Published: 8 November 2017
Consultations
Updating the guidance document 'How to change the legal classification of a medicine in New Zealand
Closing date: 15 January 2018
About the consultation
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.
At the 55th meeting on 3 May 2016, the Medicines Classification Committee (MCC) recommended that the guidance document should be updated and consulted on.
This consultation is aimed at pharmaceutical companies, health professional organisations, Medsafe, the Ministry of Health or individuals who have an interest in the classification of medicines.
Proposal
The guidance document has been updated and includes, but is not limited to, the following changes:
- a template form 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 has been included.
Invitation to comment
Medsafe is seeking comments from interested parties on the updated guidance document.
Consultation documents
How to change the legal classification of a medicine in New Zealand (PDF 355 KB, 15 pages)
How to change the legal classification of a medicine in New Zealand - Appendix 1 - Application form (PDF 54 KB, 4 pages)
How to change the legal classification of a medicine in New Zealand - Appendix 2 - Pharmacy Council process for medicines reclassification (PDF 80 KB, 2 pages)
Timetable
1. Documents released for consultation on 8 November 2017.
2. Interested parties should respond by close of business on 15 January 2018.
3. Feedback will be released following consideration of submissions in January 2018.
How to respond
Please complete one of the following Medsafe Consultation Submission forms:
Medsafe Consultation Submission form (PDF 45 KB, 6 pages)
Medsafe Consultation Submission form (Word document 48 KB, 6 pages)
Electronic submissions are preferred and should be emailed to committees@health.govt.nz with 'Updating the guidance document - How to change the legal classification of a medicine in New Zealand' in the subject line.
Alternatively, hard copy submissions may be posted to:
Product Regulation
Medsafe
PO Box 5013
Wellington 6140
Confidentiality
All submissions will be published on the Medsafe website unless there is a request for the comments to be kept confidential. The first page of the Medsafe Consultation Submission form will not be published.
Reasons for a claim of confidentiality must be included in the space provided on the first page of the Medsafe Consultation Submission form. These reasons must meet Official Information Act 1982 requirements if the submission (or part thereof) is not to be displayed.
A list of parties making submissions may be published. For submissions made by individuals, your name may be published. If you do not wish to be identified with your submission, or if you do not wish your submission to be associated with a party, you must specifically request this in the space provided on the first page of the Medsafe Consultation Submission form.
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 committees@health.govt.nz
