Document ID: chunk:federal_register_of_legislation:F2024C00959:schedule:6:p1
Version: federal_register_of_legislation:F2024C00959
Segment Type: schedule
Provision Reference: sch 6 (pt 1/4)
Character Range: 299868–302705

Schedule 6—Application fees and assessment periods
Note: See regulations 70, 70B, and 76 to 78.

Part 1—Preliminary

1.1  Definitions
  In this Schedule:
closely similar, used of 2 chemical products, has the meaning given by clause 1.2 and subclause 1.5(1).
major change, in relation to a registered chemical product or approved label, means a change to a registered chemical product or its approved label that is expected to require data for technical assessment of one or more of the following:
 (a) efficacy;
 (b) potential risks to the safety of humans, the environment or the host crop or animal;
 (c) potential risks to Australian trade.
maximum residue limit means the maximum concentration of a residue, resulting from the officially authorised safe use of an agricultural or veterinary chemical, that is recommended to be legally permitted or recognised as acceptable in or on a food, agricultural commodity, or animal feed.
minor change means a change that is not a major change.
restricted, in relation to the use of information by the APVMA in determining an application: see subclause 1.5(2).
similar, used of 2 chemical products, has the meaning given by clause 1.3 and subclause 1.5(1).
the same, used of 2 chemical products, has the meaning given by clause 1.4 and subclause 1.5(1).

1.2  When chemical products are closely similar
 (1) Subject to clause 1.5, an agricultural 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 other ingredients in the formulations of the proposed and reference chemical products are the same; or
 (ii) 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
 (d) the formulation type of the proposed and reference chemical products are the same; and
 (e) 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
 (f) 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
 (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