XV.A. 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).

Safety communication is a broad term covering different types of information on medicines, including statutory information as contained in the product information (i.e. the summary of product characteristics (SmPC), package leaflet (PL) and the labelling of the packaging) and public assessment reports. Although some principles in this Module (i.e. XV.B.1. and XV.B.2.) apply to all types of safety communication, the Module itself focuses on the communication of ‘important new safety information’, which means new information about a previously known or unknown risk of a medicine which has or could have an impact on a medicine’s risk-benefit balance and its condition of use. Unless otherwise stated, the term ‘safety communication’ in this Module should be read as referring to new safety information.

Experience so far has demonstrated the need to coordinate safety communication within the EU regulatory network. High levels of public interest are anticipated when new safety concerns arise and it is important that clear and consistent messages are provided across the EU in a timely manner. The new legislation on pharmacovigilance therefore includes a number of provisions to strengthen safety communication and its coordination1 .

Communication of important new safety information on medicinal products should take into account the views and expectations of concerned parties, including patients and healthcare professionals, with due consideration given to relevant legislation.

Communication, which in this Module refers to the active dissemination of safety information for an intended audience, is distinct from transparency. Transparency aims to provide public access to information related to data assessment, decision-making and safety monitoring performed by competent authorities. The new EU legislation on pharmacovigilance envisages an unprecedented level of transparency. Transparency provisions applicable to each pharmacovigilance process are provided in the relevant GVP Modules.

XV.B. of this Module describes principles and means of safety communication. XV.C. provides guidance on the coordination and dissemination of safety communication within the EU network. Both sections give particular consideration to direct healthcare professional communications (DHPCs), and provide specific guidance for preparing them. This is because of the level of coordination required between marketing authorisation holders and competent authorities in their preparation. The same principles also apply to proactive communications by competent authorities.

Throughout this Module, legal obligations are referred to as stated in the GVP Introductory Cover Note and are usually identified by the modal verb ‘shall’ (e.g. ‘the marketing authorisation holder shall’). When guidance is provided on how to implement legal provisions, the modal verb ‘should’ is used (e.g. ‘the marketing authorisation holder should’).

In Section B, the term “competent authority” is to be understood in its generic meaning of an authority regulating medicinal products and/or an authority appointed at national level for being in charge of all or individual pharmacovigilance processes. The term “competent authority” covers the relevant competent authorities in the EU Member States and the Agency.