0.1. Is a technical assessment required for my proposed variation?

Application for a formulation change as a prescribed variation (Item 13A) is only permitted in very limited circumstances. These circumstances are described below (select Item 13A Prescribed Variation). 

Applications for formulation changes where the supporting information does not require a technical assessment to satisfy the safety, efficacy and trade criteria can be processed under a non-technical fixed fee variation (Item 12). Formulation variations of an agricultural product that may be eligible for submission under Item 12 include formulation changes where:

  • excipients in the formulation are the same and at similar concentrations to those in the approved formulation
  • one or more excipients in the formulation have been substituted with similar chemicals that perform the same function and are not expected to impact on the physico chemical properties of the formulation or on efficacy or crop safety
  • the variation is to add, remove or substitute dyes or fragrances
  • the existing formulation is closely similar (see below) to the proposed new formulation
  • the formulation has previously been assessed for a reference product which has the same label instructions as the current product.

0.1.1. Closely similar

For an agricultural product formulation to be considered closely similar to another formulation:

  • its active constituent/s and concentration of active constituent/s must be the same as the reference formulation
  • other ingredients in the formulation of the product may be different from those in the reference formulation, but must perform similar functions (eg emulsifier, surfactant, dye, solvent)
  • its formulation type must be the same as that of the reference formulation.

Other formulation changes are likely to require technical assessment and should be made as Item 14 applications.

0.1.2. 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.

1. Introduction

In certain limited circumstances, holders of registered chemical products may apply to the APVMA to replace one or more non-active constituents (excipients). These variations can be submitted to the APVMA as a prescribed variation, using an Item 13A application if:

(a) the constituent (the original constituent) is replaced with another constituent (the replacement constituent); and
(b) the original constituent is not an active constituent of the product; and
(c) the replacement constituent will not be an active constituent of the product; and
(d) the original and replacement constituents have the same purpose in the product; and
(e) the original and replacement constituents differ only in solvates or hydrates; and
(f) the original and replacement constituents have the same:

(i) pH; and
(ii) dissolution profile; and
(iii) hydrophilic or hydrophobic behaviour; and
(iv) hygroscopic behaviour; and

(g) neither the original nor replacement constituent are a nanomaterial; and
(h) in the case of the original and replacement constituents being a straight or branched unsaturated hydrocarbon—the change in the length of the hydrocarbon chain is not more than 33 per cent of the length of the original constituent’s hydrocarbon chain; and
(i) the replacement constituent does not introduce material of human or animal origin into the product; and
(j) the variation does not require variation to the signal words required by the current Poisons Standard to be on the label of the product; and
(k) in the case of a product that is a molluscicide in the form of a bait or a product applied to seeds to be stored before planting or sowing—the variation does not change the colour of the product; and
(l) the variation does not require the formulation type entered in the Register for the product to be varied; and
(m) in the case of a product that has nine or more constituents entered in the Register for the product—the variation is to no more than 25 per cent of the number of constituents entered in the Register for the product; and
(n) in the case of a product that has less than nine constituents entered in the Register for the product—the variation is to one or two of the constituents entered in the Register for the product.

AND the product is NOT:

a) an antibiotic product; or
b) an immunobiological product; or
c) a product that is administered through direct injection into an animal.

2. Legislation

The Agvet Code allows some variations to be lodged as Prescribed Variations (ss 26A to 26D).

The Agvet Code Regulations set out the timeframes and fees for Prescribed Variations.

The Agricultural and Veterinary Chemicals Code (Prescribed Variations) Instrument 2019 prescribes the variations of the relevant particulars that can be made as Prescribed Variations.

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the requirements for application for prescribed variations.

2.1. Prescribed Variations

The following table prescribes, as prescribed variations for the purposes of paragraph 26B(4)(b) of the Code, variations of the relevant particulars that are listed in an item in the table, for the registrations listed in the table for that item.

Item

Prescribed variation of relevant particular

Registration

3

A variation of one or more constituents of a chemical product if:

 

(a) the constituent (the original constituent) is replaced with another constituent (the replacement constituent); and

(b) the original constituent is not an active constituent of the product; and

(c) the replacement constituent will not be an active constituent of the product; and

(d) the original and replacement constituents have the same purpose in the product; and

(e) the original and replacement constituents differ only in solvates or hydrates; and

(f) the original and replacement constituents have the same:

 

(i) pH; and

(ii) dissolution profile; and

(iii) hydrophilic or hydrophobic behaviour; and

(iv) hygroscopic behaviour; and

 

(g) neither the original nor replacement constituent are a nanomaterial; and

(h) in the case of the original and replacement constituents being a straight or branched unsaturated hydrocarbon—the change in the length of the hydrocarbon chain is not more than 33% of the length of the original constituent’s hydrocarbon chain; and

(i) the replacement constituent does not introduce material of human or animal origin into the product; and

(j) the variation does not require variation to the signal words required by the current Poisons Standard to be on the label of the product; and

(k) in the case of a product that is a molluscicide in the form of a bait or a product applied to seeds to be stored before planting or sowing—the variation does not change the colour of the product; and

(l) the variation does not require the formulation type entered in the Register for the product to be varied; and

(m) in the case of a product that has 9 or more constituents entered in the Register for the product—the variation is to no more than 25% of the number of constituents entered in the Register for the product; and

(n) in the case of a product that has less than 9 constituents entered in the Register for the product—the variation is to one or 2 of the constituents entered in the Register for the product.

A registration of a chemical product, other than a chemical product that is:

 

(a) an antibiotic product; or

(b) an immunobiological product; or

(c) a product that is administered through direct injection into an animal.

2.2. Application requirements

The Agvet Code, s 8A provides the definition of 'meets the application requirements'.

Parts 2 and 4 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the information that must be contained in, or accompany an, application under the Agvet Code.

For formulation changes made as a prescribed variation, the application must include a statement that the applicant holds:

(a) evidence that the physical properties and storage stability of the product, as varied and relevant to the product’s formulation type or dosage form, are the same as the product’s existing physical properties and storage stability, when measured using the same methodology used for the product before being varied; and

(b) if the application relates to a veterinary chemical product—the following evidence about the product, as varied:

(i) a dissolution profile (if relevant) of at least two pilot scale batches that is comparable to the formulation of the product immediately before the application is made;
(ii) at least three consecutive months of data on the storage stability of the product.

2.3. Applications may be withdrawn

The Agvet Code, s 8D states that at any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.

3. Timeframe and fees

The fee for a prescribed variation is a fixed fee of $175 per product. The timeframe is one month. The variation is taken as having been accepted if the APVMA has not notified you of a proposal to refuse the application within one month.

4. What you need to provide

4.1. Completed online application form

First time applicants will need to complete an online services new user access form to access the APVMA Online Services Portal.

If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.

Prescribed variations need to meet the application requirements as set out in the Agvet Code (s 8A)—'Definition of meets the application requirements'.

To meet the application requirements you will need to provide:

  • a completed online application form
  • supporting information detailing the original and replacement constituent
  • a statement that the applicant holds evidence that the product as varied will have the same physical properties and storage stability as the product before the variation, and for vet products, holds information on the dissolution profile and three months data on storage stability
  • the fee of $175 per product application should accompany the application form.

4.2. The application fee

The fee for a prescribed variation is a fixed fee of $175 per product. You can choose to pay by credit card, electronic funds transfer or BPAY.

Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).

4.3. Supporting information

The application should contain a description of how the proposed formulation change meets the criteria for a prescribed variation. Supporting information would include chemical names and CAS numbers, composition and specifications for the original and replacement constituent, the proposed new formulation, and product specifications. Other information demonstrating how the original and replacement constituents meet the criteria may be provided.

5. Start an application

If you want to vary the formulation of your product and the change meets the criteria of a prescribed variation:

Start application

You will be redirected to online services to log in.