This content is current only at the time of printing. This document was printed on 30 March 2017. A current copy is located at http://apvma.gov.au/node/656
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Satisfying the statutory criteria
You must indicate in your application how you expect us to be satisfied that the statutory criteria relevant to your application have been addressed by using one, or a combination, of the methods below:
- providing relevant data
- providing a valid scientific argument
- submitting previously provided reports from the APVMA
- using overseas data assessments and decisions
- providing evidence of GMP compliance for veterinary chemical manufacture.
Testimonials or anecdotal evidence on their own are not acceptable methods of satisfying the statutory criteria and are generally given little weight but may be used as additional supporting information.
Providing relevant data
You may choose to provide data to satisfy us of one or more of the statutory criteria (safety criteria, trade criteria, and efficacy criteria) in relation to determining a permit application. You are encouraged to review the specific regulatory guidelines page for guidance as to the sorts of information that may be submitted.
Providing a valid scientific argument
You may choose to provide a valid scientific argument to satisfy us of one or more of the statutory criteria (safety criteria, trade criteria, and efficacy criteria) in relation to determining a permit application.
A valid scientific argument may be supported by published information provided in the dossier. For example, an applicant may choose to address the efficacy criteria by providing efficacy studies that were generated overseas using the same product formulation on the same or similar target species proposed in Australia. Alternatively, you may provide valid scientific argument as to why data generated in Australia was not provided. For example, the scientific argument could consist of the following text:
The applicant considers that data generated under Australian conditions should not be required as the product is for use in companion animals only, the product is to be used in the same way as it is used overseas, and there are no environmental differences between Australia and the overseas country that would be relevant to the efficacy of the product. z
Submitting previously provided reports from the APVMA
You may choose to provide a report from us demonstrating that you have previously provided data that satisfied the APVMA of one or more of the statutory criteria (safety criteria, trade criteria, and efficacy criteria) in relation to the determination (whether positive or negative) of a previously submitted application. The data provided would include use of the same product formulation on the same or similar target species.
In providing a previous report, you should also demonstrate that the data remains valid in relation to determining the application.
For example, an application for a product registration was refused because we could not be satisfied with the residues aspects of the product (related to the safety criteria); however, we were satisfied that the product would be safe and effective to the target animal/crop when used in accordance with the approved instructions. You submit a fresh application with new data to satisfy us of the residues aspects of the safety criteria. To satisfy the target animal/crop efficacy and safety criteria, you provide and reference the previously provided efficacy and safety report, indicating that the formulation and instructions for use of the chemical product are unchanged and therefore the findings of the report are still valid.
Using overseas data assessments and decisions
You may choose to submit data generated overseas to support your application for a permit. In assessing overseas data, we may take into account the results of any trials or experiments already carried out in a foreign country or any decisions or evaluations made by regulators of agricultural or veterinary chemicals in a foreign country. However, we will consider other matters as we think appropriate when assessing overseas data, including but not limited to:
- any significant differences in the use of the constituent or product in Australia and in the foreign country
- any different environmental factors, or agricultural practices affecting the use of the constituent or product in Australia and in the foreign country
- any significant additional information relating to the properties of the constituent or product that has become available since the conduct of those experiments or trials
- any significant differences between the way that evaluations are made in Australia and how they are conducted by the overseas regulatory authority.
Providing evidence of GMP compliance when applying for a manufacturing permit
Manufacturers applying for a manufacturing permit should provide objective evidence that the proposed activities would be undertaken in compliance with the Manufacturing Principles and the GMP Code as well as any conditions that relate to the issue of such a permit. Depending on any exceptional circumstances that may apply, evidence could be in various forms including, but not limited to, an APVMA licence or an audit report from an APVMA-authorised auditor.