Monitoring safety of medicines for patients : pharmacovigilance activities related to medicines for human use in the EU

This report describes the activities of the networked and collaborative system for monitoring and controlling the safety of human medicines in the EU over a period covering three years following the start of operation of new European legislation designed to improve that system. While the legislation foresees different timelines for reports on tasks of the Member State and of the EMA, reporting on the EMA tasks has been brought forward for this report in order to allow a joined-up overview of the tasks of the EU network. This report specifically includes quantitative data gathered over the period from July 2012 to December 2014 (the data lock point), but includes information on some relevant tasks and processes over the whole 3-year period up to July 2015. The body of the report gives a summary of the activities with technical data provided in full in annexes. It contains a high-level description of the EU pharmacovigilance system (the system for monitoring and maintaining the safety of medicines in Europe), the roles of various parties within that system, key activities undertaken by the system during the reporting period, discussion of the co-operation between various stakeholders and interested parties, and consideration of the ways in which the system is being developed and adapted for future improvement.