect must be shown.

Trials should be conducted in accordance with the principles of an established scientific method. They should be replicated and treatments should be compared with untreated controls and with existing standard methods of treatment.

Procedures for preparing data to support an application are explained in guidelines and other publications.