This content is current only at the time of printing. This document was printed on 19 October 2018. A current copy is located at https://apvma.gov.au/node/32901
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I want to submit a timeshift application
A timeshift application provides for the staged submission of supporting data packages allowing commencement of longer assessments (such as toxicology and environment) while other supporting data packages for efficacy and crop safety are being completed.
Timeshift applications are typically used for applications involving multiple assessment modules including:
- registration of a product that contains a new active constituent
- where there is a previously approved active constituent not in any currently registered products
- global joint reviews (GJRs)
- to facilitate the use of overseas assessments.
The assessment of the product is undertaken according to a project plan which is developed and agreed between the applicant and the APVMA as part of pre-application assistance (PAA) tier 2 or tier 3. A timeshift application cannot be submitted without an agreed project plan.
The agreed project plan sets out the sequence for the submission of each data package (chemistry and manufacture, toxicology, WHS, residues, environment, efficacy, crop safety, trade—including non-food and any special data if required) and timeframe for conducting the necessary modular assessments.
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 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 agvet 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 to 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 section 5A criteria, the APVMA considers chemistry and manufacture, toxicology (including poison scheduling), residues, worker health and safety, 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, legibility 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 guidelines etc.
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 them, but from time to time may depart from them when determining the modules and supporting data and information necessary for a particular application. The APVMA has a number of guidelines which describe:
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.
Definitions
Timeshift application means an application that:
(a) is for:
(i) approval of an active constituent that is not a previously endorsed active constituent
(ia) registration of a chemical product which contains a previously endorsed active constituent and for which a full assessment is required
(ii) registration of a chemical product containing an active constituent that is not an active constituent contained in any other registered chemical product
(b) will, by agreement of the applicant and the APVMA, be assessed in accordance with assessment periods set out in a project plan for the application agreed to by the applicant and the APVMA.
Timeframe and fees
The following modules are required for all timeshift applications, unless otherwise indicated during PAA and documented in the agreed project plan for the application:
| Module type | Module level | Timeframe | Fee |
|---|---|---|---|
| Preliminary assessment | 1 | As set out in the agreed project plan | $710 |
| Chemistry | 2.4 | $9 220 | |
| Toxicology | 3.4 | $27 920 | |
| Toxicology—poison scheduling | 4.2 | $2 435 | |
| Residues and trade | 5.6 | $18 170 | |
| Workplace health and safety | 6.4 | $4 410 | |
| Environment | 7.4 | $26 390 | |
| Efficacy and safety | 8.4 | $2 370 | |
| Non-food trade | 9 | $1 175 | |
| Special data | 10.4 | Nil | |
| Finalisation | 11.1 | $4 055 | |
| Limits of use | 12 | $460 |
The same fees apply as for a non-timeshift application, as the assessment components are the same.
Note: If the applicant is issued with a requirement to provide additional information under section 159, or the applicant misses an agreed data submission deadline, the APVMA may revise the project plan to reflect any delays and/or the extended assessment period.
Which application form do you need?
Agricultural products
Veterinary products
Agricultural applications: further information
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 or actives available and you should consider any of the specific guidelines which relate to your product type.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 2.4 | Chemistry – timeshift application | See project plan | $9 220 |
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 or active.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 3.4 | Toxicology – timeshift application | See project plan | $2 435 |
Module 4: Toxicology – poison 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.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 4.2 | Toxicology requiring poison schedule classification – timeshift application | See project plan | $2 435 |
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.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 5.6 | Residues and trade | See project plan | $18 170 |
Module 6: Work health and safety
Several types of applications for registration of a new chemical product will require WHS assessment for any potential risks to human health.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 6.4 | Work health and safety – timeshift application | See project plan | $26 390 |
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.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 7.4 | Environment – timeshift application | See project plan | $26 390 |
Module 8: Efficacy and safety
Efficacy assessment ensures the product works as described on the label when used according to label directions.
Safety assessment ensures the product is safe to use on/in the target crop or animal when used according to label directions.
An efficacy and safety assessment may include assessing the products effect on following crops, non-target crops and germination, effects of residues, organoleptic tests or pharmacologic studies.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 8.4 | Efficacy and safety – timeshift application | See project plan | $2 370 |
Module 9: Non-food trade
The non-food trade module is applied to applications involving trade risks not related to food residues.
Module descriptor 9.a
9.a. A product involving trade risks not related to food residues, including:
- residues in fibre; or
- 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:
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 10.4 | Special data – timeshift | As per project plan | Nil |
Module 11: Finalisation
This module encompasses administrative steps relating to the finalisation of the application, which 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.
Module descriptor 11.1A
11.1.a A product where three of more modules from 2.1 to 10.3 apply.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 11.1 | Finalisation | 3 months | $4 055 |
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 a 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 incude it once an assessment of the application is undertaken.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 12 | Data protection | Not applicable | $460 |
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
- the project plan agreed to with the APVMA
- a completed online application form
- the application fee plus any amount that is due to the APVMA
- supporting information to demonstrate the proposed product or active will be efficacious and will not cause unintended harm
- an information list
- consent for use (if any of the information provided is subject to limits of use)
- e-label.
Project plan as agreed with APVMA
The project plan is developed and agreed to with the APVMA as part of pre-application assistance (PAA) tier 2 or tier 3.
Completed online application form
First time applicants will need to complete an APVMA online system 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.
The application fee
You may choose to:
- pay the total fee on submission
- 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.
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.
- Toxicology
- Detailed data guidelines for toxicology are available in Part 3
- Residues
- Detailed data guidelines for residues are in Part 5A Detailed data guidelines for trade are in Part 5B
- Occupational Health and Safety
- Detailed data guidelines for occupational health and safety are in Part 6
- 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 guideline, 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.
Data guidelines
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.
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 and GMP certificates, 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 for it 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.
Example
Scenario 1
Registration of a new insecticide containing a new active constituent for control of aphids in wheat.
The applicant proposes to submit their data in three stages so that chemistry, toxicology, WHS and environment assessments can be started prior to the completion of field trials for efficacy, target safety and residues.
The applicant submits a PAA proposing that chemistry, toxicology, WHS and environment are to be submitted in January, residues in June and efficacy to be submitted in September of Year 1. The APVMA agrees to the project plan and the applicant proceeds to submit a timeshift application.
Figure 1 below shows the different stages of the agreed project plan. The timeframes for each assessment module in the project plan are usually those that would apply if the application was submitted as either an Item 1 or Item 2.
- Preliminary Assessment (PA) undertaken – January Year 1
- Assessments of the first data packages commence – February Year 1
- Submission and assessment of the residue data package commences – June Year 1
- Submission and assessments of the efficacy and target safety data package commences – September Year 1
- Finalisation (including public consultation) commences – July Year 2
- Final decision – September Year 2.
Figure 1 – different stages of an agreed project plan for a timeshift application
The timeshift approach allows the completion of the registration process within a 21 month timeframe. Without the benefit of a timeshift application, the Applicant would not have been able to submit until September of Year 1 when the Efficacy and Safety data was available. This would have resulted in a shorter overall assessment timeframe of 18 months but the assessments would have been scheduled for completion by March Year 3 (6 months beyond that achieved through the timeshift application).
Application type
The application is submitted as a timeshift (Item 27), as the product contains a new active constituent and full submission of chemistry, toxicology, WHS data packages can be made prior to submission of the other data packages.
Modules and fees
Module type Module level Timeframe Fee Preliminary assessment 1 As set out in the agreed project plan $710 Chemistry 2.4 $9 220 Toxicology 3.4 $27 920 Toxicology—poison scheduling 4.2 $2 435 Residues and trade 5.6 $18 170 Workplace health and safety 6.4 $4 410 Environment 7.4 $26 390 Efficacy and safety 8.4 $2 370 Non-food trade 9 $1 175 Special data 10.4 Nil Finalisation 11.1 $4 055 Limits of use 12 $460 Pre-application assistance
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.What you should do
If you want to submit an agricultural timeshift application:
You will be redirected to online services to log in.
Veterinary applications: further information
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 or actives available and you should consider any of the specific guidelines which relate to your product type.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 2.4 | Chemistry – timeshift application | See project plan | $9 220 |
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 or active.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 3.4 | Toxicology – timeshift application | See project plan | $2 435 |
Module 4: Toxicology – poison 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.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 4.2 | Toxicology requiring poison schedule classification – timeshift application | See project plan | $2 435 |
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.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 5.6 | Residues and trade | See project plan | $18 170 |
Module 6: Work health and safety
Several types of applications for registration of a new chemical product will require WHS assessment for any potential risks to human health.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 6.4 | Work health and safety – timeshift application | See project plan | $26 390 |
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.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 7.4 | Environment – timeshift application | See project plan | $26 390 |
Module 8: Efficacy and safety
Efficacy assessment ensures the product works as described on the label when used according to label directions.
Safety assessment ensures the product is safe to use on/in the target crop or animal when used according to label directions.
An efficacy and safety assessment may include assessing the products effect on following crops, non-target crops and germination, effects of residues, organoleptic tests or pharmacologic studies.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 8.4 | Efficacy and safety – timeshift application | See project plan | $2 370 |
Module 9: Non-food trade
The non-food trade module is applied to applications involving trade risks not related to food residues.
Module descriptor 9.a
9.a. A product involving trade risks not related to food residues, including:
- residues in fibre; or
- genetically modified produce.
- the presence of disease or seropositive testing to exotic or notifiable agents.
- hormonal growth promotants and other endocrine substances.
| 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:
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 10.4 | Special data – timeshift | As per project plan | Nil |
Module 11: Finalisation
This module encompasses administrative steps relating to the finalisation of the application, which 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.
Module descriptor 11.1A
11.1.a A product where three of more modules from 2.1 to 10.3 apply.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 11.1 | Finalisation | 3 months | $4 055 |
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 a 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 incude it once an assessment of the application is undertaken.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 12 | Data protection | Not applicable | $460 |
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
- the project plan agreed to with the APVMA
- a completed online application form
- the application fee plus any amount that is due to the APVMA
- supporting information to demonstrate the proposed product or active will be efficacious and will not cause unintended harm
- an information list
- consent for use (if any of the information provided is subject to limits of use)
- e-label.
Project plan as agreed with APVMA
The project plan is developed and agreed to with the APVMA as part of pre-application assistance (PAA) tier 2 or tier 3.
Completed online application form
First time applicants will need to complete an APVMA online system 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.
The application fee
You may choose to:
- pay the total fee on submission
- 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.
Relevant data for module levels—veterinary 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.
- Toxicology
- Detailed data guidelines for toxicology are available in Part 3
- Residues
- Detailed data guidelines for residues are in Part 5A Detailed data guidelines for trade are in Part 5B
- Occupational Health and Safety
- Detailed data guidelines for occupational health and safety are in Part 6
- 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 guideline, 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.
Data guidelines
Relevant data for module levels—veterinary 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.
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 and GMP certificates, 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 for it 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.
Example
Scenario 1
Register a new ectoparasiticide (pour-on) containing a new active constituent to control blowfly strike on sheep.
The applicant proposes to submit their data in three stages so that chemistry, toxicology, WHS and environment assessments can be started prior to the completion of current field trials for efficacy, target safety and residues.
The applicant submits a PAA proposing that chemistry, toxicology WHS and environment are to be submitted in January Year 1, residues (including non-food trade) in June Year 1 and efficacy and safety to be submitted in September of Year 1. The APVMA agrees to the project plan and the applicant proceeds to submit a timeshift application.
Figure 1 below shows the different stages of the agreed project plan. The timeframes for each assessment module in the project plan are usually those that would apply for new active ingredients subject to level 1 assessments.
- Preliminary Assessment (PA) undertaken – January Year 1
- Assessments of the first data packages commence – February Year 1
- Submission and assessment of the residue and non-food trade data package commences – June Year 1
- Submission and assessments of the efficacy and target safety data packages commence – September Year 1
- Finalisation (including public consultation) commences – July Year 2.
- Final decision – September Year 2.
Figure 1 – different stages of an agreed project plan for a timeshift application
The timeshift approach allows the completion of the registration process within a 21 month timeframe. Without the benefit of a timeshift application, the applicant would not have been able to submit until September of Year 1 when the efficacy and safety data was available. Based on the longest assessment module and preliminary assessment and finalisation, the overall timeframe would have been 19 months with completion by March Year 3 (7 months beyond that achieved through the timeshift application).
Application type
The application is submitted as a timeshift (Item 27), as the product contains a new active constituent and full submission of chemistry, toxicology, WHS and environment data packages can be made prior to submission of the other data packages.
Modules and fees
Module type Module level Timeframe Fee Preliminary assessment 1 As set out in the agreed project plan $710 Chemistry 2.4 $9 220 Toxicology 3.4 $27 920 Toxicology—poison scheduling 4.2 $2 435 Residues and trade 5.6 $18 170 Workplace health and safety 6.4 $4 410 Environment 7.4 $26 390 Efficacy and safety 8.4 $2 370 Non-food trade 9 $1 175 Special data 10.4 Nil Finalisation 11.1 $4 055 Limits of use 12 $460 Total $97 315 Pre-application assistance
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.What you should do
If you want to submit an veterinary timeshift application:
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