I want to register a new veterinary product with an existing active or new combination of approved actives

1. Legislation

1.1. Framework

The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act contains all of the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals.

The Agricultural and Veterinary Chemicals Act 1994 contains the constitutional and other legal provisions that enable the Agvet Code to have effect.

The Agricultural and Veterinary Chemicals Code Act 1994, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels); and to issue permits and to license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products; and provisions ensuring compliance with, and for the enforcement of, the code.

The Agricultural and Veterinary Chemicals Code Regulations 1995 prescribe detailed provisions of the Agvet Code.

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the information that must be contained in, or accompany an, application under the Agvet Code.

1.2. Statutory criteria

In addressing the criteria, the applicant may provide information, or valid scientific argument that might address a specific criterion. The following sections of the Agvet Code provide definitions for meeting the criteria:

• Safety (section 5A).

An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:

a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
b) is not, or would not be, likely to have an effect that is harmful to human beings; and
c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

To satisfy the s 5A criteria, the APVMA considers chemistry and manufacture, health (including poison scheduling and work health and safety), residues, environment and target safety.

• Efficacy (section 5B)

A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.

• Trade (section 5C)

A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.

• Labelling (section 5D)

In approving a label for a container for chemical products, the APVMA must be satisfied that the label contains adequate instructions. This allows the APVMA to ensure that the risks of using the agvet chemical product are adequately mitigated through appropriate instructions.

The APVMA’s Agricultural Labelling Code and Veterinary Labelling Code also contain further labelling requirements that ensure a standard layout, eligibility and further help in mitigating the risk of using agvet chemical products when used in accordance with the label instructions.

1.3. Application requirements

The Agvet Code, s 8A provides the definition of 'meets the application requirements'.

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014, Parts 2 and 4, sets out the information that must be contained in, or accompany an, application under the Agvet Code.

1.4. Guidelines

The APVMA has designed guidelines to help inform the APVMA and applicants as to the modules, data and information that will apply for different types of applications. The guidelines are not the law. The APVMA will have regard to it, but from time to time may depart from it when determining the modules, data and information are necessary for a particular application. The APVMA has a number of guidelines that fall under this, for example:

• module descriptors
• data guidelines
• limits on use of information.

1.5. Applications may be withdrawn

The Agvet Code, s 8D states that at any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.

1.6. Major formulation change

For the purpose of selecting the appropriate level of module assessment, a major formulation change is defined as any change to the formulation compared to a reference product formulation that includes:

• a new combination of existing (registered) active constituents
• a significant increase in the concentration of an active constituent
• a change to a non-active constituent that significantly affects the performance, stability or other attributes of the product
• a change to the formulation type to accommodate a new application method, dose form or use pattern
• a significant change to product specifications.

2. Timeframe and fees

This application type is subject to an extended assessment period if an Agvet Code s 159 notice is sent requesting additional information or clarification of submitted information. The extended assessment period will vary, depending on the nature of the application and the modules specified for that particular application.

An Item 10 is a modular application type, therefore the fees and timeframe are variable. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.

Applications to register a new product with an existing active or new combination of approved actives must satisfy the statutory criteria of safety, efficacy and trade. The following table examines each assessment module and provides guidance on what modular assessments, levels, timeframe and associated fees may apply to this application. Preliminary assessment, Finalisation and Limits on use are mandatory modules for this application.

Module type	Module level	Timeframe	Fee
Preliminary assessment	N/A	Not applicable	$902
Chemistry	3	6 months	$1 954
Health	3 or 4 or 5	9 months 5 months 4 months	$18 980 $7 963 $4 000
Residues and Trade	1 or 2 or 3 or 4 or 5	13 months 8 months 6 months 4 months 3 months	$25 650 $11 149 $9 000 $7 465 $2 000
Environment	1 or 2 or 4	13 months 7 months 4 months	$26 390 $7 659 $1 490
Efficacy and Safety	1 or 2 or 3	6 months 4 months 3 months	$4 740 $1 950 $1 160
Non-food Trade	n/a	6 months	$1 175
Special Data	2 3	7 months 7 months	Nil
Finalisation	1 or 2	3 months 2 months	$8 110 $3 090
Limits on use (data protection)	n/a	N/A	$460

An Item 10 is a modular application type, therefore the fees and timeframe are variable. Legislative timeframes commence once the application has passed Preliminary assessment and fees have been paid.

Applications to register a new product with an existing active or new combination of approved actives must satisfy the statutory criteria of safety, efficacy and trade. The following table examines each assessment module and provides guidance of what modular assessments, levels, timeframe and associated fees may apply to this application. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for this extension for Modules 2–10.

Module type	Module level	Timeframe	Fee
1: Preliminary assessment	1.0	Not applicable	$710
2: Chemistry	2.3	6 months	$1 580
3: Toxicology	3.3	5 months	$4 050
5: Residues and trade	5.2 or 5.4	8 months 4 months	$10 525 $7 465
6: Work health and safety	6.2 or 6.3	7 months 4 months	$3 185 $2 910
7: Environment	7.1 or 7.2 or 7.3	13 months 7 months 4 months	$26 390 $7 315 $2 910
8: Efficacy and safety	8.1 or 8.2 or 8.3	6 months 4 months 3 months	$2 370 $975 $580
9: Non-food trade	9.0	6 months	$1 175
10: Special data	10.2 10.3	7 months 7 months	Nil
11: Finalisation	11.1 or 11.2	3 months 2 months	$4 055 $1 545
12: Limits of use	12.0	N/A	$460

Example

Scenario	Modules	Timeframe	Fee
Scenario 1: New product containing a combination of existing actives	1, 2.3, 8.1, 11.2 and 12	8 months 12 months (extended assessment period)	$6 665
Scenario 2: New product containing an existing active constituent but with a new formulation type	1, 2.3 8.1, 11.2 and 12	8 months 12 months (extended assessment period)	$6 665
Scenario 3: New product containing an existing active constituent but with a new dose form	1, 2.3, 3.3, 6.2, 8.1, 11.1 and 12	10 months 14 months (extended assessment period)	$16 410

3. Modules

The APVMA has developed the module descriptors to provide guidance as to the modules that will apply for different types of applications. The APVMA will have regard to this document, but may depart from it, when determining which modules are necessary on a case-by-case basis. 

3.1. Preliminary assessment

Preliminary assessment is an initial examination of the application for administrative completeness. It is an administrative check that the form and content of the application meet the application requirements. In other words, the outward look of the application and its accompanying information appears to be in order and complete. It is not a completeness check of the technical aspects of your submission.

Applies to all modular application items.

3.2. Health

A Health assessment is required where there is a change to human exposure compared to situations that have already been assessed by the APVMA. Changes to human exposure can occur when extending into new crops or situations. This includes changes such as application rate, method, worker rates and practices including post-application activities. The change may result in a change to the entry in the first aid instructions and safety directions (FAISD) Handbook, including changes to first aid statements, personal protective equipment (PPE) and re-entry into treated areas following application.

This module also assesses both toxicological data and scientific argument, together with any cited references, which characterise the risks to humans using or coming into contact with the substances in your product.

Module level	Timeframe	Fee
Health 3	9 months	$18 980

Module level	Module type	Timeframe	Fee
6.3	Workplace health and safety	4 months	$3 913

Module level	Module type	Timeframe	Fee
7.2	Environment	7 months	$7 659

Module level	Module type	Timeframe	Fee
8.2	Efficacy and target safety	4 months	$1 950

Module level	Module type	Timeframe	Fee
8.3	Efficacy and target safety	3 months	$1 160

3.3. Non-food Trade

The Non-food Trade module is applied to applications involving trade risks not related to food residues.

Module level	Module type	Timeframe	Fee
9	Non-food trade	6 months	$1 175

Module level	Module type	Timeframe	Fee
10.3	Genetically modified organism	7 months	$Nil

3.4. Finalisation

This module encompasses administrative steps relating to the finalisation of the application. This can include public consultation, entering the required information into the relevant record or register, and the completion of the technical evaluation and risk assessment report outlining the evaluation of the application.

Module level	Module type	Timeframe	Fee
12	Data protection	N/A	$460

Module	Timeframe	Fee
Residues 1	13 months	$25 650

Module level	Timeframe	Fee
Residues 4	4 months	$7 465

3.5. Environment

Where there is any potential risk to the environment, an appropriate environmental assessment is required. This assessment will take into account the expected volume of use; the expected exposure, behaviour and fate of the active constituent/s; and the potential harmful effects on flora and fauna; resulting from use of the product.

In situations where the proposed use pattern does not change the risk to the environment, and this can be determined without further assessment, no environmental assessment is required.

Module level	Module type	Timeframe	Fee
7.3	Environment	4 months	$2 979

Module level	Module type	Timeframe	Fee
11.1	Finalisation	3 months	$8 110

Module level	Module type	Timeframe	Fee
11.2	Finalisation	2 months	$3 090

3.6. Limits on use of information

Limits on use of information relate to the protection, handling and use of information provided to the APVMA. In general, the APVMA must not use the information given to it in connection with one application to assess or make a decision on another application, except in specific circumstances. These circumstances include, but are not limited to, where the applicant has given consent for the information to be shared or in an emergency situation; see CCI Practice Statement. This ‘limited use data’ includes information such as reports, studies and scientific arguments that may or may not include confidential commercial information. The applicant can request the module at the time an application is lodged, but the APVMA may also include it once an assessment of the application is undertaken.

Module level	Timeframe	Fee
Limits on use	N/A	$460

3.6.1. Finalisation 2

Registration of a new product where:

• fewer than 3 technical assessment modules (Chemistry, Health, Residues, Environment, Efficacy) apply; or
• the consideration of fewer than 3 assessment reports from technical assessment modules (Chemistry, Health, Residues, Environment, Efficacy) conducted under previous applications is required.

Module level	Timeframe	Fee
Finalisation 2	2 months	$3 090

3.7. Residues and Trade

Residues assessment includes the establishment of residues definition, maximum residue limits (MRLs), and withholding periods (WHPs), and the assessment of the trade implications including the establishment of any export intervals (EIs).

There are general guidelines for both Residues Part 5A and Overseas trade Part 5B available and you should consider any of the specific guidelines which relate to your product type or extension of use.

The APVMA may decide that a residues assessment is not required when a veterinary chemical is unlikely to enter the food chain through the proposed use pattern.

This would apply to situations such as companion animal products. A Residues assessment is also not required for veterinary vaccines which do not contain novel adjuvants and/or excipients.

3.7.1. Special Data 3

Registration of a new product containing a GMO.

Module level	Timeframe	Fee
Special Data 3	7 months	$Nil

3.7.2. Finalisation 1

Registration of a new product where:

• 3 or more technical assessment modules (Chemistry, Health, Residues, Environment, Efficacy) apply; or
• the consideration of 3 or more assessment reports from technical assessment modules (Chemistry, Health, Residues, Environment, Efficacy) conducted under previous applications is required.

Module level	Timeframe	Fee
Finalisation 1	3 months	$8 110

3.8. Efficacy and Safety

Efficacy assessment ensures that the product works as described on the label when used according to label directions.

Safety assessment ensures that the product is safe to use on or in the target crop or animal when used according to label directions.

An efficacy and safety assessment may include assessing the effect of the product on target and non-target animals, effects of residues and pharmacologic studies.

3.8.1. Special Data 2

Registration of a product containing an approved antibiotic active constituent and which is expected to result in significantly increased volume of use of the approved antibiotic active constituent or an increased risk to public health including:

• a variation of use in a new food species, or a dog or a cat;
• a variation of use to another major group within the same food species (for example, broiler chickens to layers; beef cattle to dairy cattle); or
•  a change in dosage form or use pattern (for example: from use in individual animals to mass medication).

Module level	Timeframe	Fee
Special data 2	7 months	$Nil

3.9. Chemistry

The chemistry module includes assessment of the following aspects:

• The active constituent
• The formulated chemical product
• The manufacturing process
• Quality control
• Specifications
• Batch analysis
• Storage stability
• Analytical methods
• Packaging and labelling

There are general guidelines for chemistry and manufacture of agricultural and veterinary products available and you should consider any of the specific guidelines which relate to your product type.

3.9.1. Chemistry 3

Registration of a new product containing an approved active constituent.

Module level	Timeframe	Fee
Chemistry 3	6 months	$1 954

Registration of a new product containing an approved active constituent.

A Limited Residues Assessment (Module 5.4) is required for the registration of chemical products containing a new active consistent where the product is to be used in a food species and the establishment of MRLs is unlikely for the proposed use pattern.

Note that the following products do not normally require toxicological assessment:

a. mineral, vitamin or nutritional supplements for a single animal or a small number of animals that are administered directly to the animal or are administered daily in food or water

b. animal bacterial and viral vaccines.

3.9.2. Health 4

Registration of a new product containing an approved active constituent, which results in one or more of:

• changes to the Poisons Standard
• establishment of first aid instructions and hazard statements where exposure modelling is also required
• a new combination of approved actives
• a major formulation change.

Module level	Timeframe	Fee
Health 4	5 months	$7 963

3.9.3. Health 5

Registration of a new product containing an approved active constituent requiring the establishment of hazard-based safety directions, where exposure does not exceed currently registered products.

Module level	Timeframe	Fee
Health 5	4 months	$4 000

3.9.4. Residues 1

Registration of a new product containing an approved active constituent, with first uses in a food species, other than mentioned in Residues 4.

Module level	Timeframe	Fee
Residues 1	13 months	$25 650

3.9.5. Residues 2

Registration of a new product containing an approved active constituent approved for use on certain food species to include new food species, which produce a major export commodity, where finite residues are expected and consideration of Maximum Residue Limits, Withholding Periods, and/or trade implications is required.

Module level	Timeframe	Fee
Residues 2	8 months	$11 149

3.9.6. Residues 3

Registration of a new product for use requiring the establishment of Maximum Residue Limits for a minor species, which does not produce a major export commodity.

Module level	Timeframe	Fee
Residues 3	6 months	$9 000

3.9.7. Residues 4

Registration of a new product for use on food species, which produce major export commodities where finite residues are not expected, or no changes to Maximum Residue Limits are required.

Module level	Timeframe	Fee
Residues 4	4 months	$7 465

3.9.8. Residues 5

Registration of a new product where the active constituent is already listed in Table 5 in the Agricultural and Veterinary Chemicals Code (MRL Standard) Instrument 2019 to add a new use.

Module level	Timeframe	Fee
Residues 5	3 months	$2 000

3.9.9. Environment 1

Registration of a new product containing an approved active constituent requiring a VICH Phase II assessment, where the reference product has only been subject to a VICH Phase I assessment.

Module level	Timeframe	Fee
Environment 1	13 months	$26 390

3.9.10. Environment 2

Registration of a new product containing an approved active constituent, not mentioned in Environment 1 or Environment 4, unless there is a registered reference product with the same active constituent, for use in the same situation or herd animal, at an equivalent or higher dose, and does not require environmental exposure consideration.

Module level	Timeframe	Fee
Environment 2	7 months	$7 659

3.9.11. Environment 4

Registration of a new product containing an approved active constituent requiring a VICH Phase I assessment, except where the reference product is a registered product with the same active constituent, for use in the same situation or herd animal, at an equivalent or higher dose, not requiring consideration of environmental exposure.

Module level	Timeframe	Fee
Environment 4	3 months	$1 490

3.9.12. Efficacy and Safety 1

Registration of a new product containing an approved active constituent that involves:

• use in/on a food species or dog, cat, or horse for the first time; or
• a new formulation type; or
• a new combination of approved active constituents.

Module level	Timeframe	Fee
Efficacy and Safety 1	6 months	$4 740

3.9.13. Efficacy 2

Registration of a new product that contains an approved active constituent that involves:

• a new pest or disease or for a new purpose in/on a food species or dog, cat, or horse; or
• new dosage or administration instructions in/on the species. This includes having consideration of dose, frequency, duration, and route of administration; or
• a product that is not the same, nor closely similar, nor similar to an existing registered reference product.

Module level	Timeframe	Fee
Efficacy 2	4 months	$1 950

3.9.14. Efficacy 3

Register a new product that contains an approved active constituent that involves:

• use in or on a non-food species (other than a dog, cat or horse); or
• a product that is similar to a registered reference product.

Module level	Timeframe	Fee
Efficacy 3	3 months	$1 160

Register a new product involving trade risks not related to food residues, including:

1. residues in wool and fibre;
2. genetically modified produce;
3. the presence of disease or seropositive testing to exotic or notifiable agents;
4. hormonal growth promotants and other endocrine substances.

Module level	Timeframe	Fee
Non-food Trade	6 months	$1 175

3.10. Special Data

This module applies to all applications for registration of a new chemical product or variation of the particulars or conditions of a registered chemical product, which contain active constituents that are new antibiotic substances or which contain genetically modified organisms (GMOs) require a Special Data assessment.

Specifically, you should consider the following guidelines:

• Products of gene technology
• Products of nanotechnology

3.10.1. Health 3

Registration of a new product containing an approved active constituent for first use in food species, requiring the establishment of an ADI and/or ARfD.

Module level	Timeframe	Fee
Health 3	9 months	$18 980

4. What you need to provide

4.1. Completed online application form

First time applicants will need to complete an online services new user access form to access the APVMA Online Services Portal.

If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.

4.2. The application fee

You may choose to:

• pay the total fee on submission or
• pay the preliminary assessment fee of $902 on submission and the remaining balance once the application has been accepted.

You can choose to pay by credit card, electronic funds transfer or BPAY.

Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).

4.3. Information list

It is an application requirement that all applications for approval, registration or variation include a short description of each item of information contained in or accompanying the application – an information list.

Any document (information) submitted with the application constitutes information for the purposes of the information list. This includes supporting information, such as consent for use letters, manufacturer's declarations, MSDS, certificates of analysis, GMP certificates and other such documentation, in addition to the scientific studies or data that may be submitted to specifically address the safety, trade and efficacy criteria.

The online application form contains fields to assist applicants in entering the information required to generate the information list.

Note: Information lists are published, including details of the holders of the information. Applicants should take care not to inadvertently divulge confidential commercial information (CCI) when creating the list.

4.4. Supporting information

The application must contain, or be accompanied by, information relevant to the whether the chemical product meets the safety and efficacy criteria, but only to the extent that the variation proposed affects whether the product meets the safety and efficacy criteria. Applicants should include an explanation of why they believe supporting information is not required, if they choose not to provide it with the application.

Relevant data for module levels – veterinary chemical products sets out the data that may be relevant to particular assessment modules detailed in the Agvet Regulations. This list is not exhaustive and is only intended to provide you with guidance in putting your application together.

• Chemistry
  Detailed data guidelines for chemistry and manufacture are available in Part 2
• Health
  Detailed data guidelines for health are available in Part 3 and Part 6
• Residues
  Detailed data guidelines for residues are in Part 5A
  Detailed data guidelines for trade are in Part 5B
• Environment
  Detailed data guidelines for environment are in Part 7
• Efficacy and host safety
  Detailed data guidelines for efficacy and safety are in Part 8
• Trade
  Detailed data guidelines for trade are in Part 5B
• Non-food trade
  For applications referred to at 9 of the module descriptors , data specifically relevant to the trade risk may be submitted
• GM organism/other special data
  Published data and results of Australian field trials, relevant to the criteria for approval of an active constituent or registration of a product described in s 14 of the Agvet Code, may be submitted

4.5. Data requirements

Relevant data for module levels— veterinary chemical products sets out the data that may be relevant to particular assessment modules detailed in the Agvet Regulations. This list is not exhaustive and is only intended to provide you with guidance in putting your application together.

4.6. Consent for use from the relevant authorising party (if applicable)

An application cannot be determined to be the same when protected information is listed for the reference product, unless one of the following exceptions apply:

• the applicant is the authorising party for the data associated with the reference product
• the applicant has obtained consent for use from the relevant authorising party or parties. This consent for use must be explicit and include the relevant data numbers.

Protected data details are listed in our product search database record for the reference product.

To meet the application requirements you will need to provide:

• an online application form
• the application fee plus any amount that is due to the APVMA
• supporting information
• APVMA product number(s) for your nominated reference product(s)
• an information list
• consent for use (if any of the information provided is subject to limits on use)
• e-label.

4.7. Electronic label (e-label)

The APVMA must have regard to certain matters or details in order to satisfy itself that a label meets the labelling criteria and approve the label (Agvet Code, ss 5D and 14). Applicants must use the e-label template to submit the label details that the APVMA must take into account.

Introduction to preparing a label and the label approval process provides more detailed information.

5. Examples

5.1. Scenario 1: Registration of a new product containing a combination of existing actives

5.1.1. Application type

An applicant wishes to register a new joint health product which contains a combination of existing active constituents for use in dogs. There are two reference products nominated, one for each of the proposed active constituents. In each case the formulation type is the same and has a use pattern with similar frequency, duration, dose, and route of administration as those proposed for this product.

As the new product is based on a new combination of existing actives and is not the same, similar or closely similar to a registered product, nor does it comply with the Agvet Code Standard 2014, it is considered under a modular assessment—new product (Item 10).

5.1.2. Assessment

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this application.

Module type	Module level	Timeframe	Fee
Preliminary assessment	1	Not applicable	$902
Chemistry	Assessment is required of the chemistry and manufacturing aspects of the new formulation are required
	3	6 months	$1 954
Health	Assessment is required to consider the acute toxicology and new safety directions of the novel combination of existing actives
	4	5 months	$7 963
Poisons scheduling	Not required – the active constituents are scheduled
Residues	Not required – dogs are not a food-producing species and do not pose a trade risk for Australia
Environment	Not required – the risk to the environment is to the risk already assessed for registered products containing the individual active constituents. Existing disposal and environmental protection statements will apply.
Efficacy and Safety	An efficacy assessment is required to determine that the label claims are supported and the product is safe and efficacious
	1	6 months	$4 740
Non-food Trade	Not required – dogs do not produce a non-food trade commodity
Special Data	Not required – joint health products are not antibacterial agents
Finalisation	2	2 months	$3 090
Limits on use (data protection)		Not applicable	$460
Total		9 months	$19 109

5.2. Scenario 2: Registration of a new product containing a combination of existing actives

5.2.1. Application type

Registration of a new live bacterial vaccine, which contains a combination of existing antigens, for use in companion and food-producing animals.

As the new product is based on a new combination of existing actives and is not the same, similar or closely similar to a registered product this application is considered under a modular assessment—new product (Item 10).

5.2.2. Assessment

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this application.

Module type	Module level	Timeframe	Fee
Preliminary assessment			$902
Chemistry	A chemistry assessment is required to assess the quality of the product and to establish its shelf life
	Chemistry 3	6 months	$1 954
Health	Not required – the risk is equivalent to other registered vaccines containing the approved antigens and a common adjuvant
Poisons scheduling	Not required – the existing schedule is applicable
Residues	Not required – viral vaccines containing the approved antigens already exist and the vaccine contains a commonly used adjuvant
Environment	Not required – the risk is equivalent to other registered vaccines containing the approved antigens and a common adjuvant
Efficacy and Safety	An assessment is required for a new combination of existing antigens
	Efficacy 1	6 months	$4 740
Non-food Trade	Not required – the risk is equivalent to other registered vaccines containing the approved antigens and a common adjuvant
Special Data	Not required – the risk is equivalent to other registered vaccines containing the approved antigens and a common adjuvant
Finalisation	Finalisation 2	2 months	$3 090
Limits on use (data protection)			$460
Total		8 months	$11 146

5.3. Scenario 3: Registration of a new product containing an existing active constituent but with a new dose form

5.3.1. Application type

An application is made to register a spot-on solution product for use on dogs. The existing active constituent is registered as a chewable tablet for dogs.

As the new product is based on a new combination of existing actives but with a new dose form and is not the same, similar or closely similar to a registered product, this application is considered under a modular assessment – new product (Item 10).

5.3.2. Assessment

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this application.

Module type	Module level	Timeframe	Fee
Preliminary assessment			$902
Chemistry	A chemistry assessment is required to assess the quality of the new dosage form and to establish a shelf life for the product
	Chemistry 3	6 months	$1 954
Health	Assessment is required to determine the toxicity profile of the new product formulation and assess new safety directions
	Health 4	5 months	$7 963
Poisons scheduling	Generally, not required as the existing schedule should be applicable, but check the Poisons Standard for any explicit wording that may limit the Poisons Standard entry to formulation type, species and/or concentration
Residues and Trade	Not required – dogs are not a food-producing species and do not pose a trade risk for Australia
Environment	Not required – the environmental risk is likely to be equivalent to the risk posed by other registered dosage forms of the active constituents. Existing disposal and environmental protection statements will apply
Efficacy and Safety	An efficacy assessment is required for a new dosage form
	Efficacy 1	6 months	$4 740
Non-food Trade	Not required – dogs do not produce a non-food trade commodity
Special Data	Not required – an anti-inflammatory and analgesic product is not an antibacterial agent, nor does the product contain a genetically modified organism.
Finalisation	Finalisation 1	3 months	$8 110
Limits on use (data protection)			$460
Total		10 months	$24 129

6. Start an application

If you want to register a new product that contains a combination of existing actives in registered products:

Start application

You will be redirected to the Online Services Portal to log in.