Table of contents
1. Legislation
1.1. 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.
1.2. 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.
1.3. 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.
1.4. 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.
1.5. 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:
1.6. 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.
2. Timeframe and fees
2.1. Pre-application assistance
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.
A technical variation is a modular application type, therefore the fees and timeframe are variable according to the assessments necessary. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.
Applications for varying a withholding period and/or export interval must satisfy the statutory criteria of safety, efficacy and trade. 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. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for this extension for Modules 2–10.
| Module type | Module level* | Timeframe | Fee |
|---|---|---|---|
| 1: Preliminary assessment | 1.0 | Up to 1 month | $902 |
| 2: Chemistry | No assessment required as the product is currently registered and no change is proposed to the product chemistry | ||
| 3: Toxicology | No assessment required as the product is currently registered and relevant health standards have previously been established | ||
| 4: Toxicology—Poison scheduling | No assessment required as appropriate scheduling is already in place | ||
| 5: Residues and trade |
5.2 or 5.4 |
8 months 4 months |
$11 149 $7 465 |
| 6: Work health and safety | No assessment required as the product is currently registered and the dose rate, route of administration and timing of application is unchanged | ||
| 7: Environment | No assessment required as the product is currently registered and the dose rate, route of administration and timing of application is unchanged | ||
| 8: Efficacy and safety | No assessment required as the registered product formulation and application are unchanged | ||
| 9: Non-food trade | 9.0 | 6 months | $1 175 |
| 10: Special data |
10.2 or 10.3 |
7 months 7 months |
Nil Nil |
| 11: Finalisation | 11.2 | 2 months | $3 090 |
| 12: Limits on use (data protection) | This module applies to any application which attracts limits on use of information (data protection) under Division 4A of Part 2; or Part 3 of the Agvet Code | ||
| 12.0 | – | $460 | |
*Only those module levels applicable for this type of variation are listed.
| Scenario | Modules | Timeframe | Fee |
|---|---|---|---|
|
1: Variation to the WHP and ESI of a product |
1, 5.4, 11.2 and 12 |
6 months 9 months (extended assessment period) |
$11 917 |
|
2: Variation to the ESI of a product for use in cattle, sheep or pigs |
1, 5.2, 11.2 and 12 |
10 months 14 months (extended assessment period) |
$15 601 |
3. Modules
The APVMA has developed the module descriptors to provide guidance as to the modules that will apply for different types of applications. The APVMA will have regard to this document, but may depart from it, when determining which modules are necessary on a case-by-case basis.
3.1. Preliminary assessment
Preliminary assessment is an initial examination of the application for administrative completeness. It is an administrative check that the form and content of the application meet the application requirements. In other words, the outward look of the application and its accompanying information appears to be in order and complete. It is not a completeness check of the technical aspects of your submission.
Applies to all modular application items.
3.2. Non-food Trade
The Non-food Trade module is applied to applications involving trade risks not related to food residues.
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 9 | Non-food trade | 6 months | $1 175 |
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 10.3 | Genetically modified organism | 7 months | $Nil |
3.3. 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 |
|
Module |
Timeframe |
Fee |
|---|---|---|
|
Residues 1 |
13 months |
$25 650 |
| Module level | Timeframe | Fee |
|---|---|---|
| Residues 4 | 4 months | $7 465 |
| Module level | Module type | Timeframe | Fee |
|---|---|---|---|
| 11.2 | Finalisation | 2 months | $3 090 |
3.4. Limits on use of information
Limits on use of information relate to the protection, handling and use of information provided to the APVMA. In general, the APVMA must not use the information given to it in connection with one application to assess or make a decision on another application, except in specific circumstances. These circumstances include, but are not limited to, where the applicant has given consent for the information to be shared or in an emergency situation; see CCI Practice Statement. This ‘limited use data’ includes information such as reports, studies and scientific arguments that may or may not include confidential commercial information. The applicant can request the module at the time an application is lodged, but the APVMA may also include it once an assessment of the application is undertaken.
|
Module level |
Timeframe |
Fee |
|---|---|---|
|
Limits on use |
N/A |
$460 |
3.5. 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 |
3.5.1. 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 |
3.6. Residues and Trade
Residues assessment includes the establishment of residues definition, maximum residue limits (MRLs), and withholding periods (WHPs), and the assessment of the trade implications including the establishment of any export intervals (EIs).
There are general guidelines for both Residues Part 5A and Overseas trade Part 5B available and you should consider any of the specific guidelines which relate to your product type or extension of use.
3.6.1. Non-food Trade
A product involving trade risks not related to food residues, including:
- residues in wool and fibre, or
- genetically modified produce.
|
Module level |
Timeframe |
Fee |
|---|---|---|
|
Non-food Trade |
6 months |
$1 175 |
3.6.2. Special Data 3
Registration of a new product containing a GMO.
|
Module level |
Timeframe |
Fee |
|---|---|---|
|
Special Data 3 |
7 months |
$Nil |
3.6.3. 5.4: Residues—level 4
Applications for variations to trade statements must continue to satisfy safety (Section 5A), efficacy (Section 5B), and trade (Section 5C) criteria. As the risk profile associated with a variation of this type is directly related to trade, generally applications of this type will require the provision of supporting data and/or scientific argument to satisfy the trade criteria.
3.6.4. 5.2: Residues—level 2
Applications to vary an established MRL for a major export commodity may require a reduced residue assessment (Module 5.2), all other applications to vary an MRL, or those related only to a variation of WHP or EI will generally be assessed through a limited residue assessment (Module 5.4).
3.6.5. Special Data 2
Registration of a product containing an approved antibiotic active constituent and which is expected to result in significantly increased volume of use of the approved antibiotic active constituent or an increased risk to public health including:
- a variation of use in a new food species, or a dog or a cat;
- a variation of use to another major group within the same food species (for example, broiler chickens to layers; beef cattle to dairy cattle); or
- a change in dosage form or use pattern (for example: from use in individual animals to mass medication).
|
Module level |
Timeframe |
Fee |
|---|---|---|
|
Special data 2 |
7 months |
$Nil |
4. What you need to provide
4.1. Completed online application form
First time applicants will need to complete an online services new user access form to access the APVMA Online Services Portal.
If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.
4.2. The application fee
You may choose to:
- pay the total fee on submission or
- pay the preliminary assessment fee of $902 on submission and the remaining balance once the application has been accepted.
You can choose to pay by credit card, electronic funds transfer or BPAY.
Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).
4.3. Information list
It is an application requirement that all applications for approval, registration or variation include a short description of each item of information contained in or accompanying the application – an information list.
Any document (information) submitted with the application constitutes information for the purposes of the information list. This includes supporting information, such as consent for use letters, manufacturer's declarations, MSDS, certificates of analysis, GMP certificates and other such documentation, in addition to the scientific studies or data that may be submitted to specifically address the safety, trade and efficacy criteria.
The online application form contains fields to assist applicants in entering the information required to generate the information list.
Note: Information lists are published, including details of the holders of the information. Applicants should take care not to inadvertently divulge confidential commercial information (CCI) when creating the list.
4.4. Pre-application assistance
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.
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 variation will not alter the safety, efficacy or trade risks related to the product
- an information list
- consent for use (if any of the information provided is subject to limits on use)
- e-label (if required).
4.5. 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 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.
- Residues
Detailed data guidelines for residues are in Part 5A
Detailed data guidelines for trade are in Part 5B.
4.6. 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.
5. Examples
5.1. Scenario 1: Variation to the withholding period (WHP) and export slaughter interval (ESI) of a product
5.1.1. Objective
Application is made to reduce the WHP, and add an ESI for a registered antibiotic. The product is currently registered with a withholding period of 14 days for cattle and pigs, and no export slaughter interval is specified for either species.
The applicant has undertaken tissue residue studies to demonstrate that residues in tissues will comply with established maximum residue limits. The applicant has also provided overseas trade information to support the establishment of export slaughter intervals for cattle and pigs.
5.1.2. Application type
This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the reduction in withholding period and establishment of export slaughter intervals do not impact on the safety (Section 5A), efficacy (Section 5B), and trade (Section 5C) criteria.
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. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for this variation for Modules 2–10.
| 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 no change is proposed to the product chemistry |
||
| 3: Toxicology |
No assessment required as the product is currently registered and relevant health standards are already established |
||
|
4: Toxicology—Poison scheduling |
No assessment required if appropriate scheduling is already in place |
||
|
5: Residues and trade |
An assessment is required to ensure residue levels are below established MRLs after the amended withholding period and that the proposed export slaughter intervals will not unduly prejudice Australian trade |
||
|
5.4 |
4 months |
$7 465 | |
|
6: Work health and safety |
No assessment required as the product is currently registered and the rate, method and timing of application is unchanged |
||
| 7: Environment |
No assessment required as the product is currently registered and the dose rate, method and timing of application is unchanged |
||
| 8: Efficacy and safety |
No assessment required as the registered product formulation and application are unchanged |
||
|
9: Non-food trade |
No assessment required as cattle and pigs are not a risk to non-food trade |
||
| 10: Special data |
No assessment required as the product does not contain approved antibiotic active constituent/s or genetically modified organisms |
||
|
11: Finalisation |
11.2 |
2 months |
$3 090 |
|
12: Limits on use (data protection) |
12.0 |
Not applicable |
$460 |
|
Total |
6 months |
$11 917 | |
5.2. Scenario 2: Variation to the export slaughter interval of a product for use in cattle, sheep or pigs
5.2.1. Objective
Application is made to reduce the export slaughter interval for a registered parasiticide from 60 to 35 days in cattle. No relevant MRL has been established by major international trading partners. The recent establishment of relevant international maximum residue limits has prompted the applicant to apply for a reduction to the export slaughter interval, and update the approved label.
No new residue depletion studies are required to support the application as the residue data considered at product registration demonstrates that the proposed export slaughter interval will be sufficient for residue levels to fall under the new international MRLs.
5.2.2. Application type
This application is considered under a technical variation (Item 14) as an assessment is needed to demonstrate that the reduction of the export slaughter interval does not impact on the safety (Section 5A), efficacy (Section 5B), and trade (Section 5C) criteria.
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. Modules 1, 11 and 12 are mandatory modules for this application.
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. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for this variation for Modules 2-10.
| 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 no change is proposed to the product chemistry |
||
| 3: Toxicology |
No assessment required as the product is currently registered and relevant health standards are already established |
||
|
4: Toxicology—Poison scheduling |
No assessment required if appropriate scheduling is already in place |
||
|
5: Residues and trade |
An assessment is required to ensure the proposed ESI will not unduly prejudice Australian trade |
||
|
5.2 |
8 months |
$11 149 | |
|
6: Work health and safety |
No assessment required as the product is currently registered and the rate, method and timing of application is unchanged |
||
| 7: Environment |
No assessment required as the product is currently registered and the dose rate, method and timing of application is unchanged |
||
| 8: Efficacy and safety |
No assessment required as the registered product formulation and application are unchanged |
||
|
9: Non-food trade |
No assessment required as cattle are not a risk non-food trade |
||
| 10: Special data |
No assessment required as the product does not contain approved antibiotic active constituent/s or genetically modified organisms |
||
|
11: Finalisation |
11.2 |
2 months |
$3 090 |
|
12: Limits on use (data protection) |
12.0 |
Not applicable |
$460 |
|
Total |
10 months |
$15 601 | |
6. Start an application
If you want to vary your product to amend a trade statement (ie withholding period and/or export slaughter interval) and a technical variation (Item 14) is required:
You will be redirected to online services to log in.