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/18006
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I want to register a product that is based on an existing registered reference product
Applications to register a new product based on that product being similar or closely similar to a registered reference product can be made via one of the following item numbers:
Item 5—new product—similar to a reference product (efficacy and safety and chemistry and manufacture data required)
Item 6—new product—closely similar to a reference product (chemistry and manufacture data required)
Item 7—new product—closely similar to a reference product (no further data required).
Applicants can also seek approval of a new source of an existing active constituent in conjunction with a product registration under Item 5 and 6 applications. 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.
If your proposed product is:
- the same as a reference product (ie only the product name and owner are changing), then you should submit your application under an Item 8 (also referred to as a 'repack')
- not similar, or closely similar to a reference product, or requires a technical assessment other than chemistry or efficacy and safety, you should submit your application under an Item 10.
This tailored guidance covers applications to register a new product on the basis that it is similar, or closely similar, to an existing registered product (referred to as a reference product). This allows the APVMA to consider the proposed new product based on the risk assessments previously conducted for the registration of the reference product.
Reference products should be agvet chemical products currently registered by the APVMA. Registered chemical products can be searched on APVMA’s product search tool. Where there are relevant limits on the use of information associated with the reference product, the APVMA will require consent from the holder of that information before it can be considered as a reference product to support your application.