EMA: Guideline on good pharmacovigilance practices: Module XV – Safety communication

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 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 and contributing to the protection of patients’ and public health.