Revised: 27 May 2013

Medicines

Application Status

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.