Table of contents
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 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.
2. 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 to clause 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.
3. Timeframe and fees
Item 8 repack applications are a fixed fee application with a statutory timeframe of 3 months.
| Application type | Timeframe | Fee |
|---|---|---|
| Item 8 | 3 months | $2 632* |
*Includes $902 preliminary assessment fee.
Item 8 applications are subject to an extended assessment period if a notice requiring additional information is issued. In these circumstances, the maximum extended assessment period is 5 months.
4. What you need to provide
4.1. 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.
4.2. The application fee
You may choose to pay either the:
- total fee on submission
- 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).
4.3. 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.
4.4. 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
- formulation and ingredients are the same
- manufacturing processes will be the same
- formulation will be the same
- 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.
4.5. 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.
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
- written consent for use of information from the relevant authorising party (if applicable)
- a manufacturer’s declaration
- an electronic label (e-label).
4.6. Consent for use from the relevant authorising party (if applicable)
A proposed product cannot be determined to be the same as a reference product if the reference product has protected information unless the applicant provides written consent for use of the protected information from the relevant authorising party or parties.
Protected information details are listed in our PubCRIS database for the reference product under the protected data tab.
The consent document should identify the application it applies to and the relevant reference product. It should be signed by an authorised person.
Consent, once given, cannot be withdrawn.
If the applicant is the authorising party for all protected information associated with a reference product, consent is considered to be given.
5. Examples
5.1. Scenario 1: Repack own product
5.1.1. Objective
XYZ Agvet Chemicals currently has a registered product named XYZ Fleekilla (APVMA product number: xyzjlk) for the control of fleas on dogs and cats:
- The product has protected data.
- XYZ Agvet Chemicals wishes to register a repack of this product and market it with a different new name: XYZ FleesGo.
- The new product XYZ FleesGo will have the same label claims, instructions for use, packaging, pack sizes, formulation, and manufacturer(s) as XYZ Fleekilla.
5.1.2. Application type
An application of this nature is considered a repack and would be assessed under Item 8.
5.2. Scenario 2: Repack to another holder/registrant
5.2.1. Objective
XYZ Agvet Chemicals currently has a registered product named XYZ Fleekilla (APVMA product number: xyzjlk), for the control of fleas on dogs and cats. Another business, ABC ChemAg, would like to repack XYZ Fleekilla and market it under a different name – FleesAway:
- The new product, FleesAway, will have the same label claims, instructions for use, packaging, pack sizes, formulation, and manufacturer(s) as XYZ Fleekilla.
5.2.2. Application type
An application of this nature is considered a repack and would be assessed under Item 8.
6. Start an application
To register a product which is the same as a registered reference product (Item 8):
You will be redirected to our Online Services Portal to log in.