I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only)

For registration, veterinary chemical products must be shown to be safe and effective when used in accordance with any approved directions for use. Product labels must adequately reflect these directions, including restraints, contraindications, precautions and side effects of the product where applicable.

Restraints are absolute limitations or restrictions placed on the use of the product, usually to manage a risk associated with the product related to human safety, public health or environmental protection.

Contraindications are included on a label to indicate conditions or specific situations that render a particular type of treatment undesirable or unacceptable. They are normally used when there is evidence that toxicity will occur in a particular situation or physiological state or in an off-label animal species.

Precautions minimise health risks to target animals from approved uses of a product. They are normally used when there is insufficient evidence to demonstrate safety in a particular situation.

Side effects are included on a label to advise end users of effects that may occur in the target animal from approved use(s) of a product. These statements include details of the severity, clinical importance and treatment of the effects.

Applications to vary these statements may be made via:

  • Item 12: No data of a technical nature is required. This type of application is used when risks are equivalent to a registered product not subject to data protection.
  • Item 14: Technical modular application. All applications not meeting the requirements of Item 12.

Is a technical assessment required for my proposed variation?

Most variations of this type are likely to be made as Item 14 applications, as they will require a technical assessment.

Variations that don’t require a technical assessment to satisfy the safety, efficacy and trade criteria can be processed under a non-technical fixed fee variation (Item 12). These applications are generally supported through reference to statements which are already approved on another registered product (reference product).

In these cases the APVMA will apply the same approach as conducted for Items 6, 7 and 8 for the purposes of defining if the reference product is either the same or closely similar.

The product when compared to the reference product must meet the following criteria:

  • same active constituent(s)
  • same concentration of active(s)
  • non-active constituents are equivalent substances, at the same or equivalent concentrations or differences are minor and not expected to have adverse implications on product quality or biological activity in terms of efficacy, safety or residues
  • the specifications and properties are the same or equivalent or differences are minor and are not expected to have adverse implications for product quality or biological activity in terms of efficacy, safety or residues
  • same dose form and formulation type
  • same use pattern and instructions
  • label claims are the same
  • reference product information is not subject to limit on use of information or the applicant has obtained consent from the owner to use the data from the reference product.

Limits on use (data protection): Where there are limits on use of information on the reference product, written consent from the authorising party is required when access to the information is necessary to determine the application.

Where the reference product does not fully support all risk areas or the product is subject to limits on use and additional data is being provided to satisfy the safety, efficacy or trade criteria these applications should be lodged as Item 14 applications.

Which application form do you need?

Application guidance

Specific information on completing this application form is provided below. Once you are familiar with the content you can proceed to ‘Start an application’ at the button below.

Please note: the fees referenced in this tailored guidance take effect from 1 July 2020. For a list of fees and charges up to 30 June 2020, please view the timeframe and fees section on our website.

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 S 5A 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.

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 (Section 29 of the Agvet Code).

Section 20(1)(c) of the Agvet Code 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
(b)  the constituents of the chemical product
(c)  the concentration of each constituent of the chemical product
(d)  if possible, the composition and purity of each active constituent of the chemical product
(da)  the formulation type for the chemical product
(db)  the net contents for the chemical product
(e)  identifying information for the holder of the registration of the chemical product
(g)  the name of each manufacturer of the chemical product
(h)  the address of each site at which the chemical product is manufactured by the manufacturer
(j)  the date of entry of these particulars in the Register of Chemical Products
(k)  identifying information for any nominated agent for the registration.

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

(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
(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 subregulation (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

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.

Timeframe and fees

The fee for a non-technical variation (Item 12) is a fixed fee of $2018. The timeframe is three months. Legislative timeframes commence once the application has passed preliminary assessment and fees have been paid.

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 for a non-technical variation (Item 12) is five months.

Pre-application assistance

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

What you need to provide

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 the variation will not alter the safety, efficacy or trade risks related to the product
  • an information list
  • consent for use (if any of the information provided is subject to limits on use)
  • e-label (if required).

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 a summary as to why it does not require technical assessment to satisfy the statutory criteria. In particular, why it does not require technical assessment of risks to residues/trade, workplace health and safety, environment, target safety and efficacy. For example, this may include nomination of a single reference product.

Reference product details

Applicants must nominate one, and only one, registered reference product. Details to provide include the product/active constituent number and the full name of the product/active. Reference products must be agvet chemical products currently registered by the APVMA. Registered chemical products can be searched on APVMA’s product search database.

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

When protected information is listed for a reference product, the applicant must obtain consent for use from the relevant authorising party or parties. This consent for use must be explicit and include the relevant data numbers.

You can check the APVMA PubCRIS database record to determine if protected data details exist 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.

Pre-application assistance

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

Examples

Scenario 1: Variation to amend a side effect statement on a registered veterinary product related to target species safety (relying on protected data)

Objective

An application is made to amend the approved label of a flea and tick collar to remove a side effect statement.

The flea and tick collar product was originally registered under Item 7 using a closely similar reference product. This reference product was recently varied under an Item 14 application to reflect the results of a new study that indicated the side effect statement was not required. The applicant has permission from the holder of the reference product to use this study to support this application.

The following table includes the currently approved side effect statement and the proposed new side effect statement.

Current label text

Proposed label text

Side effects:

Application site reactions such as dermatitis, inflammation, eczema or lesions may occur and in these instances, a temporary collar removal may be recommended until the symptoms have disappeared.

 

Also in rare cases, slight and transient reactions such as depression, change of food intake, salivation, vomiting and diarrhoea might occur initially

 

In the unlikely event of the animal eating the collar, mild gastrointestinal symptoms (eg loose stools) may occur.

Side effects:

Application site reactions such as dermatitis, inflammation, eczema or lesions may occur and in these instances, a temporary collar removal may be recommended until the symptoms have disappeared.

 

In the unlikely event of the animal eating the collar, mild gastrointestinal symptoms (eg loose stools) may occur.

Application type

This application may be considered under a non-technical fixed fee variation (Item 12). The registered reference product shows equivalent risk has already been assessed and the product will continue to meet the safety (Section 5A), and efficacy (Section 5B) criteria. The trade (Section 5C) criteria is not applicable for cat and dog flea collars.

An updated label reflecting the changed instructions will need to be included in the application.

Risk Area

Reason technical assessment is not required

2: Chemistry

The product is currently registered and there are no changes to the product formulation

3: Toxicology

The product is currently registered and the proposed variation does not affect human health

4: Toxicology—Poison scheduling

The product is currently registered and relevant scheduling is established

5: Residues and trade

The product is currently registered. Residues and trade is not relevant for a cat or dog flea collar

6: Work health and safety

The product is currently registered. Risk to human health through exposure is not changing as a result of the variation application

7: Environment

The product is currently registered. Risk to the environment is not changing as a result of the variation application

8: Efficacy and safety

Efficacy and target animal safety is equivalent to that previously assessed for the reference product

9: Non-food trade

Not relevant

10: Special data

Not relevant

Application type

Timeframe

Extended timeframe

Fee

Item 12

3 months

5 months

$2 018

Scenario 2: Variation to amend a contraindication on a registered veterinary product related to target species safety (no data protection)

Objective

An application is made to amend a contraindication on a registered non-steroidal anti-inflammatory for use in dogs and cats younger than six weeks of age.

The applicant has nominated a registered reference product with the same active at the same concentration, the same formulation type and the same product uses. The holder of the reference product had previously submitted data to show the contraindication statement was not required. This data is no longer protected and this application seeks to rely on the registered reference product to have the contraindication statement removed from the label.

Approved label text

Proposed label text

Contraindication:

 

This product is contraindicated in pregnant or lactating animals.

 

This product is contraindicated for use in animals less than six weeks of age.

Contraindication:

 

This product is contraindicated in pregnant or lactating animals.

 

Application type

This application may be considered under a non-technical fixed fee variation (Item 12). The registered reference product shows equivalent risk has already been assessed and the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria.

An updated label reflecting the changed instructions will need to be included in the application.

Risk Area

Reason technical assessment is not required

2: Chemistry

The product is currently registered and there are no changes to the product formulation

3: Toxicology

The product is currently registered and the proposed variation does not affect human health

4: Toxicology—Poison scheduling

The product is currently registered and relevant scheduling is established

5: Residues and trade

The product is currently registered. Residues and trade is not relevant for a cat and dog product

6: Work health and safety

The product is currently registered. Risk to human health through exposure is not changing as a result of the variation application

7: Environment

The product is currently registered. Risk to the environment is not changing as a result of the variation application

8: Efficacy and safety

Efficacy and target animal safety is equivalent to that previously assessed for the reference product

9: Non-food trade

Not relevant

10: Special data

Not relevant

Application type

Timeframe

Extended timeframe

Fee

Item 12

3 months

5 months

$2 018

Note: If during assessment, the APVMA determines that the reference product is not closely similar to the product being varied, the APVMA would not able to be satisfied that the product if varied would continue to meet the statutory criteria. In this case, the APVMA would propose to refuse the application.

Scenario 3: Variation to amend a side effect statement on a registered veterinary product related to target species safety

Objective

An application is made to amend the approved label of a companion animal general anaesthetic to include a new side effects statement on respiratory depression as a result of local and overseas adverse experience reporting. The side effect was not observed in the clinical trials to register this product. Similar label changes have also been made on an overseas approved label for the same product.

Current label text

(APVMA label and original overseas label)

Proposed label text

(new approved overseas label)

Side effects: Adverse events include minimal hypotension and muscle twitching during recovery.

Side effects: Adverse events include minimal hypotension, respiratory depression and muscle twitching during recovery.

Application type

This application may be considered under a non-technical fixed fee variation (Item 12). The proposed side effects are known to occur with certain anaesthetics and data is not required. The addition of the side effect will not change the previous risk assessment. The product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria.

The overseas label and assessment report should be submitted with the Item 12 application. A justification can be included in the application form executive summary.

An updated label reflecting the changed instructions will also need to be included in the application.

Risk Area

Reason technical assessment is not required

2: Chemistry

The product is currently registered and there are no changes to the product formulation

3: Toxicology

The product is currently registered and the proposed variation does not affect human health

4: Toxicology—Poison scheduling

The product is currently registered and relevant scheduling is established

5: Residues and trade

The product is currently registered. Residues and trade is not relevant for a companion animal product

6: Work health and safety

The product is currently registered. Risk to human health through exposure is not changing as a result of the variation application

7: Environment

The product is currently registered. Risk to the environment is not changing as a result of the variation application

8: Efficacy and safety

Efficacy and target animal safety is equivalent to that previously assessed for the product. The addition of the side effect statement does not change this assessment

9: Non-food trade

Not relevant

10: Special data

Not relevant

Application type

Timeframe

Extended timeframe

Fee

Item 12

3 months

5 months

$2 018

Start an application

If you want to vary a restraint, contraindication, precaution or side effect statement on your product label and a non-technical assessment (Item 12) is required:

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