21 February 2012

EMA: Pre-authorization procedural advice for users of the centralized procedure (Question & Answers Document)

This document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are typically addressed during the course of pre-submission meetings.

This guidance information and fruitful pre-submission meetings should enable applicants to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated speedily. Pre-submission meetings will also enable applicants to establish contact with the EMA staff closely involved with the application as it proceeds.

Questions and answers are being updated continuously in this document, and will be marked by “NEW” or “Rev.” with the relevant date upon publication. 

To find the document please use the below mentioned EMA weblink

No comments:

Post a Comment