This content is current only at the time of printing. This document was printed on 8 September 2020. A current copy is located at http://www.gitygostar.com/node/14411
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Permits 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 permits and the process for applying for a permit through the Australian Pesticides and Veterinary Medicines Authority (APVMA).
The module will take you approximately 10 minutes to complete and covers the following topics:
- What is a permit?
- What types of permits are there?
- What are the fees for applying?
- What criteria must be met?
- How do I apply for a permit?
- Can I withdraw my application?
- What is the permit application process?
- Confidentiality of your information
- Roles and responsibilities
- Questions or further assistance
What is a permit?
A permit allows for the legal possession, supply or use of AgVet registered chemicals in certain ways that are contrary to the label instructions or, in certain circumstances allows for the limited use of an unregistered chemical product that may be otherwise illegal.
Without a permit, you may be committing possession and supply offences under the Agricultural and Veterinary Chemical Code Act 1994 and/or offences under state or territory control-of-use legislation.
Are permits subject to conditions?
Permits may be unconditional or subject to conditions that we consider appropriate.
We may impose conditions on a permit as an assurance that all statutory criteria are met.
In issuing a permit, we must also be satisfied that you, as the applicant and subsequent holder of a permit, are able to comply with any conditions of the permit.
Permits may be suspended or cancelled if we believe the statutory criteria, or the conditions have not been met.
Permit conditions may be imposed as part of our decision to issue a permit.
Conditions can relate to:
- supply and possession
- record keeping
- monitoring and reporting
- the scale of treatment (such as the area to be treated)
- the fate of treated produce
- advertising and packaging.
More information can be found in our guidelines on the APVMA website.
How is a permit different to registration?
Registration is the mechanism for someone seeking to supply a product into the Australian market.
Permits allow for chemical products to be used in ways that would otherwise be a breach of the legislation. For example, situations often arise where chemicals are needed for a use not specified on the label, these are often termed ‘off-label’ uses.
Permits are subject to the same statutory criteria as those for product registration for safety, efficacy and trade.
Note: Permit applications should not be made in circumstances where registration is more appropriate.
To learn more about registration, explore the registration eLearning module.
What types of permits are there?
Under the Agricultural and Veterinary Chemicals Code, we can consider issuing and extending permits for several purposes:
Minor use permit
May be issued where no or limited registered products exist and where the use would not produce sufficient economic return to an applicant to justify application to register.
Emergency use permit
May be issued to support primary producers during emergencies or impending emergencies. For example, during unforeseen outbreaks of pests and diseases, by allowing the use of a chemical product or an active constituent if there is a genuine belief that the use is required because of the emergency.
May be issued to allow the conduct of research and development activities associated with novel active ingredients and products, and their uses.
This might include the generation of data to support future regulatory submissions seeking registration.
An export permit may be issued to allow the possession and supply of an unregistered product or unapproved active constituent for export from Australia. For registered products and approved actives, an export permit is not required.
Veterinary manufacturing permit
May be issued to authorise the carrying out of a step (or steps) of manufacture of veterinary product/s, that would otherwise be an offence or a contravention of a civil penalty provision set out in the Agvet Code, in relation to manufacture and licensing.
This type of permit may only be issued for exceptional circumstances, where compliance with the APVMA’s Manufacturing Principles can be demonstrated, and is restricted to a maximum period of 90 days.
May be issued for a circumstance not covered by the other permits. For example, a permit to:
- supply specific batches of a registered product that do not comply with the conditions of registration
- supply a registered product with an unapproved label
- extend the shelf life of a batch.
What are the fees for applying?
The fee for a permit application varies and is dependent on the type of permit and the areas of risk that are assessed.
The periods for completion and fees table?on our website provides current information on the fees for applying for a permit.
If a fee is applicable, you will be asked to pay this at the time you lodge your application.
What criteria must be met?
We must issue a permit if we are satisfied of the following:
The application requirements are defined by Section 8A of the Agricultural and Veterinary Chemicals Code.
For more information, refer to the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014.
- A permit meets the safety criteria if the proposed use, supply or possession of the chemical product:
- 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.
A permit meets the efficacy criteria is the proposed use of the chemical product, in accordance with any instructions approved, is or would be effective according to criteria determined by the APVMA.
A permit meets the trade criteria if the proposed use of the chemical product, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.
Under section 112(2) of the Agricultural and Veterinary Chemicals Code Act 1994 the APVMA must also be satisfied that there are reasonable grounds to issue a permit in lieu of a registration application.
For further information see statutory criteria on our website.
Fit and proper person test
Under the Agricultural and Veterinary Chemicals Code Act 1994 we must refuse a permit application if the applicant, or persons with a specified relationship with the applicant, have been convicted or been ordered to pay a pecuniary penalty relating to chemical products or a law involving fraud or dishonesty within the last ten years.
In addition, we must refuse an application if the applicant, or a person with a specified relationship with the applicant, has held a permit that was cancelled where the permit holder failed to comply with permit conditions or provided false or misleading information.
How do I apply for a permit?
An application for a permit 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 permit application 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.
The APVMA portal includes an application aid that guides you through the application process.
What are the assessment time frames?
The assessment periods for the different types of permits can be found in table 1 on our website under assessment periods and fees.
The assessment period will change if we require further information from you during evaluation, or we are required to change our approach to assessing your application.
Can I withdraw my application?
You can choose not to continue with your permit application at any stage in the process, by advising us in writing:email@example.com.
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.
What is the permit application process?
There are three steps in the permit application process, after an application is lodged: preliminary assessment, evaluation and determination.
Preliminary assessment is the first step in considering your application.
Preliminary assessment only examines an application to determine whether it appears to meet the application requirements.
Only applications that appear to meet the application requirements can proceed to evaluation.
Opportunity to correct defects
The preliminary assessment for permit applications is different to that for other applications, as it allows for a single opportunity to correct defects.
Defects are a failure to provide information in your application, including:
- information specified in the application requirements
- declarations including the fit and proper person
- information relating to the chemical product or active ingredient, including relevant details of the product formulation or manufacture
- information on the details of the use that is being applied for (such as rate, dose, timing or method of application)
- information demonstrating how your application meets the safety, efficacy or trade criteria.
If it appears the defects in the application can reasonably be rectified, then we must:
- advise you that the application has defects
- provide you with details of those defects
- allow one month for you to rectify the defects.
You cannot seek an extension to the one month time frame.
Notifying you of the outcome
You will be notified of the outcome of the preliminary assessment, within four to six weeks of your application being lodged.
If the application fails preliminary assessment and is refused, you will receive a notice that will include the reasons for the refusal.
Applications refused at preliminary assessment are not open to review.
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 time frame.
If your application appears to meet the application requirements, it will proceed to evaluation.
During evaluation, we assess your application against the statutory criteria, ensuring that the proposed use, possession or supply meets the safety, efficacy and trade criteria; we will determine if the applicant meets the fit and proper person test and if there are reasonable grounds to issue a permit in lieu of a registration application.
We also consider if other suitable registered products are already available.
Request 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. We will not seek information that would require you to undertake substantial work.
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 only request an extension to respond to a notice under extraordinary events or circumstance beyond your control.
When we have evaluated your application against the statutory criteria, we will provide you with a decision.
If successful, you will receive notification that the permit has been issued. This notification will also include additional requirements for any future renewals or extensions to the permit.
How long is a permit issued for?
Permits are issued for limited durations.
The duration of a permit varies, according to the type of permit issued and the specific circumstances surrounding the need for a permit.
Who else will know about my permit?
When a permit is issued we advise relevant state or territory coordinators.
The details of minor and emergency use permits and some miscellaneous permits are also available through the publicly available database.
Research and export permits are generally not publicly available.
Information in the PubCRIS and Permits databases are now available in a handy free mobile app for iPhone.
What if the APVMA propose to refuse my application?
If we propose to refuse your 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.
You can only request an extension to respond to a notice under extraordinary events or circumstance beyond your control.
You can seek a review of our decisions.
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 permits can be reviewed, including the decision to:
- issue a permit altered from your original application
- refuse to issue a permit based on our evaluation
- impose permit conditions.
If a decision can be reviewed, you will be notified in writing and provided with information about how to request a review.
In reviewing a decision, we are only required to consider information that is related to information already provided to us, or information on which our reasons are based.
Confidentiality of your information
Occasionally the APVMA will seek advice from external agencies and reviewers to help assess your permit application
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.
Note: Limits on use of information does not apply to permits.
Generally speaking ‘Official Information’ is any information supplied in connection with an application, including an application for a permit. 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 restricted 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 and responsibilities
Explore the following roles and responsibilities in relation to applications for permits:
As an applicant, you will:
- lodge you application for a permit electronically, using the APVMA portal
- pay all fees in relation to your application
- meet the requirements of the fit and proper person test
- respond to notices issued by the APVMA in the timeframe required
- notify the APVMA of any new relevant information in respect of a pending application
- provide accurate information that is not false or misleading.
As a permit holder, you must:
- comply with all permit conditions
- continue to meet the requirements of the fit and proper person test
- provide information that is not false or misleading to the APVMA, when requested
- notify the APVMA of any new relevant information?about the safety of the specified product a permit is held for.
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, including actions that you can take
- advise you of any additional fees or if further information is required.
- The APVMA provides permits to allow for the possession, supply and/or use of specified products that may otherwise be illegal.
- The fee for a permit application varies and is dependent on the type of permit. If the initial payment does not cover the full application fee, you will be provided with a notice requesting the outstanding amount
- There are three steps in the application assessment process: preliminary assessment, evaluation and determination.
- You must submit an application for a permit electronically through the APVMA Portal.
- An application for a permit can be refused if the applicant does not meet the fit and proper person test and /or if it assessed as not meeting the application requirements or any of the statutory criteria during evaluation.
- An application for a permit can also be refused if you do not respond to a notice within the period specified.
Questions or further assistance
If you have a general question or if you have an enquiry about an application you have already lodged, please send an enquiry to our Case Management Team: firstname.lastname@example.org.
You can also find additional support material on our website: www.www.gitygostar.com.
If you require assistance in preparing or prior to making an application you may like to consider seeking formal pre-application assistance from us.
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.