This content is current only at the time of printing. This document was printed on 11 September 2020. A current copy is located at http://www.xlg888.com/node/633
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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
- using a reference product
- providing a valid scientific argument
- submitting previously provided reports from the APVMA
- using overseas data assessments and decisions.
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 relevant data to satisfy us of one or more of the statutory criteria (safety criteria, trade criteria, and efficacy criteria) in order to determine the application. You are encouraged to review the specific?data guidelines?page for guidance as to the sorts of information that may be submitted.
Applications for veterinary chemical products must also ensure that the manufacturers who are performing any step of the manufacture of veterinary chemical products are required to either be licensed by the APVMA if manufacturing in Australia or provide recognised evidence of good manufacturing practice (GMP) if manufacturing overseas.
Using a reference product
You may choose to nominate a reference product to satisfy us of one or more of the statutory criteria (safety criteria, trade criteria, and efficacy criteria) in relation to determining the application. A reference product must be an agvet chemical product that is currently registered by the APVMA. If the registered product contains information where the use of that information is limited, you must obtain written consent from the authorising party for us to access that information. This not only applies to information subject to a limitations of use period, but also to confidential commercial information.
For example, to address the safety criteria related to human health for a companion animal product, you may nominate a registered reference product which contains the same active constituent at the same concentration and is registered for use in the same species as is indicated for the proposed product. However consent to access any confidential commercial information must be provided with your application if you are not the holder of the reference product.
Providing a valid scientific argument
You may choose to provide a scientific argument to satisfy us of one or more of the statutory criteria (safety criteria, trade criteria, and efficacy criteria) in relation to determining the 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. Or 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.?
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.
In providing a previous report, you should also demonstrate that the data remains valid in relation to determining the application, as science may have progressed since the data was last assessed.
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 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 approval, registration or variation. 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:
- the similarities between the product registered in the foreign country and the product proposed for registration in Australia, including formulation
- 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.