The Revised Notice to Applicants on EU Marketing Authorisation Procedures

摘要

The European Commission recently issued a revised version of chapter I1 of the notice to applicants, which provides viewpoints and explanations related to marketing authorisations granted in accordance with the revised EU pharmaceutical legislation2'3. As has been widely reported, this legislation has now entered in force. This document was therefore eagerly awaited, as clarifications were needed with respect to changes introduced by the new legislation. The aim of this paper is to describe briefly some of the key points included in or deriving from the revised chapter. Other chapters of the notice to applicants have also been revised; this article does not aim to cover them. It also does not include a comprehensive analysis of the changes relating to data exclusivity.