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Category 10 Application

1.   DEFINITION

Schedule 6 of the Agvet Code Regulations describes a Category 10 application as:

Application for registration of a chemical product containing an approved active constituent (or an active for which the APVMA has received an application for approval) and approval of the product label for all situations other than as described in items 3 to 9.

Category 10 is a modular category. The fee payable and timeframe for evaluation 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 veterinary applications are eligible for assessment under Category 10:

• a new product containing approved active constituents with a formulation which is similar to that of a registered product, for use in food-producing animals where residues data are required
• a new product containing approved active constituents with a formulation which is similar to that of a registered product, where the label has a different claim, directions for use, withholding period, poisons scheduling (signal heading), first aid or user safety direction/statement, or environmental instructions/warnings
• a new product containing approved active constituents with a formulation which is NOT similar to a registered product (major formulation difference)
• any other application for a new product containing approved active constituents not described above and not described in Categories 3 to 9.

Applications to register a veterinary product where the active constituent is under application for approval, are uncommon. The levels of modular assessment required for such applications may differ from those given in the examples in section 4 below, and applicants should contact the APVMA for advice if necessary.

2.   REQUIREMENTS

When making a Category 10 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)
• 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 2.7).

Immunobiological products

A specific application form (KP25_F19) 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 (KP25_F26). 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 10 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-parts 1.1–1.10 of the Application Overview must all be completed.

Sub-part 1.1 must include details of the reference product if relevant.

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

2.2.   Data

Category 10 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 10, 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	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); 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 10 is a modular category, therefore the fee payable and timeframe depend on which of the modules are required for assessment of the application.

The fee for a Category 10 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 10 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.   Use of reference products

Application data requirements are normally addressed by submission of data and/or relevant scientific argument or nomination of a suitable reference product. If an applicant does not provide data or relevant scientific argument to support aspects of their application, the applicant must nominate a suitable registered reference product.

2.6.   Public consultation

Public consultation will be required prior to registration of certain products, for example where the product is for use in a new animal species, or where a new withholding period requires changes to the maximum residue limits (MRL) in the MRL Standard. In such cases the APVMA will conduct a round of public consultation. This is normally by means of publication of a Gazette Notice called a Public Release Summary (PRS) 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 variation.

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.

If the new product is for use to a new food-producing animal species, or if residues in animal commodities require changes to MRLs in the MRL Standard, and the APVMA does not publish a PRS, the APVMA will publish a Trade Advice Notice (TAN) inviting comment.

2.7   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.

2.7.1   Companion animal products are not eligible for data protection

Applications involving companion animal products (for example dogs, cats, horses, aviary birds and aquarium fish), which contain an existing active constituent, are not eligible for data protection and do not require Module 12.

3.   GUIDELINES

3.1.   Secondary applications

When applications are simultaneously submitted to the APVMA for registration of more than one new product containing the same active constituents, one product application may be assessed as the primary application and the others 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 both products. 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 10. 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 examples in this section show how data requirements can be determined by using Data requirements and guidelines in Volume 3.

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 product containing approved active constituents, which is similar to a registered product for use in food-producing animals, and where residues data are required

Requirements

For a product to be considered similar to a reference product and be eligible for assessment under this section of Category 10, all of the following criteria must apply:

• the active constituents must be the same substances (the same APVMA-approved active constituent/s) and their concentration must be the same
• the non-active constituents must have similar properties to those in the reference product and be in similar proportions
• the dose form, use pattern (including target animal species, dose rates, route of administration, withholding periods), and label instructions must all be the same as for the reference product
• the label claims must not exceed or be inconsistent with those of the reference product, however there may be fewer or reduced claims compared with the reference product.

Application can be made under Category 5 to register products which are similar to a registered reference product, where residues assessment is NOT required. For example, generic products for use in non-food (companion) animals and for use in a food-producing animal species where residues assessment is not required are eligible for assessment under Category 5.

Application can be made under Category 6, 7 or 8 to register products which are closely similar or the same as a registered reference product.

Immunobiologicals, direct-fed microbials and complementary medicines generally do not require residues data and may be eligible for assessment under a different section of Category 10.

Applications of this nature will require submission of the Application Overview (Part 1), chemistry and manufacture data (Part 2), residues and trade data (Part 5), and target animal efficacy and safety data (Part 8). For products applied to fibre-producing animals, fibre residues and trade data (Part 9) may also be required.

Where label information is derived by reference to another product, the target animal efficacy and safety submission (Part 8) must contain data to demonstrate similarity of the proposed product to the Australian-registered reference product. Comparable efficacy with the reference product may be demonstrated using one of the following:

• blood level bioequivalence studies
• measurement of biological effect/clinical end-point studies
• clinical studies in the target animal species.

If data are submitted from studies conducted overseas, using products that are registered in other countries but not in Australia, applicants must provide evidence or data to demonstrate that the overseas ‘reference’ product is the same as the Australian-registered reference product. If a non-active constituent is different from that in the reference product, tissue irritancy studies may be required and confirmation of the margin of safety may be necessary.

Food-residues studies (Part 5), generated using the proposed product, will generally be required where the new product is in one of the following dose forms:

• non-aqueous products for injection by subcutaneous and/or intramuscular routes
• intramammary infusions for use in dry cows
• pour-on formulations
• implants
• intraruminal devices.

For all other dose forms, applicants may submit scientifically valid arguments to demonstrate that expected residues resulting from use of the product will not exceed the established Australian maximum residue limits (MRL) for the active constituents. Data from blood level bioequivalence studies are not acceptable in lieu of residues data.

Guidelines

Example 1: Application is made to register a pour-on product to control external and internal parasites of sheep, based on similarity to a registered reference product. Compared to the reference product the proposed new product has the same concentration of the active constituent, but different proportions of the non-active constituents. The use pattern and claims of the two products are the same. The applicant has conducted studies on wool to demonstrate that this trade commodity is unaffected by the differences in formulation between the proposed product and reference product.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Residues and Trade	Part 5
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 2.3	Chemistry – Level 3	$1,030
Module 5.4	Residues – Level 4	$2,230
Module 8.3	Efficacy and Safety – Level 3	$500
Module 9	Non-food Trade	$1,175
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$7,840
	Timeframe:	8 months

4.2.   New product containing approved active constituents with a formulation similar to a reference product, but where the label has a different claim, or directions for use, or withholding period, or poisons scheduling (signal heading), or first aid or user safety direction/statement, or environmental instruction/warning

Requirements

For a proposed product to be considered to have a formulation similar to a reference product and be eligible for consideration under this section, all of the following criteria must apply:

• the active constituents must be the same substances (the same APVMA-approved active constituent/s) and their concentration must be the same
• the non-active constituents must have similar properties to those in the reference product and be in similar proportions
• the dose form/formulation type must be the same as for the reference product.

If the formulation is not similar to a reference product registered by the APVMA, paragraph 4.3 may apply.

Multiple label differences may be included as part of a single application under this section of Category 10.

If label information is derived by reference to another product, the target animal efficacy and safety submission (Part 8) must contain data to demonstrate similarity of the proposed product to the Australian-registered reference product. Any new label claim or instruction must be supported by additional data.

Applicants may demonstrate comparable efficacy with the reference product by using one of the following:

• blood level bioequivalence studies
• measurement of biological effect/clinical end-point studies
• clinical studies in the target animal species.

If data are submitted from studies conducted overseas, using products that are registered in other countries but not in Australia, applicants must provide evidence or data to demonstrate that the overseas reference product is the same as the Australian-registered reference product. If a non-active constituent is different from that in the reference product, tissue irritancy studies may be required and confirmation of the margin of safety may be necessary.

For products used in food-producing animals, food-residues studies (Part 5), generated using the proposed product, will generally be required where the new product is in one of the following dose forms:

• non-aqueous products for injection by subcutaneous and/or intramuscular routes
• intramammary infusions for use in dry cows
• pour-on formulations
• implants
• intraruminal devices.

For all other dose forms, applicants may submit scientifically valid arguments to demonstrate that expected residues resulting from use of the product will not exceed the established Australian MRL for the active constituents. Data from blood level bioequivalence studies are not acceptable in lieu of residues data.

If an application involves a product containing an active constituent which has not previously been used in a food-producing situation, toxicology (Part 3) and metabolism and kinetics (Part 4) data will be required in order to establish an acceptable daily intake (ADI).

Antibiotics

Applications involving use of an antibiotic in a new target animal species must consider potential risks to humans associated with antibiotic resistance. If the APVMA has not previously granted a product registration for use of the antibiotic in the new target animal species, the application will be subject to assessment by the Expert Advisory Group on Antimicrobial Resistance (EAGAR), with respect to the risk of contributing to antimicrobial resistance in humans. If EAGAR has not previously assessed the antibitoic, applicants must submit a full Part 10 data package.

If EAGAR has previously assessed the antibiotic, scientific argument may be used in appropriate sections of Part 10.

Guidelines

Example 1: Application is made to register an anthelmintic drench for use in sheep and cattle, with a formulation similar to that of a registered reference product. The claim and use pattern are the same as the reference product except for a shorter meat withholding period, in support of which the applicant has generated residues data.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Residues and Trade	Part 5
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 5.4	Residues – Level 4	$2,230
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$6,665
	Timeframe:	8 months

Example 2: Application is made to register an injectable antibiotic for use in sheep, based on an approved active constituent. Use of the active constituent has previously only been approved in cattle. The formulation, specifications, packaging materials and manufacturing processes of the proposed sheep product and the reference cattle product are identical. EAGAR has previously assessed the antibiotic for use in cattle.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Residues and Trade	Part 5
Efficacy and Safety	Part 8
Special Data (antibiotic resistance)	Part 10

The following modules are expected to apply:

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 10.2	Special Data (antibiotic resistance) – Level 2	$0
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$9,535
	Timeframe:	9 months

Example 3: Application is made to register an injectable Schedule 4 non-steroidal anti-inflammatory product for use in horses. Use of the active constituent has previously only been approved in dogs. The formulation of the proposed equine product is similar to that of the canine reference product.

The specific 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 2.3	Chemistry – Level 3	$1,030
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.2	Finalisation – Type 2	$1,175
	Total fee:	$3,460
	Timeframe:	7 months

Example 4: Application is made to register an injectable Schedule 4 non-steroidal anti-inflammatory product for use in cattle. Use of the active constituent has previously only been approved in dogs. The formulation of the proposed bovine product is similar to that of the canine reference product.

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
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.2	Toxicology – Level 2	$14,620
Module 5.1	Residues – Level 1	$5,595
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:	$26,015
	Timeframe:	15 months

4.3.   New product, containing approved active constituents, with a formulation which is NOT similar to a registered product (ie major formulation difference)

4.3.1.   New combination of approved active constituents

This section of Category 10 is relevant to applications to register a product with approved active constituents where the combination of active constituents is not present in any previously registered product.

Requirements

Applications in this section will require submission of data on chemistry and manufacture (Part 2), and target animal efficacy and safety (Part 8).

The possibility of interactions between the active constituents and other components of the formulated product should always be considered and investigated if necessary. Particular attention should be paid to toxicity, residues/withholding periods and efficacy and safety of new combination products. Data or scientific argument must be provided to address toxicology (Part 3).

If the new product involves a significant change in the pattern of use of an active constituent, data may be required to address residues and trade (Part 5), occupational health and safety (Part 6), environmental safety (Part 7), non-food residue and trade aspects (such as effects on wool in the case of sheep products) (Part 9), and special data requirements (such as applications involving use of an antibiotic – Part 10).

Guidelines

Example 1: Application is made to register a Schedule 4 non-aqueous injectable antibiotic product for use in pigs. The product contains a new combination of two approved antibiotics. The concentrations and use patterns of both active constituents are the same as those of existing registered pig products which contain the individual antibiotics.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Residues and Trade	Part 5
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 5.4	Residues – Level 4	$2,230
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:	$8,030
	Timeframe:	8 months

Example 2: Application is made to register an anticoccidial premix product for in-feed administration to poultry. The product contains a new combination of two approved anticoccidial active constituents. The concentrations of both active constituents are the same as those in existing registered poultry products which contain the individual anticoccidial agents, but the non-active component contains an increased proportion of the carrier, calcium carbonate. The proposed use pattern in poultry involves the same dose rate of both active constituents.

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
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 6.3	OHS – Level 3	$1,435
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:	$10,135
	Timeframe:	8 months

Example 3: Application is made to register a new injectable vaccine for use in cats. The vaccine contains a new combination of two live attenuated viruses, both of which are approved active constituents present in registered monovalent feline vaccines.

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 2.3	Chemistry – Level 3	$1,030
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.2	Finalisation – Type 2	$1,175
	Total fee:	$3,460
	Timeframe:	7 months

Example 4: Application is made to register a new anaesthetic for use in companion animals. The product contains a new combination of two volatile anaesthetic agents, both of which are approved active constituents.

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
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 6.3	OHS – Level 3	$1,435
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.1	Finalisation – Type 1	$2,230
	Total fee:	$8,850
	Timeframe:	8 months

4.3.2.   Different concentration of active constituent

This section is relevant to applications to register a product with an approved active constituent where the concentration of the active constituent is significantly different from that of any registered reference product.

Requirements

Applications in this section will require submission of data on chemistry and manufacture (Part 2), and where the dose rate to the animal is changed, target animal efficacy and safety (Part 8).

If the concentration of the active constituent in the new product is significantly increased compared with registered products, poisons scheduling may be necessary and data will be required to address toxicology (Part 3), residues and trade (Part 5), occupational health and safety (Part 6), environmental safety (Part 7), non-food residue and trade aspects (such as effects on wool in the case of sheep products) (Part 9), and special data requirements (such as applications involving use of an antibiotic) (Part 10).

If the concentration of the active constituent in the new product is significantly decreased compared with registered products, target animal efficacy data are critically important.

Guidelines

Example 1: Application is made to register an anticoccidial premix for use in poultry based on similarity to a registered reference product. The proposed new product has twice the concentration of the active constituent compared with the reference product, and the cereal carrier has been replaced with a combination of cereal and calcium carbonate. The dose rate of the active constituent for poultry and other aspects of the use pattern and claims are the same as those of the reference product.

The applicant provided scientific argument relating to target animal efficacy and safety. The increased concentration of active constituent and the inclusion of a calcium carbonate carrier require assessment of toxicological and occupational health and safety aspects of the proposed product. After screening, OCS advises the APVMA that assessment for poisons scheduling is necessary for the proposed concentration of this particular active constituent.

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

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 4	Toxicology – Scheduling	$3,720
Module 6.3	OHS – Level 3	$1,435
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$11,990
	Timeframe:	15 months

Example 2: Application is made to register an ectoparasiticide dip for use on sheep and cattle, based on an active constituent which has previously been approved in products for use on horses as a topical spray. The active constituent in the proposed product is present at five times the concentration of the horse product. Use of the active constituent has not previously been approved in any food-producing animal species. The applicant has conducted studies on wool to demonstrate that this trade commodity is not adversely affected by use of the proposed product on sheep.

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
Other Trade Aspects	Part 9

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.2	Toxicology – Level 2	$14,620
Module 5.1	Residues – Level 1	$5,595
Module 6.3	OHS – Level 3	$1,435
Module 7.2	Environment – Level 2	$3,255
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:	$31,880
	Timeframe:	15 months

Example 3: Application is made to register a teat dip for use on cows which contains an approved active constituent. In order to reduce the volume (pack size) of the product the active constituent is present at twice the concentration compared with existing registered products that contain this active constituent. The dose rate for application to the animal, following dilution of the product with water, is the same as for registered teat dip products. The applicant has provided data on pH levels and the availability and potency of the active constituent in the final diluted product, and a VICH Phase 1 environmental impact assessment.

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

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 6.3	OHS – Level 3	$1,435
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$8,270
	Timeframe:	8 months

4.3.3.   Different dose form

This section is relevant to applications to register a product with an approved active constituent where the dose form is different from that of any registered product containing the active constituent.

Requirements

Applications in this section will require submission of data on chemistry and manufacture (Part 2), and target animal efficacy and safety (Part 8).

Products with certain new dose forms (eg topically applied products, oral powders and solutions) may have the potential to affect human safety or the environment. New dose forms for use in food-producing animals may have residues implications, particularly if associated with a new route of administration. Therefore, depending on the new dose form, data may be required to address toxicology (Part 3), metabolism and kinetics (Part 4), residues and trade (Part 5), occupational health and safety (Part 6), environmental safety (Part 7), non-food residue and trade aspects (such as effects on wool in the case of sheep products) (Part 9), and special data requirements (such as applications involving use of an antibiotic) (Part 10).

Guidelines

Example 1: Application is made to register a new complementary medicine product, with a claim for joint health and containing an approved active constituent, for use in dogs as an oral capsule medication. Use of the active constituent in dogs has previously been approved only for products which are in powder dose forms for administration in-feed.

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 2.3	Chemistry – Level 3	$1,030
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.2	Finalisation – Type 2	$1,175
	Total fee:	$3,460
	Timeframe:	7 months

Example 2: Application is made to register a pour-on product with an approved active constituent for use on cattle as a treatment for liver fluke. Use of the active constituent in cattle has previously been approved only for products which are oral drench solution dose forms.

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 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 5.1	Residues – Level 1	$5,595
Module 6.3	OHS – Level 3	$1,435
Module 7.2	Environment – Level 2	$3,255
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$17,870
	Timeframe:	15 months

4.3.4.   Formulation not identical, not closely similar or not similar to an existing registered product

This section is relevant to applications to register a product with an approved active constituent where the formulation is significantly different to that of any registered product containing the active constituent, and which is not covered by the previous sections. An example is a major difference in the non-active constituents which may affect the performance, stability or other attributes of the product.

Requirements

Applications in this section will require submission of data on chemistry and manufacture (Part 2), and target animal efficacy and safety (Part 8).

Products with very different formulations (eg vaccines with new adjuvants, pour-on products with new solvents) may have the potential to affect human safety, residues or the environment. Data may be required to address toxicology (Part 3), residues and trade (Part 5), occupational health and safety (Part 6), environmental safety (Part 7), non-food residues and trade aspects (such as effects on wool in the case of sheep products) (Part 9), and special data requirements (such as applications involving use of an antibiotic) (Part 10).

Guidelines

Example 1: Application is made to register a direct-fed microbial product for in-feed administration to pigs to increase feed conversion efficiency. The same micro-organism has previously been approved by the APVMA as an active constituent in a product with a different formulation for use in dogs. The micro-organism is genetically modified and requires assessment of environmental aspects. OHS assessment is required because of differences in application methods and increased use volumes for pigs compared to dogs.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
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 2.3	Chemistry – Level 3	$1,030
Module 6.3	OHS – Level 3	$1,435
Module 7.2	Environment – Level 2	$3,255
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:	$10,490
	Timeframe:	9 months

Example 2: Application is made to register a direct-fed microbial product for in-feed administration to dogs and cats to aid in establishing gastrointestinal microflora. The same micro-organism has previously been approved by the APVMA as an active constituent in a product with a different formulation for use in pigs. The micro-organism is not genetically modified.

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 2.3	Chemistry – Level 3	$1,030
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.2	Finalisation – Type 2	$1,175
	Total fee:	$3,460
	Timeframe:	7 months

Example 3: Application is made to register a new injectable vaccine for use in sheep. The vaccine is inactivated and contains five bacterial antigens, all of which are approved active constituents in the applicant’s existing registered product. The applicant wishes to change the release titres of two of the antigens and also to change the adjuvant to a novel adjuvant that has not previously been used in Australian vaccines.

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
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 6.3	OHS – Level 3	$1,435
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$9,020
	Timeframe:	8 months

Example 4: Application is made to register a new pour-on product for use on cattle to treat external and internal parasites. The active constituent is approved and present in the same concentration as in the applicant’s existing registered pour-on product. However, the applicant wishes to substitute the solvent component with a solvent which has not been used before in other registered products. The applicant has conducted blood level bioequivalence studies to demonstrate efficacy comparable to the registered reference product, and animal safety studies using the proposed formulation.

Data requirements are expected to be drawn from:

Application Overview	Part 1
Chemistry and Manufacture	Part 2
Toxicology	Part 3
Residues and Trade	Part 5
Occupational Health and Safety	Part 6
Efficacy and Safety	Part 8

The following modules are expected to apply:

Module	Description	Fee
Module 1	Screening	$505
Module 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 5.4	Residues – Level 4	$2,230
Module 6.3	OHS – Level 3	$1,435
Module 8.3	Efficacy and Safety – Level 3	$500
Module 11.1	Finalisation – Type 1	$2,230
Module 12	Data Protection	$170
	Total fee:	$11,000
	Timeframe:	8 months

Example 5: Application is made to register an ectoparasiticide (tick and flea) shampoo for dogs. Use of the active constituent has previously only been approved in dip products for cattle and sheep. The formulation of the shampoo is significantly different to the registered dip products.

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 2.3	Chemistry – Level 3	$1,030
Module 3.3	Toxicology – Level 3	$2,900
Module 8.2	Efficacy and Safety – Level 2	$750
Module 11.1	Finalisation – Type 1	$2,230
	Total fee:	$7,415
	Timeframe:	8 months

4.4.   Any other application for a new product containing existing approved active constituents not described above and not described in any other category

This section is relevant to applications to register products which contain approved active constituents and are not described in the sections above or in any other category. Such applications for product registration will be assessed on their merits. Some secondary applications may fit into this section.

If the new product formulation is not similar to an existing registered product, a toxicological assessment (Part 3) may be required.

If a new use pattern is involved which could result in increased exposure to workers or animal handlers, or to the environment, OHS issues (Part 6) or environmental safety issues (Part 7) must be addressed.

If the product is immunogenic or is for use in fibre-producing animals, other trade aspects (Part 9) may need to be addressed.

Applications for new antibiotic products must consider antibiotic resistance (Part 10).

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