Product/Application Search
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 | 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 | 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* | ** | |
| 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 |
*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.
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 applicable* | Not applicable |
| 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 days** | 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 |
*Second requests for information are unlikely to be required for these applications.
**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
Application Status Information
The application status used for NMAs and CMNs is the same. Once an application has been received and an invoice issued it will appear in the Product/Application search. While the invoice is awaiting payment the status column will indicate 'awaiting payment'.
Once payment has been received the application is assigned to an evaluator for initial evaluation. During this period the status column of the application in the application search will indicate 'initial evaluation'. The outcome of the initial evaluation may result in a Request for Information (RFI).
When an RFI is issued the status of the application will indicate 'information requested'.
When the response to the RFI is under evaluation the status of the application will indicate 'additional evaluation'.
Once evaluation of a CMN has been completed, and consent to sell and supply a changed medicine under section 24(3) of the Medicines Act 1981 has been made, the application status will indicate 'granted' with the date of consent alongside.
If any concerns with a CMN that have not been resolved within 90 days of receipt of payment, 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.
Once the evaluation of a NMA has been completed the product will 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 under evaluation at any one time.
Medsafe's Evaluation Policy for Priority and Abbreviated Assessments
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 being not available and there being no regulatory activity on it for more than five years, or where provisional consent has expired or where a sponsor has advised in writing that the product is no longer distributed in New Zealand.
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 and is actively marketed or is available upon request.
Consent refused: where a product has been refused consent under section 20 of the Medicines Act 1981.
Consent Revoked: where consent has been revoked under section 35(1)(a) of the Medicines Act 1981.
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 available: where a product has been granted consent but the company has advised in writing that they do not supply the product upon request or actively market it.
Pending: where an NMA is still under assessment.
Provisional consent: where provisional consent has been granted under section 23 of the Medicines Act 1981.
Notes:
- If approval has lapsed consent to the distribution of a new medicine needs to be granted before the product can be reintroduced onto the New Zealand market.
- If a product is not available, a CMN is required to reintroduce it into the market or a justification submitted in writing demonstrating that the regulatory file is current, prior to the registration situation being updated. CMNs or justifications must be submitted 90 days prior to commencing distribution.
- For prescription or restricted medicines a CMN must be submitted for evaluation that includes a revised data sheet to demonstrate that all required updates have been included. Self-assessable change notifications will not be accepted.