Examples


Examples – Type 15 – Item 14 (Vet): Scenario 6

Scenario 6: Variation to the route of administration for an anaesthetic for companion animals from intravenous injection to intramuscular injection

Objective

An application is made to change the route of administration for an anaesthetic from intravenous to intramuscular.

The applicant has provided safety, efficacy and pharmacokinetics data to support the application.

An updated label with the new instructions for intramuscular injection has also been provided.

Examples – Type 15 – Item 14 (Vet): Scenario 5

Scenario 5: Variation to the application method to use hand jetting in a product approved for automatic jetting

Objective

An application is made to vary a fly and lice control product in sheep to provide directions for use by hand jetting. The product is registered for this use by automatic jetting.

The applicant has provided scientific argument that the proposed application method is as effective and safe as the approved application method.

The applicant has provided an updated label with the instructions.

Examples – Type 15 – Item 14 (Vet): Scenario 4

Scenario 4: Changing the duration of immunity on a vaccine product

Objective

An application is made to vary a vaccine product for use in dogs to amend the dosage and administration section of the label including the duration of immunity. The proposed change will require a booster vaccination after 3 years instead of 12 months.

The applicant has submitted a safety and efficacy study with the new dose regime as well as scientific argument.

An updated label has been provided.

Examples – Type 15 – Item 14 (Vet): Scenario 3

Scenario 3: Variation to increase the dose rate for a sheep drench product and to increase the interval between treatments

Objective

An application is made to increase the dose rate of a sheep drench product to allow a claim that the product will remain effective for a longer period of time between treatments.

The applicant has provided data on the efficacy and safety of the higher dose. Meat and milk WHP and ESI will need to be amended and residues data has been submitted at the new dose and frequency. No changes to MRLs are proposed.

Examples – Type 15 – Item 14 (Vet): Scenario 1

Scenario 1: Variation to increase the dose of a euthanasia solution

Objective

An application is made to increase the dose of an intravenous (IV) product used for the euthanasia of various animals. The dose is being increased from 2 mg/kg to 3 mg/kg. 

The applicant has nominated a reference product (which has no relevant protected data) and provided scientific argument as how the product will continue to meet the statutory criteria once the variation is made.

The applicant has provided an updated label with the new dose rate.

Examples – Type 14 – Item 14 (Vet): Scenario 2

Scenario 2: Change in product formulation resulting in a change to physico-chemical properties

Objective

An application is made to vary the formulation of a horse parasiticide paste product. The amount of humectant in the formulation has been increased and exceeds one percent of the product formulation.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the formulation variation will not affect the stability of the product. The application includes a chemistry data package.

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