Due Date: 
Monday, 15 January 2018
Submitting to: 
Medsafe
Issue Area: 
Other

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.

More Informaion here: http://www.medsafe.govt.nz/consultations/Observers/Observers%20at%20Ministerial%20Advisory%20Committee%20meetings.asp

How to write a submission

how-to-write-a-submission.pdf