I want to vary my veterinary product to make a change to the product formulation and a technical assessment is required (Item 14)

0.1. Is a technical assessment required for my proposed variation?

Application for a formulation change as a prescribed variation (Item 13A) is only permitted in very limited circumstances. These circumstances are described below (select ‘Item 13A Prescribed Variation’). 

Applications for formulation changes where a technical assessment is not required to satisfy the safety, efficacy and trade criteria can be processed under a non-technical fixed fee variation (Item 12). This includes where the proposed new formulation is closely similar to the existing formulation or where a suitable reference product is nominated. Minor changes to non-active constituents may also be considered as non-technical assessments. Select ‘Item 12’ below to see the full list of circumstances where an Item 12 application is likely to be appropriate.

A technical assessment (Item 14) is required for variations to formulations that include changes:

• to immunobiological products and peptide products
• to active constituents or constituents that act as synergists
• to non-active constituents such as addition, substitution or removal of an excipient (some changes can be made as an Item 12 non-technical assessment—select ‘Item 12’ below to see a full list)
• to ligands
• to ingredients that are subject to scheduling in the Poisons Standard
• where there are concerns about stability
• which affect the permeability and bioavailability of the active constituent in a product (eg solvents and surfactants in topical or injectable formulations)
• that result in a change in drug:excipient ratio of greater than five per cent from the original product formulation

Other formulation changes that require a technical assessment will also be considered as Item 14 applications.

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. Varying relevant particulars and conditions

The APVMA must vary the relevant particulars or conditions if it is satisfied application requirements and statutory criteria have been met (Agvet Code, s 29).

The Agvet Code, s 20(1)(c) defines relevant particulars in relation to the registration of a chemical product as:

• the distinguishing number
• any instructions for the use of the product
• any other particulars prescribed by the regulations.

Other particulars for chemical products prescribed by the regulations are:

(a)  the distinguishing name of the chemical product

(i) the constituents of the chemical product
(ii) the concentration of each constituent of the chemical product
(iii) if possible, the composition and purity of each active constituent of the chemical product
(iv) the formulation type for the chemical product
(v) the net contents for the chemical product
(vi) identifying information for the holder of the registration of the chemical product
(vii) the name of each manufacturer of the chemical product
(viii) the address of each site at which the chemical product is manufactured by the manufacturer
(ix) the date of entry of these particulars in the Register of Chemical Products
(x) identifying information for any nominated agent for the registration.

The Agvet Code defines particulars in relation to approval of a label:

b)

(i) the name of the person who applied for the approval as the holder of the approval
(ii) the name of any nominated agent for the approval
(ii) the name of any nominated agent for the approval
(iii) the distinguishing number
(iv) the instructions and any particulars that are to be contained on the label
(iva) any other particulars prescribed by the regulations
(v) any conditions of the approval imposed by the APVMA.

Other particulars for labels prescribed by the regulations are:

Regulation 17(1)

a) the appropriate signal words required by the current Poisons Standard
b) the name of the chemical product that is to appear on a label for containers of the chemical product
c) the name of each active constituent of the product
d) the proportion of each active constituent of the product
e) the name of each constituent for the product that is

a. not an active constituent; and
b. classified as a poison in the current Poisons Standard

f) the proportion of each constituent referred to in paragraph (e)
g) the net contents of the product
h) particulars determined by the APVMA CEO under sub-regulation (2).

Regulation 17(2)

For paragraph 6(2)(c) of the Act, the APVMA CEO may determine additional particulars to be placed on a label for a product.

Regulation 17(3)

a) identifying information for the holder of the approval
b) identifying information for any nominated agent for the approval
c) the distinguishing name of the chemical product that is prescribed under paragraph 16(a) and entered in the Register
d) the distinguishing number of the chemical product that is entered in the Register.

Conditions are:

a) the conditions prescribed by the regulations (whether or not the conditions are prescribed at the time the constituent, product or label is approved or registered); and
b) any conditions imposed on the approval or registration as the APVMA thinks appropriate.

1.3. 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.

1.4. 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.

1.5. 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.

1.6. 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.

For variations to formulations, the Applications Requirements Instrument requires the submission of formulation information:

(1) The following information is the formulation information in relation to a chemical product:

(a) for each active or other constituent in relation to the chemical product:

(i) the name of the constituent; and
(ii) the CAS number of the constituent; and
(iii) the applicable constituent standard (if any); and
(iv) the concentration of the constituent; and
(v) the purpose of the constituent in the formulation of the product;
(b) the total weight or volume of the product (as applicable);
(c) if the product is a liquid –the specific gravity of the product;
(d) the formulation type of the product;
(e) whether the product contains any ingredients that have a risk of transmitting agents of animal spongiform encephalopathies
(f) whether the product contains any genetically modified organism or any product derived from a genetically modified organism;
(g) whether the product contains any ingredients intentionally engineered to be less than 100 nanometres in one or more dimensions and, if so, those ingredients.

(2) Where this Instrument requires an application to contain, or be accompanied by, formulation information:

(a) the information need not be provided by the applicant (for example, it may be provided by a manufacturer of the product); and
(b) the person providing the information must state the persons, if any, to whom the information may be disclosed; and
(c) the information must be accompanied by a declaration, signed by the person providing the information, that the information is complete and correct.

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.

2.1. Pre-application assistance

Pre-application assistance is available to give applicants advice on the requirements of an application before submission.

A technical variation is a modular application type, therefore the fees and timeframe are variable according to the assessments necessary. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.

Applications for change in formulation must satisfy the statutory criteria of safety, efficacy and trade. Depending on the change in formulation being sought, one or more of the following Module types 2–10 will require the provision of supporting data and/or scientific argument. Where an applicant considers that an assessment of any particular module is not necessary justification must be provided.

Major formulation changes (eg changes to the active constituent, active concentration or formulation type) may require higher module levels. In general, the modules that would be applied for a major formulation change would be the same that would apply if the product were being registered for the first time. In this case, applicants should refer to the tailored guidance on new product registrations.

Module type	Module level	Timeframe	Fee
1: Preliminary assessment	1.0	Up to 1 month	$902
2: Chemistry	2.3	6 months	$1 954
3: Toxicology (if required)	3.3	5 months	$4 050
4: Toxicology—Poison scheduling	No assessment is required if appropriate scheduling is already in place.
5: Residues and trade (if required)	5.4	4 months	$7 465
6: Work health and safety (if required)	6.3	4 months	$3 913
7: Environment	No assessment required if formulation change does not alter risks related to the environment.
8: Efficacy and safety (if required)	8.3	3 months	$1 160
9: Non-food trade	No assessment required as minor formulation changes should not alter risks related to non-food trade.
10: Special data (if required)	10.2 or 10.3	7 months 7 months	Nil Nil
11: Finalisation	11.1 or 11.2	3 months 2 months	$8 110 $3 090
12 Limits on use (data protection)	12	N/A	$460

2.1.1. Examples

Scenario	Modules	Timeframe	Fee
Scenario 1: Change in product formulation involving a change in viscosity in a pour-on product	1, 2.3, 3.3, 5.4, 6.3, 8.3, 11.1 & 12	9 months 13 months (extended assessment period)	$28 014
Scenario 2: Change in product formulation resulting in a change to physico-chemical properties	1, 2.3, 11.2 & 12	8 months 12 months (extended assessment period)	$6 406
Scenario 3: Change in excipients in an immuno-biological product	1, 2.3, 8.3, 11.2 & 12	8 months 12 months (extended assessment period)	$7 566

3. Modules

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
8.3	Efficacy and target safety	3 months	$1 160

3.3. 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

3.3.1. Health 3

Registration of a new product containing an approved active constituent requiring approval first time for food uses, requiring the establishment of an ADI and/or ARfD.

Module level	Timeframe	Fee
Health 3	9 months	$18 980

Module level	Timeframe	Fee
Residues 4	4 months	$7 465

3.3.2. 8.3: Limited efficacy and safety

3.3.3. 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 conducted under previous applications is required.

Module level	Timeframe	Fee
Finalisation 1	3 months	$8 110

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

3.3.4. 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 conducted under previous applications is required.

Module level	Timeframe	Fee
Finalisation 2	2 months	$3 090

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

3.4. 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

3.5. 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.

3.5.1. 6.3: Work health and safety—level 3

3.6. Chemistry

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.

3.7. Pre-application assistance

Pre-application assistance is available to give applicants advice on the requirements of an application before submission. 

3.7.1. Chemistry 3

Registration of a new product containing an approved active constituent.

Module level	Timeframe	Fee
Chemistry 3	6 months	$1 954

Module level	Module type	Timeframe	Fee
2.3	Chemistry—Limited assessment	6 months	$1 954

3.8. Efficacy and safety

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

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

An efficacy and safety assessment may include assessing data that validates the request to vary the product and label (for example, pharmacovigilance data) and ensures the APVMA can be satisfied that with the proposed amendment the product will continue to meet the safety, efficacy and trade criteria.

An efficacy assessment would only be required if the variation affects efficacy or target safety. For example, a change to a precaution related to target safety

Module	Timeframe	Fee
Efficacy 2	4 months	$1 950

Module	Timeframe	Fee
Efficacy 3	3 months	$1 160

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.

Applications to vary a formulation must satisfy the statutory criteria of safety (Section 5A), efficacy (Section 5B), and trade (Section 5C). The assessment modules will depend on the nature of the formulation change and how it might impact on the previous consideration of residues and trade, work health and safety, environment and efficacy and target species safety.

3.9. 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 animal species or situations. These exposures include changes such as application dose, route of administration, 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 or handling of treated animals following application.

3.10. 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.

Where the formulation change does not change the risk to the environment, and this can be determined without further assessment, no environmental assessment is needed.

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. Pre-application assistance

Pre-application assistance is available to give applicants advice on the requirements of an application before submission.

4.6. Formulation information

The application must contain (or be accompanied by) the proposed new formulation including:

(a) for each active or other constituent in relation to the chemical product:

(i) the name of the constituent; and
(ii) the CAS number of the constituent; and
(iii) the applicable constituent standard (if any); and
(iv) the concentration of the constituent; and
(v) the purpose of the constituent in the formulation of the product;

(b) the total weight or volume of the product (as applicable);
(c) if the product is a liquid –the specific gravity of the product;
(d) the formulation type of the product;
(e) whether the product contains any ingredients that have a risk of transmitting agents of animal spongiform encephalopathies;
(f) whether the product contains any genetically modified organism or any product derived from a genetically modified organism;
(g) whether the product contains any ingredients intentionally engineered to be less than 100 nanometres in one or more dimensions and, if so, those ingredients.

The information can be provided by the applicant, or by a third party. The person providing the information must state to whom the information may be disclosed, and the information must be accompanied by a declaration, signed by the person providing the information, that the information is complete and correct.

Only one new formulation should be submitted per variation application.

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.

An example of when a proposed formulation change would require an updated label is when an excipient that is listed in the Poisons Standard is added or removed and this changes the scheduling of the product. The name and concentration of any excipients in Schedule 5 or Schedule 6 of the Poison Standard also need to be included in the constituent panel on the product label.

To meet the application requirements you will need to provide:

• a completed online application form
• the application fee plus any amount that is due to the APVMA
• formulation information
• supporting information to demonstrate the variation to product formulation will not alter the safety, efficacy or trade risks related to the product
• an information list
• consent for use (if any of the information is subject to limits on use)
• an e-label (if label changes are required).

5. Examples

5.1. Scenario 1: Change in product formulation involving a new solvent that changes the viscosity of a pour-on product

5.1.1. Objective

An application is made to vary the formulation of a registered pour-on parasiticide for use in food producing animals (cattle and sheep) to substitute one solvent for another.

The new solvent is a major component of the formulation (90%). The change will alter the viscosity of the product.

The applicant sought pre-application assistance because of the significant change and was advised that the new solvent has some minor health risks to humans and may require changes to the label instructions for use, re-handling and first aid. Residues assessment will also be required to assess if a change to the withholding periods is necessary.

Target animal efficacy and safety studies are also required to demonstrate comparable efficacy with the previously approved formulation.

5.1.2. Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the change in formulation will not affect the product’s capacity to meet the statutory criteria.

As the formulation change will result in changes to the label (safety directions and first aid instructions), an updated label must be included in the application.

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 variation. Modules 1, 11 and 12 are mandatory modules for this application.

Module type	Module level	Timeframe	Fee
1: Preliminary assessment	1.0	Up to 1 month	$902
2: Chemistry	An assessment is required to ensure the proposed formulation changes are acceptable.
	2.3	6 months	$1 954
3: Toxicology	An assessment is required to establish the toxicological profile of the new formulation.
	3.3	5 months	$4 050
4: Toxicology—Poison scheduling	No assessment required if appropriate scheduling is already in place.
5: Residues and trade	An assessment is required as the change to the product formulation is expected to alter residue risks and requires an assessment of withholding periods or MRLs.
	5.4	4 months	$7 465
6: Work health and safety	An assessment is required to establish new safety directions and precautionary statements.
	6.3	4 months	$3 913
7: Environment	No assessment required as there is no change to environmental risk.
8: Efficacy and safety	An assessment is required to ensure changes to product formulation do not affect target animal safety and the efficacy of the product.
	8.3	3 months	$1 160
9: Non-food trade	No assessment required as formulation change does not alter risks related to non-food trade.
10: Special data	No assessment required as this product is not an antibiotic or GMO.
11: Finalisation	11.1	3 months	$8 110
12: Limits on use (data protection)	12	N/A	$460
Total		9 months	$28 014

5.2. Scenario 2: Change in product formulation resulting in a change to physico-chemical properties

5.2.1. Objective

An application is made to vary the formulation of a horse parasiticide paste product. The amount of humectant in the formulation has been increased and exceeds one percent of the product formulation.

5.2.2. Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the formulation variation will not affect the stability of the product. The application includes a chemistry data package.

No change to the product label is required.

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 variation. Modules 1, 11 and 12 are mandatory modules for this application.

Module type	Module level	Timeframe	Fee
1: Preliminary assessment	1.0	Up to 1 month	$902
2: Chemistry	An assessment is required to ensure the proposed formulation changes are acceptable.
	2.3	6 months	$1 954
3: Toxicology	No assessment is required as the product is currently registered and the proposed variation is not expected to impact on the toxicological profile of the product.
4: Toxicology—Poison scheduling	No assessment required as there are no changes to the scheduling of the constituent.
5: Residues and trade	No assessment is required.
6: Work health and safety	An assessment is not required as the product is currently registered and the rate and method of application are unchanged.
7: Environment	No assessment required as there is no change to environmental risk.
8: Efficacy and safety	No assessment is required as the proposed change is not expected to alter the safety or efficacy of the product.
9: Non-food trade	No assessment required.
10: Special data	No assessment required as the product does not contain approved antibiotic active constituent/s or genetically modified organisms.
11: Finalisation	11.3	2 months	$3 090
12: Limits on use (data protection)	12	N/A	$460
Total		8 month	$6 406

5.3. Scenario 3: Change in product formulation of an immuno-biological product

5.3.1. Objective

An application is made to change the proportions of excipients in a live attenuated viral vaccine product for use in dogs. No constituents are to be removed or new ones introduced, only the relative proportions of the non-active constituents are to be varied. Stability and in-use stability data have been included in the chemistry submission, and data have been generated using the varied formulation to demonstrate comparable efficacy and animal safety with the previously approved formulation.

5.3.2. Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the formulation variation will not affect the product’s capacity to satisfy the statutory criteria.

No change to the label is required.

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 variation. Modules 1, 11 and 12 are mandatory modules for this application.

Module type	Module level	Timeframe	Fee
1: Preliminary assessment	1.0	Up to 1 month	$902
2: Chemistry	An assessment is required to ensure the proposed formulation changes are acceptable.
	2.3	6 months	$1 954
3: Toxicology	No assessment is required as the product is currently registered and the proposed variation is not expected to impact on the toxicological profile of the product.
4: Toxicology—Poison scheduling	No assessment required as there are no changes to the scheduling of the constituent.
5: Residues and trade	No assessment required as the formulation change will not alter the previous assessment of risks to residue and trade.
6: Work health and safety	An assessment is not required as the product is currently registered and the rate and method of application are unchanged.
7: Environment	No assessment required as there is no change to environmental risk.
8: Efficacy and safety	An assessment is required to ensure changes to product formulation do not affect target animal safety and the efficacy of the product.
	8.3	3 months	$1 160
9: Non-food trade	No assessment required.
10: Special data	No assessment required as the product does not contain approved antibiotic active constituent/s or genetically modified organisms.
11: Finalisation	11.2	2 months	$3 090
12: Limits on use (data protection)	12	N/A	$460
Total		8 months	$7 566

6. Start an application

If you want to make a change to the formulation of your product and a technical variation (Item 14) is required:

Start application

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