Revised: 7 September 2023
Revised: 20 May 2026
Medicines
Target Evaluation Times for NMAs and CMNs
Medsafe timeframes are working days. Working days exclude weekends and New Zealand national public holidays.
| INE Medsafe | RFI response requested by applicant | EAI Medsafe | |
|---|---|---|---|
| NMAs (full) | 150 days | 150 days | 75 days |
| NMAs (abbreviated) | 75 days | 38 days | 38 days |
| Low risk L1 | 35 days | 35 days | 21 days |
| Low risk L2 | 75 days | 75 days | 42 days |
| Low risk L3 | 110 days | 110 days | 63 days |
| CMNs | 32 days | 16 days | 32 days |
| CMN 24(5)(a) | 150 days | 150 days | 75 days |
CMNs are referred to the Minister under section 24(5)(b) of the Medicines Act 1981 if they are not resolved within 64 working days of receipt of payment. There is no limit to the number of RFIs issued for CMNs during the 64 working-day period, providing all issues are resolved within 64 working-days of receipt of payment.
Abbreviations
NMA - New Medicine Application
INE - Initial Evaluation
RFI - Request for Information
EAI - Evaluation of additional information
CMN - Changed Medicine Notification
CMN 24(5)(a) - CMN applications referred under section 24(5) of the Medicines Act 1981, due to the size and/or complexity of the change
Medsafe performance against target timeframes can be found here https://www.medsafe.govt.nz/regulatory/Performance.asp
