EMA 药品安全特性问答-第17版.pdf

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems and products Medical products – quality, safety and innovation SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS - VERSION 17 1 (Submitted for discussion to the Member State expert group on the safety features ) Document history: Date of submission of draft to the Member State February 2020 expert group on the safety features : Date of publication: 9 March 2020 Supersedes: Version 16 Changes compared to superseded version : New QAs: 5.11 Revised QAs: 1.22 Important disclaimer: The views expressed in this questions and answers document are not a formal interpretation of Union law, nor are legally binding. Ultimately, only the European Court of Justice can give an authoritative interpretation of Union law. This document aims at informing on the technical aspects of Commission Delegated Regulation (EU) 2016/161 with a view to facilitating its implementation. This documents sets out frequently-asked questions and answers regarding the implementation of the rules on the safety features for medicinal products for human use. These rules are enshrined in Articles 47a, 54(o) and 54a of Directive 2001/83/EC, and in 2 Commission Delegated Regulation (EU) 2016/ 161 . This document is only available in English. 1 http://