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Category 24 Application

Registration of a chemical product or approval of an active constituent requiring technical assessment and not covered by Categories 1–8, 10, or   15–17.

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 24 application as:

Application made under section 10 of the Code (other than those of the kinds in items 1, 2, 3, 4, 5, 6, 7, 8, 10, 15, 16 or 17) requiring assessment of a technical nature.

Applications made under Category 24 are for registration of a product and/or approval of an active constituent, which are not covered by Categories 1–8, 10, or 15–17 and which require technical assessment.

Applications to register a product that contain a new source of active constituent are eligible for assessment under Category 24.

The APVMA expects that few other applications will be assessed under Category 24.

Category 24 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.

2.   REQUIREMENTS

When making a Category 24 application for registration of a new product and/or approval of a new active constituent, 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 if applicable (refer to paragraph 2.3)
• the relevant fee (refer to paragraph 2.4)
• a data list (refer to paragraph 2.5).

2.1.   Combined Application Form and Overview

The Application Form and Application Overview have been combined into a single document (KP25F15) 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.

2.2.   Data

Category 24 is a modular category, therefore data studies, fee and timeframe are determined by the module levels required for assessment of the product and/or active constituent, which themselves are determined by the type of product/active constituent and the situations in which the product will be used.

All applications made under Category 24 will require submission of data for the product and/or active constituent which may include some or all of the following:

Application Overview	Part 1
Chemistry and Manufacture data for the product	Part 2
Toxicology data for the active constituent and product	Part 3
Metabolism and Kinetics	Part 4
Residues and Trade	Part 5
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8
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 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 24 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 24 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.   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.

3.   EXAMPLES

Example 1: Application is made to register a new insecticide product that contains a new source of an approved active constituent at the same concentration as a reference product, with similar non-active constituents, the same formulation type, and the same label claims and instructions.

An application of this nature is ineligible for assessment under Category 6 because the new source of active constituent requires approval. Application should be made under Category 24.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.2	Chemistry – Level 2	$2,230
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$3,710
	Timeframe:	10 months

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