This content is current only at the time of printing. This document was printed on 23 June 2021. A current copy is located at http://www.plural-consulting.com/node/44
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Applicants can apply to the Australian Pesticides and Veterinary Medicines Authority (APVMA) for a technical assessment before making an application for an approval, registration, license or permit.
A technical assessment is designed to inform the approach to a proposed application by seeking the APVMA’s assessment before it is submitted.
Applications for technical assessment are made through our?Online Services Portal.
Examples of technical assessments include the assessment of:
- data an applicant is considering submitting to the APVMA as part of a proposed application for registration of a chemical product or approval for an active constituent to determine whether the data is sufficient to address the statutory criteria (or a component of the criteria)
- a scientific argument the applicant is considering submitting to the APVMA to support an application in lieu of scientific studies or data
- an overseas data package to determine whether the data is sufficient to address the statutory criteria for a regulatory proposal to be made in Australia.
What are the benefits of getting a technical assessment?
Technical assessment can provide added certainty to a proposed application.
For example, a technical assessment of a data package an applicant is considering submitting to the APVMA as part of a proposed application can be used by the APVMA as part of the determination of a future application related to that proposal.
This means the APVMA does not need to reassess that data when it is later submitted in connection with the registration application and can rely on its earlier assessment of that data.
Note: an applicant would be expected to submit the APVMA’s report and the underpinning data with any subsequent registration application.
Fees and assessment periods
The fees and assessment period for technical assessment are determined by the relevant?assessment modules – use the decision tree in our?Online Services Portal?to work out the relevant fees and assessment periods for your technical assessment application.
Within one month of receiving an application for technical assessment we will notify you:
- of the date on which the assessment of the application will commence
- of the balance of the application fee payable (if any), which must be paid within 28 days of the date of the notice
- of 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
- of the assessment period for the application and the expected date by which the application will be determined
- of the modules to be completed in relation to the application
- that the assessment period will be extended if the APVMA or another prescribed authority makes a request under?section?159 of the Agvet Code
- that you may withdraw your application at any time before an application is determined, by giving the APVMA a signed, written notice.
You may notify the APVMA you wish to treat the application as having been refused, and you may seek review of the refusal in accordance with subsection 165(3) of the Agvet Code, if the APVMA does not determine the application within the assessment period for the application – and any extension to the assessment period.
The assessment period commences on the day:
- the application is submitted online, or
- the applicant complies with the notice requesting the balance of fees or additional copies.
The assessment period can change if the APVMA issues a notice requiring further information under?section 159 of the Agvet Code. In this case, the extended assessment period for an application for technical assessment is one and one third of the modular assessment period, rounded to the nearest whole month, plus one month. This extension can only be applied once, regardless of how many notices are issued under section?159.