Ag Volume 2

Category 2


	Category 2 application Approval of a new active constituent and registration of an associated chemical product: Modular assessment
		Table of Contents

1. DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 2 application as:

Application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring less than full assessment of the active constituent and chemical product.

A Category 2 application is for registration of a new product, containing new active constituent/s, where a full (comprehensive) assessment is NOT required for data Parts 2 to 8¹.

Category 2 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.

1.1. Application types

The following types of agricultural applications are eligible for assessment under Category 2:

a new chemically synthesised active constituent and a product containing that active constituent for use as a rodenticide in agricultural, commercial and industrial buildings for use in bait stations only, with restrictions on use around animals and food:
- this application would be assessed under Category 2 because residues assessment would not be required
a new biologically-derived active constituent and a product containing that active constituent for use as an insecticide in vegetables. The active constituent is the virus toxin of the intended pest-specific virus:
- this application would be assessed under Category 2 because a full residues assessment would not be required if the toxicological data demonstrated negligible mammalian toxicity. In addition, it could be possible that a reduced environmental assessment would be suitable depending on the nature of the toxin
a new biologically-derived active constituent and a product containing that active constituent for use as an insecticide in pome fruit orchards. The active constituent is the spores of a fungus pathogenic to insects:
- this application would be assessed under Category 2 for the same reasons as given above
a product containing a new active constituent which is a commonly-used household or industrial chemical with a history of safe use.

2. REQUIREMENTS

When making a Category 2 application for approval of an active constituent and 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 have been combined into a single document (KP25F03) which is available on the APVMA website. A single unbound copy of the combined document must be provided to the APVMA.

The Application Form is divided into separate sections for application for registration of the product and approval of the active constituent.

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

2.2. Data

Category 2 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 2, 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 data for both the active constituent and the product, including poisons scheduling	Part 3
Metabolism and Kinetics	Part 4
Residues and Trade	Part 5
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)
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 2 is a modular category and therefore the fee payable and timeframe depend on which of the modules are required for assessment of the application.

The fee for a Category 2 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 2 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.

2.5. Public consultation

Prior to approval of the active constituent and registration of the product, the APVMA will conduct a round of public consultation. This is normally by means of publication of a Gazette Notice 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 active constituent and register the product.

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.

2.6. 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 the APVMA grants an application.

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 also applies to secondary applications which rely on protected data 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.

3. GUIDELINES

3.1. Secondary applications

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

Products containing more than one new active constituent, except for veterinary vaccines, direct-fed microbials and enzymes, will require more than one application because each active constituent will require separate chemistry and toxicological assessments.

A secondary application exists when an applicant has another product containing the same active constituent/s 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 method of application and use pattern are the same, the product with the highest concentration or application rate 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 2. 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 following examples 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 approval of a new chemically-synthesised active constituent and registration of a product containing that active constituent, for use as a rodenticide in agricultural, commercial and industrial buildings for use in bait stations only, with restrictions on use around animals and food.