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

Registering a new agvet chemical product containing an existing active may be assessed under:

  • Item 10 – New product – Modular assessment.

Common application types submitted under Item 10 include:

  • a new formulation type for an existing active
  • a new combination of existing actives
  • novel uses for an existing active

Applications that do not meet the requirements of Item 10 include:

Note: If your proposed product meets the requirements of Item 3, 4, 5, 6, 7, 8 or 9 then you must lodge your application under the relevant item and not as an Item 10.

Under an Item 10 application, you must address all of the statutory criteria. This may be done by any one, or a combination of, the following methods:

  • nominating a reference product
  • providing supporting data for assessment
  • providing a valid scientific argument
  • submitting technical reports previously undertaken by the APVMA
  • provision of overseas data assessments together with associated data underpinning the assessment.

The supporting data required by the APVMA for an Item 10 application will vary according to how novel the proposed product is compared to existing registered products and their approved uses and the relevance to the statutory criteria for the proposed new product.

In addition to the provision of new data, a valid scientific argument can be provided to satisfy specific risk areas. This may refer to other currently registered products (reference product), be supported by published information or be used to validate extrapolation from similar situations including the relevance of overseas studies to the Australian situation.

Reference products must be agvet chemical products currently registered by the APVMA. You can find registered chemical products and actives via APVMA’s registered chemical products search tool. Where nomination of an existing registered product is provided as the reference product applicants should justify the relevance of the reference product to each of the relevant risk areas.

If an assessment has previously been undertaken by the APVMA (eg a technical assessment under Item 25, or assessment undertaken as part of a previous application where the individual assessment was supportive), you may submit that assessment in support of the application. You may need to resubmit the data underpinning the assessment for the APVMA to apply limits of use of information. If the assessment is historical, the relevance to the assessment to current agronomic practices and the current application should be addressed.

Which application form do you need?

Legislation

Framework

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

The Agricultural and Veterinary Chemicals Code Act, 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.

Section 6A of the Agricultural and Veterinary Chemicals Code Act states that the APVMA may make guidelines. The APVMA has a number of guidelines which fall under this, for example:

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:

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 S5A criteria, the APVMA considers chemistry and manufacture, toxicology (including poison scheduling, residues, work health and safety, environment and target safety).

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.

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.

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.

Application requirements

Section 8A of the Agvet Code provides the definition of 'meets the application requirements'.

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

Guidelines

6A of the Agvet Code states that the APVMA may make written guidelines for performing its functions and exercising its powers under this Code.

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 which fall under this, for example:

Applications may be withdrawn

Section 8D of the Agvet Code 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.

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.

Timeframe and fees

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

$1 720

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

1: New product containing a combination of existing actives

1, 2.3, 3.3, 6.2, 8.1, 11.2 and 12

8 months

12 months (extended assessment period)

$13 900

2: 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

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

This application type is subject to an extended assessment period if a section 159 of Agvet Code 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.

Modules

The APVMA has developed a guideline for module descriptors to provide guidance as to the modules that will apply for different types of applications. The APVMA will have regard to it, but may depart from it, when determining which modules are necessary on a case by case basis. The guideline is not the law.

Module 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.

Module 2: 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.

2.3: Chemistry – Level 3

Register a new product that contains an approved active constituent:

a. All products

Module level Module type Timeframe Fee
2.3 Chemistry—Limited assessment 6 months $1 580

Module 3: Toxicology

This module 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.

For the purpose of determining the appropriate module under module 3.1, 3.2 and 3.3, 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.

3.3: Toxicology – Level 3

b. A product containing an approved active constituent which requires or involves:

  1. changes to the Poisons Standard; and/or
  2. establishing first aid and hazard statements..
Module level Module type Timeframe Fee
3.3 Toxicology 5 months $4 050

Module 5: 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.

A Reduced residue assessment (Module 5.2) applies to applications requiring assessment of the residues and trade implications for a crop producing a major export food commodity group with risks of residues and a change to established MRLs is required.

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

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. Residues assessment is also not required for veterinary vaccines which do not contain novel adjuvants and/or excipients.

5.2: Residues – Level 2

a. A product containing an approved active constituent for use in a new food species where establishment or variation of MRLs and WHPs and/or trade implications are required. Such circumstances may include the establishment or variation of any ESIs and consideration of a new route of administration.

Module level Module type Timeframe Fee
5.2 Residues  and trade 8 months $10 525

5.4: Limited residue assessment

a. A product for use in a food species where use of the active constituent is currently approved for a similar formulation type and route of administration with consideration of variation of MRLs and WHPs and/or ESIs.

Module level Module type Timeframe Fee
5.4 Residues and trade—limited residue assessment 4 months $7 465

Module 6: Work health and safety

A work health and safety (WHS) assessment is required where there is a change to human exposure. Changes to human exposure can occur when extending into new crops or situations. These exposures include changes such as application rate, method, worker rates and practices including post application activities. The change in exposure may result in a change to the entry in the First aid instructions and safety directions (FAISD) handbook, including changes to personal protective equipment (PPE) and re-entry into treated areas following application.

6.2: Work health and safety – Level 2

b. A product containing an approved active constituent which requires or involves:

1. changes to the Poisons Standard; and/or
2. establishing safety directions.

Module level Module type Timeframe Fee
6.2 Workplace health and safety 7 months $3 185

6.3: Work health and safety – Level 3

a. A product that is not referred to in module 6.2 above including an assessment of human exposure to establish re-handling statements and/or vary safety directions.

Module level Module type Timeframe Fee
6.3 Workplace health and safety 4 months $2 910

Module 7: 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 assesment is required.

7.1: Environment – Level 1

b. Applies where a VICH Phase II assessment is required and the reference product (including the approved active constituent of the reference product) has only been subject to a VICH Phase I assessment.

The VICH website has guidance on both Phase I and Phase II assessments.

Module level Module type Timeframe Fee
7.1 Environment 13 months $26 390

7.2: Environment – Level 2

a. A product which involves:

  1. a new combination of approved active constituents; or
  2. use in any situation or herd animal unless the active is currently approved in the species for a similar formulation type and use pattern.
Module level Module type Timeframe Fee
7.2 Environment 7 months $7 315

7.3: Environment – Level 3

a. Applications involving a VICH Phase I environmental impact assessment. A VICH Phase I environmental impact assessment may apply to applications to register a product.

The VICH website has guidance on both Phase I and Phase II assessments.

Module level Module type Timeframe Fee
7.3 Environment 4 months $1 720

Module 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 crops, non-target crops and germinaton, effects of residues, organoleptic tests or pharmacologic studies.

Major changes in formulation normally require an Efficacy and Safety Assessment Level 1 (Module 8.1). If, however, the applicant provides valid scientific argument regarding submission of relevant efficacy or safety data to justify a lower level of assessment a Efficacy and Safety Assessment Level 2 (Module 8.2) can be applied. An Efficacy and Safety Assessment Level 3 (Module 8.3) can be applied where the change in formulation is likely to affect only efficacy or safety, or if comparable efficacy or bioequivalence with the previous formulation.

8.1: Efficacy and safety – Level 1

b. Registration of a product which involves:

  1. Use in/on a food species or dog, cat or horse for the first time; or
  2. a new formulation type; or
  3. a new combination of approved active constituents.
Module level Module type Timeframe Fee
8.1 Efficacy and target animal safety 6 months $2 370

8.2: Efficacy and safety – Level 2

b. Registration of a product which involves:

  1. a new pest or disease or for a new purpose in/on a food species or dog, cat or horse; or
  2. new dosage or administration instructions in/on the species. This includes having consideration of dose, frequency, duration, and route of administration; or
  3. a product is not the same, nor closely similar, nor similar to an existing registered reference product.
Module level Module type Timeframe Fee
8.2 Efficacy and target safety 4 months $975

8.3: Efficacy and safety – Level 3

b. A product which involves:

  1. use in or on a non-food species (other than a dog, cat or horse); or
  2. a product which is similar to a registered reference product.
Module level Module type Timeframe Fee
8.3 Efficacy and target safety 3 months $580

Module 9: Non-food trade

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

a. A 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; or
Module level Module type Timeframe Fee
9 Non-food trade 6 months $1 175

Module 10: Special data assessment

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 module 10 assessment.

Specifically, you should consider the following guidelines:

10.2: Special data – Level 2

a. 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:

  1. a variation of use to a new food species, or a dog or a cat;
  2. 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
  3. a change in dosage form or use pattern (for example: from use in individual animals to mass medication).
Module level Module type Timeframe Fee
10.2 Antimicrobial resistance 7 months $Nil

10.3: Special data – Level 3

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

Module 11: 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.

11.1: Finalisation – Level 1

a. A product where three or more modules from 2.1 to 10.3 apply.

Module level Module type Timeframe Fee
11.1 Finalisation 3 months $4 055

11.2: Finalisation – Level 2

a. A product where less than three modules from 2.1 to 10.3 apply.

Module level Module type Timeframe Fee
11.2 Finalisation 2 months $1 545

Module 12: Limits on use of information

Module 12 relates to the protection, handling and use of information provided to the APVMA. In general, the APVMA must not use 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 Module type Timeframe Fee
12 Data protection N/A $460

What you need to provide

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 of use)
  • e-label.

Completed online application form

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

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

The application fee

You may choose to:

  • pay the total fee on submission or
  • pay the preliminary assessment fee of $710 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).

Supporting information

The application must contain, or be accompanied by, information relevant to the whether the chemical poduct 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 relvant 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.

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.

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.

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.

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 (sections 5D and 14 of the Agvet Code). 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.

Examples

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

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).

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

1: Preliminary assessment

1

Not applicable

$710

2: Chemistry

Assessment is required of the chemistry and manufacturing aspects of the new formulation are required

2.3

6 months

$1 580

3: Toxicology

Assessment is required to consider the acute toxicology of the novel combination of existing actives

3.3

5 months

$4 050

4: Toxicology—Poison scheduling

Not required—the active constituents are scheduled

5: Residues and trade

Not required—dogs are not a food-producing species and do not pose a trade risk for Australia

6: Work health and safety

Assessment of the health and safety is required as new safety directions will be assessed for the new combination

6.2

7 months

$3 185

7: 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.

8: Efficacy and safety

An efficacy assessment is required to determine that the label claims are supported and the product is safe and efficacious

8.1

6 months

$2 370

9: Non-food trade

Not required—dogs do not produce a non-food trade commodity

10: Special data

Not required—joint health products are not antibacterial agents

11: Finalisation

11.2

2 months

$1 545

12: Limits of use

12

Not applicable

$460

Total

9 months

$13 900

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

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).

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

1: Preliminary assessment

1

Not applicable

$710

2: Chemistry

A chemistry assessment is required to assess the quality of the product and to establish its shelf life

2.3

6 months

$1 580

3: Toxicology

Not required—the risk is equivalent to other registered vaccines containing the approved antigens and a common adjuvant

4: Toxicology—Poison scheduling

Not required—the existing schedule is applicable

5: Residues and trade

Not required—viral vaccines containing the approved antigens already exist and the vaccine contains a commonly used adjuvant

6: Work health and safety

Not required—the risk is equivalent to other registered vaccines containing the approved antigens and a common adjuvant

7: Environment

Not required—the risk is equivalent to other registered vaccines containing the approved antigens and a common adjuvant

8: Efficacy and safety

An assessment is required for a new combination of existing antigens

8.1

6 months

$2 370

9: Non-food trade

Not required—the risk is equivalent to other registered vaccines containing the approved antigens and a common adjuvant

10: Special data

Not required—the risk is equivalent to other registered vaccines containing the approved antigens and a common adjuvant

11: Finalisation

11.2

2 months

$1 545

12: Limits of use

12

Not applicable

$460

Total

8 months

$6 665

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

Application type

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).

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

1: Preliminary assessment

1

Not applicable

$710

2: Chemistry

A chemistry assessment is required to assess the quality of the new dosage form and to establish a shelf life for the product

2.3

6 months

$1 580

3: Toxicology

Assessment is required to determine the toxicity profile of the new product formulation

3.3

5 months

$4 050

4: Toxicology—Poison scheduling

Generally, not required as the existing schedule should be applicable, but check the SUSMP for any explicit wording that may limit the SUSMP entry to formulation type, species and/or concentration

5: Residues and trade

Not required—dogs are not a food-producing species and do not pose a trade risk for Australia

6: Work health and safety

Assessment of the health and safety is required as new safety directions will be assessed for the new combination

6.2

7 months

$3 185

7: 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

8: Efficacy and safety

An efficacy assessment is required for a new dosage form

8.1

6 months

$2 370

9: Non-food trade

Not required—dogs do not produce a non-food trade commodity

10: Special data

Not required—an anti-inflammatory and analgesic product is not an antibacterial agent. The product does not contain a genetically modified organism

11: Finalisation

11.1

3 months

$4 055

12: Limits of use

12

Not applicable

$460

Total

10 months

$16 410

Start an application

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

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