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Guidelines and Codes

Update to Section 5.7:
Processing times for Applications and Notifications

Added to web site: July 2006

Medsafe has made changes to new medicine application processing times and the evaluation process. These changes reflect industry comment and a continuation of Medsafe’s desire to progress applications that have been pending for sometime.

1. For new medicine applications received after 21st of August 2006:
   • the initial evaluation will be completed with 135 working days, or less.
2. For all new medicine applications:
   • During evaluation, where an application is found to be incomplete, the evaluation process will stop immediately. The evaluator will notify the applicant of the deficiency and if the applicant cannot provide the missing information within 10 working days, the applicant will be invited to withdraw the application or it will be rejected.
   • Where a Request for Further Information (RFI) resulting from an initial evaluation is made, the applicant has a maximum of 135 working days to provide a complete response to this letter. If a complete response is not received within this time the application may be declined.
   • The applicant’s RFI response will be evaluated within 90 working days or less, following receipt by Medsafe.
   • If an additional RFI letter is required the applicant has a maximum of 90 working days to provide a complete response to this second letter. If a complete response is not received within this time the application may be declined.
   • The applicant’s second RFI response will be evaluated within 90 working days, during which time Medsafe will make a decision to accept, or decline the new medicine application.
3. Where an RFI response is received from the applicant within 15 working days of the request being sent, this response will be prioritised for assessment.
4. The sponsor of any application which has not reached the standard required for approval within 5 years of the date of receipt of the application, will be invited to withdraw the application. If the application is not withdrawn within 10 working days, it may be declined.
5. Once the evaluation of a new medicine application has commenced applicants will not be allowed to make substantial changes to registration details, unless requested to do so by the evaluator.

These changes in policy will take effect from August 14th 2006.