This content is current only at the time of printing. This document was printed on 8 September 2020. A current copy is located at http://www.gitygostar.com/taxonomy/term/18141
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I want to register a new product with an existing active or new combination of approved actives
Registering a new agvet chemical product containing an existing active may be assessed under:
- Item 10—New product—modular assessment.
Common application types submitted under Item 10 include:
- a new formulation type for an existing active
- a new combination of existing actives
- novel uses for an existing active
Applicants can also seek approval of a new source of an existing active constituent in conjunction with a product registration under this application type. Please see 'I want to register a product and apply for the concurrent approval of a new source of active' for further information about this pathway.
Applications that do not meet the requirements of Item 10 include:
- I want to register a product that is the same as a reference product (repack—Item 8)
- I want to register a product that is based on an existing registered reference product (Item 5, 6 or 7)
- a listed chemical product (Item 9) for certain:
- home swimming pool and spa products
- joint health products for dogs and horses
- registration of a product with an approved active requiring a full assessment where no product has previously been registered (Item 3)
- registration of a product with an approved active requiring a full assessment (Item 4).
Note: If your proposed product meets the requirements of Item 3, 4, 5, 6, 7, 8 or 9 then you must lodge your application under the relevant item and not as an Item 10.
Under an Item 10 application, you must address all of the statutory criteria. This may be done by any one, or a combination of, the following methods:
- nominating a reference product
- providing supporting data for assessment
- providing a valid scientific argument
- submitting technical reports previously undertaken by the APVMA
- provision of overseas data assessments together with associated data underpinning the assessment.
The supporting data required by the APVMA for an Item 10 application will vary according to how novel the proposed product is compared to existing registered products and their approved uses and the relevance to the statutory criteria for the proposed new product.
In addition to the provision of new data, a valid scientific argument can be provided to satisfy specific risk areas. This may refer to other currently registered products (reference product), be supported by published information or be used to validate extrapolation from similar situations including the relevance of overseas studies to the Australian situation.
Reference products must be agvet chemical products currently registered by the APVMA. You can find registered chemical products and actives via APVMA’s registered chemical products search tool. Where nomination of an existing registered product is provided as the?reference product applicants should justify the relevance of the reference product to each of the relevant risk areas.
If an assessment has previously been undertaken by the APVMA (eg a technical assessment under Item 25, or assessment undertaken as part of a previous application where the individual assessment was supportive), you may submit that assessment in support of the application. You may need to resubmit the data underpinning the assessment for the APVMA to apply limits of use of information. If the assessment is historical, the relevance to the assessment to current agronomic practices and the current application should be addressed.