Revised: 7 September 2023

Medicines

Target Evaluation Times for NMAs and CMNs

Note, Medsafe timeframes are calendar days, not working days.

Intermediate and Higher Risk Medicines

	INE Medsafe	RFI response requested by applicant	EAI Medsafe
NMAs (full)	200 days	200 days1	120 days2
NMAs (abbreviated)	100 days	200 days1	120 days2

1. For NMAs that have been granted priority assessment the applicant’s response must be received by Medsafe within 28 days to retain priority status.
2. For NMAs that have been granted priority assessment or submitted via the abbreviated evaluation route, and the response is received within 28 days, Medsafe target EAI evaluation time is 28 days.

Lower Risk Medicines

	INE Medsafe	RFI response requested by applicant	EAI Medsafe
L1	50 days	50 days	30 days
L2	100 days	100 days	60 days
L3	150 days	150 days	90 days

Changed Medicine Notifications

	INE Medsafe	RFI response requested by applicant	EAI Medsafe
CMNs3	45 days	21 days	45 days4
CMN 24(5)(a)	200 days	200 days	120 days

3. CMNs are referred to the Minister under section 24(5)(b) of the Medicines Act 1981 if they are not resolved within 90 days of receipt of payment.
4. There is no limit to the number of RFIs issued for CMNs during the 90-day period, providing all issues are resolved within 90 days of receipt of payment.

Abbreviations

NMA - New Medicine Application
INE - Initial Evaluation
RFI - Request for 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
EAI - Evaluation of additional information