Published: 8 November 2017

Consultations

Observers at Ministerial Advisory Committee meetings

Closing date: 15 January 2018

About the consultation

This consultation is aimed at pharmaceutical companies, health professional organisations, Medsafe, the Ministry of Health or individuals who are interested or involved in activities affected by any of the four Ministerial Advisory Committees that receive secretarial support from Medsafe (ie, Medicines Classification Committee, Medicines Assessment Advisory Committee, Medicines Adverse Reactions Committee and Medicines Review Committee).

Proposal

The consultation documents below provide background information on the history and current format of observers at Ministerial Advisory Committee meetings, and propose processes regarding observers at future meetings.

The term observers includes Medsafe or Ministry of Health staff, representatives of pharmaceutical companies, health professional organisations, and other interested parties.

Invitation to comment

Medsafe is seeking comments from interested parties on whether the process for observers at the:

• Medicines Classification Committee should not change, whether observers representing applicants are no longer allowed to attend or whether the observers are widened
• Medicines Assessment Advisory Committee should not change or whether observers representing the sponsor are no longer allowed to attend
• Medicines Adverse Reactions Committee should not change, whether there should be no observers other than from the Ministry or whether sponsors should be allowed to attend for section 36 issues to provide a presentation and answer questions
• Medicine Review Committee should not change or whether applicants for a review are allowed to present their case to the Committee.

Consultation documents

Observers at Ministerial Advisory Committees (PDF 140 KB, 9 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 47 KB, 6 pages)

Medsafe Consultation Submission form (Word document 49 KB, 6 pages)

Electronic submissions are preferred and should be emailed to committees@health.govt.nz with 'Observers at Ministerial Advisory Committees' 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.

Feedback will also be presented to each Committee for consideration and a recommendation will be sought. Implementation of any changes will take place at the meeting following the recommendation by each Committee after agreement from the Minister of Health’s delegate.

Enquiries

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