This content is current only at the time of printing. This document was printed on 27 August 2020. A current copy is located at http://www.gitygostar.com/node/13081
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Registrations eLearning module (text only)
Online learning module
This eLearning module is presented by the APVMA for the purpose of disseminating information free of charge for the benefit of the public and stakeholders.
The APVMA does not guarantee, and accepts no legal liability whatsoever arising from or connected to, the use of or reliance upon any material contained within this eLearning module or on any website that the eLearning module links to.
The APVMA has assessed the quality of the information available in this eLearning module and is satisfied that it is correct as at the time of writing. However, changes in the circumstances after time of publication may impact on the accuracy of this information. For this reason, the APVMA gives no assurance as to the accuracy of any information or advice contained within it.
The APVMA recommends that users exercise their own skill and care with respect to their use of and reliance on this material and that they carefully evaluate the accuracy, currency, completeness and relevance of the information contained within the eLearning module for their purposes.
The material in this eLearning module is not a substitute for independent professional advice and users should obtain any appropriate professional advice relevant to their particular circumstances.
Welcome. This module is designed to provide you with an overview of registrations and the process for registering a chemical product through the Australian Pesticides and Veterinary Medicines Authority (APVMA).
The module will take you approximately 10-20 minutes to complete and covers the following topics:
- Why chemical products need to be registered?
- Who can apply to register a product?
- What are the fees and timeframe for registration?
- What are the registration criteria?
- How do I register a product?
- Can I withdraw my application?
- What is the registration application process?
- Roles and responsibilities
- Questions and further assistance
What is registration?
Australian law generally requires that all agricultural and veterinary chemical products sold in Australia are registered by the APVMA.
Once a product is registered, it is approved for the purposes and uses stated on the product’s label.
How is registration different from a permit?
Permits allow for chemical products to be used in ways that would otherwise be a breach of the Agvet Code. For example, situations often arise where chemicals are needed for a use not specified on the label, these are often termed ‘off-label’ uses.
The APVMA considers applications for permits that allow for the legal use of chemicals in ways different from those set out on the product label. In certain circumstances, the limited use of an unregistered chemical may also be allowed by Permit.
Are registrations subject to conditions?
Registration of chemical products are subject to conditions that are prescribed by Agvet legislation. The APVMA can also impose further conditions to meet the particular circumstances and the objects of the Agvet Code.
More information can be found in our guidelines on conditions set by the APVMA.
How do I know if my product requires registration?
It is important that you have a good understanding of the rules that determine whether or not your product needs to be registered.
To help you work out whether your product needs to be registered, we have developed some resources to guide you through the regulatory requirements:
- does my veterinary product need to be registered?
- does my agricultural product need to be registered?
To find out if a biological or natural product requires registration, contact us at email@example.com.
Who can register a product?
Any individual or body corporate can make an application to register an agricultural or veterinary chemical product.
What are the fees and timeframe for registration?
The application fee and timeframe required to determine an application varies depending on the complexity of the application.
The periods for completion and fees table on our website provides current information on the fees for registration. This fee is payable at the time you lodge your application to register.
Requests for further fees
Requests for additional fees can occur where the initial application fee does not cover the activities required to assess the product you propose to register or the active ingredient you propose to approve.
Failure to pay requested fees in the time we specify may result in your application being refused. We will notify you if you are required to pay any additional fees during your application.
What are the assessment time frames?
The assessment period for registration is calculated with reference to table 1 found on our website under assessment periods and fees.
The assessment period will change if we require further information from you or we are required to change our approach to assessing your application.
The APVMA must complete preliminary assessment of your application within one month after it is lodged. If the APVMA finds that your application appears to meet the application requirements, we must give you notice of this within 14 days.
Can fees and timeframe vary during evaluation?
Fees and timeframe may vary during an evaluation, when further assessment is required to allow us to continue to assess your application.
What are the registration criteria?
We must register a chemical product if we are satisfied that it meets the following:
The application requirements are defined by Section 8A of the Agricultural and Veterinary Chemicals Code.
Refer to the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014.
A chemical product meets the safety criteria if use of the product, in accordance with any instructions approved or to be approved by the APVMA or contained in an established standard:
- is not, or would not be, an undue hazard to the safety of people exposed to the product during its handling or people using anything containing its residues
- is not, or would not be, likely to have an effect that is harmful to human beings
- is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.
For further information see safety criteria on our website.
A chemical product meets the efficacy criteria if use of the product, in accordance with any instructions approved or to be approved by the APVMA, is or would be effective according to criteria determined by the APVMA by legislative instrument or contained in an established standard.
For further information see efficacy criteria on our website.
A chemical product meets the trade criteria if use of the product, in accordance with any 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.
For further information, refer to trade criteria on our website.
A chemical product meets the labelling criteria if the label contains adequate instructions relating to the following (as appropriate):
- the circumstances in which the product should be used
- how the product should be used
- the times when the product should be used
- the frequency of the use of the product
- the withholding period after the use of the product
- the re-entry period after the use of the product
- the disposal of the product when it is no longer required
- the disposal of containers of the product
- the safe handling of the product and first aid in the event of an accident caused by the handling of the product
- any matters prescribed by the Agvet Code Regulations.
For further information, refer to labelling criteria on our website.
How do I register a product?
An application for registration of an agricultural or veterinary chemical product can only be made through the APVMA portal.
The portal provides a secure online environment and allows you to monitor the status of your request and application.
What information do I need to provide?
You should provide enough information to satisfy the APVMA that your chemical product meets the statutory criteria. The guidelines on our website, provides some additional information that may help guide you as what to include in your application.
You are responsible for providing all supporting data and information for the registration and must supply enough information to establish that the product meets the criteria. You will not be able to provide any new information unless we specifically request you to.
The APVMA portal includes an online training module and a decision tree that guides you through the application process.
Can I withdraw my application?
You can choose not to continue with your application at any stage in the process, by advising us in writing to firstname.lastname@example.org. After receiving a request to withdraw an application, we will provide you with confirmation of the withdrawal.
Do I get my money back?
Any unused portion of the cost may be refunded. The amount of fee refunded will depend on how soon a withdrawal request is received. For applications withdrawn during evaluation the costs associated with preliminary assessment cannot be refunded, as this step will have been completed.
What is the registration process?
There are three steps in the registration process, after an application is lodged:
Preliminary assessment is the first step in considering your application. Preliminary assessment only examines an application to determine if it appears to meet the application requirements. Applications that do not meet the application requirements will be refused and changes to rectify errors cannot be made.
Notifying you of the outcome
The APVMA must complete the preliminary assessment of your application within one month of your lodging it. If it appears from the preliminary assessment that your application meets the application requirements, we must notify you of this within 14 days. If your application does not appear to meet the application requirements it will be refused. You will receive a notice that will include the reasons for the refusal.
Applications refused at preliminary assessment are not open to review.
See 'how we make decisions' for further information.
After passing preliminary assessment, your application moves to the technical evaluation phase.
During evaluation, we assess your application against the statutory criteria, ensuring that the product meets the safety, trade, efficacy, and labelling criteria. We will also confirm that the application product meets the application requirements.
Requests for additional information
In order to assess your application, we may send you a notice stating we require additional information from you.
This will be information that is already known or in existence that was not submitted with your application. We will not seek information that would require you to undertake substantial work to generate information to comply with the notice.
Failure to provide this additional information within the timeframe provided may result in your application being refused.
Requirements for additional information will also result in an extended assessment period. You can request an extension to respond to a notice under extraordinary events or circumstances beyond your control.
Changes to your application
Once lodged, you cannot change your application without our agreement.
In some instances changes to your application may be needed. This allows us to continue to assess the application, where it would be more efficient for us to do so, rather than refuse the application.
We will notify you if your application needs to be changed and if this affects the fee or timeframe.
What if the APVMA proposes to refuse my application?
If we propose to refuse your application, or propose to register a product with particulars or conditions that are different to those proposed in your original application, you will receive a notice that:
- outlines our proposed decision, including the reasons for our decision
- invites you to make a written submission, within 28 days, in response to our proposal.
After considering your response we will either register your product or issue a notice of refusal.
Review of decisions
If you are dissatisfied with a decision made by the APVMA under the Agvet Code or Regulations, you may be able to:
- request that we reconsider the decision (that is, seek internal review) within 42 days from the date the decision was made, or
- apply to the Administrative Appeals Tribunal (AAT) for review of the decision.
Some of the decisions we make in regard to registrations can be reviewed, including the decision to:
- register a product with particulars or instructions different to those provided in your original application
- refuse to register a product.
If a decision can be reviewed, you will be notified in writing. For more detail refer to reviewing decisions.
When we have evaluated your application against the statutory criteria, we will provide you with a decision. If successful, you will receive notification that your product has been registered.
How long is a product registered for?
Products remain registered as long as:
- the registration holder continues to pay the renewal of registration fee
- the registration holder continues to pay the annual registration levy
- the product, or its active ingredient, continues to meet the statutory criteria.
We review registered products against the statutory criteria to ensure the product is safe, will work when used according to the label and will not negatively affect trade.
Who else will know my product is registered?
Certain details of all new registrations of chemical products are published in the APVMA gazette. Furthermore, these details of your registration will be listed in the publicly available PubCRIS database.
The database includes the product name, registering company, active constituents and product category (for example: insecticide, fungicide or herbicide).
Information in the PubCRIS and Permits databases are now available in a handy free mobile app for iPhone.
Confidentiality of your information
Occasionally the APVMA will seek advice from external agencies and reviewers to help assess your application for registration.
If you provided confidential commercial information with your application, this information may be disclosed to these parties to allow them to provide advice to the APVMA. The Agricultural and Veterinary Code sets out safeguards that apply to the disclosure of this information.
Generally, ‘official Information’ is any information supplied in connection with an application, including an application for registration of a product. Official information is subject to strict limitations on how it can be used.
In some cases this information is not subject to limitations, for example when it is already available to the public.
Some applications require access to the information of a third party. If your application is one of these, you must provide the APVMA with the consent of the third party to access the information. If you cannot provide this, your application will be refused.
Roles an responsibilities
Explore the following roles and responsibilities in relation to applications for registration:
The person or body corporate who submits an application for registration is the applicant.
As an applicant, you (or a nominated agent or authorised agent) will:
- lodge your application for registration electronically, using the APVMA portal with the required information
- pay all fees in relation to your application
- respond to notices issued by the APVMA in the timeframe required
- notify the APVMA of any new information in respect of a pending application
- provide accurate information that is not false or misleading.
Once a product is registered, the applicant becomes ‘the holder’ of the registration. As a registration holder, you must:
- apply to us to make changes to the registered particulars of your product
- pay the renewal of registration fee
- pay the annual registration levy for your product
- notify the APVMA of any new relevant information about the safety of the registered product or approved active ingredient
- provide information that is not false or misleading to the APVMA, when requested.
The APVMA case managers
The case managers are a dedicated team responsible for your application. As an applicant or holder, you will have a designated case manager who will:
- ensure applications move smoothly through the assessment process
- communicate effectively with you
- advise you of the outcome of your preliminary assessment
- advise you of any additional fees or if further information is required
- advise you of the outcome of your application
- answer any queries you have about your application.
Once a product is registered, the holder of that registration may appoint a person to be the nominated agent for the approval or registration.
A nominated agent has the same rights and obligations as the holder, and is treated in the same way. They may do anything a holder may do under the Agvet Code. The APVMA may do anything in relation to the nominated agent that it would do in relation to the holder, including impose penalties and criminal sanctions, if appropriate.
Nominated agents must reside and carry on business in Australia. Holders who do not reside in Australia or carry on business in Australia are required to appoint a nominated agent.
A nominated agent may withdraw from being the nominated agent at any time by giving a signed written request to the APVMA to this effect.
This is a business arrangement between the applicant/holder and a third party who is to act on their behalf (the authorised agent).
The APVMA plays no role except to deal with the authorised agent if directed to do so by the applicant.
The APVMA assesses registration applications for agricultural and veterinary chemical products to ensure products are safe, will work when used according to the label and will not negatively affect trade.
The fee for registration varies depending on the complexity of the application.
You must submit a registration application electronically through the APVMA Portal.
There are three steps in the application assessment process: preliminary assessment, evaluation and determination.
For your application to be successful, you must meet the statutory criteria (including the application requirements), respond to notices and pay all required fees within the period specified.
Questions or further assistance
If you require assistance in preparing or prior to making an application you may like to consider seeking formal pre-application assistance from us.
You can also find additional support material on our website: www.www.gitygostar.com.
Pre-application assistance is provided to potential applicants to ensure that their application is complete and contains the information necessary to allow us to make an assessment.
Requests for pre-application assistance need to be made electronically through the APVMA portal. Fees apply, some of which may be rebated when you lodge your application. It is not mandatory to request pre-application assistance before making an application.