EMA GVP Module 15

Guideline on good pharmacovigilance practices (GVP) Module XV – Safety communication (Rev 1):

Introduction:

This Module provides guidance to marketing authorisation holders, competent authorities in Member States and the European Medicines Agency on how to communicate and coordinate safety information concerning medicinal products authorised in the EU. Communicating safety information to patients and healthcare professionals is a public health responsibility and is essential for achieving the objectives of pharmacovigilance in terms of promoting the rational, safe and effective use of medicines, preventing harm from adverse reactions, minimising risks and contributing to the protection of patients’ and public health (see GVP Module I).

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Table of contents

XV.A. Introduction

XV.B. Structures and processes

XV.B.1. Objectives of safety communication

XV.B.2. Principles of safety communication

XV.B.3. Target audiences

XV.B.4. Content of safety communication

XV.B.5. Means of safety communication

XV.B.5.1. Direct healthcare professional communication (DHPC)

XV.B.5.2. Communication materials from competent authorities targeted at healthcare professionals

XV.B.5.3. Documents in lay language to patients and the general public

XV.B.5.4. Press communication

XV.B.5.5. Website

XV.B.5.6. Social media and other online communications

XV.B.5.7. Bulletins and newsletters

XV.B.5.8. Inter-authority communication

XV.B.5.9. Responding to enquiries from the public

XV.B.5.10. Other means of communication

XV.B.6. Effectiveness of safety communication

XV.B.7. Quality system requirements for safety communication

XV.C. Operation of the EU regulatory network

XV.C.1. Coordination of safety announcements in the EU

XV.C.1.1. Process for exchange and coordination of safety announcements

XV.C.1.2. Exchange of safety information produced by third parties

XV.C.1.3. Requirements for the marketing authorisation holder in the EU

XV.C.1.4. Consideration for third parties

XV.C.1.5. Languages and translations

XV.C.2. Direct healthcare professional communications (DHPCs) in the EU

XV.C.2.1. Processing of DHPCs

XV.C.2.2. Translation and dissemination of DHPCs

XV.C.2.3. Publication of DHPCs 

Figure XV.1: Flow chart for the processing of Direct Healthcare Professional Communications (DHPCs) in the EU

GVP Annex II – Templates: Direct Healthcare Professional Communication

GVP Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication

EMA GVP Module 15: