The European Commission Directorate-General for Health and Food Safety has prepared Question and Answers document to address questions regarding 2019 requirements for Safety Features for Medicinal Products for Human Use per Articles 47a, 54(o), 54a of Directive 2001/83/EC and, and Commission Delegated Regulation (EU) No 2016/161
This document is Version 8.0 October 2017.
EU SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS VERSION 8
