1. Introduction

The following material provides guidance for varying the use of a veterinary medicine where the change involves an extension of use to a non-food species as a technical modular variation (Item 14). Depending on the nature of the variation, different technical modules will apply. In general, an extension of use requires the submission of new information or data to support the safety and efficacy of the new use. The amount of new information or data required however can vary depending upon how significant the change is, and what new assessments are 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

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 will vary, depending on the nature of the application and the modules specified for that particular application.

A technical variation is a modular application type, therefore the fees and timeframe are variable. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.

Applications for ‘extension of use’ to a non-food species must satisfy the statutory criteria of safety, efficacy and trade. Depending on the extension being sought, one or more of the following Module types 2–10 will require the provision of supporting data and/or scientific argument. Where an applicant considers that an assessment of any particular module is not necessary justification must be provided.

Extension of use: required modules
Module type Module level* Timeframe Fee
1: Preliminary assessment 1.0 Up to 1 month $902
2: Chemistry No assessment required as there has been no change to formulation or packaging
3: Toxicology 3.3 5 months $4 050
4: Toxicology—Poison scheduling No assessment required if appropriate scheduling is already in place
5: Residues and trade No assessment required as non-food are not considered a trade or residue risk
6: Workplace health and safety 6.3 4 months $3 913
7: Environment

7.2 or

7.3

7 months

4 months

$7 659

$2 979
8: Efficacy and  safety

8.1 or

8.3

6 months

3 months

$4 740

$1 160
9: Non-food trade No assessment required as non-food animals do not present a trade risk
10: Special data

10.2 and/or

10.3

7 months

7 months

Nil

Nil
11: Finalisation

11.1 or

11.2

3 months

2 months

$8 110

$3 090
12: Limits on use (data protection) 12.0 – $460

*Only those module levels applicable for this type of variation are listed.

Extension of use: examples
Scenario Modules Timeframe Fee

1: Extension to include a new non-food use

 1, 8.1, 11.2 and 12

8 months

12 months (extended assessment period)

 $9 192

2: Extension to include a new situation

 1, 8.3, 11.2 and 12

5 months

8 months (extended assessment period)

 $5 612

3.1. Pre-application assistance

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

4. Modules

The APVMA has developed the module descriptors to provide guidance as to the modules that will apply for different types of applications. The APVMA will have regard to this document, but may depart from it, when determining which modules are necessary on a case-by-case basis. 

4.1. Preliminary assessment

Preliminary assessment is an initial examination of the application for administrative completeness. It is an administrative check that the form and content of the application meet the application requirements. In other words, the outward look of the application and its accompanying information appears to be in order and complete. It is not a completeness check of the technical aspects of your submission.

Applies to all modular application items.

4.2. Health

A Health assessment is required where there is a change to human exposure compared to situations that have already been assessed by the APVMA. Changes to human exposure can occur when extending into new crops or situations. This includes changes such as application rate, method, worker rates and practices including post-application activities. The change may result in a change to the entry in the first aid instructions and safety directions (FAISD) Handbook, including changes to first aid statements, personal protective equipment (PPE) and re-entry into treated areas following application.

This module also assesses both toxicological data and scientific argument, together with any cited references, which characterise the risks to humans using or coming into contact with the substances in your product.

Module level Timeframe Fee
Health 3 9 months $18 980
Module level Module type Timeframe Fee
6.3 Workplace health and safety 4 months $3 913
Module level Module type Timeframe Fee
7.2 Environment 7 months $7 659
Module level Module type Timeframe Fee
8.3 Efficacy and target safety 3 months $1 160
Module level Module type Timeframe Fee
10.3 Genetically modified organism 7 months $Nil

4.3. Finalisation

This module encompasses administrative steps relating to the finalisation of the application. This can include public consultation, entering the required information into the relevant record or register, and the completion of the technical evaluation and risk assessment report outlining the evaluation of the application.

Module level Module type Timeframe Fee
12 Data protection N/A $460

4.3.1. Health 3

Registration of a new product containing an approved active constituent requiring approval first time for food uses, requiring the establishment of an ADI and/or ARfD.

Module level Timeframe Fee
Health 3 9 months $18 980

4.4. Health

A Health assessment is required where there is a change to human exposure. Changes to human exposure can occur when extending into new crops or situations. This includes changes such as application rate, method, worker rates and practices including post-application activities. The change may result in a change to the entry in the first aid instructions and safety directions (FAISD) Handbook, including changes to first aid statements, personal protective equipment (PPE) and re-entry into treated areas following application.

4.5. Environment

Where there is any potential risk to the environment, an appropriate environmental assessment is required. This assessment will take into account the expected volume of use; the expected exposure, behaviour and fate of the active constituent/s; and the potential harmful effects on flora and fauna; resulting from use of the product.

In situations where the proposed use pattern does not change the risk to the environment, and this can be determined without further assessment, no environmental assessment is required.

4.5.1. Environment 1

Registration of a product containing an approved active constituent with first use as an agricultural product not mentioned in Environment 2 or Environment 3

Module level Timeframe Fee
Environment 1 13 months $26 390

4.5.2. Environment 2

Registration of a new product containing an approved active constituent which is:

  • a new combination of approved active constituents
  • a vertebrate poison
  • a major formulation change
  • for use in any crop (or situation other than those mentioned in Environment 3), except where a registered product exists with the same uses, actives, similar formulation type at an equivalent or higher dose, frequency or rate of application, and no new consideration of environmental exposure is required.

Module level

Timeframe

Fee

Environment 2

7 months

$7 659
Module level Module type Timeframe Fee
7.3 Environment 4 months $2 979

4.5.3. 8.1: Comprehensive efficacy and safety

4.5.4. 8.3: Limited efficacy and safety

Module level Module type Timeframe Fee
11.1 Finalisation 3 months $8 110
Module level Module type Timeframe Fee
11.2 Finalisation 2 months $3 090

4.6. Limits on use of information

Limits on use of information relate to the protection, handling and use of information provided to the APVMA. In general, the APVMA must not use the information given to it in connection with one application to assess or make a decision on another application, except in specific circumstances. These circumstances include, but are not limited to, where the applicant has given consent for the information to be shared or in an emergency situation; see CCI Practice Statement. This ‘limited use data’ includes information such as reports, studies and scientific arguments that may or may not include confidential commercial information. The applicant can request the module at the time an application is lodged, but the APVMA may also include it once an assessment of the application is undertaken.

Module level

Timeframe

Fee

Limits on use

N/A

$460

4.6.1. 6.3: Limited workplace health and safety

An extension of use to a food producing animal species must satisfy the section 5A-D safety, efficacy and trade criteria for the new use. However, the amount of new information or data required varies depending upon how significant the change is, and what new assessments are necessary.

Module level Module type Timeframe Fee
8.1 Efficacy and target animal safety 6 months $4 740

4.7. Module 10: Special data assessment

This module applies to all applications for registration of a new chemical product or variation of the particulars or conditions of a registered chemical product, which contain active constituents that are new antibiotic substances or which contain genetically modified organisms (GMOs) require a Module 10 assessment.

Module level Module type Timeframe Fee
10.2 Antimicrobial resistance 7 months $Nil

4.7.1. 11.1: Finalisation

4.7.2. Finalisation 2

Registration of a new product where:

  • fewer than 3 technical assessment modules (Chemistry, Health, Residues, Environment, Efficacy) apply; or
  • the consideration of fewer than 3 assessment reports from technical assessment modules (Chemistry, Health, Residues, Environment, Efficacy) conducted under previous applications is required.

Module level

Timeframe

Fee

Finalisation 2

2 months

$3 090

A reduced environment assessment (Module 7.2) applies for variations that involve:

(i) a new herd animal or new situation;
(ii) changes to application method; or
(iii) increase in application rate, dose or frequency for an existing use pattern.

A limited environment assessment (Module 7.3) applies when the VICH phase I assessment stops between questions 5 and 13 (aquatic branch) or 19 (terrestrial branch).

4.8. Module 8: Efficacy and safety

A comprehensive efficacy and safety assessment (Module 8.1), is required when the extension of use involves use in or on a cat, dog or horse for the first time.

A limited efficacy and safety assessment (Module 8.3) is required when extending use to a non-food species (other than a dog, cat or horse).

4.9. Pre-application assistance

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

5. 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.

5.1. 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.

5.2. 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).

5.3. 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.

5.4. Supporting information

The application must contain, or be accompanied by, information relevant to the whether the chemical product meets the safety and efficacy criteria, but only to the extent that the variation proposed affects whether the product meets the safety and efficacy criteria. Applicants should include an explanation of why they believe supporting information is not required, if they choose not to provide it with the application.

Relevant data for module levels – veterinary chemical products sets out the data that may be relevant to particular assessment modules detailed in the Agvet Regulations. This list is not exhaustive and is only intended to provide you with guidance in putting your application together.

  • Chemistry
    Detailed data guidelines for chemistry and manufacture are available in Part 2
  • Health
    Detailed data guidelines for health are available in Part 3 and Part 6
  • Residues
    Detailed data guidelines for residues are in Part 5A
    Detailed data guidelines for trade are in Part 5B
  • Environment
    Detailed data guidelines for environment are in Part 7
  • Efficacy and host safety
    Detailed data guidelines for efficacy and safety are in Part 8
  • Trade
    Detailed data guidelines for trade are in Part 5B
  • Non-food trade
    For applications referred to at 9 of the module descriptors , data specifically relevant to the trade risk may be submitted
  • GM organism/other special data
    Published data and results of Australian field trials, relevant to the criteria for approval of an active constituent or registration of a product described in s 14 of the Agvet Code, may be submitted

You should also consult the international technical guidance material which have been adopted by the APVMA to satisfy the s 5 legislative criteria. In particular you should consult the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products also known as the VICH guidelines.

Specifically, you should consider the guidelines listed under the following headings:

Before deciding on the use of international data and standards you should consult the guidance for applicants to ensure this data meets the APVMA requirements.

5.5. 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.

6. Examples

6.1. Scenario 1: Food to non-food animal

6.1.1. Objective

Application is made to vary an oral veterinary anthelmintic chemical product to extend the use from control of internal parasites in cattle, to control of internal parasites in horses. The anthelmintic product is a registered veterinary chemical product with a statement of claims to treat a variety of intestinal parasites in cattle. The product contains an active constituent that has not been registered for use in horses before in Australia.

6.1.2. Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria when used on horses.

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this application.

Module type Module level Timeframe Fee
1: Preliminary assessment 1.0 Up to 1 month $902
2: Chemistry No assessment required as there has been no change to formulation or packaging
3: Toxicology No assessment required as the product is currently registered and relevant health standards are already established
4: Toxicology—Poison scheduling No assessment required if appropriate scheduling is already in place
5: Residues and trade No assessment required as companion animals are not considered a trade or food risk
6: Workplace health and safety No assessment required as there will be no change to the  dose form
7: Environment No assessment required because the risk is lower or equivalent to an existing product
8: Efficacy and safety Assessment is required to determine the efficacy of the product against internal parasites of horses
8.1 6 months $4 740
9: Non-food trade No assessment required
10: Special data No assessment required as the product does not contain approved antibiotic active constituent/s or genetically modified organisms
11: Finalisation 11.2 2 months $3 090
12: Limits on use (data protection) 12.0 Not applicable $460
Total   8 months $9 192

6.2. Scenario 2: Non-food to non-food animal

6.2.1. Objective

Application is made to vary a veterinary ectoparasiticide spray chemical product to extend the use from flea, lice and tick control on dogs and cats to include lice control on ornamental birds.

The rinse concentrate product is a registered veterinary chemical product with a statement of claims to treat fleas, lice and ticks on dogs and cats. The product contains a combination of active constituents that has not been registered for use in ornamental birds before in Australia.

6.2.2. Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria when used on ornamental birds.

Module type Module level Timeframe Fee
1: Preliminary assessment 1.0 Up to 1 month $902
2: Chemistry No assessment required as there has been no change to formulation or packaging
3: Toxicology No assessment required as the product is currently registered and relevant health standards are already established
4: Toxicology—Poison scheduling No assessment required if appropriate scheduling is already in place
5: Residues and trade No assessment required as companion animals are not considered a trade or food risk
6: Workplace health and safety No assessment required as there will be no change to the  dose form
7: Environment No assessment required because the risk is lower or equivalent to an existing product
8: Efficacy and safety Assessment is required to assess the toxicity and efficacy of the product against lice on ornamental birds. Ornamental birds are considered a minor companion animal species so a reduced efficacy and safety module applies
8.3 3 months $1 160
9: Non-food trade No assessment required
10: Special data No assessment required as the product does not contain approved antibiotic active constituent/s or genetically modified organisms
11: Finalisation 11.2 2 months $3 090
12: Limits on use (data protection) 12.0 Not applicable $460
Total   5 months $5 612

7. Start an application

If you want to extend the use of your product and a technical variation (Item 14) is required:

Start application

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