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Published: 25 May 2018

Consultations

Proposed Changes to Fees Payable under the Medicines Regulations 1982: Outcome of Consultation

Background

On 21 March 2018 Medsafe released for consultation a document outlining a proposal to increase fees under the Medicines Regulations 1984. The closing date for response to the consultation document was 23 April 2018.

Summary of Submissions and Outcomes

The document summarising the submission received, Medsafe's response and the outcome of the consultation can be found on the following link

Review of fees payable under the Medicines Act 1981: Analysis of submissions and outcomes documents(PDF 300KB, 17 pages)

Summary of Outcomes

The proposal to increase the fees under the Medicines Regulations will proceed. As a result of feedback received during the consultation the following changes have been made to the original proposal.

  • Medsafe will align the fee for an abbreviated route higher-risk new medicine application (with no new active ingredients) with that of an abbreviated route intermediate-risk new medicine application. The new fee will be $21,940.
  • Medsafe will delay implementation of the new fees from 1 June 2018 to 1 July 2018.
  • Medsafe will give applicants the option of staggering the payment of the increased fee for new medicine applications (NMA). Under this option the new NMA (including applications for additional dose forms) fees will be applicable from 1 July 2018, however, this can be paid in two parts. From 1 July to 31 December 2018 it will be possible to select to pay the existing fee when the application is submitted, with the remaining balance being invoiced by Medsafe in January 2019. This option will be available until 31 December 2018.

Implementation:

The revised fees apply to applications received from 1 July 2018 onwards. The current fee schedule applies to all applications received up to and including 30 June 2018.

The application form that accompanies new medicine applications will be amended to allow the option of indicating whether sponsors would like to stagger the new fee and be published on the Medsafe website prior to 1 July 2018.

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