Product/Application Search
Evaluation Timeframes
Indicative Processing Times for NMAs and CMNs
| Initial evaluation | RFI #1 response time | Evaluation of additional information 1 | RFI #2 response time | Evaluation of additional information 2 | |
|---|---|---|---|---|---|
| NMAs | 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 |
| CMNs (not CMN 24.5) |
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 days* | ** |
*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.
**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.
Processing Times for NMAs
Medsafe's target is to complete the initial evaluation of all New Medicine Applications (NMAs) within 200 calendar days of the receipt of payment. During this period the status column of the application in the application search will indicate 'initial evaluation'. The outcome of the initial evaluation usually results in a Request for Information (RFI).
Applicants are given 200 calendar days to submit their response to an RFI. During this period, the status of the application will indicate 'information requested'.
The evaluation of the response to any RFI will be completed within 120 calendar days of receipt. During the evaluation of the response to an RFI, the status of the application will indicate 'additional evaluation'.
Once the evaluation has been finalised and the product has either been forwarded for the gazettal process or referred for the next MAAC meeting, the status of the application will indicate 'evaluation complete' or 'referral to MAAC'. Once the product has been gazetted, the status will read 'granted' with the date of gazettal underneath.
When applications accepted for priority assessment are allocated to an evaluator, it is assigned as their next piece of work to be completed. The evaluation of responses to RFIs for priority assessments are treated the same way. The time taken to complete the evaluation depends on the complexity of the dossier, the quality of the dossier, and the total number of priority assessments received during any particular month.
Medsafe’s Evaluation Policy for Priority and Abbreviated Assessments
Processing Times for CMNs
The initial evaluation of all Changed Medicine Notifications (CMNs) will be completed within 45 calendar days of the receipt of payment. During this period the status column of the application will indicate 'initial evaluation'.
Applicants are given 21 calendar days to submit their response to an RFI. During this period, the application status will be 'Information requested'.
Medsafe will complete the evaluation of the response to an RFI for a CMN within 45 calendar days. During this period the application status will read 'additional evaluation'.
If any concerns with the CMN that have not been resolved within 90 days, the application will be referred under section 24 (5) (b) of the Medicines Act 1981 to undergo evaluation according to the NMA timeframes. This referral of the CMN under section 24 (5) (b) will occur regardless of whether the resolution of issues identified resides with Medsafe or the applicant.
Evaluation Queue Information
Please note that the progress of applications from the time they are assigned to an evaluator will depend on a number of factors, such as the number and complexity of applications with a common application date. Please remember that the workload of individual evaluators does vary so it is possible that the evaluation reports may not be reviewed and issued in chronological order.
Although the timelines referred to above indicate Medsafe's intended timeframes, occasionally an application may exceed the target time due to its complexity, and/or need to solicit independent expert advice.
Medsafe requests that companies do not seek more specific information concerning queue status as researching these queries takes evaluators away from their technical assessments.
Registration Situation
The regulatory status of the medicinal product is detailed in the Registration Situation and has the following meanings:
Approval lapsed: where consent has lapsed due to a product not being marketed and there being no regulatory activity on it for more than five years, or where provisional consent has expired.
Clinical trial: where a product is for clinical trial only.
Consent given: where a product has been granted consent to market in New Zealand under section 20 of the Medicines Act 1981.
Consent refused: where a product has been refused consent under section 20 of the Medicines Act 1981.
Discontinued: where a product has been granted consent but the sponsor has advised in writing that they do not intend to market the product any longer and do not envisage reintroducing the product to the market.
Excluded product: where a product is declared by regulation 58A of the Medicines Regulations 1984 not to be a medicine or related product.
Export only: where a product is for export only and is not to be marketed in New Zealand.
File closed: where a product has been rationalized. This may mean that some of the previous product history is on another file.
Never approved: where an application is still pending but it is no longer possible to contact the applicant to either obtain additional information or confirmation of withdrawal.
NMA withdrawn: where the applicant has advised in writing that they no longer want to proceed with the application.
Not marketed: where a product has been granted consent but the company has advised in writing that they do not intend to market the product at this stage.
Pending: where an NMA is still under assessment.
Provisional consent: where provisional consent has been granted under section 23 of the Medicines Act 1981.
Consent Revoked: where consent has been revoked under section 35(1)(a) of the Medicines Act 1981.
Note: If a product has been discontinued or approval lapsed consent to the distribution of a new medicine needs to be granted before the product can be reintroduced onto the New Zealand market.