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

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 varying a restraint, contraindication, precaution or side effect statement must satisfy the statutory criteria of safety, efficacy and trade. The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframes and associated fees are likely to apply to this application type. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for this extension for Module types 2–10.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

No assessment required as the product is currently registered and no change is proposed to the product chemistry.

3: Toxicology

No assessment required as the product is currently registered and relevant health standards are already established.*

4: Toxicology—Poison scheduling

No assessment required if appropriate scheduling is already in place.*

5: Residues and trade

An assessment would only be required if the variation affects residues, a WHP or requires a change to an MRL, for example a variation to a re-treatment interval.**

5.2 or

5.4

8 months

4 months

$11 149

$7 465

6: Work health and safety

An assessment would only be required if the variation affects work health and safety risk, for example a change to a re-handling restraint.**

6.2 or

6.3

7 months

4 months

$3 185

$3 913

7: Environment

An assessment would only be required if the proposed variation alters the environmental risk. For example a change to a restraint related to environmental protection is likely to require an environmental assessment.**

7.2 or

7.3

7 months

4 months

$7 659

$2 979

8: Efficacy and safety

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

8.2 or

8.3

4 months

3 months

$1 950

$1 160

9: Non-food trade

 

No assessment required as there are no proposed changes to particulars related to trade.

10: Special data

No assessment required if the product does not contain approved antibiotic active constituent/s or genetically modified organisms.

11: Finalisation

 

11.1 or

11.2

3 months

2 months

$8 110

$3 090

12: Limits on use (data protection)

 

This module applies to any application which attracts limits on use of information (data protection) under Division 4A of Part 2; or Part 3 of the Agvet Code.

12.0

N/A

$460

* Toxicology, and Toxicology—Poison scheduling assessments are not required for most of these types of variations. However, if the proposed variation may impact on the risk in these areas (for example the re-evaluation of toxicological endpoints to support the removal of a health-related restraint), it is recommended that you seek Pre-Application Assistance, as these assessment modules may be required.

** Should it be unclear from a product label whether a restraint or precaution is related to residues and trade, environment, work health and safety, or efficacy and target safety, please seek further advice from the APVMA.

Examples

Scenario

Modules

Timeframe

Fee

Scenario 1: Variation to amend a side effect statement on a registered veterinary product related to target species safety.

1, 8.3, 11.2, 12

6 months

8 months (extended assessment period)

$5 612

Scenario 2: Variation to remove a side effect statement on a registered veterinary product related to target species safety.

1, 8.2, 11.2, 12

6 months

8 months (extended assessment period)

$6 402

Scenario 3: Variation to remove a precaution on a registered veterinary product.

1, 8.2, 11.2, 12

6 months

8 months (extended assessment period)

$6 402

Pre-application assistance

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

Modules

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

Applications to vary restraints, contraindications, precautions or side effect statements 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 variation and if the proposed change might impact on the previous consideration of residues and trade, work health and safety, environment and efficacy and target species safety.

Module 1: Preliminary assessment

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

Applies to all modular application items.

Module 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.

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

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

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.

Module level Module type Timeframe Fee
5.2 Residues and trade 8 months $11 149

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.

c. where residues do not occur in foods or animal feeds; or where the residues are identical to or indistinguishable from natural food components; or otherwise are of no toxicological significance and an MRL is not necessary (Table 5 entry in the MRL Standard is appropriate).

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

Module 6: Work health and safety

A work health and safety (WHS) assessment is required where there is a change to human exposure. Changes to human exposure can occur when extending into new 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.

Typically, variations to amend re-entry or handling instructions for agricultural chemical products will require a limited WHS assessment (Module 6.3).

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.

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

Work health and safety—level 3 (Module 6.3) is required where the application involves a change or reassessment of user safety directions and/or re-entry or re-handling statements.

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

Module 7: Environment

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

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

If it is unclear whether the variation to a restraint or precaution affects the previous environmental assessment, Pre-Application Assistance is recommended to help determine if an environmental assessment is required.

A reduced environment assessment (Module 7.2) applies for variations that involve:

(i) a new herd animal or new situation;
(ii) changes to application method; or
(iii) increase in application rate, dose or frequency for an existing use pattern.

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

A limited environment assessment (Module 7.3) applies when the VICH phase I assessment stops between questions 5 and 13 (aquatic branch) or 19 (terrestrial branch).

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

Module 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.

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

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

Module 11: Finalisation

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

11.1: Finalisation—level 1

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

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

11.2: Finalisation—level 2

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

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

Module 12: Limits on use of information

Module 12 relates to the protection, handling and use of information provided to the APVMA. In general, the APVMA must not use information given to it in connection with one application to assess or make a decision on another application, except in specific circumstances. These circumstances include, but are not limited to, where the applicant has given consent for the information to be shared or in an emergency situation; see CCI Practice Statement. This ‘limited use data’ includes information such as reports, studies and scientific arguments that may or may not include confidential commercial information. The applicant can request the module at the time an application is lodged, but the APVMA may also include it once an assessment of the application is undertaken.

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

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, 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.

Efficacy and safety
Detailed data guidelines for efficacy and safety are in Part 8

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

Objective

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

To support the application and demonstrate that the product continues to be safe, the applicant provides pharmaceutical equivalence data to a registered reference product that does not include the statement about rare side effects, along with the updated label.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that upon removal of the statement: Also in rare cases, slight and transient reactions such as depression, change of food intake, salivation, vomiting and diarrhoea might occur initially that the product continues to meet target animal safety (Section 5A) 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.

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

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

No assessment required as the product is currently registered and no change is proposed to the product chemistry.

3: Toxicology

No assessment required as the product is currently registered and relevant health standards are already established.

4: Toxicology—Poison scheduling

No assessment required if appropriate scheduling is already in place.

5: Residues and trade

No assessment required as there are no changes to product residue risks.

6: Work health and safety

No assessment required as the product is currently registered and the rate, method and timing of application is unchanged.

7: Environment

No assessment required as the product is currently registered and the rate, method and timing of application is unchanged.

8: Efficacy and safety

An assessment will be required to ensure the varied advice is consistent with the possible effects.

8.3

3 months

$1 160

9 Non-food trade

 

No assessment required as there are no changes to product risks to non-food trade.

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)

12.0

N/A

$460

Total

 

5 months

$5 612

Scenario 2: Variation to remove 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 general anaesthetic for cats and dogs to remove a side effects statement.

Approved label text

(and original overseas label)

Proposed label text

(and approved overseas label)

Side effects: Adverse events include minimal hypotension and muscle twitching during recovery. Long term use (more than 60 mins) can result in prolonged sedation and vomiting.

Side effects: Adverse events include minimal hypotension and muscle twitching during recovery. Long term use (more than 60 mins) is not associated with any specific side effects.

The purpose of the application is to align the label with an overseas label. The applicant sought Pre Application Assistance (PAA) and received guidance from the APVMA on the necessary information to support the application. This included how to ensure that the overseas assessment and data complies with the APVMA’s submission of international data guidance

Following the PAA advice, to support the application and demonstrate that the product continues to be safe, the applicant provides an overseas assessment report accompanied by raw data and the overseas approved label.

Application type

This application is considered under a technical variation (Item 14) as assessment is required to confirm that product with the modified side effect statement continues to meet target animal safety (Section 5A) 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.

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

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

 

1.0

Up to 1 month

$902

2: Chemistry

 

No assessment required as the product is currently registered and no change is proposed to the product chemistry.

3: Toxicology

 

No assessment required as the product is currently registered and relevant health standards are already established.

4: Toxicology—Poison scheduling

 

No assessment required if appropriate scheduling is already in place.

5: Residues and trade

No assessment required as there are no changes to product residue risks.

6: Work health and safety

No assessment required as the product is currently registered and the rate, method and timing of application is unchanged.

7: Environment

 

No assessment required as the product is currently registered and the rate, method and timing of application is unchanged.

8: Efficacy and safety

An assessment will be required to ensure the varied advice is consistent with the possible effects.

8.2

4 months

$1 950

9: Non-food trade

 

No assessment required as there are no changes to product risks to non-food trade.

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)

 

12.0

N/A

$460

Total

 

6 months

$6 402

Scenario 3: Variation to remove a precaution

Objective

An application is made to amend the approved label of an injectable cattle parasiticide to remove a precaution in relation to use in calves. The product had been registered with the precaution because there was insufficient evidence provided to demonstrate safety in calves.

Current label text

Proposed label text

Precaution: Use with caution in calves less than 50 kg.

[no precaution required]

To support the application and demonstrate that the product continues to be safe, the applicant provides safety studies in calves less than 50 kg, along with the updated label.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that product with removal of the precautionary statement continues to meet target animal safety (Section 5A) 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.

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

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

No assessment required as the product is currently registered and no change is proposed to the product chemistry.

3: Toxicology

No assessment required as the product is currently registered and relevant health standards are already established.

4: Toxicology—Poison scheduling

No assessment required if appropriate scheduling is already in place.

5: Residues and trade

No assessment required as there are no changes to product residue risks.

6: Work health and safety

No assessment required as the product is currently registered and the rate, method and timing of application is unchanged.

7: Environment

No assessment required as the product is currently registered and the rate, method and timing of application is unchanged.

8: Efficacy and safety

An assessment will be required to ensure the use of the product in young calves is safe and effective.

8.2

4 months

$1 950

9: Non-food trade

No assessment required as there are no changes to product risks to non-food trade.

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)

12.0

N/A

$460

Total

 

6 months

$6 402

Start an application

If you want to vary a restraint, contraindication, precaution or side effect statement on your product label and a technical assessment (Item 14) is required:

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