Published: 21 March 2018

Consultations

Proposed Changes to fees payable under the Medicines Regulations 1984

Closing date: 27 April 2018

About the consultation

The purpose of the consultation is to notify Medsafe's intention to increase the majority of fees for:

  • New Medicines
  • Changed Medicines Notifications
  • Clinical Trials

It is also proposed to increase the hourly fee charged for discretionary GMP audits and the fees charged for issuing:

  • GMP Certificates
  • Medical Devices – Regulatory Statements to Foreign Governments
  • Dietary Supplements - Regulatory Statements to Foreign Governments
  • Dietary Supplements – additional copies issued at the same time

This consultation is aimed at pharmaceutical companies, and health professional organisations.

This is the first proposed increase in fees since 2006. The proposed fees would incorporate increased costs to Medsafe since 2008, with the cost increase being in line with the Consumer Price Index (CPI) movement from 2008 to 2017. Medsafe is seeking your feedback on the proposed increases.

Invitation to comment

Medsafe is seeking comments from interested parties on the updated fees document.

Medsafe is particularly interested in how the proposed changes will affect the operation of organisations and individuals involved in the industry.

Consultation documents

Timetable

  1. Documents released for consultation on 21 March 2018.
  2. Interested parties should respond by close of business on 27 April 2018.
  3. Feedback will be released following consideration of submissions in May 2018.

How to respond

Please complete one of the following Medsafe Consultation Submission forms:

Electronic submissions are preferred and should be emailed to medsafeapplications@health.govt.nz with Medsafe Fees Review in the subject line.

Alternatively, hard copy submissions may be posted to:

Fees Review
Medsafe
PO Box 5013
Wellington 6140

Confidentiality

Please ensure that you provide an email address to which acknowledgement of receipt of your submission and feedback on the analysis of submissions can be sent.

Submissions may be released under the Official Information Act 1982. Any information you do not want made public should be sent separately and clearly marked CONFIDENTIAL.

Once the analysis of submissions has been completed and a recommendation made, the outcome will be notified on the Medsafe website. To subscribe to an automatic email notification of website updates, please register here

Next Steps

Submissions will be reviewed by Medsafe and feedback will be provided on the Medsafe website.

The updated guidance document will also be published on the Medsafe website.

Enquiries

Any questions relating to this consultation should be directed via email to medsafeapplications@health.govt.nz

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