I want to vary my product to include a new dose rate, frequency, route of administration or application method (vet products only)

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.

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, toxicology (including poison scheduling, residues, work health and safety, 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.

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.

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.

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.

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.

Timeframe and fees

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 to include a new dose rate or frequency must satisfy the statutory criteria of safety, efficacy and trade. Depending on the extension being sought, one or more of the following Module types 2 to 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.

Examples

Pre-application assistance

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

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. 

An application to vary a dose or frequency of application must satisfy the statutory criteria of safety (Section 5A), efficacy (Section 5B), and trade (Section 5C). However, the amount of new information or data required will vary depending upon how significant the change is, and what new assessments are necessary.

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.

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.

Residues 2 module

A reduced residue assessment (Module 5.2) applies to applications requiring assessment of the residues and trade implications for a new food species or a variation to the dose rate or frequency of application to a food species and where a change to established MRLs are required.

c. Variation to change the dose rate or frequency of application to food species and where a change to established MRLs are required.

5.4: Residues—level 4

A limited residue assessment (Module 5.4) applies to variations which involve review of WHPs and trade implications including:

b. A variation which involves review of WHPs and trade implications including:

1. a minor formulation change;
2. changes to a label which have potential risk of residues where no change to the established MRLs is required; or
3. residues assessment that is not referred to in Module 5 above including establishing or amending Table 5 entries.

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.

Several types of applications for registration of a new product do not require WHS assessment, as the product is not normally associated with any potential risks to human health. Where, however, there is any such risk, an appropriate WHS assessment is required. The types of application for products which do not normally require WHS assessment are as follows:

a. Applications for a permit for a product, registration of a new product or variation of the particulars or conditions of a registered product that are:

1. animal therapeutics and mineral and nutritional supplements in tablet, capsule, slow release bolus or skin implant form
2. animal therapeutics which have Therapeutic Goods Administration approval for direct administration to humans and the use pattern indicates low worker exposure potential (that is, not mob or flock treatments with a drench or a pour on, or as a feed additive, or other equivalent use pattern, as these have high worker exposure potential)
3. mineral, vitamin and nutritional supplements for a single animal or a small number of animals and are administered directly to the animal or into daily food or water
4. vitamins; digestive enzyme supplements; electrolytes; iron and haematopoietic agents; tonics and stimulants; or preservatives
5. micro organism and enzyme products for use in non-food species
6. stockfood additives and nutrition or metabolism products (other than those listed in this paragraph) with established safety directions, which are directly applicable to the concentration of the additive and the form in which it is to be used
7. animal bacterial and viral vaccines.

6.2: Work health and safety—level 2

A reduced work health and safety assessment (Module 6.2) is required when the application involves a new species or situation or a new application method.

c. A variation which involves:

1. a change in use pattern to include a new species or situation; or
2. a new application method.

b. A variation that is not referred to in Module 6.2 above, that requires a WH&S assessment due to a varied exposure scenario (for example, to consider re-entry/re-handling statements and/or safety directions).

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.

7.2: Environment—level 2

b. Variations of an approval which involves:

1. a new herd animal or new situation;
2. changes to application method; or
3. increase in application rate, dose or frequency for an existing use pattern.

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.

Efficacy and Safety 2

a. Registration of a product that involves:

1. a new domestic or home garden use;
2. a new minor use with the same general use pattern as an existing registered product;
3. a new pest or new crop within the same crop group or situation with the same general use pattern as an existing registered product; or
4. a formulation change not considered similar to an existing registered product, not covered by Efficacy and Safety 1 or Efficacy and Safety 3 and where efficacy and crop safety data is required.

Efficacy and Safety 3

Registration of a product where only bioequivalence (including scientific argument) is required to demonstrate the efficacy and crop safety to a currently registered product where the product is defined as similar to an existing registered product.

A reduced efficacy and safety assessment (Module 8.2) applies for:

c. A variation which involves:

1. use on a new pest or disease or for a new purpose in the same food species or companion animal; or
2. a change to the dosage or administration instructions—including treatment number, frequency, duration, dose, and route of administration—in the same food species or companion animal.

A limited efficacy and safety assessment (Module 8.3) applies for:

h. A variation which involves:

1. use in a non-food species (other than a dog, cat or horse): or
2. where only bioequivalence or pharmaceutical equivalence is required to demonstrate the efficacy and safety.

Non-food Trade

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

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.

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).

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.

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.

b. A variation where three or more modules between 2.1 to 10.3 apply.

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.

b. A variation where fewer than three modules between 2.1 to 10.3 apply.

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.

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
• supporting information to demonstrate that the proposed variation will be efficacious and will not cause unintended harm
• an information list
• consent for use (if any of the information provided is subject to limits on use)
• an 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 $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).

Supporting information

The application must contain, or be accompanied by, information relevant to 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, efficacy and trade 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.

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 (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.

Scenario 1: Variation to increase the dose of a euthanasia solution

Objective

An application is made to increase the dose of an intravenous (IV) product used for the euthanasia of various animals. The dose is being increased from 2 mg/kg to 3 mg/kg. 

The applicant has nominated a reference product (which has no relevant protected data) and provided scientific argument as how the product will continue to meet the statutory criteria once the variation is made.

The applicant has provided an updated label with the new dose rate.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product’s capacity to meet the safety (Section 5A) and efficacy (Section 5B) criterion will not be affected by the increased dosage.

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

Scenario 2: Variation to change the dose and dosage frequency for an antibiotic product

Objective

An application is made to change the dose and frequency of an intravenous injection antibiotic product used in horses.

The applicant has provided safety, efficacy and pharmacokinetics data to support the application.

An updated label with the new dosing regime has also been provided.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product will continue to meet the safety and efficacy criteria.

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

Scenario 3: Variation to increase the dose rate for a sheep drench product and to increase the interval between treatments

Objective

An application is made to increase the dose rate of a sheep drench product to allow a claim that the product will remain effective for a longer period of time between treatments.

The applicant has provided data on the efficacy and safety of the higher dose. Meat and milk WHP and ESI will need to be amended and residues data has been submitted at the new dose and frequency. No changes to MRLs are proposed.

An updated label with the new dose rate and dosing interval has also been provided.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product will continue to meet the safety and efficacy criteria.

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

Scenario 4: Changing the duration of immunity on a vaccine product

Objective

An application is made to vary a vaccine product for use in dogs to amend the dosage and administration section of the label including the duration of immunity. The proposed change will require a booster vaccination after 3 years instead of 12 months.

The applicant has submitted a safety and efficacy study with the new dose regime as well as scientific argument.

An updated label has been provided.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product will continue to meet the safety and efficacy criteria.

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

Scenario 5: Variation to the application method to use hand jetting in a product approved for automatic jetting

Objective

An application is made to vary a fly and lice control product in sheep to provide directions for use by hand jetting. The product is registered for this use by automatic jetting.

The applicant has provided scientific argument that the proposed application method is as effective and safe as the approved application method.

The applicant has provided an updated label with the instructions.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product’s capacity to meet the safety (Section 5A) criterion will not be affected by the increased application rate.

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

Scenario 6: Variation to the route of administration for an anaesthetic for companion animals from intravenous injection to intramuscular injection

Objective

An application is made to change the route of administration for an anaesthetic from intravenous to intramuscular.

The applicant has provided safety, efficacy and pharmacokinetics data to support the application.

An updated label with the new instructions for intramuscular injection has also been provided.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product will continue to meet the safety and efficacy criteria.

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

If you want to vary your product to change a dose rate or frequency, and a technical variation (Item 14) is required:

Start application

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