This content is current only at the time of printing. This document was printed on 20 February 2017. A current copy is located at http://apvma.gov.au/node/20276
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The APVMA ran a pilot on fast-track registration for applications that met the following criteria from 29 July to 31 December 2016:
- repack registrations (Item 8)—where the proposed product and reference product are the same in all respects
- the applicant is using their own product as the reference product
- there is no protected data associated with the reference product.
The APVMA is continuing with the fast-track registration process for applications that meet these criteria to enable quick processing of applications of low regulatory concern. The process aims to reduce regulatory burden by:
- accelerating approvals
- reducing the number of detailed assessments
- reducing the resources required for these applications.
The APVMA is also working to identify additional applications that could be included in the next phase, including any IT system, business process or legislative changes that are required to support this approach.
Process for applications
The fast-track process involves streamlining current application requirements and internal processes to reduce the time taken to assess simpler applications.
If all required information is provided (including correct manufacturer declarations and identical labels) the application will be progressed through the new registration process and given a processing time frame of 21 days.
It is important that labels submitted are:
- identical in respect of the use pattern, including:
- host crop or animal species
- application or dose rate
- application method or route of administration
- withholding periods.
Labels must include:
- label claims and use instructions (including precautionary or safety instructions).
If the proposed product label is not identical to the reference product or the declarations are incorrect, fast-tracking an application will not be possible and the current Item 8 time frame (3 months) will apply.
How to apply
If your application meets the above criteria, the decision tree will direct you to the fast-track process.
The fee and application requirements will remain the same for an application submitted through this process as a current repack (item 8) application.
All information must be submitted with a fast-track application. This includes the full application fee, proposed label and relevant declarations from manufacturers and applicants. The 28 day period to supply supporting documentation does not apply to fast-track applications.