The MHRA Licensing Division has implemented an improvement initiative for standard and complex national initial marketing authorisation applications.

The assessment report will be sent to the applicant with the request for further information at the initial assessment stage.

Following the applicant’s submission of responses, a new assessment report (containing the assessment of the responses only) will be sent to the applicant.

The aim of this initiative is to help applicants better understand the context and basis of the comments raised by assessors.

 

Posted on the UK MHRA website on 21 February 2014