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I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only)
For registration, veterinary chemical products must be shown to be safe and effective when used in accordance with any approved directions for use. Product labels must adequately reflect these directions, including restraints, contraindications, precautions and side effects of the product where applicable.
Restraints are absolute limitations or restrictions placed on the use of the product, usually to manage a risk associated with the product related to human safety, public health or environmental protection.
Contraindications are included on a label to indicate conditions or specific situations that render a particular type of treatment undesirable or unacceptable. They are normally used when there is evidence that toxicity will occur in a particular situation or physiological state or in an off-label animal species.
Precautions minimise health risks to target animals from approved uses of a product. They are normally used when there is insufficient evidence to demonstrate safety in a particular situation.
Side effects are included on a label to advise end users of effects that may occur in the target animal from approved use(s) of a product. These statements include details of the severity, clinical importance and treatment of the effects.
Applications to vary these statements may be made via:
- 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.