Published: 19 June 2009
Consultations
Outcome of Consultation on Proposed Changes To Fees Payable Under The Medicines Regulations 1984
19 June 2009
In April 2009, Medsafe published a set of proposed changes to the fees payable under the Medicines Regulations 1984 and sought feed back on the proposals by 22 May 2009.
Medsafe received 8 submissions on the proposals (two from industry associations, five from pharmaceutical companies and one from a government agency). A summary of the feedback received, and Medsafe's decisions following consideration of the feedback, is provided below.
Proposal 1: New standard waiver for applications for approval of new innovative medicines using the full application process
Feedback received
Submitters supported the application of a new standard fee waiver to reduce the fee for full applications for approval of new innovative medicines.
Outcome
The new standard waiver brought into effect 8 April 2009 will continue to be applied to these applications.
Proposal 2: New standard waiver for applications for approval of clinical trials
Feedback received
Submitters supported the application of a new standard fee waiver to reduce the fee for applications for approval of clinical trials.
Outcome
The new standard waiver brought into effect 0n 8 April 2009 will continue to be applied to these applications.
Proposal 3: Changes to the way in which fees are applied to applications for approval of new medicines and related products
Feedback received
Submitters supported the proposal to charge a single fee when applications for multiple strengths or flavours of a new medicine or related product are submitted simultaneously. It was suggested this should be extended to include an application for a product presentation with a different medicines classification.
One submitter was concerned about the proposed fees when additional strengths or flavours are applied for separately, believing that the proposed fee could be significantly higher than the current fee in some cases.
Outcome
From 1 July, no additional fee will apply when applications for multiple strengths or flavours of a product, or applications for product presentations with different medicines classifications, are submitted simultaneously.
Proposed changes to the way in which fees are calculated when additional strengths or flavours are applied for separately will not proceed. However, the fees that currently apply in these situations will reduce by 10% from 1 July 2009.
The reduced fees are shown in the attached revised fee schedule.
Proposal 4: Changes to the way in which fees are calculated for changed medicine or related product notifications
Feedback received
Opinion was divided on the proposals for changes to the application of fees for Changed Medicine Notifications. Two industry associations made submissions - one supported the proposal and one did not.
Some companies supported the use of the proposed simplified fee schedule, while others opposed it and provided examples of cases in which they believed a higher fee would result.
Three submitters suggested that the current structure of the fee schedule for Changed Medicine Notifications should be retained and a reduction in fee revenue achieved by applying a 10% across-the-board fee reduction for Changed Medicine Notifications.
Outcome
The proposed changes were intended to achieve a reduction in fee revenue for Changed Medicine Notifications. Given that the proposals could result in increased fees in some cases, the proposed changes will not be implemented at this time. Further consideration will be given to options for decreasing the complexity of the fee schedule in relation to Changed Medicine Notifications at the time of the next fee review (due 2011).
From 1 July 2009, fees for changed medicine notifications will instead be reduced by 10%. There will be no change to the way in which fees are applied. The reduced fees are shown in the revised fee schedule.
