A registered chemical product can be varied via a number of different pathways. To vary the details for the net contents (a relevant particular: see regulation 16(db)) and the corresponding pack size, a variation can be made via the following application types:
- Notifiable variation – NV
- Non-technical fixed fee application – Item 12
- Technical modular application – Item 14
This information applies to both agricultural and veterinary chemical products unless otherwise stated.
Note: You can remove a pack size from your product range, and the e-label net contents statement, via any of the nominated pathways, as no technical data is required to remove a pack size.
The legislation
The Agvet Code sets out the requirements for varying the relevant particulars and conditions, of a registered chemical product (see Agvet Code, s 29). A variation to the pack size constitutes a change to the relevant particular – net content. A variation to the net contents will also involve a variation to the product label.
To determine any kind of variation, the APVMA must be satisfied that the chemical product would still meet the safety criteria, the trade criteria, and the efficacy criteria, if the relevant particulars were varied. For a variation to the net contents the APVMA must take into account any relevant particulars that would be entered in the register (see s 5A(3)(a)(vi)). In considering a variation to the pack size the APVMA may have regard to the stability of the product (see s 5A(3)(b)(iv)) and the specifications for the containers of the product (see s 5A(3)(b)(v)). The APVMA may also have regard to other 5A safety criteria where relevant such as where the exposure to human safety is impacted by the variation to the pack size.
The legislation allows some variations to be lodged as notifiable variations (see s 26AA–AD). Notifiable variations are not an application, but you will be issued with a notification to confirm that the variation to the relevant particulars has been applied.
The Agvet Code Regulations (see regulation 19AE) sets out the types of changes that are permissible for notifiable variations. Note that the information in the regulations should be read in conjunction with the Agricultural and Veterinary Chemicals Code (Notifiable Variations) Instrument 2016.
Selecting the appropriate pathway
When and how each of these pathways apply is detailed below. Please choose from the list for tailored guidance on the type of variation you wish to make.
Note: due to the differences in the generation for the e-label template, the pathways although often the same, are split between agricultural and veterinary chemical products.
Information on each pathway will appear at the bottom of this page once you have made a selection. You can change your selection at any time.
Agricultural products
Veterinary products
a) I want to vary the net contents where the new pack size is within an already approved range
For both agricultural and veterinary chemical products, variations to the pack size, where the proposed pack size falls within the range of the already approved pack sizes, are all processed as a minor variation – notifiable variation.
Timeframe and fees
Notifiable variations can be submitted to encompass changes across various products. There is a fee of $50 for each notification (per product, NOT per variation). More than one notifiable variation can be applied per product for the same fee.
A notifiable variation is taken to have effect on the day it is lodged, provided it meets the notice requirements. The APVMA must vary the relevant particulars within 14 days after the notice is lodged. APVMA must give written notice to the holder of the registration within 14 days of varying the relevant particulars.
What you need to provide
To meet the notice requirements, you will need to provide:
- a completed form for the notification – if you are unfamiliar with the application process you may wish to consult the guide to completing an online application
- the fee of $50 per product notification, which should accompany the notification form
- an e-label that contains the new net contents statement, and contains no other alterations, such that it satisfies regulation 19AE(1)(6).
Summary
All variations to the pack size, where the proposed pack size falls within the range of the already approved pack sizes for both agricultural and veterinary chemical products are processed via notifiable variation.
Example
Objective: Application is made to vary an agricultural chemical product to add a new 25 L pack size for a liquid herbicide product.
Background: The product already has 5 L, 10 L and 100 L pack sizes approved. There are no changes to the product label other than to add the new net contents.
Application requirements: An application of this nature is considered under a notifiable variation as the new pack size falls within the range of the approved pack sizes. A new electronic label (e-label) must be provided.
Where you have an agricultural chemical product that has set of specified pack sizes (e.g. 5 L, 10 L, 100 L) and you wish to apply for a pack size range (e.g. 5 to 100 L) this can be determined under a notifiable variation when the pack size falls within the already approved range. A pack size range is NOT available for veterinary chemical products.
What you should do
If you want to add a pack size that is within an already approved range [only]:
You will be redirected to the Online Services Portal to log in.
b) I want to vary the pack size for my agricultural product where the new pack size is outside an already approved range and I am not providing data
For both agricultural and veterinary chemical products, variations to the pack size, where the proposed pack size falls outside the range of the already approved pack sizes, can sometimes be processed as a non-technical assessment, when the APVMA can be satisfied of the product’s stability and safety without data being provided.
Timeframe and fees
The fee for a non-technical assessment (Item 12) is a fixed fee of $2,018. The timeframe is 3 months.
This application type is subject to an extended assessment period if a notice under the Agvet Code, s 159, is issued, requiring additional information. In these circumstances, the maximum extended assessment period would be 5 months.
What you need to provide
A non-technical variation needs to meet the application requirements as defined at s 8A of the extended assessment period in the Agvet Code. The application must contain, or be accompanied by, information specified for this type of application as set out in Part 4 (Division 1) of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014.
To meet the application requirements, you will need to provide:
- a completed application form – if you are unfamiliar with the application process you may wish to consult the guide to completing an online application
- the fee of $,2018, which should accompany the application. You may choose to pay the initial preliminary assessment fee of $902 on submission with the balance due prior to evaluation
- an e-label that contains the new net contents statement. The e-label may contain other minor alterations including updates to ensure that the label meets the 5D labelling criteria and the relevant labelling code, such that it satisfies regulation 19AE(1)(6).
You will also need to provide valid scientific argument, to justify why you have not provided chemistry data, and to demonstrate the stability of your product in the new pack size. In most cases this argument will only be considered acceptable when:
- a reference product is nominated, which is suitably similar, and it has a pack size already approved that is the same or similar to the proposed new pack size
- the proposed pack size will not alter the instructions for use of the product – changes to the storage and disposal statement may be acceptable
- the proposed pack size will not change the use of the product from home garden to commercial or vice versa (for agricultural chemical products)
- the proposed pack size will not change the use of the product from individual use to use in a multi-dose situation or vice versa (for veterinary chemical products) where the human safety risk may need to be re-assessed.
Summary
Some variations, to add a new pack size that is outside the approved range can be processed via non-technical variation (Item 12), when the APVMA can be satisfied of the products stability and safety without a technical assessment being needed.
Example
Objective: Application is made to vary an agricultural chemical product to add a new 5 x 30 g pack size for a cockroach bait product.
Background: The product already has 3 x 30 g pack sizes approved. The applicant has provided argument that the proposed pack size is outside their current range but that the immediate bait packaging is not changing and therefore no additional data is required.
Application requirements: An application of this nature could be considered under a non-technical variation as the new pack size falls outside the range of the approved pack sizes, but no data is required as the immediate packaging remains unchanged. A new electronic label (e-label) must be provided.
What you should do
If you want to add a pack size that is outside an already approved range [only] and are not providing any data:
You will be redirected to the Online Services Portal to log in.
c) I want to vary the net contents where the new pack size is for my agricultural product where the new pack size is outside an already approved range and I am providing data
For both agricultural and veterinary chemical products, variations to the pack size, where the proposed pack size falls outside the range of the already approved pack sizes, can sometimes be processed as a technical modular application (Item 14), which includes a technical assessment, to evaluate data provided to demonstrate product stability.
Timeframe and fees
A technical modular variation (Item 14) is a modular application type, with fees and timeframes determined according to the modules required to complete the assessment.
Most applications of this type (to add a new pack size that is outside an approved range) will require the following modules:
| Module | Timeframe | Fee |
|---|---|---|
| Preliminary assessment | Not applicable | $902 |
| Chemistry 4 | 3 months | $970 |
| Finalisation 2 | 2 months | $3 090 |
| Data protection | Not applicable | $460 |
| Total | 5 months | $5 422 |
This application type is subject to an extended assessment period if a notice under the Agvet Code, s 159, is issued, requiring additional information. In these circumstances, the maximum extended assessment period would be 12 months.
What you need to provide
A technical variation will need to meet the application requirements. These are defined in the Agvet Code, s 8A. The application must contain, or be accompanied by, information specified for this type of application in Part 4 (Division 1) of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014. To meet the application requirements, you will need to provide:
- a completed application form for the variation. If you are unfamiliar with the application process you may wish to consult the Guide to completing an online application
- the fee of $5,422, which should accompany the application. You may choose to pay the initial preliminary assessment fee of $902 on submission with the balance due prior to evaluation
- an e-label that contains the new net contents statement. The e-label may contain other minor alterations including updates to ensure that the label meets the 5D labelling criteria and the relevant labelling code, such that it satisfies regulation 19AE(1)(6).
The application should include an information list that includes the details for all the information that has been provided in support of your application. If you are unfamiliar with the process, then you should consult the guidance for preparing information lists.
If any of the information provided is subject to limits on use then you must provide Consent for Use of that information for your application.
You will also need to provide:
- evidence that your agricultural chemical product will remain stable in the proposed new pack size (stability data)
- a Chemistry 4 module. View information on the required chemistry data for agricultural products.
To determine what information you should provide to address the safety criteria in relation to ‘the stability of the product’ which we may have regard to, you should consult the chemistry data guidelines.
Specifically for agricultural chemical products you should consult the following guidelines:
- Chemistry and manufacture (Part 2)
- Generation of storage stability data for agricultural chemical products
- Validation of analytical methods for active constituents and agricultural products.
Special considerations for some agricultural chemical products
Some agricultural chemical products may require more specific information. If your product is:
- an impregnated product
- a bait station product
- a date controlled product
- a granular or powder product.
Or
- if the proposed new pack size will result in a change in use from home garden to commercial use or vice versa
- if the proposed pack size is the addition of a very large pack size (>1,000 L).
You should consider whether the proposed pack size may pose new risks to the environment and/or human safety and would require additional technical assessment modules.
If you are unsure, then you may consider submitting an application for pre-application assistance to determine the most suitable pathway as additional modules may apply.
Summary
A variation to add a new pack size that is outside an already approved range for either agricultural or veterinary chemical products can be processed via a modular technical variation (Item 14).
Example
Objective: Application is made to vary an agricultural chemical product to add a new 25 L pack size for a liquid herbicide product.
Background: The product already has 50 L and 100 L pack sizes approved. The label instructions remain unchanged other than to add the new net contents. The herbicide is a relatively new chemical and no publicly available data exists to support the new pack size.
Application requirements: An application of this nature would be considered under a modular technical variation (Item 14) as the new pack size falls outside the range of the approved pack sizes, and data is required to demonstrate that the product will remain stable in the proposed smaller pack size. A Chemistry 4 module will apply. A new electronic label (e-label) must be provided.
What you should do
If you want to add a new pack size and you are providing data [only]:
You will be redirected to the Online Services Portal to log in. You will be able to select the appropriate modules once you have generated the decision ID.
d) I want to vary the pack size for my veterinary product where the new pack size is within an already approved range
For both agricultural and veterinary chemical products, variations to the pack size, where the proposed pack size falls within the range of the already approved pack sizes, are all processed as a minor variation – notifiable variation.
Timeframe and fees
Notifiable variations can be submitted to encompass changes across various products. There is a fee of $50 for each notification (per product, NOT per variation). More than one notifiable variation can be applied per product for the same fee.
A notifiable variation is taken to have effect on the day it is lodged, provided it meets the notice requirements. The APVMA must vary the relevant particulars within 14 days after the notice is lodged. APVMA must give written notice to the holder of the registration within 14 days of varying the relevant particulars.
What you need to provide
To meet the notice requirements, you will need to provide:
- a completed form for the notification – if you are unfamiliar with the application process you may wish to consult the guide to completing an online application
- the fee of $50 per product notification, which should accompany the notification form
- an e-label that contains the new net contents statement, and contains no other alterations, such that it satisfies regulation 19AE(1)(6).
Summary
All variations to the pack size, where the proposed pack size falls within the range of the already approved pack sizes for both agricultural and veterinary chemical products are processed via notifiable variation.
Example
Objective: Application is made to vary a veterinary chemical product to add a new 15 L pack size for a liquid ectoparasiticide sheep dip product.
Background: The product already has 5 L, and 20 L pack sizes approved. There are no changes to the product label other than to add the new net contents.
Application requirements: An application of this nature is considered under a Notifiable Variation as the new pack size falls within the range of the approved pack sizes. A new electronic label (e-label) must be provided. A pack size range is NOT available for veterinary chemical products.
What you should do
If you want to add a pack size that is within an already approved range [only]:
You will be redirected to the Online Services Portal to log in.
e) I want to vary the pack size for my veterinary product where the new pack size is outside an already approved range and I am not providing data
For both agricultural and veterinary chemical products, variations to the pack size, where the proposed pack size falls outside the range of the already approved pack sizes, can sometimes be processed as a non-technical assessment, when the APVMA can be satisfied of the product’s stability and safety without data being provided.
Timeframe and fees
The fee for a non-technical assessment (Item 12) is a fixed fee of $2,018. The timeframe is 3 months.
This application type is subject to an extended assessment period if a notice under the Agvet Code, s 159, is issued, requiring additional information. In these circumstances, the maximum extended assessment period would be 5 months.
What you need to provide
A non-technical variation needs to meet the application requirements as defined in the Agvet Code, s 8A. The application must contain, or be accompanied by, information specified for this type of application as set out in the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014, Part 4 (Division 1).
To meet the application requirements you will need to provide:
- a completed application form. If you are unfamiliar with the application process you may wish to consult the guide to completing an online application
- the fee of $2,018, which should accompany the application. You may choose to pay the initial preliminary assessment fee of $902 on submission with the balance due prior to evaluation
- an e-label that contains the new net contents statement. The e-label may contain other minor alterations including updates to ensure that the label meets the 5D labelling criteria and the relevant labelling code, such that it satisfies regulation 19AE(1)(6).
You will also need to provide:
- valid scientific argument, to justify why you have not provided chemistry data, to demonstrate the stability of your product in the new pack size. In most cases this argument will only be considered acceptable when:
- a reference product is nominated, which is suitably similar, and it has a pack size already approved that is the same or similar to the proposed new pack size
- the proposed pack size will not alter the instructions for use of the product – changes to the storage and disposal statement may be acceptable
- the proposed pack size will not change the use of the product from individual use to use in a multi-dose situation or vice versa (for veterinary chemical products) where the human safety risk may need to be re-assessed.
Summary
Some variations, to add a new pack size that is outside the approved range can be processed via non-technical variation (Item 12), when the APVMA can be satisfied of the products stability and safety without a technical assessment being needed.
Example
Objective: Application is made to vary a veterinary chemical product to add a new 6 x 0.1 mL pack size for a topical parasiticide liquid product.
Background: The product already has 3 x 0.1mL pack sizes approved. The applicant has provided argument that the proposed pack size is outside their current range but that the immediate pipette packaging is not changing and therefore no additional data is required.
Application requirements: An application of this nature could be considered under a non-technical variation as the new pack size falls outside the range of the approved pack sizes, but no data is required as the immediate packaging remains unchanged. A new electronic label (e-label) must be provided.
What you should do
If you want to add a pack size that is outside an already approved range [only] and are not providing any data:
You will be redirected to the Online Services Portal to log in.
f) I want to vary the net contents where the new pack size is for my veterinary product where the new pack size is outside an already approved range and I am providing data
For both agricultural and veterinary chemical products, variations to the pack size, where the proposed pack size falls outside the range of the already approved pack sizes, can sometimes be processed as a technical modular application (Item 14), which includes a technical assessment, to evaluate data provided to demonstrate product stability.
Timeframe and fees
A technical modular variation (Item 14) is a modular application type, with fees and timeframes determined according to the modules required to complete the assessment.
Most applications of this type (to add a new pack size that is outside an approved range) will require the following modules:
| Module | Timeframe | Fee |
|---|---|---|
| Preliminary assessment | Not applicable | $902 |
| Chemistry 4 | 3 months | $970 |
| Finalisation 2 | 2 months | $3 090 |
| Data Protection | Not applicable | $460 |
| Total | 8 months | $5 4226 |
This application type is subject to an extended assessment period if a notice under the Agvet Code, s 159, is issued, requiring additional information. In these circumstances, the maximum extended assessment period would be 12 months.
What you need to provide
A technical variation will need to meet the application requirements. These are defined by the Agvet Code, s 8A.
To meet the application requirements, you will need to provide:
- a completed application form for the variation. If you are unfamiliar with the application process you may wish to consult the guide to completing an online application
- the fee of $6,406, which should accompany the application. You may choose to pay the initial preliminary assessment fee of $902 on submission with the balance due prior to evaluation.
- an e-label that contains the new net contents statement and contains no other alterations including updates to ensure that the label meets the 5D labelling criteria and the relevant labelling code, such that it satisfies regulation 19AE(1)(6).
The application should include an information list that includes the details for all the information that has been provided in support of your application. If you are unfamiliar with the process, then you should consult the guidance for preparing information lists.
If any of the information provided is subject to limits on use then you must provide consent for use of that information for your application.
Evidence that your veterinary chemical product will remain stable in the proposed new pack size (stability data).
You will need to provide a Chemistry 4 module.
View information on the required chemistry data for veterinary products.
To determine what information you should provide to address the safety criteria in relation to ‘the stability of the product’ which we may have regard to, you should consult the chemistry data guidelines.
Specifically for veterinary chemical products you should consult the following guidelines:
- Chemistry and manufacture of products (Part 2)
- Additional data guidelines for chemistry and manufacture (Part 2)
Special considerations for some veterinary chemical products:
Some veterinary chemical products may require more specific information.
If your product is:
- an antibiotic product where the only ingredient is the active constituent.
You should also consult the following additional guidelines:
Part 10 – Special data – Antibiotic resistance and Antibiotic resistance risk assessments.
- An immunobiological product or a vaccine product.
You should also consult the following additional guidelines:
Guideline for variations to registered veterinary vaccines
Or
- if the proposed new pack size will result in a change in use from individual to herd/multi-dose use or vice versa
You should consider whether or not the proposed pack size may pose new risks to the environment and/or human safety and would require additional technical assessment modules.
If you are unsure, then you may consider submitting an application for pre-application assistance to determine the most suitable pathway.
Summary
A variation to add a new pack size that is outside an already approved range for either agricultural or veterinary chemical products can be processed via a modular technical variation (Item 14).
Example
Objective: application is made to vary a veterinary chemical product to add a new 10 mL pack size for an oral anti-inflammatory liquid product.
Background: the product already has 25 mL and 50 mL pack sizes approved. The label instructions remain unchanged other than to add the new net contents.
Application requirements: an application of this nature would be considered under a modular technical variation (Item 14) as the new pack size falls outside the range of the approved pack sizes, and data is required to demonstrate that the product will remain stable in the proposed smaller pack size. A Chemistry 4 module will apply. A new electronic label (e-label) must be provided.
What you should do
If you want to add a new pack size and you are providing data [only]:
You will be redirected to the Online Services Portal to log in. You will be able to select the appropriate modules once you have generated the decision ID.