Medsafe Fees Review

Closes 21 May 2021

Opened 8 Apr 2021

Overview

This 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.

Medsafe is responsible for administering the Medicines Act 1981 (the Act) and Medicines Regulations 1984 (the Regulations). Its functions are mainly funded through third party fees set under the Act, with additional Crown funding for enforcement and medical devices activities.

Reviews are conducted to ensure an appropriate balance between cost recovery and Crown funding and ensure those that derive benefit or create risks within the medicines regulatory system pay for those services. There is also a balance between how these fees affect individuals and business and on maintaining/encouraging participation in the regulatory system and wider government policies. Medsafe is committed to a three-year fee review cycle. The last review was in 2017.

Medsafe has a responsibility to be transparent about costs, and how the fees are used to ensure efficiency and effectiveness. This consultation document explains the rationale behind the fees review, the options to achieve the desired outcome of the fees review and indicates how changes in fees will be applied. Any changes to the fees will require amendment of the Regulations.

Consultation document

Making your submission

You can provide feedback by either:

  • completing the online survey. This is our preferred way to receive feedback
    • Note: you can complete your submission over a number of sessions and save it as you go. If you select ‘Save and come back later’, you will be sent an email with a unique link that will let you return to edit and submit your response. This link can be shared with your colleagues if you require their contribution to, or review of, the submission. Once you have completed your submission, you will be sent a pdf copy for your records
  • sending an electronic submission to medsafeapplications@health.govt.nz – please include the following information:
    • the title of this discussion document in the Subject box
    • your name and title, your organisation’s name (if you are submitting on behalf of an organisation) and whether your submission represents the whole organisation or a section of it
    • your contact details (such as phone number, address and/or email)
    • whether you want part or all of your submission withheld under the Official Information Act 1982.

Give us your views

Audiences

  • Pharmaceutical companies

Interests

  • Therapeutic products
  • Medical devices