I want to vary my veterinary product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions and no technical assessment is required (Item 12)

1. Legislation

1.1. Framework

The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act contains all of the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of chemicals.

The Agricultural and Veterinary Chemicals Act 1994 contains the constitutional and other legal provisions that enable the Agvet Code to have effect.

The Agricultural and Veterinary Chemicals Code Act 1994, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels); and to issue permits and to license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products; and provisions ensuring compliance with, and for the enforcement of, the code.

The Agricultural and Veterinary Chemicals Code Regulations 1995 prescribe detailed provisions of the Agvet Code.

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the information that must be contained in, or accompany an, application under the Agvet Code.

1.2. Varying relevant particulars and conditions

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

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

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

Other particulars for chemical products prescribed by the regulations are:

(a)  the distinguishing name of the chemical product

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

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

b)

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

Other particulars for labels prescribed by the regulations are:

Regulation 17(1)

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

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

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

Regulation 17(2)

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

Regulation 17(3)

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

Conditions are:

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

1.3. Statutory criteria

In addressing the criteria, the applicant may provide information, or valid scientific argument that might address a specific criterion. The following sections of the Agvet Code provide definitions for meeting the criteria:

• Safety (section 5A).

An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:

a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
b) is not, or would not be, likely to have an effect that is harmful to human beings; and
c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.

To satisfy the s 5A criteria, the APVMA considers chemistry and manufacture, health (including poison scheduling and work health and safety), residues, environment and target safety.

• Efficacy (section 5B)

A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.

• Trade (section 5C)

A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.

• Labelling (section 5D)

In approving a label for a container for chemical products, the APVMA must be satisfied that the label contains adequate instructions. This allows the APVMA to ensure that the risks of using the agvet chemical product are adequately mitigated through appropriate instructions.

The APVMA’s Agricultural Labelling Code and Veterinary Labelling Code also contain further labelling requirements that ensure a standard layout, eligibility and further help in mitigating the risk of using agvet chemical products when used in accordance with the label instructions.

1.4. Application requirements

The Agvet Code, s 8A provides the definition of 'meets the application requirements'.

The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014, Parts 2 and 4, sets out the information that must be contained in, or accompany an, application under the Agvet Code.

1.5. Guidelines

The APVMA has designed guidelines to help inform the APVMA and applicants as to the modules, data and information that will apply for different types of applications. The guidelines are not the law. The APVMA will have regard to it, but from time to time may depart from it when determining the modules, data and information are necessary for a particular application. The APVMA has a number of guidelines that fall under this, for example:

• module descriptors
• data guidelines
• limits on use of information.

1.6. Applications may be withdrawn

The Agvet Code, s 8D states that at any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.

2. Timeframe and fees

The fee for a non-technical variation (Item 12) is a fixed fee of $2,018. The timeframe is 3 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 an Agvet Code s 159 notice is sent requesting additional information or clarification of submitted information. The extended assessment period for a non-technical variation (Item 12) is 5 months.

2.1. Pre-application assistance

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

3. What you need to provide

3.1. Completed online application form

First time applicants will need to complete an online services new user access form to access the APVMA Online Services Portal.

If you are unfamiliar with the application process you may wish to consult the guide to completing an online application.

3.2. The application fee

You may choose to:

• pay the total fee on submission or
• pay the preliminary assessment fee of $902 on submission and the remaining balance once the application has been accepted.

You can choose to pay by credit card, electronic funds transfer or BPAY.

Note: To meet the application requirements you must pay any amount (including an amount in respect of a tax or penalty) that is due and payable by you to the APVMA (including under a law of another jurisdiction or the agvet law).

3.3. 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.

3.4. 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.

3.5. 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.

3.6. Pre-application assistance

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

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).

3.7. Electronic label (e-label)

The APVMA must have regard to certain matters or details in order to satisfy itself that a label meets the labelling criteria and approve the label (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.

4. Examples

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

4.1.1. Objective

An application is made to vary the registered particulars of an injectable antibiotic product and to update the label to reflect the same in-use shelf life as a nominated reference product.  The applicant’s original registration (an Item 8) was supported by nominating a reference product. This reference product was subsequently varied to increase the in-use shelf life. No supporting information has been provided other than nomination of the reference product. Consent has been provided to access limits on use of information relating to the increased in-use shelf life of the reference product.

4.1.2. 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
Chemistry	The product is currently registered and there are no changes to the product formulation. The change to the in-use shelf life is supported by the reference product.
Health	Risks to human health are equivalent to that previously assessed
Poisons scheduling	The product is currently registered and relevant scheduling is established
Residues and trade	Risks to residues and trade are equivalent to that previously assessed
Environment	Risk to environment is equivalent to that previously assessed
Efficacy and safety	Efficacy and target animal safety is equivalent to that previously assessed
Non-food trade	Risk is equivalent to that previously assessed
Special data	Risk is equivalent to that previously assessed

Application type	Timeframe	Extended timeframe	Fee
Item 12	3 months	5 months	$2 018

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

4.2.1. Objective

An application is made to extend the shelf life of the ear gel from two to three years. The original registration (an Item 7) was supported by nomination of a reference product, for which no limits on use of information apply. This reference product was subsequently varied to increase the in-use shelf life.  While the manufacture and expiry dates (printed on each individual label as two years from the manufacture date) are contained on the approved label, no statements relating to the shelf life of the product appears, and the in-use shelf life of the product (three months from opening of the container) is unchanged. Therefore, no variation to the label is required.

4.2.2. 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 does not need to be included in the application as no statements relating to the shelf life of the product appears, and the in-use shelf life of the product is unchanged.

Risk area	Reason technical assessment is not required
Chemistry	The product is currently registered and there are no changes to the product formulation. The change to the shelf life is supported by the reference product.
Health	Risks to human health are equivalent to that previously assessed
Poisons scheduling	The product is currently registered and relevant scheduling is established
Residues and trade	Risks to residues and trade are equivalent to that previously assessed
Environment	Risk to environment is equivalent to that previously assessed
Efficacy and safety	Efficacy and target animal safety is equivalent to that previously assessed
Non-food trade	Risk is equivalent to that of the reference product
Special data	Risk is equivalent to that of the reference product

Application type	Timeframe	Extended timeframe	Fee
Item 12	3 months	5 months	$2 018

5. Start an application

If you want to vary your product to amend the shelf life or expiry date, and a non-technical assessment (Item 12) is required:

Start application

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