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I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only)
Varying the dose, the frequency of administration, or the route of administration of a veterinary medicine product can be done through either:
- Item 12: No data of a technical nature is required. This type of application is used when risks are equivalent to a registered product not subject to data protection.
- Item 14: Technical modular application. All applications not meeting the requirements of Item 12.
Is a technical assessment required for my proposed variation?
Most variations of this type are likely to be made as Item 14 applications, as they will require a technical assessment.
Variations that don’t require a technical assessment to satisfy the safety, efficacy and trade criteria can be processed under a non-technical fixed fee variation (Item 12). These applications are generally supported through reference to statements which are already approved on another registered product (reference product).
In these cases the APVMA will apply the same approach as conducted for Items 6, 7 and 8 for the purposes of defining if the reference product is either the same or closely similar.
The product when compared to the reference product must meet the following criteria:
- Same active constituent(s)
- Same concentration of active(s)
- Non-active constituents are equivalent substances, at the same or equivalent concentrations or differences are minor and not expected to have adverse implications on product quality or biological activity in terms of efficacy, safety or residues
- The specifications and properties are the same or equivalent or differences are minor and are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues
- Same dose form and formulation type
- Same use pattern and instructions
- Label claims are the same
- Reference product information is not subject to limit on use of information or the applicant has obtained consent from the owner to use the data from the reference product
Limits on use (data protection): Where there are limits on use of information on the reference product, written consent from the authorising party is required when access to the information is necessary to determine the application.
Where the reference product does not fully support all risk areas or the product is subject to limits on use and additional data is being provided to satisfy the safety, efficacy or trade criteria these applications should be lodged as Item 14 applications.