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

Legislation
Timeframe and fees
Modules
What you need to provide
Examples
Start an application

1. Legislation

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.

1.1. 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:

Safety (section 5A).

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.

Efficacy (section 5B)

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.

Trade (section 5C)

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.

Labelling (section 5D)

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.

1.2. 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.

1.3. 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:

1.4. 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.

1.5. 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.

2. 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.

2.1. Pre-application assistance

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

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. Preliminary assessment, Finalisation and Limits on use modules are mandatory modules for this application. Considerations are necessary for this extension for other, technical modules.

Module type	Module level	Timeframe	Fee
Preliminary assessment	N/A	Not applicable	$902
Chemistry	3	6 months	$1 954
Health	3 or 4	9 months 5 months	$18 980 $7 963
Poisons Scheduling	N/A	13 months	$2 435
Residues and Trade	1 or 2 or 3 or 4 or 5	13 months 8 months 6 months 4 months 3 months	$25 650 $11 149 $9 000 $7 465 $2 000
Environment	1 or 2 or 3 or 4	13 months 7 months 4 months 3 months	$26 390 $7 659 $2 979 $1 490
Efficacy and Safety	1 or 2 or 3	6 months 4 months 3 months	$4 740 $1 950 $1 160
Non-food Trade	N/A	6 months	$1 175
Special Data	3	7 months	Nil
Finalisation	1 or 2	3 months 2 months	$8 110 $3 090
Limits on use (data protection)	N/A	N/A	$460

3. 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.

3.1. 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.

3.2. 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.

3.3. Non-food Trade

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

3.4. Special Data

This module applies to all applications for registration of a new chemical products that contain active constituents which contain genetically modified organisms (GMOs).

Specifically, you should consider the following guidelines:

3.5. 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.

3.5.1. Health 3

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

Module level	Timeframe	Fee
Health 3	9 months	$18 980

3.6. 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.

3.6.1. 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

3.6.2. Residues 4

Registration of a new product for use in one to 3 crops or crop groups.

Registration of a new product containing an approved active constituent, to be first used on a food crop 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	4 months	$7 465

3.7. 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 assessment is required.

3.7.1. Environment 1

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

Module level	Timeframe	Fee
Environment 1	13 months	$26 390

3.7.2. Environment 2

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

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

Module level	Timeframe	Fee
Environment 2	7 months	$7 659

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

3.8.1. 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

3.8.2. Finalisation 2

Registration of a new product where:

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

Module level	Timeframe	Fee
Finalisation 2	2 months	$3 090

3.9. 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

3.9.1. Efficacy and Safety 1

b. Registration of a product that involves:

use in a new crop which is in a new crop group or new situation; or
a new formulation type; or
a new combination of approved active constituents.

Module level	Timeframe	Fee
Efficacy and Safety 1	6 months	$4 740

3.9.2. Non-food Trade

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

residues in wool and fibre, or
genetically modified produce.

Module level	Timeframe	Fee
Non-food Trade	6 months	$1 175

3.9.3. Special Data 3

Registration of a new product containing a GMO.

Module level	Timeframe	Fee
Special Data 3	7 months	$Nil

3.9.4. Efficacy and Safety 2

a. Registration of a product that involves:

a new domestic or home garden use;
a new minor use with the same general use pattern as an existing registered product;
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
a formulation change not considered similar to an existing registered product, not covered by Efficacy and Safety 1 or Efficacy and Safety 3 and where efficacy and crop safety data is required.

Module level	Timeframe	Fee
Efficacy and Safety 2	4 months	$1 950

3.9.5. Efficacy and Safety 3

Registration of 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	Timeframe	Fee
Efficacy and Safety 3	3 months	$1 160

3.10. 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.

3.10.1. Chemistry 3

Registration of a new product containing an approved active constituent.

Module level	Timeframe	Fee
Chemistry 3	6 months	$1 954

Major changes in formulation normally require an efficacy and safety assessment 1. If, however, the applicant provides valid scientific argument regarding submission of relevant efficacy or safety data to justify a lower level of assessment an efficacy and safety assessment 2 can be applied. Efficacy and safety assessment 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.

3.10.2. Health 4

Registration of a new product containing an approved active constituent, which results in one or more of:

changes to the Poisons Standard/Health Based Guidance Value (ADI/ARfD)
establishment of first aid instructions and hazard statements where exposure modelling is also required
a new combination of approved actives
a major formulation change compared to previously assessed formulations.

Module level	Timeframe	Fee
Health 4	5 months	$7 963

3.10.3. Residues 2

Registration of a new product containing an approved active constituent for use on:

a food crop that produces a major export commodity, where finite residues are expected, and consideration of Maximum Residue Limits, Withholding Periods, and/or trade implications is required
more than 6 food crops or crop groups.

Module	Timeframe	Fee
Residues 2	8 months	$11 149

3.10.4. Residues 3

Registration of a new product for use on:

a food crop that produces a major export commodity, where finite residues are not expected, or where no changes to Maximum Residue Limits are required
4 to 6 crops or crop groups.

Module	Timeframe	Fee
Residues 3	6 months	$9 000

3.10.5. Residues 5

Registration of a new product where the active constituent is already listed in Table 5 in the Agricultural and Veterinary Chemicals Code (MRL Standard) Instrument 2019 to add a new use.

Registration of a new product to add a new use on one crop which is not a major export commodity and does not produce animal feed.

Module	Timeframe	Fee
Residues 5	3 months	$2 000

3.10.6. Environment 3

Registration of a new product containing an 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
is for use in 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.

Registration of a new product functioning as an adjuvant or surfactant, or a new biological product containing an approved active constituent unless another registered product exists 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

3.10.7. Environment 4

Registration of a new product containing an approved active constituent, requiring assessment of only new spray-drift reduction technology, and/or deposition curve

Module level	Timeframe	Fee
Environment 4	3 months	$1 490

4. What you need to provide

4.1. Completed online application form

First time applicants will need to complete an online services new user access form to access the APVMA Online Services Portal.

If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.

4.2. The application fee

You may choose to:

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

You can choose to pay by credit card, electronic funds transfer or BPAY.

Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).

4.3. 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.

4.4. 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.

4.5. 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.

4.6. 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.

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 on use)
e-label.

4.7. 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 to 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 modules -- 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 health assessment are available in Part 3 and Part 6
Residues
- Detailed data guidelines for residues are in Part 5A
- Detailed data guidelines for trade are in Part 5B
Environment
- Detailed data guidelines for environment are in Part 7
Efficacy and host crop safety
- Detailed data guidelines for efficacy and safety are in Part 8
Trade
- Detailed data guidelines for trade are in Part 5B
Non-food trade
- For applications referred to at 9 of the module descriptors 6A guidelines, 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

5. Examples

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

5.1.1. 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.

5.1.2. 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.

5.1.3. 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	Module	Timeframe	Fee
Preliminary assessment			$902
Chemistry	Assessment is required of the chemistry and manufacturing aspects of the new formulation
Chemistry	Chemistry 3	6 months	$1 954
Health	Assessment is required to consider the acute toxicology of the novel formulation/combination of existing actives, to consider exposure to the actives in combination, and new safety directions will be assessed for the new combination
Health	Health 3	9 months	$18 980
Poisons scheduling	No assessment required as both active constituents have previously been scheduled
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 would be required
Environment	An environment assessment is required as the new product is based on a combination of existing actives
Environment	Environment 2	7 months	$7 659
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
Efficacy and Safety	Efficacy 1	6 months	$4 740
Non-food Trade	No assessment required as this application is for a food producing crop or situation
Special Data	No assessment required as neither the product nor the crop contain any GMOs
Finalisation	Finalisation 1	3 months	$8 110
Limits on use (data protection)			$460
Total		10 months	$31 060

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

5.2.1. Objective

An application for new insecticide product for foliar application in pome fruit based on a reference product that has the same active constituent is made. 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 the active constituent, timing of application and critical comments for the proposed label are the same as those on the reference product.

5.2.2. 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.

5.2.3. Assessment