REGULATORY INFORMATION

Product/Application Search

	Product search. Allows you to search for any product that has been given consent to market in New Zealand.
	Application search. Coloured fields apply only to the Application search Allows you to search for New Medicine Applications submitted to Medsafe since 1^st January 2006.
	For Ingredient, Trade name and Sponsor you only need to enter the first few letters of the name. Use % for a wild card.
Ingredient:
Trade name:
Sponsor:
Classification:
Date from:		Date to:	(use format 31 Dec 1999)
Type:
Status:

Notice of Medsafe Office Closure Christmas/New Year 2009/2010

This year Medsafe will close for the Christmas/New Year break at 5.00 pm on Thursday 24 December 2009 and will re-open on Tuesday 5 January 2010.

In the case of an emergency during this period please call 04 819 6800 and leave a message. Messages will be cleared daily.

To ensure that applications can be invoiced and paid before Christmas, applications will need to be received at Medsafe by Wednesday 16 December 2009.

Evaluation Queue Information

In response to requests from industry, Medsafe is now publishing a monthly update to assist companies to assess the anticipated time before their applications are likely to be referred to an evaluator for the initial evaluation phase of the evaluation process.

The update comprises the "date received" for applications currently being assigned to evaluators in each of the evaluation work streams for high-risk and intermediate-risk medicines as shown in the table below.

Please note that the progress of applications from the point of assignment 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 initial evaluation reports may not be issued in chronological order.

Medsafe asks that companies do not seek more specific information concerning queue status. Researching these queries takes evaluators away from their technical assessments.

Current evaluation queue status as at: 26th March 2009

Application type	Applications being assigned to evaluators were received on:
High-risk medicine applications received after 21/08/2006.	December 2008
Intermediate-Risk medicine applications received after 21/08/2006	October 2008

Application queries of a technical nature should be referred to either Kathy Daly (Team Leader, OTC Medicines), or Antony Fake (Team Leader, Prescription Medicines).