This content is current only at the time of printing. This document was printed on 16 December 2021. A current copy is located at http://www.ipagescanada.com/taxonomy/term/18131
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I want to vary a re-entry or handling instruction for my product
Applications to vary a registered product to amend the re-entry or handling instruction 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.
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
- 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.
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:
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, toxicology (including poison scheduling, residues, work health and safety, 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.
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:
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).
For paragraph 6(2)(c) of the Act, the APVMA CEO may determine additional particulars to be placed on a label for a product.
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.
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.
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.
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
The fee for a non-technical variation (Item 12) is a fixed fee of $2018. The timeframe is three 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 a section 159 of Agvet Code notice is sent requesting additional information or clarification of submitted information. The extended assessment period for a non-technical variation (Item 12) is five months.
Pre-application assistance is?available to give applicants advice on the requirements of an application before submission.
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).
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.
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.
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.
Scenario 1: Variation to amend the handling instructions of a product
Application is made to vary a registered sheep dip product to reduce the sheep rehandling interval from six weeks to four. If sheep must be handled during this interval, cotton overalls buttoned to the neck (or equivalent clothing) should be worn. Other similar products in the market containing the same active constituents at the same concentration and formulation type are approved with only a four week re-handling period. There is no relevant protected information associated with the reference product.
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.
|Module type||Reason technical assessment is not required|
The product is currently registered and there are no changes to the product formulation
Risks to human health are equivalent to that previously assessed
4: Toxicology—Poison scheduling
The product is currently registered and relevant scheduling is established
5: Residues and trade
|Risks to residues and trade are equivalent to that previously assessed|
|6: Work health and safety||Risk to human health through exposure is equivalent to that previously assessed for the reference product|
Risk to environment is equivalent to that previously assessed
|8: Efficacy and safety||Efficacy and target animal safety is equivalent to that previously assessed|
9: Non-food trade
|Risk is equivalent to that previously assessed|
|10: Special data||Risk is equivalent to that previously assessed|
|Application type||Timeframe||Extended timeframe||Fee|
|Item 12||3 months||5 months||$2 018|
Start an application
If you want to amend the re-entry or handling instructions, and a non-technical assessment (Item 12) is required:
You will be redirected to online services to log in.