1. Introduction

(This section is organised in the form of a book, please follow the blue arrows to navigate through the book or by following the navigation panel on the right side of the page.)

The European Medicines Agency (EMA) and European Union (EU) member states regulatory authorities share the responsibility to communicate safety information on medicinal products after their marketing authorisation to patients and healthcare professionals. As healthcare professionals play an essential role in disseminating safety information, direct healthcare professional communication (DHPC) is the primary way of communicating ‘new or emerging safety information’.