This content is current only at the time of printing. This document was printed on 24 June 2021. A current copy is located at http://www.plural-consulting.com/node/1147
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What happens next
The APVMA will assess all permit applications in accordance with the APVMA legislation and will complete that assessment within the applicable assessment period.
We will begin preliminary assessment of an application only after it has been lodged. The application is considered to be lodged when you provide the APVMA with the application information on the approved form accompanied by any other information as specified by the legislative instrument. From when you submit the application, you have seven days to submit any other information as specified by the legislative instrument. If, within this period, you do not submit the other information specified by the legislative instrument , you are taken to have lodged the application.
We will notify you that the application has been received within 10 days of it being lodged.
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.?
Any amount payable to us must be paid before we can complete our evaluation.
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.
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.