Category 5 application
Registration of a new chemical product which is similar to a registered chemical product

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 5 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 similar to a registered chemical product; and
2. chemistry and manufacture, efficacy and target species safety data are the only data required to demonstrate the similarity of the chemical product to the registered chemical product.

Category 5 applications do NOT require technical assessment of any data other than chemistry and manufacture, efficacy and host crop safety. Because the formulation and use pattern of the reference and proposed product are similar, the products would be expected to be equivalent in terms of their environmental safety, human health and occupational health and safety.

The criteria for a product to be considered similar to a reference product and eligible for assessment under Category 5 are less stringent than those required for Categories 6, 7 and 8. If assessment is required of data other than chemistry and manufacture, comparative efficacy and host crop safety, the application would be assessed under Category 10. The flowchart below shows how an application may fit into categories 5, 6, 7, 8 or 10:

1.1.   Definition of similar agricultural products

Applications to register new products under Category 5 are those where the formulation and label instructions of the new product are similar to those of a registered reference product, but there are sufficient differences to require Part 2 chemistry and manufacture data to demonstrate product quality, plus Part 8 target crop/situation efficacy and safety data to demonstrate that the new product is bioequivalent to the reference product.

For a new product to be considered similar to a reference product, 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 at: http://www.apvma.gov.au/actives/downloads/aa_AK.pdf
  • if an active constituent is not present on the Record of Approved Active Constituents, the APVMA may not need to approve separate sources. For further details on approval of active constituents, applicants may contact the APVMA's Chemistry and Residues Program on 02 6210 4818
• 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 or 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 5 include products which are similar to the reference product, but fall outside the definition of Category 6 (closely similar) due to differences which may include:

• differences in the concentration of the active constituent
• differences in the non-active constituents.

If the APVMA determines that the proposed product is not similar to the nominated reference product, for example due to differences in the formulation or label instructions or uses, additional data and assessments may be required. In this case the APVMA will inform the applicant that the submission is outside the scope of Category 5 and application under a different category is required. For example, if the formulation or label instructions/uses are significantly different and require other types of assessment (eg toxicology, residues and trade, OHS or environment), the application would be assessed under Category 10.

Applications to register similar products which contain a new source of active constituent are ineligible for Category 5. Such applications require approval of the new source of active constituent, and 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 cancelled or stopped, the application would be ineligible for Category 5. The application may be assessed under modular Category 10.

Where possible the original pioneer product should be used as the reference product for Category 5 applications.

2.   REQUIREMENTS

When making a Category 5 application for registration of a new product, applicants must provide:

• one unbound copy of the combined Application Form and Application 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 2.5).

2.1.   Combined Application Form and Overview

The Application Form and Application Overview have been combined into a single document (KP25_F25) 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 5 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.

Applicants must provide a statement under the appropriate heading with brief argument why data are not required for each sub-part 1.3–1.7 and 1.9–1.10.

2.2.   Data

Data requirements for Category 5 applications are as follows:

A single Category 5 application may include more than one crop use on the label if the assessments described above cover all the crops. However, if there are deficiencies or requirements relating to only one of these assessments, none of the crop uses contained in that application can be approved until all deficiencies or requirements for all crops have been addressed satisfactorily. An alternative is for the applicant to remove one of the crop uses from the application.

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 5 application is $3,300.

The timeframe is five months.

2.5.   Data protection

Data protection applies for all applications which are assessed under Category 6, where the applicant is providing data to the APVMA that are eligible for protection. Publicly available data are ineligible for protection.

Applicants must provide a Data List, which includes chemistry and manufacture data. This requirement applies irrespective of whether an application is eligible for data protection.

Further information is available on the APVMA website data protection page at http://www.apvma.gov.au/registration/data_protection.shtml .

Applicants under Category 5 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 Category 5 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 fungicide in pome, stone and various other fruit crops, of the same formulation type and containing an approved active constituent at the same concentration as the reference product, with the same label claims and instructions. However, the product differs from the reference product in the concentration and types of surfactants used.

An application of this nature would be assessed under Category 5 because only chemistry and bioequivalence data would be required.

Efficacy studies should use both the new product and the proposed reference product wherever possible, ensuring that the trial design is suitable to allow an appropriate statistical analysis ie sufficiently and properly replicated and randomised treatments to demonstrate that treatments were not significantly different, at an appropriate level of significance.

Example 2: Application is made for registration of a new product for use as an adjuvant (eg wetter, spreader, sticker, penetrant), of the same formulation type and containing an approved active constituent at a slightly lower concentration (10 per cent less) than the reference product, with the same label claims and instructions, including application rates. Other formulation constituents may also vary slightly.

An application of this nature would be assessed under Category 5 because only chemistry and bioequivalence data would be required.

The minimum data required for this application are the same as discussed in Example 1. However, the applicant should carefully consider what range of use situations the product will need to be tested in. For example, if the product is to be used with insecticides, fungicides and herbicides, which in turn could be used on a wide range of crop types and situations, a suitable sample must be used in trials.

Alternatively, the applicant may be able to support limited trial data by providing appropriate physico-chemical analysis of both the new product and reference product when diluted, to demonstrate that the properties of the two products when applied are not significantly different.

Example 3: Application is made for registration of a new product for use as an insecticide in a wide variety of crop and non-crop situations, of the same formulation type and containing an approved active constituent at 50 per cent of the concentration of the reference product, with the same label claims and instructions other than requiring that the product be applied at double the rate. The product is closely similar to the reference product in concentration and types of non-active constituents used.

An application of this nature would be assessed under Category 5. Applicants may be able to provide scientific argument acceptable to the APVMA that bioequivalence trials are not required. For example, if the product is applied at double the rate and non-active constituents are not important for product efficacy, technical argument may be acceptable in lieu of bioequivalence data.

Example 4: Application is made for registration of a new product for use as a personal insect repellent, of the same formulation type and containing the same approved active constituents, some at slightly different concentrations, and some at higher concentrations (eg 5-20 per cent higher) compared to the reference product. Other formulation constituents may vary slightly compared to the reference product. Label claims and instructions are the same as for the reference product.

An application of this nature would be assessed under Category 5 if the active constituents present at higher concentrations were of low toxicological significance (eg food-grade substances). However, if there is any doubt over the toxicity of the active constituents a toxicological assessment will be required. In this case the APVMA would assess the application under Category 10, using the appropriate toxicological assessment modules, plus other relevant modules.

Example 5: Application is made for registration of a new product for use as a post-emergent selective herbicide, containing an approved active constituent at the same concentration as the reference product, with the same label claims and instructions. However, the non-active constituents are different to the extent that the formulation type has changed to one where no safety directions exist.

An application of this nature would not be assessed under Category 5 because toxicological and OHS assessments would be required in order to set appropriate safety directions, so as to allow the APVMA to be satisfied that the product can be used safely. The applicant would be required to apply under Category 10 with the appropriate modules to cover the different assessments required.

Example 6: Application is made for registration of a new product for use as a fungicide in fruit crops, of the same formulation type and containing a new source of an 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 source of active constituent and concentration and types of surfactants used.

An application of this nature would not be assessed under Category 5 because the new source of active constituent requires approval. Application under modular Category 24 would be appropriate.

Footnotes

1. There may be fewer or reduced claims compared with the reference product.
2. Category 5 is a fixed category for which the fee and timeframe are predetermined. Although Category 5 is not a modular category, the chemistry and manufacture data required correspond with those described for a Module 2.3 assessment in Module levels for modular categories in Volume 3.
   
   The efficacy and host crop safety data required to demonstrate similarity to a registered reference product generally correspond with those described for a Module 8.3 assessment.
   
   Detailed Part 2 and Part 8 data requirements can be determined by reference to Volume 3: Data requirements and guidelines.

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