Consultations

Published: 25 May 2018

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.

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.