When chemical products are closely similar
1.2 When chemical products are closely similar
Subject to clause 1.5, an agricultural chemical product (the proposed chemical product) and a reference chemical product are closely similar if:
the active constituents in the proposed chemical product are the same as the approved active constituents in the reference chemical product; and
the concentration of the active constituents referred to in paragraph (a) are the same; and
either:
the other ingredients in the formulations of the proposed and reference chemical products are the same; or
if the other ingredients in the formulations of the proposed and reference chemical products are different, those other ingredients perform similar functions (for example, as emulsifiers, surfactants, dyes or solvents); and
the formulation type of the proposed and reference chemical products are the same; and
the label of the proposed chemical product refers to the same crops, situations and pests as the approved label of the reference chemical product (that is, the proposed chemical product must have no uses additional to those of the reference chemical product); and
the label of the proposed chemical product includes similar instructions on how to use the product, and precautionary or safety instructions, as the approved label of the reference chemical product; and
either:
the claims on the labels of the proposed and reference chemical products are the same; or
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.
Subject to clause 1.5, a veterinary chemical product (the proposed chemical product) and a reference chemical product are closely similar if:
the active constituents in the proposed chemical product are the same as the approved active constituents in the reference chemical product; and
the concentration of the active constituents referred to in paragraph (a) are the same; and
either:
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
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
either:
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
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.
the dose form and formulation type of the proposed and reference chemical products are the same; and
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
either:
the claims on the labels of the proposed and reference chemical products are the same; or
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.
The statute text is free to read above. View Pro plans to unlock the case-law research tools for each provision.