I want to vary my product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions

Applications to vary the shelf life details or storage conditions for registered products 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.

Which application form do you need?

All veterinary chemical products are date-controlled. Shelf life must be recorded, and product labels must contain information on the storage conditions and expiry date of the product. Some veterinary chemical products also have an in-use shelf life, which is the shelf life of the product after first broaching the container.

Is a technical assessment required for my proposed variation?

For a variation to be processed without a technical assessment (Item 12), all risk areas must be supported by solely referencing another registered product (reference product). Applicants seeking to rely on a reference product should explain the reasons why the reference product supports the variation. This should include how the risks are equivalent between the two products including:

  • similarity in instructions for use (animals, claims, dose, route of administration)
  • the active constituent and its concentration
  • the formulation type.
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.

Most product shelf life variations are likely to be made as Item 14 applications.

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.

An application for varying a product’s shelf life or storage conditions 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, timeframe and associated fees are likely to apply to this type of application. Modules 1, 11 and 12 are mandatory modules for this application type. Considerations are necessary for this variation for Modules 2–10.

Module type

Module level*

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

?

A limited chemistry assessment is required to ensure the product will continue to meet product specifications during the proposed shelf life

2.3

6 months

$1 954

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

No assessment required as the registered product formulation and use pattern are unchanged

9: Non-food trade

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

10: Special data assessment

No assessment required as the change to shelf life does not alter any previous assessment of risks associated with antibiotic active constituents or products of genetically modified organisms

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12.0

N/A

$460

Examples

Scenario

Modules

Timeframe

Fee

Scenario 1

Variation to the in-use shelf life of a registered veterinary product (e-Label required)

1, 2.3, 11.2, 12

8 months

12 months (extended assessment period)

$6 406

Scenario 2

Variation to the condition of shelf life of a registered product that does not require a change to the label

1, 2.3, 11.2, 12

8 months

12 months (extended assessment period)

$6 406

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.

Module 1: Preliminary assessment

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

Applies to all modular application items.

Module 2: Chemistry

The chemistry module includes assessment of the following aspects:

  • the active constituent
  • the formulated chemical product
  • the manufacturing process
  • quality control
  • specifications
  • batch analysis
  • storage stability
  • analytical methods
  • packaging and labelling.

There are general guidelines for chemistry and manufacture of agricultural and veterinary products available and you should consider any of the specific guidelines which relate to your product type.

2.3: Chemistry—level 3

b. A variation to:

(i) extension of shelf life;
(ii) extension of in use shelf life;?
(iii) changes to storage temperature or conditions; or
(iv) a formulation change.

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

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.

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

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 the whether the chemical product meets the safety and efficacy criteria, but only to the extent that the variation proposed affects whether the product meets the safety and efficacy criteria. Applicants should include an explanation of why they believe supporting information is not required, if they choose not to provide it with the application.

Relevant data for module levels—veterinary chemical products sets out the data that may be relevant to particular assessment modules detailed in the Agvet Regulations. This list is not exhaustive and is only intended to provide you with guidance in putting your application together.

  • Chemistry
    Detailed data guidelines for chemistry and manufacture are available in Part 2.

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.

Note: In many cases a change to shelf life will only result in a change to the Conditions of Registration, not the label itself. An application must include an updated e-label for review if changes to shelf-life result in a change to the current relevant label particulars.

Examples

Scenario 1: Variation to the in-use shelf life of a registered veterinary product (e-label required)

Objective

Application is made to extend the in-use shelf life (ie the shelf life of the product after first broaching the container) of an injectable antibiotic from seven to 28 days.

The applicant has undertaken in-use stability trials demonstrating that the product continues to meet the product specifications for up to 28 days after broaching.

Application type

This application is considered under a technical variation (Item 14) as evidence is needed to demonstrate that the proposed new shelf life for the product does not impact the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria.

An updated label reflecting the change in storage details must be included in the application.

The following table examines each assessment module and provides an explanation of what modular assessments, levels, timeframe and associated fees are likely to apply to this extension. Modules 1, 11 and 12 are mandatory modules for this application. Considerations are necessary for this extension for Modules 2–10.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

A limited chemistry assessment is required to ensure that changes to the product shelf life particulars will not change the safety, efficacy or trade related aspects of the currently considered specifications for the product.

2.3

6 months

$1 954

3: Toxicology

No assessment required as the product is currently registered and relevant health standards are already established and there are no changes to the use pattern.

4: Toxicology—Poison scheduling

No assessment required as 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/administration is unchanged.

7: Environment

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

8: Efficacy and safety

No assessment required as the registered product formulation and use pattern are unchanged.

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 there is no change in risk from the in-use shelf life extension.

11: Finalisation

11.2

2 months

$3 090

12: Limits on use (data protection)

12.0

N/A

$460

Total

?

8 months

$6 406

Scenario 2: Variation to the shelf life of a registered veterinary product (no e-label required)

Objective

An application is made to extend the current shelf life for a canine ear gel from two to three years. The applicant has undertaken stability studies that demonstrate the product continues to meet the product specifications for up to three years.

No label is required with this application as the change only applies to a condition of label approval.

Application type

This application is considered under a technical variation (Item 14) as assessment is needed to demonstrate that the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria during the extended shelf life period.

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.

Module type

Module level

Timeframe

Fee

1: Preliminary assessment

1.0

Up to 1 month

$902

2: Chemistry

?

A limited chemistry assessment is required to demonstrate the product will continue to meet the safety (Section 5A), efficacy (Section 5B) and trade (Section 5C) criteria during the extended shelf life period.

2.3

6 months

$1 954

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

No assessment required as the registered product formulation and application are unchanged.

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

?

8 months

$6 406

Start an application

If you want to vary your product’s shelf life/expiry date, in-use shelf life and/or storage conditions and a technical assessment (Item 14) is required:

You will be redirected to online services to log in.