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Category 2 Application

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.

Module 6.1 in Module levels for modular categories in Volume 3 states that applications for registration of a new veterinary active constituent and associated product will not require a full (comprehensive) assessment of Part 6 OHS data. For this reason, all applications for approval of a new active constituent and registration of a new veterinary product containing the new active constituent will be assessed under Category 2.

1.1.   Application types

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

• a new pharmaceutical veterinary medicine, including ectoparasiticides, containing a new active constituent
• a new immunobiological product containing a new active constituent
• a new direct-fed microbial or enzyme product containing a new active constituent
• a new complementary medicine product containing a new active constituent
• a new nutritional product containing a new active constituent.

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).

Immunobiological products

A specific application form (KP25F19) is available for immunobiological products.

2.1.   Combined Application Form and Overview

The Application Form and Application Overview have been combined into a single document (KP25F20). 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-producing animal species, 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. More 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 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 $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.   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 food-producing animals 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

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.

Module 12 also applies to secondary applications which rely on protected data provided 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.

Applicants applying under Category 10 may need to refer to data relied on by the APVMA to register a reference product. The reference product may also have required access to protected data in relation to its active constituent/s or reference product. Where the applicant is not the authorising party for the data used to approve the active constituent/s 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.   GUIDELINES

3.1.   Secondary applications

When applicants wish to simultaneously register more than one new product containing a new active constituent, one product application may be assessed as the primary application and the other products may be assessed as secondary applications.

A secondary application exists when an applicant has another product containing the same active constituents 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 the secondary applications. The product requiring the highest level of assessment should always be presented as the primary application.

Where the dose form and use pattern are the same, the product with the highest concentration or dose 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.   SPECIFIC REQUIREMENTS, GUIDELINES AND 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.

4.1.   New pharmaceutical veterinary medicine containing a new active constituent

Pharmaceutical veterinary medicines include all the veterinary parasitological products (including ectoparasiticides), ethical products and antibiotic products which fit the definition of a veterinary chemical product and which are not:

• immunobiologicals
• direct-fed microbials or enzymes
• complementary medicines.

Pharmaceutical veterinary medicines usually contain synthetic, semi-synthetic or highly purified molecules as active constituents.

Guidelines

Example 1: Application is made to register two anthelmintic products (administered in drinking water) which contain a new active constituent. The formulations, specifications and manufacturing details of the two products are identical, but one is for use in pigs and the other is for use in poultry. The pig product may be assessed as the primary application and the poultry product may be assessed as a secondary application.

Data requirements for the primary application are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	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

The following modules are expected to apply for the primary application:

Module	Description	Fee
Module 1	Screening	$505
Module 2.1	Chemistry – Level 1	$3,255
Module 3.1	Toxicology – Level 1	$19,490
Module 4	Toxicology – Scheduling	$3,720
Module 5.1	Residues – Level 1	$5,595
Module 6.2	OHS – Level 2	$2,900
Module 7.1	Environment – Level 1	$12,605
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$52,335
	Timeframe:	15 months

Data requirements for the secondary application are expected to be drawn from:

Application Overview	Part 1
Residues and Trade	Part 5
Efficacy and Safety	Part 8

The following modules are expected to apply for the secondary application:

Module	Description	Fee
Module 1	Screening	$505
Module 5.2	Residues – Level 2	$4,765
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$8,480
	Timeframe:	Same as primary

Example 2: Application is made to register a new non-steroidal anti-inflammatory injection for use in dogs which contains a new active constituent that is not scheduled in Australia and for which an acceptable overseas toxicology report has been supplied.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	Part 3
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.1	Chemistry – Level 1	$3,255
Module 3.3	Toxicology – Level 3	$2,900
Module 4	Toxicology – Scheduling	$3,720
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$13,530
	Timeframe:	15 months

Example 3: Application is made to register an ectoparasiticide pour-on product for use on cattle, which contains a new active constituent.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	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

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.1	Chemistry – Level 1	$3,255
Module 3.1	Toxicology – Level 1	$19,490
Module 4	Toxicology – Scheduling	$3,720
Module 5.1	Residues – Level 1	$5,595
Module 6.2	OHS – Level 2	$2,900
Module 7.1	Environment – Level 1	$12,605
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$52,335
	Timeframe:	15 months

Example 4: Application is made to register a range of antibiotic products for use in dogs and cats, which contain a new active constituent that is not scheduled in Australia. There are four products: 500 mg tablet for large dogs, 250 mg tablet for medium size dogs, 50 mg tablet for small dogs and cats, and an oral paste formulation for small dogs and cats. The tablets are direct scale formulations.

Clinical field trials have been conducted to demonstrate efficacy and animal safety of the 250 mg tablet in dogs and the 50 mg tablet in cats. A comparative dissolution study has been conducted with all tablet strengths. A blood concentration bioequivalence study has been conducted to demonstrate comparable efficacy of the paste formulation with the tablet formulation in dogs and cats. The 250 mg tablet is the primary product application.

Data requirements for the 250 mg tablet primary application are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	Part 3
Metabolism and Kinetics	Part 4
Efficacy and Safety	Part 8
Special Data (antibiotic resistance)	Part 10

The following modules are expected to apply for the primary application:

Module	Description	Fee
Module 1	Screening	$505
Module 2.1	Chemistry – Level 1	$3,255
Module 3.2	Toxicology – Level 2	$14,620
Module 4	Toxicology – Scheduling	$3,720
Module 8.2	Efficacy and Safety – Level 2	$750
Module 10.1	Special Data (antibiotic resistance) – Level 1	$0
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$25,250
	Timeframe:	15 months

Data requirements for the 50 mg tablet secondary application are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

The following modules are expected to apply for the 50 mg tablet application:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$2,800
	Timeframe:	Same as primary

Data requirements for the 500 mg tablet application are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

The following modules are expected to apply for the 500 mg tablet application:

Module	Description	Fee
Module 1	Screening	$505
Module 2.4	Chemistry – Level 4	$200
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$2,550
	Timeframe:	Same as primary

Data requirements for the paste secondary application are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

The following modules are expected to apply for the paste secondary application:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$3,380
	Timeframe:	Same as primary

Example 5: Application is made to register four growth promotant products with a new active constituent, administered in-feed for use in food-producing animals. One product is for use in three species (cattle, pigs and poultry). The other three products have the same formulation, specifications and packaging material of the immediate container/closure system, but each is to be marketed for use in one species only (as a cattle product, a pig product and a poultry product).

The product for use in all three species may be assessed as the primary application and the other three products may be assessed as secondary applications.

Data requirements for each of the secondary applications are expected to be drawn from:

Application Overview

Part 1

The following modules are expected to apply for each of the secondary applications:

Module	Description	Fee
Module 1	Screening	$505
Module 11.4	Finalisation – Type 4	$160
Module 12	Data Protection	$170
	Total fee:	$835
	Timeframe:	Same as primary

4.2.   New immunobiological product containing a new active constituent

Immunobiological products are products derived from a living organism which, when administered to the host, provide, induce or change an immune response to a target biological entity. The most common immunobiologicals are vaccines for protection against disease-causing agents.

For registration purposes, immunobiological products are classed as:

Vaccines: Products designed to produce an immune response in the treated animal. These may be produced in a variety of systems, for example, specific pathogen free (SPF) eggs, tissue and cell culture, microbial culture, chemical synthesis and live animals.

The immunogenic components of the vaccine may include viable organisms (virulent or attenuated), inactivated organisms, or partly or highly purified extracts from production organisms. Such organisms may include recombinant organisms.

Antisera: Serum or other non-vaccine products purified from animals (including transgenic animals), for example, snake antivenene, anti-tick serum and gammaglobulin.

Other immunobiologicals: Products which are autoantibodies or immunologically active molecules, such as cytokines or monoclonal antibodies.

Guidelines

Applicants should refer to the APVMA guideline Data requirements and guidelines for registration of new veterinary immunobiological products in Volume 4.

Example 1: Application is made to register an injectable viral vaccine product for use in cats. The vaccine contains two live attenuated viruses – one virus is a new active constituent and the other is an existing approved active constituent.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.2	Chemistry – Level 2	$2,230
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$4,830
	Timeframe:	10 months

Example 2: Application is made to register an injectable viral vaccine product for use in cattle. The vaccine contains two live attenuated viruses, both of which are new active constituents, and the vaccine is to prevent an exotic or notifiable disease.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8
Other Trade Aspects	Part 9

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.2	Chemistry – Level 2	$2,230
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 9	Non-food trade	$1,175
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$8,175
	Timeframe:	11 months

4.3.   New direct-fed microbial or enzyme product containing a new active constituent

Direct-fed microbial products are products which contain viable micro-organisms for oral administration.

Enzyme products usually contain enzymes produced by micro-organisms. They may be administered as mass medications in feed or water, or individually to single animals.

Guidelines

Applicants should refer to specific guidelines in Volume 4 for the registration of direct-fed microbial products used in stock feeds, or guidelines for the registration of enzyme-based products.

Example 1: Application is made to register a direct-fed microbial product for in-feed administration to poultry to increase feed conversion efficiency. The micro-organism is a new bacterial active constituent. The bacterium is genetically modified, sourced from a European country and has not previously been assessed by the Office of the Gene Technology Regulator (OGTR). Because of the bacterial species, assessments are required of toxicology, occupational health and safety and environmental safety.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	Part 3
Occupational Health and Safety	Part 6
Environment	Part 7
Efficacy and Safety	Part 8
Other Trade Aspects	Part 9
Special Data (genetically modified organism)	Part 10

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.2	Chemistry – Level 2	$2,230
Module 3.3	Toxicology – Level 3	$2,900
Module 4	Toxicology – Scheduling	$3,720
Module 6.2	OHS – Level 2	$2,900
Module 7.1	Environment – Level 1	$12,605
Module 8.1	Efficacy and Safety – Level 1	$1,865
Module 9	Non-food trade	$1,175
Module 10.3	Special Data: genetically modified organism	$0
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$30,300
	Timeframe:	15 months

4.4.   New complementary medicine product containing a new active constituent

Veterinary complementary medicines are those veterinary chemical products containing naturally occurring constituents that are approved as complementary medicines for use in humans by the Therapeutic Goods Administration (TGA). They include herbal and other natural remedies.

Guidelines

Applicants should refer to specific guidelines in Volume 4 for the registration of veterinary complementary medicines.

Example 1: Application is made to register a herbal extract tablet product for use in dogs and cats with a claim to relieve stress and travel sickness. The product contains a new herbal active constituent which has been approved by the TGA for use in humans.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.2	Chemistry – Level 2	$2,230
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.2	Finalisation – Type 2	$1,175
Module 12	Data Protection	$170
	Total fee:	$4,830
	Timeframe:	10 months

Example 2: Application is made to register a feed additive powder product for use in dogs with a claim to aid in the treatment of osteoarthritis. The product contains a new active constituent, derived from a marine plant, which has not been approved by the TGA for use in humans, but which is considered to be of low toxicity based on overseas experience.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	Part 3
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.2	Chemistry – Level 2	$2,230
Module 3.3	Toxicology – Level 3	$2,900
Module 4	Toxicology – Scheduling	$3,720
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$12,505
	Timeframe:	15 months

4.5.   Any other new product containing a new active constituent not described above and not described in Category 1

This section is for applications to register a product containing new active constituent/s, which is not described in sections 4.1–4.4 or in Category 1. This section covers nutritional products, which may contain new active constituents. Such applications will be assessed on their merits.

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