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Permits guidelines, data requirements, applications
This page provides an general overview of permit guidelines, data requirments and application processes. Once you determine the type of permit you require, you can follow the detailed guidance and requirements available under applying for a permit.
General Information
National Registration Scheme
Before agvet products can be supplied, sold or used in Australia, they must be registered by the APVMA.
'Control of use' legislation
Each State/Territory maintains its own 'control of use' legislation that determines how registered products are to be used in a manner other than the uses specified on the approved label (i.e. off-label use). The legislation can vary between states, so an off-label use may be an offence in one State (requires a permit) yet legal in another (does not require a permit). Contact State Co-ordinators or the APVMA for confirmation on whether a permit is required.
Role and types of permits
A permit allows a person or an organisation to use agvet products in situations that would, if it were not for the issue of the permit, be an offence either against certain provisions of the federal legislation (Agvet Code) or of appropriate State control of use legislation. Permits can only be issued, in response to an application for:
- a minor use
- an emergency use
- research purposes.
To cover these situations, the APVMA has established the following permit types - OFF-LABEL PERMIT (OLP); EMERGENCY PERMIT (EP); SUPPLY/USE PERMIT (SUP); EXPORT PERMIT (XP), and RESEARCH PERMIT (RP). Refer to Gazette Notice in Latest Permit New for a detailed description.
Categories of applications
Refer to decision tree to assist in determining application category.
Assessing permits
The APVMA can only grant a permit if it is satisifed that the use of a product as specified in the permit:
- 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
- would not be likely to have an effect that is harmful to human beings;and
- would not be likely to have an effect that is harmful to animals, plants or things or to the environmant; and
- would not unduly prejudice trade or commerce between Australia and places outside of Australia; and
- would be effective according to criteria that the APVMA has proposed for the product; and
- that any requirements prescribed by the regulations have been complied with; and
- if the product is not registered, that there are reasonable grounds for an application not having been made or for issuing a permit pending determination of an application for registration; and
- that the applicant is a suitable person to hold the permit, according to criteria determined by the APVMA.
The APVMA generally grants a permit in response to an application. The legislation, however, includes a provision whereby the APVMA may grant a permit under its own initiative, i.e. without an application having been made. These permits are called 'section 114 (or s.114)' permits. The APVMA will only grant a s.114 permit on special occasions
.Existing state-issued permits
Prior to the commencement of the National Registration Scheme (NRS) on the 15th March 1995, each state regulatory authority granted their own permits (or equivalent). At the start of the NRS all state-based permits that were still in effect were automatically transferred to the Comonwealth. These permits continue to operate until they either expire, were cancelled or surrendered.
Guidelines
Lodging an application
All applications must be lodged with the APVMA. Only complete applications will be accepted. To be complete, an application must:
- be in writing or to the effect of the approved form (or in another format agreed to by the APVMA); and
- contain all the information and/or data that the APVMA requires to assess an application; and
- be signed by the approved person; and
- contain the prescribed fee.
Acknowledgement of receipt
The APVMA will only send out an acknowledgement letter upon receipt of an application if the applicant has indicated that they wish to receive one. Acknowledgement does not mean that the application is accepted. An application will only be accepted once it has received an initial assessment (screen) to ensure that it is complete. This process generally takes 3-5 working days.
Suitability of permit holders
Any person or organisation can apply for a permit. Once a permit is granted, the applicant becomes the 'permit holder'. The APVMA. Refer to Gazette Notice in Latest Permit News.
Uses that contradict label directions
Generally, permits to allow off-label and emergency uses can be viewed as additional or an addendum to the use pattern or instructions on an approved label. For a number of the older registered products, their labels no longer accurately represent or instruct the use in a manner that follows recent standards of use that have been adopted throughout a particular commodity industry. Some examples include:
- a reduction to the label WHP;
- products being applied by air when the label states "Do not apply by air" or "Ground application only"; or
- products being applied in aquatic situations when the label states "Do not apply near waterways".
Permits are not meant to correct out-dated or inaccurate labels. A permit that contains a use or instruction that directly contradicts a label instruction is confusing. The APVMA will only consider granting OLPs or EPs for a use that contradicts a label instruction if a 'strong' case can be presented.
Trial protocols
See Category 25, trial protocol (KP25F16)
Amending an application
The APVMA can alter an application with the written consent of the applicant prior to making a determination on the application.
Justifying use of alternative products
Permits are not intended to be used to circumvent the normal process of registering products and approving the uses on their labels. Therefore, permits will not be granted for an off-label use (OLP), for an emergency use (EP) or to allow supply/use of an unregistered product (SUP), if there is a registered product currently available for that purpose. Consideration will only be given to permitting use of an alternative product if there is sufficient justification based on the circumstances listed below. The onus is on the applicant to demonstrate that the currently registered products are unsuitable. The circumstances include:
- loss of effectiveness
- undue phytotoxicity or animal hazard
- unsuitable method of application
- unavailability
- trade or quarantine requirements
- occupational health and safety hazard
- Integrated Pest Management (IPM).
For more details on the information required to adequately demonstrate why the registered products are unsuitable in accordance with the above circumstances, refer to Gazette Notice in Latest Permit News.
Importation of unregistered products
A person must not import an unregistered product or an unapproved active into Australia without receiving consent in writing from the APVMA. When the importation is required to undertake a use covered by a permit then the written consent will be incorporated into the permit process and assessment.
Use of labels with permits
Permits that may allow the supply and/or use of an unregistered product, i.e. SUPs, EPs and RPs, may often incorporate a copy of a product label as part of the complete permit document. Labels that are incorporated into a permit do not have to be 'approved' in teh same manner as labels that are attached toa container for a registered product. However, the APVMA will require such labels to comply with the matters covered in section 14(3)(g)(i-x) of the AgVet Code. Furthermore, the container supplied with the product must comply with the requirements of 18(1) of the Regs.
GMOs
GMOs (or Genetically Manipulated Organisms) are regulated by the new Gene Technology legislation which has come into effect on 21 June 2001. Refer to OGTR website for more details.
Data Requirements
Registration vs permit data
In the case of product registration the necessary data requirements are detailed in the appropriate guidelines series. If it is the case that the data required to support a permit application is the same or similar to registration data requirements, then reference will be made to the appropriate part of the requirements series. The onus is on the applicant to ensure that any required data meets the guidelines as set out in the appropriate part(s).Whilst the majority of data requirements for toxicology, OH&S and environmental safety may be similar irrespective of whether the use is major or minor, there are some situations where permitted uses may require less data than generally required for a major use. For example, an application for an RP with a new, unapproved active where use is only by a few employees of the applicant would generally require less toxicology and OH&S data than a new product being considered for registration where it will be supplied and used throughout a particular industry.
Use of registered products
When a permit covers the use of a registered product there is generally no requirement to submit toxicology, metabolism and chemistry and manufacture data. A registered product has already been assessed to ensure that:
- it contains an active ingredient that has been assessed in regards to human toxicology and has received appropriate poison scheduling; and
- has had its full formulation assessed in regards to stability and toxicology; and
- has had its specific uses assessed in regards to OH&S and safety to the environment; and
- if it is used on food crops or animals, it has had the appropriate MRLs established plus trade considerations assessed; and
- contains an approved label which includes a use pattern plus appropriate first aid and safety directions.
Therefore, use of a registered product under permit will not require the submission of as much data as would generally be required to support the use of an unregistered product. Refer to the following table for a summary of the type of data required:
| Identical to label | Different to label | Data to support an application |
| Hosts & Rates | Pests |
|
| Hosts & Pests | Rate (higher); More frequent applications |
|
| Hosts & Pests | Different method of application (e.g. ground spray to aerial application) |
|
| Hosts, Pests & Rates | States |
|
| Hosts, Pests & Rates | Shorter WHP |
|
| Pests | Hosts (non-food) |
|
| Pests | Hosts (food) |
|
| None | Hosts, Pests & Rates |
|
Chemistry and manufacture
Where a permit involves the use of a registered product, no additional chemistry and manufacture data is required.
Toxicology and metabolism
Where a permit involves the use of a registered product, no further toxicology and metabolism data is required.
Residues and trade
Refer to Residues and Minor Crops Factsheet.
Occupational health and safety
To be developed.
Environmental safety
To be developed.
Efficacy and host safety
To be developed
Data protection
To be developed.
Granting or refusing a permit
Refusing an application
If the APVMA is not satisified that a proposed APVMA will provide written notice to the applicant including the reasons for refusal.
Granting a permit
If the APVMA is satisified that an application meets all requirements, then it will grant a permit. A copy of the permit document will be forwarded to the applicant. Copies will also be made available for appropriate government agencies (federal and state).
Permit documents
The permit document must contain:
- a distinguishing number; and
- the period that the permit is in effect; and
- the persons covered by the permit; and
- the products that can be used and/or supplied; and
- the approved use or other thing allowed to be done; and
- the states where use and/or supply is allowed to occur; and
- any other conditions deemed appropriate by the APVMA.
Duration of permits
Permits can be either granted for a definite period (i.e. start and finish date) or for an indefinite period (i.e. no finish date). Permits remain in force until they expire, are cancelled or are surrendered. Generally, RPs and EPs are granted for the period of the trial or the emergency.
Responsibility of permit holders
Criteria for determining suitability of permit holders
Responsibility of users
Persons who are covered by a permit and wish to undertake the permitted use, must comply with all instructions and any conditions stated in the permit. Users must also be aware that, unless otherwise stated in a permit, the use of any registered product must be in accordance with the instructions on its label. Grant of a permit does not mean that the existing label instructions can be ignored, unless of course they are the specific instructions that are 'over written' or 'replaced' by the permit.
Renewing a permit
A permit holder wishing to renew a permit, must apply in writing to the APVMA. An application to renew a permit does not require the submission of a completed application form. Applicants may submit a covering letter explaining the reasons for the renewal, any findings or additional supporting information and a copy of the expired permit containing any proposed amendments or additions that are to be included in teh new permit. A renewal will only be granted if the proposed use continues to meet all necessary criteria and if all conditions or requests for additional data have been complied with. Additionally, a fee, if required, must also be submitted.
Amending a permit
Once a permit has been granted, a permit holder can request an amendment under the current circumstances:
- the APVMA has granted the permit with an error (typographical or incorrect detail or condition); or
- the applicant has realised that certain submitted details were inaccurate, thereby requiring a change to the permit details or conditions.
The APVMA will only agree to an amendment, with respect to the second point, if the proposed change to the permit does not require a further or additional assessment. If additional assessment is required, then the permit holder will need to surrender the permit and reapply for a new permit or operate within the limitations of the existing permit.
Surrendering a permit
A permit holder may, at any time, advise in writing that the holder surrenders the permit. It comes into effect when the APVMA receives the request.
Cancelling a permit
The APVMA may cancel a permit if:
- it appears that the continued use covered by the permit does not meet all legislative criteria; or
- the permit holder has been convicted of an offence against the Agvet Code or an offence against another law relating to chemical products; or
- the permit holder has contravened a condition of the permit; or
- information about the permit holder comes to the APVMA's knowledge and it is of the opinion, if it would have known that information prior to grant of the permit, it would have refused the application.
If the APVMA cancels a permit, it will give written notice containing the reasons for the cancellation.
Notification of new information
If a permit holder becomes aware of any relevant information in relation to the use of the product under permit, they must inform the APVMA as soon as practicable. This information is relevant if:
- it contradicts any information previously supplied to the APVMA; or
- it shows that use of the product, as permitted, may be a hazard to human health and safety to the environment, may result in excess residues and may jeopardise trade, may be ineffective or adversely harm the target host.