Varying the use of an agricultural or veterinary chemical product to include a new use is also known as an ‘extension of use’. This variation is made via:

  • Item 11 – full assessment fixed fee application
  • Item 12 – no technical assessment is required
  • Item 14 – technical modular application—all applications not described in any of items 11 to 13A.

Most ‘extension of use’ variations are likely to be made as Item 14 applications.

1. Introduction

Applications for extension of use to a new animal species or situation 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).
These applications are generally supported through either:

  1. reference to animal species or situations already approved on another registered product (reference product), and/or
  2. extensions to animal species or situations based on a scientific argument (extrapolation) from similar animal species or situations already registered.

1.1. Nomination of a reference product

Reference to new claims already approved for a currently registered product (reference product). In these cases the APVMA will apply the same approach as conducted for Items 6, 7 & 8 for the purposes of defining either the same or closely similar.
The product when compared to the reference product must meet the following criteria:

  • same active constituent(s)
  • same concentration of active(s)
  • non-active constituents are equivalent substances, at the same or equivalent concentrations or
    differences are minor and not expected to have adverse implications on product quality or biological activity in terms of efficacy, safety or residues
  • the specifications and properties are the same or equivalent or
    differences are minor and are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues
  • same dose form and formulation type
  • same use pattern and instructions
  • label claims are the same
  • reference product information is not subject to limit of use of information or
    the applicant has obtained consent from the owner to use the data from the reference product.

1.2. Scientific argument

The use of a scientific argument for supporting extensions to new animals or situations based on extrapolation from currently approved animals or situations already registered may be suitable in limited circumstances. In these instances a technical assessment MUST NOT be necessary to determine that the extension meets the safety, efficacy and trade criteria. Applicants seeking this pathway should consider lodging an application for a Tier 2 Pre-Application Assistance for advice on the possible suitability of proposed extrapolations.

1.3. Note: Limits on use of information

Whether using a reference product or providing a scientific argument where there are relevant limits on use of information on the product which is being referenced written consent from the authorising party will be necessary.

2. Legislation

2.1. Framework

The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act contains all of the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals.

The Agricultural and Veterinary Chemicals Act 1994 contains the constitutional and other legal provisions that enable the Agvet Code to have effect.

The Agricultural and Veterinary Chemicals Code Act 1994, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels); and to issue permits and to license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products; and provisions ensuring compliance with, and for the enforcement of, the code.

The Agricultural and Veterinary Chemicals Code Regulations 1995 prescribe detailed provisions of the Agvet Code.

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.

2.2. Varying relevant particulars and conditions

The APVMA must vary the relevant particulars or conditions if it is satisfied application requirements and statutory criteria have been met (Agvet Code, s 29).

The Agvet Code, s 20(1)(c) defines relevant particulars in relation to the registration of a chemical product as:

  • the distinguishing number
  • any instructions for the use of the product
  • any other particulars prescribed by the regulations.

Other particulars for chemical products prescribed by the regulations are:

(a)  the distinguishing name of the chemical product

(i) the constituents of the chemical product
(ii) the concentration of each constituent of the chemical product
(iii) if possible, the composition and purity of each active constituent of the chemical product
(iv) the formulation type for the chemical product
(v) the net contents for the chemical product
(vi) identifying information for the holder of the registration of the chemical product
(vii) the name of each manufacturer of the chemical product
(viii) the address of each site at which the chemical product is manufactured by the manufacturer
(ix) the date of entry of these particulars in the Register of Chemical Products
(x) identifying information for any nominated agent for the registration.

The Agvet Code defines particulars in relation to approval of a label:

b)

(i) the name of the person who applied for the approval as the holder of the approval
(ii) the name of any nominated agent for the approval
(ii) the name of any nominated agent for the approval
(iii) the distinguishing number
(iv) the instructions and any particulars that are to be contained on the label
(iva) any other particulars prescribed by the regulations
(v) any conditions of the approval imposed by the APVMA.

Other particulars for labels prescribed by the regulations are:

Regulation 17(1)

a) the appropriate signal words required by the current Poisons Standard
b) the name of the chemical product that is to appear on a label for containers of the chemical product
c) the name of each active constituent of the product
d) the proportion of each active constituent of the product
e) the name of each constituent for the product that is

a. not an active constituent; and
b. classified as a poison in the current Poisons Standard

f) the proportion of each constituent referred to in paragraph (e)
g) the net contents of the product
h) particulars determined by the APVMA CEO under sub-regulation (2).

Regulation 17(2)

For paragraph 6(2)(c) of the Act, the APVMA CEO may determine additional particulars to be placed on a label for a product.

Regulation 17(3)

a) identifying information for the holder of the approval
b) identifying information for any nominated agent for the approval
c) the distinguishing name of the chemical product that is prescribed under paragraph 16(a) and entered in the Register
d) the distinguishing number of the chemical product that is entered in the Register.

Conditions are:

a) the conditions prescribed by the regulations (whether or not the conditions are prescribed at the time the constituent, product or label is approved or registered); and
b) any conditions imposed on the approval or registration as the APVMA thinks appropriate.

2.3. Statutory criteria

In addressing the criteria, the applicant may provide information, or valid scientific argument that might address a specific criterion. The following sections of the Agvet Code provide definitions for meeting the criteria:

An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:

a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
b) is not, or would not be, likely to have an effect that is harmful to human beings; and
c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

To satisfy the s 5A criteria, the APVMA considers chemistry and manufacture, health (including poison scheduling and work health and safety), residues, environment and target safety.

A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.

A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.

In approving a label for a container for chemical products, the APVMA must be satisfied that the label contains adequate instructions. This allows the APVMA to ensure that the risks of using the agvet chemical product are adequately mitigated through appropriate instructions.

The APVMA’s Agricultural Labelling Code and Veterinary Labelling Code also contain further labelling requirements that ensure a standard layout, eligibility and further help in mitigating the risk of using agvet chemical products when used in accordance with the label instructions.

2.4. Application requirements

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

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

2.5. Guidelines

The APVMA has designed guidelines to help inform the APVMA and applicants as to the modules, data and information that will apply for different types of applications. The guidelines are not the law. The APVMA will have regard to it, but from time to time may depart from it when determining the modules, data and information are necessary for a particular application. The APVMA has a number of guidelines that fall under this, for example:

2.6. 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 non-technical variation (Item 12) is a fixed fee of $2,018. The timeframe is 3 months. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.

This application type is subject to an extended assessment period if an Agvet Code s 159 notice is sent requesting additional information or clarification of submitted information. The extended assessment period for a non-technical variation (Item 12) is 5 months.

3.1. Pre-application assistance

Pre-application assistance is available to give applicants advice on the requirements of an application before submission.

4. What you need to provide

To meet the application requirements you will need to provide:

  • an online application form
  • the application fee plus any amount that is due to the APVMA
  • supporting information to demonstrate the proposed extension will be efficacious and will not cause unintended harm
  • an information list
  • consent for use (if any of the information provided is subject to limits on use)
  • e-label.

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.

4.2. The application fee

You may choose to:

  • pay the total fee on submission or
  • pay the preliminary assessment fee of $902 on submission and the remaining balance once the application has been accepted.

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 must contain a summary as to why it does not require technical assessment to satisfy the statutory criteria. In particular, why it does not require technical assessment of risks to residues/trade, workplace health and safety, environment, target safety and efficacy. For example, this may include nomination of a single reference product.

4.4. Consent for use from the relevant authorising party (if applicable)

When protected information is listed for a reference product, the applicant must obtain consent for use from the relevant authorising party or parties. This consent for use must be explicit and include the relevant data numbers.

You can check the APVMA PubCRIS database record to determine if protected data details exist for the reference product.

4.5. Information list

It is an application requirement that all applications for approval, registration or variation include a short description of each item of information contained in, or accompanying the application—an information list.

Item 12 applications rely on the information list of the reference product.

The online application form contains fields to assist applicants in entering the information required to generate the information list.

Note: Information lists are published, including details of the holders of information. Applicants should take care not to inadvertently divulge confidential commercial information (CCI) when creating the list.

4.6. Electronic label (e-label)

The APVMA must have regard to certain matters or details in order to satisfy itself that a label meets the labelling criteria and approve the label (Agvet Code, ss 5D and 14). Applicants must use the e-label template to submit the label details that the APVMA must take into account.

Introduction to preparing a label and the label approval process provides more detailed information.

5. Examples

5.1. Scenario 1: Addition of a new target animal species based on a registered reference product

5.1.1. Objective

A registrant is seeking to extend the label claim of their registered product to include cattle for the control of internal parasites. The registrant is seeking to support the extension by citing a registered reference product which is currently approved for the control of internal parasites in cattle.

To support the application the applicant claims that their product when compared to the reference product meets the following criteria:

  • same active constituent(s)
  • same concentration of active(s)
  • non-active constituents are equivalent substances, at the same or equivalent concentrations or
    differences are minor and not expected to have adverse implications on product quality or biological activity in terms of efficacy, safety or residues
  • the specifications and properties are the same or equivalent or
    differences are minor and are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues
  • same dose form and formulation type
  • same use pattern and instructions
  • label claims are the same.

There are no limits of use on the reference product which apply to the proposed new species (including but not limited to residues, target animal safety and efficacy data).

5.1.2. Application type

This application may be considered under a non-technical fixed fee variation (Item 12). The registered reference product shows equivalent risk has already been assessed and the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria.

Risk area Reason technical assessment is not required
2: Chemistry The product is currently registered and there are no changes to the product formulation or packaging
3: Toxicology Risks to human health are equivalent to that previously assessed for the reference product
4: Toxicology—Poison scheduling The product is currently registered and relevant scheduling is established
5: Residues and trade Risks to residues and trade are equivalent to that previously assessed for the reference product
6: Workplace health and safety Risk to human health through exposure is equivalent to that previously assessed for the reference product
7: Environment Risk to environment is equivalent to that previously assessed for the reference product
8: Efficacy and safety Efficacy and target animal safety is equivalent to that previously assessed for the reference product
9: Non-food trade Risk is equivalent to that of the reference product
10: Special data Risk is equivalent to that of the reference product

 

Application type Timeframe Extended timeframe Fee
Item 12 3 months 5 months $2 018

6. Start an application

If you want to extend the use of your product and a non-technical variation (Item 12) is required:

Start application

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