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 the APVMA’s PubCRIS database. 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.
Which application form do you need?
Schedule 6 of the Agvet Code Regulations provides statutory definitions of when a proposed product is similar or closely similar to a reference product. To determine the appropriate Item number, you need to first establish whether your product meets the statutory definition of similar or closely similar in relation to your nominated reference product. The following table lists the criteria to assist you through this step:
| Criteria (proposed product compared to reference product) |
Similar | Closely similar |
|---|---|---|
| Same active | Y | Y |
| Same concentration of actives | Y | Y |
Either the non-active constituents in the formulation:
|
N/A | Y |
Either the specifications and physico chemical properties:
|
N/A | Y |
| Formulation type and dosage form are the same | Y | Y |
| Same use patterns and instructions on the label | Y | Y |
| Label claims are the same, fewer or reduced | Y | Y |
| Reference product information is not subject to limit of use of information or the applicant has obtained consent from the owner to use the data from the reference product |
Y | Y |
The following table depicts for each relevant risk area where either:
- a specific ‘assessment’ will apply, or
- where the submission relies on the ‘reference product’.
|
|
Similar |
Closely similar |
|
|---|---|---|---|
|
Risk area by module type |
Item 5 |
Item 6 |
Item 7 |
|
Chemistry |
Assessment |
Assessment |
Reference product |
|
Health |
Reference product |
||
|
Poisons scheduling |
Reference product |
||
|
Residues and trade |
Reference product |
||
|
Environment |
Reference product |
||
|
Efficacy and Safety |
Assessment |
Reference product |
|
|
Non-food trade |
Reference product |
||
|
Special data |
Reference product |
||
Reference product = risk assessment can be satisfied by that previously undertaken on a single reference product.
I want to register a new product that is: