I want to register a new product which contains a new active constituent

For a new agvet chemical product that contains a new active constituent, the APVMA must approve both the active constituent and register the product.

Registering a new product which contains a new active constituent is made via:

Item 1 – New product, new active constituent—full assessment required of the active constituent and product
Item 2 – New product, new active constituent—less than full assessment required of the active constituent and product
Item 27 – Timeshift application (requires PAA and an agreed project plan).

 

Which application form do you need?

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.

Pre-application assistance

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

My application will require:

Application Guidance

Specific information on completing this application form is provided below. Once you are familiar with the content you can proceed to ‘Start an application’ at the button below.

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.

Timeframe and fees

Timeframe and fees

The fee for approval of a new active constituent and registration of a product requiring full assessment (Item 1) is a fixed fee of $96 135.
The timeframe is eighteen months. This timeframe is subject to an extended assessment period if a section 159 notice is sent requesting additional information. The extended assessment period for a registration requiring full assessment (Item 1) is twenty-five months

Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.

The following modules types and levels are required to satisfy the statutory criteria:

Module type Module level Timeframe Fee
1: Preliminary assessment 1 18 months $96 135
2: Chemistry 2.1
3: Toxicology 3.1
4: Toxicology – Poison scheduling 4.1
5: Residues and trade 5.1
6: Work health and safety 6.1
7: Environment 7.1
8: Efficacy and safety 8.1
9: Non-food trade (if applicable) 9
10: Special data (if applicable) 10.3
11: Finalisation 11.1
12: Limits of use 12

Example

Scenario Timeframe Fee
Scenario 1 18 months
25 months (extended assessment period)
$96 135

 

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.

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

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.

2.1: Chemistry – Level 1

a. A product containing a new active constituent (other than applications referred to in module 2.2 below).

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.

3.1: Toxicology – Level 1

a. A product containing a new active constituent for food crop (other than applications referred to in module 3.2 or 3.3 below).

Module 4: Toxicology (scheduling)

In addition to a module 3 toxicology assessment, a module 4 scheduling assessment is required for the consideration of a new active constituent for inclusion in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), 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 is registered by the APVMA.

Applications that are referred to the Secretary of the Department of Health for poisons scheduling, in addition to a module 3 level.

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.

5.1: Residues – Level 1

a. A product containing a new active constituent to be used on a food crop.

Module 6: Work health and safety

A work health and safety (WHS) assessment is required where there is a change to human exposure. 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 area following application.

6.1: Work health and safety – Level 1

a. A new product containing a new active constituent.

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.

7.1: Environment – Level 1

a. A product with a new active constituent unless included in module 7.3 below.

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 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.

8.1: Efficacy and safety – Level 1

a. A product containing a new active constituent.

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 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 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 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.

Pre-application assistance

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

What you need to provide

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 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. 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
  • 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.

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)

The APVMA may not consider supporting information when relevant 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 the APVMA product search database 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.

Pre-application assistance

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

Examples

Scenario 1: Register a new product with a new active constituent requiring a full assessment

Objective

An application to register a new insecticide to control aphids in wheat.

This application is considered under Item 1 – Register a new product that also contains a new active constituent, as a full assessment is required.

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 Assessment
1: Preliminary assessment Preliminary assessment
2: Chemistry A full assessment is required as the active constituent in the insecticide is manufactured by chemical synthesis
3: Toxicology A full assessment is required as the product will be used on a food crop
4: Toxicology –
Poison scheduling
Poison scheduling is required as the product contains a new active constituent
5: Residues and trade A full assessment is required as the new active constituent will be used on food crops. The potential impact on Australian trade will also need to be considered
6: Work health and safety As the product contains a new active constituent, a full assessment is required of the potential risks to human health
7: Environment A full assessment is required as the product will be applied to food crops by ground spray methods
8: Efficacy and safety A full assessment is required as the new active constituent will be used on food crops and has not previously been evaluated to verify the manufacturer’s claims and risk mitigation recommendations
9: Non-food trade Not required as wheat does not produce a non-food traded commodity
10: Special data Not required as the new active constituent is not intended for use on animals and does not contain any GMOs
11: Finalisation Finalisation
12: Limits of use
Total 18 months $96 135

 

 

Start an application

To register a new product which contains a new active constituent (Item 1):

You will be redirected to online services to log in.