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18

MEDSAFE

NZNO seeks your feedback on MEDSAFE’s consultation on the process for observers at Ministerial Advisory Committees. ie whether 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; and
  • Medicine Review Committee should not change or whether applicants for a review are allowed to present their case to the Committee.

Read here: Ministerial Advisory Committees (opens in new window)

MEDSAFE  is also updating its guidance document: How to change the legal classification for Medicines in NZ  (opens in new window)

Feedback due: to marilynh@nzno.org.nz by 20 December 2017.