Category 8 application
Repack of a registered chemical product

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 8 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 the same as a registered chemical product; and
2. the chemical product is to be registered with a different name.

Category 8 applications are applications to register a ‘repack’ product that is the same in all respects, except for the product name, as a registered reference product. Data for technical assessment are not required for a Category 8 application because the formulation and use pattern of the reference and repack product are identical, and the products would be expected to be equivalent in terms of their efficacy and host crop safety, residues and trade, environmental safety, toxicology and occupational health and safety.

A minor variation to a product’s name does not result in a new additional product (ie this is not a repack situation) and application for a change of this nature must be made under Category 12.

The criteria for a product to be considered eligible for assessment under Category 8 are more stringent than those required for categories 5, 6 and 7. The flowchart below shows how an application may fit into categories 5, 6, 7, 8 or 10:

1.1.   Definition of ‘the same’ agricultural product

For a new product to be considered the same as a reference product and eligible for assessment under Category 8, the new product must meet all of the following criteria:

• the formulation must be the same (same ingredients of the same standards at the same concentrations)
• the product specifications (release and expiry limits and test methods) and physico-chemical properties (including pH, particle size, crystal form) must all be the same
• the formulation type must be the same
• the use pattern (including target crop species, application rates, application method, withholding periods), label claims and use instructions (including precautionary/safety instructions) must all be the same
• the immediate container must be the same (same packaging materials and closure systems, and no additional pack size)
• the sites of product manufacture must be the same (same sites of manufacture using the same equipment)
• the manufacturing processes must be the same (including quality assurance and test procedures).

New products which have minor differences in formulation, or additional pack sizes, or reduced claims, or minor differences in label information (other than product name and details of registrant/distributor) compared with the reference product, may be eligible for assessment under Category 7.

When the registrant of the repack product is different from the registrant of the reference product, the registrant of the reference product must inform the repack registrant of any changes to the chemistry or manufacturing details of the reference product so that the repack registrant can apply for a change to their product. If some of the details are confidential commercial information (CCI), details can be provided direct to the APVMA.

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, or is the subject of a pending application for registration, the application would be ineligible for Category 8 and may be assessed under modular Category 10.

Where possible the original pioneer product should be used as the reference product for Category 8 applications.

1.3.   Confidential commercial information

For all Category 8 applications, except where the applicant is the formulator, the APVMA will consider the product formulation to be confidential commercial information not to be disclosed to the applicant, unless the applicant provides evidence to the contrary.

2.   REQUIREMENTS

When making a Category 8 application for registration of a repack of a reference product, applicants must provide:

• the specific Category 8 Application Form (refer to paragraph 2.1)
• the formulator’s declaration (refer to paragraph 2.2)
• the applicant's declaration (refer to paragraph 2.3)
• the product label (refer to paragraph 2.4)
• the relevant fee (refer to paragraph 2.5).

2.1.   Application form

The specific Category 8 application form (KP25F05) is available on the APVMA website.

2.1.1.   Electronic Application Registration System (EARS) submissions

In May 2007 the APVMA released EARS client software which enables applicants to electronically complete and submit Category 8 applications to the APVMA.

To gain access and use of the EARS software client applicants must complete the EARS user enrolment form at www.apvma.gov.au/registration/EARS.shtml.

Once enrolled, applicants are supplied with a username and account and CD with the EARS software client. Account holders are able to use EARS to submit electronic applications over a secure encrypted internet connection.

2.2.   Data

Data are not required for Category 8 applications.

2.3.   Formulator’s declaration

For a new product to be considered eligible for consideration as a Category 8 application (repack), it must have the same site of manufacture as the reference product. The definition of formulators (sites of product manufacture) includes any subcontractors engaged in a step of manufacture including formulating, filling, packaging, labelling, analysis or testing.

Category 8 applications must be accompanied by a signed and dated declaration on company letterhead from the formulators of the proposed and reference products. If more than one formulator is involved in manufacture of a product, each formulator must provide a declaration covering the manufacturing steps they perform.

If an applicant or approved person provides evidence that the applicant and formulator are part of the same company structure, the applicant or approved person may complete and submit the formulator’s declaration on company letterhead. If this is not possible, an application with formulation details should be made under Category 7.

The formulator’s declaration must include all of the following statements with regard to the proposed repack and reference products:

• the sites of product manufacture will be the same (same sites of manufacture using the same equipment)
• the formulations will be the same (same ingredients of the same standards at the same concentrations)
• the manufacturing processes will be the same (including quality assurance and test procedures)
• the formulation type, physico-chemical properties (including pH, particle size, crystal form and, where applicable, dissolution profile, payout rate and payout period), and product specifications (release and expiry limits and test methods) will all be the same
• the immediate containers will be the same (same packaging materials and closure systems, and no additional pack size).

If the formulator is also the authorising party for protected data associated with the reference product, the APVMA will consider the formulator’s declaration of support for the repack of the reference product, as sufficient to provide consent for the use of that protected data unless otherwise specified. Refer to paragraph 2.8 for more information on data protection.

A ‘consent for use’ letter is not required.

2.4.   Applicant's declaration

The applicant must also provide a declaration that the use pattern (including host crop species, application rates, application method, withholding periods), label claims and use instructions (including precautionary/safety instructions) are all the same as those of the reference product.

2.5.   Label

Applicants must provide a label with the Application Form. 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.

2.6.   Fee

The fee for a Category 8 application is $540.

The timeframe is three months.

2.7.   Finalisation of the application

A Category 8 application cannot be finalised if there is a current application to vary the reference product that will impact on its particulars or conditions of registration.

2.8.   Data protection

Data are not required for Category 8 applications, therefore a data list is not required.

However, applicants under Category 8 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.

If the applicant is not the authorising party for the data used to approve the active constituents or register the product, or if the applicant has not received consent for use of protected data via the formulator’s declaration (see paragraph 2.3) 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.

2.8.1.   Formulators who do not intend to consent to use of protected data pertaining to certain claims

Formulators who provide a declaration that demonstrate that the proposed and reference chemical product are chemically identical, but do not intend to consent to the use of protected data pertaining to certain claims, should state this in their formulator’s declaration. The effect of this will be that those claims cannot be placed on the new product label.

New products that differ from the reference product in terms of reduced or different claims are not eligible for assessment under Category 8, but may be eligible for assessment under Category 7 or Category 10.

3.   EXAMPLES

Example 1: 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, made by the same formulator to exactly the same formulation as the reference product, with the same packaging and pack sizes and the same label claims and instructions.

An application of this nature would be assessed under Category 8.

Example 2: Application is made for registration of a new product for use as a fungicide, with the same formulation and formulator as the reference product, with the same label claims and instructions and packaging but with only some of the pack sizes of the reference product.

An application of this nature would be assessed under Category 8.

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, with the same formulation, formulator and packaging as the reference product, with fewer label claims but other instructions being the same.

An application of this nature would not be assessed under Category 8 because the label claims are not the same. This application would be eligible for assessment under Category 7.

Example 4: Application is made for registration of a new product for use as a herbicide, with the same formulation and formulator as the reference product, with the same label claims and instructions but with an additional pack size.

An application of this nature would not be assessed under Category 8 because of the different pack size. This application could be eligible for assessment under Category 7. If the additional pack size has implications for poison scheduling or safety directions then it would be assessed under Category 10.

Example 5: Application is made for registration of a new product for use as a fungicide in pome, stone and various other fruit crops, with exactly the same formulation as the reference product, with the same label claims and instructions, except that the new product is aimed at the home garden market and the reference product is registered for commercial use only.

An application of this nature would not be assessed under Category 8 because the APVMA must evaluate the suitability of the product to be used by home gardeners. The applicant would be required to apply under Category 10 with the appropriate modules to cover the different assessments required.

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