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Category 7 Application

Registration of a new chemical product that is closely similar to a registered chemical product: Chemistry and manufacture data not required.

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 7 application as:

Application for registration of a chemical product containing an approved active constituent and approval of the product label if:

1. the chemical product is closely similar to a registered chemical product; and
2. efficacy and safety data are not required to demonstrate the similarity of the chemical product to the registered chemical product; and
3. chemistry and manufacture data are not required.

Category 7 applications are applications for registration of an ‘image’ product containing approved active constituents, and approval of the product label, where the product is closely similar to an APVMA-registered reference product and chemistry and manufacture data are NOT required. Other data for technical assessment are also NOT required because the formulation and use pattern of the reference and proposed product are closely similar, and the products would be expected to be equivalent in terms of their efficacy and host crop safety, residues and trade, environmental safety, human health and occupational health and safety.

The criteria for a product to be considered eligible for assessment under Category 7 are less stringent than those for Category 8, but more stringent than those for Category 6. For example, if the proposed and reference products have different non-active constituents compare with the reference product (eg emulsifier, surfactant, dye, solvent), chemistry data would be required and the application may be eligible for assessment under Category 6. The flowchart below shows how an application may fit into categories 5, 6, 7, 8 or 10:

1.1.   Definition of closely similar agricultural products

Applications to register new products under Category 7 are those where the formulation and label instructions of the new product are closely similar to those of a registered reference product, and no data are required to demonstrate product quality or target crop/situation efficacy and safety.

For a new product to be considered closely similar to a registered reference product and NOT require chemistry and manufacture data, and so be eligible for assessment under Category 7, the new product must meet all of the following criteria:

• the active constituents must be the same and be approved by the APVMA
  • ie the source or manufacturer must appear on the Record of Approved Active Constituents
  • if an active constituent is not present on the Record of Approved Active Constituents, the APVMA may need to approve separate sources. For further details on approval of active constituents, applicants may contact the Pesticides Program Contact Officer on 02 6210 4748.
• the active constituents must be the same concentration
• the non-active constituents must be the same or equivalent substances at the same or equivalent concentrations
  • minor differences may be acceptable if they are not expected to have adverse implications for product quality or biological activity such as efficacy, safety or residues.
• the formulation type must be the same
• the label must have the same crops/situations and pests (ie no additional uses) and must include similar use and precautionary/safety instructions
  • however, there may be fewer or reduced claims compared to the reference product.

Examples of product types which may be eligible for application under Category 7 include products which are the same as the reference product, but fall outside the definition of Category 8 (repack) due to differences which may include:

• additional pack sizes
• minor change in formulation
• fewer or reduced claims compared with the reference product
• other label changes (apart from product name and registrant details) compared with the reference product.

If the formulation, specifications or pack size or label instructions of the proposed product are sufficiently different from those of the reference product, the APVMA may determine that the application requires submission of data for technical assessment (eg chemistry, toxicology, residues and trade, OHS, environment or efficacy and host crop safety data).

Differences that have the potential to affect product quality or other aspects such as efficacy, safety and residues are outside the scope of a Category 7 application, and data will be required for technical assessment under another category. In this instance the APVMA may consider that assessment under Category 5 or 6 or 10 is required.

Applications to register closely similar products that contain a new source of active constituent are ineligible for Category 7. Such applications, which require approval of the new source of active constituent, may be assessed under modular Category 24.

1.2.   Reference product

A reference product is a chemical product which is registered under Part 2 of the Agvet Code, and has an approved label. It does not include a product for which the registration has been cancelled or a product which is the subject of an application for registration.

If an applicant nominates a reference product for which registration has been stopped or cancelled, the application would be ineligible for Category 7 and may be assessed under modular Category 10.

Where possible the original pioneer product should be used as the reference product for Category 7 applications.

2.   REQUIREMENTS

When making a Category 7 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)
• the product label (refer to paragraph 2.2)
• the relevant fee (refer to paragraph 2.3).

2.1.   Combined Application Form and Overview

The Application Form and Application Overview have been combined into a single document (KP25_F25). 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 7 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-part 1.1 must include details of the reference product.

Sub-part 1.2 of the Application Overview must specify and justify all minor differences in formulation, product specifications and pack size compared with the reference product.

2.2.   Data

Data are not required for Category 7 applications.

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

The fee for a Category 7 application is $660.

The timeframe is three months.

2.5.   Data protection

Data are not required for Category 7 applications, therefore a data List is not required.

However, applicants under Category 7 may need to refer to data relied on by the APVMA to register the reference product. The reference product may also have required access to protected data in relation to the active constituents or its reference product. Where the applicant is not the authorising party for the data used to approve the active constituents 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.   EXAMPLES

Example 1: Application is made for registration of a new product for use as a herbicide, of the same formulation type and containing the same approved active constituent at the same concentration as the reference product. The proposed product has the same label claims and instructions, including application rates, with emulsifiers and a solvent of the same type and amount as in the reference product.

An application of this nature would be assessed under Category 7 because no chemistry data would be required provided the applicant can demonstrate equivalence of all the constituents (eg different brands of the same inactive constituent).

Example 2: Application is made for registration of a new product for use as a fumigant for stored commodities. The product consists only of the active constituent. Uses are the same as for the nominated reference product.

An application of this nature would be assessed under Category 7.

Example 3: Application is made for registration of a new product for use as a fungicide in pome, stone and various other fruit crops, of the same formulation type and containing the same approved active constituent at the same concentration as the reference product, with the same label claims and instructions. The product differs from the reference product in the concentration and types of surfactants used.

An application of this nature would not be assessed under Category 7 because the differences in formulation could change the efficacy and crop safety risks associated with the product. This application would be assessed under Category 5.

Example 4: Application is made for registration of a new product for use as a post-emergent selective herbicide, containing the same approved active constituent at the same concentration as the reference product, with the same label claims and instructions. However, the non-active constituents vary such that the formulation type has changed.

An application of this nature would not be assessed under Category 7 because toxicological and OHS assessments would be required in order to set appropriate safety directions. The applicant would be required to apply under Category 10 with the appropriate modules to cover the different assessments required.

Example 5: Application is made for registration of a swimming pool algicide and bactericide that would comply with an APVMA Standard for such a product but where the applicant wishes to make label statements additional to those allowed under that APVMA Standard.

An application of this nature would be assessed under Category 7 unless the label changes were trivial and allowed under general permits (in which case Category 9 would be appropriate) or the label changes were substantial and required data to support them, in which case Category 5 or 10 would be appropriate.

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