Category 14 application
Variation to a registered chemical product or approved label: Modular assessment

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 14 application as:

Application to vary particulars or conditions of registration or listed registration or label approval if the application is not of a kind described in item 11 to 13.

Category 14 is a modular category. Data requirements, the fee payable and timeframe for assessment depend on which of the modules are required for a particular application. The modules are described in Module levels for modular categories in Volume 3 and also in the guidelines included with the examples later in this chapter.

A Category 14 application may include variations to chemistry and manufacturing details of the product where the new formulation is ‘similar’ to the previous formulation, and/or variations to an approved label.

Variations to product details include details of the formulation (including names, concentrations and standards for each constituent), release and expiry specifications, immediate container specifications, shelf life, and site of product manufacture.

Data must be provided when a technical assessment is required. The data requirements and level of assessment required depend on the type of product and the type of variation to the product.

1.1.    Application types

The following types of agricultural applications are eligible for assessment under Category 14:

• variation to the label claims of a product (including new pests, diseases or target crop species)

• variation to the label to include new major food use where major assessment is required other than as described in Category 11

• variation to the label to include a new non-food use

• variation to the label to include a new minor food crop

• variation to the label to include new pest/s for an approved crop/situation

• variation to the label to include use in a new State or Territory

• variation to label application instructions

• variation to label withholding period instructions

• variation to label environmental safety statements, or disposal instructions

• variation to the poisons scheduling (signal heading), first aid or user safety directions where these are different from the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) or Handbook of First Aid Instructions and Safety Directions (FAISD Handbook)

• variation to formulation details for a product

• variation to product details to include a new pack size of different construction or material, or which changes the market sector for the product

• any other variation to the label and/or product details (excluding active constituents), where technical assessment is required.

Each of these types of application is explained in detail, with examples, in section 4 of this chapter.

1.2.    Major formulation variation is not included in Category 14

Variations to product particulars or conditions of registration do not include major formulation changes to the product, which in effect result in a new product. Major formulation change is defined in Module levels for modular categories in Volume 3. Major formulation changes may affect target species efficacy and safety, dietary residues, human health and safety and the environment.

Major formulation changes require an application under a category other than Category 14, for registration of a new product with a new name and new product number.

2.   REQUIREMENTS

When making a Category 14 application for variation to the details or particulars of registration of a product and/or label approval, applicants must provide:

• one unbound copy of the combined Application Form and Overview (refer to paragraph 2.1)

• one bound copy of each of the relevant data Parts (refer to paragraph 2.2)

• the product label (refer to paragraph 2.3)

• the relevant fee (refer to paragraph 2.4)
• a data list (refer to paragraph 2.7)

2.1.    Combined Application Form and Overview

The Application Form and Application Overview have been combined into a single document (KP25F08) which is available on the APVMA website. A single unbound copy of the combined document must be provided to the APVMA.

The Application Form requires information which is relevant to a Category 14 application.

The Application Overview section of the combined document is in the form of a template. Applicants may use this template, or may submit their own Application Overview although this must conform to the instructions and format provided in Part 1 – Application overview in Volume 3.

Sub-parts 1.1–1.10 of the Application Overview must all be completed.

When there is no information relevant to the variation a statement to this effect must be made under the relevant sub-part heading. For example, if the withholding period or the claim is being varied, sub-parts 1.5 or 1.8 respectively must summarise the data submitted and refer to separate Part 5 or Part 8 data. If in this example the chemistry and manufacturing details remain unchanged, this can be stated in sub-part 1.2 and a separate Part 2 need not be submitted with the application.

2.2.    Data

Category 14 is a modular category, therefore data studies, fee and timeframe are determined by the module levels required for product assessment, which themselves are determined by the type of product and the situations in which the product will be used.

All applications made under Category 14, except for secondary applications, will normally require submission of data for the product, relating to:

Note: The Parts relate to Volume 3: Data requirements and guidelines. Further information on data requirements is provided in that volume.

2.3.    Label

Applicants must provide a label with the Application Form and Overview. The APVMA recommends that the label be in draft form so that it can be amended if necessary, however applicants may choose to submit the marketed product label (MPL).

Applicants may provide the draft label as either:

• two copies of the text label (TXL) printed on paper; or
• an e-label on CD. The CD must be attached to the Application Form and Overview and not submitted separately or by email.

The draft label must include all label components ie primary pack, immediate container and leaflet, as relevant.

All parts of the draft label must be in accordance with the latest editions of the:

• Labelling Code
• Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)
• Handbook of First Aid Instructions and Safety Directions (FAISD Handbook).

After the APVMA has assessed the draft label and is satisfied that the label is acceptable, the APVMA will ask the applicant to provide an e-label of the MPL for approval. If the MPL is acceptable and all other matters relevant to the application are acceptable, the APVMA will approve the label and grant the application.

Refer to Label Approval Process in Volume 5 for further information.

2.4.    Fee and timeframe

Category 14 is a modular category, therefore the fee payable and timeframe depend on which of the modules are required for assessment of the application.

The fee for a Category 14 application will always include the fees for Module 1 (Screening), plus the relevant Finalisation module (11.1, 11.2, or 11.4).

A fee must accompany a Category 14 application. Applicants may provide the complete fee when submitting the application, or may choose to provide $460 (Screening module fee) when submitting the application and provide the remainder of the fee when requested by the APVMA, after the application passes screening.

To calculate the timeframe assigned to an application, the longest assessment period for the specific data modules should be added to the timeframe for the relevant finalisation module.

The fee and timeframe for each application may be calculated by reference to Module levels for modular categories in Volume 3.

2.4.1.  Fee for identical variations to multiple products where no technical assessment is required

Paragraph 2.3.1 of Category 12 states that if an applicant wishes to apply for variations to the particulars, conditions, or approved label for a product, where no technical assessment is required, and if:

• the application would normally be made under Category 12; and
• the applicant wishes to make identical changes to multiple products;
  
  - the applicant may apply for the changes under Category 14. Under Category 14, the APVMA will charge a fee constructed from the screening fee and finalisation fee, which is considerably less expensive than if the applicant makes multiple applications under Category 12.

An example is where a registrant applies for approval for a change in the site of manufacture for the registrant’s entire range of products.

The APVMA will charge a fee which is constructed from the screening fee and the finalisation fee. If the application is relevant to more than 5 products, the finalisation fee is ‘broadbanded’ over every 5 products. The table of fees is set out in Table 1.

Table 1:  Table of fees for a Category 14 application for an identical change to multiple products

Requirements

1. If the product label will not change:

The applicant must use the Category 14 application form, and in the 4th row of section 1, write next to ‘APVMA Product Number’:

‘Multiple products – see attached list’.

The attached list must be a list of all products to which the application applies, in a 3 column format:

APVMA product number

Product name

Pack sizes

Sections 4, 7, 8, 11 and 14 of the Category 14 application form need NOT be filled out if not relevant to the types of change proposed.
Sections 1.3 – 1.10 of the Application Overview need NOT be filled out if not relevant to the types of change proposed.

2. If the product label will change:

The applicant must use the Category 14 application form, and in the 4th row of section 1, write next to ‘APVMA Product Number’:

‘Multiple products – see Section 14’.

Sections 4, 7, 8, and 11 of the Category 14 application form need NOT be filled out if not relevant to the types of change proposed.

Sections 1.3 – 1.10 of the Application Overview need NOT be filled out if not relevant to the types of change proposed.

2.4.2.  Fee for variations to multiple products where a technical assessment is required

For some variations to multiple products where a single technical assessment applies to all products, the APVMA may not need to do a separate screening for each product. In these cases the APVMA will consider a single application for the multiple products. However, this can only be done on a case-by-case basis, and applicants should discuss this with the relevant APVMA Team Manager before submitting the application.

2.5.   Use of reference products

Application data requirements are normally addressed by submission of data and/or relevant scientific argument or nomination of a suitable reference product. If an applicant does not provide data or relevant scientific argument to support aspects of their application, the applicant must nominate a suitable registered reference product.

2.6.    Public consultation

Public consultation will be required prior to approval of certain variations, for example where the application is for an extension of use to a new food-producing crop, or where a new withholding period requires changes to the maximum residue limits (MRL) in the MRL Standard. In such cases the APVMA will conduct a round of public consultation. This is normally by means of publication of a Gazette Notice called a Public Release Summary (PRS) which invites comment on the APVMA’s intention to approve the variation.

If the variation is for an extension of use to a new food-producing crop, or if residues in animal commodities require changes to MRLs in the MRL Standard, the APVMA will publish a Trade Advice Notice (TAN) inviting comment.

2.7.    Data protection

Applicants must provide a data list, including an entry for all information that meets the definition given on the APVMA website data protection page at http://www.apvma.gov.au/registration/data_protection.shtml . This requirement applies irrespective of whether an application is eligible for data protection.

Module 12 (Data Protection) is required for all applications which are assessed under a modular category, where the applicant provides data to the APVMA that are eligible for protection. This applies to the great majority of applications in this category. Publicly available data are ineligible for protection.

Module 12 covers the cost of steps required to protect data and is mandatory for all applications which provide data eligible for protection. Applicants cannot waive the right to protected data before an application is granted.

Note that applications which involve assessment of chemistry data require provision of a chemistry data list, and the fee for Module 12 (data protection) will apply to these applications if the data are eligible for protection.

Module 12 also applies to secondary applications (see 3.2) which rely on protected data provided for the primary application, or which require assessment of data that are not common with the primary application. Data related only to the secondary product must be included on a separate data list and must not be included on the data list of the primary product application. Data related only to the secondary product cannot be considered required and relied on to grant the primary application and therefore will not receive protection if provided in this manner.

Applicants applying under Category 14 may need to refer to data relied on by the APVMA to register a reference product. The reference product may also have required access to protected data in relation to its active constituent/s or reference product. If the applicant is not the authorising party for the data used to approve the active constituent/s or register the product, the applicant must obtain consent for use from the relevant authorising parties. Applicants can determine whether they are using protected data by checking the product details on the product search facility on the APVMA website.

3.   GUIDELINES

3.1.    Multiple variations

A single Category 14 application may include more than one variation, for example a new pest addition plus a formulation change. In this situation, only a single screening module and finalisation module, together with the relevant assessment modules, will be required. However, if an application for multiple extensions of use requires the APVMA to use multiple external efficacy reviewers, the APVMA will assign multiple efficacy modules (at the appropriate level) to the application.

In addition, if the APVMA finds deficiencies relating to only one module, none of the variations contained in the application can be approved until all deficiencies have been addressed satisfactorily, or the deficient use is withdrawn. An additional application including screening, finalisation and any other necessary modules and fees will be required in order to approve the deficient variation if the deficiencies can only be addressed by the provision of new data.

If an applicant wishes to make administrative label variations at the same time as making a Category 14 application, and if these label variations would normally be subject to an application under Category 12 or 13, all of the label variations may be made under a single Category 14 application. There is no need to make a separate Category 12 or 13 application for the administrative label variations.

3.2.    Secondary applications

A secondary application exists where the registrant has another product undergoing the same or similar variation to the first or primary product at the same time, and the assessment of data for the first product can be used for both products (see Category 2).

Secondary applications must be made as separate Category 14 applications. They cannot be made as part of the application to vary the first or primary product.

Secondary applications will generally require less data and assessment than the first or primary application. Data and module requirements for related or secondary applications will depend on the type of product, the type of change, and the required assessments that are not common with the first or primary product.

If the primary application requires one or more assessment modules and no further technical assessments are required for the secondary application, only Modules 1 (Screening) and 11.4 (Finalisation), and where relevant Module 12 (Data Protection), will apply to the secondary applications. If the primary application does not require any assessment modules, only Module 11.4 (Finalisation) will apply to the secondary applications.

Secondary applications will only be finalised after the first or primary product application is finalised.

Note that the product with the highest concentration of active constituent or dose should always be presented as the first or primary application.

4.   SPECIFIC REQUIREMENTS, GUIDELINES AND EXAMPLES

The paragraphs below set out specific requirements, guidelines and examples for each of the types of application eligible for assessment under Category 14. The examples show how data requirements can be determined by using Data requirements and guidelines in Volume 3.

In the examples, applicants must submit the relevant data as indicated or must provide valid scientific argument why certain data should not be required. If the APVMA accepts that the scientific argument is valid, those data need not be submitted.

4.1.    Variation to the product label claims to include a new major food use where major assessment is required, other than necessary for Category 11

This section is relevant to extensions of use where the previous approved uses for the product or active constituent did not require a full toxicology, residues or environmental module.

Requirements

Applications to extend the use of a product to a new major food use where major assessment is necessary, will require as a minimum, submission of an Application Overview (Part 1), the relevant major assessment (Parts 3, 5 and/or 7) and crop efficacy and/or safety data (Part 8).

If the product or active constituent have not previously been used in a food-producing situation, prior applications may not have required a full toxicology data package because an acceptable daily intake (ADI) was not required. Extending the label to allow use on crops (including pasture) for the first time may therefore require toxicological assessment (Part 3) and if so, will also require a full residues and trade assessment (Parts 5A and 5B).

The new use will normally result in additional exposure to workers and to the environment and therefore applicants must provide data on OHS issues (Part 6) and environmental safety issues for the new use (Part 7). If the applicant believes this is unnecessary, the applicant may provide argument supporting this view in the relevant sections of the Application Overview (Part 1).

Guidelines

Example 1: An insecticide is registered for use in non-crop situations. Application is made to include its use on pastures.

The original application did not require a full toxicology data package because no ADI was required. No residues or plant or animal metabolism data have been previously provided. Therefore, these data and assessment gaps must be filled in this application.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

.

Example 2: A rodenticide is registered for use inside buildings for application in bait stations only. Application is made to extend its use to food crops such as cereals, sugarcane and macadamias , without the need for bait stations.

A full toxicological package has already been assessed with the original application. No residues or plant metabolism data have previously been provided and a full environmental data package was not provided due to the limited exposure. Therefore, these data and assessment gaps must be filled in this application.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.2.    Variation to the label to include a new non-food use

Requirements

Applications to extend the use of a product to a new non-food use will require, as a minimum, submission of an Application Overview (Part 1) and efficacy data (Part 8).

If a new use pattern is involved which could result in increased exposure to the public (eg house occupants), neighbouring livestock or crops (including pasture) via spray drift, workers, or to the environment, the applicant must provide data to address toxicology/public health issues (Part 3), residue and trade issues (Part 5A and 5B), OHS issues (Part 6) and/or environmental safety issues (Part 7), or provide argument in the relevant sections of the Application Overview (Part 1) that no new data should be required.

Guidelines

Example 1: An insecticide is registered for use in urban pest control. Application is made to include its use on golf and bowling greens for a new pest. The new label will include restrictions on feeding any treated turf clippings to animals.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

Example 2: A herbicide is registered for use in horticulture through ground equipment. Application is made to extend its use to forestry by air. The potential for spray drift to conservation areas, pastures and crops is a significant concern.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.3.    Variation to the label to include a new minor food crop

The definition of a minor food crop is given in the permits section of the APVMA website at Permits and Minor Use - definitions.

A list of what is not considered a minor crop (ie a list of major food crops) is provided in Category 11, Table 1 in this volume.

Requirements

Applications to extend the use of a product to a minor food crop will require, as a minimum, submission of an Application Overview (Part 1) and residues and possibly trade data (Part 5).

A toxicological assessment (Part 3) may be required where an ADI has not been established, for example where the active constituent in the product has not previously been approved for use in a food crop species.

If a new use pattern is involved which could result in increased exposure to workers or the environment, applicants must address OHS issues (Part 6) and/or environmental safety issues (Part 7). However, it is likely that the minor nature of the crop will ensure that extrapolation can be made from current environmental information held for the active constituent/product. In addition, if the crop morphology, crop locations, application method and rate are very similar to already approved label uses, little extra information will be required to satisfy OHS and environment requirements.

Efficacy and crop safety data (Part 8) will be required if the pest is not already named on the product label or if the crop has different sensitivities with respect to pest thresholds and phytotoxicity than crops already on the label.

Guidelines

Example 1: A fungicide is registered with broad agricultural uses. Application is made to extend its use to include a new fungal pathogen on leeks.

Use of the active constituent in leeks or other stalk vegetables has not previously been approved; therefore no MRL exists. The proposed rate is less than or equal to the maximum label rate and application is via the same application methods.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

Example 2: An insecticide is registered for use in grapes and other fruit crops. Application is made to extend its use to blueberries for control of a pest already on the label and at the same application rate.

A temporary MRL for blueberries already exists due to a previous permit, therefore only supplementary residue trial data are required for assessment. Support from the State Agriculture Department has been given with respect to efficacy due to previous use under permit.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.4.    Variation to the label to include a new pest for an approved crop/situation

Requirements

Applications to extend the use of a product to include additional pests or diseases in a crop or situation already approved on the label require as a minimum, submission of an Application Overview (Part 1) and supportive target crop efficacy data (Part 8).

If an increased use rate or new method of application is involved which could result in increased exposure to the crop, workers or the environment, applicants must address residues and trade (Part 5A and 5B), OHS (Part 6) and/or environmental safety issues (Part 7).

Guidelines

Example 1: A herbicide is registered for pre-emergence treatment. Application is made to extend its use to control an additional species of weed in the same situation, where the rate has not increased.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

.

Example 2: A fungicide is registered for use in cereals and pulses. Application is made to extend its use to include an additional species at a higher application rate (ie double). The applicant is proposing new MRLs for various crop and animal commodities.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

Example 3: An insecticide is registered for use in orchard crops. Application is made to add control of a new species using a new bait application method. Residue trials are provided to demonstrate that no measurable residues are expected.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.5.    Variation to the label to include use in a new State or Territory

Requirements

Applications to extend the use of a product to include a new State or Territory for a crop or situation already approved on the label require, as a minimum, submission of an Application Overview (Part 1) and supportive target crop efficacy data (Part 8).

If an increased use rate or new method of application is involved which could result in increased exposure to the crop, workers or the environment, applicants must address residues and trade (Part 5A and 5B), OHS (Part 6) and/or environmental safety issues (Part 7).

Guidelines

Example 1: A selective herbicide is registered for post-emergence treatment of cereal crops in Victoria only. Application is made to extend its use to NSW, where the weed species previously limited to Victoria is now a concern. Identical use rate and application methods are proposed. Use in northern NSW requires efficacy data due to the different climatic conditions.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

Example 2: An insecticide is registered for use in all states except Tasmania. Application is made to extend its use to include Tasmania. The applicant has provided technical argument as to why use in Tasmania should be no different from other states.

The specific data requirements are expected to be drawn from:

The following modules are expected to apply:

4.6.    Variation to label application instructions

This paragraph covers all variations to the label with respect to application instructions, ie restraints, application rates, number per season and frequency or re-treatment intervals, and application methods.

Requirements

As a minimum, submission of an Application Overview (Part 1) addressing all requirements will be required. Where data are provided to justify certain matters, applicants should provide a separate data volume for each respective data Part.

4.6.1.    Variation to restraints

This variation may involve deletion, modification or addition of a restraint statement. Restraints cover situations in which the use of a product has an absolute limitation, usually relating to efficacy. However they have also been used to manage residue, trade and environmental risks.

Guidelines

Example 1: A termiticide is registered for soil application under and around buildings. Application is made to delete a label restraint which restricts use of the product in wall cavities. The label restraint statement is required due to insufficient justification that the use will not be an undue health risk to occupants of the house and that the use will be effective as claimed.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.6.2.    Variation to application rates, number of treatments, and treatment frequency instructions

Requirements

Variation to the application rates of a product may involve an increase or decrease in the application rate, the number of treatments or period between treatments. All of these variations will require submission of an Application Overview (Part 1) and efficacy data (Part 8).

Residues and possibly trade data (Part 5), OHS (Part 6) and environment (Part 7) will generally be required when the variation relates to a crop use when there is an increase in application rate, number of treatments or treatment frequency.

Guidelines

Example 1: An insecticide is registered for use in cotton at a maximum of two applications per season. Application is made for approval of an increased number of applications (up to four) to allow early and late season use. No new MRL is proposed.

Data requirements are expected to be drawn from:

The following modules are expected to apply:

Example 2: A fungicide is registered for use in pome fruit with minimum treatment intervals of three weeks. Application is made to reduce the interval between applications to two weeks in areas of high disease pressure (the total number of applications per year remains unchanged).

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.6.3.    Variation to application method

Requirements

Variation to the application method for a product will require assessments related to the new exposures presented by the new method of application.

All of these variations will require submission of an Application Overview (Part 1) and any combination of the following Parts – residues and possibly trade data (Part 5), OHS (Part 6), environment (Part 7) and efficacy data (Part 8).

Guidelines

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.7.    Reduction of label withholding period instructions

Requirements

All applications of this nature will require an Application Overview (Part 1) and residues and trade data (Part 5).

Data will be required to demonstrate that expected residue levels in food commodities and treated produce will not exceed the MRL when the product is used in accordance with the proposed new withholding period (Part 5A). If the data indicate that residues will exceed the existing MRL when the product is used according to the proposed new withholding period, the applicant must also propose a new MRL and address trade issues (Part 5A and 5B).

Guidelines

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.8.    Variation to the label poisons scheduling (signal heading), first aid, user safety directions, or personal protective equipment statements

4.8.1.    Variation to poisons scheduling

Requirements

Applications to change the poisons schedule of a product which result in a change to the signal heading on the label, and which require assessment of data, will require submission of an Application Overview (Part 1) and toxicology data (Part 3).

Guidelines

Example: A domestic use pesticide is registered with a Schedule 5 signal heading. Application is made to have a new cut-off level for exempt preparations to allow this product to be considered exempt from poisons scheduling (an acute toxicity data package is provided).

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.8.2.    Variation to label first aid statements

Requirements

Applications for variations to label first aid statements which require assessment of data will require submission of an Application Overview (Part 1) and a toxicology package (Part 3). Applicants should submit new toxicological data to support the proposed variation, if they are available.

Guidelines

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.8.3.    Variation to label user safety directions

Requirements

Applications for variation to user safety direction (hazard statements) which require assessment of data will require submission of an Application Overview (Part 1), toxicology data (Part 3) and OHS data (Part 6).

New toxicology data to support the proposed variation should be submitted.

Varying the hazard statement may make it necessary to vary the label personal protective equipment statement.

Guidelines

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.8.4.    Variation to label personal protective equipment statements

Requirements

Applications to vary personal protective equipment statements which require assessment of data will require submission of an Application Overview (Part 1) and OHS data (Part 6).

If the justification for the variation requires toxicological assessment, toxicological data (Part 3 – partial) and Module 3.3 (Toxicology – Level 3) will also apply.

Guidelines

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.9.    Variation to label environmental safety statements, including disposal instructions

Requirements

Applications to delete, modify, or add label environmental safety statements which require assessment of data will require submission of an Application Overview (Part 1) and environmental safety data (Part 7).

Guidelines

Data requirements are expected to be drawn from:

The following modules are expected to apply:

4.10.  Variation to product formulation

4.10.1.  Variation to concentration of, or substitution, addition or deletion of, non-active constituents

Applications of this nature are to vary the concentration of non-active constituents, or to substitute, add or delete non-active constituents other than as specified for Category 13. In these cases the new formulation remains similar to the old formulation with respect to formulation type. Small variations to the level of active constituent may be acceptable if the variation requires no significant changes to label instructions. Significant changes in active constituent level or formulation type that require label modifications are likely to be considered new products so that users recognise the changes and use the product accordingly.

Requirements

Applicants must specify the proposed variations in the relevant sections of the Application Overview (Part 1). The Part 1 submission must include a new formulation table and a copy of the unchanged product specifications.

Applicants should provide stability data on trial batches in the chemistry and manufacture submission (Part 2).

If the APVMA considers the change in formulation to be sufficiently different from the original or previously-approved formulation, the applicant must demonstrate that the new formulation is ‘bioequivalent’, ie it will produce the same biological effect in the pest at the same rate. Bioequivalence trial data and/or argument must be provided in this case.

Information must also be provided in the Application Overview demonstrating that the modified formulation is unlikely to have any significantly different toxicological properties or behave differently in the environment.

Guidelines

As a minimum, data requirements are expected to be drawn from:

As a minimum, the following modules are expected to apply:

Note: If the variation to non-active constituents involves a change which has the potential to affect the physico-chemical [check earlier] properties of the formulation, further data Parts and modules may be required.

4.10.2.  Extension of shelf life

Applications to extend the shelf life of a product where the product specifications remain unchanged will, as a minimum, require stability data to support the proposed change.

Applicants must specify the proposed variations in the relevant sections of the Application Overview (Part 1) and must include the product specifications and any other relevant documentation.

Chemistry and manufacture data (Part 2) must include the test results for the stability trial.

Guidelines

As a minimum, data requirements are expected to be drawn from:

As a minimum, the following modules are expected to apply:

4.11.  Variation to product details to include a new pack size, construction or material where technical assessment is required

Assessment of stability data is generally required if there is a change to the packaging material of the immediate container. Applicants must specify the proposed variations in the relevant sections of the Application Overview (Part 1).

The chemistry and manufacture (Part 2) submission must include stability data, sterility verification (where appropriate) and container/closure specifications.

Guidelines

Data requirements are expected to be drawn from:

The following modules are expected to apply: