I want to vary a withholding period and/or export interval

An application to vary a withholding period and/or export interval statement must contain sufficient information to demonstrate that the proposed label changes will:

(i) not result in an exceedance of established maximum residue limits (MRLs), or
(ii) support any proposed changes to MRLs.

The product, once varied as proposed, must continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria.

Applications to vary withholding period and/or export interval details for registered products may be made via:

  • Item 14 – Technical modular application—requiring submission of new residues data
  • Item 12 – No data of a technical nature is required—this type of application is used where the risks for proposed amendment to the withholding period/export interval are consistent with a reference product not subject to data protection.

Is a technical assessment required for my proposed variation?

For a variation to be processed without a technical assessment (Item 12), all risk areas must be supported by solely referencing another registered product (reference product). Applicants seeking to rely on a reference product should explain the reasons why the reference product supports the variation. This should include how the risks are equivalent between the two products including:

  • similarity in instructions for use (crops, species, situations, claims, rate/dose, method of application/route of administration)
  • the active constituent and its concentration
  • the formulation type.

Limits of use (data protection): Where there are limits of use of information on the reference product written consent from the authorising party is required when access to the information is necessary to determine the application.

Where the reference product does not fully support all risk areas or the product is subject to Limits of use and additional data is being provided to satisfy the safety, efficacy or trade criteria these applications should be lodged as Item 14 applications.

Which application form do you need?

Application guidance

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

Legislation

Framework

The Agricultural and Veterinary Chemicals (Administration) Act establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act contains all of the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals.

The Agricultural and Veterinary Chemicals Act contains the constitutional and other legal provisions that enable the Agvet Code to have effect.

The Agricultural and Veterinary Chemicals Code Act, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels); and to issue permits and to license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products; and provisions ensuring compliance with, and for the enforcement of, the code.

The Agricultural and Veterinary Chemicals Code Regulations 1995 prescribe detailed provisions of the Agvet Code.

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the information that must be contained in, or accompany an, application under the Agvet Code.

Section 6A of the Agricultural and Veterinary Chemicals Code Act states that the APVMA may make guidelines. The APVMA has a number of guidelines which fall under this, for example:

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 (Section 29 of the Agvet Code).

Section 20(1)(c) of the Agvet Code 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
(b)  the constituents of the chemical product
(c)  the concentration of each constituent of the chemical product
(d)  if possible, the composition and purity of each active constituent of the chemical product
(da)  the formulation type for the chemical product
(db)  the net contents for the chemical product
(e)  identifying information for the holder of the registration of the chemical product
(g)  the name of each manufacturer of the chemical product
(h)  the address of each site at which the chemical product is manufactured by the manufacturer
(j)  the date of entry of these particulars in the Register of Chemical Products
(k)  identifying information for any nominated agent for the registration.

The Agvet Code defines particulars in relation to approval of a label as:
(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
(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 subregulation (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.

Statutory criteria

In addressing the criteria, the applicant may provide information, or valid scientific argument that might address a specific criterion. The following sections of the Agvet Code provide definitions for meeting the criteria:

An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:

a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
b) is not, or would not be, likely to have an effect that is harmful to human beings; and
c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

To satisfy the S5A criteria, the APVMA considers chemistry and manufacture, toxicology (including poison scheduling, residues, work health and safety, environment and target safety).

A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.

A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.

In approving a label for a container for chemical products, the APVMA must be satisfied that the label contains adequate instructions. This allows the APVMA to ensure that the risks of using the agvet chemical product are adequately mitigated through appropriate instructions.

The APVMA’s Agricultural Labelling Code and Veterinary Labelling Code also contain further labelling requirements that ensure a standard layout, eligibility and further help in mitigating the risk of using agvet chemical products when used in accordance with the label instructions.

Application requirements

Section 8A of the Agvet Code provides the definition of 'meets the application requirements'.

Parts 2 and 4 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument sets out the information that must be contained in, or accompany an, application under the Agvet Code.

Guidelines

6A of the Agvet Code states that the APVMA may make written guidelines for performing its functions and exercising its powers under this Code.

The APVMA has designed guidelines to help inform the APVMA and applicants as to the modules, data and information that will apply for different types of applications. The guidelines are not the law. The APVMA will have regard to it, but from time to time may depart from it when determining the modules, data and information are necessary for a particular application. The APVMA has a number of guidelines which fall under this, for example:

Applications may be withdrawn

Section 8D of the Agvet Code states that at any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.

Timeframe and fees

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 30 days $710
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
$10 525
$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 $1 545
12: Limits of use 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.

Extension of use: examples
Scenario Modules Timeframe Fee

Scenario 1:

Variation to the WHP and ESI of a product

1, 5.4,

11.2 and 12

6 months
9 months (extended assessment period)
$10 180

Scenario 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)
$13 240

 

Pre-application assistance

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

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.

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.

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 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.

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).

5.2: Residues – Level 2

c. Variation to change the dose rate or frequency of application to food species and where a change to established MRLs are required.

Module level Module type Timeframe Fee
5.2 Residues  and trade 8 months $10 525

 

5.4: Residues – Level 4

b. A variation which involves review of WHPs and trade implications including:

  1. a minor formulation change;
  2. changes to a label which have potential risk of residues where no change to the established MRLs is required; or
  3. residues assessment that is not referred to in module 5 above including establishing or amending Table 5 entries.
Module level Module type Timeframe Fee
5.4 Residues and trade—limited residue assessment 4 months $7 465

 

Module 9: Non-food trade

The non-food trade module is applied to applications involving trade risks not related to food residues.

9: Non-food trade

a. A product involving trade risks not related to food residues, including:

  1. residues in wool and fibre;
  2. genetically modified produce;
  3. the presence of disease or seropositive testing to exotic or notifiable agents;
  4. hormonal growth promotants and other endocrine substances; or
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.

10.2: Special data – Level 2

b. A product containing an approved antibiotic active constituent and which are for use in a new species.

Module level Module type Timeframe Fee
10.2 Antimicrobial resistance 7 months $Nil

 

10.3: Special data – Level 3

b. A product containing GMOs requiring a module 10 assessment that is not included in module 10 above.

Module level Module type Timeframe Fee
10.3 Genetically modified organism 7 months $Nil

 

Module 11: Finalisation

This module encompasses administrative steps relating to the finalisation of the application. This can include public consultation, entering the required information into the relevant record or register, and the completion of the technical evaluation and risk assessment report outlining the evaluation of the application.

11.2: Finalisation

Module level Module type Timeframe Fee
11.2 Finalisation 2 months $1 545

 

Module 12: Limits on use of information

Module 12 relates to the protection, handling and use of information provided to the APVMA. In general, the APVMA must not use information given to it in connection with one application to assess or make a decision on another application, except in specific circumstances. These circumstances include, but are not limited to, where the applicant has given consent for the information to be shared or in an emergency situation; see CCI Practice Statement. This ‘limited use data’ includes information such as reports, studies and scientific arguments that may or may not include confidential commercial information. The applicant can request the module at the time an application is lodged, but the APVMA may also include it once an assessment of the application is undertaken.

Module level Module type Timeframe Fee
12 Data protection N/A $460

 

What you need to provide

To meet the application requirements you will need to provide:

  • a completed online application form
  • the application fee plus any amount that is due to the APVMA
  • supporting information
  • an information list
  • consent for use (if any of the information provided is subject to limits of use)
  • e-label.

Completed online application form

First time applicants will need to complete an online services new user access form to access APVMA online services.

If you are unfamiliar with the application process you may wish to consult the Guide to completing an online application.

The application fee

You may choose to:

  • pay the total fee on submission or
  • pay the preliminary assessment fee of $710 on submission and the remaining balance once the application has been accepted.

You can choose to pay by credit card, electronic funds transfer or BPAY.

Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).

Supporting information

The application must contain, or be accompanied by, information relevant to whether the chemical product meets the safety and efficacy criteria, 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.

Information list

It is an application requirement that all applications for approval, registration or variation include a short description of each item of information contained in, or accompanying the application—an information list.

Any document (information) submitted with the application constitutes information for the purposes of the information list. This includes supporting information, such as consent for use letters, manufacturer's declarations, MSDS, certificates of analysis, GMP certificates and other such documentation, in addition to the scientific studies or data that may be submitted to specifically address the safety, trade and efficacy criteria.

The online application form contains fields to assist applicants in entering the information required to generate the information list.

Note: Information lists are published, including details of the holders of the information. Applicants should take care not to inadvertently divulge confidential commercial information (CCI) when creating the list.

Electronic label (e-Label)

The APVMA must have regard to certain matters or details in order to satisfy itself that a label meets the labelling criteria and approve the label (sections 5D and 14 of the Agvet Code). Applicants must use the e-label template to submit the label details that the APVMA must take into account.

Introduction to preparing a label and the label approval process provides more detailed information.

Pre-application assistance

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

Examples

Scenario 1: Variation to the withholding period (WHP) and export slaughter interval (ESI) of a product

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.

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 30 days

$710
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 will be 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

$1 545

12: Limits of use

12.0

Not applicable

$460

TOTAL

6 months

$10 180

 

Scenario 2: Variation to the export slaughter interval of a product for use in cattle, sheep or pigs

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.

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 30 days

$710
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 will be required to ensure the proposed ESI will not unduly prejudice Australian trade.

5.2

8 months

$10 525

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

$1 545

12: Limits of use

12.0

Not applicable

$460

TOTAL

6 months

$13 240

 

Start an application

IIf 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:

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