Document ID: chunk:federal_register_of_legislation:F2024C00959:schedule:6:p2
Version: federal_register_of_legislation:F2024C00959
Segment Type: schedule
Provision Reference: sch 6 (pt 2/4)
Character Range: 302478–305396

as the approved label of the reference chemical product; and
 (g) either:
 (i) the claims on the labels of the proposed and reference chemical products are the same; or
 (ii) if the claims are different, the claims on the label of the proposed chemical product are fewer or reduced compared to the claims on the approved label of the reference chemical product.
 (3) Subject to clause 1.5, a veterinary chemical product (the proposed chemical product) and a reference chemical product are closely similar if:
 (a) the active constituents in the proposed chemical product are the same as the approved active constituents in the reference chemical product; and
 (b) the concentration of the active constituents referred to in paragraph (a) are the same; and
 (c) either:
 (i) the non‑active constituents in the formulations of the proposed and reference chemical products are the same, or are equivalent substances, at the same or equivalent concentrations; or
 (ii) if the non‑active constituents in the formulations of the proposed and reference chemical products are neither the same nor equivalent, the differences in the formulations are minor and are not expected to have adverse implications on product quality or biological activity in terms of efficacy, safety or residues; and
 (d) either:
 (i) the proposed and reference chemical products specifications (including release and expiry limits and test methods) and physico‑chemical properties (including pH, particle size, crystal form and, where applicable, dissolution profile, payout rate and payout period) are the same or equivalent; or
 (ii) if the specifications and physico‑chemical properties of the proposed and reference chemical products are neither the same nor equivalent, the differences in the specifications and properties are minor and are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues; and
Note for paragraphs (c) and (d): Efficacy, safety and residues data are not required to demonstrate similarity of the proposed chemical product to the reference chemical product.
 (e) the dose form and formulation type of the proposed and reference chemical products are the same; and
 (f) the use patterns (including target animal species, dose rates, routes of administration and withholding periods) and instructions on the labels of the proposed and reference chemical products are the same; and
 (g) either:
 (i) the claims on the labels of the proposed and reference chemical products are the same; or
 (ii) if the claims are different, the claims on the label of the proposed chemical product are fewer or reduced compared to the claims on the approved label of the reference chemical product.

1.3  When chemical products are similar
 (1) Subject to clause 1.5, an agricultural chemical product (the proposed agricultural chemical product) and a reference chemical