I want to register a product that is the same as a reference product

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.

Definitions

The Agvet Code s 14 sets out the requirements for the registration of a chemical product. A repack has to meet the definition of 'the same' as detailed in s 1.4 of Schedule 6 of the Agvet Code Regulations:

1.4 When chemical products are the same

(1) Subject toclause 1.5, a proposed chemical product and a reference chemical product are the same if they are the same in all respects except their names, their distinguishing numbers, and the name and business address of the applicant.

1.5 When chemical products are not closely similar, similar or the same

(1) Despite clauses 1.2, 1.3 and 1.4, a proposed chemical product and a reference chemical product are not closely similar, similar or the same if:

(a) the APVMA is required to use information in determining an application in respect of the proposed chemical product; and
(b) the use of the information by the APVMA in determining that application is restricted.

(2) The use of information by the APVMA in determining an application is restricted if the APVMA is restricted from using the information in determining the application by:

(a) Division 4A of Part 2 of the Code; or
(b) Part 3 of the Code.

Note: Information about the reference product will not be considered restricted information if the applicant provides written consent from the authorising party to use the restricted information. The authorising party can be identified in our PubCRIS database.

Item 8 repack applications are a fixed fee application with a statutory timeframe of three months, however, the APVMA seeks to evaluate applications eligible for fast track within 21 days.

If an application is submitted as a fast track but found to be ineligible, it will revert to the statutory Item 8 timeframe of three months.

Item 8 applications, including fast track, are subject to an extended assessment period if a notice requiring additional information is issued. In these circumstances, the maximum extended assessment period is five months.

To meet the application requirements you will need to provide:

• a completed online application form
• a nomination of an authorised agent (if applicable)
• the application fee plus any amount that is due to the APVMA
• a manufacturer’s declaration
• an electronic label (e-label).

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.

Nomination of an authorised agent

If you are not a resident of and do not carry on business in Australia, it is a condition of the approval or registration that a nominated agent is provided. The nominated agent must be a resident of or carry on business in Australia.

The application fee

Fast track applications require the total fee of $2632 to be paid at lodgement.

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).

Manufacturer's declaration

Applications must include a declaration by or on behalf of each manufacturer of the new product—who must also be a manufacturer of the reference product, that the products are the same.

The declaration should identify the new product by name and identify the reference product by name and product number. It should be provided on company letterhead and signed by an authorised person.

The declaration must contain words to the effect that:

• the sites of manufacture are the same and the equipment used is the same
• the formulation and ingredients are the same
• the manufacturing processes will be the same
• the formulation will be the same
• the containers will be the same and there will be no additional pack sizes.

A template is provided that includes all required statements.

Note: The manufacturer’s declarations provided must cover all steps of manufacture.

The manufacturer’s declaration/s can be uploaded into the data and information section of the application form.

Electronic label (e-label)

An e-label for the repacked product should be uploaded into the e-label portal within the online application form. The label for the new product and the reference product must be identical in all respects, other than the product name and, where the application is from a new holder, the details of the holder. This allows the APVMA to be satisfied that the label is equivalent to the approved label of the reference product and will meet the 5D Labelling criteria.

Scenario 1: Repack own product

Objective

ABC Agvet Chemicals currently has a registered product named ABC Fleekilla (APVMA product number: xyzjlk) for the control of fleas on dogs and cats:

• the product has no protected data
• ABC Agvet Chemicals wishes to register a repack of this product and market it with a different new name—ABC FleeOff
• the new product ABC FleeOff will have the same label claims, instructions for use, packaging, pack sizes, formulation and manufacturer(s) as ABC Fleekilla.

Application type

This application is eligible to be assessed under Item 8—fast track.

To register a product which is the same as a registered reference product and eligible for fast track (Item 8FT):

Start application

You will be redirected to online services to log in.

The APVMA provides a fast track processing timeframe for ‘repack’ (Item 8) applications which meet additional criteria where:

• you nominate your own product as the reference product
• it does not have any protected data associated with it
• you submit your manufacturer’s declaration(s) at lodgement
• you pay the full fee at lodgement.

If an application is submitted as a fast track but found to be ineligible it will revert to the statutory Item 8 timeframe of three months.