The consultation document provides proposals on changes to Medsafe fees by way of improved and targeted cost recovery of evaluation and licensing effort and other efficiency changes and asks for stakeholder feedback on these proposals.
Refer to the consultation website page for details:
Three options are proposed for the fees review:
- Status quo: this option means that no changes to fees are implemented.
- Flat fee increase only: this option would apply the full required increase across all fees charged.The flat fee increase is calculated as 19%.
- Proposed cost recovery fees and the CPI increase: this is a mixture of cost recovery and the CPI increase, with the CPI increase affecting all applications but the cost recovery increases only affecting those set out in the proposals.The CPI increase on fees is calculated at 4.2% over a three-year period and is applied to all fees, except clinical trial fees. Cost recovery adjustments are made to a select group fees where cost recovery has not been reviewed for some time.