Published: 1 December 2018
Consultations
Outcome of consultation on updating the guidance document 'How to change the legal classification of a medicine in New Zealand'
About the consultation
This project and consultation was initiated following a recommendation from the Medicines Classification Committee (MCC) at the 55th meeting on 23 May 2016 that the guidance document should be updated and consulted on.
The purpose of the guidance document 'How to change the legal classification of a medicine in New Zealand' is to provide general advice on the process for changing the legal classification of a medicine in New Zealand to help ensure the process is easy to understand and transparent.
Through the consultation process, Medsafe sought comments from interested parties on the updated document, including the following changes:
- a template for reclassification applications
- communal harm has been added to the value-tree framework of benefits and risks
- parameters considered by the MCC when reviewing a medicine for reclassification have been more clearly defined
- complete applications will be published on the Medsafe website unless a request is made under the Official Information Act 1982
- objections will be published on the Medsafe website
- the proposed process from the Pharmacy Council/Pharmaceutical Society of New Zealand has been included.
The consultation ran from 8 November 2017 to 15 January 2018.
Submissions received
Medsafe received eight submissions (PDF 3.6 MB, 29 pages) in response to this consultation.
Note: One submitter has requested that their submission be kept confidential. Personal information that can identify submitters have been removed (where requested).
Medsafe would like to thank everyone who provided a submission for their valuable contribution to this project.
Consultation feedback
Submissions received have been reviewed by Medsafe. Feedback from this consultation have been used to amend the guideline and associated documents.
Submitters were generally supportive of the updated guideline. Several submitters suggested wording, requested clarity and noted minor errors for correction. Where appropriate, these have been incorporated into the final document.
Implementation
The revised guidance document on 'How to change the legal classification of a medicine in New Zealand' (PDF 418 KB, 16 pages) will be effective from 1 December 2018. All submissions received for consideration at the 63rd meeting of the Medicines Classification Committee would be expected to comply with the revised guidance document.
Enquiries
Please send any questions relating to this consultation or guideline to the Secretary of the MCC (email: committees@health.govt.nz).
