A full assessment (Item 1) involves a comprehensive assessment of data for both the active constituent/s and the proposed chemical product is required for chemistry and manufacture, toxicology, poisons scheduling, residues and trade, worker health and safety, environment and efficacy and safety. It may also include trade and special data modules, if applicable.

Applications involving less than full assessment (Item 2) include where the active constituent is:

  • a biological
  • currently used in domestic or industrial chemicals
  • an adjuvant for use with other agricultural products
  • proposed for uses (excluding vertebrate poisons) only in:
    • a non-food crop
    • domestically in the home, home garden or a swimming pool or spa
    • buildings not used in animal production (for example, warehouses, offices, or glasshouses).

Alternatively, a timeshift application (Item 27) may apply which allows flexibility for the staged submission of data to support an application. This can streamline an application with longer assessments such as toxicology and environment by commencing those assessments before the data for efficacy and crop safety are submitted for assessment. Timeshift applications can also be used to facilitate global joint reviews (GJRs) and the use of overseas assessments.

Note: The APVMA encourages the submission of international assessments to support applications for the approval of new active constituents and registration of new products. The submission of international assessments and underlying data may reduce assessment timeframes for major applications.

1. Pre-application assistance

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

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. 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.

2.3. 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.

2.4. 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:

2.5. 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.

4. Timeframe and fees

An application for approval of a new active constituent and registration of a product where less than a full assessment is required is a modular application type, therefore the fees and timeframe are variable according to the assessments necessary. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.

Depending on the registration being sought, one or more of the following module types and levels will be relevant to Item 2 applications:

Module type Timeframe Fee
Preliminary assessment Not applicable $902
Chemistry 1 or
Chemistry 2

13 months

9 months

$11 074

$3 075
Health 1 or
Health 2 or
Health 3

13 months

11 months

9 months

$36 740

$27 920

$18 980
Poisons scheduling 13 months

$2 435
Residues 1 or
Residues 4

13 months

4 months

$25 650

$7 465
Environment 1 or
Environment 2 or
Environment 3

13 months
7 months

4 months

$26 390

$7 659

$2 979
Efficacy 1 6 months $4 740
Non-food trade (if applicable) 6 months $1 175
Special data 3 (if applicable) 7 months Nil
Finalisation 1 3 months $8 110
Limits on use (data protection) Not applicable $460

5. 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. 

5.1. 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.

5.2. 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
8.1 Efficacy and target crop safety 6 months $4 740

5.3. Non-food Trade

The Non-food Trade module is applied to applications involving trade risks not related to food residues.

Module level Module type Timeframe Fee
9 Non-food trade 6 months $1 175
Module level Module type Timeframe Fee
10.3 Genetically modified organism 7 months $Nil

5.4. 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.

5.5. 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.

The APVMA may decide that a residues assessment is not required when an agricultural chemical is unlikely to enter the food chain through the proposed use pattern.

This would apply to situations such as termiticides, pool products and turf products where grazing of turf and feeding of grass clippings to livestock is not permitted and products for control of urban pests where contact with food is not expected.

5.5.1. Residues 1

Registration of a new product containing a new active constituent requiring approval with first uses in a food species, other than mentioned in Residues 4.

Module

Timeframe

Fee

Residues 1

13 months

$25 650
Module level Timeframe Fee
Residues 4 4 months $7 465

5.6. 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.

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

5.7. 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 germination, effects of residues, organoleptic tests or pharmacologic studies.

5.7.1. Finalisation 1

Registration of a new product where:

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

Module level

Timeframe

Fee

Finalisation 1

3 months

$8 110
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

5.8. 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
Module level Module type Timeframe Fee
7.1 Environment 13 months $26 390

5.9. Chemistry

There are general guidelines for chemistry and manufacture of agricultural and veterinary products available and you should consider any of the specific guidelines which relate to your product type.

5.10. Poisons scheduling

A poisons scheduling assessment is required for the consideration of a new active constituent for inclusion in the Poisons Standard, produced by the Therapeutic Goods Administration.

All new agricultural and veterinary substances require consideration under the Poisons Standard, before an active constituent can be approved, and a product containing that substance registered by the APVMA.

Module level

Timeframe

Fee

Poisons scheduling

13 months

$2 435

5.10.1. 5: Residues – Level 1

5.10.2. 7.1: Environment—Level 1

The APVMA may decide that a residues assessment is not required when an agricultural chemical is unlikely to enter the food chain through the proposed use pattern.

This would apply to situations such as termiticides, pool products and turf products where grazing of turf and feeding of grass clippings to livestock is not permitted and products for control of urban pests where contact with food is not expected.

5.10.3. 7.1: Environment—level 1

5.10.4. Special Data 3

Registration of a new product containing a GMO.

Module level

Timeframe

Fee

Special Data 3

7 months

$Nil

5.10.5. Chemistry 1

Approval of a new active constituent with or without registration of a new product and requiring a full chemistry assessment.

Module level

Timeframe

Fee

Chemistry 1

13 months

$11 074

5.10.6. Chemistry 2

Registration of a new product containing a new active constituent requiring approval or approval of a new active constituent alone and not mentioned in Chemistry 1. Chemistry 2 includes, for example:

  • new biological active constituents not mentioned below or in Chemistry 1
  • new immunobiologicals
  • immunobiological products with a major change to seed strains (including substitution of source or the addition of antigen) such that it is considered a new product
  • new direct fed microbial products
  • new enzyme products
  • new herbal products.

Module level

Timeframe

Fee

Chemistry 2

9 months

$3 075

5.10.7. Health 1

Registration of a new product for food species, containing a new active constituent requiring approval, including a toxicology and exposure assessment, other than described in Health 3.

Module level

Timeframe

Fee

Health 1

13 months

$36 740

5.10.8. Health 2

Approval of a new active constituent with food species uses requiring approval, where no exposure assessment is required.

Module level

Timeframe

Fee

Health 2

11 months

$27 920

5.10.9. Health 3

Approval of a new active constituent for use in a non-food species.

Registration of a new product, or approval of a permit for a product, with a new active constituent requiring approval for use in a non-food species.

Module level

Timeframe

Fee

Health 3

9 months

$18 980

5.10.10. Residues 4

Registration of a new product containing a new or approved active constituent, to be first used on a food crop, or approval of a permit, where a Table 5 entry in the Agricultural and Veterinary Chemicals Code (MRL Standard) Instrument 2019 is likely to be appropriate.

Module level

Timeframe

Fee

Residues 4

13 months

$25 650

5.10.11. Environment 1

Registration of a new product containing a new active constituent requiring approval, not mentioned in Environment 3.

Module level

Timeframe

Fee

Environment 1

13 months

$26 390

5.10.12. Environment 2

Registration of a new product containing a new biological active constituent requiring approval.

Module level

Timeframe

Fee

Environment 2

7 months

$7 659

5.10.13. Environment 3

Registration of a new product containing a new or approved active constituent, where the product is not a vertebrate poison and is for use in:

  • the home, home garden, swimming pool, or spa; or
  • buildings not used in animal production (e.g. warehouses, glasshouses, offices); and
  • the product is not comparable to a registered product with the same active constituent and use, applied at equivalent or high dose, rate or frequency, and no new consideration of environment exposure is required.

Module level

Timeframe

Fee

Environment 3

4 months

$2 979

5.10.14. Efficacy and Safety 1

Registration of a new product containing a new active constituent.  

Module level

Timeframe

Fee

Efficacy and Safety 1

6 months

$4 740

5.10.15. Non-food Trade

A product involving trade risks not related to food residues, including:

  1. residues in wool and fibre, or
  2. genetically modified produce.

Module level

Timeframe

Fee

Non-food Trade

6 months

$1 175

5.11. Special Data

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).

5.11.1. Special Data 1

Approval of a new active constituent containing a GMO.

Module level

Timeframe

Fee

Special Data 1

13 months

$Nil

6. What you need to provide

6.1. 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.

6.2. 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).

6.3. 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.

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.

6.4. 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.

To meet the application requirements you will need to provide:

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

6.5. Supporting information

The application must contain, or be accompanied by, information relevant to whether the chemical 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 provide it with the application. If the APVMA accepts the justification for non-submission of specific data the application may be recategorised as an Item 2 application and appropriate modules will apply.

Relevant data for module levels – agricultural 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 toxicology 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 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 non-food trade 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.

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

The APVMA may not consider supporting information when relevant restricted information is listed for the reference product unless one of the following exceptions apply:

  • The applicant is the authorising party for the data associated with the reference product.
  • The applicant has obtained consent for use from the relevant authorising party or parties. This consent for use must be explicit and include the relevant data numbers.

Protected/restricted data details are listed in the APVMA PubCRIS database for the reference product.

6.7. Pre-application assistance

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

6.8. Supporting information

The application must contain, or be accompanied by, information relevant to 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, efficacy and trade criteria. Applicants should include an explanation of why they believe supporting information is not required if they choose not provide it with the application.

Relevant data for module levels—agricultural 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
  • Residues
    Detailed data guidelines for residues are in Part 5A
    Detailed data guidelines for trade are in Part 5B
  • 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.

7. Examples

7.1. Scenario 1: Register a new product with a new biological active constituent requiring less than a full assessment

7.1.1. Objective

An application to register a pathogenic fungi (active constituent) as a soluble powder (product), for control of insects in defined agricultural and horticultural situations.

7.1.2. Application type

This application is considered under Item 2 (Register a new product that also contains a new active constituent) less than a full assessment is required, i.e. reduced assessments for some modules can be justified even though the application involves a new active constituent.

7.1.3. Assessment

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 Timeframe Fee

Preliminary assessment

N/A

$902

Chemistry 2

A reduced assessment is applied as the active consistent is a biological chemical active

9 months

$3 075

Health 4

A limited assessment is required as the product contains a new biological active for food crop uses

5 months

$7 963

Poisons scheduling

Poison scheduling needs to be considered as the active constituent involves new chemistry

13 months

$2 435

Residues and Trade 4

A reduced assessment can be applied as the residues are indistinguishable from natural food components

4 months

$7 465

Environment 2

As the product contains a new biological active constituent, assessment is required to determine the impacts on the environment for the proposed usage pattern(s)

7 months

$7 659

Efficacy and Safety 1

A full assessment is required to assess application rates, methods of application and label claims

6 months

$4 740

Non-food Trade

Not required as none of the target crop groups includes non-food traded commodity

Special Data

Not required as the new active constituent is not intended for use on animals and does not contain any GMOs

Finalisation 1

3 months

$8 110

Limits on use (data protection)

N/A

$460

Total

16 months

$42 809

7.2. Scenario 2: Register a new product with a new active constituent for a non-food related use only in urban situations

7.2.1. Objective

An application to register a new insecticide product for the control of ants in urban situations.

7.2.2. Application type

This application is considered under Item 2 (Register a new product that also contains a new active constituent) less than a full assessment is required ie reduced assessments for some modules can be justified even though the application involves a new active constituent.

7.2.3. Assessment

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

Module type Timeframe Fee

Preliminary assessment

N/A

$902

Chemistry 1

A full assessment is required as the active constituent in the insecticide is an active constituent manufactured by chemical synthesis

13 months

$11 074

Health 3

As the product contains a new active constituent for non-food uses, a reduced assessment is required

9 months

$18 980

Poisons scheduling

Poison scheduling needs to be considered as the active constituent involves new chemistry.

13 months

$2 435

Residues and Trade

A residues assessment is not required as the product is not intended for use in a non-food-producing situation

Environment 3

A limited assessment can be applied as the product is only intended for use in urban situations.

4 months

$2 979

Efficacy and Safety 1

A full assessment is required to assess application rates, methods of application and label claims

6 months

$4 740

Non-food Trade

Not required as none of the target crop groups includes non-food traded commodity

Special Data

Not required as the new active constituent is not intended for use on animals and does not contain any GMOs

Finalisation 1

3 months

$8 110

Limits on use (data protection)

N/A

$460

Total

16 months

$49 680

8. Start an application

To register a new product which contains a new active constituent (Item 2):

Start application

You will be redirected to our Online Services Portal to log in.