I want to register a new product with an existing active or new combination of approved actives

Registering a new agvet chemical product containing an existing active may be assessed under:

  • Item 10 – New product – Modular assessment.

Common application types submitted under Item 10 include:

  • a new formulation type for an existing active
  • a new combination of existing actives
  • novel uses for an existing active

Applications that do not meet the requirements of Item 10 include:

Note: If your proposed product meets the requirements of Item 3, 4, 5, 6, 7, 8 or 9 then you must lodge your application under the relevant item and not as an Item 10.

Under an Item 10 application, you must address all of the statutory criteria. This may be done by any one, or a combination of, the following methods:

  • nominating a reference product
  • providing supporting data for assessment
  • providing a valid scientific argument
  • submitting technical reports previously undertaken by the APVMA
  • provision of overseas data assessments together with associated data underpinning the assessment.

The supporting data required by the APVMA for an Item 10 application will vary according to how novel the proposed product is compared to existing registered products and their approved uses and the relevance to the statutory criteria for the proposed new product.

In addition to the provision of new data, a valid scientific argument can be provided to satisfy specific risk areas. This may refer to other currently registered products (reference product), be supported by published information or be used to validate extrapolation from similar situations including the relevance of overseas studies to the Australian situation.

Reference products must be agvet chemical products currently registered by the APVMA. You can find registered chemical products and actives via APVMA’s registered chemical products search tool. Where nomination of an existing registered product is provided as the reference product applicants should justify the relevance of the reference product to each of the relevant risk areas.

If an assessment has previously been undertaken by the APVMA (eg a technical assessment under Item 25, or assessment undertaken as part of a previous application where the individual assessment was supportive), you may submit that assessment in support of the application. You may need to resubmit the data underpinning the assessment for the APVMA to apply limits of use of information. If the assessment is historical, the relevance to the assessment to current agronomic practices and the current application should be addressed.

Which application form do you need?

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.

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.

Major formulation change

For the purpose of selecting the appropriate level of module assessment, a major formulation change is defined as any change to the formulation compared to a reference product formulation that includes:

  • a new combination of existing (registered) active constituents
  • a significant increase in the concentration of an active constituent
  • a change to a non-active constituent that significantly affects the performance, stability or other attributes of the product
  • a change to the formulation type to accommodate a new application method, dose form or use pattern
  • a significant change to product specifications.

Timeframe and fees

An Item 10 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 to register a new product with an existing active or new combination of approved actives must satisfy the statutory criteria of safety, efficacy and trade. The following table examines each assessment module and provides guidance of what modular assessments, levels, timeframe and associated fees may apply to this application. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for this extension for Modules 2–10.

Module type Module level Timeframe Fee
1: Preliminary assessment 1.0 Not applicable $710
2: Chemistry 2.3 6 months $1 580
3: Toxicology

3.2 or

3.3

9 months

5 months

$15 795

$4 050

5: Residues and trade

5.2 or

5.4

8 months

4 months

$10 525

$7 465

6: Work health and safety

6.2 or

6.3

7 months

4 months

$3 185

$2 910

7: Environment

7.2 or

7.3

7 months

4 months

$7 315

$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 10.3 7 months Nil
11: Finalisation

11.1 or

11.2

3 months

2 months

$4 055

$1 545

12: Limits of use 12.0 N/A $460
Example
Scenario Modules Timeframe Fee

1: New product containing a combination of existing actives in registered products

1, 2.3, 3.3, 6.2, 7.2, 8.1, 11.1 and 12

11 months

16 months (extended assessment period)

$23 725

2: New product containing an existing active constituent but with a new formulation type

1, 2.3, 3.3, 5.2, 6.2, 7.2, 8.1, 11.1 and 12

11 months

16 months (extended assessment period)

$34 250

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 available to give applicants advice on the requirements of an application before submission.

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.

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 2: Chemistry

The chemistry module includes assessment of the following aspects:

  • the active constituent
  • the formulated chemical product
  • the manufacturing process
  • quality control
  • specifications
  • batch analysis
  • storage stability
  • analytical methods
  • packaging and labelling.

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.

2.3: Chemistry – Level 3

Register a new product that contains an approved active constituent:

b. All products.

Module level Module type Timeframe Fee
2.3 Chemistry—Limited assessment 6 months $1 580

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.

3.2: Toxicology – Level 2

b. A product containing an approved active constituent for use in a food crop 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

b. A product containing an approved active constituent which requires or involves:

  1. changes to the Poisons Standard; and/or
  2. establishing first aid and hazard statements;
  3. a new combination of approved actives; and/or
  4. a major formulation change.
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 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.

A Limited Residue Assessment (Module 5.4) is required for the registration of chemical products containing a new active constituent where the product is to be used in a food producing crop or animal feed and the establishment of MRLs is unlikely for the proposed use pattern.

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, 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.

5.2: Reduced residue assessment

a. A product containing an approved active constituent where consideration of MRLs and WHPs and/or trade implications are required for:

  1. a food crop that produces a major export food commodity group; or
  2. six or more food crops.
Module level Module type Timeframe Fee
5.2 Residues  and trade 8 months $10 525

5.4: Limited residue assessment

a. A product containing an approved active constituent where consideration of MRLs and WHPs and/or trade implications are required for:

  1. less than six food crops; and
  2. where trade consultations are not required.
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 crops or situations. These exposures include changes such as application rate, method, 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 following application.

Work Health and Safety – Level 2 (Module 6.2) is required when the application involves an extension to a new crop group or situation.

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.

6.2: Work health and safety – Level 2

a. A product containing an approved active constituent which requires or involves:

  1. changes to the Poisons Standard; and/or
  2. establishing safety directions.
Module level Module type Timeframe Fee
6.2 Workplace health and safety 7 months $3 185

6.3: Work health and safety – Level 3

a. A product that is not referred to in module 6.2 above including an assessment of human exposure to establish re-entry/re-handling statements and/or vary 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.

An Environment Assessment Level 2 (Module 7.2) will apply to most applications to register or vary a chemical product, except those that meet the criteria for an Environment Assessment Level 3 (Module 7.3) ie new products (other than a vertebrate poison) for use in a domestic or commercial setting.

7.2: Environment – Level 2

a. A product which involves:

  1. a new combination of approved active constituents;
  2. vertebrate poisons;
  3. a major formulation change; or
  4. use in any crop or situation (other than those described in module 7.3 below) unless there is a registered product with the same use, active(s) in a similar formulation type at an equivalent or higher dose, rate and frequency and no new consideration of environmental exposure is required.
Module level Module type Timeframe Fee
7.2 Environment 7 months $7 315

7.3: Environment – Level 3

a. A product with a new active constituent (excluding vertebrate poisons) where the product is for use:

  1. domestically in the home, home garden or a swimming pool or spa;
  2. in buildings not used in animal production (for example, warehouses, offices, or glasshouses).
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.

Major changes in formulation normally require an Efficacy and Safety Assessment Level 1 (Module 8.1). If, however, the applicant provides valid scientific argument regarding submission of relevant efficacy or safety data to justify a lower level of assessment a Efficacy and Safety Assessment Level 2 (Module 8.2) can be applied. An Efficacy and Safety Assessment Level 3 (Module 8.3) can be applied where the change in formulation is likely to affect only efficacy or safety, or if comparable efficacy or bioequivalence with the previous formulation.

8.1: Efficacy and safety – Level 1

b. Registration of a product which involves:

  1. use in a new crop which is in a new crop group or new situation; or
  2. a new formulation type; or
  3. a new combination of approved active constituents.
Module level Module type Timeframe Fee
8.1 Efficacy and target crop safety 6 months $2 370

8.2: Efficacy and safety – Level 2

a. Registration of a product which involves:

  1. a new domestic or home garden use;
  2. a new minor use with the same general use pattern as an existing registered product;
  3. a new pest or new crop within the same crop group or situation with the same general use pattern as an existing registered product; or
  4. a formulation change not considered similar to an existing registered product, not covered by 8.1 or 8.3 and where efficacy and crop safety data is required.
Module level Module type Timeframe Fee
8.2 Efficacy and target safety 4 months $975

8.3: Efficacy and safety – Level 3

a. A product where only bioequivalence (including scientific argument) is required to demonstrate the efficacy and crop safety to a currently registered product where the product is defined as similar to an existing registered product.

Module level Module type Timeframe Fee
8.3 Efficacy and target safety 3 months $580

Module 9: Non-food trade

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

9: Non-food trade

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

  1. residues in wool and fibre, or
  2. genetically modified produce.
Module level Module type Timeframe Fee
9 Non-food trade 6 months $1 175

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.

Specifically, you should consider the following guidelines:

10.3: Special data – Level 3

a. A product containing GMOs.

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.

11.1: Finalisation – level 1

a. A product where three or more modules from 2.1 to 10.3 apply.

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

11.2: Finalisation – Level 2

a. A product where less than three modules from 2.1 to 10.3 apply.

Module level Module type Timeframe Fee
11.2 Finalisation 2 months $1 545

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

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
  • APVMA product number(s) for your nominated reference product(s)
  • 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 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. 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 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.

Data requirements

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.

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

An application cannot be determined to be the same when protected 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 data details are listed in our product search database record for the reference product.

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.

Examples

Scenario 1: Registration of a new product containing a combination of existing actives in registered products

Objective

An applicant wishes to register an SC fungicide which includes two active constituents for the control of a range of fungal diseases in wheat. There are two reference products nominated, one for each of the proposed active constituents. In each case the reference product is a soluble concentrate and has a use pattern with similar application rates and application methods as those proposed for this product. Both reference products are currently registered for the control of stripe rust in wheat, the proposed use pattern for the new product includes additional fungal diseases in wheat at the same application rate, frequency and timing of application.

Application type

This application is considered under a modular assessment—new product (Item 10) as the new product is based on a new combination of actives which are in other registered products and is not the same, similar or closely similar to a registered product.

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 Module level Timeframe Fee

1: Preliminary assessment

1

Not applicable

$710

2: Chemistry

Assessment is required of the chemistry and manufacturing aspects of the new formulation are required

2.3

6 months

$1 580

3: Toxicology

Assessment is required to consider the acute toxicology of the novel formulation/combination of existing actives

3.3

5 months

$4 050

4: Toxicology—Poison scheduling

No assessment required as both active constituents have previously been scheduled

5: Residues and trade

In this situation, no assessment of residues and trade is required as the new product is applied at the same rate of active, frequency and timing and same crop as previously assessed for both actives

 

In situations where the change also leads to a change in formulation type or when additional crops or higher rates of application are sought, compared to other registered products, a residues assessment is required

6: Work health and safety

Assessment of the health and safety is required as new safety directions will be assessed for the new combination

6.2

7 months

$3 185

7: Environment

A reduced environment assessment is required as the new product is based on a combination of existing actives

7.2

7 months

$7 315

8: Efficacy and safety

Assessment of efficacy and safety is required as the new product is a new combination of existing active constituents and includes the control of new diseases

8.1

6 months

$2 370

9: Non-food trade

No assessment required as this application is for a food producing crop or situation

10: Special data

No assessment required as neither the product nor the crop contain any GMO’s

11: Finalisation

11.1

3 months

$4 055

12: Limits of use

12

Not applicable

$460

Total

10 months

$23 725

Scenario 2: Registration of a new product which contains an existing active constituent but with a new formulation type

Objective

An applicant applies for a new insecticide product for foliar application in pome fruit based on a reference product which has the same active constituent. The proposed product is a wettable granule (which is to be mixed with water before application), whereas the reference product is a soluble concentrate. The label claims, application rate of active constituent, timing of application and critical comments for the proposed label are the same as those on the reference product.

Application type

This application is considered under a modular assessment—new product (Item 10) as the new product is based on an existing active constituent but with a new formulation type and is not the same, similar or closely similar to a registered product.

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 Module level Timeframe Fee

1: Preliminary assessment

1

Not applicable

$710

2: Chemistry

Assessment of the chemistry of the product is required

2.3

6 months

$1 580

3: Toxicology

Assessment is required to consider the acute toxicology of the new formulation type

3.3

5 months

$4 050

4: Toxicology—Poison scheduling

No assessment required as the active constituents have previously been scheduled (unless scheduling was limited to a specific formulation type)

5: Residues and trade

Assessment of residues and trade implications is required as the new product involves a new formulation type in a major export commodity

5.2

8 months

$10 525

6: Work health and safety

Assessment of the health and safety is required as the new product involves a new formulation type requiring the assessment of new safety directions

6.2

7 months

$3 185

7: Environment

Assessment of the environmental impact is required due to the new formulation type

7.2

7 months

$7 315

8: Efficacy and safety

Assessment of efficacy and crop safety is required due to the new formulation type

8.1

6 months

$2 370

9: Non-food trade

No assessment required as this application is for a food producing crop or situation

10: Special data

No assessment required as neither the product nor the crop contain any GMO’s

11: Finalisation

11.1

3 months

$4 055

12: Limits of use

12

Not applicable

$460

Total

11 months

$34 250

Start an application

If you want to register a new product which contains a combination of existing actives in registered products (Item 10):

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