I want to vary my product to make a change to the product formulation

Changes to the formulation of an agricultural or veterinary chemical product may be required for a variety of reasons, including the availability of excipients or changes to the purity of the source of active used in the formulation.

All variations to approved product formulation details require an application to be made. The level of information supporting the variation and the assessment required will vary according to the proposed change and significance it may have with respect to ensuring the continued safety and efficacy of the product.

Depending on the change the following registration pathways may be utilised:

  • Item 12: No data of a technical nature is required—this application type is used when the change is minor and does not affect the physico-chemical properties of the product.
  • Item 13A: Prescribed variation—changes to non-active constituents (excipients) in certain limited circumstances.
  • Item 14: Technical modular application—all applications that are not Items 12 or 13A.

Most formulation variations are likely to be made as Item 14 applications. Applicants should familiarise themselves with the scope of each of these pathways and select the pathway which is most appropriate for the formulation change being sought.

This guidance does not cover changes to use patterns, or to the frequency or rate of application. This information is provided in other tailored guidance pathways.

Which application form do you need?

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 a technical assessment is not required to satisfy the safety, efficacy and trade criteria can be processed under a non-technical fixed fee variation (Item 12). This includes where the proposed new formulation is closely similar to the existing formulation or where a suitable reference product is nominated. Minor changes to non-active constituents may also be considered as non-technical assessments. Select ‘Item 12’ below to see the full list of circumstances where an Item 12 application is likely to be appropriate.

A technical assessment (Item 14) is required for variations to formulations that include changes:

  • to immunobiological products and peptide products
  • to active constituents or constituents that act as synergists
  • to non-active constituents such as addition, substitution or removal of an excipient (some changes can be made as an Item 12 non-technical assessment—select ‘Item 12’ below to see a full list)
  • to ligands
  • to ingredients that are subject to scheduling in the Poisons Standard
  • where there are concerns about stability
  • which affect the permeability and bioavailability of the active constituent in a product (eg solvents and surfactants in topical or injectable formulations)
  • that result in a change in drug:excipient ratio of greater than five per cent from the original product formulation

Other formulation changes that require a technical assessment will also be considered as Item 14 applications.

Application guidance

Specific information on completing this application form is provided below. Once you are familiar with the content you can proceed to ‘Start an application’ at the button below.

Please note: the fees referenced in this tailored guidance take effect from 1 July 2020. For a list of fees and charges up to 30 June 2020, please view the?timeframe and fees section on our website.

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.

Legislation

The Agvet Code allows some variations to be lodged as Prescribed Variations (see sections 26A–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.

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.

Application requirements

Section 8A of the Agvet Code provides the definition of 'meets the application requirements'.

Parts 2 and 4 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 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.

Applications may be withdrawn

Section 8D of the Agvet Code 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.

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.

What you need to provide

Prescribed variations need to meet the application requirements as set out in section 8A of the Agvet Code—'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.

Completed online application form

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

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

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).

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.

Start an application

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

You will be redirected to online services to log in.