Revised: 24 September 2013

Medicines

Evaluation Timeframes

Indicative Processing Times for New Medicine Applications (NMAs) and Changed Medicine Notifications (CMNs)

Prescription Medicines

	Initial evaluation	Request for information #1 response time	Evaluation of additional information #1	Request for information #2 response time	Evaluation of additional information #2
NMAs (full evaluation)	To be completed by Medsafe within 200 calendar days	The applicant's response is required within 200 calendar days1	To be completed by Medsafe within 120 calendar days2	The applicant's response is required within 120 calendar days1	To be completed by Medsafe within 120 calendar days2
NMAs (abbreviated evaluation)	To be completed by Medsafe within 100 calendar days	The applicant's response is required within 200 calendar days1	To be completed by Medsafe within 120 calendar days2	The applicant's response is required within 120 calendar days1	To be completed by Medsafe within 120 calendar days2
CMNs	To be completed by Medsafe within 45 calendar days	The applicant's response is required within 21 calendar days	To be completed by Medsafe within 45 calendar days3	4
CMN 24(5)	To be completed by Medsafe within 200 calendar days	The applicant's response is required within 200 calendar days	To be completed by Medsafe within 120 calendar days	The applicant's response is required within 120 calendar days	To be completed by Medsafe within 120 calendar days

1. For NMAs that have been granted priority assessment the applicants response must be received by Medsafe within 28 days to retain priority assessment.
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 will evaluate the response within 28 days.
3. Please note that 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 during the 90 day period, as long as all issues are resolved within 90 days of receipt of payment.

Over-the-Counter (OTC) Medicines

	Initial evaluation	Request for information #1 response time	Evaluation of additional information #1	Request for information #2 response time	Evaluation of additional information #2
N1	To be completed by Medsafe within 30 calendar days	The applicant's response is required within 7 calendar days	To be completed by Medsafe within 7 calendar days	Not applicable5	Not applicable5
N3	To be completed by Medsafe within 60 calendar days	The applicant's response is required within 30 calendar days	To be completed by Medsafe within 30 calendar days	The applicant's response is required within 30 calendar days	To be completed by Medsafe within 30 calendar days
N4	To be completed by Medsafe within 90 calendar days	The applicant's response is required within 30 calendar days	To be completed by Medsafe within 30 calendar days	The applicant's response is required within 30 calendar days	To be completed by Medsafe within 30 calendar days
N5	To be completed by Medsafe within 120 calendar days	The applicant's response is required within 60 calendar days	To be completed by Medsafe within 60 calendar days	The applicant's response is required within 60 calendar days	To be completed by Medsafe within 60 calendar days
CMNs	To be completed by Medsafe within 21 calendar days	The applicant's response is required within 21 calendar days	To be completed by Medsafe within 21 calendar days6	The applicant's response is required within 10 calendar days	To be completed by Medsafe within 10 calendar days
CMN 24(5)	To be completed by Medsafe within 120 calendar days	The applicant's response is required within 60 calendar days	To be completed by Medsafe within 60 calendar days	The applicant's response is required within 60 calendar days	To be completed by Medsafe within 60 calendar days

5. Second requests for information are unlikely to be required for these applications.
6. Please note that 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.

Note: Category N2 is not currently applicable in New Zealand. This category of NMA may be implemented in New Zealand following trial in Australia