This content is current only at the time of printing. This document was printed on 19 February 2019. A current copy is located at https://apvma.gov.au/node/170
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New or novel products are usually subject to a full assessment against all statutory criteria. In order to grant registration, the APVMA must be satisfied that the product meets the safety criteria, as well as the efficacy and trade criteria (where relevant). To register a new product, you must show us how the product meets the criteria.
If the product is of a type that we do not believe warrants a full assessment, our ‘modular’ assessment arrangements allow us to assess only those aspects that are necessary. The assessment fees and timeframes for modular assessments are in line with the regulatory effort needed and the regulatory risk posed by the product. This is also the case for applications associated with existing products.