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Category 10 Application

Registration of a new chemical product: Modular assessment.

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 10 application as:

Application for registration of a chemical product containing an approved active constituent (or an active for which the APVMA has received an application for approval) and approval of the product label for all situations other than as described in items 3 to 9.

Category 10 is a modular category. The fee payable and timeframe for evaluation 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.

1.1.   Application types

The following types of agricultural applications are eligible for assessment under Category 10:

• a new product containing an approved active constituent (which is present in a currently registered product) for use in a new situation where either toxicology, occupational health and safety, residues, or environment assessments are required (in any combination) in conjunction with an efficacy and/or chemistry assessment
• a new product containing a new combination of approved active constituents which are present in a currently-registered product
• a new product which is similar to a registered product, but proposed for use in a different situation
• any other application for a new product containing approved active constituents not described above and not described in Categories 3 to 9.

Applications to register products which contain a new source of active constituent are ineligible for assessment under Category 10. Such applications require approval of the new source of active constituent, and may be assessed under modular Category 24.

2.   REQUIREMENTS

When making a Category 10 application for registration of a new product, 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 2.6).

2.1.   Combined Application Form and Overview

The Application Form and Application Overview (RTF, 491kb) have been combined into a single document 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 10 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.

Sub-part 1.1 must include details of the reference product if relevant.

When the product is only for use in a non-food situation, sub-part 1.5 need only state this and a separate Part 5 (Residues and Trade) need not be submitted.

2.2.   Data

Category 10 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 10, except for secondary applications, will normally require submission of data for the product, relating to:

Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

Where applicable, the following data Parts may also be required:

Toxicology	Part 3
Metabolism and Kinetics	Part 4
Residues and Trade	Part 5a and Part 5b
Occupational Health and Safety	Part 6
Environment	Part 7
Other Trade Aspects	Part 9
Special Data Requirements	Part 10

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; and
• Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP); and
• 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 10 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 10 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 10 application. Applicants may provide the complete fee when submitting the application, or may choose to provide $505 (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.

2.5.   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 registration of certain products, for example where the product is for use in 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 notifies the public that the APVMA has published on the website a notice called a Public Release Summary (PRS) which invites comment on the APVMA’s intention to approve the variation.

If the product is intended for use in crops or situations that will result in residues in food or animal commodities, the PRS invites comment on whether use of the product would unduly prejudice overseas trade.

If the new product is for use to a new food-producing crop, or if residues in crop commodities require changes to MRLs in the MRL Standard, and the APVMA does not publish a PRS, 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. This requirement applies irrespective of whether an application is eligible for data protection.

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

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.

Module 12 also applies to secondary applications 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 10 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. Where 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.   Secondary applications

When applications are simultaneously submitted to the APVMA for registration of more than one new product containing the same active constituents, one product application may be assessed as the primary application and the others as secondary applications.

A secondary application exists when an applicant has another product containing the same active constituents as the primary product undergoing registration at the same time, and the assessment of some of the data for the first product can be used for both products. The product requiring the highest level of assessment should always be presented as the primary application.

Where the dose form and use pattern are the same, the product with the highest concentration or dose should be presented as the primary application. Both the primary application and the secondary applications, involving modular assessments of data which are not common with the primary application, can be assessed under Category 10. When technical assessment is not required for a secondary application, only Modules 1 (Screening) and 11.4 (Finalisation) will apply, and where relevant, Module 12 (Data Protection). Secondary applications will only be finalised once the primary product application is finalised.

4.   EXAMPLES

The examples in this section show how data requirements can be determined by using Volume 3: Data requirements and guidelines.

In these 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.

Example 1: Application is made for registration of a new product containing an approved active constituent for use as a herbicide in food crops. The active constituent is currently used in an antifouling paint product registered for use on ships. Poisons scheduling is not required.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	Part 3
Metabolism and Kinetics	Part 4
Residues and Trade	Part 5a and Part 5b
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.2	Toxicology – Level 2	$14,620
Module 5.1	Residues and Trade – Level 1	$5,595
Module 6.2	OHS – Level 2	$2,900
Module 7.2	Environment – Level 2	$3,255
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$32,170
	Timeframe:	15 months

Example 2: Application is made for registration of a new product with an approved active constituent for use as a fungicide in cereal crops. Use of the active constituent has previously only been approved as a fungicide in pome fruit. The proposed product has a new formulation, which in this instance does not trigger a change to the poisons scheduling.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	Part 3
Residues and Trade	Part 5a and Part 5b
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 5.2	Residues and Trade – Level 2	$4,765
Module 6.2	OHS – Level 2	$2,900
Module 7.2	Environment – Level 2	$3,255
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$19,620
	Timeframe:	9 months

Example 3: Application is made for registration of a new product containing an approved active constituent for use as a termiticide in buildings and structures. Use of the active constituent has previously only been approved as an insecticide in agricultural crops. The concentration of the active constituent is higher than in other registered products.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	Part 3
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 4	Toxicology – Scheduling	$3,720
Module 6.2	OHS – Level 2	$2,900
Module 7.2	Environment – Level 2	$3,255
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$18,575
	Timeframe:	15 months

Example 4: Application is made for registration of a new product proposed for use as a post-harvest fungicide dip for fruit and vegetables. The formulation of the product is identical to an existing registered product. The application for registration of the new product is supported by the formulator of the original product which is registered for use in the same agricultural crops in field situations.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Residues and Trade	Part 5a and Part 5b
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 5.4	Residues – Level 4	$2,230
Module 6.2	OHS – Level 2	$2,900
Module 7.3	Environment – Level 3	$620
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$10,520
	Timeframe:	9 months

Example 5: Application is made for registration of a new wettable granule product containing an approved active constituent, for use in an identical manner (identical use patterns, identical amount of active constituent applied) to an existing registered product containing the same active constituent. The existing product is a suspension concentrate formulation and access to any protected data is available.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	Part 3
Occupational Health and Safety	Part 6
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 6.2	OHS – Level 2	$2,900
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$10,485
	Timeframe:	9 months

Example 6: Application is made for registration of a new product containing an approved active constituent, for use as a fungicide for tomatoes in the home garden. Use of the active constituent has previously only been approved as a fungicide in commercial citrus crops.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Toxicology	Part 3
Residues and Trade	Part 5a and Part 5b
Environment	Part 7
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 3.3	Toxicology – Level 3	$2,900
Module 5.4	Residues and Trade – Level 4	$2,230
Module 7.3	Environment – Level 3	$620
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$10,520
	Timeframe:	8 months

Example 7: Application is made for registration of a new product containing an approved active constituent for the home garden. The formulation is identical to a currently registered product. The application for registration of the new product is supported by the formulator/registrant of the original product which is registered for commercial/industrial use. The proposed home garden use pattern is identical to the registered commercial use pattern. Poisons scheduling is not required and access to any protected data is available.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Toxicology	Part 3

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 3.3	Toxicology – Level 3	$2,900
Module 11.2	Finalisation – Type 2	$1,175
	Total fee:	$4,580
	Timeframe:	6 months

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