This content is current only at the time of printing. This document was printed on 24 June 2021. A current copy is located at http://www.plural-consulting.com/taxonomy/term/17931
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I want to register a product that is the same as a reference product
Registering a new product that is the same as a registered reference product is also known as a ‘repack’.
The new product must be the same formulation with the same ingredients as the reference product, be in the same containers and be manufactured by a manufacturer of the reference product. The use pattern, label claims and use instructions for the new product must be the same as those of the reference product. The legislated definition of 'the same' can be found in the Legislation section of this page.
Additional marketing labels for an existing product can be obtained through an application for approval of an additional label—an Item 10A.
Applications to register a product that is the same as a reference product are processed via a fixed fee, non-technical application (Item 8). Applications for repacks of your own product where no protected data is associated with the reference product will be eligible for fast track.
Note: Once the repack product is registered there is no ongoing relationship between the new product and the reference product.
Which application form do you need?
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.
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:
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 subsection (2), 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.
(2) However, a proposed chemical product and a reference chemical product are taken not to be the same if information about the reference chemical product is protected information.
Note: Information about the reference product will not be considered protected information if the applicant provides written consent from the authorising party to use the protected information. The authorising party can be identified in our product search database.
When a proposed product meets this definition the APVMA can be satisfied that the repacked product is equivalent to the registered reference product, and no technical assessment is required. The APVMA can also be satisfied that the Section 5 statutory criteria have been met in relation to safety, efficacy and trade.
Applications need to meet the application requirements as defined at s 8A of the Agvet Code. The application must contain, or be accompanied by, information specified for this type of application as set out in Part 3 (Division 1) of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014. Information specific to an Item 8 application can be found below in the what you need to provide section.
Timeframe and fees
Item 8 repack applications are a fixed fee application with a statutory timeframe of three months.
|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 five months.
What you need to provide
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).
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.
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
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).
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 the APVMA Product search 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.
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
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.
An application of this nature is considered a repack and would be assessed under Item 8.
Scenario 2: Repack to another holder/registrant
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.
An application of this nature is considered a repack and would be assessed under Item 8.
Start an application
To register a product which is the same as a registered reference product (Item 8):
You will be redirected to online services to log in.