This content is current only at the time of printing. This document was printed on 6 December 2019. A current copy is located at https://apvma.gov.au/node/20501
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New fast-track registration system
The APVMA has developed a new fast track registration system to quickly process applications of low regulatory concern. The system aims to reduce regulatory burden by:
- accelerating approvals
- reducing the number of detailed assessments
- increasing capacity for applications that require more detailed consideration.
This system is being rolled out as a ‘pilot’ for repack (item 8) applications where the applicant is referencing their own product. Following the pilot study, It is expected that this fast track capability will be expanded over time.
The pilot will be available from 29 July 2016 until 31 December 2016.
After the pilot period, an implementation plan identifying the applications that will be included in the next phases of the system will be developed.
More information on the new fast-track registration system is available here.