I want to vary the use of a product to include a new crop, animal species or situation

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 data of a technical nature is required—this application type is used when risks are equivalent to a registered product not subject to data protection
  • 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.

This guidance does not consider an extension of use where the variation is to extend the use from commercial use to domestic use in the home or home garden.

Definitions for food crop, non-food crop, non-food situations, food-producing animal species, and non-food producing animal species (companion animals) are listed in the APVMA’s Definition of terms.

Note: Food producing crops include any crop that is consumed in Australia by humans or livestock. This includes pasture and forage crops which are grown specifically for the purpose of being grazed.

Which application form do you need?

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.

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.

Introduction

The following material provides guidance for varying the use of a veterinary medicine where the change involves an extension of use to a food producing animal species as a technical modular variation (Item 14). Depending on the nature of the variation, different technical assessment 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.

Legislation

Framework

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

The Agricultural and Veterinary Chemicals Code Act, 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.

Section 6A of the Agricultural and Veterinary Chemicals Code Act states that the APVMA may make guidelines. The APVMA has a number of guidelines which fall under this, for example:

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 S5A criteria, the APVMA considers chemistry and manufacture, toxicology (including poison scheduling, residues, work health and safety, 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.

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 (Section 29 of the Agvet Code).

Section 20(1)(c) of the Agvet Code 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
(b)  the constituents of the chemical product
(c)  the concentration of each constituent of the chemical product
(d)  if possible, the composition and purity of each active constituent of the chemical product
(da)  the formulation type for the chemical product
(db)  the net contents for the chemical product
(e)  identifying information for the holder of the registration of the chemical product
(g)  the name of each manufacturer of the chemical product
(h)  the address of each site at which the chemical product is manufactured by the manufacturer
(j)  the date of entry of these particulars in the Register of Chemical Products
(k)  identifying information for any nominated agent for the registration.

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

(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
(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 subregulation (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.

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.

Guidelines

6A of the Agvet Code states that the APVMA may make written guidelines for performing its functions and exercising its powers under this Code.

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 which fall under this, for example:

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

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 food producing animal 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.

Module type Module level* Timeframe Fee
1: Preliminary assessment 1.0 Up to 30 days $710
2: Chemistry No assessment required as there has been no change to formulation or packaging
3: Toxicology

3.2

3.3

9 months

5 months

$15 795

$4 050

4: Toxicology—Poison scheduling No assessment required if appropriate scheduling is already in place
5: Residues and trade

5.1 or

5.2 or

5.4

13 months

8 months

4 months

$18 170

$10 525

$7 465

6: Work health and safety 6.2 or
6.3
7 months
4 months
$3 185
$2 910
7: Environment 7.1 or
7.3
13 months
4 months
$26 390
$1 720
8: Efficacy and safety 8.1 or
8.2 or
8.3
6 months
4 months
3 months
$2 370
$975
$580
9: Non-food trade 9.0 6 months $1 175
10: Special data 10.2 or 7 months Nil
10.3 7 months Nil
11: Finalisation 11.1 or
11.2
3 months
2 months
$4 055
$1 545
12: Limits of use 12.0 $460

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

Extension of use: examples
Scenario Modules Timeframe Fee

1: Addition of a new food producing species

1, 3.2, 5.1, 7.3, 8.1, 11.1 and 12

16 months
23 months (extended assessment period)
$43 280

This application type is subject to an extended assessment period if a section 159 of Agvet Code 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.

Pre-application assistance

Pre-application assistance is designed to give applicants advice on the information and module requirements of an application prior to submission. It can also be used to obtain an appraisal on a trial protocol or for agreement on project plans for time shift applications.

Tier 1: $577.50
This tier is designed to support the early stages of preparing an application, such as guidance and clarification on the types of assessments necessary for the proposed application.

Tier 2: $962.50
This is used for technical advice to support a particular application and to give applicants greater confidence that their proposed submission will contain the relevant information to address the safety, efficacy and trade criteria.

Tier 3: $1,347.50 + $1,155 per additional module chosen
This advice level can include an appraisal of a specific study design and finalisation of project plans for time shift applications.

Rebate: In some circumstances, where a pre-application assistance fee was paid in relation to a proposed product application, your product application fee will be reduced by an amount prescribed in the Agvet Code Regulations.

Modules

The APVMA has developed a guideline for module descriptors to provide guidance as to the modules that will apply for different types of applications. The APVMA will have regard to it, but may depart from it, when determining which modules are necessary on a case by case basis. The guideline is not the law.

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 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.

Module 3: Toxicology

This module 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.

A toxicological assessment is required when moving to a food producing crop or situation for the first time and health based guidance values, such as the Acceptable Dietary Intake (ADI) and/or Acute Reference Dose (ARfD), for the active constituent have not previously been established. This information is needed to ascertain the effects of substances when consumed in the diet, and may result in the development of maximum residue limits (MRLs) in commodities.

A Toxicology – Level 2 (Module 3.2) should be included when moving to a food producing crop or situation for the first time.

A Toxicology – Level 3 (Module 3.3) should be included when there are risks to human health not referred to in module descriptor 3.2. For example, changes required or proposed to existing safety directions, first aid statements and/or poison scheduling.

For the purpose of determining the appropriate module under module 3.1, 3.2 and 3.3, the following products do not normally require toxicological assessment:

a. mineral, vitamin or nutritional supplements for a single animal or a small number of animals that are administered directly to the animal or are administered daily in food or water

b. animal bacterial and viral vaccines.

3.2: Toxicology – Level 2

c. A product containing an approved active constituent for use in a food species for the first time (to establish an ADI, and/or an ARfD).

Module level Module type Timeframe Fee
3.2 Toxicology 9 months $15 795

3.3: Toxicology – Level 3

c. A variation which requires or involves:

  1. changes to the Poisons Standard; and/or
  2. establishing first aid and hazard statements..
Module level Module type Timeframe Fee
3.3 Toxicology 5 months $4 050

Module 5: Residues and trade

Residues assessment includes the establishment of residues definition, maximum residue limits (MRLs), and withholding periods (WHPs), and the assessment of the trade implications including the establishment of any export intervals (EIs).

There are general guidelines for both Residues Part 5A and Overseas trade Part 5B available and you should consider any of the specific guidelines which relate to your product type or extension of use.

A Comprehensive residues assessment (Module 5.1) is required for applications which involve extension of an active constituent to a food crop for the first time.

5.1: Comprehensive residue assessment

c. A variation which involves use on a food species for the first time.

Module level Module type Timeframe Fee
5.1 Residues and trade 13 months $18 170

A Reduced residue assessment (Module 5.2) applies to applications requiring assessment of the residues and trade implications for a crop producing a major export food commodity group with risks of residues and a change to established MRLs is required.

b. Variation of use in a new food species.

c. Variation to change the dose rate or frequency of application to food species and where a change to established MRLs are required.

Module level Module type Timeframe Fee
5.2 Residues  and trade 8 months $10 525

5.4: Limited residue assessment

A Limited Residue Assessment (Module 5.4) applies to variations of WHPs and, where necessary, the establishment of MRLs and the assessment of trade implications of an application to extend use to less than 6 food crops or crops producing feed for food-producing species (not including major export food commodity groups).

b. A variation which involves review of WHPs and trade implications including:

  1. a minor formulation change;
  2. changes to a label which have potential risk of residues where no change to the established MRLs is required; or
  3. residues assessment that is not referred to in module 5 above including establishing or amending Table 5 entries.
Module level Module type Timeframe Fee
5.4 Residues and trade—limited residue assessment 4 months $7 465

Module 6: Work health and safety

A work health and safety (WHS) assessment is required where there is a change to human exposure. Changes to human exposure can occur when extending into new animal species or situations. These exposures include changes such as application dose, route of administration, worker rates and practices including post application activities. The change in exposure may result in a change to the entry in the First aid instructions and safety directions (FAISD) handbook including changes to personal protective equipment (PPE) and re-entry into treated areas or handling of treated animals following application.

Several types of applications for registration of a new product do not require WHS assessment, as the product is not normally associated with any potential risks to human health. Where, however, there is any such risk, an appropriate WHS assessment is required. The types of application for products which do not normally require WHS assessment are as follows:

a. Applications for a permit for a product, registration of a new product or variation of the particulars or conditions of a registered product that are:

  1. animal therapeutics and mineral and nutritional supplements in tablet, capsule, slow release bolus or skin implant form
  2. animal therapeutics which have Therapeutic Goods Administration approval for direct administration to humans and the use pattern indicates low worker exposure potential (that is, not mob or flock treatments with a drench or a pour on, or as a feed additive, or other equivalent use pattern, as these have high worker exposure potential)
  3. mineral, vitamin and nutritional supplements for a single animal or a small number of animals and are administered directly to the animal or into daily food or water
  4. vitamins; digestive enzyme supplements; electrolytes; iron and haematopoietic agents; tonics and stimulants; or preservatives
  5. micro organism and enzyme products for use in non-food species
  6. stockfood additives and nutrition or metabolism products (other than those listed in this paragraph) with established safety directions, which are directly applicable to the concentration of the additive and the form in which it is to be used
  7. animal bacterial and viral vaccines.

A reduced work health and safety assessment (Module 6.2) is required when the application involves a new species or situation or a new application method.

6.2: Reduced work health and safety assessment

c. A variation which involves:

  1. a change in use pattern to include a new species or situation; or
  2. a new application method.
Module level Module type Timeframe Fee
6.2 Workplace health and safety 7 months $3 185

6.3: Work health and safety – Level 3

Work Health and Safety—Level 3 (Module 6.3) is required where the application involves a change or reassessment of user safety directions and/or re-entry or re-handling statements.

b. A variation that is not referred to in module 6.2 above, that requires a WH&S assessment due to a varied exposure scenario (for example, to consider re-handling statements and/or safety directions).

Module level Module type Timeframe Fee
6.3 Workplace health and safety 4 months $2 910

Module 7: 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 assesment is required.

A previous assessment for a companion animal product would have stopped at Question 3 of the VICH phase I assessment. To extend to a food producing species, it will proceed to Question 5 at a minimum.

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).

A Comprehensive Environment Assessment (Module 7.1) applies if the assessment cannot stop in Phase I and a VICH phase II assessment is triggered.

7.1: Comprehensive environment assessment

c. A product, where a VICH Phase II assessment is required and the reference product (including the approved active constituent of the reference product) has only been subject to a VICH Phase I assessment.

The VICH website has guidance on both Phase I and Phase II assessments.

Module level Module type Timeframe Fee
7.1 Environment 13 months $26 390

7.3: Limited environment assessment

b. Applications involving a VICH Phase I environmental impact assessment.

The VICH website has guidance on both Phase I and Phase II assessments.

Module level Module type Timeframe Fee
7.3 Environment 4 months $1 720

Module 8: Efficacy and safety

Efficacy assessment ensures that the product works as described on the label, when used according to label directions.

Safety assessment ensures that the product is safe to use on or in the target crop or animal, when used according to label directions.

An efficacy and safety assessment may include assessing the effect of the product on crops, non-target crops and germinaton, effects of residues, organoleptic tests or pharmacologic studies.

A Comprehensive Efficacy and Safety Assessment (Module 8.1), is required for applications that involve use in or on new food producting species or companion animals.

A Reduced Efficacy and Safety Assessment (Module 8.2) is required for use in/on the same food producing species or companion animal.

A Limited efficacy and safety assessment (Module 8.3) is required where only bioequivalence or pharmaceutical equivalence is required to demonstrate efficacy. Safety will also need to be addressed separately to the efficacy bioequivalence.

8.1.e  A variation which involves use in a new food species or dog, cat or horse.

Module level Module type Timeframe Fee
8.1 Efficacy and target animal safety 6 months $2 370

8.2: Reduced efficacy and safety

c. A variation which involves:

  1. use on a new pest or disease or for a new purpose in the same food species or companion animal; or
  2. a change to the dosage or administration instructions—including treatment number, frequency, duration, dose, and route of administration—in the same food species or companion animal.
Module level Module type Timeframe Fee
8.2 Efficacy and target safety 4 months $975

8.3: Limited efficacy and safety

h. A variation which involves:

  1. use in a non-food species (other than a dog, cat or horse): or
  2. where only bioequivalence or pharmaceutical equivalence is required to demonstrate the efficacy and safety.
Module level Module type Timeframe Fee
8.3 Efficacy and target safety 3 months $580

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.

a. A product containing an approved antibiotic active constituent and which is expected to result in significantly increased volume of use of the approved antibiotic active constituent or an increased risk to public health including:

  1. a variation of use to a new food species, or a dog or a cat;
  2. a variation of use to another major group within the same food species (for example: broiler chickens to layers; beef cattle to dairy cattle); or
  3. a change in dosage form or use pattern (for example: from use in individual animals to mass medication).
Module level Module type Timeframe Fee
10.2 Antimicrobial resistance 7 months $Nil

b. A product containing GMOs requiring a module 10 assessment that is not included in module 10 above.

Module level Module type Timeframe Fee
10.3 Genetically modified organism 7 months $Nil

Module 11: 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.

Note: Module 11.2 is included when fewer than 3 modules between 2.1 to 10.3 apply and module 11.1 is included when 3 or more modules between 2.1 to 10.3 apply.

11.1: Finalisation

b. A variation where three or more modules between 2.1 to 10.3 apply.

Module level Module type Timeframe Fee
11.1 Finalisation 3 months $4 055

11.2: Finalisation – Level 2

b. A variation where fewer than three modules between 2.1 to 10.3 apply.

Module 12: Limits on use of information

Module 12 relates to the protection, handling and use of information provided to the APVMA. In general, the APVMA must not use 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 Module type Timeframe Fee
12 Data protection N/A $460

Pre-application assistance

Pre-application assistance is designed to give applicants advice on the requirements for an application before submission. It can also be used to obtain an appraisal on a trial protocol or for agreement on project plans for time shift applications.

Tier 1: $577.50
This tier is designed to support the early stages of preparing an application, such as guidance and clarification on the types of assessments necessary for the proposed application.

Tier 2: $962.50
This is used for technical advice to support a particular application and to give applicants greater confidence that their proposed submission will contain the relevant information to address the safety, efficacy and trade criteria.

Tier 3: $1,347.50 + $1,155 per additional module chosen
This advice level can include an appraisal of a specific study design and finalisation of project plans for time shift applications.

Rebate: In some circumstances, where a pre-application assistance fee was paid in relation to a proposed product application, your product application fee will be reduced by an amount prescribed in the Agvet Code Regulations.

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 of use)
  • e-label.

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

You may choose to:

  • pay the total fee on submission or
  • pay the preliminary assessment fee of $710 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).

Supporting information

The application must contain, or be accompanied by, information relevant to the whether the chemical poduct 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 relvant 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.

You should also consult the international technical guidance material which have been adopted by the APVMA to satisfy the s5 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.

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.

Any document (information) submitted with the application constitutes information for the purposes of the information list. This includes supporting information, such as consent for use letters, manufacturer's declarations, MSDS, certificates of analysis, GMP certificates and other such documentation, in addition to the scientific studies or data that may be submitted to specifically address the safety, trade and efficacy criteria.

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 the information. Applicants should take care not to inadvertently divulge confidential commercial information (CCI) when creating the list.

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 (sections 5D and 14 of the Agvet Code). 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.

Pre-application assistance

Pre-application assistance is designed to give applicants advice on the information and module requirements of an application prior to submission. It can also be used to obtain an appraisal on a trial protocol or for agreement on project plans for time shift applications.

Tier 1: $577.50
This tier is designed to support the early stages of preparing an application, such as guidance and clarification on the types of assessments necessary for the proposed application.

Tier 2: $962.50
This is used for technical advice to support a particular application and to give applicants greater confidence that their proposed submission will contain the relevant information to address the safety, efficacy and trade criteria.

Tier 3: $1,347.50 + $1,155 per additional module chosen
This advice level can include an appraisal of a specific study design and finalisation of project plans for time shift applications.

Rebate: In some circumstances, where a pre-application assistance fee was paid in relation to a proposed product application, your product application fee will be reduced by an amount prescribed in the Agvet Code Regulations.

Examples

Scenario 1: Addition of a food-producing species

Objective

Application is made to vary a veterinary injectable analgesic chemical product to extend the use from dogs and horses, to a use in cattle.

The analgesic product is a registered veterinary chemical product with a statement of claims for use for pain relief in dogs and horses. The product has not been registered for use in cattle before in Australia. There are no other variations proposed.

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 cattle.

Application requirements

An application of this nature is considered under a technical variation as data would need to be provided to demonstrate that the product would continue to meet the efficacy and safety criteria, when used on cattle. You will need to provide information that demonstrates the toxicity of the product in relation to human consumption to allow the establishment of an ADI and ARfD, as well as residues information to allow the MRL and WHP and ESIs to be determined. You will also need to provide evidence of any trials or experiments have been carried out to determine the efficacy and safety of the product as an analgesic for cattle.

Assessment modules

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 30 days $710
2: Chemistry No assessment required as the product is currently registered and there are no changes to the product formulation or packaging
3: Toxicology Assessment of toxicology is required as it is noted that health based guidance values such as an Acceptable Daily Intake (ADI) and/or Acute Reference Dose (ARfD) are not established for this analgesic. This is likely as the only approved uses are for non-food producing species. In this instance when extending to a food producing species for the first time the establishment of an ADI and/or ARfD is necessary
3.2 9 months $15 795
4: Toxicology—Poison scheduling No assessment required as the product is currently registered and relevant scheduling is established
5: Residues and trade Assessment of residues is required with cattle being the first food producing species. A residue assessment is required to establish a residue definition, MRLs, withholding period and export intervals. The assessment would consider metabolism of the active and ensure residues are within acceptable residual limits (MRLs). As cattle is considered a major export commodity a trade assessment will also be necessary
5.1 13 months $18 170
6: Workplace health and safety No assessment required as the method of application remains the same
7: Environment Assessment of environment is required as the environmental exposure from the use in cattle is increased compared to that previously assessed for use in dogs and horses
7.3 4 months $1 720
8: Efficacy and safety Assessment of efficacy and target animal safety will be necessary to determine the efficacy of the product as an anaesthetic for cattle
8.1 6 months $2 370
9: Non-food trade No assessment required as cattle are a traded food commodity
10: Special data No assessment required as not antibiotic and doesn’t contain any GMOs
11: Finalisation 11.1 3 months $4 055
12: Limits of use 12.0 N/A $460
Total   16 months $43 280

Start an application

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

You will be redirected to online services to log in.