This content is current only at the time of printing. This document was printed on 12 September 2020. A current copy is located at http://www.xlg888.com/node/1092
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Extend the duration of a permit
All applications to extend the duration of a permit must be made online through the APVMA portal. The APVMA will assess all permit applications in accordance with the APVMA legislation and will complete that assessment within the applicable assessment period.
What to include in your application
Applications must meet the application requirements and statutory criteria in accordance with APVMA legislation and should be:
- made in writing, using the APVMA portal and signed by the applicant
- accompanied by the relevant fee
- accompanied by any information that is specified in a legislative instrument.
When making an application of this type you will need to determine if the previous assessment(s) remains valid. If parts are no longer valid, you will need to provide appropriate information to satisfy us that it meets the statutory criteria.
The APVMA does not research or collate the data needed to support an application. Permit applicants are responsible for providing supporting data and/or information for the proposed use. This information must satisfy the statutory criteria, by addressing areas of human health, environment, crop residues (including trade), efficacy and crop/host safety.
After you apply
An application to extend the duration of a permit made under section 115(3) of the Agvet Code is not subject to a preliminary assessment and cannot be altered. After the application is lodged, we will determine it under this section of the Agvet Code.
Within one month of receiving an application for an extension of the duration of a permit we must give you a notice that includes the following details:
- that the application will be determined under section?115 of the Agvet Code
- the date on which the assessment of the application will commence
- the balance of the application fee payable (if any) which must be paid within 28?days of the date of the notice
- the number of copies (if any) of the application you must give to the APVMA, within 28?days of the date of the notice and in the required format
- the assessment period for the application and the expected date by which the application will be determined
- the?modules (if any) that apply to the application
- your obligations regarding relevant information that contradicts previous information given to us or shows that the constituent or product to which the application relates may not meet the safety criteria, the trade criteria or the efficacy criteria
- advice that if we do not determine the application within the assessment period (and any extension to the assessment period), you may notify us that you wish to treat the application as having been refused, and may seek review of the refusal
- that you may withdraw your application at any time before it is determined, by giving us a signed, written notice
- that if the balance of fees or additional copies are requested, the assessment period will commence on the day the notice is complied with, within the allowable 28-day period, and that the application will be refused if the notice is not complied with within the 28-day period.
We consider the provisions of a permit (including any instructions, conditions, or authorisations) when determining whether use of an active constituent or chemical product under a permit meets the safety criteria, efficacy criteria or trade criteria stipulated in the APVMA legislation.
The APVMA must issue a permit related to an active constituent or an agvet chemical product if we are satisfied that:
- the application meets the application requirements
- the constituent or product the permit relates to meet the safety, trade and efficacy criteria, as well as any matters prescribed in the Agvet Code Regulations
- if an application for approval or registration has not been made, there are reasonable grounds for this.?
The APVMA must issue a permit related to the manufacture of veterinary chemical products if we are satisfied that:
- the application meets the application requirements (this includes meeting the requirements of an APVMA notice within the allocated timeframe or providing an adequate response)
- the exceptional circumstances justify issuing a permit
- there are reasonable grounds to be satisfied that the proposed manufacturing activities can be conducted in compliance with the Manufacturing Principles and the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products, as well as any other statutory criteria or conditions that may apply to the permits.
Note that we will not usually grant an extension to the duration period of a permit related to the manufacture of veterinary chemical products.
The APVMA must refuse a permit if:
- the application does not meet the application requirements (this includes not meeting the requirements of an APVMA notice within the allocated timeframe or providing an inadequate response)
- it does not satisfy the statutory criteria listed above
- the applicant will be unable to comply with the conditions of the permit
- the APVMA or another prescribed authority has required a person to provide information, a report or a sample and that person fails to provide that information, report or sample, or
- the applicant or associated parties are deemed to be not fit and proper to hold a permit.