Published:  31 October 2011
Revised:  29 September 2017

Medicines Assessment Advisory Committee

Administrative Process

The Medicines Assessment Advisory Committee (MAAC) process consists of the following six steps:
  1. A New Medicine Application is received by Medsafe or a Changed Medicine Notification is referred to the Minister under section 24(5) of the Medicines Act 1981.
  2. The application is assigned to Medsafe evaluators for assessment of the quality, safety and efficacy data.
  3. Evaluation is undertaken and an evaluation report prepared. The applicant is given two opportunities to address any issues and concerns, and the evaluation is concluded as described in section 2(1) of the Medicines Act 1981.
  4. Based on the evaluation, Medsafe either makes a recommendation to the Minister's delegate to grant consent OR refers the application under section 22(2) of the Medicines Act 1981 to the MAAC for further advice.
  5. The MAAC considers applications referred to it and makes a recommendation to the Minister's delegate on whether or not consent should be granted.
  6. The Minister's delegate makes a decision on whether to grant or refuse to grant consent to distribute the new medicine.

Key features of the MAAC process:

Any correspondence regarding the MAAC should be addressed to the MAAC Secretary at