Varying the use of an agricultural or veterinary chemical product to include a new use is also known as an ‘extension of use’. This variation is made via:
- Item 11 – full assessment fixed fee application
- Item 12 – no technical assessment is required
- Item 14 – technical modular application—all applications not described in any of items 11 to 13A.
Most ‘extension of use’ variations are likely to be made as Item 14 applications.
Table of contents
1. Introduction
The following material provides guidance for varying the use of a veterinary medicine where the change involves an extension of use to a food producing animal species as a technical modular variation (Item 14). Depending on the nature of the variation, different technical assessment modules will apply. In general, an extension of use requires the submission of new information or data to support the safety and efficacy of the new use. The amount of new information or data required however can vary depending upon how significant the change is, and what new assessments are necessary.
2. Legislation
2.1. Framework
The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act contains all of the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals.
The Agricultural and Veterinary Chemicals Act 1994 contains the constitutional and other legal provisions that enable the Agvet Code to have effect.
The Agricultural and Veterinary Chemicals Code Act 1994, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels); and to issue permits and to license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products; and provisions ensuring compliance with, and for the enforcement of, the code.
The Agricultural and Veterinary Chemicals Code Regulations 1995 prescribe detailed provisions of the Agvet Code.
The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the information that must be contained in, or accompany an, application under the Agvet Code.
2.2. Varying relevant particulars and conditions
The APVMA must vary the relevant particulars or conditions if it is satisfied application requirements and statutory criteria have been met (Agvet Code, s 29).
The Agvet Code, s 20(1)(c) defines relevant particulars in relation to the registration of a chemical product as:
- the distinguishing number
- any instructions for the use of the product
- any other particulars prescribed by the regulations.
Other particulars for chemical products prescribed by the regulations are:
(a) the distinguishing name of the chemical product
(i) the constituents of the chemical product
(ii) the concentration of each constituent of the chemical product
(iii) if possible, the composition and purity of each active constituent of the chemical product
(iv) the formulation type for the chemical product
(v) the net contents for the chemical product
(vi) identifying information for the holder of the registration of the chemical product
(vii) the name of each manufacturer of the chemical product
(viii) the address of each site at which the chemical product is manufactured by the manufacturer
(ix) the date of entry of these particulars in the Register of Chemical Products
(x) identifying information for any nominated agent for the registration.
The Agvet Code defines particulars in relation to approval of a label:
b)
(i) the name of the person who applied for the approval as the holder of the approval
(ii) the name of any nominated agent for the approval
(ii) the name of any nominated agent for the approval
(iii) the distinguishing number
(iv) the instructions and any particulars that are to be contained on the label
(iva) any other particulars prescribed by the regulations
(v) any conditions of the approval imposed by the APVMA.
Other particulars for labels prescribed by the regulations are:
Regulation 17(1)
a) the appropriate signal words required by the current Poisons Standard
b) the name of the chemical product that is to appear on a label for containers of the chemical product
c) the name of each active constituent of the product
d) the proportion of each active constituent of the product
e) the name of each constituent for the product that is
a. not an active constituent; and
b. classified as a poison in the current Poisons Standard
f) the proportion of each constituent referred to in paragraph (e)
g) the net contents of the product
h) particulars determined by the APVMA CEO under sub-regulation (2).
Regulation 17(2)
For paragraph 6(2)(c) of the Act, the APVMA CEO may determine additional particulars to be placed on a label for a product.
Regulation 17(3)
a) identifying information for the holder of the approval
b) identifying information for any nominated agent for the approval
c) the distinguishing name of the chemical product that is prescribed under paragraph 16(a) and entered in the Register
d) the distinguishing number of the chemical product that is entered in the Register.
Conditions are:
a) the conditions prescribed by the regulations (whether or not the conditions are prescribed at the time the constituent, product or label is approved or registered); and
b) any conditions imposed on the approval or registration as the APVMA thinks appropriate.
2.3. 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.
2.4. Application requirements
The Agvet Code, s 8A provides the definition of 'meets the application requirements'.
The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014, Parts 2 and 4, sets out the information that must be contained in, or accompany an, application under the Agvet Code.
2.5. Guidelines
The APVMA has designed guidelines to help inform the APVMA and applicants as to the modules, data and information that will apply for different types of applications. The guidelines are not the law. The APVMA will have regard to it, but from time to time may depart from it when determining the modules, data and information are necessary for a particular application. The APVMA has a number of guidelines that fall under this, for example:
2.6. Applications may be withdrawn
The Agvet Code, s 8D states that at any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.
3. Timeframe and fees
This application type is subject to an extended assessment period if an Agvet Code s 159 notice is sent requesting additional information or clarification of submitted information. The extended assessment period will vary, depending on the nature of the application and the modules specified for that particular application.
3.1. Pre-application assistance
Pre-application assistance is designed to give applicants advice on the information and module requirements of an application prior to submission. It can also be used to obtain an appraisal on a trial protocol or for agreement on project plans for time shift applications.
Tier 1: $577.50
This tier is designed to support the early stages of preparing an application, such as guidance and clarification on the types of assessments necessary for the proposed application.
Tier 2: $962.50
This is used for technical advice to support a particular application and to give applicants greater confidence that their proposed submission will contain the relevant information to address the safety, efficacy and trade criteria.
Tier 3: $1,347.50 + $1,155 per additional module chosen
This advice level can include an appraisal of a specific study design and finalisation of project plans for time shift applications.
Rebate: In some circumstances, where a pre-application assistance fee was paid in relation to a proposed product application, your product application fee will be reduced by an amount prescribed in the Agvet Code Regulations.
A technical variation 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 for ‘extension of use’ to a food producing animal species must satisfy the statutory criteria of safety, efficacy and trade. Depending on the extension being sought, one or more of the following Module types 2–10 will require the provision of supporting data and/or scientific argument. Where an applicant considers that an assessment of any particular module is not necessary justification must be provided.
| Module type | Module level* | Timeframe | Fee |
|---|---|---|---|
| 1: Preliminary assessment | 1.0 | Up to 1 month | $902 |
| 2: Chemistry | No assessment required as there has been no change to formulation or packaging | ||
| 3: Toxicology |
3.2 3.3 |
9 months 5 months |
$15 795 $4 050 |
| 4: Toxicology—Poison scheduling | No assessment required if appropriate scheduling is already in place | ||
| 5: Residues and trade |
5.1 or 5.2 or 5.4 |
13 months 8 months 4 months |
$25 650 $11 149 $7 465 |
| 6: Work health and safety | 6.2 or 6.3 |
7 months 4 months |
$3 185 $3 913 |
| 7: Environment | 7.1 or 7.3 |
13 months 4 months |
$26 390 $2 979 |
| 8: Efficacy and safety | 8.1 or 8.2 or 8.3 |
6 months 4 months 3 months |
$4 740 $1 950 $1 160 |
| 9: Non-food trade | 9.0 | 6 months | $1 175 |
| 10: Special data | 10.2 or | 7 months | Nil |
| 10.3 | 7 months | Nil | |
| 11: Finalisation | 11.1 or 11.2 |
3 months 2 months |
$8 110 $3 090 |
| 12: Limits on use (data protection) | 12.0 | – | $460 |
*Only those module levels applicable for this type of variation are listed.
| Scenario | Modules | Timeframe | Fee |
|---|---|---|---|
|
1: Addition of a new food producing species |
1, 3.2, 5.1, 7.3, 8.1, 11.1 and 12 |
16 months 23 months (extended assessment period) |
$58 636 |
3.2. Pre-application assistance
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.
4. 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.
4.1. 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.
4.2. Health
A Health assessment is required where there is a change to human exposure compared to situations that have already been assessed by the APVMA. Changes to human exposure can occur when extending into new crops or situations. This includes changes such as application rate, method, worker rates and practices including post-application activities. The change may result in a change to the entry in the first aid instructions and safety directions (FAISD) Handbook, including changes to first aid statements, personal protective equipment (PPE) and re-entry into treated areas following application.
This module also assesses both toxicological data and scientific argument, together with any cited references, which characterise the risks to humans using or coming into contact with the substances in your product.
| Module level | Timeframe | Fee |
|---|---|---|
| Health 3 | 9 months | $18 980 |
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 6.2 | Workplace health and safety | 7 months | $3 185 |
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 6.3 | Workplace health and safety | 4 months | $3 913 |
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 8.2 | Efficacy and target safety | 4 months | $1 950 |
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 8.3 | Efficacy and target safety | 3 months | $1 160 |
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 10.3 | Genetically modified organism | 7 months | $Nil |
4.3. 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.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 12 | Data protection | N/A | $460 |
4.4. Pre-application assistance
Pre-application assistance is designed to give applicants advice on the requirements for an application before submission. It can also be used to obtain an appraisal on a trial protocol or for agreement on project plans for time shift applications.
Tier 1: $577.50
This tier is designed to support the early stages of preparing an application, such as guidance and clarification on the types of assessments necessary for the proposed application.
Tier 2: $962.50
This is used for technical advice to support a particular application and to give applicants greater confidence that their proposed submission will contain the relevant information to address the safety, efficacy and trade criteria.
Tier 3: $1,347.50 + $1,155 per additional module chosen
This advice level can include an appraisal of a specific study design and finalisation of project plans for time shift applications.
Rebate: In some circumstances, where a pre-application assistance fee was paid in relation to a proposed product application, your product application fee will be reduced by an amount prescribed in the Agvet Code Regulations.
A toxicological assessment is required when moving to a food producing crop or situation for the first time and health based guidance values, such as the Acceptable Dietary Intake (ADI) and/or Acute Reference Dose (ARfD), for the active constituent have not previously been established. This information is needed to ascertain the effects of substances when consumed in the diet, and may result in the development of maximum residue limits (MRLs) in commodities.
A Toxicology—level 2 (Module 3.2) should be included when moving to a food producing crop or situation for the first time.
A Toxicology—level 3 (Module 3.3) should be included when there are risks to human health not referred to in module descriptor 3.2. For example, changes required or proposed to existing safety directions, first aid statements and/or poison scheduling.
4.4.1. 3.2: Toxicology—level 2
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 3.2 | Toxicology | 9 months | $15 795 |
4.4.2. 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 |
A comprehensive residues assessment (Module 5.1) is required for applications which involve extension of an active constituent to a food crop for the first time.
Residues 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) applies to variations of WHPs and, where necessary, the establishment of MRLs and the assessment of trade implications of an application to extend use to less than 6 food crops or crops producing feed for food-producing species (not including major export food commodity groups).
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 5.1 | Residues and trade | 13 months | $25 650 |
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Residues 1 |
13 months |
$25 650 |
4.4.3. 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 |
| Module level | Timeframe | Fee |
|---|---|---|
| Residues 4 | 4 months | $7 465 |
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.
4.5. Environment
Where there is any potential risk to the environment, an appropriate environmental assessment is required. This assessment will take into account the expected volume of use; the expected exposure, behaviour and fate of the active constituent/s; and the potential harmful effects on flora and fauna; resulting from use of the product.
In situations where the proposed use pattern does not change the risk to the environment, and this can be determined without further assessment, no environmental assessment is required.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 7.3 | Environment | 4 months | $2 979 |
4.6. 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.
4.6.1. 8.2: Reduced efficacy and safety
4.6.2. 8.3: Limited efficacy and safety
4.6.3. 5.1: Comprehensive residue assessment
Note: Module 11.2 is included when fewer than three modules between 2.1 to 10.3 apply and Module 11.1 is included when three or more modules between 2.1 to 10.3 apply.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 11.1 | Finalisation | 3 months | $8 110 |
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 11.2 | Finalisation | 2 months | $3 090 |
4.7. 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 |
4.7.1. 6.2: Reduced work health and safety assessment
4.8. 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 animal species or situations. These exposures include changes such as application dose, route of administration, 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 or handling of treated animals following application.
Several types of applications for registration of a new product do not require WHS assessment, as the product is not normally associated with any potential risks to human health. Where, however, there is any such risk, an appropriate WHS assessment is required. The types of application for products which do not normally require WHS assessment are as follows:
a. Applications for a permit for a product, registration of a new product or variation of the particulars or conditions of a registered product that are:
- animal therapeutics and mineral and nutritional supplements in tablet, capsule, slow release bolus or skin implant form
- animal therapeutics which have Therapeutic Goods Administration approval for direct administration to humans and the use pattern indicates low worker exposure potential (that is, not mob or flock treatments with a drench or a pour on, or as a feed additive, or other equivalent use pattern, as these have high worker exposure potential)
- mineral, vitamin and nutritional supplements for a single animal or a small number of animals and are administered directly to the animal or into daily food or water
- vitamins; digestive enzyme supplements; electrolytes; iron and haematopoietic agents; tonics and stimulants; or preservatives
- micro organism and enzyme products for use in non-food species
- stockfood additives and nutrition or metabolism products (other than those listed in this paragraph) with established safety directions, which are directly applicable to the concentration of the additive and the form in which it is to be used
- animal bacterial and viral vaccines.
An extension of use to a food producing animal species must satisfy the section 5A-D safety, efficacy and trade criteria for the new use. However, the amount of new information or data required varies depending upon how significant the change is, and what new assessments are necessary.
A previous assessment for a companion animal product would have stopped at question 3 of the VICH phase I assessment. To extend to a food producing species, it will proceed to question 5 at a minimum.
A limited environment assessment (Module 7.3) applies when the VICH phase I assessment stops between questions 5 and 13 (aquatic branch) or 19 (terrestrial branch).
A comprehensive environment assessment (Module 7.1) applies if the assessment cannot stop in phase I and a VICH phase II assessment is triggered.
4.8.1. 7.1: Comprehensive environment assessment
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 7.1 | Environment | 13 months | $26 390 |
4.8.2. 7.3: Limited environment assessment
A comprehensive efficacy and safety assessment (Module 8.1), is required for applications that involve use in or on new food producing species or companion animals.
A reduced efficacy and safety assessment (Module 8.2) is required for use in/on the same food producing species or companion animal.
A limited efficacy and safety assessment (Module 8.3) is required where only bioequivalence or pharmaceutical equivalence is required to demonstrate efficacy. Safety will also need to be addressed separately to the efficacy bioequivalence.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 8.1 | Efficacy and target animal safety | 6 months | $4 740 |
4.9. 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.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 10.2 | Antimicrobial resistance | 7 months | $Nil |
4.9.1. 11.1: Finalisation
4.9.2. 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 (Chemistry, Health, Residues, Environment, Efficacy) conducted under previous applications is required.
|
Module level |
Timeframe |
Fee |
|---|---|---|
|
Finalisation 2 |
2 months |
$3 090 |
4.10. 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 work health and safety assessment (Module 6.2) is required when the application involves a new species or situation or a new application method.
4.10.1. 6.3: Work health and safety—level 3
4.11. Pre-application assistance
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.
5. 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 to demonstrate the proposed extension 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 on use)
- e-label.
5.1. 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.
5.2. 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).
5.3. 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.
5.4. Pre-application assistance
Pre-application assistance is designed to give applicants advice on the information and module requirements of an application prior to submission. It can also be used to obtain an appraisal on a trial protocol or for agreement on project plans for time shift applications.
Tier 1: $577.50
This tier is designed to support the early stages of preparing an application, such as guidance and clarification on the types of assessments necessary for the proposed application.
Tier 2: $962.50
This is used for technical advice to support a particular application and to give applicants greater confidence that their proposed submission will contain the relevant information to address the safety, efficacy and trade criteria.
Tier 3: $1,347.50 + $1,155 per additional module chosen
This advice level can include an appraisal of a specific study design and finalisation of project plans for time shift applications.
Rebate: In some circumstances, where a pre-application assistance fee was paid in relation to a proposed product application, your product application fee will be reduced by an amount prescribed in the Agvet Code Regulations.
5.5. Supporting information
The application must contain, or be accompanied by, information relevant to the 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 and efficacy 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.
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 - Health
Detailed data guidelines for health 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 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 , 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
You should also consult the international technical guidance material which have been adopted by the APVMA to satisfy the s 5 legislative criteria. In particular you should consult the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products also known as the VICH guidelines.
Specifically, you should consider the guidelines listed under the following headings:
- Pharmaceuticals – Efficacy – Good Clinical Practice (GL9)
- Pharmaceuticals – Safety – Target Animal Safety (GL43)
- Pharmaceuticals – Efficacy – Anthelmintics
- Biologicals – Safety – Target Animal Safety (for vaccines and immunobiological veterinary chemical products).
Before deciding on the use of international data and standards you should consult the guidance for applicants to ensure this data meets the APVMA requirements.
5.6. 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.
6. Examples
6.1. Scenario 1: Addition of a food-producing species
6.1.1. Objective
Application is made to vary a veterinary injectable analgesic chemical product to extend the use from dogs and horses, to a use in cattle.
The analgesic product is a registered veterinary chemical product with a statement of claims for use for pain relief in dogs and horses. The product has not been registered for use in cattle before in Australia. There are no other variations proposed.
6.1.2. Application type
This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria when used on cattle.
6.1.3. Application requirements
An application of this nature is considered under a technical variation as data would need to be provided to demonstrate that the product would continue to meet the efficacy and safety criteria, when used on cattle. You will need to provide information that demonstrates the toxicity of the product in relation to human consumption to allow the establishment of an ADI and ARfD, as well as residues information to allow the MRL and WHP and ESIs to be determined. You will also need to provide evidence of any trials or experiments have been carried out to determine the efficacy and safety of the product as an analgesic for cattle.
6.1.4. Assessment modules
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 | 1.0 | Up to 1 month | $902 |
| 2: Chemistry | No assessment required as the product is currently registered and there are no changes to the product formulation or packaging | ||
| 3: Toxicology | Assessment of toxicology is required as it is noted that health based guidance values such as an Acceptable Daily Intake (ADI) and/or Acute Reference Dose (ARfD) are not established for this analgesic. This is likely as the only approved uses are for non-food producing species. In this instance when extending to a food producing species for the first time the establishment of an ADI and/or ARfD is necessary | ||
| 3.2 | 9 months | $15 795 | |
| 4: Toxicology—Poison scheduling | No assessment required as the product is currently registered and relevant scheduling is established | ||
| 5: Residues and trade | Assessment of residues is required with cattle being the first food producing species. A residue assessment is required to establish a residue definition, MRLs, withholding period and export intervals. The assessment would consider metabolism of the active and ensure residues are within acceptable residual limits (MRLs). As cattle is considered a major export commodity a trade assessment will also be necessary | ||
| 5.1 | 13 months | $25 650 | |
| 6: Workplace health and safety | No assessment required as the method of application remains the same | ||
| 7: Environment | Assessment of environment is required as the environmental exposure from the use in cattle is increased compared to that previously assessed for use in dogs and horses | ||
| 7.3 | 4 months | $2 979 | |
| 8: Efficacy and safety | Assessment of efficacy and target animal safety will be necessary to determine the efficacy of the product as an anaesthetic for cattle | ||
| 8.1 | 6 months | $4 740 | |
| 9: Non-food trade | No assessment required as cattle are a traded food commodity | ||
| 10: Special data | No assessment required as not antibiotic and doesn’t contain any GMOs | ||
| 11: Finalisation | 11.1 | 3 months | $8 110 |
| 12: Limits on use (data protection) | 12.0 | N/A | $460 |
| Total | 16 months | $58 636 | |
7. Start an application
If you want to extend the use of your product and a technical variation (Item 14) is required:
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